2022 台灣版高血脂治療指引-針對心血管疾病高風險族群 8.Ischemic stroke/TIA 其他非STATIN降LDL藥物

2025-12-09 14:10

2022 focused update of the 2017 Taiwanlipid guidelines for high risk patients:Coronary artery disease, peripheral arterydisease and ischemic stroke

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除他汀類藥物以外的其他降低低密度脂蛋白膽固醇（LDL-C）的藥物

一項包含 6 項隨機臨床試驗的統合分析表明，與他汀類藥物單藥治療相比，依折麥布聯合他汀類藥物治療可降低非致命性中風的風險（風險比 [RR] 0.83，95% CI 0.71e0.97）。 42TST 試驗顯示，在 LDL-C < 70 mg/dL 的強化 LDL-C 降低組中，41% 的患者接受了依折麥布聯合治療；而在LDL-C介於90至110 mg/dL的患者組中，僅有7%的患者接受了依折麥布治療。 IMPROVE-IT試驗也顯示，與單獨使用辛伐他汀相比，依折麥布合併辛伐他汀可降低ACS合併既往中風史患者發生任何病因中風（HR 0.60，95% CI 0.38-0.95）和缺血性中風（HR 0.52，95% CI 0.0.6%）的風險。 在IMPROVE-IT試驗中，LDL-C < 30 mg/dL的患者與LDL-C ≥ 70 mg/dL的患者相比，出血性中風的風險並未增加。 PCSK9抑制劑也證實了其在預防中風方面的療效。在 FOURIER 試驗中，使用 evolocumab 治療穩定的 ASCVD 患者，與他汀類藥物單藥治療相比，evolocumab 聯合他汀類藥物顯著降低了所有卒中（HR 0.79，95% CI，0.66e0.95）和缺血性卒中（HR 0.75，95% CI 20.95% CI 20.909）。 45 出血性中風方面沒有顯著差異（HR 1.16，95% CI 0.68e1.98）。在有無既往缺血性中風的各組中，此效應均一致。 45 在 ODYSSEY OUTCOMES 試驗中，使用阿利西尤單抗治療近期發生 ACS 的患者，阿利西尤單抗降低了任何中風的風險（HR 0.72，95% CI 0.57-0.91）和缺血性中風的風險（HR 0.73，95% CI 0.577.5757）。 46 出血性中風的風險並未增加（HR 0.83，95% CI 0.42-1.65）。同樣，阿利西尤單抗對卒中的影響在有卒中史和無卒中史的患者中相似。一項包含39篇隨機對照試驗的統合分析顯示，PCSK9抑制劑（阿利西尤單抗或依洛尤單抗）與他汀類藥物合併治療可降低缺血性中風的風險（RR 0.78，95% CI 0.67-0.89）。 ⁴⁷

推薦

對於患有缺血性中風或 TIA 以及腦動脈粥樣硬化性狹窄或已知 CAD 的患者，將他汀類藥物與依折麥布聯合使用以達到 LDL-C < 70 mg/dL 是合理的（COR IIa，LOE B）。

對於患有缺血性中風或 TIA 以及腦動脈粥樣硬化性狹窄或已知 CAD 的患者，如果在聯合使用最大耐受劑量的他汀類藥物和依折麥布的情況下 LDL-C > 70 mg/dL，則添加 PCSK9 抑製劑是合理的（LOR IIa，LOE B）。

LDL-C lowering agents other than statins

A meta-analysis of 6 randomized clinical trials suggested that ezetimibe added to statins compared to statins monotherapy was associated with a lower risk of nonfatal stroke (risk ratio [RR] 0.83, 95% CI 0.71e0.97).42The TST trial showed that 41% of patients assigned to the intensive LDL-C lowering group with LDL-C < 70 mg/dL received ezetimibe combination therapy; whereas only 7% of patients received ezetimibe in the group with LDL-C between 90 and 110 mg/dL.4 The IMPROVE-IT trial also showed that combined ezetimibe with simvastatin compared with simvastatin alone reduced the risk of stroke of any etiology (HR 0.60, 95% CI 0.38e0.95) and ischemic stroke (HR, 0.52, 95% CI, 0.31e0.86) among patients with ACS and a prior history of stroke.43 In the IMPROVE-IT trial, the risk of hemorrhagic stroke was not increased in patients with LDLC < 30 mg/dL compared to those with LDL-C 70 mg/dL.44 PCSK9 inhibitors also demonstrated their efficacy in preventing stroke. In the FOURIER trial using evolocumab for stable ASCVD patients, evolocumab plus statin significantly reduced all stroke (HR 0.79, 95% CI, 0.66e0.95) and ischemic stroke (HR 0.75, 95% CI 0.62e0.92) compared with statin monotherapy.45 There was no significant difference in hemorrhagic stroke (HR 1.16, 95% CI 0.68e1.98). The effect was consistent across among the groups with and without prior ischemic stroke.45 In the ODYSSEY OUTCOMES trial using alirocumab for patients with recent ACS, alirocumab reduced the risk of any stroke (HR 0.72, 95% CI 0.57e0.91) and ischemic stroke (HR, 0.73, 95% CI, 0.57e0.93).46 There was no increased risk of hemorrhagic stroke (HR 0.83, 95% CI 0.42e1.65). Similarly, the effect of alirocumab on stroke was similar between patients with and without a history of previous stroke.46 A meta-analysis of 39 randomized controlled trials showed that combination therapy of PCSK9 inhibitors (alirocumab or evolocumab) with statins were associated with a reduced risk of ischemic stroke (RR 0.78, 95% CI 0.67e0.89).47

Recommendation

In patients with ischemic stroke or TIA and cerebral or carotid atherosclerotic stenosis or known CAD, it is reasonable to combine statin with ezetimibe to achieve LDL-C < 70 mg/dL (COR IIa, LOE B).

In patients with ischemic stroke or TIA and cerebral or carotid atherosclerotic stenosis or known CAD, adding a PCSK9 inhibitor is reasonable if LDL-C > 70 mg/dL under combined maximally tolerated statins plus ezetimibe (LOR IIa, LOE B).

2022 台灣版高血脂治療指引-針對心血管疾病高風險族群 7.Ischemic stroke/TIA LDL-C target

2025-12-09 14:10

2022 focused update of the 2017 Taiwanlipid guidelines for high risk patients:Coronary artery disease, peripheral arterydisease and ischemic stroke

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LDL-C 目標

一項包含24項隨機對照試驗的統合分析表明，他汀類藥物的使用與既往無卒中史人群卒中風險降低有關。低密度脂蛋白膽固醇（LDL-C）每降低10%，中風風險降低7.5%；LDL-C每降低1 mmol/L（39 mg/dL），中風風險可降低15%至21%。 ^35,36 在SPARCL試驗中，4731例先前有非心臟中風或6個月內發生短暫性腦缺血發作（TIA）病史的患者被隨機分配接受阿托伐他汀80 mg/天或安慰劑治療。研究發現，在4.9年的追蹤期間，接受阿托伐他汀治療的患者中風復發率較低（HR 0.84，95% CI 0.71-0.99）。阿托伐他汀組和安慰劑組的平均 LDL-C 水準分別為 73 mg/dL 和 129 mg/dL。 37 最近發表的「治療中風至目標」（Treat Stroke to Target，TST）試驗隨機將 2860 名有 3 個月內缺血性中風史或 15 天內短暫性腦缺血發作史的患者分配到兩個 LDL-C 治療目標組：< 70 mg/dL 和 90-110 mg/dL。 4 為入組此試驗，患者必須有記錄在案的動脈粥狀硬化性疾病，包括顱外或顱內腦動脈狹窄、主動脈弓動脈粥樣硬化斑塊厚度至少為 4 mm，或有冠狀動脈疾病史。在3.5年的追蹤期間，LDL-C < 70 mg/dL組患者發生主要心血管事件的風險低於LDL-C 90~110 mg/dL組（HR 0.78，95% CI 0.61~0.98）。兩組患者的平均LDL-C水準分別為65 mg/dL和96 mg/dL。 ⁴ 出血性中風或新發生糖尿病的風險未顯著增加。在接受強化LDL-C降低治療的患者中，24%接受了高強度他汀類藥物治療，76%接受了中等強度他汀類藥物治療，41%接受了他汀類藥物/依折麥布合併治療。 TST試驗納入了來自法國和韓國的受試者。整體主要終點結果為陽性，且未發現顯著的治療與國家/地區交互作用。然而，韓國隊列亞組分析中未觀察到顯著療效的結果，仍令人擔憂TST試驗的結果可能無法推廣至韓國或亞洲患者。儘管如此，在TST試驗的2860名研究參與者中，2,148名（75.1%）來自法國，而僅有712名（24.9%）來自韓國。此外，法國的中位追蹤時間也遠長於韓國（5.3年 vs. 2.0年）。這些因素可能導致韓國隊列缺乏足夠的統計效力來檢測顯著療效。香港最近一項針對 904 名中國缺血性中風患者的前瞻性隊列研究表明，事件後平均 LDL-C < 70 mg/dL 的患者，在平均 6.5 年的隨訪後，與 LDL-C > 70 mg/dL 的患者相比，發生重大心血管事件的風險較低。 38 平均 LDL-C < 70 mg/dL 也與嚴重大動脈疾病的患者發生腦出血的風險較低有關。38 SPARCL 試驗表明，與安慰劑相比，每天服用 80 毫克阿托伐他汀治療的患者發生出血性中風的風險增加（HR 1.68，95% CI 1.09e2.59）。然而，SPARCL試驗的事後分析表明，出血性中風風險增加與基線血壓升高（收縮壓>160 mmHg或舒張壓>100 mmHg）和出血性中風相關，但與低密度脂蛋白膽固醇（LDL-C）水平無關。 ³⁹一項包含31篇隨機對照試驗的統合分析顯示，他汀類藥物的使用與顱內出血風險增加無關（HR 1.08，95% CI 0.88-1.32）。 ⁴⁰丹麥一項全國性研究表明，與不使用他汀類藥物相比，使用他汀類藥物不會增加基線時存在顱內出血患者的複發性顱內出血風險，並且與基線時存在缺血性卒中患者的顱內出血風險降低相關。 ⁴¹建議：對於缺血性中風或短暫性腦缺血發作（TIA）且伴隨腦或頸動脈粥狀硬化性狹窄的患者，應考慮使用他汀類藥物。對於已知患有冠狀動脈疾病 (CAD) 的患者，將低密度脂蛋白膽固醇 (LDL-C) 控制在 < 70 mg/dL 以降低重大心血管事件的風險是合理的（COR IIa，LOE B）。

LDL-C target

A meta-analysis of 24 randomized controlled trials suggests that statin use is associated with a reduced stroke risk in people without a prior stroke. Every 10% decrease of LDL-C is associated with 7.5% stroke risk reduction and every 1 mmol/ L (39 mg/dL) LDL-C reduction can decrease the risk of stroke by 15%e21%.35,36 In the SPARCL trial, 4731 patients with a history of non-cardioembolic stroke or TIA within 6 months were randomly assigned to receive either atorvastatin 80 mg/day or placebo. The study found that patients received atorvastatin had a lower recurrent stroke during 4.9 years follow up (HR 0.84, 95% CI 0.71e0.99). The average LDL-C levels were 73 mg/dL and 129 mg/dL in atorvastatin and placebo groups, respectively.37 The recently published Treat Stroke to Target (TST) trial randomly assigned 2860 patients with a history of ischemic stroke within 3 months or TIA within 15 days to two LDL-C treatment goals, < 70 mg/dL vs. 90e110 mg/dL.4 To be enrolled in the trial, patients had to have documented atherosclerotic diseases, including stenosis of an extracranial or intracranial cerebral artery, atherosclerotic plaques of the aortic arch measuring at least 4 mm in thickness, or a known history of CAD. During 3.5 years of follow-up, patients in the LDL-C < 70 mg/dL group had a lower risk of major cardiovascular events (HR 0.78, 95% CI 0.61e0.98) compared to those in the 90e110 mg/dL group. The average achieved LDL-C levels were 65 mg/dL and 96 mg/dL in the 2 groups, respectively.4 There was no significantly increased risk of hemorrhagic stroke or newonset diabetes. For patients assigned to the intensive LDLC lowering group, 24% received high-intensity statin, 76% received moderate-intensity statin, and 41% received statin/ ezetimibe combination therapy. The TST trial contains subjects from France and South Korea. The overall primary endpoint is positive and there is no significant treatment-bycountry interaction. However, the neutral outcomes in the subgroup analysis of Korean cohort still raise the concern that the results of TST trial may not be generalizable to Korean or Asian patients. Nevertheless, among the 2860 study participants in TST trial, there were 2148 (75.1%) from France and only 712 (24.9%) from South Korea. The median follow-up time was also much longer in France (5.3 years versus 2.0 years). These factors potentially caused a lack of power to detect a significant effect in Korean cohort. A recent prospective cohort study from Hong Kong with 904 Chinese ischemic stroke patients showed that patients with a mean post-event LDL-C < 70 mg/dL were associated with a lower risk of major cardiovascular events compared to those with LDL-C > 70 mg/dL after a mean follow up of 6.5 years.38 A mean LDL-C < 70 mg/dL was also associated with a lower risk of intracerebral hemorrhage in patients with significant large artery diseases.38 The SPARCL trial showed that patients treated with atorvastatin 80 mg/day were associated with an increased risk of hemorrhagic stroke (HR 1.68, 95% CI 1.09e2.59) compared with the placebo. However, post hoc analysis of the SPARCL trial showed that the increased risk of hemorrhagic stroke was associated with increased blood pressure (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) and hemorrhagic stroke at baseline, but not the LDL-C levels.39 A meta-analysis including 31 randomized controlled trials showed that statin use was not associated with an increased risk of intracranial hemorrhage (HR 1.08, 95% CI 0.88e1.32).40 A nationwide study conducted in Denmark suggested that stain use compared with no statin use was not associated with an increased risk of recurrent intracerebral hemorrhage in patients with intracerebral hemorrhage at baseline and was associated with a lower risk of intracerebral hemorrhage in patients with ischemic stroke at baseline.41 Recommendation In patients with ischemic stroke or TIA and cerebral or carotid atherosclerotic stenosis or known CAD, it is reasonable to control LDL-C target < 70 mg/dL to reduce the risk of major cardiovascular events (COR IIa, LOE B).

