健保給付規定: 10.6.4. Terbinafine ( 如 Lamisil
tab )：(85/1/1、91/4/1、98/8/1)限
1.手指甲癬及足趾甲癬病例使用，
每日 250 mg，手指甲癬限用 42
顆，需於 8 週內使用完畢。足趾
甲癬限用 84 顆，需於 16 週內使
用完畢。治療結束日起算，各在 6
及 12 個月內不得重複使用本品或
其他同類口服藥品。(98/8/1)
2.其他頑固性體癬及股癬病例使
用，每日一次，最長使用 2 週，
治療期間不得併用其他同類藥
品。
3.頭癬病例使用，每日一次，最長使
用 4 週，若確需延長治療時間，須
於病歷詳細載明備查。(98/8/1)
輕度至中度定義: 影響 50% 以下指甲. 沒有侵犯至 Matrix 及 lunula
輕度至中度定義: 影響 50% 以下指甲. 沒有侵犯至 Matrix 及 lunula
治療選項包括一種口服藥物, 或數種外用藥物
口服藥物: Terbinafine 鹽酸特比萘芬 (商品是 Lamasil 療黴舒)
(下面 terbinafine 名稱都用療黴舒替代)
外用藥物:
efinaconazole (商品: 舒步利安外用液10％ JUBLIA topical solution 10%)
amorolfine(商品Amocoat Nail Lacquer -5%;5mL/Bot雅舒安抗甲癬油劑)
tavaborole(商品 Kerydin® 5%外用溶液)
ciclopirox(商品 Brumixol Cream 1% 10gm膚爽乳膏)
口服抗黴菌藥物的療效與治療時間會優於外用藥(治癒率較高,治療時間較短)
不建議給予口服藥物的情況
1. 有治療禁忌患者
2. 因服用其他藥物, 有藥物交互作用疑慮
3. 感染部位較少(例如只有兩三個指甲受感染)
另外, 兒童通常建議用外用藥物, 使用 ciclopirox 反應較好
口服療黴舒是治療輕度至中度感染的第一線藥物, 使用方式與嚴重感染相同.
口服 Itraconazole (Sporanox Cap -100mg 適撲諾膠囊)可作為替代選擇. 當患者使用療黴舒治療無效. 或無法忍受口服療黴舒的副作用, 可以改用這個.
局部治療. 第一線選擇可使用 efinaconazole, amorolfine, tavaborole, and ciclopirox
目前並沒有高質量醫學研究證實哪一種外用藥物效果最好. 所以都可以選.
因為一般針對皮膚黴菌感染的外用藥物. 不一定能滲透指甲, 建議使用專門用於甲癬的商品.
下面是參考資料中對於各種外用藥物的描述.
Efinaconazole (商品: 舒步利安外用液. 下面以中文商品名稱代替)
10%舒步利安是三唑類抗黴菌藥(具有五環結構)。兩篇第三期多中心隨機試驗, 分別收錄 870 及 785 名患者. 患者指甲受感染比例 20~50%, 沒有侵犯到 matrix 和 lunula,
使用10%舒步利安, 每天一次治療 48 周, 治療結束四周 (開始治療後 52 周) 完全治癒率 18% 及 15%. 對照組的治癒率 3% 及 6%(有些人沒治療也自己好了? )
如果以 ≤5% 灰指甲做治療目標. 使用10%舒步利安達標的比例是 26% 及 23 %. 而使用安慰劑的達標比例是 7% 及 8%
口服藥物: Terbinafine 鹽酸特比萘芬 (商品是 Lamasil 療黴舒)
(下面 terbinafine 名稱都用療黴舒替代)
外用藥物:
efinaconazole (商品: 舒步利安外用液10％ JUBLIA topical solution 10%)
amorolfine(商品Amocoat Nail Lacquer -5%;5mL/Bot雅舒安抗甲癬油劑)
tavaborole(商品 Kerydin® 5%外用溶液)
ciclopirox(商品 Brumixol Cream 1% 10gm膚爽乳膏)
口服抗黴菌藥物的療效與治療時間會優於外用藥(治癒率較高,治療時間較短)
不建議給予口服藥物的情況
1. 有治療禁忌患者
2. 因服用其他藥物, 有藥物交互作用疑慮
3. 感染部位較少(例如只有兩三個指甲受感染)
另外, 兒童通常建議用外用藥物, 使用 ciclopirox 反應較好
口服療黴舒是治療輕度至中度感染的第一線藥物, 使用方式與嚴重感染相同.
口服 Itraconazole (Sporanox Cap -100mg 適撲諾膠囊)可作為替代選擇. 當患者使用療黴舒治療無效. 或無法忍受口服療黴舒的副作用, 可以改用這個.
