中华皮肤科杂志

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利拉萘酯乳膏治疗体股癣及足癣的多中心随机双肓对照观察

王英1, 沈永年2, 朱红梅3, 张丽娟1, 胡芳1, 温海3, 刘维达2, 顾军1   

  1. 1. 第二军医大学长海医院皮肤科 上海 200433;
    2. 中国医学科学院皮肤病医院;
    3. 第二军医大学长征医院皮肤科
  • 收稿日期:2006-08-28 出版日期:2007-08-15 发布日期:2007-08-15
  • 通讯作者: 顾军,email:gujun01@medmail.com.cn E-mail:gujun01@medmail.com.cn

Liranaftate cream in the treatment of tinea cruris,tinea corporis and tinea pedis:a multicentre,randomized,double-bind,controlled trial

WANG Ying1, SHEN Yong-nian2, ZHU Hong-mei3, ZHANG Li-juan1, HU Fang1, WEN Hai3, LIU Wei-da2, GU Jun1   

  1. Department of Dermatology, Changhai Hospital Attached to Second Military Medical University, Shanghai 200433, China
  • Received:2006-08-28 Online:2007-08-15 Published:2007-08-15

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摘要： 目的 探讨2%利拉萘酯乳膏治疗体股癣、足癣的临床疗效和安全性。方法 采用多中心随机双盲阳性药平行对照法,分别在3个中心进行,入选288例患者,2%利拉萘酯乳膏试验组144例,1%联苯苄唑乳膏对照组144例;每组中体股癣患者各72例,足癣患者各72例。每日涂药1次,足癣疗程4周,每2周复诊1次;体股癣疗程2周,每周复诊1次;停药后2周均再复诊1次。结果 试验组体股癣患者中有1例脱落。停药时体股癣试验组的痊愈率和有效率分别为59.2%和94.4%,足癣试验组分别为41.7%和81.9%,与对照组比较,差异均无统计学意义(P>0.05)。在用药结束后2周时,体股癣试验组的痊愈率和有效率分别为67.6%和94.4%,足癣试验组分别为54.2%和81.9%,与对照组比较,差异无统计学意义(P>0.05)。在用药结束后2周,体股癣和足癣试验组符合方案分析集真菌学清除率分别为97.18%和90.28%,试验组和对照组差异均无统计学意义(P>0.05)。用药后发生的不良反应表现为用药部位红肿、疼痛,其中体股癣试验组不良反应发生率为2.78%。结论 2%利拉萘酯乳膏治疗体股癣、足癣有良好的疗效和安全性。

关键词: 癣, 随机对照试验, 利拉萘酯

Abstract: Objective To evaluate the efficacy and safety of 2% liranaftate cream in the treatment of tinea cruris,tinea corporis and tinea pedis.Methods A randomized,double blind,controlled study was performed in three centers.A total of 288 patients were enrolled into this study,and equally divided into 2 groups to receive 2% liranaftate cream (test group) and 1% bifonazole cream (control group) respectively. In every group,there were 72 patients with tinea cruris or tinea corporis and 72 patients with tinea pedis. Patients were instructed to apply the medications once a day.The patients with tinea cruris or tinea corporis were treated for 2 weeks and followed up every week;those with tinea pedis applied the drug for 4 weeks and were evaluated every 2 weeks.All patients were given a further consultation at 2 weeks after the end of treatment.Results A patient withdrew from the test group with tinea corporis or tinea cruris.At the end of treatment,the clinical cure rate and response rate in the test group amounted to 59.2% and 94.4% respectively for tinea corporis or tinea cruris,41.7% and 81.9% respectively for tinea pedis.Two weeks after the treatment ended,the clinical cure rate and response rate in the test group was 67.6% and 94.4% respectively for tinea corporis or tinea cruris,54.2% and 81.9% respectively for tinea pedis.The mycological clearance rates were 97.18% for tinea corporis or tinea cruris and 90.28% for tinea pedis in the per protocol set of test group at 2 weeks after the end of treatment,No significant difference (P>0.05) was noted in the above results between the test and control groups,Adverse reactions mainly included flare and pain at the site of application,occuring in 2.78% of patients with tinea corporis or tinea cruris in the test group.Conclusion Our study demonstrates that 2% liranaftate cream has a satisfactory effect on the treatment oftinea corporis,tinea cruris and tinea pedis.

Key words: Tinea, Randomized controlled trials, Liranaftate