2022 台灣版高血脂治療指引-針對心血管疾病高風險族群 6. Ischemic stroke/TIA -STATIN

2025-12-09 14:10

2022 focused update of the 2017 Taiwanlipid guidelines for high risk patients:Coronary artery disease, peripheral arterydisease and ischemic stroke

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缺血性中風/短暫性腦缺血發作

他汀類藥物用於急性中風

根據台灣中風登記處2006年至2008年間30,599例中風入院病例的數據，台灣絕大多數中風事件（>70%）為缺血性中風。在缺血性中風或短暫性腦缺血發作（TIA）患者中，高血壓（79.2%）和血脂異常（49.4%）是兩個最常見的危險因子。 ²⁹ 多項大型臨床研究探討了入院期間他汀類藥物治療對中風患者的影響。一項研究分析了2000年1月至2007年12月期間加州一家大型綜合醫療保健系統中12,689例缺血性中風入院患者的病歷。 ³¹ 研究發現，入院前和住院期間使用他汀類藥物與較高的存活率有關。相反，在住院期間停用他汀類藥物的患者死亡風險更高。住院期間使用較高劑量和更早開始使用他汀類藥物的益處更大。同樣，台灣中風登記處和GWTG中風登記處也顯示，在急性缺血性中風患者住院期間早期開始他汀類藥物治療具有有益效果。 31,32 此外，一項隨機臨床試驗招募了215名在缺血性中風後24小時內入院的患者和89名在中風前服用他汀類藥物的患者，並將他們進一步隨機分配到入院後前3天停用他汀類藥物組（n=46）或立即恢復服用阿托伐他汀20毫克/天組（n=43）。結果顯示，停用他汀類藥物的患者在3個月時功能預後不良的發生率較高，最終梗塞體積較大，且急性期早期神經功能惡化的風險較高。 ³³ 統合分析的結果進一步支持了住院期間早期啟動他汀類藥物治療，以及入院後不停用中風前服用的他汀類藥物的理念。 ³⁴ 此統合分析研究也表明，在接受溶栓治療的患者中，中風前服用他汀類藥物與良好的功能預後相關，儘管症狀性出血性轉化的風險增加。

推薦

對於急性缺血性中風或 TIA 且 LDLC 為 100 mg/dL 的患者，建議處方他汀類藥物（COR I，LOE A）。

對於在中風前已服用他汀類藥物的患者，在因急性缺血性中風或 TIA 入院後繼續服用他汀類藥物是合理的（COR IIa，LOE B）。

Ischemic stroke/TIA

Statins in acute stroke

According to the data from Taiwan Stroke Registry with 30,599 stroke admissions between 2006 and 2008, the majority of stroke events (>70%) were ischemic in Taiwan. Among patients with ischemic stroke or TIA, hypertension (79.2%) and dyslipidemia (49.4%) were the two most prevalent risk factors.29 Several large-scale clinical studies investigated the effect of statin treatment in stroke patients during admission. One study analyzed medical records from 12,689 patients admitted with ischemic stroke from a large integrated healthcare delivery system in California between January 2000 and December 2007.30 Statin used before and during hospitalization was associated with a better survival rate. On the contrary, patients who underwent statin withdrawal in the hospital had a greater risk of death. The benefit was greater for higher statin dose and earlier initiation during stroke admission. Similarly, the beneficial effects of early initiation of statin therapy during hospitalization in patients with acute ischemic stroke were also shown in the Taiwan Stroke Registry and GWTG-Stroke Registry.31,32 Moreover, one randomized clinical trial recruiting 215 patients admitted within 24 h of ischemic stroke and 89 patients having statins before stroke were further assigned either to statin withdrawal for the first 3 days after admission (n Z 46) or to immediately resumed atorvastatin 20 mg/day (n Z 43). The results showed that patients with statin withdrawal had a higher frequency of poor functional outcome at 3 months, greater final infarct volume and higher risk of early neurological deterioration at acute stage.33 The concept of early initiation of statin during hospitalization and do not withdrawal pre-stroke statin after admission was further supported by results of meta-analysis.34 The meta-analysis study also showed that in patients treated with thrombolytic agents, pre-stroke statin was associated with good functional outcome, despite an increased risk of symptomatic hemorrhagic transformation.

Recommendation

In patients with acute ischemic stroke or TIA and LDLC 100 mg/dL, it is indicated to prescribe statins (COR I, LOE A).

It is reasonable to continue statins after admission for acute ischemic stroke or TIA in patients who have already received statins before the stroke (COR IIa, LOE B).

2022 台灣版高血脂治療指引-針對心血管疾病高風險族群 5 PAD-New PCSK9 inhibitor data

2025-12-09 14:10

2022 focused update of the 2017 Taiwanlipid guidelines for high risk patients:Coronary artery disease, peripheral arterydisease and ischemic stroke

下面中文使用google自動翻譯

PCSK9抑制劑新數據

在使用依洛尤單抗治療 ASCVD 的 FOURIER 試驗中，入組時有 3642 名受試者（佔總參與者的 13.2%）患有 PAD，其中包括有既往外周血管重建史、因血管原因截肢史和/或踝臂指數 <0.85 且有間歇性跛行症狀的患者。 10 48 週時，接受依洛尤單抗合併他汀類藥物治療的 PAD 組患者的 LDL-C 中位數為 31 mg/dL（四分位數間距為 19-49 mg/dL）。 FOURIER試驗中周邊動脈疾病（PAD）患者的結局分析顯示，在2.5年的追蹤期內，依洛尤單抗合併他汀類藥物治療可顯著降低主要終點事件的發生率，此主要終點事件包括心血管死亡、心肌梗塞、中風、不穩定型心絞痛住院或冠狀動脈血運重建，降低幅度達21%（ 0.66-0.94）。 ¹⁰ 此外，依洛尤單抗合併他汀類藥物治療的PAD患者發生主要肢體不良事件的風險也顯著降低，此主要不良肢體事件包括急性肢體缺血、截肢或緊急血管重建（HR 0.58，95% CI 0.38-0.88）。此分析結果為積極降低PAD患者的低密度脂蛋白膽固醇（LDL-C）水平提供了臨床效益的證據。

推薦

對於有症狀的外周動脈疾病（PAD）患者，低密度脂蛋白膽固醇（LDL-C）目標值為<70 mg/dL，包括：(1)既往有外周動脈血運重建史；(2)既往因動脈粥樣硬化性疾病導致肢體缺血而截肢；(3)臨床表現為PAD，且影像學檢查證實外周動脈狹窄>50%（證據I，等級。對於合併冠狀動脈疾病（CAD）或頸動脈狹窄的有症狀PAD患者，可考慮將LDL-C目標值設定為<55 mg/dL（證據等級IIa，證據等級B）。

New PCSK9 inhibitor data

In the FOURIER trial using evolocumab for ASCVD, there were 3642 subjects (13.2% of total participants) had PAD at enrollment, including those with a history of prior peripheral revascularization, a history of amputation for vascular cause, and/or had an ankle brachial index <0.85 with symptoms of claudication.10 At 48 weeks, the median LDL-C level among the PAD group was 31 mg/dL (interquartile range, 19e49 mg/dL) with evolocumab plus statin therapy. The outcome analysis of PAD patients in the FOURIER trial showed that add-on evolocumab to statin significantly reduced the incidence of primary endpoint which was a composite of cardiovascular death, MI, stroke, hospitalization for unstable angina or coronary revascularization by 21% (hazard ratio [HR] 0.79; 95% confidence interval [CI] 0.66e0.94) in a follow-up of 2.5 years.10 Moreover, PAD patients with evolocumab plus statin had significantly lower risk of major adverse limb events which was a composite of acute limb ischemia, major amputation or urgent revascularization (HR 0.58, 95% CI 0.38e0.88). The results of the analysis provided evidence supporting the clinical benefit of aggressive LDLC reduction in patients with PAD.

Recommendation

The LDL-C target is < 70 mg/dL in patients with symptomatic PAD including (1) history of peripheral artery revascularization, (2) history of amputation for ischemic limb due to atherosclerotic disease and (3) clinical symptoms of PAD with > 50% stenosis of peripheral arteries confirmed by imaging studies (COR I, LOE B). In symptomatic PAD with CAD or carotid stenosis, a lower target of LDL-C < 55 mg/dL may be considered (COR IIa, LOE B).

2022 台灣版高血脂治療指引-針對心血管疾病高風險族群 4 PAD-LDL控制目標

2025-12-09 14:10

2022 focused update of the 2017 Taiwanlipid guidelines for high risk patients:Coronary artery disease, peripheral arterydisease and ischemic stroke

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LDL-C 目標

週邊動脈疾病（PAD）是全身性動脈粥狀硬化的臨床表現。由於動脈粥狀硬化導致下肢動脈狹窄，造成供血不足，進而引起PAD的臨床症狀，包括間歇性跛行、缺血性潰瘍、急性或危重肢體缺血。 ^15,16 PAD患者發生心肌梗塞、缺血性中風和心血管死亡的風險更高。 ^17,18 事實上，PAD患者的心血管事件風險甚至高於冠狀動脈疾病（CAD）患者。 ¹⁹ 由於動脈粥狀硬化是PAD發病機制的主要因素，且其心血管風險較高，因此對PAD患者更積極地治療低密度脂蛋白膽固醇（LDL-C）水平是合理的。一項名為「心臟保護研究」的隨機對照試驗，旨在研究辛伐他汀降低低密度脂蛋白膽固醇（LDL-C）的療效，結果顯示，在接受每日40毫克辛伐他汀治療的外周動脈疾病（PAD）患者中，5年隨訪期間血管事件發生率較安慰劑組降低了22%。 ²⁰ 一項統合分析報告稱，他汀類藥物降低PAD患者的LDL-C水平與全因死亡率降低、非致命性中風發生率降低以及心肌梗塞風險降低的趨勢有關。 ²¹ 降血脂治療降低LDL-C水平還能緩解臨床症狀，提高運動耐力，減緩PAD患者動脈粥狀硬化斑塊的進展。 ^22-24 在斯堪的納維亞辛伐他汀存活研究的事後分析中，接受辛伐他汀治療的患者在5.4年的中位追蹤期內，間歇性跛行發生率較安慰劑組降低了38%。 ²⁵ West等人有研究通報，辛伐他汀合併或不合併依折麥布降低低密度脂蛋白膽固醇（LDL-C）水準可延緩週邊動脈疾病（PAD）病患股淺動脈粥狀硬化斑塊的進展²⁴。基於科學證據，大多數最新指南將PAD歸類為高風險或極高風險，並建議將LDL-C水平控制在<70或55 mg/dL^6,14,26,27。一項韓國回顧性隊列研究評估了LDL-C對接受血管內治療的PAD患者臨床結果的影響²⁸。研究發現，在中位追蹤4.8個月期間，LDL-C<70 mg/dL的患者發生主要不良心血管事件（MACE，包括全因死亡、非致死性心肌梗塞和中風）的風險低於LDL-C≥70 mg/dL的患者。此結果表明，對於亞洲PAD患者而言，將LDL-C控制在<70 mg/dL的目標值也十分重要。大多數指引和臨床研究對症狀性週邊動脈疾病 (PAD) 的定義包括：(1) 有周邊動脈血管重建史；(2) 有因動脈粥狀硬化性疾病導致肢體缺血而截肢的病史；(3) 出現 PAD 臨床症狀，且影像學檢查證實週邊動脈狹窄程度 > 50%。對於這些定義明確的症狀性 PAD 患者，強化低密度脂蛋白膽固醇 (LDL-C) 控制是有益的。

PAD

LDL-C target

PAD is a clinical manifestation of systemic atherosclerosis. Insufficient blood supply due to atherosclerotic narrowing of lower extremity arteries leads to clinical symptoms of PAD, including claudication, ischemic ulcer and acute or critical limb ischemia.15,16 PAD patients have higher risk of MI, ischemic stroke and cardiovascular mortality.17,18 In fact, the risk of cardiovascular events is even higher in patients with PAD than CAD.19 Because atherosclerosis accounts for the majority of pathogenesis and its high cardiovascular risk, it is reasonable to treat LDL-C more aggressively for PAD patients. A randomized controlled trial, the Heart Protection Study, investigating the efficacy of LDL-C lowering by simvastatin revealed a 22% decrease of vascular events in 5-year follow-up in PAD patients taking simvastatin 40 mg daily compared to those taking placebo.20 A meta-analysis reported that LDL-C lowering by statin in PAD was associated with lower all-cause mortality, lower nonfatal stroke as well as a trend of lower risk of MI.21 LDL-C reduction with lipid-lowering therapy also alleviated clinical symptoms, improved exercise endurance, and slowed down the progression of atherosclerotic plaques in patients with PAD.22e24 In the post hoc analysis of Scandinavian Simvastatin Survival Study, patients receiving simvastatin had a 38% decrease of intermittent claudication than those receiving placebo in a median follow-up of 5.4 years.25 West et al. reported that reduction of LDL-C by simvastatin with or without ezetimibe hold the progression of atherosclerotic plaques in superficial femoral artery in PAD patients.24 Based on the scientific evidence, most of the recent guidelines classify PAD as high risk or very high risk and recommend to achieve a LDL-C level <70 or 55 mg/dL.6,14,26,27 A Korean retrospective cohort study assessed the influence of LDL-C on clinical outcomes in PAD patients receiving endovascular treatment.28 They found patients with LDL-C < 70 mg/dL had lower risk of MACE which was a composite of all-cause mortality, nonfatal MI and stroke than those with LDL-C 70 mg/dL in a median follow-up of 4.8 months. The result implied that achieving a goal of LDL-C < 70 mg/dL is also important in Asian PAD patients. In most guidelines and clinical studies, the definitions of symptomatic PAD include (1) history of peripheral artery revascularization, (2) history of amputation for ischemic limb due to atherosclerotic disease, (3) clinical symptoms of PAD with > 50% stenosis of peripheral arteries confirmed by imaging studies. Intensive LDL-C control is beneficial in these well-defined symptomatic PAD patients.

2022 台灣版高血脂治療指引-針對心血管疾病高風險族群 3.ACS/CAD PCSK9 亞洲新證據

2025-12-09 14:102022 focused update of the 2017 Taiwanlipid guidelines for high risk patients:Coronary artery disease, peripheral arterydisease and ischemic stroke

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ACS/CAD
PCSK9抑制劑新數據


臨床試驗評估了使用PCSK9抑制劑（一種新型強效的LDL-C降低療法）將LDL-C水平降至<70 mg/dL的益處。 PCSK9抑制劑單一治療可降低60%的LDL-C，而PCSK9抑制劑合併高強度他汀類藥物治療可使LDL-C降低高達75%。 ⁶ 目前台灣地區可用的PCSK9抑制劑包括evolocumab和alirocumab。在PCSK9抑制劑的結局試驗，即FOURIER和ODYSSEY OUTCOMES研究中，已證實較低的LDL-C值能夠降低冠心病/急性冠狀動脈綜合症（CAD/ACS）患者發生主要不良心血管事件（MACE）的風險。 ^2,3 在FOURIER研究中，對於既往有心肌梗塞、非出血性中風或症狀性週邊動脈疾病史的穩定型動脈粥樣硬化性心血管疾病（ASCVD）患者，依洛尤單抗合併他汀類藥物治療可將LDL-C水平中位數降低至30 mg/dL（四分位數間距19-4666000 mg/dL（BLDL19-460000 mg/dL（BLDL19-46），他為四分位間距19-46960000 mg/dL（BLDL19-466000C)，C30909000 mg/dL（BLDL19-4609000C），他為第96000 mg/dL（BLDL19-4666000C)。 mg/dL的患者相比，MACE風險顯著降低15%。 ² 在ODYSSEY OUTCOMES研究中，對於先前1-12個月內發生過急性冠狀動脈症候群的患者，阿利西尤單抗合併他汀類藥物治療與僅接受他汀類藥物治療的患者相比，MACE風險顯著降低15%。 ³在接受阿利西尤單抗合併他汀類藥物治療的患者組中，4週和48週追蹤時的低密度脂蛋白膽固醇（LDL-C）水準分別為40和53 mg/dL，而單一他汀類藥物組則分別為93和101 mg/dL。儘管PCSK9抑制劑具有臨床療效，但由於其價格昂貴，成本效益已成為一個主要問題，限制了這些藥物在台灣的使用。 ⁷
對於高風險 CAD/ACS 患者，專注於使用 PCSK9 抑制劑以達到更低的 LDL-C 目標值，可能會帶來最大的臨床效益並提高成本效益。在 FOURIER 研究中，研究人員對病情穩定的 ASCVD 患者進行了亞組分析，包括 (1) 先前有心肌梗塞病史的患者和 (2) 有症狀性下肢週邊動脈疾病 (PAD) 的患者。 ^8-10 結果顯示，近期發生心肌梗塞（< 1 年）、既往發生過 2 次心肌梗塞、存在多支血管冠狀動脈疾病（2 支大血管狹窄 40%）以及總共發生過 2 次心肌梗塞、存在多支血管冠狀動脈疾病（2 支大血管狹窄 40%）以及總共發生 2 次心肌梗塞、存在多支血管冠狀動脈疾病（2 支大血管狹窄 40%）以及總共有症狀性 PAD 的患者，發生主要不良心血管事件 (MACE) 的風險更高，並且符合這些條件減少的患者，發生主要不良心血管事件 (MACE) 的風險更高，並且與不符合這些條件的患者相比，BACEC-BACE.風險降低幅度更大。 ^8-10 在 FOURIER 研究中，糖尿病亞組分析顯示，PCSK9 抑制劑降低 MACE 風險的效果在糖尿病患者和非糖尿病患者之間幾乎相同。 ¹¹ 在 ODYSSEY OUTCOMES 研究中，研究人員對近期發生急性冠狀動脈綜合症 (ACS) 的患者進行了亞組分析，包括 (1) 多血管疾病患者（冠狀動脈疾病合併 PAD 或頸動脈狹窄）和 (2) 糖尿病患者。 ^12,13 研究發現，這些患者的風險更高。 MACE 和使用阿利西尤單抗進行強化 LDL-C 降低治療可帶來更大的風險降低。 ^12,13 正如 2017 年指南建議 ACS 和糖尿病患者設定較低的 LDL-C 目標值一樣，這些研究表明，對於 CAD/ACS 的高風險族群，強化 LDL-C 降低治療以達到更低的 LDL-C 目標值可能獲得更多臨床獲益。事實上，2018 年美國心臟協會/美國心臟病學會膽固醇指南¹⁴ 也提出了類似的觀點。在這個 2018 年美國指引中，曾經有多次主要 ASCVD 事件史的患者，包括近期 ACS（過去 12 個月內）、過去 MI 史、過去缺血性中風史和症狀性 PAD，被認為是極高風險族群，建議強化 LDL-C 降低治療。 ¹⁴