局部治療. 第一線選擇可使用 efinaconazole, amorolfine, tavaborole, and ciclopirox
目前並沒有高質量醫學研究證實哪一種外用藥物效果最好. 所以都可以選.
因為一般針對皮膚黴菌感染的外用藥物. 不一定能滲透指甲, 建議使用專門用於甲癬的商品.
下面是參考資料中對於各種外用藥物的描述.
Efinaconazole (商品: 舒步利安外用液. 下面以中文商品名稱代替)
10%舒步利安是三唑類抗黴菌藥(具有五環結構)。兩篇第三期多中心隨機試驗, 分別收錄 870 及 785 名患者. 患者指甲受感染比例 20~50%, 沒有侵犯到 matrix 和 lunula,
使用10%舒步利安, 每天一次治療 48 周, 治療結束四周 (開始治療後 52 周) 完全治癒率 18% 及 15%. 對照組的治癒率 3% 及 6%(有些人沒治療也自己好了? )
如果以 ≤5% 灰指甲做治療目標. 使用10%舒步利安達標的比例是 26% 及 23 %. 而使用安慰劑的達標比例是 7% 及 8%
Amorolfine(商品Amocoat Nail Lacquer -5%;5mL/Bot雅舒安抗甲癬油劑)
在兩項劑量比較隨機試驗(同一藥物不同濃度)中，患者受感染的指甲<80%, 且 matrix, lunula 沒被感染, 每週一次使用雅舒安5% 指甲油治療6 個月，臨床治癒率 38% 和 46% 的患者 [ 13,14 ]。值得注意的是，在一項試驗中，臨床治愈被定義為完全清除或≤10%的指甲仍受影響[ 14 ]，而在另一項試驗中沒有明確定義[ 13 ]。
參考資料: 下面內容來自uptodate. 每一段的中文是用google中文翻譯
Managemen of Mild to Moderate dermatophyte onychomycosis
的治療治療選擇— 輕至中度甲真菌病（例如，遠端外側甲下甲真菌病，累及指甲≤50%，不累及基質/月牙）的一線治療選擇包括口服特比萘芬和幾種外用藥物，包括艾芬康唑、阿莫羅芬、他瓦硼羅和環吡酮。
Treatment selection — First-line treatment options for mild to moderate onychomycosis (eg, distal lateral subungual onychomycosis involving ≤50 percent involvement of the nail and sparing the matrix/lunula) include oral terbinafine and several topical agents including efinaconazole, amorolfine, tavaborole, and ciclopirox.
儘管口服抗真菌治療由於與局部治療相比具有更高的完全治愈率和更短的療程而被認為是甲真菌病的金標準治療，但臨床情況決定了口服治療是否是輕至中度甲真菌病最合適的一線治療。可能首選局部治療的情況示例包括：
Although oral antifungal therapy is considered the gold standard treatment for onychomycosis because of higher complete cure rates and shorter courses of treatment when compared with topical therapy, the clinical scenario determines whether oral therapy is the most appropriate first-line treatment for mild to moderate onychomycosis. Examples of scenarios in which topical therapy may be preferred include:
有全身抗真菌治療禁忌的患者
●有與全身抗真菌藥物發生藥物相互作用風險的患者
●傾向於避免全身治療的患者（尤其是涉及三個或更少指甲的患者）
●Patients with contraindications to systemic antifungal therapy
●Patients at risk for drug-drug interactions with systemic antifungal drugs
●Patients who prefer to avoid systemic treatment (especially with three or fewer nails involved)
兒童可能比成人更適合接受局部治療，因為兒童的指甲板更薄，指甲生長速度可能更快。一項小型隨機試驗表明，兒童對局部環吡酮產生反應的可能性更高[ 7 ]。(參見“環吡酮：藥物信息” )
Children may be more favorable candidates for topical therapy than adults because of a thinner nail plate and potentially faster nail growth rate. A small randomized trial suggested that the likelihood of response to topical ciclopirox is higher in children [7]. (See "Ciclopirox: Drug information".)
甲真菌病的治療費用差異很大，可能會影響治療選擇。2015年，在美國一療程的口服特比萘芬價格低至10美元。相比之下，艾夫康唑一個療程的費用超過 2000 美元[ 6 ]。
The cost of therapies for onychomycosis varies widely and may influence treatment selection. In 2015, a course of oral terbinafine could be obtained for as low as $10 in the United States. In contrast the cost of a course of treatment with efinaconazole was greater than $2000 [6].
