肺炎鏈球菌疫苗-每年死亡個案數

2025-05-29 11:52AM
剛剛遇到一個年長女性. 七天前接種13價肺炎鏈球菌疫苗, 昨天疫苗注射部位紅腫痛. 順便查詢了一下肺炎鏈球菌每年死亡人數及紅腫反應發生率

[113-08-07] 衛福部焦點新聞. 肺炎躍居十大死因第三位，父親節守護爸爸健康，呼籲爸爸們踴躍接種肺炎鏈球菌疫苗，提升免疫保護力


疾管署說明，依據疾管署監測資料顯示，國內今(2024)年截至8月5日累計199例侵襲性肺炎鏈球菌感染症確定病例，為2020年以來同期新高，其中23例死亡，病例中以65歲以上民眾占38%(75例)、男性占61%(122例)為多；另根據衛福部十大死因統計，去(2023)年肺炎死亡1.7萬人，已躍居十大死因第三位，且男性肺炎死亡率為女性1.5倍，顯示男性更須注意防範肺炎威脅。


關於13價肺鏈疫苗的遲發性腫脹發生率. 查到 2018 年一篇文章

是否發生延遲腫脹主要跟年齡有相關. 跟疫苗是否有cross-reactive material 197 (CRM197) 相關. 

注射含AlPO4佐劑的PVC13 人數 5667 
注射不含AlPO4佐劑的PVC13 人數 304
注射6-13天之間的腫脹發生率

65歲以上. PCV13 + AlPO4佐劑= 0.9%~10.8%

65歲以上. PCV13 不含AlPO4佐劑=7.5%

50-64 歲. PCV13= 1~3.2%

不含cross-reactive material 197 (CRM197)18-49歲有一篇研究. 沒發生案例

不含cross-reactive material 197 (CRM197)53歲以上有兩篇研究. 沒發生案例

不含cross-reactive material 197 (CRM197)60歲以上有三篇研究. 沒發生案例

Late onset of injection site reactions after vaccination with the 13-valent pneumococcal conjugate vaccine in adult study populations
Christine Juergens 1, James Trammel 2, Yasuko Shoji 3, Scott Patterson 4, Wendy Watson 4, Chris Webber 5, William C Gruber 5, Daniel A Scott 4, Beate Schmoele-Thoma 1
Affiliations ExpandPMID: 29543583
PMCID: PMC6149808
DOI: 10.1080/21645515.2018.1452576

Abstract
Injection site reactions (ISRs; redness, swelling and pain) commonly occur within 1-2 days after vaccination. After administration of toxoid vaccines including diphtheria toxoid, a later onset of ISRs has also been observed. As the serotype capsular polysaccharides in the 13-valent pneumococcal conjugate vaccine (PCV13) are conjugated to cross-reactive material 197 (CRM197), a nontoxic variant of diphtheria toxin, the onset of ISRs over 14 days was explored in 8 adult studies with 19 cohorts. Subjects received PCV13 with aluminum phosphate (AlPO4, n = 5667) or without AlPO4 (n = 304); 1097 subjects received 23-valent pneumococcal polysaccharide vaccine (PPSV23). Late ISRs with onset between days 6-14 were observed in 8/8 cohorts aged ≥65 years after PCV13 with AlPO4 (incidence across cohorts for redness, 2.3%-19.6%; swelling, 0.9%-10.8%; pain, 1.6%-10.0%) and in 1/1 cohort after PCV13 without AlPO4 (redness 10.5%; swelling 7.5%; pain 12.3%); and in 2/4 cohorts aged 50 to 64 years after PCV13 (redness 3.1%-4.8%; swelling 1.0%-3.2%; pain 3.7%-5%). 

Late ISRs were not generally observed in 1/1 cohort aged 18 to 49 years after PCV13; in 2/2 cohorts aged ≥53 years after PCV13 revaccination; and in 3/3 cohorts aged ≥60 years who received PPSV23, which does not contain CRM197.

Post hoc analysis demonstrated numerically higher pneumococcal immune responses in subgroups with late ISRs versus those without. In conclusion, causality of late ISRs is likely multifactorial, with age and the PCV13 carrier protein CRM197 potentially associated. AlPO4, a vaccine adjuvant, did not appear causally related. Observations do not affect the favorable risk-benefit profile of PCV13.