推薦


CAD/ACS 患者的 LDL-C 目標值為 < 70 mg/dL（COR I，LOE B）。


除了 ACS 合併糖尿病外，對於 CAD/ACS 高風險患者，包括近期發生 MI（<12 個月）、2 次先前 MI、多支血管 CAD 或伴隨 PAD（包括肢體或頸動脈）的患者，可考慮將 LDL-C 目標值設定為 < 55 mg/dL（COR IIa，LOE B）。


ACS/CAD
New PCSK9 inhibitor data


The benefit of an even lower LDL-C level <70 mg/dL was evaluated in clinical trials using PCSK9 inhibitor which is a novel and powerful class of LDL-C lowering therapy. PCSK9 inhibitor monotherapy provides 60% LDL-C reduction and PCSK9 inhibitor plus high-intensity statin decrease LDL-C up to 75%.6 Currently available PCSK9 inhibitors in Taiwan are evolocumab and alirocumab. The benefits of even lower LDL-C values to reduce the risk of major adverse cardiovascular events (MACE) in CAD/ACS were demonstrated in the outcome trials of PCSK9 inhibitors, the FOURIER and ODYSSEY OUTCOMES studies.2,3 In stable ASCVD with a prior history of MI, nonhemorrhagic stroke, or symptomatic PAD in the FOURIER study, evolocumab plus statin reduced the LDL-C level to a median of 30 mg/ dL (interquartile range 19e46 mg/dL) and obtained a 15% significant risk reduction of MACE compared with those given statin therapy only with an LDL-C level of 92 mg/ dL.2 In patients with recent ACS in previous 1e12 months in the ODYSSEY OUTCOMES study, alirocumab plus statin was associated with a 15% significant risk reduction of MACE compared with statin only group.3 The mean achieved LDL-C level was 40 and 53 mg/dL at 4 weeks and 48 weeks follow-up in the alirocumab plus statin group compared to 93 and 101 mg/dL in the statin only group. Despite their clinical efficacy, due to the high drug price, the cost-effectiveness of PCSK9 inhibitors becomes a major problem and limits the use of these drugs in Taiwan.7
Focusing the use of PCSK9 inhibitors to achieve a lower LDL-C target in CAD/ACS with higher risk is likely to provide maximal clinical benefit and improve the costeffectiveness. In the FOURIER study with stable ASCVD patients, subgroup analyses were performed in (1) patients with prior MI and (2) patients with symptomatic lower extremity PAD.8e10 It turns out that patients with a recent MI < 1 year, 2 prior MIs, presence of multivessel CAD (40% stenosis in 2 large vessels), and concomitant symptomatic PAD were at higher risk of MACE and obtained greater risk reduction from a lower LDL-C level achieved with evolocumab than those without these conditions.8e10 For diabetic subgroup analysis in the FOURIER study, the risk reduction of MACE from PCSK9 inhibitor was almost similar between those with and without diabetes.11 In the ODYSSEY OUTCOMES study with recent ACS patients, subgroup analyses were performed in (1) patients with polyvascular disease (CAD plus PAD or carotid stenosis) and (2) patients with diabetes.12,13 The studies found these patients were at higher risk of MACE and intensive LDL-C lowering with alirocumab caused a larger risk reduction.12,13 Just like a lower LDL-C target for ACS and diabetes recommended in the 2017 guideline, these studies indicate that more intensive LDL-C lowering therapy to achieve an even lower LDL-C target in these very high risk groups of CAD/ACS could obtain more clinical benefits. Actually, the similar concept was also raised in the 2018 American Heart Association/American College of Cardiology Cholesterol Guideline.14 In this 2018 American guideline, patients with a history of multiple major ASCVD events, including recent ACS (within the past 12 months), history of MI, history of ischemic stroke and symptomatic PAD, are considered at very high risk and more intensive LDL-C reduction is recommended.14




Recommendation


The LDL-C target is < 70 mg/dL in patients with CAD/ACS (COR I, LOE B).


In addition to ACS plus diabetes, CAD/ACS at very high risk, including those with recent MI (<12 months), 2 prior MIs, multivessel CAD, or concomitant PAD (including extremity or carotid artery), a lower target of LDL-C < 55 mg/dL can be considered (COR IIa, LOE B).

2022 台灣版高血脂治療指引-針對心血管疾病高風險族群 2 ACS/CAD STATIN 亞洲新證據

2025-12-09 14:10
2022 focused update of the 2017 Taiwanlipid guidelines for high risk patients:Coronary artery disease, peripheral arterydisease and ischemic stroke

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亞洲最新他汀類藥物數據

2017年台灣高風險病患血脂指引建議冠心病/急性冠狀動脈症候群（CAD/ACS）病患的低密度脂蛋白膽固醇（LDL-C）目標值為70 mg/dL。近期在日本進行的大型隨機臨床試驗REAL-CAD研究證實，將亞洲冠心病患者的LDL-C降低至70 mg/dL左右具有益處。 ⁵ 研究納入了符合以下條件的穩定性冠心病患者：（1）有急性冠脈綜合徵病史，包括急性心肌梗塞（MI）或不穩定型心絞痛超過3個月；（2）既往接受過冠狀動脈血運重建術，包括經皮冠狀動脈介入治療或冠狀動脈旁路移植術超過3個月；這些患者被隨機分配至高劑量（4 mg/天）或低劑量（1 mg/天）匹伐他汀治療組。主要終點為複合終點，包括心血管死亡、非致死性心肌梗塞、非致死性缺血性中風或需要緊急住院治療的不穩定型心絞痛。接受強化他汀治療以使低密度脂蛋白膽固醇（LDL-C）水平達到約 73 mg/dL 的患者，其 4 年累積主要終點事件發生率顯著低於接受強度較低的他汀治療以使 LDL-C 水平達到約 90 mg/dL 的患者。 ⁵ 這項試驗是首個在亞洲進行的試驗，結果表明，使用高劑量他汀類藥物積極降低 LDL-C 水平不僅有益，而且在亞洲人群中耐受性良好。

ACS/CAD

New statin data in Asia

In the 2017 Taiwan Lipid Guidelines for High Risk Patients, the recommended target of low-density lipoprotein cholesterol (LDL-C) for patients with CAD/ACS is 70 mg/dL. The benefit of lowering down LDL-C to around 70 mg/dL for Asian CAD patients was recently proved in the REAL-CAD study, a large-scale randomized clinical trial performed in Japan.5 The study included stable CAD patients with (1) history of ACS, including acute myocardial infarction (MI) or unstable angina >3 months, or (2) previous coronary revascularization, including percutaneous coronary intervention or coronary artery bypass graft >3 months, or (3) angiographically documented coronary artery stenosis of at least 75% diameter stenosis. These patients were randomized to high dose (4 mg/day) or low dose (1 mg/day) pitavastatin therapy. The primary outcome was a composite end point of cardiovascular death, nonfatal MI, nonfatal ischemic stroke, or unstable angina requiring emergency hospitalization. The cumulative 4-year incidence of the primary outcome events was significantly lower in patients treated with intensive statin therapy to achieve an LDL-C level around 73 mg/dL compared to those with less intensive statin therapy with an LDL-C level around 90 mg/dL.5 This trial was the first one performed in Asia and demonstrated that aggressive LDL-C lowering with high dose statin is not only beneficial but also well tolerated in Asian population.

2022 台灣版高血脂治療指引-針對心血管疾病高風險族群 1.簡介

2025-12-09 14:10
2022 focused update of the 2017 Taiwanlipid guidelines for high risk patients:Coronary artery disease, peripheral arterydisease and ischemic stroke

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引言 

2017年，台灣血脂與動脈粥狀硬化學會聯合台灣心臟學會、台灣心血管介入學會、台灣中風學會、台灣糖尿病學會、台灣糖尿病教育者協會及台灣腎臟病學會，發布了《2017年台灣高風險病患血脂指南》¹。本指引建議了冠狀動脈疾病（CAD）、急性冠狀動脈症候群（ACS）、週邊動脈疾病（PAD）、缺血性中風、糖尿病、慢性腎臟病及家族性高膽固醇血症患者的最佳血脂目標值及治療策略¹。 2017年指引發布後，關於動脈粥狀硬化性心血管疾病（ASCVD）患者降血脂治療的新科學證據相繼發表。尤其值得一提的是，近期發表了關於前蛋白轉化酶枯草桿菌蛋白酶/kexin 9型（PCSK9）抑製劑治療急性冠脈綜合徵/冠狀動脈疾病（ACS/CAD）以及他汀類藥物強化降脂治療動脈粥樣硬化性缺血性卒中或短暫性腦缺血發作（TIA）患者的重要臨床試驗。 ^2e4 研究結果改變了這些高風險病患的治療理念。因此，有必要更新針對這些患者的降血脂治療策略。本次更新的重點在於，其建議基於近期發表的臨床試驗的科學證據，並結合專家意見和台灣地區實際情況進行了調整。本指南更新草稿由台灣血脂與動脈粥狀硬化學會起草，並送交台灣心臟學會、台灣心血管介入學會及台灣中風學會審查。最終版本經上述學會認可。與往常一樣，本次指南更新採用了與 2017 年指南相同的實證分類系統，包括 3 個建議等級 (COR) 和 3 個證據等級 (LOE)。

Introduction In 2017, the Taiwan Society of Lipids and Atherosclerosis, in association with the Taiwan Society of Cardiology, Taiwan Society of Cardiovascular Intervention, Taiwan Stroke Society, Taiwan Diabetes Association, Taiwanese Association of Diabetes Educators and Taiwan Society of Nephrology, published the 2017 Taiwan Lipid Guidelines for High Risk Patients.1 The optimal lipid target and treatment strategy were recommended for patients with coronary artery disease (CAD), acute coronary syndrome (ACS), peripheral artery disease (PAD), ischemic stroke, diabetes mellitus, chronic kidney disease, and familial hypercholesterolemia.1 After publication of the 2017 guideline, new scientific evidence regarding lipid lowering therapy in patients with atherosclerotic cardiovascular disease (ASCVD) was reported successively. In particular, there were important clinical trials published about proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors for ACS/CAD and intensive lipid lowering with statins among patients with ischemic stroke or transient ischemic attack (TIA) of atherosclerotic origin.2e4 The study results changed the treatment concept in these high risk patients. Therefore, an update focusing on the lipid treatment strategy for these patients becomes necessary. The recommendations in this focused update were made based on the scientific evidence from recently published clinical trials but modified by the expert opinions and considerations of the real-world situation in Taiwan. The draft of this guideline update was developed by the Taiwan Society of Lipids and Atherosclerosis and sent to the Taiwan Society of Cardiology, Taiwan Society of Cardiovascular Intervention and Taiwan Stroke Society for review. The final document was endorsed by these societies. As usual, the guideline update adopted the same evidence-based classification system as the 2017 guideline, including 3 classes of recommendation (COR) and 3 levels of evidence (LOE)

2022-台灣高血脂初級預防指引-19-其他血脂數值控制目標 TG三酸甘油脂

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三酸甘油酯

儘管極低密度脂蛋白 (VLDL) 和乳糜微粒都是富含三酸甘油酯 (TG) 的顆粒，但由於乳糜微粒的半衰期極短，VLDL 顆粒構成循環 TG 的絕大部分。此外，VLDL 顆粒大多直徑小於 70 nm，且含有載脂蛋白 B (apoB)，它們可能滯留在動脈壁上，並啟動動脈粥狀硬化過程。儘管 VLDL 顆粒具有致動脈粥樣硬化的潛力，但 TG 與動脈粥樣硬化性心血管疾病 (ASCVD) 之間的關聯仍未有定論。主要問題在於，在調整其他脂蛋白後，三酸甘油酯（TG）的預測能力微乎其微。 孟德爾遺傳學研究也觀察到了相同的結果。 對TG資料的解讀也應謹慎，因為TG與高密度脂蛋白膽固醇（HDL-C）、低密度脂蛋白膽固醇（LDL-C）或脂蛋白(a)有顯著相關性。 然而，儘管使用了他汀類藥物治療，人們仍然認為血清TG水平升高似乎與動脈粥狀硬化性心血管疾病（ASCVD）的殘餘風險有關。 PREDIMED研究的次要分析表明，極低密度脂蛋白（VLDL）顆粒及其殘餘顆粒與先前無ASCVD病史患者的心血管結果相關。 與降低LDL的藥物在預防ASCVD方面取得的巨大成功不同，幾乎所有降低TG的藥物在臨床試驗中均未能改善他汀類藥物治療下的心血管結果。 REDUCE-IT試驗評估了純化高劑量二十碳五烯酸（EPA）的療效。研究參與者為已確診動脈粥狀硬化性心血管疾病 (ASCVD) 或糖尿病且伴隨其他一項危險因子的患者，他們已接受他汀類藥物治療，空腹三酸甘油酯 (TG) 水平為 135～499 mg/dL，低密度脂蛋白膽固醇 (LDL-C) 水平為 41～100 mg/dL。患者被隨機分配至每日兩次服用 2 g 二十碳五烯酸乙酯或安慰劑組。經過中位數為 4.9 年的隨訪，二十碳五烯酸乙酯組的心血管事件風險較安慰劑組降低了 25%。值得注意的是，研究期間平均 LDL-C 水平未發生變化，顯示二十碳五烯酸乙酯的益處主要體現在降低 TG 水平。在 EVAPORATE 試驗中，與安慰劑相比，二十碳五烯酸乙酯也顯示出顯著降低冠狀動脈斑塊體積（透過電腦斷層掃描檢測）的效果。 

建議：對於已接受最大耐受劑量他汀類藥物治療且三酸甘油酯水平較高（>150 mg/dL）的ASCVD患者或伴隨1項危險因子的糖尿病患者，可考慮使用高劑量EPA（二十碳五烯酸乙酯）治療。 （COR IIa，LOE B）