口服特比萘芬 —特比萘芬是治療輕度至中度皮膚癬菌甲癬的一線口服藥物。治療方法與治療更嚴重疾病的特比萘芬相同。伊曲康唑是無法耐受特比萘芬或對特比萘芬無反應的患者的替代全身治療方法。(參見下文‘中度至重度皮膚癬菌性甲癬’ )
Oral terbinafine — Terbinafine is the first-line oral agent for mild to moderate dermatophyte onychomycosis. Treatment is given in the same manner as terbinafine therapy for more severe disease. Itraconazole is an alternative systemic treatment for patients who cannot tolerate terbinafine or fail to respond to terbinafine. (See 'Moderate to severe dermatophyte onychomycosis' below.)
局部治療 — 一線局部治療包括艾芬康唑、阿莫羅芬、他瓦硼羅和環吡酮。由於缺乏高質量的頭對頭試驗，因此沒有足夠的數據來得出這些療法的比較療效的明確結論。
Topical therapy — First-line topical therapies include efinaconazole, amorolfine, tavaborole, and ciclopirox. High-quality, head-to-head trials are lacking, leaving insufficient data for definitive conclusions on the comparative efficacy of these therapies.
局部治療僅限於專門針對指甲疾病的藥物。由於指甲板的滲透性差，針對皮膚真菌感染開發的外用抗真菌藥物通常對甲真菌病效果不佳[ 8-10 ]。
Topical treatment is limited to agents specifically indicated for nail disease. Topical antifungal agents developed for cutaneous fungal infections generally are poorly effective for onychomycosis because of poor penetration of the nail plate [8-10].
艾芬康唑 —艾芬康唑是一種外用三唑類抗真菌藥。艾夫康唑治療甲真菌病的療效已在兩項III 期多中心隨機試驗（n = 870 和n = 785）中得到證實，其中皮膚癬菌或皮膚癬菌和念珠菌遠端外側甲下甲真菌病累及20% 至50% 的目標腳趾甲，且不影響基質和月牙以 3 比 1 的比例隨機接受 10% 艾夫康唑溶液或載體治療，每天一次，持續 48 週 [ 11]。治療結束後4 週，使用艾芬康唑治療的患者中分別有18% 和15% 的患者實現了完全治愈（目標指甲的臨床受累和真菌學治愈率為0%），而使用賦形劑治療的患者中只有3% 和6% 實現了完全治愈。對完全或幾乎完全治愈（目標趾甲臨床受累≤5%且真菌學治愈）的次要終點進行評估，艾夫康唑組的緩解率為26% 和23%，安慰劑組為7% 和8% 。
Efinaconazole — Efinaconazole is a topical triazole antifungal agent. The efficacy of efinaconazole for onychomycosis was demonstrated in two phase III multicenter randomized trials (n = 870 and n = 785) in which patients with dermatophytic or dermatophytic and candidal distal lateral subungual onychomycosis involving 20 to 50 percent of the target toenail and sparing the matrix and lunula were randomized in a 3 to 1 ratio to treatment with efinaconazole 10% solution or vehicle once daily for 48 weeks [11]. Four weeks after the end of treatment, complete cure (0 percent clinical involvement of the target nail and mycologic cure) was achieved by 18 and 15 percent of patients treated with efinaconazole compared with only 3 and 6 percent of patients treated with vehicle. Evaluation of the secondary endpoint of complete or almost complete cure (≤5 percent clinical involvement of the target toenail and mycologic cure) yielded response rates of 26 and 23 percent with efinaconazole and 7 and 8 percent for placebo.
艾立康唑將 10% 溶液直接塗在指甲上，每天一次，持續 48 週。在每個受影響的指甲表面滴一滴；對於大腳趾甲，應在腳趾甲末端再滴一滴。使用塗抹刷將溶液塗抹到腳趾甲床、鄰近的甲襞、甲下和指甲板的下表面。建議在治療期間避免修腳、塗指甲油或美甲產品。
Efinaconazole 10% solution is applied directly to the nails once daily for 48 weeks. One drop is applied to the surface of each affected nail; for the great toenail, an additional drop should be applied at the end of the toenail. The application brush is used to spread the solution to the toenail bed, adjacent nail folds, hyponychium, and undersurface of the nail plate. Avoidance of pedicures, nail polish, or cosmetic nail products is recommended during treatment.
艾芬康唑耐受性良好。腳趾甲向內生長和局部皮膚刺激或不適的情況很少發生。
Efinaconazole is well tolerated. Ingrown toenails and local skin irritation or discomfort occur infrequently.
