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目的观察和评价山东省医药工业研究所研制的1%盐酸布替萘芬喷雾剂治疗体股癣、足癣的临床疗效和安全性。方法采用多中心随机、双盲、平行对照法,对照药为1%联苯苄唑喷雾剂。在治疗开始、中间、结束和2周随访时记录症状、体征积分及真菌学检查结果,以评价疗效,并监测不良事件。结果体股癣共117例,试验组58例,对照组59例。足癣共119例,试验组59例,对照组60例。体股癣停药时试验组与对照组痊愈率分别为25.86%和40.68%,有效率为86.21%和91.53%;2周随访痊愈率为58.62%和74.58%,有效率为96.55%和96.61%。足癣停药时痊愈率分别为23.73%和25.00%,有效率为81.36%和78.33%;2周随访痊愈率为37.29%和41.57%,有效率为81.36%和90.00%。试验组有13例出现局部不良反应,发生率为10.16%;对照组有20例,发生率为16.67%。上述各项指标经统计学检验,与对照药物差异均无统计学意义。结论1%盐酸布替萘芬喷雾剂治疗体股癣、足癣安全有效。
Objective To observe and evaluate the clinical efficacy and safety of 1% butenafine hydrochloride spray developed by Shandong Institute of Pharmaceutical Industry in the treatment of tinea corporis and tinea pedis. Methods A multicenter randomized, double-blind, parallel-controlled trial was used. The reference drug was 1% bifonazole spray. Symptoms, signs, and mycological examinations were recorded at the beginning, middle, end, and 2-week follow-up to evaluate efficacy and monitor adverse events. Results Totally 117 cases of tinea corporis, test group 58 cases, control group 59 cases. A total of 119 cases of tinea pedis, test group 59 cases, control group 60 cases. The cure rates of test group and control group were 25.86% and 40.68%, respectively. The effective rates were 86.21% and 91.53% respectively. The follow-up cure rates were 58.62% and 74.58% at 2 weeks, and the effective rates were 96.55% and 96.61% . The cure rate of tinea pedis was 23.73% and 25.00%, the effective rates were 81.36% and 78.33% respectively. The follow-up rates at 2 weeks were 37.29% and 41.57%, and the effective rates were 81.36% and 90.00%. There were 13 cases of local adverse reactions in the experimental group, the incidence was 10.16%; control group, 20 cases, the incidence was 16.67%. The above indicators by statistical tests, and the control drug differences were not statistically significant. Conclusion 1% butenafine hydrochloride spray for the treatment of tinea corporis, tinea pedis is safe and effective.