1%盐酸布替萘芬溶液治疗趾间型足癣和体股癣随机双盲对照临床试验

A Double Blind Randomized Controlled Clinical Trial of Butenafine Hydrochoride 1% Solution in the Treatment of Interdigital Tinea Pedis and Tinea Corporis & Cruris

目的：评价１％盐酸布替萘芬溶液治疗趾间型足癣和体股癣的疗效及安全性，并与１％联苯苄唑溶液对比。方法：每天外用１次，疗程体股癣２周，足癣４周，随访２周。对照组３０例。体股癣试验组３２例，对照组３２例。结果：试验组对足癣，在停药时的临床有效率８７．１％（对照组９３．３％），真菌学清除率９０．３％（对照组９３．３％）。在停药后２周分别为１００％（对照组９６．７％）和 １００％（对照组９６．７％）。试验组对体股癣，在停药时的临床有效率９６，９％（对照组８７．５％），真菌学清除率９６．９％（对照组９３．８％）。在停药后２周分别为１００％（对照组９０．６％）和１００％（对照组９６，９％）。试验组药物不良反应发生率１２．５％（对照组１６．１％），表现为局部轻度刺激。结论：１％盐酸布替萘芬溶液治疗趾间型足癣和体股癣的疗效和安全性与１％联苯苄唑 溶液相似。

OBJECTIVE:This study is to assess the efficacy and safety of butenafine hydrochoride 1% solution.METHODS: Butenafine hydrochoride 1% solution was compared with bifonazole 1% solution and was applied once daily for 4 weeks in the treatment of interdigital tinea pedis and for 2 weeks in the treatment of tinea corporis & cruris, both treatment groups had 2 weeks of follow-up observation after the end of treatment.31 cases in trial group and 30 cases in control group were enrolled for tinea pedis;32 cases in the trial group and 32 cases in control group were enrolled for tinea corporis & cruris.RESULTS:Overall effective treatment rates for tinea pedis at end of treatment were 87. 1% in trial group and 93.3% in control group;and 100% versus 96.7% at follow-up 2 weeks respectively. Mycological cure rates for tinea pedis at the end of treatment were 90.3% in trial group and 93.3% in control group; and 100% versus 96.7% at follow-up 2 weeks respectively. Overall effective treatment rates for tinea corporis & cruris at end of treatment were 96.9% in trial group and 87.5% in control group; and 100% versus 90.6% at follow-up 2 weeks respectively. Mycological cure rates for tinea corporis & cruris at end of treatment were 96.9% in trial group and 93.8% in control group; and 100% versus 96.9% at follow-up 2 weeks respetively. An local irritation occurred equally treatments but was well tolerated by the patients. Adverse reaction rate were 12.5% in trial group and 16. 1% in control group.CONLUSION: The efficacy and safety of butenafine hydrochoride 1% solution in the treatment of interdigital tinea pedis and tinea corporis & cruris is as same as bifonazole 1% solution.