阿莫羅芬 — 阿莫羅芬是一種外用抗真菌劑，具有對抗皮膚癬菌、酵母菌、二形性真菌以及多種絲狀和暗色真菌的活性[ 12]。該藥物在美國不可用。
Amorolfine — Amorolfine is a topical antifungal agent with activity against dermatophytes, yeasts, dimorphic fungi, and a variety of filamentous and dematiaceous fungi [12]. The drug is not available in the United States.
在兩項劑量比較隨機試驗中，每週一次使用阿莫羅芬5% 指甲油治療6 個月，治療累及不到80% 指甲表面且不累及指甲基質和月牙的甲真菌病，結果獲得了臨床治愈和真菌學治愈。 38% 和 46% 的患者 [ 13,14 ]。值得注意的是，在一項試驗中，臨床治愈被定義為完全清除或≤10%的指甲仍受影響[ 14 ]，而在另一項試驗中沒有明確定義[ 13 ]。In two dose-comparison randomized trials, once-weekly application of amorolfine 5% nail lacquer for six months to onychomycosis involving less than 80 percent of the nail surface and lacking involvement of the nail matrix and lunula led to both clinical cure and mycologic cure in 38 and 46 percent of patients [13,14]. Of note, clinical cure was defined as complete clearance or ≤10 percent of nail remaining affected in one trial [14] and was not clearly defined in the other trial [13].
此外，有證據表明阿莫羅芬與口服抗真菌藥物聯合使用可能會提高治愈率[ 15 ]。在一項隨機、開放標籤試驗中比較特比萘芬（每天250 毫克，持續三個月）加阿莫羅芬（每週一次，持續12 個月）與單獨使用特比萘芬相比，接受聯合治療的患者更有可能實現臨床和真菌學治愈（59% 與45%）[16 ]。需要進一步的研究來確定哪些患者應該接受聯合治療。
In addition, there is evidence that amorolfine may increase cure rates when used in combination with oral antifungals [15]. In a randomized, open-label trial comparing terbinafine (250 mg per day for three months) plus amorolfine (once weekly for 12 months) versus terbinafine alone, patients who received combination therapy were more likely to achieve both clinical and mycologic cure (59 versus 45 percent) [16]. Further studies are necessary to determine which patients should be treated with combination therapy.
用一次性銼刀銼指甲表面並用酒精擦拭後，每週使用阿莫羅芬一次。指甲護理一般為六個月；腳趾甲的治療時間為 9 至 12 個月。局部皮膚刺激是一種不常見的副作用[ 14 ]。與需要每天使用的療法相比，較低的使用頻率（每週一次）可能有助於堅持治療[ 17]。
Amorolfine is applied once weekly after the surface of the nail is filed with a disposable file and wiped with alcohol. Fingernails are generally treated for six months; toenails are treated for 9 to 12 months. Local skin irritation is an uncommon side effect [14]. The lower frequency of application (once weekly) compared with therapies requiring daily application may facilitate adherence to therapy [17].
Tavaborole — Tavaborole 5% 溶液是一種 oxaborole 抗真菌劑。Tavaborole 在兩項多中心隨機試驗中進行了評估，其中共有 1194 名甲真菌病患者每天使用一次 5% Tavaborole 溶液或載體，持續 48 週。試驗中的患者有 20% 至 60% 的目標腳趾甲受累，並且缺乏皮膚癬菌瘤和月牙受累的臨床證據 [ 18]。在一項試驗中，接受 tavaborole 治療的患者中有 7% 在治療後實現了臨床治愈（沒有甲真菌病的臨床證據）和真菌學治愈，而媒介物組中只有 1% 的患者實現了治愈。在第二次試驗中，這些比率分別為 9% 和 2%。在兩項試驗中，完全或幾乎透明的指甲（遠端指甲營養不良或變色的比例<10%，甲剝離或甲下角化過度）加上真菌學陰性的比率，tavaborole 為15% 和18%，而媒介物為2% 和4%。
Tavaborole — Tavaborole 5% solution is an oxaborole antifungal agent. Tavaborole was evaluated in two multicenter randomized trials in which a total of 1194 patients with onychomycosis applied tavaborole 5% solution or vehicle once daily for 48 weeks. Patients in the trials had 20 to 60 percent involvement of the target toenail and lacked both clinical evidence of a dermatophytoma and involvement of the lunula [18]. In one trial, 7 percent of patients treated with tavaborole achieved both clinical cure (no clinical evidence of onychomycosis) and mycologic cure after treatment compared with only 1 percent of patients in the vehicle group. In the second trial, these rates were 9 and 2 percent, respectively. Rates of completely or almost clear nail (<10 percent of the distal nail dystrophic or discolored and minimal onycholysis or subungual hyperkeratosis) plus negative mycology in the two trials were 15 and 18 percent for tavaborole versus 2 and 4 percent for vehicle.
