国产与进口硝呋太尔-制霉菌素阴道栓随机双盲对照治疗念珠菌阴道炎

Double-blind randomized controlled clinical trial on domestic versus imported nifuratel-nysfungin suppository in the treatment of vulvovaginal candidiasis

目的评价硝呋太尔-制霉菌素阴道栓治疗念珠菌阴道炎的疗效和安全性.方法用随机双盲对照试验,试验组67例,对照组69例,分别给予国产和进口硝呋太尔-制霉菌素阴道栓,治疗6日.分别于停药后第1天和停药后月经来潮干净3～7天,观察外阴阴道瘙痒、白带和体征变化,同时进行阴道分泌物病原学检查.结果停药后第1天,试验组和对照组的临床治愈率分别为92.54%和91.30%,有效率分别为97.01%和95.65%,病原学清除率分别为97.01%和95.65%;停药后月经来潮干净后3～7天,临床治愈率分别为70.15%和68.12%,有效率分别为73.13%和72.46%,病原学清除率分别为73.13%和72.46%.经统计学处理,2组疗效无显著差异(P＞0.05).试验中未见明显药物不良反应.结论硝呋太尔-制霉菌素阴道栓治疗念珠菌阴道炎安全、有效.

Objective To evaluate efficacy and safety of domestic and importednifuratel-nysfungin suppository in the treatment of vulvovaginal candidiasis.Methods A double-blind randomized controlled clinical trail was conducted. Sixtyseven cases in test group and 69 cases in control group were given domestic andimported nifuratel-nysfungin suppository for 6 days. Vulvovaginal pruritus,leucorrhea, signs as well as pathogens were observed respectively 1 day aftertreatment and 3~7 days after menorrhea. Results After 6-days treatment, the curerates were 92.54% in test group, and 91.30% in control group; the efficacy rates were97.01% and 95.65%, the eradicated rates of pathogen were 97.01% and 95.65% ,respectively. Three to seven days after menorrhea, the cure rates were 70.15% intest group, and 68.12% in control group, the efficacy rates were 73.13% and 72.46%,the eradicated rates of pathogen were 73.13% and 72.46%, respectively. There wasno significant statistic difference between these two groups in efficacy and safety(P>0.05). Conclusion Nifuratel-nysfungin suppository is an effective and safepreparation in the treatment of vulvovaginal candidasis.