复方多粘菌素B软膏治疗细菌性皮肤病有效性和安全性评价

Evaluation of efficacy and safety of compound polymyxin B cream in treatment of bacterial skin infections

目的评价复方多粘菌素B软膏治疗细菌性皮肤病有效性和安全性。方法采用多中心、随机双盲、平行对照临床研究,并以盐酸环丙沙星软膏作对照,每日外用3次,疗程7天。结果临床有效率试验组为86.6%;对照组为91.1%(P=0.289);细菌学清除率为82.1%(对照组为86.6%,P=0.358);总有效率为85.5%(对照组为90.1%,P=0.293)。不良反应仅发生在对照组(0.9%),表现为用药局部皮肤轻度瘙痒。结论复方多粘菌素B软膏治疗细菌性皮肤病与环丙沙星软膏一样安全有效。

Objective Evaluation of efficacy and safety of compound polymyxin B cream in treatment of bacterial skin infections. Methods A randomized,double-blind,parallel study was conducted,hydrochloric ciprofloxacin cream as a control,applied three times daily for 7 days.Results The clinical response rates was 86.6%in the trial group and 91.1%in the control group(P=0.289),the bacterial clearance rate was 82.1%versus 86.6%respectively(P=0.358),the overall response rates were 85.5%versus 90.1%respectively(P=0.293). The adverse event was only occurred in the control group(0.9%) showed partly skin pruritus.Conclusion Compound polymyxin B cream and ciprofloxacin cream are equally safe and effective in bacterial skin infections.