0.25%盐酸阿莫洛芬霜治疗体股癣多中心的临床试验

A Randomized, Controlled, Clinical Single-blind Parallel Trial Comparing Amorolfine Cream(0.25%) with Mycospor Cream(1%) in Treatment of Tinea Corporis/Curuis.

目的 :评价 0 2 5 %盐酸阿莫罗芬霜治疗体股癣临床非劣效性及安全性。方法 :1 0 1例患者入选 ,采用随机单盲、阳性药 (1 %联苯苄唑霜 )平行对照临床试验 ,根据临床症状改善及病原学检查、不良反应发生情况评价治愈率及安全性。结果 :试验组和对照组治愈率分别为 80 0 %、73 3% (P >0 0 5 ,RR 1 0 9,CI0 87-1 37) ;直接显微镜检查真菌阴转率分别为 82 2 %和 73 3% (P >0 0 5 ) ;真菌培养清除率分别为 80 0 %和 73 3% (P >0 0 5 )。个别患者发生与研究药物有关的不良反应 ,主要表现为红斑、瘙痒、灼热感、脱屑 ,不影响治疗 ,均自行缓解。ITT分析结果相似。结论 :0 2 5 %盐酸阿莫罗芬霜治疗体股癣高效安全 ,且临床疗效、真菌学疗效和安全性均与 1 %联苯苄唑霜相似。

Objective:To demonstrate the non-inferiority of clinical efficacy and to assess the safety of amorolfine cream versus mycospor cream in treatment of tinea corporis/cruris. Methods:In a clinical single-blind parallel trial, 101 patients with corporis/ cruris were treated topically with amorolfine cream (0.25%) or mycospor cream (1%). They were randomly allocated to 2 groups. Assesment of the results was based on both clinical and mycological tests. Results:The clinical cured rate in amorolfine and mycospor group were 80.0% and 73.3% respectively (P>0.005, RR 1.09, CI 0.87-1.37). Negative rates by microscopic examination were 82.2%, 73.3% respectively (P>0.005), and negative rates by culture were 80.0% and 73.3%(P>0.005). The most common local adverse events were burning and itching, erythema or scaling.Conclusion:There was no significant difference between the two creams in clinical and mycological cure rates.