海肤宁软膏治疗浅部真菌病Ⅱ期临床试验

Phase Ⅱ clinical trial of Haifuning ointment in treatment of dermatophytoses

目的:观察海肤宁软膏治疗皮肤浅部真菌病湿热浸淫型证(手足癣、体股癣)的疗效及安全性。方法:采用随机、单盲、多中心、对照的方法,试验组用海肤宁软膏,对照组用达克宁软膏。共入组421例,实际完成418例,其中试验组298例,对照组120例。结果:试验组总显效率为86.36％,对照组为80.00％,无统计学差异(P>0.05);试验组对丘疹、糜烂、脱屑症状起效时间及消除红斑、丘疹、糜烂、瘙痒症状时间较对照组短(P<0.05);但真菌镜检阴转与对照组无差异(P>0.05)。试验组不良反应发生率为6.64％。结论:海肤宁软膏治疗皮肤浅部真菌病湿热浸淫型证(手足癣、体股癣)的疗效及安全性与达克宁软膏相似。

Objective: To study the efficacy and safety of Haifuning ointment, a Chinese herb medicine, in treatment of dermatophytosis (tina manum, tina pedis, tina corporis and tina cruris). Methods:421 patients were recruited into the randomized, single blind, controlled multicenter study. They were divided to receive Haifuning ointment ( n = 298) or micondazole ointment ( n = 120). 418 patients complete the trial.Results:The total response rate was 86.38% for the treatment group and 80.00% for the control group and no statistical difference was observed between groups(P >0. 05). The incidence of side effects in treatment group was 6.64 % . Conclusion: Haifuning ointment is as effective as micondazole ointment in treatment of dermatophytosis including tina manum, tina pedis, tina corporis and tina cruris.