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目的评价1%盐酸布替萘芬凝胶(山东正大福瑞达制药有限公司生产)治疗足癣、体股癣的疗效及安全性,并与市售1%盐酸特比萘芬凝胶(商品名:倍佳)作比较。方法进行随机、双盲、对照、多中心临床试验。足癣和体股癣患者按序随机进入两组中的一组用药,均为每日外用药2次。疗程足癣为4周,体股癣2周,停药后再随访2周。进入临床试验共285例,其中足癣143例(试验组72例,对照组71例);体股癣142例(试验组71例,对照组71例)。结果试验组与对照组相比,足癣的临床治愈率分别为56.52%和64.18%,临床有效率分别为98.55%和98.51%;体股癣的临床治愈率分别为78.9%和87.3%,临床有效率分别为97.2%和98.6%;两组的真菌学清除率,足癣分别为97.1%和97.0%,体股癣分别为97.2%和98.6%;两组治疗足癣和体股癣的不良反应发生率分别为2.1%(3/141)和2.2%(3/139),主要表现为用药局部皮肤反应。以上两组比较差异均无统计学意义。结论1%盐酸布替萘芬凝胶治疗足癣和体股癣的疗效及安全性与1%盐酸特比萘芬凝胶相似,值得临床广泛应用。
Objective To evaluate the efficacy and safety of 1% butenafine hydrochloride gel (manufactured by Shandong Zhengda Furuida Pharmaceutical Co., Ltd.) in the treatment of athlete’s foot and body tinea pedis, and to compare the efficacy and safety with 1% terbinafine hydrochloride gel Name: times better) for comparison. Methods Randomized, double-blind, controlled, multicenter clinical trials. Tinea pedis and tinea corporis patients were randomized into two groups in a random order, both for daily external medicine 2 times. Tinea pedis for 4 weeks, body ringworm 2 weeks, followed up for 2 weeks after stopping. A total of 285 cases entered the clinical trials, including 143 cases of athlete’s foot (experimental group, 72 cases, 71 cases of control group); body ringworm 142 cases (71 cases in the experimental group, 71 cases in the control group). Results The clinical cure rates of tinea pedis were 56.52% and 64.18% in the test group compared with those in the control group respectively. The clinical effective rates were 98.55% and 98.51% respectively. The clinical cure rates of body tinea cruris were 78.9% and 87.3% The effective rates were 97.2% and 98.6% respectively. The mycological clearance rates of the two groups were 97.1% and 97.0% for tinea pedis and 97.2% and 98.6% for tinea corporis and tinea corporis respectively. The two groups had poor tinea pedis and tinea corporis Response rates were 2.1% (3/141) and 2.2% (3/139), respectively, and were mainly manifested as topical skin reactions. There was no significant difference between the two groups above. Conclusion The efficacy and safety of 1% butenafine hydrochloride gel for tinea pedis and tinea corporis is similar to 1% terbinafine hydrochloride gel, which is worthy of clinical application.