Triglyceride

Although very low-density lipoprotein (VLDL) and chylomicrons are both TG-rich particles, VLDL particles constitute the majority of circulating TG because of the ultrashort half-life of chylomicron. Additionally, VLDL particles, which are mostly smaller than 70 nm in diameter and contain apoB, can potentially be retained in the arterial wall and initiate atherosclerotic processes. Despite the atherogenic potential of VLDL particles, the association between TG and ASCVD remains inconclusive. The major problem is the insignificant predicting power of TG after adjusting the other lipoproteins.118 The same results were also observed in the Mendelian genetic studies.119 Interpretation of the data about TG should also be cautious because there exists significant correlations of TG with HDL-C, LDL-C, or lipoprotein(a).120 However, it is still believed that elevated serum TG levels appear to be associated with a residual risk of ASCVD, despite the use of statin therapy. A secondary analysis from the PREDIMED study demonstrated that the VLDL particles and their remnant particles were associated with CV outcomes among patients without prior ASCVD.121 Unlike the great success of LDL-lowering agents in preventing ASCVD, almost all TG-lowering agents failed to improve CV outcome under statin therapy in the clinical trials. The REDUCE-IT trial evaluated the efficacy of purified high dose EPA. Study participants were patients with established ASCVD or diabetes with one additional risk factor and already received statin therapy with a fasting TG level of 135e499 mg/dL and LDL-C level of 41e100 mg/dL. The patients were randomized to 2 g of icosapent ethyl twice daily or placebo. After a median of 4.9 years followup, the icosapent ethyl group had 25% lower risk of CV events compared with the placebo group.122 Of note, the average LDL-C level did not change over the study period, indicating the benefit of isolated TG-driven effect. Icosapent ethyl also demonstrated significant effect on regression of coronary plaque volume detected by computed tomography compared with placebo in the EVAPORATE trial.123

Recommendation High dose EPA (icosapent ethyl) therapy can be considered for patients with ASCVD or with diabetes and
1 risk factor who are already on maximally tolerated statin therapy with high TG level (>150 mg/dL). (COR IIa, LOE B)

2022-台灣高血脂初級預防指引-18-其他血脂數值控制目標 Non-HDL-C and apoB

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其他脂質標靶和殘餘風險

非高密度脂蛋白膽固醇和載脂蛋白B

除了低密度脂蛋白膽固醇（LDL-C）外，其他幾種脂質或脂蛋白的水平也可用於預測動脈粥狀硬化性心血管疾病（ASCVD）的風險。非高密度脂蛋白膽固醇（非HDL-C）、載脂蛋白B（apoB）和三酸甘油酯（TG）近年來備受關注。非HDL-C的計算方法為總膽固醇（TC）減去高密度脂蛋白膽固醇（HDL-C）。高密度脂蛋白顆粒中的主要載脂蛋白成分是載脂蛋白A、C和E，但不含載脂蛋白B。因此，非HDL-C的計算反映了循環系統中所有含載脂蛋白B的脂蛋白的總和。富含膽固醇和三酸甘油酯的含載脂蛋白B的脂蛋白直徑小於70 nm，能夠輕易穿過血管內皮。滯留在動脈壁內的載脂蛋白B（apoB）脂蛋白會引發細胞反應，加速脂質/脂蛋白的進一步滯留和動脈粥狀硬化斑塊的進展。 ¹¹² 然而，一些研究發現非高密度脂蛋白膽固醇（non-HDL-C）和apoB水平之間存在差異，提示apoB可能是更準確的風險標記。 ^113,114 雖然在大多數人中，低密度脂蛋白膽固醇（LDL-C）、non-HDL-C和apoB之間存在良好的相關性，但在三酸甘油酯（TG）升高、糖尿病（DM）和肥胖人群中，LDL-C的測量值可能被低估，從而低估了動脈粥樣硬化性心血管疾病（ASCVD）的風險。 ^18,115 對於已接受他汀類藥物治療的台灣族群，non-HDL-C還可以提供殘餘風險評估。 ^116,117 由於在台灣的大多數醫院或診所，non-HDL-C的數據比apoB更容易獲得，因此建議將non-HDL-C水平作為LDL-C之後的次要目標。 ¹⁰非高密度脂蛋白膽固醇（non-HDL-C）比建議的低密度脂蛋白膽固醇（LDL-C）目標值高出30 mg/dL。例如，如果LDL-C目標值為100 mg/dL，則non-HDL-C的次要目標值為130 mg/dL。鑑於載脂蛋白B（apoB）在動脈粥狀硬化中的關鍵作用，如果實驗室具備檢測條件，也可以考慮直接測量循環apoB濃度來評估風險。在2019年歐洲血脂指引中，建議極高危險群、高危險群和中度危險群的apoB目標值分別為<65 mg/dL、<80 mg/dL和<100 mg/dL。 ¹⁸ 由於台灣大多數醫院或診所無法偵測apoB，且apoB在臨床實務中也很少使用，因此指引未建議特定的apoB目標值。

建議：非高密度脂蛋白膽固醇 (Non-HDL-C) 和載脂蛋白B (apoB) 可用於預測動脈粥狀硬化性心血管疾病 (ASCVD) 的風險，特別適用於高三酸甘油酯 (TG) 水平（>150 mg/dL）、糖尿病 (DM)、肥胖或代謝症候群患者。 （證據等級 IIa，證據等級 B）非高密度脂蛋白膽固醇作為次要目標，其目標值為比建議的低密度脂蛋白膽固醇 (LDL-C) 目標值高 30 mg/dL。 （證據等級 IIa，證據等級 B）

Other lipid target and residual risk

Non-HDL-C and apoB

In addition to LDL-C, the levels of several other lipids or lipoproteins also may be used to predict the risk of ASCVD. Non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein-B (apoB) and TG have attracted attention recently. Non-HDL-C is calculated as TC minus HDL-C. The major components of apolipoproteins in HDL particles are apolipoprotein A, C, E and without apoB. Therefore, the calculation of non-HDL-C estimates the summation of all circulatory apoB-containing lipoproteins. Cholesterol-rich and triglyceride-rich apoB-containing lipoproteins have diameter less than 70 nm and can easily flux across the vascular endothelium. The trapped apoB-lipoproteins within the arterial wall trigger cellular responses that accelerate further lipid/lipoprotein retention and progression of atheromatous plaque.112 However, some studies found there was discordance between the levels of nonHDL-C and apoB suggesting apoB as a more accurate risk marker.113,114 Although there are well correlations between LDL-C, non-HDL-C, and apoB in most people, LDL-C measurement may be underestimated in those with elevated TG, DM, and obesity, thus underestimating the risk of ASCVD.18,115 Non-HDL-C also provides residual risk estimation in Taiwanese populations who have been already on statin therapy.116,117 Since the data of non-HDL-C is much easier to obtain than apoB in most hospitals or clinics in Taiwan, the level of non-HDL-C is recommended as a secondary target after LDL-C.10 The target of non-HDL-C is 30 mg/dL above the recommended LDL-C target. For example, if the LDL-C target is 100 mg/dL, the secondary target of non-HDL-C is 130 mg/dL. Given the essential implications of apoB in atherosclerosis, direct measurement of the circulating concentration of apoB to assess the risk also can be considered if the measurement is available in the laboratory. In the 2019 European lipid guideline, ApoB is recommended to be <65, 80, and 100 mg/dL for very-high, high-, and moderate-risk people, respectively.18 Since apoB cannot be measured in most hospitals or clinics and rarely used in clinical practice in Taiwan, no specific target for apoB is recommended in this guideline.

Recommendation Non-HDL-C and apoB can be used to predict the risk of ASCVD, especially for people with high TG (>150 mg/dL), DM, obesity, or metabolic syndrome. (COR IIa, LOE B) Non-HDL-C is used as the secondary target and the target of non-HDL-C is 30 mg/dL above the recommended LDL-C target. (COR IIa, LOE B)

2022-台灣高血脂初級預防指引- 17.藥物治療 PCSK9抑制劑

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PCSK9抑制劑用於一級預防

PCSK9 與肝細胞表面的低密度脂蛋白受體 (LDL-R) 結合，導致受體降解並降低 LDL-R 的再利用率。 PCSK9 抗體可幹擾其與 LDL-R 的結合，進而導致肝臟 LDL-R 表現升高和血漿 LDL-C 水準降低。 ¹¹⁰ 對於需要額外降低 LDL-C 水平的家族性高膽固醇血症 (FH) 或動脈粥狀硬化性心血管疾病 (ASCVD) 患者，可使用 PCSK9 抑制劑，例如依洛尤單抗或阿利西尤單抗，以達到最大耐受劑量的他汀類藥物治療。一項統合分析證實，PCSK9 抑制劑對那些可能不適合其他降血脂藥物或無法透過傳統療法達到血脂目標的患者有效。 ¹¹¹ 目前大多數 PCSK9 抑制劑研究優先納入已確診 ASCVD、FH 或高風險患者。 PCSK9 抑制劑在低危險群至中危險群的療效證據有限。
推薦
對於使用高強度或最大耐受劑量他汀類藥物和依折麥布仍無法達到 LDL-C 目標值的高風險患者，可考慮使用 PCSK9 抑制劑進行一級預防。 （COR IIa，LOE B）


PCSK9 inhibitors for primary prevention


PCSK9 binds to LDL receptor (LDL-R) on the surface of hepatocytes leading to degradation of the receptors and decreasing the reuse of LDL-R. Antibodies to PCSK9 interfere its binding with the LDL-R resulting in higher hepatic LDL-R expression and lower plasma LDL-C levels.110 PCSK9 inhibitors, such as evolocumab or alirocumab, could be used in patients with FH or ASCVD who require additional LDL-C lowering in addition to maximally tolerated statins. One meta-analysis demonstrated the efficacy of PCSK9 inhibitors in those who might not be eligible for other lipidlowering drugs or who cannot meet their lipid goals on the traditional therapies.111 Most of the available studies of PCSK9 inhibitors preferentially enrolled patients with either established ASCVD, FH or at high risk. The evidence of PCSK9 inhibitors in those with low to moderate risk settings is minimal.
Recommendation
PCSK9 inhibitors can be considered for primary prevention in patients at high risk who cannot achieve LDL-C target with high-intensity or maximal tolerated statins and ezetimibe. (COR IIa, LOE B)

2022-台灣高血脂初級預防指引- 16.藥物治療-Ezetimibe

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依澤替米貝用於一級預防
依折麥布是一種膽固醇吸收抑制劑，它能阻斷腸道刷狀緣對飲食和膽汁膽固醇的吸收。在慢性腎臟病（CKD）或急性冠狀動脈綜合症（ACS）患者中，依折麥布合併他汀類藥物預防動脈粥狀硬化性心血管疾病（ASCVD）的療效已在大規模研究中得到充分證實。 ^107,108 EWTOPIA 75 試驗旨在研究依折麥布單藥治療在原發性預防的療效。 ¹⁰⁹ 這項在日本進行的多中心、前瞻性、隨機臨床試驗，考察了依折麥布對年齡在 75 歲左右、低密度脂蛋白膽固醇（LDL-C）≥ 140 mg/dL 但無冠心病史患者的預防效果。在這項嚴謹的研究中，經過 4.1 年的中位追蹤期，依折麥布顯著降低了主要複合終點事件（包括猝死、心肌梗塞、冠狀動脈血運重建或中風）的發生率。這項研究證明了依折麥佈單藥治療對預防 75 歲及以上 LDL-C 水平升高的個體發生心血管事件的益處，可用於一級預防。


建議：對於單用他汀類藥物無法達到低密度脂蛋白膽固醇（LDL-C）目標值的初級預防患者，依折麥布可與他汀類藥物合併使用。 （證據等級 IIb，證據等級 B）。對於無法耐受他汀類藥物的初級預防患者，依折麥布可作為單一藥物治療。 （證據等級 IIb，證據等級 B）。
Ezetimibe for primary prevention


Ezetimibe is a cholesterol absorption inhibitor that blocks dietary and biliary cholesterol absorption at the brush border of the intestine. The efficacy of ezetimibe in combination with statin for prevention of ASCVD has been well demonstrated in patients with CKD or ACS in large-scale studies.107,108 The EWTOPIA 75 trial is a study to investigate the efficacy of ezetimibe monotherapy in primary prevention.109 This multicenter, prospective, randomized clinical trial was conducted in Japan and examined the preventive efficacy of ezetimibe for patients aged
75 years with LDLC
140 mg/dL but without history of CAD. In this elegant study, ezetimibe significantly reduced the incidence of the primary composite outcome, including sudden cardiac death, MI, coronary revascularization, or stroke, after a median follow-up of 4.1 years. This study proved the benefit of ezetimibe monotherapy in preventing CV events in individuals aged
75 years with elevated LDL-C for primary prevention.


Recommendation Ezetimibe may be used in combination with statin in patients with primary prevention who could not reach the LDL-C target with statin alone. (COR IIb, LOE B). Ezetimibe may be used as monotherapy in patients with primary prevention who cannot tolerate statins. (COR IIb, LOE B).

2022-台灣高血脂初級預防指引- 15. 藥物治療-statin

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2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

降低低密度脂蛋白膽固醇（LDL-C）水平的藥物治療，包括HMG-CoA還原酶抑制劑（他汀類藥物）、膽固醇吸收抑制劑（依折麥布）和前蛋白轉化酶枯草桿菌蛋白酶/kexin 9型（PCSK9）抑制劑，已證實對動脈粥狀硬化性心血管疾病（ASCVD）的二級預防有效。他汀類藥物是治療的基石，也被證實對第一級預防有效。依折麥布和PCSK9抑制劑作為他汀類藥物的輔助治療，在二級預防中能有效改善臨床結局，但這些藥物在第一級預防的應用尚未得到充分研究。他汀類藥物用於一級預防：他汀類藥物是ASCVD的第一線治療藥物，其在第一級預防中的益處已得到充分證實。一項納入 19 項隨機臨床試驗（n ≥ 71,344）的系統性回顧和統合分析評估了他汀類藥物與安慰劑或不使用他汀類藥物對心血管風險增加但既往無動脈粥樣硬化性心血管疾病 (ASCVD) 的成年人的影響，結果顯示他汀類藥物顯著降低了全因死亡率、心血管死亡率、心臟疾病的心臟死亡中因卒中的風險而降低了全因死亡率、心血管死亡率。 ⁹⁹ 在迄今為止規模最大的他汀類藥物一級預防干預試驗 JUPITOR 中，17,802 名低密度脂蛋白膽固醇 (LDL-C) < 130 mg/dL 但高敏 C 反應蛋白 (hs-CRP) 水平升高（≥ 2.0 mg/L）的健康受試者被隨機分配至每日服用 20 mg 水平升高（≥ 2.0 mg/L）的健康受試者被隨機分配至每日服用 20 mg 水平。 ¹⁰⁰ 經過 1.9 年的中位追蹤時間，他汀類藥物治療顯著降低了主要心血管事件、心血管死亡率和全因死亡率的發生率。 ¹⁰⁰ 在 HOPE3 試驗中，12,705 名無 ASCVD 但有中度風險的受試者被隨機分配至瑞舒伐他汀組。每日服用 10 毫克或安慰劑。兩組受試者的基線LDL-C水平均為127 mg/dL。 ¹⁰¹ 經過5.6年的隨訪，他汀類藥物治療組的心血管事件風險顯著低於安慰劑組。 ¹⁰¹ 在MEGA研究中，這是唯一一項針對亞洲人群的大型他汀類藥物一級預防試驗，7832名無冠心病或卒中病史的日本患者被隨機分配至單純飲食組或飲食聯合普伐他汀10-20 mg/天組。 ¹⁰² 平均追蹤5.3年後，他汀類藥物治療顯著降低了日本患者的冠心病事件風險。 ¹⁰² 他汀類藥物的強度分為三類：高強度他汀類藥物（劑量使LDL-C降低≥50%）、中等強度他汀類藥物（劑量使LDL-C降低30%-49%）和低強度他汀類藥物（劑量使LDL-C降低<30%）。 ¹⁰根據台灣的科學證據和基線低密度脂蛋白膽固醇（LDL-C）水平，建議先使用中等強度的他汀類藥物進行一級預防，如果未達到治療目標，則可逐漸增加劑量至高強度他汀類藥物。他汀類藥物的安全性已被廣泛評估。雖然偶有肌肉病變和肝功能異常的發生，但大多數患者對他汀類藥物治療的耐受性良好且安全。 ¹⁰³ 他汀類藥物相關的肌肉症狀是最常見的報告副作用，然而，嚴重他汀類藥物引起的肌肉損傷的風險…包括橫紋肌溶解症在內的不良反應發生率極低。 ¹⁰⁴ 請參閱2019年台灣脂質與動脈粥狀硬化學會關於他汀類藥物不耐受的專家共識聲明，以了解他汀類藥物相關肌肉和肝臟副作用的診斷和管理。 ¹⁰⁵ 他汀類藥物治療也與新發生糖尿病風險略有增加有關。一項納入91,140名參與者的13項他汀類藥物試驗的統合分析顯示，他汀類藥物治療與新發糖尿病風險增加9%相關。 ¹⁰⁶ 統合迴歸分析也表明，老年受試者服用他汀類藥物後新發糖尿病的風險更高，且與他汀類藥物的效力相關。 ¹⁰⁶


