Title1%氟曲马唑乳膏治疗足癣疗效和安全性评价
Other TitlesEvaluation of efficacy and safety of flutrimazole cream 1% in the treatment of tinea pedis
Authors王爱平
万喆
顾军
徐金华
李明
席丽艳
郝飞
张建中
赵广
姚晨
王蕊
刘博
王玉梅
李若瑜
Affiliation北京大学第一医院皮肤性病科,皮肤病分子诊断北京市重点实验室,北京 100034
上海长海医院皮肤科,上海,200433
复旦大学附属华山医院皮肤科,上海,200040
复旦大学附属中山医院皮肤科,上海,200032
中山大学孙逸仙纪念医院皮肤科,广州,510120
中国人民解放军第三军医大学第一附属医院皮肤科,重庆,400038
北京大学人民医院皮肤科,北京,100044
中国人民解放军空军总医院皮肤科,北京,100036
北京大学第一医院医学统计室,北京,100034
江苏恩华药业股份有限公司,徐州,221009
Keywords氟曲马唑
联苯苄唑
足癣
疗效
安全性
flutrimazole
bifonazole
tinea pedis
efficacy
safety
Issue Date2016
Publisher中国真菌学杂志
Citation中国真菌学杂志.2016,11,(1),28-32.
Abstract目的:评价1%氟曲马唑乳膏治疗足癣的疗效及安全性。方法采用多中心、随机、双盲、非劣效临床试验,每天1次外用,疗程4周。结果主要疗效4周时的总有效率氟曲马唑组为71.43%,联苯苄唑组为64.81%(P =0.190)。在6周时(停药后2周),总有效率分别为82.61%和71.60%(P =0.018);真菌清除率分别为86.16%和77.50%(P =0.045);临床有效率分别为93.43%和91.58%(P =0.504)。与研究药物相关的不良反应发生率氟曲马唑组2.44%,联苯苄唑组2.46%(P =1.000),主要表现为用药局部皮肤刺激。结论1%氟曲马唑乳膏治疗足癣有效安全,4周时总疗效非劣效于1%联苯苄唑乳膏,但在6周时总疗效优于1%联苯苄唑乳膏,主要体现在真菌学疗效方面。
Objective To evaluation of efficacy and safety of flutrimazole cream 1% in the treatment of tinea pedis.Methods A multicentre,double-blind,randomised,non-inferiority study were conducted.Flutrimazole cream 1% or bifonazole cream 1% were applied once daily for 4 weeks to tinea pedis.Results The primary index of drug efficacy were determined by the to-tal effective rates at week 4,71.43% in the flutrimazole group and 64.81% in bifonazole group (P =0.1 90).At week 6 (week 2 after end of treatment),the total effective rates were 82.61% versus 71.60% (P =0.018),respectively;mycological cure rates were 86.1 6% versus 77.50% (P =0.045),respectively;the clinical effective rates were 93.50% versus 91.75% (P =0. 504),respectively.Treatment-related adverse events consisted of local skin irritation,occurred in 2.44% versus 2.46% (P =1. 000),respectively.Conclusion This study suggest that flutrimazole cream 1% was effective and safety in the treatment of tinea pedis.Flutrimazole cream 1% was found to be equally effective and non-inferior to bifonazole cream 1%.But the total effective rates of flutrimazole cream 1 % at week 6 were superior to bifonazole cream 1 %,mainly being reflected in the aspect of mycology curative effect.
URIhttp://hdl.handle.net/20.500.11897/451958
ISSN1673-3827
DOI10.3969/j.issn.1673-3827.2016.01.007
Indexed中国科技核心期刊(ISTIC)
中国科学引文数据库(CSCD)
Appears in Collections:第一医院
人民医院

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