將 5% Tavaborole溶液塗抹在受感染腳趾甲的表面和遠端下方，每天一次，持續 48 週。潛在的副作用包括腳趾甲向內生長和局部皮膚剝落或刺激。
Tavaborole 5% solution is applied to the surface and under the distal tip of infected toenails once daily for 48 weeks. Potential side effects include ingrown toenail and local skin exfoliation or irritation.
環吡酮 —環吡酮是一種羥基吡啶酮衍生物，具有對抗皮膚癬菌、酵母菌和黴菌的活性[ 19 ]。兩項隨機對照試驗（n = 223 和n = 237）的綜合結果表明，在接受環吡酮8% 指甲治療的患者中，約7% 的患者完全消退，其中納入了遠端甲下甲真菌病（累及目標指甲的20% 至65%）的患者。每天使用漆，持續 48 週，而使用安慰劑的比例為 0.4% [ 20 ]。一項小型隨機試驗表明，兒童對局部環吡酮的反應可能更好。然而，還需要更多的研究來證實這一發現[ 7 ]。Ciclopirox — Ciclopirox is a hydroxypyridone derivative with activity against dermatophytes, yeasts, and molds [19]. Combined results from two randomized, controlled trials (n = 223 and n = 237) that included patients with distal subungual onychomycosis involving 20 to 65 percent of the target nail suggest that complete resolution occurs in approximately 7 percent of patients treated with ciclopirox 8% nail lacquer daily for 48 weeks compared with 0.4 percent using placebo [20]. A small randomized trial suggested that the likelihood of response to topical ciclopirox may be better in children; however, additional studies are necessary to confirm this finding [7].
隨機試驗也評估了環吡酮的療效與口服特比萘芬聯合使用[ 21,22 ]。沒有發現比單獨使用特比萘芬更大的臨床療效。研究報告稱聯合治療的真菌學治愈率更高；然而，這是在患者仍在接受局部環吡酮治療時進行評估的，這可能影響了檢測持續性真菌感染的能力。
Randomized trials have also evaluated the efficacy of ciclopirox in combination with oral terbinafine [21,22]. No greater clinical efficacy was found than with terbinafine alone. The studies reported higher rates of mycologic cure with combination therapy; however, this was assessed while the patients were still being treated with topical ciclopirox, which may have affected the ability to detect persistent fungal infection.
將 8%環吡酮指甲油每天一次塗抹在受影響的指甲、周圍 5 毫米的皮膚上，如果可能的話，還可塗抹在甲床、甲床和甲板下表面。每週一次用酒精將指甲擦拭乾淨，並定期去除指甲未附著的感染部分。治療持續至指甲清除或長達 48 週 [ 8 ]。
Ciclopirox 8% nail lacquer is applied once daily to the affected nail, 5 mm of surrounding skin, and to the nail bed, hyponychium, and undersurface of the nail plate if possible. The nail is wiped clean with alcohol once weekly, and the unattached infected part of the nail is removed periodically. Treatment is continued until nail clearance or up to 48 weeks [8].
環吡酮是一種耐受性良好的治療方法[ 23 ]。潛在的副作用包括暫時改變指甲和局部皮膚刺激。
Ciclopirox is a well-tolerated treatment [23]. Potential side effects include temporary nail changes and local skin irritation.
Managemen of Mild to Moderate dermatophyte onychomycosis
的治療治療選擇— 輕至中度甲真菌病（例如，遠端外側甲下甲真菌病，累及指甲≤50%，不累及基質/月牙）的一線治療選擇包括口服特比萘芬和幾種外用藥物，包括艾芬康唑、阿莫羅芬、他瓦硼羅和環吡酮。
Treatment selection — First-line treatment options for mild to moderate onychomycosis (eg, distal lateral subungual onychomycosis involving ≤50 percent involvement of the nail and sparing the matrix/lunula) include oral terbinafine and several topical agents including efinaconazole, amorolfine, tavaborole, and ciclopirox.