野外與登山醫學-丹木斯禁忌症

2025-05-28 11:04AM
底下內容來自兩個不同網站.上面的是 from uptodate . 下面是 from Drug.com
中文是google自動翻譯

** 乙醯唑胺=丹木斯. 丹木斯是曾經的商品名. 乙醯唑胺是中文成分學名

筆記:
1. 曾發生嚴重全身性磺胺過敏的人, 不建議使用丹木斯

2. 曾發生輕微磺胺過敏的人, 發生丹木斯過敏機率並不高, 可與醫師討論是否試用藥物. 評估過敏反應
3. 明顯腎功能異常的人, 可能發生電解質失調(主要是 鈉 Na 鉀K), 不建議使用丹木斯(丹木斯是一種較弱的利尿劑)
4. 某些肝硬化患者, 可能出現肝腦病變, 而丹木斯在少部分民眾身上可能發生嚴重肝毒性,  增加肝腦病變風險, 因此不建議使用丹木斯 (severe hepatotoxicity is uncommon)

from uptodate
對於有中度至高度 HAI 風險的患者，乙醯唑胺是預防 AMS 的首選藥物（表 6）[ 33 ]。

系統性回顧和多項隨機試驗發現，乙醯唑胺單藥使用時，可使急性高山症症狀減輕約 75%[ 30,66-75 ]。
臨床上有效的預防劑量，同時也能最大限度地減少副作用，是每 12 小時 125 毫克（每日 250 毫克）（表 5）。然而，乙醯唑胺預防AMS的理想劑量尚未確定，大多數臨床試驗均採用較高劑量[ 20,52,54,73,76,77 ]。一些專家認為，理想的劑量是抑制腎臟碳酸酐酶的劑量（5mg/kg/天），但尚無臨床試驗證明，在成人中採用基於體重的方案能取得更好的效果[ 20 ]。對於 AMS 預防，較高的劑量不太可能提供額外的益處，但會增加副作用的發生率。
預防性使用的時間取決於上升情況。上升到固定睡眠高度的個體（例如，休閒滑雪者）可以在上升前一天開始服用乙醯唑胺並持續 48 小時。如果計劃進一步上升，可以繼續使用乙醯唑胺直至達到最大海拔。也可以間歇性服用乙醯唑胺，以加速海拔升高時的適應過程或治療輕度急性高山症。停藥後症狀不會復發。儘管急性高山症 (AMS) 的危險在幾天的適應後就會消失，但乙醯唑胺仍然可能對治療睡眠障礙有用。 （參見上文 『症狀輕微的病人』 ）乙醯唑胺

最顯著的副作用是周圍感覺異常。

其他症狀包括多尿、

碳酸飲料味覺淡化，

以及較不常見的噁心、嗜睡、頭痛、陽痿和近視。

乙醯唑胺會引起超敏反應、過敏反應，罕見情況下還會引起過敏性休克或史蒂文斯-約翰遜症候群。

對於對其他磺胺類藥物有嚴重過敏反應史的患者，應在旅行前進行評估，以確定是否可以耐受乙醯唑胺[ 78 ]。

儘管乙醯唑胺是一種磺胺類藥物，但它是一種非抗菌磺胺類藥物，據信它與磺胺類抗菌藥物（如甲氧芐啶-磺胺甲噁唑）沒有交叉反應。儘管如此，大多數乙醯唑胺產品說明書都將對任何磺胺類藥物過敏列為可能的禁忌症。 （請參閱“磺胺類藥物超敏反應”，關於‘交叉反應性’一節）來自 Drug.com乙醯唑胺

from Drug.com
乙醯唑胺是一種碳酸酐酶抑制劑，透過多種機制加速適應並改善低氧血症[ 79,80 ]。抑制腎臟碳酸酐酶會減緩二氧化碳的水化，減少碳酸氫鹽和鈉的重吸收，並導致碳酸氫鹽利尿，從而導致攝入後一小時內開始的代謝性酸中毒。乙醯唑胺可解除中樞化學感受器的抑制並刺激通氣，從而迅速改善氧合。重要的是，乙醯唑胺能在睡眠期間維持氧合，並防止極度低氧血症[ 81 ]。乙醯唑胺的溫和利尿作用有助於抵消與高山症相關的液體滯留。它還會減少夜間抗利尿激素的分泌和腦脊髓液的產生和量，並可能降低顱內壓（ICP）[ 20,82 ]。
禁忌症
對乙醯唑胺或製劑中的任何賦形劑過敏。由於乙醯唑胺是磺醯胺衍生物，乙醯唑胺、磺醯胺類藥物和其他磺醯胺衍生物之間可能存在交叉敏感性。
在鈉和/或鉀血清水平降低的情況下、在明顯的腎臟和肝臟疾病或功能障礙的情況下、在腎上腺功能衰竭的情況下以及在高氯性酸中毒的情況下，禁用乙醯唑胺治療。由於有肝性腦病變的風險，肝硬化患者禁用。
患有慢性非充血性閉角型青光眼的患者禁止長期服用乙醯唑胺，因為它可能導致角膜有機閉合，而惡化的青光眼卻被降低的眼壓所掩蓋。

