不同疗程1％卢立康唑乳膏治疗足癣的多中心、随机双盲对照研究

Comparison of 2 weeks versus 4 weeks of luliconazole 1% cream for the treatment of tinea pedis： a randomized, double-blind, multicenter, controlled trial

目的观察和评价不同疗程1％卢立康唑乳膏治疗足癣的疗效和安全性。方法采用多中心、随机、双盲、阳性药物对照研究，将入选患者按照试验中心分层随机分成3组，包括卢立康唑短疗程组（外用l％卢立康唑乳膏，每日1次，共2周，后2周使用安慰剂）、卢立康唑长疗程组（外用1％卢立康唑乳膏，每日1次，共4周）、联苯苄唑对照组（外用1％联苯苄唑乳膏，每日1次，共4周）。开始用药后第2、3、4、6周评价临床和真菌学疗效。结果420例真菌镜检阳性的患者随机分成3组，每组140例，398例患者进入疗效分析。用药2周时，对照组、短疗程组、长疗程组临床有效率分别为29．29％、31．43％和35．00％（P〉0．05），真菌清除率分别为49．29％、58．57％和57．86％（P〉0．05）；用药3周时，临床有效率分别为73．57％、78．57％和70．00％（P〉0．05）；用药4周时，临床有效率分别为89．29％、91．43％和89．29％（P〉0．05），真菌清除率分别为80．00％、87．86％和85．00％（P〉0．05）。停药后2周，对照组、短疗程组、长疗程组的临床有效率分别是92．14％、92．86％和92．14％（P〉0．05），真菌清除率分别为80．71％、90．00％和89．29％（P〈o．05）。对照组局部不良反应发生率为o．71％，短疗程组为o，长疗程组为2．14％。结论1％卢立康唑乳膏外用治疗足癣安全有效，每日1次治疗2周与治疗4周的疗效相当。

Objective To evaluate the efficacy and safety of different courses of luliconazole 1% cream in the treatment of tinea pedis. Methods A randomized, double-blind, multicenter controlled trial was conducted. According to a stratified randomization protocol, 420 patients positive for fungal elements on direct microscopy were equally and randomly divided into 3 groups： short-term group applying luliconazole 1% cream once daily for 2 weeks followed by placebo once daily for the next 2 weeks, long-term group applying luliconazole 1% cream once daily for 4 weeks, bifonazole group applying bifonazole 1% cream once daily for 4 weeks. Efficacy was assessed in terms of mycological clearance and clinical response rates on week 2, 3, 4 and 6 after initiation of treatment. Statistical analysis was carried out by paired t test, analysis of variance, chi-square test and a nonparametric test. Results Finally, 398 patients were eligible for the efficacy analysis. The clinical response rate in the bifonazole group, short- term group and long-term group was 29.29%, 31.43% and 35.00% respectively on week 2 after initiation of treatment （P 〉 0.05）, 73.57%, 78.57% and 70.00% respectively on week 3 （P 〉 0.05）, 89.29%, 91.43% and 89.29% respectively on week 4 （P 〉 0.05）, with the mycological clearance rate being 49.29%, 58.57% and 57.86% respectively on week 2 （P 〉 0.05）, 80.00%, 87.86% and 85.00% respectively on week 4 （P 〉 0.05）. Significant differences were observed on week 2 after the end of treatment in mycological clearance rate （80.71% in the bifonazole group vs. 90.00% in the short-term group vs. 89.29% in the long-term group, P 〈 0.05）, but not in clinical response rate （92.14% in the bifonazole group vs. 92.86% in the short-term group vs. 92.14% in the long- term group, P 〉 0.05）. The incidence rate of local adverse reactions was 0.71% in the bifonazole group, 0 in the short-term group and 2.14% in the long-term group. Conclusion Luliconazole 1% cream is effective and well tolerated in the treatment of tinea pedis, with the efficacy of 2-week once-daily regimen equivalent to that of 4-week once-daily regimen.