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

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.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)09658-6604