from uptodate
Acetazolamide is the preferred pharmacologic agent for the prevention of AMS for those at moderate to high risk for developing HAI (table 6) [33]. Systematic reviews and multiple randomized trials have found that acetazolamide reduces symptoms of AMS by approximately 75 percent when used as a single agent for this purpose [30,66-75].
A clinically effective preventive dose that also minimizes side effects is 125 mg every 12 hours (250 mg daily) (table 5). However, the ideal dose of acetazolamide for AMS prophylaxis is not established, and most clinical trials have been performed with higher doses [20,52,54,73,76,77]. Some experts suggest that the ideal dose is at which renal carbonic anhydrase is inhibited (5 mg/kg per day), but no clinical trial has demonstrated superior results using a weight-based regimen in adults [20]. For AMS prevention, higher doses are unlikely to provide added benefit but increase the incidence of side effects.
Duration of prophylactic use depends upon the ascent profile. Individuals ascending to a fixed sleeping altitude (eg, recreational skiers) may start acetazolamide the day before ascent and continue for 48 hours. If further ascent is planned, acetazolamide can be continued until maximum elevation is attained. Acetazolamide can also be taken episodically to speed acclimatization while gaining altitude or to treat mild AMS. Symptoms do not recur when the drug is discontinued. Although the danger of AMS passes after a few days of acclimatization, acetazolamide may still be useful to treat disturbed sleep. (See 'Patient with mild symptoms' above.)
The most notable side effect of acetazolamide is peripheral paresthesia. Others include polyuria, flattened taste of carbonated beverages, and less commonly, nausea, drowsiness, headache, impotence, and myopia. Acetazolamide can induce hypersensitivity, allergic reactions, and, rarely, anaphylaxis or Stevens-Johnson syndrome.
Patients with a history of significant allergic reactions to other sulfonamide drugs should be evaluated before travel to determine if acetazolamide is tolerated [78]. Even though acetazolamide is a sulfonamide, it is a nonantimicrobial sulfonamide, which are believed to have no cross-reactivity with sulfonamide antimicrobials, such as trimethoprim-sulfamethoxazole. Despite this, most acetazolamide product inserts list allergy to any sulfonamide as a possible contraindication. (See "Sulfonamide hypersensitivity", section on 'Cross-reactivity'.)

from Drug.com
Acetazolamide is a carbonic anhydrase inhibitor that works by many mechanisms to accelerate acclimatization and ameliorate hypoxemia [79,80]. Inhibition of renal carbonic anhydrase slows the hydration of carbon dioxide, reduces reabsorption of bicarbonate and sodium, and causes a bicarbonate diuresis with resultant metabolic acidosis starting within one hour of ingestion. Acetazolamide disinhibits the central chemoreceptors and stimulates ventilation, which rapidly improves oxygenation. Importantly, acetazolamide maintains oxygenation during sleep and prevents periods of extreme hypoxemia [81]. Acetazolamide's mild diuretic action helps to counteract fluid retention associated with high-altitude illness. It also diminishes nocturnal antidiuretic hormone secretion and cerebrospinal fluid production and volume, and possibly lowers intracranial pressure (ICP) [20,82].
Contraindications
Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible.

Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in suprarenal gland failure, and in hyperchloremic acidosis. It is contraindicated in patients with cirrhosis because of the risk of development of hepatic encephalopathy.

Long-term administration of acetazolamide is contraindicated in patients with chronic noncongestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intraocular pressure.