儘管口服抗真菌治療由於與局部治療相比具有更高的完全治愈率和更短的療程而被認為是甲真菌病的金標準治療，但臨床情況決定了口服治療是否是輕至中度甲真菌病最合適的一線治療。可能首選局部治療的情況示例包括：
Although oral antifungal therapy is considered the gold standard treatment for onychomycosis because of higher complete cure rates and shorter courses of treatment when compared with topical therapy, the clinical scenario determines whether oral therapy is the most appropriate first-line treatment for mild to moderate onychomycosis. Examples of scenarios in which topical therapy may be preferred include:
有全身抗真菌治療禁忌的患者
●有與全身抗真菌藥物發生藥物相互作用風險的患者
●傾向於避免全身治療的患者（尤其是涉及三個或更少指甲的患者）
●Patients with contraindications to systemic antifungal therapy
●Patients at risk for drug-drug interactions with systemic antifungal drugs
●Patients who prefer to avoid systemic treatment (especially with three or fewer nails involved)
兒童可能比成人更適合接受局部治療，因為兒童的指甲板更薄，指甲生長速度可能更快。一項小型隨機試驗表明，兒童對局部環吡酮產生反應的可能性更高[ 7 ]。(參見“環吡酮：藥物信息” )
Children may be more favorable candidates for topical therapy than adults because of a thinner nail plate and potentially faster nail growth rate. A small randomized trial suggested that the likelihood of response to topical ciclopirox is higher in children [7]. (See "Ciclopirox: Drug information".)
甲真菌病的治療費用差異很大，可能會影響治療選擇。2015年，在美國一療程的口服特比萘芬價格低至10美元。相比之下，艾夫康唑一個療程的費用超過 2000 美元[ 6 ]。
The cost of therapies for onychomycosis varies widely and may influence treatment selection. In 2015, a course of oral terbinafine could be obtained for as low as $10 in the United States. In contrast the cost of a course of treatment with efinaconazole was greater than $2000 [6].
口服特比萘芬 —特比萘芬是治療輕度至中度皮膚癬菌甲癬的一線口服藥物。治療方法與治療更嚴重疾病的特比萘芬相同。伊曲康唑是無法耐受特比萘芬或對特比萘芬無反應的患者的替代全身治療方法。(參見下文‘中度至重度皮膚癬菌性甲癬’ )
Oral terbinafine — Terbinafine is the first-line oral agent for mild to moderate dermatophyte onychomycosis. Treatment is given in the same manner as terbinafine therapy for more severe disease. Itraconazole is an alternative systemic treatment for patients who cannot tolerate terbinafine or fail to respond to terbinafine. (See 'Moderate to severe dermatophyte onychomycosis' below.)
局部治療 — 一線局部治療包括艾芬康唑、阿莫羅芬、他瓦硼羅和環吡酮。由於缺乏高質量的頭對頭試驗，因此沒有足夠的數據來得出這些療法的比較療效的明確結論。
Topical therapy — First-line topical therapies include efinaconazole, amorolfine, tavaborole, and ciclopirox. High-quality, head-to-head trials are lacking, leaving insufficient data for definitive conclusions on the comparative efficacy of these therapies.
局部治療僅限於專門針對指甲疾病的藥物。由於指甲板的滲透性差，針對皮膚真菌感染開發的外用抗真菌藥物通常對甲真菌病效果不佳[ 8-10 ]。
Topical treatment is limited to agents specifically indicated for nail disease. Topical antifungal agents developed for cutaneous fungal infections generally are poorly effective for onychomycosis because of poor penetration of the nail plate [8-10].
艾芬康唑 —艾芬康唑是一種外用三唑類抗真菌藥。艾夫康唑治療甲真菌病的療效已在兩項III 期多中心隨機試驗（n = 870 和n = 785）中得到證實，其中皮膚癬菌或皮膚癬菌和念珠菌遠端外側甲下甲真菌病累及20% 至50% 的目標腳趾甲，且不影響基質和月牙以 3 比 1 的比例隨機接受 10% 艾夫康唑溶液或載體治療，每天一次，持續 48 週 [ 11]。治療結束後4 週，使用艾芬康唑治療的患者中分別有18% 和15% 的患者實現了完全治愈（目標指甲的臨床受累和真菌學治愈率為0%），而使用賦形劑治療的患者中只有3% 和6% 實現了完全治愈。對完全或幾乎完全治愈（目標趾甲臨床受累≤5%且真菌學治愈）的次要終點進行評估，艾夫康唑組的緩解率為26% 和23%，安慰劑組為7% 和8% 。
Efinaconazole — Efinaconazole is a topical triazole antifungal agent. The efficacy of efinaconazole for onychomycosis was demonstrated in two phase III multicenter randomized trials (n = 870 and n = 785) in which patients with dermatophytic or dermatophytic and candidal distal lateral subungual onychomycosis involving 20 to 50 percent of the target toenail and sparing the matrix and lunula were randomized in a 3 to 1 ratio to treatment with efinaconazole 10% solution or vehicle once daily for 48 weeks [11]. Four weeks after the end of treatment, complete cure (0 percent clinical involvement of the target nail and mycologic cure) was achieved by 18 and 15 percent of patients treated with efinaconazole compared with only 3 and 6 percent of patients treated with vehicle. Evaluation of the secondary endpoint of complete or almost complete cure (≤5 percent clinical involvement of the target toenail and mycologic cure) yielded response rates of 26 and 23 percent with efinaconazole and 7 and 8 percent for placebo.
