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目的评价1%氟曲马唑乳膏治疗足癣的疗效及安全性。方法采用多中心、随机、双盲、非劣效临床试验,每天1次外用,疗程4周。结果主要疗效4周时的总有效率氟曲马唑组为71.43%,联苯苄唑组为64.81%(P=0.190)。在6周时(停药后2周),总有效率分别为82.61%和71.60%(P=0.018);真菌清除率分别为86.16%和77.50%(P=0.045);临床有效率分别为93.43%和91.58%(P=0.504)。与研究药物相关的不良反应发生率氟曲马唑组2.44%,联苯苄唑组2.46%(P=1.000),主要表现为用药局部皮肤刺激。结论 1%氟曲马唑乳膏治疗足癣有效安全,4周时总疗效非劣效于1%联苯苄唑乳膏,但在6周时总疗效优于1%联苯苄唑乳膏,主要体现在真菌学疗效方面。
Objective To evaluate the efficacy and safety of 1% flumazole cream in the treatment of athlete’s foot. Methods Multi-center, randomized, double-blind, noninferiority clinical trials were conducted once daily for 4 weeks. Results The primary efficacy at 4 weeks was 71.43% for the fluoxastrole group and 64.81% for the bifonazole group (P = 0.190). The total effective rates were 82.61% and 71.60% (P = 0.018) at 6 weeks (2 weeks after drug withdrawal). The fungal clearance rates were 86.16% and 77.50%, respectively (P = 0.045), and the clinical effective rates were 93.43 % And 91.58% (P = 0.504). The incidence of adverse drug reactions associated with the study drug was 2.44% in the flurazumab group and 2.46% in the bifonazole group (P = 1.000), mainly due to local skin irritation. Conclusion 1% flumazole cream is effective and safe for the treatment of athlete’s foot. At 4 weeks, the total efficacy is non-inferior to that of 1% bifonazole cream, but the total curative effect is better than 1% bifonazole cream at 6 weeks , Mainly reflected in the efficacy of mycology.