1％盐酸布替萘芬凝胶治疗体股癣疗效观察

The Investigation on Efficacy of 1 % Butenafine Hydrochloride Gel in Treatment of Tinea Corporis/Curuis

目的评价1％盐酸布替萘芬凝胶治疗体股癣疗效及安全性。方法94例患者入选,采用随机、双盲、阳性药(1％盐酸特比萘芬凝胶)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、对照组临床治愈率分别为95．7％、97．9％(P>0．05);真菌学清除率分别为95．7％、100％(P>0．05);总治愈率分别为91．5％和97．9％(P>0．05),总有效率分别为95．7％和100％(P> 0．05)。个别患者发生与研究药物可能有关的不良反应,表现为红斑、瘙痒,不影响治疗,均自行缓解。结论 1％盐酸布替萘芬凝胶治疗体股癣疗效肯定,耐受性好,安全性高,其临床疗效、真菌学疗效和安全性与1％盐酸特比萘芬凝胶相似。

Objective To evaluate the efficacy and safety of 1% butenafine hydrochloride gel in the treatment of tinea eorporis/eruris. Methods In a clinical double-blind parallel trial, 94 patients of tinea eorporis/eruris were treated topically with 1% butenafine hydrochloride gel or 1% tubemafine hydrochlofide gel. They were randomly divided into 2 groups. Assesment of the results was based on both clinical and mycological tests. Results The clinical cured rates in butenafine and tubemafine group were 95.7% and 97.9%, respectively （P 〉0.05）, and mycological cured rates were 95.7% and 100% ,respectivdy （P 〉0.05）.The total cured rates in butenafine and tubemafine group were 91.5% and 97.9%, respecfively（P 〉0.05）,and the total effective rates were 95.7% and 100%, respeetivdy（P 〉0.05）. The local adverse events include itching and erythema, but can be recovered spontaneously. Conclusion There was no significant difference between the two gel in clinical and mycological cure rates. 1% butenafine hydrochloride gel is effective and safe in the treatment of tinea corporis/curuis.