艾立康唑將 10% 溶液直接塗在指甲上，每天一次，持續 48 週。在每個受影響的指甲表面滴一滴；對於大腳趾甲，應在腳趾甲末端再滴一滴。使用塗抹刷將溶液塗抹到腳趾甲床、鄰近的甲襞、甲下和指甲板的下表面。建議在治療期間避免修腳、塗指甲油或美甲產品。
Efinaconazole 10% solution is applied directly to the nails once daily for 48 weeks. One drop is applied to the surface of each affected nail; for the great toenail, an additional drop should be applied at the end of the toenail. The application brush is used to spread the solution to the toenail bed, adjacent nail folds, hyponychium, and undersurface of the nail plate. Avoidance of pedicures, nail polish, or cosmetic nail products is recommended during treatment.
艾芬康唑耐受性良好。腳趾甲向內生長和局部皮膚刺激或不適的情況很少發生。
Efinaconazole is well tolerated. Ingrown toenails and local skin irritation or discomfort occur infrequently.
阿莫羅芬 — 阿莫羅芬是一種外用抗真菌劑，具有對抗皮膚癬菌、酵母菌、二形性真菌以及多種絲狀和暗色真菌的活性[ 12]。該藥物在美國不可用。
Amorolfine — Amorolfine is a topical antifungal agent with activity against dermatophytes, yeasts, dimorphic fungi, and a variety of filamentous and dematiaceous fungi [12]. The drug is not available in the United States.
在兩項劑量比較隨機試驗中，每週一次使用阿莫羅芬5% 指甲油治療6 個月，治療累及不到80% 指甲表面且不累及指甲基質和月牙的甲真菌病，結果獲得了臨床治愈和真菌學治愈。 38% 和 46% 的患者 [ 13,14 ]。值得注意的是，在一項試驗中，臨床治愈被定義為完全清除或≤10%的指甲仍受影響[ 14 ]，而在另一項試驗中沒有明確定義[ 13 ]。In two dose-comparison randomized trials, once-weekly application of amorolfine 5% nail lacquer for six months to onychomycosis involving less than 80 percent of the nail surface and lacking involvement of the nail matrix and lunula led to both clinical cure and mycologic cure in 38 and 46 percent of patients [13,14]. Of note, clinical cure was defined as complete clearance or ≤10 percent of nail remaining affected in one trial [14] and was not clearly defined in the other trial [13].
此外，有證據表明阿莫羅芬與口服抗真菌藥物聯合使用可能會提高治愈率[ 15 ]。在一項隨機、開放標籤試驗中比較特比萘芬（每天250 毫克，持續三個月）加阿莫羅芬（每週一次，持續12 個月）與單獨使用特比萘芬相比，接受聯合治療的患者更有可能實現臨床和真菌學治愈（59% 與45%）[16 ]。需要進一步的研究來確定哪些患者應該接受聯合治療。
In addition, there is evidence that amorolfine may increase cure rates when used in combination with oral antifungals [15]. In a randomized, open-label trial comparing terbinafine (250 mg per day for three months) plus amorolfine (once weekly for 12 months) versus terbinafine alone, patients who received combination therapy were more likely to achieve both clinical and mycologic cure (59 versus 45 percent) [16]. Further studies are necessary to determine which patients should be treated with combination therapy.
用一次性銼刀銼指甲表面並用酒精擦拭後，每週使用阿莫羅芬一次。指甲護理一般為六個月；腳趾甲的治療時間為 9 至 12 個月。局部皮膚刺激是一種不常見的副作用[ 14 ]。與需要每天使用的療法相比，較低的使用頻率（每週一次）可能有助於堅持治療[ 17]。
Amorolfine is applied once weekly after the surface of the nail is filed with a disposable file and wiped with alcohol. Fingernails are generally treated for six months; toenails are treated for 9 to 12 months. Local skin irritation is an uncommon side effect [14]. The lower frequency of application (once weekly) compared with therapies requiring daily application may facilitate adherence to therapy [17].