建議：對於一級預防，他汀類藥物是首選治療方案。可以先使用中等強度的他汀類藥物，如果未達到治療目標，再逐漸增加劑量至高強度他汀類藥物。 （COR I，LOE A）

Pharmacological therapy LDL-C lowering therapies with HMG CoA reductase inhibitors (statins), cholesterol absorption inhibitors (ezetimibe), and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, have demonstrated efficacy in secondary prevention of ASCVD. Statins, the cornerstone of therapy, are also found to be efficacious in primary prevention. Ezetimibe and PCSK9 inhibitors are effective in improving clinical outcomes as add-on drugs to statin therapy in secondary prevention, but these drugs have not been well investigated in patients for primary prevention. Statins for primary prevention Statins are the first-line therapy and the benefit of statins for primary prevention of ASCVD is well established. In a systematic review and meta-analysis of 19 randomized clinical trials (n Z 71,344) that evaluated the effect of statins versus placebo or no statin in adults at increased CV risk but without prior ASCVD, statins significantly reduced risk of all-cause mortality, CV mortality, stroke, MI, and composite CV outcomes.99 In JUPITOR trial, the largest statin intervention trial for primary prevention, 17,802 apparently healthy persons with LDL-C <130 mg/dL but with elevated high-sensitivity C-reactive protein levels (
2.0 mg/L) were randomly assigned to rosuvastatin 20 mg daily or placebo.100 After a median follow-up of 1.9 years, statin therapy significantly reduced the incidence of major CV events, CV mortality and all-cause mortality.100 In HOPE3 trial, 12,705 participants without ASCVD but at intermediate risk were randomly assigned to rosuvastatin 10 mg daily or placebo. The LDL-C levels at baseline were 127 mg/ dL in both groups.101 After a period of 5.6 years, treatment with statin resulted in a significantly lower risk of CV events than placebo.101 In MEGA study, the only large statin trial in Asian population for primary prevention, 7832 Japanese patients without history of CAD or stroke were randomly assigned to the diet only group or diet plus pravastatin 10e20 mg/day group.102 After a mean follow-up of 5.3 years, treatment with statin significantly reduced the risk of CAD events in Japanese patients.102 The intensity of statin is divided into 3 categories: highintensity statin (the dose reduces LDL-C by greater than or equal to 50%), moderate-intensity statin (the dose reduces LDL-C by 30%e49%), and low-intensity statin (the dose reduces LDL-C by <30%).10 Based on the scientific evidence and baseline LDL-C levels in Taiwan, it is reasonable to initiate moderate-intensity statin first for primary prevention and titrate to high-intensity statin if the treatment goal is not reached. The safety of statins has been extensively evaluated. Although myopathy and abnormal liver function are encountered occasionally, statin therapy is well tolerated and safe for most patients.103 Statinassociated muscle symptoms are the most common reported side effects, however, the risk of severe statininduced muscle injury, including rhabdomyolysis, is very low.104 Please refer to the 2019 Taiwan Society of Lipids and Atherosclerosis Expert Consensus Statement on Statin Intolerance for the diagnosis and management of statinrelated muscle and hepatic side effects.105 Statin therapy is also associated with a slightly increased risk of new-onset diabetes. In a meta-analysis including 13 statin trials with 91,140 participants, statin therapy was associated with a 9% increased risk for incident diabetes.106 The meta-regression analysis also indicated that the risk of new-onset diabetes with statins was higher in older subjects and associated with the statin’s potency.106


Recommendation For primary prevention, statins are the first-line therapy. It is reasonable to initiate moderate-intensity statin first and titrate to high-intensity statin if the treatment goal is not reached. (COR I, LOE A).

2022-台灣高血脂初級預防指引- 14. 非藥物治療-健康的生活型態

2025-12-09 11:08AM

2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

健康的生活方式 所有成年人都應保持健康的飲食習慣，包括均衡的宏量營養素，並強調攝取植物性食物、瘦肉蛋白，同時限制反式脂肪、加工紅肉和精製碳水化合物的攝取。應維持理想體重。應鼓勵規律運動，並專注於累計運動量。應提倡減少飲酒和戒菸。另一方面，也應認識到生活方式改變的潛在障礙，例如難以獲得健康飲食或運動機會。透過醫病共同決策，可以提高病人對這些建議的依從性。表3列出了生活方式改變的整體建議及其對血脂的影響。

推薦
建議飲食應富含植物性食物、ω-3脂肪酸來源（如魚類、堅果、豆類）和瘦蛋白，以維持健康的體重。 （證據等級I，證據等級B）盡量減少反式脂肪、飽和脂肪、加工肉類和精緻碳水化合物的攝取。 （證據等級IIa，證據等級B）建議定期進行體能訓練。 （證據等級I，證據等級A）建議減少飲酒並戒菸。 （證據等級I，證據等級B）

Healthy lifestyle All adults should consume a healthy diet which includes balanced macronutrients and emphasizes the intake of plant-based foods, lean animal protein with restriction of the amount of trans fat, processed red meat, and refined carbohydrate. Ideal body weight should be maintained. Regular exercise should be encouraged with emphasis on the total accumulated amount. Reduction in alcohol consumption and smoking cessation should be advocated. On the other hand, potential barriers to lifestyle modification, such as access to healthy diet or exercise options, should be recognized. Adherence to these suggestions may be enhanced through the process of shared decision making between clinicians and patients. The overall recommendations for lifestyle modification and the influences on lipid profile are shown in Table 3.

Recommendation

Diet rich in plant-based foods, sources of omega-3 fatty acids (e.g., fish, nuts, legumes), lean animal protein, which can maintain healthy body weight is suggested. (COR I, LOE B) Minimize the intake of trans and saturated fat, processed meat, and refined carbohydrate. (COR IIa, LOE B) Regular physical exercise is recommended. (COR I, LOE A) Reduction of alcohol intake and cessation of smoking are suggested. (COR I, LOE B)

2022-台灣高血脂初級預防指引- 13. 非藥物治療-戒菸

2025-12-09 11:08AM2022台灣血脂治療指引(英文版)下面中文使用googl e自動翻譯

吸菸是一種致命的成癮性疾病，每年有超過800萬人死於吸菸。 ⁹⁰ 在台灣，成年吸菸率已從2008年的21.9%（男性38.6%，女性4.8%）下降至2019年的13.1%（男性23.1%，女性2.9%）。 ⁹¹ 然而，吸菸仍在台灣造成大量生命損失，每年約有24,000人死於吸菸。 ⁹¹ 戒菸可以挽救生命，減輕醫療負擔，即使是60歲以上的老年吸菸者也能從中受益。 ⁹² 持續的醫學教育，包括對醫生和諮商師進行團體培訓，提升他們幫助人們戒菸的知識和技能，以及在各醫院之間開展戒菸服務競賽，已被證明能有效促進台灣高心血管風險吸菸者的戒菸。 ⁹³ 近年來，電子煙已成為一種流行的戒菸方式。然而，關於電子煙是否優於非電子菸戒菸方法的大規模統合分析結果卻相互矛盾。 ^94,95 此外，越來越多的證據引發了人們對電子煙使用不良反應的嚴重擔憂，例如電子煙或電子煙產品相關性肺損傷（EVALI）以及與電子煙使用相關的血壓升高和動脈僵硬。 ^96-98 總之，目前尚無確切證據顯示電子煙是更安全的戒菸替代方案，也沒有足夠的證據證明其長期心血管安全性。


建議：建議戒菸以降低整體心血管風險。 （證據等級 I，證據等級 A）
Cigarette smoking Smoking is a lethal addictive disorder and more than 8 million people die from smoking every year.90 In Taiwan, the prevalence of smoking among adult people has been declining from 21.9% (male 38.6%, female, 4.8%) in 2008 down to 13.1% (male 23.1%, female 2.9%) in 2019.91However, smoking still caused a huge loss of life in Taiwan and about 24,000 people die from smoking every year.91 Smoking cessation saves life and reduces healthcare burden and the benefits are seen even in old smokers (
60 years).92 Continued medical education with group training of doctors and counsellors regarding knowledge and skill to help people quitting smoking followed by smoking cessation service contest among hospitals has been proved effective to promote smoking cessation for high CV risk smokers in Taiwan.93 Electronic cigarettes (EC) have been emerging as a popular way to facilitate tobacco cessation in recent years. However, large-scale meta-analysis about whether EC is superior to non-EC methods for tobacco cessation showed conflicting results.94,95 In addition, growing evidence has raised critical concerns regarding the adverse effects of EC use, such as EC or vaping product-associated lung injury (EVALI) and increased blood pressure and arterial stiffness associated with EC use.96e98 Collectively, there is still no solid evidence supporting that EC is a safer alternative for tobacco cessation, neither is there sufficient evidence to claim its long-term CV safety.


Recommendation Cessation of cigarette smoking is recommended to reduce overall CV risk. (COR I, LOE A)

2022-台灣高血脂初級預防指引- 12. 非藥物治療-酒精攝取建議

2025-12-09 11:08AM

2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

酒精

酒精攝取與高密度脂蛋白膽固醇（HDL-C）水平升高有關，但酒精攝取與動脈粥狀硬化性心血管疾病（ASCVD）之間的關係尚存爭議。 ^73,74 雖然一些研究表明，少量飲酒與心血管風險和糖尿病風險降低有關，^75-77 但許多其他研究對這一觀點提出了質疑。 ^78-81 近期，一項對來自19個高收入國家（新興風險因素協作組、EPIC-CVD和英國生物銀行）的3個大型數據庫的個體參與者數據進行的綜合分析發現，酒精攝入與卒中、冠狀動脈疾病（CAD）、心力衰竭、致命性高血壓疾病和致命性主動脈瘤的風險呈線性相關，每100克/週酒精攝入量的風險比分別為1.14、1.06、1.09、1.24和1.15。 ⁸² 一項孟德爾隨機化統合分析發現，攜帶乙醇脫氫酶1B（ADH1B）變異等位基因的人群…戒酒率較高、飲酒量較低、酗酒發生率較低的人群，患冠心病（比值比 [OR] 0.90，95% 置信區間 [CI] 0.84-0.96)和腦卒中90% CI 0.72-0.95）的風險顯著降低。 ⁷⁸ 約40-50%的台灣人攜帶乙醛脫氫酶-2 (ALDH2) 功能異常等位基因（ALDH2*2 變異體），飲酒的潛在有害影響可能更為顯著。 ⁸³ ALDH2*2 功能異常等位基因會延緩飲酒後乙醛的代謝，導致「亞洲酒精潮紅症候群」或「酒精不耐受症候群」。 ^84,85 事實上，飲酒與許多急性和慢性疾病有關，並被認為是其中一些疾病負擔的主要危險因子。 ^86,87 基於越來越多的證據表明飲酒的有害影響台灣國家健康署建議，無飲酒習慣者應避免因任何原因開始飲酒。 ⁸⁸ 建議男性每週飲酒量少於100克（14克/天或1杯），女性少於50克（7克/天或0.5杯）（一杯標準飲品約含14克純酒精）。攜帶ALDH2*2功能異常等位基因者強烈建議戒酒。若攜帶ALDH2*2功能異常等位基因者無法避免飲酒，則建議男性每週飲酒量少於64克（9克/天或4杯），女性少於28克（4克/天或2杯）。 ⁸⁹ 應嚴格避免酗酒，酗酒定義為男性2小時內飲用5杯，女性2小時內飲用4杯。

建議：無飲酒習慣者應避免任何原因開始飲酒。 （證據等級 I，證據等級 C）。對於未攜帶 ALDH2*2 功能異常等位基因的男性，每週飲酒量應限制在 100 克以下（14 克/天或 1 杯/天），女性應限制在 50 克以下（7 克/天或 0.5 杯/天）。 （證據等級 I，證據等級 A）。對於攜帶 ALDH2*2 功能異常等位基因的男性，每週飲酒量應限制在 64 克以下（9 克/天或 4 杯/週），女性應限制在 28 克以下（4 克/天或 2 杯/週）。 （證據等級 IIa，證據等級 B）。應嚴格避免酗酒，酗酒定義為男性在 2 小時內飲用 5 杯，女性在 2 小時內飲用 4 杯。 （證據等級 I，證據等級 C）（一杯標準飲品含 14 克純酒精）

Alcohol

Alcohol intake is associated with an increase in HDL-C, but the relation between alcohol consumption and ASCVD is controversial.73,74 Although some studies suggest that low levels of alcohol consumption is associated with a decreased CV risk and diabetes,75e77 many other studies have challenged this view.78e81 More recently, in a combined analysis of individual-participant data from 3 large-scale databases in 19 high-income countries (the Emerging Risk Factors Collaboration, EPIC-CVD, and the UK Biobank), alcohol consumption was linearly associated with an increased risk of stroke, CAD, heart failure, fatal hypertensive disease, and fatal aortic aneurysm, with hazard ratios per 100 g/week alcohol consumption of 1.14, 1.06, 1.09, 1.24, and 1.15, respectively.82 A Mendelian randomization meta-analysis found that alcohol dehydrogenase 1B (ADH1B) variant allele carriers who had higher abstention, lower alcohol consumption, and lower prevalence of binge drinking had a significantly decreased risk of CAD (odds ratio [OR] 0.90, 95% confidence interval [CI] 0.84e0.96) and ischemic stroke (OR 0.83, 95% CI 0.72e0.95).78 The potential detrimental effect of alcohol drinking could be more pronounced in about 40e50% of Taiwanese who carry the aldehyde dehydrogenase-2 (ALDH2) dysfunctional allele (ALDH2*2 variant).83 The ALDH2*2 dysfunctional allele delays acetaldehyde metabolism following alcohol consumption and leads to “Asian alcohol flushing syndrome” or “alcohol intolerance syndrome”.84,85 Actually, alcohol use has been related to many acute and chronic diseases and is recognized as a leading risk factor for the burden of some of these diseases.86,87 Based on the growing evidence for the detrimental effect of alcohol, the Taiwan Health Promotion Administration suggests individuals without a habit of drinking alcohol should avoid starting drinking for any reason.88 A limited alcohol consumption of <100 g/week (14 g/day or 1 drink/ day) for men and <50 g/week (7 g/day or 0.5 drink/day) for women is recommended (one standard drink Z 14 g pure alcohol). Alcohol abstention is strongly advised for those who carry the ALDH2*2 dysfunctional allele. If alcohol consumption is unavoidable in people carrying the ALDH2*2 dysfunctional allele, more limited alcohol consumption of <64 g/week (9 g/day or 4 drinks/week) for men and <28 g/ week (4 g/day or 2 drinks/week) for women is recommended.89 Binge drinking, defined as
5 drinks for men and
4 drinks for women within 2 h, should be strictly avoided

Recommendation People who do not have a habit of alcohol consumption should avoid starting drinking for any reason. (COR I, LOE C). Alcohol consumption should be limited to <100 g/ week (14 g/day or 1 drink/day) in men and <50 g/ week (7 g/day or 0.5 drink/day) in women without the ALDH2*2 dysfunctional allele. (COR I, LOE A). Alcohol consumption should be limited to <64 g/ week (9 g/day or 4 drinks/week) in men and <28 g/ week (4 g/day or 2 drinks/week) in women with the ALDH2*2 dysfunctional allele. (COR IIa, LOE B). Binge drinking, defined as
5 drinks for men and
4 drinks for women within 2 h, should be strictly avoided. (COR I, LOE C) (One standard drink Z 14 g pure alcohol)

