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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-nystatin vaginal suppository in the treatment of bacterial vaginosis. Methods This study used randomized controlled trials. 80 cases in trial group and 78 cases in control group were given nifuratel-nystatin suppository and metronidazole suppository respectively. The course of treatment was 6 d and 7 d respectively. Respectively after stopping 3 ~ 5 d and withdrawal menstrual cramps 3 ~ 7 d to observe the efficacy and safety. Results The effective rates of the experimental group and the control group were 90.0% and 82.5%, respectively, with no significant difference between 3 and 5 days after stopping (P> 0.05). There was no significant difference between the two groups (P> 0.05) After 3 to 7 days after the menstrual cramps, the effective rates of the experimental group and the control group were 82.5% and 73.1%, respectively, with no significant difference (P> 0.05). There was no significant difference between the two groups (P> 0.05). No adverse reactions were observed in the trial, and the incidence of adverse reactions was lower in the experimental group than in the control group (P <0.05). Conclusion Nifuratel-Nystatin suppository is safe and effective in the treatment of bacterial vaginosis.