复方联苯苄唑乳膏治疗体股癣随机双盲对照临床试验

Bifonazole -Co Cream in the Treatment of Tinea Cruris and Tinea Corporis:A Randomized Double-blind Vehicle-controlled Clinical Trial

目的 评价复方联苯苄唑乳膏治疗体股癣的临床疗效及安全性。方法 采用随机双盲、有效对照、平行分组试验 ,与 1%联苯苄唑霜作对照比较。结果 观察了可供疗效评价的体股癣病例 67例 ,其中试验组 3 4例 ,对照组 3 3例。试验组治愈率 79.41% ,对照组为 72 .73 % ,两组有效率分别为 85 .2 9%和 81.82 % ,真菌清除率为 83 .87%和 80 .65 % ,不良反应发生率为 2 .86%和 0。两组的临床治愈率、有效率和真菌清除率及不良反应发生率差异均无显著性。但在治疗中 (第 1周 )试验组和对照组的有效率分别为 5 0 .0 0 %和 3 3 .3 3 % ,差异有非常显著性 (P <0 .0 0 5 )。结论 复方联苯苄唑乳膏治疗体股癣综合疗效和不良反应发生率与 1%联苯苄唑霜相似 ,但复方联苯苄唑乳膏治疗体股癣比 1%联苯苄唑霜起效快 ,具有很好的疗效和安全性。

Objective To evaluate the efficacy and safety of Bifonazole -Co cream in the topical treatment of tinea cruris and tinea corporis. Methods A randomized,Donble-blind vehicle-controlled,paralled trial,clinical efficacy and mycological efficacy were compared between Bifonazole-Co cream and 1% Bifonazole cream.Results 67 cases have been studied.34 cases were in the test group,33 cases were in controlled group respectively. The total cure rate was 79.41% in test group,and 72.73% in controlled group.The total efficacy rate was 85.29% in test group,and 81.82% in controlled group.The total mycological cure rate was 83.87% in test group,and 80.65% in controlled group.The side-effect rate was 2.86% in test group,and zero in controlled group.There were no signifficant differences in clinical efficacy,mycological efficacy and side-effect between this two groups.In the first week,the total efficacy rate was 50.00% in test group,and 33.33% in controlled group,and there were signifficant differences in the total efficacy rate (P<0.005). It manifested that Bifonazole-Co cream acted more quickly.Conclusion Topical Bifonazole -Co cream had a good efficacy and safety profile in the treatment of tinea cruris and tinea corporis,and Bifonazole -Co cream acted more quickly.