2022-台灣高血脂初級預防指引- 11. 非藥物治療-運動

2025-12-09 11:08AM
2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

鍛鍊

關於運動對低密度脂蛋白膽固醇（LDL-C）的影響，現有證據仍有爭議。運動似乎無法顯著降低總膽固醇（TC）和低密度脂蛋白膽固醇（LDL-C）水平。 ⁶⁸ 高強度、大運動量的運動對降低三酸甘油酯（TG）和升高高密度脂蛋白膽固醇（HDL-C）濃度有明顯作用。 ⁶⁹ 規律運動可使三酸甘油酯濃度比不運動者降低17.7 mg/dL。 ⁷⁰ 一項大規模觀察性研究表明，規律慢跑有助於提高高密度脂蛋白膽固醇水平，降低三酸甘油酯水平和三酸甘油酯/高密度脂蛋白膽固醇比值。 ⁷¹ 其他有氧運動，如游泳、跳舞（包括國際標準舞）和騎自行車，也與高密度脂蛋白膽固醇水平升高有關。 ⁷¹ 儘管阻力運動對血脂譜的影響尚無定論，但由於其具有多種健康益處，包括改善身體功能和可能降低血壓，因此仍應鼓勵進行阻力運動。鼓勵所有成年人每週至少進行150分鐘的中等強度有氧運動，或每週進行75分鐘的高強度有氧運動，以降低動脈粥狀硬化性心血管疾病（ASCVD）的風險。 ⁵⁴ 即使是持續時間較短的5分鐘或10分鐘的運動，中間穿插1至2分鐘的休息，也與持續時間較長的運動一樣有益。 ⁷²

Exercise

Existing evidence on LDL-C response to exercises is controversial. It seems that exercise does not significantly reduce TC and LDL-C levels.68 There was an apparent effect on reduction of TG and increase of HDL-C concentrations with the high-amount and high-intensity exercise.69 Regular exercise can reduce TG by 17.7 mg/dL than those without exercise.70 A large-scale observational study showed that regular jogging contributed to an increase of HDL-C and reduction of TG and TG/HDL-C ratio.71 Other aerobic exercises such as swimming, dancing (including international standard dancing), and cycling were also associated with an elevated level of HDL-C.71 Although the changes in lipid profiles by resistance exercise are inconsistent, it should still be encouraged due to several health benefits, including improving physical functioning and possibly lowering blood pressure. All adults are encouraged to engage in at least 150 min per week of accumulated moderate-intensity aerobic physical activity, or 75 min per week of vigorousintensity aerobic physical activity to lower ASCVD risk.54 Even exercise with a shorter duration of 5 or 10 min with 1- to 2-min interruption is as beneficial as the longer ones.72

2022-台灣高血脂初級預防指引- 10. 非藥物治療-補充膳食(健康食品)

2025-12-09 11:08AM

2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

膳食補充劑 

一些膳食補充劑被認為有益於健康。

魚油或海洋ω-3脂肪酸補充劑可劑量依賴性地降低三酸甘油酯（TG），這主要歸因於二十碳五烯酸（EPA）和二十二碳六烯酸（DHA）的作用，但對總膽固醇（TC）、低密度脂蛋白膽固醇（LDL-C）或高密度脂蛋白膽固醇（HDL-C）沒有明顯影響。 

紅麴萃取物已被用作降低膽固醇的營養保健品。在紅麴發酵過程中，主要生物活性化合物莫納可林K是一種弱的可逆性3-羥基-3-甲基戊二醯輔酶A（HMG-CoA）還原酶抑制劑。一項統合分析研究表明，每日服用1200毫克至4800毫克紅麴米（RYR）可使低密度脂蛋白膽固醇（LDL-C）水平較安慰劑組降低18.4毫克/分升。 然而，市面上紅麴產品品質參差不齊，且可能存在潛在的藥物交互作用風險，其安全性尚未充分研究。

可可製品中的黃酮類化合物可抑制膽固醇吸收。一項統合分析顯示，食用黑巧克力2至12週可顯著降低總膽固醇（TC）和低密度脂蛋白膽固醇（LDL-C）水平（分別降低6.2毫克/分升和5.9毫克/分升）。 然而，令人擔憂的是，黑巧克力製品中飽和脂肪和添加糖的含量各不相同。

維生素D可能透過調節維生素D受體和胰島素誘導基因2（IG2）的轉錄活性來影響循環膽固醇水平，IG2抑制HMG-CoA還原酶的表達。 臨床研究表明，補充維生素D有助於降低總膽固醇（TC）、低密度脂蛋白膽固醇（LDL-C）和三酸甘油酯（TG）水平，但對高密度脂蛋白膽固醇（HDL-C）水平無影響。

一項包含14項隨機對照試驗的統合分析顯示，飲用綠茶或其萃取物可適度降低TC和LDL-C濃度，但對HDL-C無影響。 然而，一項為期6年的縱向隊列研究表明，經常飲茶（包括紅茶和綠茶）與HDL-C濃度隨年齡增長而下降的速度減緩相關。

Dietary supplements Some dietary supplements are considered to be beneficial for health. Fish oil, or marine omega-3 fatty acid supplementation, yields a dose-dependent reduction in TG from the effect of eicosapentenoic acid (EPA) and docosahexenoic acid (DHA), but no overt changes in TC, LDL-C or HDL-C.60,61 Red yeast rice (RYR) extract has been applied as a cholesterol-lowering nutraceutical. During the rice fermentation, the main bioactive compound, monacolin K, is a weak reversible inhibitor of 3-hydroxy-3- methylglutaryl-coenzyme A (HMG-CoA) reductase. In a metaanalysis study, using RYR from 1200 mg/day to 4800 mg/ day, LDL-C was lowered with 18.4 mg/dL compared to placebo.62 However, the quality of RYR products in the market varied and RYR may possess a potential risk of pharmacological interactions and its safety outcomes have not been extensively studied yet. The flavonoids in cocoa products inhibit cholesterol absorption. A meta-analysis showed that consumption of dark chocolate for 2e12 weeks significantly reduced TC and LDL-C (6.2 and 5.9 mg/ dL), respectively.63 Nonetheless, it is a concern that dark chocolate products contained varied amount of saturated fats and added sugar. Vitamin D may affect circulating cholesterol levels by modulating the transcription activity of vitamin D receptor and insulin-induced gene-2 activity which inhibits HMG-CoA reductase expression.64,65 Clinical study indicated that vitamin D supplementation has benefits on reducing TC, LDL-C, and TG but no influence on HDLC level.64 A meta-analysis of 14 randomized controlled trials showed that consumption of green tea or its extracts resulted in a moderate reduction in TC and LDL-C concentrations, but no change in HDL-C.66 However, a longitudinal cohort study with 6-year follow-up showed that frequent tea consumption, including black tea and green tea, was associated with a slower age-related decrease in HDL-C concentrations.67

2022-台灣高血脂初級預防指引- 9. 非藥物治療-飲食

2025-12-09 11:08AM

2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

非藥物療法 

飲食 

多項觀察性和隨機臨床研究表明，健康的飲食模式與較低的動脈粥樣硬化性心血管疾病 (ASCVD) 風險相關，例如地中海飲食、DASH（膳食療法控制高血壓）飲食、台灣健康飲食 (TEA) 和台灣素食。 

台灣飲食模式研究也指出，油炸食品、甜食和含糖飲料、高脂肪和高糖糕點、肥肉和動物內臟是心血管代謝疾病的危險食物。

基於這些研究，一種有益心臟健康的飲食模式包括：

富含植物性食物，例如全穀物、蔬菜、新鮮水果、堅果和種子、茶以及富含不飽和脂肪酸的非熱帶植物油（例如大豆油、葵花籽油、橄欖油）；

富含ω-3脂肪酸的食物（例如魚類、大豆、豆類）；

低反式脂肪、油炸食品、肥肉、加工肉類或魚類製品（例如香腸、培根、火腿和熱狗）以及添加糖/精製糖的攝取量應較低。 

統合分析表明，低碳水化合物飲食可能有助於減輕體重並改善高密度脂蛋白膽固醇 (HDL-C) 和三酸甘油酯 (TG) 水平。 然而，低密度脂蛋白膽固醇 (LDL-C) 和總膽固醇 (TC) 升高的潛在後果是一個主要問題。

在過去幾十年，雞蛋攝取量與動脈粥狀硬化性心血管疾病 (ASCVD) 發生之間的關聯性已得到證實，但仍存在爭議。雞蛋不僅飽和脂肪酸含量低，而且富含蛋白質和各種微量營養素，這些營養素已被證明可以促進大分子 LDL-C 的形成，而大分子 LDL-C 的致動脈粥樣硬化作用較弱。 由於可能仍存在中等的劑量反應關係，因此應根據個人的 LDL-C 目標值和營養狀況來調整雞蛋的攝取量。

此外，乳製品攝取的影響也存在爭議，因為先前的研究發現飽和脂肪酸含量會增加低密度脂蛋白膽固醇（LDL-C）水平。 近期的一些統合分析顯示，乳製品攝取對心血管結局的影響可能是正面的，也可能是中性的，而一項台灣的前瞻性研究則顯示乳製品具有保護作用。乳製品，包括發酵乳製品以及最好是脫脂或低脂乳製品，可以作為健康飲食的一部分適量食用。

Non-pharmacological therapy 

Diet 

Several observational and randomized clinical studies have demonstrated association between a lower risk of ASCVD and healthy dietary patterns, such as Mediterranean diet, DASH (Dietary Approaches to Stop Hypertension) diet, healthy Taiwanese eating approach (TEA), and Taiwanese vegetarian diet. Taiwanese dietary pattern studies also identified fried foods, sweets and sweetened beverages, high fat and sugar-containing pastry, fatty and organ meats as risky foods for cardiometabolic diseases.47,49 Based on these studies, a cardioprotective dietary pattern includes: rich plant-based foods including whole grains, vegetables, fresh fruits, nuts and seeds, tea, and unsaturated fatty acid-rich non-tropical plant oils (e.g., soybean oil, sunflower oil, olive oil); sources of omega-3 fatty acids (e.g., fish, nuts, legumes); good protein foods (low degree processed soy product, fish, egg, and lean animal protein); low in trans-fats, fried foods, fatty meat, processed meats or fish products (e.g., sausage, bacon, ham and hot dogs), and added/refined sugars.50e54 Meta-analysis indicated that low-carbohydrate diets may help weight loss and improve HDL-C and TG levels.55 However, the potential consequence of elevated LDL-C and total cholesterol (TC) is a major concern. In the past decades, the modest association between eggs consumption and the development of ASCVD has been established but remains controversial. Eggs are not only low in saturated fatty acid but also rich in protein and various micronutrients, which have been shown to promote the formation of large LDL-C, which is less atherogenic.56,57 Since there may still be a moderate doseeresponse relationship, the appropriate amount of egg consumption should be individualized based on individual’s LDL-C target and nutrition status. Besides, the effect of dairy consumption is also controversial due to previous observation relating the saturated fatty acid content to increase LDL-C levels.58 Recent meta-analyses revealed either positive or neutral effects on CV outcomes from consumption of dairy products, while a Taiwanese prospective study showed protective association.47 Dairy, including fermented and preferably no-fat or low-fat products, may be consumed moderately as part of a healthy diet.59

2022-台灣高血脂初級預防指引- 8. LDL目標值-低度風險民眾

2025-12-09 11:08AM

2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

低危險群至微危險因子（<2個危險因子）：無危險因子或僅有一個危險因子的個體被歸類為低危險群至微危險群。對於低危險群至微危險群但LDL-C水準升高的患者，最佳管理方案仍有爭議。國際指引通常使用風險計算器進行10年風險評估，但往往忽略低風險的年輕患者，因為在未來十年內不太可能出現與動脈粥狀硬化性心血管疾病（ASCVD）相關的不良事件，然而，LDL-C水平升高仍然與日後ASCVD風險增加相關。 ⁴¹ 多項證據表明，ASCVD風險與終生LDL-C累積暴露量密切相關。 ^42,43 因此，有必要在生命早期採取措施控制LDL-C水平，以預防日後ASCVD的發生。新出現的證據表明，即使在初級預防中風險較低的人群中，降血脂治療的益處也可能非常顯著，尤其是在基線低密度脂蛋白膽固醇（LDL-C）水平為 135 mg/dL 時。 ⁴⁴ 對於沒有任何危險因子的族群，本指引建議，根據專家共識，LDL-C 水準的起始治療目標值為 160 mg/dL。對於僅有 1 個危險因子的族群，LDL-C 水準的起始治療目標值為 130 mg/dL。毫無疑問，對於這類人群，應優先考慮並強調非藥物治療和生活方式介入。在日本指引中，中度風險族群的低密度脂蛋白膽固醇（LDL-C）目標值為<140 mg/dL，低風險族群的目標值為<160 mg/dL。 ³⁹ 在韓國指引中，對於僅有一項或更少主要危險因子的族群，LDL-C目標值為<160 mg/dL。 ⁴⁰ 若在生活型態調整3個月後，LDL-C仍高於目標值，則先考慮使用中等強度的他汀類藥物。對於這類族群，可考慮進行進一步檢查，例如冠狀動脈鈣化評分，以重新評估動脈粥狀硬化性心血管疾病（ASCVD）風險並調整他汀類藥物的治療強度。對於低風險或微風險族群，是否需要進一步檢查或長期他汀類藥物治療，應在充分解釋和理解檢查及治療的益處和風險後，與患者共同做出決策。圖 1 總結了 LDL-C 一級預防的整體治療流程。

建議：對於具有 1 項危險因子且 LDL-C ≥ 130 mg/dL 的受試者，應開始非藥物治療，LDL-C 目標值為 < 130 mg/dL。 （COR IIa，LOE C）
對於無危險因子且低密度脂蛋白膽固醇 (LDL-C) ≥ 160 mg/dL 的受試者，應開始非藥物治療，LDL-C 目標值為 < 160 mg/dL。 （證據等級 IIa，C 級）對於有 0 至 1 項危險因子的受試者，如果經過 3 個月的非藥物治療後 LDL-C 仍未達到目標值，則在共同決策後可考慮使用中等強度他汀類藥物。 （證據等級 IIa，C 級）

Minimal to low risk (<2 risk factors) Individuals with no or only one risk factor are classified as the minimal to low risk category. The optimal way to manage subjects at minimal to low risk but with elevated LDL-C is still controversial. International guidelines using risk calculator for 10-year risk estimation are prone to ignore younger patients with low risk because it is unlikely to see ASCVD-related adverse outcomes in the forthcoming decade, but increased LDL-C is still associated with an increased risk of ASCVD later in life.41 Multiple evidences have proved that the risk of ASCVD is strongly correlated with the cumulative exposure to LDL-C in one’s lifetime.42,43 Therefore, it is necessary to act early in life to control LDL-C and prevent ASCVD later in life. Emerging evidence indicates that even among individuals with low risk at primary prevention, the benefit of lipid lowering therapy can be significant, especially when the baseline LDL-C is
135 mg/dL.44 For subjects without any risk factor, this guideline suggests that the LDL-C level for initiation of therapy and treatment target is 160 mg/dL based on the experts’ consensus. For subjects with only 1 risk factor, the LDL-C level for initiation of therapy and treatment target is 130 mg/dL. There is no doubt that nonpharmacologic therapy with lifestyle modification is preferred and should be emphasized in this group. In the Japanese guidelines, the LDL-C target is <140 mg/dL in moderate risk and <160 mg/dL in low risk category.39 In Korean guidelines, the LDL-C target is <160 mg/dL in those with one or fewer major risk factors.40 Moderate-intensity statins are considered first if LDL-C remains higher than the target after 3 months of lifestyle adjustment. Further examinations, such as coronary calcium score, could be considered in redefining ASCVD risk and changing the intensity of statin treatment in this category. The decision of further examinations or long-term statin therapy in subjects at minimal to low risk category should be made after shared decision making with explanation and understanding of the benefit and risk of the examinations and treatment. The overall treatment algorithm of LDL-C for primary prevention is summarized in Fig. 1.