Tavaborole — Tavaborole 5% 溶液是一種 oxaborole 抗真菌劑。Tavaborole 在兩項多中心隨機試驗中進行了評估，其中共有 1194 名甲真菌病患者每天使用一次 5% Tavaborole 溶液或載體，持續 48 週。試驗中的患者有 20% 至 60% 的目標腳趾甲受累，並且缺乏皮膚癬菌瘤和月牙受累的臨床證據 [ 18]。在一項試驗中，接受 tavaborole 治療的患者中有 7% 在治療後實現了臨床治愈（沒有甲真菌病的臨床證據）和真菌學治愈，而媒介物組中只有 1% 的患者實現了治愈。在第二次試驗中，這些比率分別為 9% 和 2%。在兩項試驗中，完全或幾乎透明的指甲（遠端指甲營養不良或變色的比例<10%，甲剝離或甲下角化過度）加上真菌學陰性的比率，tavaborole 為15% 和18%，而媒介物為2% 和4%。
Tavaborole — Tavaborole 5% solution is an oxaborole antifungal agent. Tavaborole was evaluated in two multicenter randomized trials in which a total of 1194 patients with onychomycosis applied tavaborole 5% solution or vehicle once daily for 48 weeks. Patients in the trials had 20 to 60 percent involvement of the target toenail and lacked both clinical evidence of a dermatophytoma and involvement of the lunula [18]. In one trial, 7 percent of patients treated with tavaborole achieved both clinical cure (no clinical evidence of onychomycosis) and mycologic cure after treatment compared with only 1 percent of patients in the vehicle group. In the second trial, these rates were 9 and 2 percent, respectively. Rates of completely or almost clear nail (<10 percent of the distal nail dystrophic or discolored and minimal onycholysis or subungual hyperkeratosis) plus negative mycology in the two trials were 15 and 18 percent for tavaborole versus 2 and 4 percent for vehicle.
將 5% Tavaborole溶液塗抹在受感染腳趾甲的表面和遠端下方，每天一次，持續 48 週。潛在的副作用包括腳趾甲向內生長和局部皮膚剝落或刺激。
Tavaborole 5% solution is applied to the surface and under the distal tip of infected toenails once daily for 48 weeks. Potential side effects include ingrown toenail and local skin exfoliation or irritation.
環吡酮 —環吡酮是一種羥基吡啶酮衍生物，具有對抗皮膚癬菌、酵母菌和黴菌的活性[ 19 ]。兩項隨機對照試驗（n = 223 和n = 237）的綜合結果表明，在接受環吡酮8% 指甲治療的患者中，約7% 的患者完全消退，其中納入了遠端甲下甲真菌病（累及目標指甲的20% 至65%）的患者。每天使用漆，持續 48 週，而使用安慰劑的比例為 0.4% [ 20 ]。一項小型隨機試驗表明，兒童對局部環吡酮的反應可能更好。然而，還需要更多的研究來證實這一發現[ 7 ]。Ciclopirox — Ciclopirox is a hydroxypyridone derivative with activity against dermatophytes, yeasts, and molds [19]. Combined results from two randomized, controlled trials (n = 223 and n = 237) that included patients with distal subungual onychomycosis involving 20 to 65 percent of the target nail suggest that complete resolution occurs in approximately 7 percent of patients treated with ciclopirox 8% nail lacquer daily for 48 weeks compared with 0.4 percent using placebo [20]. A small randomized trial suggested that the likelihood of response to topical ciclopirox may be better in children; however, additional studies are necessary to confirm this finding [7].
隨機試驗也評估了環吡酮的療效與口服特比萘芬聯合使用[ 21,22 ]。沒有發現比單獨使用特比萘芬更大的臨床療效。研究報告稱聯合治療的真菌學治愈率更高；然而，這是在患者仍在接受局部環吡酮治療時進行評估的，這可能影響了檢測持續性真菌感染的能力。
Randomized trials have also evaluated the efficacy of ciclopirox in combination with oral terbinafine [21,22]. No greater clinical efficacy was found than with terbinafine alone. The studies reported higher rates of mycologic cure with combination therapy; however, this was assessed while the patients were still being treated with topical ciclopirox, which may have affected the ability to detect persistent fungal infection.
將 8%環吡酮指甲油每天一次塗抹在受影響的指甲、周圍 5 毫米的皮膚上，如果可能的話，還可塗抹在甲床、甲床和甲板下表面。每週一次用酒精將指甲擦拭乾淨，並定期去除指甲未附著的感染部分。治療持續至指甲清除或長達 48 週 [ 8 ]。
Ciclopirox 8% nail lacquer is applied once daily to the affected nail, 5 mm of surrounding skin, and to the nail bed, hyponychium, and undersurface of the nail plate if possible. The nail is wiped clean with alcohol once weekly, and the unattached infected part of the nail is removed periodically. Treatment is continued until nail clearance or up to 48 weeks [8].
環吡酮是一種耐受性良好的治療方法[ 23 ]。潛在的副作用包括暫時改變指甲和局部皮膚刺激。
Ciclopirox is a well-tolerated treatment [23]. Potential side effects include temporary nail changes and local skin irritation.
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