克林霉素磷酸酯栓治疗细菌性阴道病多中心随机双盲对照临床试验

目的:评价克林霉素磷酸酯栓治疗细菌性阴道病的疗效和安全性。方法:本研究采用多中心随机双盲对照试验。试验组109例,对照组110例,分别阴道置入克林霉素磷酸酯栓100 mg·d-1和甲硝唑栓500 mg·d-1治疗,疗程均为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92．7％和82．7％,试验组高于对照组(P<0．05),2组间疗效比较差异无显著意义(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82．6％和75．4％,2组疗效无显著差异(P>0．05)。不良反应发生率试验组和对照组分别为6．7％和8．3％(P>0．05)。结论:克林霉素磷酸酯栓治疗细菌性阴道病安全、有效。

Clindamycin phosphate suppository in treatment of bacterial vaginosis: a multicenter, randomized, and double-blind clinical trail

AIM:To evaluate the efficacy and safety of clindamycin phosphate suppository in the treatment of bacterial vaginosis. METHODS; A multicenter randomized and double-blind controlled clinical trail was conducted. One hundred and nine patients in trial group were treated with clindamycin phosphate suppository via vagina 100 mg·d-1 and 110 patients in control group were given metronidazole suppository 500 mg·d-1. Seven successive days were taken as a course for both groups. The efficacy and safety were observed respectively 3 - 5 d after end of treatment and 3 - 7 d after menorrhea. RESULTS: The efficacy rates were 92.7 % in trial group, higher than that in control group (82.7 %, P < 0.05) 3 - 5 d after end of treatment. But there was no significant difference in clinical efficacy between two groups (P > 0.05). The efficacy rates were 82.6 % in trial group and 75.4 % in control group respectively 3 - 7 d after menorrhea, with no significant difference in clinical efficacy between these two groups (P > 0.05). The rate of adverse reactions in trial group was 6.7 % and in control group was 8.3 % respectively (P > 0.05). CONCLUSION; Clindamycin phosphate suppository is an effective and safe preparation in the treatment of bacterial vaginosis.