Recommendation In subjects with 1 risk factor and LDL-C
130 mg/dL, non-pharmacological therapy should be initiated and the LDL-C target is <130 mg/dL. (COR IIa, LOE C)
In subjects without risk factor and LDL-C
160 mg/ dL, non-pharmacological therapy should be initiated and the LDL-C target is <160 mg/dL. (COR IIa, LOE C) In subjects with 0 to 1 risk factor, if the LDL-C target is not achieved after 3 months of nonpharmacological therapy, moderate-intensity statins could be considered after shared decision making. (COR IIa, LOE C)

2022-台灣高血脂初級預防指引- 7. LDL目標值-中度風險民眾

2025-12-09 11:08AM
2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

中度風險（≥2個風險因子）：根據專家共識，對於具有2個風險因子的受試者，啟動治療和治療目標的LDL-C水準為115 mg/dL。此建議的LDL-C水平與2019年ESC血脂指引中建議的低風險族群LDL-C目標值<116 mg/dL相近。 ¹⁸ 建議的LDL-C目標值115 mg/dL低於日本和韓國血脂指引中的數值，日本指引中中度風險族群的LDL-C目標值為<140 mg/dL，韓國指引中具有2個或以上主要風險因子族群的LDL-C目標值為<130 mg/dL。 ^39,40 如果在生活方式調整3個月後，LDL-C水平仍高於目標值，則首先考慮使用中等強度的他汀類藥物。

建議：對於具有 2 項危險因子且 LDL-C ≥ 115 mg/dL 的受試者，應開始非藥物治療，LDL-C 目標值為 < 115 mg/dL。 （證據等級 IIa，證據等級 C）如果非藥物治療 3 個月後仍未達到治療目標，則應考慮中等強度他汀類藥物治療。 （證據等級 IIa，證據等級 C）

Moderate risk (‡2 risk factors) The LDL-C level for initiation of therapy and treatment target in subjects with
2 risk factors is 115 mg/dL based on the experts’ consensus. This recommended LDL-C level is close to the 2019 ESC lipid guidelines suggesting the LDLC target <116 mg/dL in the low risk individuals.18 The recommended LDL-C target of 115 mg/dL is lower than that in the Japanese and Korean lipid guidelines where the LDLC target is <140 mg/dL for moderate risk in Japan and <130 mg/dL for those with 2 or more major risk factors in Korea.39,40 Moderate-intensity statins are considered first if LDL-C remains higher than the target after 3 months of lifestyle adjustment.

Recommendation In subjects with
2 risk factors and LDL-C
115 mg/ dL, non-pharmacological therapy should be initiated and the LDL-C target is <115 mg/dL. (COR IIa, LOE C) If the treatment target is not met after 3 months of non-pharmacological therapy, moderate-intensity statin therapy should be considered (COR IIa, LOE C)

2022-台灣高血脂初級預防指引-6 LDL目標值-高風險族群

2025-12-09 11:08AM
2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

LDL-C 目標值：高風險族群（糖尿病、慢性腎臟病、LDL-C ≥ 190 mg/dL）：

對於患有糖尿病、非透析慢性腎臟病或 LDL-C ≥ 190 mg/dL 的受試者，本指南建議 LDL-C 水平達到 100 mg/dL 時開始治療。由於 ASCVD 風險較高，應立即開始降血脂治療並進行生活方式介入。目前尚無僅針對 LDL-C ≥ 190 mg/dL 受試者的他汀類藥物治療的隨機、安慰劑對照試驗。 WOSCOPS 試驗是一項針對高膽固醇血症（平均 LDL-C 水平為 192±17 mg/dL）且無血管疾病史的受試者進行的普伐他汀（40 mg/天）隨機、安慰劑對照試驗。 ³⁸ 普伐他汀的使用顯著降低了心肌梗塞和心血管死亡的發生率。 WOSCOPS試驗中2560名基線LDL-C水平為190 mg/dL的受試者的事後分析顯示，他汀類藥物治療在試驗初期和超過20年的隨訪期內均顯著降低了主要不良心血管事件（MACE）的風險。 ³² 由於ASCVD風險較高，LDL-C水平為190 mg/dL的受試者的治療目標為LDL-C <100 mg/dL。鑑於基線LDL-C水平較高，建議LDL-C水平為190 mg/dL的受試者使用中高強度他汀類藥物合併依折麥布治療。

建議：對於患有糖尿病、非透析慢性腎臟病且低密度脂蛋白膽固醇（LDL-C）≥190 mg/dL 的患者，應立即開始降血脂治療，LDL-C 目標值為 <100 mg/dL。 （證據等級 I，證據等級 B）對於 LDL-C ≥190 mg/dL 的患者，建議使用中高強度他汀類藥物合併依折麥布。 （證據等級 I，證據等級 B）

LDL-C target High risk (DM, CKD, LDL-C ‡ 190 mg/dL) For subjects with DM, non-dialysis CKD, or LDL-C ‡190 mg/ dL, this guideline suggests the LDL-C level for initiation of therapy and treatment target is 100 mg/dL. Because the ASCVD risk is high, lipid lowering therapy should be started immediately with lifestyle modification. There has been no randomized, placebo-controlled trial of statin therapy performed only in subjects with LDL-C
190 mg/dL. The WOSCOPS trial was a randomized placebo-controlled trial of pravastatin (40 mg/day) for subjects with hypercholesterolemia (mean LDL-C level of 192  17 mg/ dL) and without history of vascular disease.38 The use of pravastatin significantly reduced the incidence of MI and CV mortality. The post hoc analyses among the 2560 subjects in the WOSCOPS trial with baseline LDL-C
190 mg/dL showed that statin therapy significantly reduced the risk of major adverse cardiovascular events (MACE) in the initial trial phase and over 20 years of follow-up.32 Because of the high risk for ASCVD, the treatment target of LDL-C is <100 mg/ dL in subjects with LDL-C
190 mg/dL. Since the baseline LDL-C level is high, moderate-to high-intensity statins combined with ezetimibe is recommended for subjects with LDL-C
190 mg/dL

Recommendation In subjects with DM, non-dialysis CKD, LDL-C
190 mg/dL, immediate lipid lowering therapy should be started and the LDL-C target is <100 mg/ dL. (COR I, LOE B) In subjects with LDL-C
190 mg/dL, moderate-to high-intensity statins combined with ezetimibe is recommended. (COR I, LOE B)

2022-台灣高血脂初級預防指引-5. 無風險因子的民眾

2025-12-09 11:08AM2022台灣血脂治療指引(英文版)

下面中文使用google自動翻譯

無高風險受試者
對於無糖尿病、慢性腎臟病且低密度脂蛋白膽固醇（LDL-C）低於190 mg/dL的受試者，應評估其他動脈粥狀硬化性心血管疾病（ASCVD）危險因子。這些因素包括：

（1）高血壓；

（2）男性年齡大於45歲或女性年齡大於55歲或已停經；

（3）早期冠心病（CAD）家族史（男性小於55歲或女性小於65歲）；

（4）男性高密度脂蛋白膽固醇（HDL-C）低於40 mg/dL或女性低於50 mg/dL；5）

（5）吸菸。

由於一些研究也認為中心性肥胖、糖尿病前期和三酸甘油酯（TG）是ASCVD的危險因素，因此本指南將包含所有這些因素的代謝症候群視為第六個獨立危險因子。

代謝症候群的定義參照美國國家膽固醇教育計畫成人治療組第三次報告（NCEP ATP III）中針對亞洲人群的修訂版。

符合以下五項標準中三項或三項以上者，即可診斷為代謝症候群：

(1) 男性腰圍大於90 cm，女性腰圍大於80 cm；

(2) 血壓≥130/85 mmHg或正在服用降血壓藥物；

(3) 空腹血糖≥100 mg/dL或正在服用降血糖藥物

(4) 空腹甘油三酯（1095 mg）；男性高密度脂蛋白膽固醇（HDL-C）<40 mg/dL，女性HDL-C<50 mg/dL

基於上述危險因子評估，初級預防對象可分為下列風險類別。

高風險族群指患有糖尿病 (DM)、慢性腎臟病 (CKD) 或低密度脂蛋白膽固醇 (LDL-C) ≥ 190 mg/dL 的受試者。

對於未患有 DM、CKD 或 LDL-C ≥ 190 mg/dL 的族群，中度風險指具有 2 項或以上風險因子的受試者，低風險指有 1 項風險因子的受試者，極低風險指無風險因子的受試者。

高風險族群需要立即接受降血脂治療以達到建議的 LDL-C 目標值。對於非高風險族群，建議先進行 3 個月的生活方式乾預，然後再考慮降血脂治療。初級預防的總體風險類別總結於表 2。

建議

對於初級預防，患有糖尿病、非透析慢性腎臟病或低密度脂蛋白膽固醇（LDL-C）≥190 mg/dL 的個體發生動脈粥狀硬化性心血管疾病（ASCVD）的風險較高，需要立即進行降血脂治療。 （證據等級 I，證據等級 A）

對於未患糖尿病、慢性腎臟病或 LDL-C≥190 mg/dL 的個體，應根據危險因子將 ASCVD 風險分為極低、低或中等。 （證據等級 I，證據等級 C）


Subjects without high risk
In subjects without DM, CKD, and LDL-C
190 mg/dL, other risk factors of ASCVD should be evaluated. These include: (1) hypertension, (2) age greater than 45 years in men or greater than 55 years in women or menopausal women, (3) family history of premature CAD (less than 55 years in men or less than 65 years in women), (4) high-density lipoprotein cholesterol (HDL-C) less than 40 mg/dL in men or less than 50 mg/dL in women and (5) smoking.35 Because central obesity, prediabetes and triglyceride (TG) are also considered to be ASCVD risk factors in some studies, metabolic syndrome that include all these items is regarded as the sixth independent risk factor in this guideline. Metabolic syndrome is defined according to the modified National Cholesterol Education Program Adult Treatment Panel III for Asians.36,37 Patients who meet three or more of the following criteria are considered to have metabolic syndrome: (1) waist circumference greater than 90 cm in men or greater than 80 cm in women, (2) blood pressure of 130/ 85 mmHg or higher or use of antihypertensive medication, (3) fasting glucose level of 100 mg/dL or higher or use of antidiabetic drug, (4) fasting TG level of 150 mg/dL or higher or use of lipid-lowering agent for increased TG, and (5) HDL-C less than 40 mg/dL in men or less than 50 mg/dL in women (Table 1). Based on the above-mentioned risk factor evaluation, the subjects with primary prevention can be classified into the following risk categories. High risk indicates subjects with DM, CKD or LDL-C
190 mg/dL. In those without DM, CKD or LDL-C
190 mg/dL, moderate risk indicates subjects with 2 or more risk factors, low risk indicates with 1 risk factor and minimal risk indicates no risk factor. Subjects with high risk need immediate lipid lowering therapy to reach the recommended LDL-C target. Lifestyle modification first is recommended for 3 months before considering lipid lowering therapy in the subjects without high risk. The overall risk categories for primary prevention are summarized in Table 2.


Recommendation
For primary prevention, subjects with DM, nondialysis CKD, or LDL-C
190 mg/dL are at high risk of ASCVD and immediate lipid lowering therapy is necessary. (COR I, LOE A) In subjects without DM, CKD, or LDL-C
190 mg/dL, the risk of ASCVD should be classified as minimal, low, or moderate according to the risk factors. (COR I, LOE C)

2022-台灣高血脂初級預防指引-4. 風險分級

2025-12-09 11:08AM
2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

風險類別

高風險族群（糖尿病、慢性腎臟病和低密度脂蛋白膽固醇≥190 mg/dL）：本一級預防指南決定沿用傳統的目標值控制方法，低密度脂蛋白膽固醇的治療目標值根據心血管危險因子的存在情況進行調整。由於動脈粥狀硬化性心血管疾病是糖尿病和慢性腎臟病患者死亡的主要原因，因此這兩類患者被認為是高風險族群。糖尿病的診斷和糖尿病血脂異常的管理策略已在2017年台灣高風險患者血脂指南¹⁰中進行了描述。對於慢性腎臟病，蛋白尿是用於檢測和診斷慢性腎臟病的重要生物標記。蛋白尿是指尿液中白蛋白排泄量增加。非定時尿液樣本中的尿液白蛋白與肌酸酐比值 (UACR) 已取代 24 小時尿液白蛋白排泄量，成為測量蛋白尿的首選方法。 23e26 蛋白尿液定義為 UACR ≥ 30 mg/g，可進一步分為微量白蛋白尿 (UACR 30-300 mg/g) 和大量白蛋白尿 (UACR > 300 mg/g)。美國國家腎臟基金會腎臟疾病預後品質倡議（KDOQI）指引將慢性腎臟病（CKD）定義為腎損傷（尿液白蛋白/肌酸酐比值[UACR] ≥ 30 mg/g）或腎小球濾過率（GFR）< 60 mL/min/1.73 m²，且持續至少三個月。 ^27,28 GFR通常根據血清肌酸酐水平，以腎臟疾病飲食改良（MDRD）²⁹或慢性腎臟病流行病學協作組（CKD-EPI）³⁰方程式進行估算。對於合併糖尿病和非透析CKD的患者，建議立即進行降血脂治療。嚴重高膽固醇血症（定義為低密度脂蛋白膽固醇[LDL-C] ≥ 190 mg/dL）會增加動脈粥狀硬化性心血管疾病（ASCVD）和過早心血管事件的風險。這些族群罹患冠心病的風險比一般人高5至6倍，男性罹患冠心病的時間比一般人早10至20年，女性早20至30年。 ³¹早期開始降血脂治療可顯著降低這些族群的發生率和死亡率。 ³²低密度脂蛋白膽固醇（LDL-C）≥190 mg/dL顯著增加家族性高膽固醇血症（FH）的發生率。 LDL-C≥190 mg/dL的族群中約有7%可能符合FH的診斷標準。 ³³應考慮這類族群進行基因檢測以診斷FH。先前研究表明，與LDL-C<130 mg/dL且未檢測到FH基因突變的參考組相比，LDL-C≥190 mg/dL且未檢測到FH基因突變的受試者發生冠心病的風險高出6倍，而LDL-C≥190 mg/dL且同時攜帶FH基因突變的受試者發生冠心病的風險則高出sup.22</sup>202倍。由於LDL-C≥190 mg/dL是一個非常特殊且高風險的群體，具有顯著的長期臨床預後，因此被歸類為高風險族群。與糖尿病和慢性腎臟病一樣，由於這些患者的心血管風險極高，建議立即進行降血脂治療並強化LDL-C控制。

Risk category

High risk (DM, CKD and LDL-C ‡ 190 mg/dL) This primary prevention guideline decides to keep a conventional target approach and the LDL-C treatment targets are tailored according to the presence of CV risk factors. Since ASCVD is a major problem contributing to significant mortality in populations with DM and CKD, these 2 groups of patients are considered at high risk. The diagnosis of DM and management strategy of diabetic dyslipidemia was described in the 2017 Taiwan Lipid Guidelines for High Risk Patients.10 For CKD, albuminuria is an important biomarker which is used to detect and define CKD. Albuminuria refers to increased urinary excretion of albumin. The urine albumin-to-creatinine ratio (UACR) in an untimed urine specimen has replaced 24-h urine albumin excretion as the preferred method for measuring albuminuria.23e26 Albuminuria is defined as a UACR
30 mg/g and can be further categorized into microalbuminuria (UACR 30e300 mg/g) and macroalbuminuria (UACR > 300 mg/g). The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines defined CKD as kidney damage (UACR
30 mg/g) or a glomerular filtration rate (GFR) < 60 mL/min/1.73 m2 for at least three months.27,28 The GFR is usually estimated from the serum creatinine level according to equations of the Modification of Diet in Renal Disease (MDRD)29 or the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).30 Immediate lipid lowering therapy is recommended for DM and non-dialysis CKD. Severe hypercholesterolemia, defined as having an LDLC
190 mg/dL, carries a high risk of ASCVD and premature CV events. These individuals have a 5 to 6-fold higher risk of CAD and develop CAD 10e20 years earlier in men and 20e30 years earlier in women than general population.31 Early initiation of lipid-lowering therapy can significantly reduce morbidity and mortality in these subjects.32 LDL-C
190 mg/dL significantly increases the likelihood for the presence of FH. Approximately 7% of the subjects with LDLC
190 mg/dL may fulfill the diagnostic criteria of FH.33 Genetic testing should be considered for this group of subjects for diagnosis of FH. Previous study demonstrated that, compared with a reference group with LDL-C <130 mg/dL without detected FH genetic mutation, subjects with LDL-C
190 mg/dL without detected FH mutation had a 6-fold higher risk for CAD, whereas those with both LDL-C
190 mg/dL and an FH mutation demonstrated a 22-fold increased risk.34 Because LDL-C
190 mg/dL is a very unique and high risk group with a distinct long-term clinical outcome, it is classified as high risk. Just like DM and CKD, immediate lipid lowering therapy with intensive LDL-C control is recommended because the CV risk is so high in these patients.