野外與登山醫學－丹木斯使用於HAPE高海拔肺水腫 from WMS 2024 practice guideline

2025-05-06 中午 12:39

先看我的建議: 

1. 服用丹木斯可加速高度適應,可預防AMS/HACE, 建議中等風險等級的行程服用丹木斯(危險分級-高海拔疾病風險評估)

2. 不曾罹患HAPE的民眾, 不需服用預防 HAPE 的藥物

3. 曾在相似的風險狀態罹患HAPE的民眾, 再次遇到相似風險等級的行程, 僅服用丹木斯可能不夠, 建議預防性服用Nifedipine

下面是臨床指引的重點整理

1. 丹木斯對於預防HAPE無效(無研究報告顯示有效)

---- 無法降低HAPE發病率

---- 無法顯著降低肺動脈壓

2. 丹木斯可預防再返性HAPE(高海拔居民到低海拔生活之後重返高海拔地區)

Wilderness Medical Society Clinical Practice Guidelines for the Prevention, Diagnosis, and Treatment of Acute Altitude Illness: 2024 Update

中文使用google翻譯
乙醯唑胺
儘管有證據表明乙醯唑胺可加速適應並減弱動物模型117 - 119和一項人體研究120中的缺氧性肺血管收縮，但沒有數據支持其在 HAPE 預防中的作用。一項針對 13 名有 HAPE 病史的健康、未適應環境的低地居民進行的隨機、安慰劑對照、雙盲研究發現，與安慰劑組相比，服用乙醯唑胺組在快速上升至 4559 公尺後，儘管 AMS 減少、氧合改善，但 HAPE 發病率或肺動脈壓並未顯著降低。121臨床觀察顯示乙醯唑胺可以預防復發性高海拔肺水腫122 ，這種疾病常見於居住在高海拔地區、前往低海拔地區、然後在快速返回住所後患上高海拔肺水腫的個體。

建議
我們建議，對於曾經在高海拔地區旅行時患有高海拔肺水腫的人，不要使用乙醯唑胺來預防高海拔肺水腫。強烈推薦，中等品質證據。

建議
我們建議有高海拔肺水腫病史的人考慮使用乙醯唑胺來預防再次發生高海拔肺水腫。弱建議，中等品質證據。

Acetazolamide

Despite evidence that acetazolamide hastens acclimatization and blunts hypoxic pulmonary vasoconstriction in animal models117-119 and a single study in humans,120 no data support a role in HAPE prevention. A randomized, placebo-controlled, double-blind study of 13 healthy unacclimatized lowlanders with a history of HAPE found no significant reduction in the incidence of HAPE or pulmonary artery pressure after rapid ascent to 4559 m in those taking acetazolamide compared with placebo despite reductions in AMS and improved oxygenation.121 Clinical observations suggest that acetazolamide may prevent re-entry HAPE,122 a disorder seen in individuals who reside at high altitude, travel to lower elevation, and then develop HAPE upon rapid return to their residence.

Recommendation
We recommend that acetazolamide not be used for HAPE prevention in those with a history of the disease during prior trips to high altitude. Strong recommendation, moderate-quality evidence.

Recommendation
We suggest that acetazolamide be considered for prevention of re-entry HAPE in people with a history of the disorder. Weak recommendation, moderate-quality evidence.

醫療器材可以上網販賣嗎？

2025-05-02 10:33am

［衛福部 101-11-01 ］公告
第一等級醫療器材包括OK繃、紗布、棉花棒、一般醫療用口罩（外科手術口罩除外）、護具、束腹帶、機械式助行器、機械式輪椅等，依據「藥商得於郵購買賣通路販賣之醫療器材及應行登記事項」公告之內容，具實體通路營業處所之醫療器材販賣業藥商，必須先向所在地之衛生局提出申請經核准後，才得以郵購買賣通路販賣醫療器材

［衛福部 105-06-18］新聞稿：網路販售醫材多留意，聰明賣家好安心
節錄：網路通路販售醫療器材有一定的門檻，應先取得藥商資格並向衛生局登記郵購買賣通路類型、郵購買賣通路連結及諮詢專線，並具有實體通路營業場所，才可在網路販售已開放且經核准的醫療器材。網頁中應刊登醫療器材產品之許可證字號、品名、藥商名稱、製造廠名稱及地址及藥商許可執照所載之名稱、地址及執照字號等相關資訊。食藥署再次呼籲，可用郵購通路販賣之醫療器材僅包含第一等級醫療器材及衛生套、衛生棉條、免縫膠帶等第二等級醫療器材（如附件），且僅限領有販賣業藥商許可執照且具有實體店面之藥商於網路公開販售

食品藥物管理署～醫療器材新手上路專區　 發布日期：2021-06-18
醫療器材販賣業者：
經營醫療器材之批發、零售、輸入、輸出、租賃或維修之業者。
醫療器材製造業者或販賣業者，應向所在地衛生局辦理登記

法規名稱： 醫療器材分類分級管理辦法 EN
最下面附錄列出現行有登記分類的醫療器材．

非充氣式止血帶屬於一級(低風險)

奇美醫院-醫療器材簡介