盐酸特比萘芬乳膏1周与咪康唑乳膏1周、4周治疗趾间型足癣的多中心随机双盲研究  

Comparison of 1-week terbinafine hydrochloride cream, 1- and 4-week miconazole nitrate cream in the treatment of interdigital tinea pedis： a multi-center, randomized and double-blind study

作　　者：李岷[1] 张建中[2] 王家俊[3] 章强强[3] 温海[4] 顾军[5] 曾凡钦[6] 赖维[7] 姚晨[8] 张文娟[2] 顾菊林[4] 徐红[4] 陈江汉[4] 毕新岭[5] 张军民[6] 黄怀球[7] 朱敏[3] 张超英[3] 李莉 吕桂霞[1] 沈永年[1] 刘维达[1] 

机构地区：[1]中国医学科学院北京协和医学院皮肤病研究所真菌科,南京210042 [2]北京大学人民医院皮肤科 [3]复旦大学附属华山医院皮肤科 [4]第二军医大学长征医院皮肤科 [5]第二军医大学长海医院皮肤科 [6]中山大学孙逸仙纪念医院皮肤科 [7]中山大学第三附属医院皮肤科 [8]北京301医院医学统计教研室

出　　处：《中华皮肤科杂志》2011年第9期658-660,共3页Chinese Journal of Dermatology

摘　　要：目的探讨1％特比萘芬乳膏1周、2％硝酸咪康唑乳膏1周、4周治疗趾间型足癣的疗效、安全性及复发情况。方法采用多中心、随机、双盲、平行对照法，入选患者分层随机分为3组，包括特比萘芬1周组（特比萘芬外用每日2次连续1周后再使用3周安慰剂）、咪康唑1周组（咪康唑每日2次连用1周＋3周安慰剂）和咪康唑4周组（咪康唑每日2次连用4周），用药后第1、3、4、6、9、12周随访进行临床、真菌学评估。结果152例真菌培养阳性的患者进入疗效分析。4周随访时，特比萘芬1周组，咪康唑4周组和咪康唑1周组的真菌治愈率分别为94．7％、87．8％和82．6％；3组综合疗效有效率分别89．5％、81．6％和63．0％；第12周随访时，3组真菌复发率分别为12．96％、13．95％和21．05％；不良反应发生率3组分别为2．38％、2．38％和3．57％。结论外用1％特比萘芬乳膏1周治疗趾间型足癣与外用咪康唑乳膏4周疗效和复发率相近。Objective To compare the efficacy and tolerability of 1-week 1% terbinafine hydrochloride cream, 1- and 4-week 2% miconazole nitrate cream in the treatment of interdigital tinea pedis, and to observe the relapse in patients treated with these regimens. Methods A multi-center, randomized, double-blind and parallel group study was conducted. By using a stratified randomization protocol, patients were divided into 3 groups to apply terbinafine cream twice daily for 1 week and inert cream （placebo） for the next 3 weeks （1- week terbinafine group）, miconazole cream twice daily for 1 week and inert cream （placebo） for the next 3 weeks （1-week miconazole group）, and miconazole cream twice daily for 4 weeks （4-week miconazole group）, respectively. Clinical and mycological assessment was made on week 1, 3, 4, 6, 9 and 12 after the initiation of treatment. Results A total of 152 patients with positive baseline mycological culture were eligible for the effi- cacy analysis. After 4-week treatment, the mycological cure rates were 94.7%, 87.8% and 82.6%, global effec- tive rates 89.5%, 81.6% and 63.0%, respectively for the 1-week terbinafine group, 4-week miconazote group and 1-week miconazole group. On week 12, the mycological relapse rates in 1-week terbinafine, 4-week miconazole and 1-week miconazole group were 13%, 14% and 21% respectively, and the incidence of adverse reaction was 2.38%, 2.38% and 3.57%, respectively. Conclusions As far as the efficacy and recurrence in patients are concerned, the 1-week terbinafine cream regimen is similar to the 4-week miconazole cream regimen for the treatment of interdigital tinea pedis.

关 键 词：抗真菌药 癣 脚 治疗 临床研究性 

分 类 号：R756[医药卫生—皮肤病学与性病学]