2022-台灣高血脂初級預防指引-3.風險計算

2025-12-09 11:08AM
2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

風險計算

對於初級預防，通常使用基於人群研究的動脈粥狀硬化性心血管疾病（ASCVD）風險評估計算，例如弗雷明漢風險評分，來決定受試者是否應接受降血脂治療。近年來，美國心臟病學會（ACC）和美國心臟協會（AHA）開發了合併隊列方程式。歐洲心臟學會（ESC）和歐洲動脈粥狀硬化學會（EAS）使用SCORE（系統性冠狀動脈風險評估）進行ASCVD風險評估。英國國家健康與臨床優化研究所（NICE）指引使用QRISK2作為ASCVD風險評估工具。儘管有許多針對特定族群的風險評估工具，但目前尚無任何模式源自東亞族群或經過前瞻性驗證。美國心臟協會/美國心臟病學會 (AHA/ACC) 總結隊列方程式用於估算 40 至 79 歲黑人和非西班牙裔白人男性和女性的 10 年 ASCVD 事件風險。 此風險預測指標可能高估了華人族群的 ASCVD 風險。  Framingham 風險評分也高估了華裔族群的 ASCVD 風險。

在台灣，20 世紀 90 年代，基於金山社區心血管隊列研究開發了一種基於積分的 10 年冠心病 (CAD) 風險預測模型。 然而，該模型並未明確定義高風險的臨界值。一些檢查，例如踝臂指數、脈搏波速度、頸動脈超音波和冠狀動脈鈣化評分，已被用於 ASCVD 風險評估。這些檢查在地方診所的可近性是一個主要問題。此外，冠狀動脈鈣化評分檢查的費用和輻射暴露也是需要考慮的重要因素。基本上，該指南並不鼓勵對無症狀族群進行亞臨床動脈粥狀硬化的常規篩檢。目前，在台灣，使用危險因子的數量進行風險分層更為便利。

Risk calculator

For primary prevention, population study-derived ASCVD risk estimate calculators, such as the Framingham risk score, are commonly used to decide whether a subject should receive lipid-lowering therapy or not. In recent years, the American College of Cardiology (ACC) and the American Heart Association (AHA) developed the pooled cohort equation.15,16 The European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) used SCORE (Systematic COronary Risk Evaluation) for ASCVD risk assessment.17,18 The UK National Institute for Health and Care Excellence (NICE) guidelines used the QRISK2 as the ASCVD risk assessment tool.19 Although several populationspecific risk assessment tools exist, none of the currently available models are derived from or prospectively validated in East Asians. The AHA/ACC pooled cohort equation for estimating the 10-year risk of ASCVD event is applicable to black and non-Hispanic white men and women 40 through 79 years of age.15 This risk predictor may overestimate the ASCVD risk in the Chinese population.20 The Framingham risk score also overestimated the ASCVD risk for ethnic Chinese.21 In Taiwan, a point-based prediction model to predict the 10-year risk of CAD was developed from the Chin-Shan Community Cardiovascular Cohort study in 1990s.22 However, the definite cut-off point to define high risk was not indicated. Some examinations, such as ankle-brachial index, pulse wave velocity, carotid ultrasound, and coronary calcium score, have been used in ASCVD risk assessment. The accessibility of these examinations is a major problem in local clinics. Concerns of cost and radiation exposure for examination of coronary calcium score are also important considerations. Basically, this guideline does not encourage to routinely screen the presence of subclinical atherosclerosis in asymptomatic subjects. At current stage, using the numbers of risk factors is a more convenient way for risk stratification in Taiwan.

2022-台灣高血脂初級預防指引-2 初級預防定義

2025-12-09 11:08AM

初級預防是指尚未發生疾病. 但因具備疾病危險因子. 發生疾病機率會提高. 所以採取各種策略降低危險因子. 

2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

初級預防的定義 

由於這是初級預防指南，因此首先應描述具有臨床意義的動脈粥樣硬化性心血管疾病（ASCVD）的定義。已有研究表明，動脈粥狀硬化最早可追溯至2歲兒童時期。一系列病理學研究，從朝鮮戰爭和越南戰爭中陣亡士兵的屍檢，到最近的青少年動脈粥樣硬化病理生物學決定因素研究和博加盧薩心臟研究，均表明冠狀動脈脂肪紋在生命早期形成，並且一部分青少年體內存在晚期纖維斑塊。過去幾十年來的大量證據表明，吸菸、血脂異常、高血壓、胰島素抗性、肥胖和糖尿病等心血管危險因子會加速整個生命週期的動脈粥狀硬化進程。 「初級預防」的主要目的是透過消除或改變危險因子來預防具有臨床意義的動脈粥狀硬化性心血管疾病（ASCVD）。

具有臨床意義的ASCVD包括：

（1）冠狀動脈疾病（CAD），例如運動負荷試驗陽性的心絞痛和/或影像學檢查顯示主要冠狀動脈直徑狹窄>50%；

（2）急性冠脈綜合徵（ACS），例如心肌梗塞和不穩定型心絞痛；

（3）腦血管疾病，如短暫性腦缺血發作、缺血性中風和影像學檢查顯示頸動脈狹窄>50%；

（4）週邊動脈疾病（PAD），影像學檢查顯示主要肢體動脈直徑狹窄>50%；以及

（5）主動脈粥樣硬化性疾病，如影像學檢查顯示腹主動脈瘤。

對於臨床顯著的動脈粥狀硬化性心血管疾病（ASCVD）患者，血脂異常的治療應參考2017年台灣高風險族群血脂指引及其更新版的建議。本初級預防指引闡述了無臨床顯著ASCVD族群血脂控制的一般原則。

風險分層是決定一級預防降血脂策略的第一步。

建議：
臨床上顯著的ASCVD患者需要立即強化降低低密度脂蛋白膽固醇（LDL-C）水準。 （建議等級I，證據等級A）

對於無臨床顯著ASCVD族群的一級預防，需要進行風險分層以確定降血脂策略。 （建議等級I，證據等級B）
Definition of primary prevention Since this is a primary prevention guideline, the definitions of clinically significant ASCVD should be described first. It has been demonstrated that atherosclerosis originates in childhood as early as 2 years of age. A series of pathology studies, from autopsies of soldiers killed in the Korean and Vietnam Wars to the more recent Pathobiological Determinants of Atherosclerosis in Youth12 and Bogalusa Heart studies,13 demonstrated that coronary fatty streaks develop early in life and advanced fibrous plaques are present in a proportion of adolescents. During the past decades, convincing evidence has emerged that CV risk factors, such as cigarette smoking, dyslipidemia, hypertension, insulin resistance, obesity, and DM, accelerate the atherosclerotic process throughout the life span.14 The major purpose of “primary prevention” refers to prevention of clinically significant ASCVD by removing or modifying risk factors. The clinically significant ASCVD include: (1) CAD, such as angina with positive stress test and/or major coronary artery diameter stenosis >50% by imaging studies; (2) ACS, such as myocardial infarction and unstable angina; (3) cerebrovascular disease, such as transient ischemic attack, ischemic stroke, and carotid artery stenosis >50% by imaging studies; (4) PAD with major extremity artery diameter stenosis >50% by imaging studies; and (5) aortic atherosclerotic disease, such as abdominal aortic aneurysm by imaging studies. Treatment of dyslipidemia for clinically significant ASCVD should be referred to the recommendations in the 2017 Taiwan Lipid Guidelines for High Risk Patients and its focused update. This primary prevention guideline addresses the general principles of lipid control in subjects without clinically significant ASCVD. Risk stratification is the first step to determine the lipid lowering strategy in primary prevention.
Recommendation
Clinically significant ASCVD needs immediate and intensive reduction of LDL-C. (COR I, LOE A) For primary prevention in subjects without clinically significant ASCVD, risk stratification is necessary to determine the lipid lowering strategy. (COR I, LOE B)

2022-台灣高血脂初級預防指引-1 引言

2025-12-09 11:08AM
2022台灣血脂治療指引(英文版)下面中文使用google自動翻譯

引言 

心血管疾病（CVD），包括動脈粥狀硬化性心血管疾病（ASCVD），是台灣地區的主要死因之一。多項實驗室、流行病學和遺傳學研究證據表明，循環中低密度脂蛋白膽固醇（LDL-C）水平升高會導致膽固醇在動脈壁加速沉積，進而引發血管發炎和動脈粥狀硬化。許多臨床試驗進一步證實了LDL-C與ASCVD之間的因果關係，結果表明，強化降低LDL-C水平是減緩冠狀動脈粥樣硬化進展和改善心血管預後的有效療法。 近期研究表明，對於未確診冠狀動脈粥樣硬化的個體，早期開始使用他汀類藥物降低LDL-C水平，可以獲得與未接受治療的低LDL-C水平個體相似的心血管風險。  顯然，在生命早期維持適當的LDL-C水平是預防ASCVD的有效介入措施。然而，台灣的低密度脂蛋白膽固醇（LDL-C）控制率令人失望。即使在動脈粥狀硬化性心血管疾病（ASCVD）患者中，僅有54%的患者LDL-C水平能達到<100 mg/dL。 台灣血脂與動脈粥狀硬化學會聯合台灣其他七個主要學會於2017年發布了《台灣高危險群血脂指南》。 此指引針對高風險族群，包括冠狀動脈疾病（CAD）、急性冠狀動脈症候群（ACS）、缺血性中風、週邊動脈疾病（PAD）、糖尿病（DM）、慢性腎臟病（CKD）和家族性高膽固醇血症（FH）患者，建議了最佳血脂目標值和治療策略。 2017年版《台灣高危險群血脂指南》在台灣廣受好評，並成為高風險族群血脂異常治療的標準指南。但該指引並未提及不具備上述高風險特徵族群的血脂異常管理。 2005年至2008年台灣營養與健康調查顯示，高膽固醇血症（定義為膽固醇水平≥240 mg/dL）在男性中的盛行率為12.5%，在女性中為10%。 台灣血脂與動脈粥狀硬化學會決定推進一級預防，並制定了一項新的血脂指南，旨在針對無臨床顯著動脈粥樣硬化性心血管疾病（ASCVD）但可能存在其他各種血管危險因素的人群。台灣血脂與動脈粥狀硬化學會於2020年11月至2021年3月召開了諮詢委員會會議。來自台灣家庭醫學會、台灣心臟學會、台灣中風學會、台灣糖尿病學會、台灣糖尿病教育者協會、台灣腎臟病學會和台灣血脂教育者協會的專家和意見領袖出席了諮詢委員會會議並提出了重要建議。科學證據是該指引的主要依據。然而，我們認識到，台灣可能缺乏足夠的數據來支持血脂異常一級預防管理各個方面的建議。許多建議是專家討論後達成的共識。與2017年台灣高風險族群血脂診療指引類似，本指引採用建議等級（COR）和證據等級（LOE）來描述建議的強度及其相關的科學證據。 建議等級分為三級：I級（建議有用、有指徵且必要）、IIa級（建議可能有用且有指徵，但證據強度低於I級）、IIb級（建議可以考慮，但其效果尚不明確）和III級（建議涉及有害、禁忌且不應進行的治療）。

證據等級也分為三級：A級（建議有多項隨機臨床試驗支援）、B級（建議僅來自有限的隨機試驗或觀察性研究）和C級（建議來自專家共識）。


Introduction Cardiovascular (CV) disease, including atherosclerotic cardiovascular disease (ASCVD), is one of the major leading causes of death in Taiwan.1 Multiple evidences from laboratory, epidemiological, and genetic studies indicate that increased circulating low-density lipoprotein cholesterol (LDL-C) causes accelerated deposition of cholesterol in the arterial wall leading to vascular inflammation and atherosclerosis.2,3 The causal link of LDL-C and ASCVD was further proved in many clinical trials showing that intensive reduction of LDL-C is an effective therapy to attenuate the progression of coronary atherosclerosis and improve CV outcomes.4e7 Recent study demonstrated that, in individuals without established coronary atherosclerosis, early initiation of statin therapy to decrease LDL-C could obtain a similar CV risk as those with untreated low LDL-C levels.8 It is clear that maintaining an adequate LDL-C level earlier in life is an effective intervention for prevention of ASCVD. However, the control rate of LDL-C is disappointing in Taiwan. Even in patients with ASCVD, only 54% of them could achieve an LDL-C level <100 mg/dL.9 The Taiwan Society of Lipids and Atherosclerosis, in association with seven other major societies in Taiwan, published the Taiwan Lipid Guidelines for High Risk Patients in 2017.10 The optimal lipid target and treatment strategy were recommended for high risk patients, including those with coronary artery disease (CAD), acute coronary syndrome (ACS), ischemic stroke, peripheral artery disease (PAD), diabetes mellitus (DM), chronic kidney disease (CKD), and familial hypercholesterolemia (FH). The 2017 Taiwan Lipid Guidelines for High Risk Patients received critical acclaim in Taiwan and became the standard guidance for dyslipidemia treatment in high risk patients. The management of dyslipidemia for subjects without the above-mentioned high risk features was not mentioned in the 2017 guidelines. In the Nutrition and Health Surveys in Taiwan performed from 2005 to 2008, hypercholesterolemia defined as a cholesterol level
240 mg/dL was found in 12.5% in men and 10% in women.11 The Taiwan Society of Lipids and Atherosclerosis decided to move forward to primary prevention and developed a new lipid guideline targeting the subjects without clinically significant ASCVD, but may carry other various vascular risk factors. Advisory board meetings were held by the Taiwan Society of Lipids and Atherosclerosis from November 2020 to March 2021. Experts and opinion leaders from the Taiwan Association of Family Medicine, Taiwan Society of Cardiology, Taiwan Stroke Society, Taiwan Diabetes Association, Taiwan Association of Diabetes Educators, Taiwan Society of Nephrology and Taiwan Association of Lipid Educators attended the advisory board meetings and gave important suggestions. Scientific evidence is the major consideration of the guideline. However, we recognized that there may be insufficient data in Taiwan to support the recommendations in every aspect of dyslipidemia management for primary prevention. Many recommendations were consensus from the expert opinions after discussion. Similar to the 2017 Taiwan Lipid Guidelines for High Risk Patients, this guideline uses class of recommendation (COR) and level of evidence (LOE) to describe the intensities of the recommendations and their related scientific evidence.10 The COR includes 3 levels, including class I (the recommendations are useful, indicated, and necessary), class IIa (the recommendations maybe useful and indicated, but their intensity of evidence are less than class I), class IIb (the recommendations could be considered but their effects are less well established) and class III (the recommendations refer to the treatment that is harmful, contraindicated, and should not be done). The LOE also has 3 levels, including LOE A (the recommendations are supported by multiple randomized clinical trials), LOE B (the recommendations are from limited randomized trials or observational studies only), LOE C (the recommendations are from experts’ consensus).