乳酸杆菌活菌制剂治疗细菌性阴道病疗效和安全性的系统评价

目的:系统评价乳酸杆菌活菌制剂治疗细菌性阴道病的疗效和安全性。方法:计算机检索CENTRAL(The Co-chrane Library 2010,Issue 1)、PubMed(1966~2010年1月)、EMBASE(1974~2010年1月)、CBMd isc(1978~2010年1月)、CNKI(1979~2010年1月)、VIP(1989~2010年1月)和万方数据库(1989~2010年1月);手工检索相关专业杂志。收集乳酸杆菌活菌制剂治疗细菌性阴道病的临床对照试验,文章语种不限,检索时间截止至2010年1月31日。由两名研究者按照Co-chrane系统评价的方法,独立纳入研究、提取资料、评价纳入研究的偏倚风险,提取有效数据,并使用RevMan 5.0软件对纳入研究进行M eta分析。结果:共纳入11个RCT,包含1 316例患者。M eta分析结果显示:乳酸杆菌活菌制剂阴道局部用药与甲硝唑阴道局部用药疗效差异无统计学意义〔总有效率(OR=0.85,95% CI 0.55~1.31,P=0.46),复发率(OR=0.28,95% CI 0.02~3.58,P=0.33)〕,未发现明确的药物不良反应;二者合用可降低细菌性阴道病的复发率〔联合用药(OR=0.05,95% CI 0.01~0.43,P=0.006),序贯用药(OR=0.25,95% CI 0.10~0.63,P=0.003)〕。结论:乳酸杆菌活菌制剂阴道局部用药与甲硝唑阴道局部用药疗效一致,未发现明确的药物不良反应;二者合用可降低细菌性阴道病的复发率。

A systematic evaluation of clinical efficacy and safety of lactobacillus preparation in treatment of bacterial vaginosis

Objective:To evaluate the clinical efficacy and safety of lactobacillus preparation in treatment of bacterial vaginosis systematically.Methods:CENTRAL(The Cochrane Library 2010,Issue 1),PubMed(1966～January,2010),EMBASE(1974～January,2010),CBMdisc(1978～January,2010),VIP(1989～January,2010) and Wanfang Database(1989～January,2010) were searched;related professional magazines were searched manually;the clinical controlled trials about lactobacillus preparation in treatment of bacterial vaginosis were collected,all foreign languages were welcome;the cut-off time of searching was 31st,January 2010;two investigators included researches independently,extracted data,evaluated bias risk of included researches and extracted effective data according to Cochrane systematic evaluation;RevMan 5.0 software was used for Meta analysis.Results:11 RCTs(1 316 cases) were included in the study;the results of Meta analysis indicated that there was no significant difference in clinical efficacy between vaginal medication of lactobacillus preparation and vaginal medication of metronidazole(total effective rate(OR=0.85,95% CI: 0.55~1.31,P=0.46),recurrence rate(OR=0.28,95% CI: 0.02~3.58,P=0.33));no obvious adverse reaction was found;union medication of lactobacillus preparation and metronidazole could reduce the recurrence rate of bacterial vaginosis(union medication(OR=0.05,95% CI: 0.01～0.43,P=0.006),sequential medication(OR=0.25,95% CI: 0.10～0.63,P=0.003)).Conclusion:The clinical efficacies of vaginal medication of lactobacillus preparation and vaginal medication of metronidazole are similar,no obvious adverse reaction is found;union medication of lactobacillus preparation and metronidazole may reduce the recurrence rate of bacterial vaginosis.