利拉萘酯乳膏治疗体股癣的多中心随机双盲平行对照临床研究  

Liranaftate cream in treatment of tinea cruris and tinea corporis:a muiticenter randomized double-blind vehicle-controlled clinical trial

作　　者：陶苏江[1] 王英[1] 顾军[1] 温海[2] 刘维达[3] 

机构地区：[1]中国人民解放军第二军医大学附属长海医院皮肤科,上海200433 [2]中国人民解放军第二军医大学附属长征医院皮肤科,上海200003 [3]中国医学科学院皮肤病研究所,江苏南京210042

出　　处：《中国新药与临床杂志》2007年第12期881-884,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的:观察和评价2%利拉萘酯乳膏治疗体、股癣的临床疗效和安全性。方法:采用多中心、随机、双盲、阳性药平行对照法对144例体、股癣病人进行4 wk的临床研究,病人随机分成试验组(予2%利拉萘酯乳膏)及对照组(予1%联苯苄唑乳膏),均为每日用药1次外涂患处,于治疗1,2 wk及停药2 wk随访观察。结果:142例病人完成试验,对照组70例,试验组72例,2组间性别、年龄、病情严重程度积分等比较无显著差异(P>0.05)。2组综合疗效试验组痊愈率为68%,对照组为61%,有效率分别为99%和90%,真菌清除率分别为99%和96%,在治疗结束(2 wk)和停药2 wk时2组病人的临床疗效、真菌学疗效和综合疗效的差异亦无显著意义(P>0.05)。2组均无不良事件发生。结论:2%利拉萘酯乳膏治疗体、股癣综合疗效和不良反应发生率与1%联苯苄唑乳膏相似,具有较好的疗效和安全性。AIM： To study and evaluate the efficacy and safety of 2 %liranaftate cream in the topical treatment of tinea cruris and tinea corporis. METHODS： Clinical study was done on 144 patients with tinea cruris and tinea corporis for 4 weeks in a multiple-center randomized, double-blind, parallel trial. Patients were randomly divided into trial group （treated with 2 % liranaftate cream） and control group （treated with 1% bifonazole cream） ; and creams were locally administered once daily in each group for 2 weeks. The clinical follow up was taken at 1 st, 2nd week since the beginning of treatment and 2 weeks after the treatment. RESULTS： One hundred and forty-two patients had completed the trials, with 70 in the control group and 72 in the trial group. The total cure rates were 68 % in trial group, and 61% in control group. The total efficacy rate was 99 % in trial group, and 90 % in control group. The mycological cure rate was 99 % and 96 % in trial group and control group, respectively. No adverse effects occurred in both groups. There were no significant differences between the two groups involving clinical efficacy, mycological effectiveness, integrative efficiency and adverse effects （P 〉 0.05） . CONCLUSION： 2 % topical liranaftate cream has the same good efficacy and safety profile as 1% bifonazole cream in the treatment of tinea cruris and tinea corporis.

关 键 词：利拉萘酯 癣 随机对照试验 双盲法 

分 类 号：R756.2[医药卫生—皮肤病学与性病学] R978.5[医药卫生—临床医学]