硝呋太尔-制霉菌素阴道栓治疗细菌性阴道病的疗效及安全性分析

Efficacy and Safety of Nifuratel-nysfungin Suppository in the Treatment of Bacterial Vaginosis

目的评价硝呋太尔-制霉菌素阴道栓治疗细菌性阴道病的疗效和安全性。方法本研究采用随机对照试验。试验组80例,对照组78例,分别给予硝呋太尔-制霉菌素栓和甲硝唑栓,疗程分别为6 d和7 d。分别于停药后3～5 d和停药后月经来潮干净3～7 d观察疗效和安全性。结果停药后3～5 d,试验组和对照组有效率分别为90.0%和82.5%,差异无统计学意义(P>0.05),两组间疗效比较无显著差异(P>0.05);停药后月经来潮干净后3～7 d,试验组和对照组有效率分别为82.5%和73.1%,差异无统计学意义(P>0.05),两组疗效无显著差异(P>0.05)。试验中未见严重不良反应,不良反应发生率试验组低于对照组(P<0.05)。结论硝呋太尔-制霉菌素栓治疗细菌性阴道病安全、有效。

OBJECTIVE To evaluate the efficacy and safety of nifuratel-nysfungin suppository in the treatment of bacterial vaginosis.METHODS A randomized and controlled clinical trial was conducted.The 80 patients in trial group were treated with nifuratel-nysfungin suppository and 78 patients in control group were given metronidazole suppository.Six successive days were taken as a course for nifuratel-nysfungin suppository group and seven successive days for metronidazole suppository.The efficacy and safety were observed respectively 3-5 d after treatment and 3-7 d after menorrhea.RESULTS The efficacy rate was 90.0% in trial group and 82.5% in control group on 3-5 d after treatment（P0.05）.There was no significant difference in clinical efficacy between two groups（P0.05）.The efficacy rate was 82.5% in trial group and 73.1% in control group on 3-7 d after menorrhea（P0.05）.There was no significant difference in clinical efficacy between two groups（P0.05）.No severe adverse reactions were found in the trial.The adverse reactions incidence in trial group was lower than that in control group（P0.5）.CONCLUSION Nifuratel-nysfungin suppository is an effective and safe preparation in the treatment of bacterial vaginosis.