Ling M R, Swinyer L J, Jarratt M T, Falo L, Monroe E W, Tharp M, Kalivas J, Weinstein G D, Asarch R G, Drake L, Martin A G, Leyden J J, Cook J, Pariser D M, Pariser R, Thiers B H, Lebwohl M G, Babel D, Stewart D M, Eaglstein W H, Falanga V, Katz H I, Bergfeld W F, Hanifin J M, Young M R
Department of Dermatology, Emory University School of Medicine, Atlanta, Georgia 30322, USA.
J Am Acad Dermatol. 1998 Jun;38(6 Pt 2):S95-102. doi: 10.1016/s0190-9622(98)70492-x.
Fluconazole is a bis-triazole antifungal agent approved for the treatment of oropharyngeal, esophageal, and vaginal candidiasis, serious systemic candidal infections, and cryptococcal meningitis.
The purpose of this study was to evaluate three different durations of once-weekly fluconazole for the treatment of onychomycosis of the toenail caused by dermatophytes.
In a multicenter, randomized, double-blind, parallel, placebo-controlled trial, 384 patients with distal subungual onychomycosis of the toenail received fluconazole, 450 mg once weekly, or placebo for 4, 6, or 9 months. For inclusion, patients were required to have mycologically confirmed distal subungual onychomycosis of the toenail with a large toenail at least 25% clinically affected but having at least 2 mm of healthy nail between the nail fold and the proximal onychomycotic border. Efficacy was assessed by clinical and mycologic (microscopic and microbiologic) measures at screening, at every treatment visit starting at month 3, and at months 2, 4, and 6 after therapy. Observed or volunteered adverse events were recorded and classified at all visits.
At the end of treatment, very significantly superior clinical and mycologic results were achieved in all fluconazole groups compared with placebo (p=0.0001). This superiority was largely maintained over 6 months of follow-up. The clinical and mycologic responses of the 9-month treatment duration were significantly superior to the 4- and 6-month durations. Similar percentages of patients in the fluconazole and placebo groups reported adverse experiences for all three durations of the study.
Results of this study support the efficacy and safety of fluconazole in the treatment of distal subungual onychomycosis of the toenail.
氟康唑是一种双三唑类抗真菌药物，被批准用于治疗口咽、食管和阴道念珠菌病、严重的系统性念珠菌感染以及隐球菌性脑膜炎。
本研究的目的是评估三种不同疗程的每周一次氟康唑治疗由皮肤癣菌引起的趾甲甲真菌病的效果。
在一项多中心、随机、双盲、平行、安慰剂对照试验中，384例远端甲下型趾甲甲真菌病患者接受每周一次450mg氟康唑治疗或安慰剂治疗，疗程分别为4、6或9个月。纳入标准为患者经真菌学证实为远端甲下型趾甲甲真菌病，大脚趾临床受累面积至少25%，但在甲褶与近端甲真菌病边界之间至少有2mm健康指甲。在筛查时、从第3个月开始的每次治疗访视时以及治疗后第2、4和6个月，通过临床和真菌学（显微镜和微生物学）指标评估疗效。在所有访视中记录并分类观察到的或患者自述的不良事件。
治疗结束时，与安慰剂相比，所有氟康唑组在临床和真菌学方面均取得了非常显著的更好结果（p=0.0001）。这种优势在6个月的随访中基本保持。9个月疗程的临床和真菌学反应明显优于4个月和6个月疗程。在研究的所有三个疗程中，氟康唑组和安慰剂组报告不良经历的患者百分比相似。
本研究结果支持氟康唑治疗远端甲下型趾甲甲真菌病的有效性和安全性。
