Title | 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 |
Other Titles | Comparison of 1-week terbinafime hydrochloride cream, 1- and 4-week miconazole nitrate cream in the treatment of interdigital tinea pedis: a multi-center, randomized and double-blind study |
Authors | 李岷 张建中 王家俊 章强强 温海 顾军 曾凡钦 赖维 姚晨 张文娟 顾菊林 徐红 陈江汉 毕新岭 张军民 黄怀球 朱敏 张超英 李莉 吕桂霞 沈永年 刘维达 |
Affiliation | 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 北京大学人民医院皮肤科 复旦大学附属华山医院皮肤科 第二军医大学长征医院皮肤科 第二军医大学长海医院皮肤科 中山大学孙逸仙纪念医院皮肤科 中山大学第三附属医院皮肤科 北京301医院医学统计教研室 |
Keywords | 抗真菌药 癣,脚 治疗,临床研究性 Antifungal agents Tinea pedis Therapies,investigational |
Issue Date | 2011 |
Publisher | 中华皮肤科杂志 |
Citation | 中华皮肤科杂志.2011,44,(9),658-660. |
Abstract | 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 (1week 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 efficacy analysis. After 4-week treatment, the mycological cure rates were 94.7%, 87.8% and 82.6%, global effective rates 89.5%, 81.6% and 63.0%, respectively for the 1-week terbinafine group, 4-week miconazole 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. |
URI | http://hdl.handle.net/20.500.11897/286845 |
ISSN | 0412-4030 |
DOI | 10.3760/cma.j.issn.0412-4030.2011.09.019 |
Indexed | 中文核心期刊要目总览(PKU) 中国科技核心期刊(ISTIC) 中国科学引文数据库(CSCD) |
Appears in Collections: | 人民医院 |