中华皮肤科杂志 ›› 2011, Vol. 44 ›› Issue (9): 658-660.

• 论著 • 上一篇    下一篇

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

李岷1,张建中2,王家俊3,章强强4,温海5,顾军6,曾凡钦7,赖维8,张文娟2,顾菊林9,徐红10,陈江汉10,毕新岭11,张军民12,黄怀球13,吕桂霞1,沈永年1,刘维达1   

  1. 1. 南京 中国医学科学院北京协和医学院皮肤病研究所
    2. 北京大学人民医院皮肤科
    3. 上海华山医院皮肤科真菌室
    4. 上海复旦大学华山医院皮肤科
    5. 上海第二军医大学长征医院皮肤科
    6. 上海第二军医大学附属长海医院皮肤科
    7. 广州市中山大学第二医院皮肤科
    8. 广州中山大学附属第三医院皮肤科
    9. 上海市凤阳路415号第二军医大学长征医院
    10. 上海第二军医大学附属长征医院皮肤科
    11. 上海第二军医大学长海医院皮肤科
    12. 广州中山大学附属第二医院皮肤科
    13. 广州中山医科大学第三附属医院皮肤科
  • 收稿日期:2011-05-11 修回日期:2011-06-30 出版日期:2011-09-15 发布日期:2011-08-31
  • 通讯作者: 刘维达 E-mail:liumyco@hotmail.com

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

  • Received:2011-05-11 Revised:2011-06-30 Online:2011-09-15 Published:2011-08-31

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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。

关键词: 咪康唑

Abstract:

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 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.

Key words: miconazole