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 TitlesComparison 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 Date2011
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.
URIhttp://hdl.handle.net/20.500.11897/286845
ISSN0412-4030
DOI10.3760/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

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