国产特比萘芬软膏与进口特比萘芬软膏对照治疗浅部真菌病

目的 :比较国产和进口 1%特比萘芬软膏治疗浅部真菌病的疗效和安全性。方法 :50例国产特比萘芬试验组中男性 2 7例 ,女性 2 3例 ,年龄 38a±s 17a ;进口特比萘芬对照组中男性 2 5例 ,女性2 3例 ,年龄 39a± 17a。 2种药物的用药剂量和疗程相同 ,外涂患处 ,每日 2次 ,体、股癣 ,花斑癣用药1wk为一个疗程 ,手、足癣和皮肤念珠菌病用药 2wk为一个疗程。结果 :国产特比萘芬软膏治疗浅部真菌病 ,临床有效率为 96 % ,真菌清除率为 90 % ,不良反应发生率为 2 % ;进口特比萘芬软膏治疗浅部真菌病 ,临床有效率为 98% ,真菌清除率为92 % ,不良反应发生率为 2 %。 2种药物治疗浅部真菌病的临床疗效和安全性经统计学处理差异均无显著意义 (P >0 .0 5)。结论 :国产与进口特比萘芬软膏治疗浅部真菌病有相似疗效及安全性。

Domestic terbinafine cream vs imported terbinafine cream in treatment of superficial mycoses

AIM: To compare the efficacy and safety of domestic terbinafine cream and imported terbinafine cream in treating superficial mycoses. METHODS: Fifty patients of the domestic terbinafine group, (M27, F23, age 38 a± s 17 a) and forty eight patients of the imported terbinafine group, (M25, F23, age 39 a±17 a) administered the two creams twice daily with the same dose and duration of treatment, 1 week for tinea corporis/cruris and pityriasis versicolor, 2 weeks for tinea manum/pedis and cutaneous candidosis. RESULTS: Data obtained showed that clinical effective rates were 96 % for domestic terbinafine group and 98 % for imported terbinafine group respectively, mycological cure rates were 90 % and 92 % and the adverse reaction rates of both groups were 2 %. There were no statistically significant difference between the two treatments on their efficacy and safety. CONCLUSION: Dometic terbinafine cream is effective and safe in treating superficial mycoses, and has almost the same efficacy as imported cream.