特比萘芬软膏与疗霉舒软膏随机对照治疗浅部真菌病多中心临床研究

Multicentre Randomized Comparative Clinical Study of Topical 1% Terbinafine Cream vs 1% Lamisil Cream in the Treatment of Superficial Mycoses.

目的 比较研究山东齐鲁制药厂生产的１ ％ 特比萘芬软膏和诺华公司生产的１ ％ 疗霉舒软膏治疗浅部真菌病的有效性和安全性。方法 随机、多中心临床研究。两种药物的用药剂量和疗程相同，外涂患处，每日２ 次，体股癣、花斑癣疗程１ 周，手足癣和皮肤念珠菌病疗程２ 周。结果 １ ％ 特比萘芬软膏治疗浅部真菌病，临床治愈率为７０ ．８ ％ ，总有效率９６ ．２ ％ ，真菌清除率为９０ ．６ ％ ，不良反应发生率０ ．９ ％ ；对照组疗霉舒临床治愈率为７４ ．５ ％ ，总有效率９７ ．１ ％ ，真菌清除率为９３ ．１ ％ ，不良反应发生率为２ ．０ ％ 。两种药物治疗浅部真菌病的临床疗效和安全性在统计学上差异均无显著性意义。结论１ ％ 特比萘芬软膏治疗浅部真菌病疗效好、安全性高，与１ ％ 疗霉舒软膏比较疗效相似。

Aim To compare the efficacy and safety of topical treatment of 1% terbinafine cream produeed by Shandong Qilu Pharmaceutical Factory and 1% Lamisil Cream produced by Novartis Ltd.Methods Randomized comparative multicentre clinical study.The two creams were administered 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 cure rates were 70.8% for terbinafine compared to 74.5% for Lamisil,effective rates were 96.2% compared to 97.1%,mycological cure rates were 90.6% compared to 93.1% and side effects rates were 0.9% compared to 2%.There were no statistically significance between the two treatment on their efficact and safety.Conclusion 1% terbinafine cream produced by Qilu Pharmacological factory is effective and safe in treating superficial mycoses,and has almost the same efficacy as Lamisil cream.