奥培米芬治疗绝经后外阴阴道萎缩效果的meta分析

Meta-analysis of the efficacy of Ospemifene in the treatment of postmenopausal vulvovaginal atrophy

目的 评估奥培米芬治疗绝经后外阴阴道萎缩的效果,为外阴阴道萎缩的临床治疗提供一定的理论支撑。方法 检索中国知网、万方知识服务平台、维普网、中国生物医学数据库、Pub Med、Embase、Cochrane Library、Web of Science核心合集数据库中关于奥培米芬治疗绝经外阴阴道萎缩的中英文文献,搜索时间为建库至2023年4月。文献质量评价采用Cochrane手册中随机对照试验偏倚风险评估工具;使用Review Manager 5.3对纳入文献进行meta分析。结果 最终纳入7篇随机对照试验,包括2 649例患者,其中奥培米芬组1 624例,安慰剂组1 025例。两组子宫内膜增殖情况比较,差异无统计学意义(OR=3.74,95%CI:0.79,17.75,P=0.10)。奥培米芬较安慰剂组子宫内膜增厚发生率增加(OR=1.22,95%CI:1.01,1.47,P=0.03)、阴道p H值下降(SMD=-1.22,95%CI:-1.45,-0.98,P<0.000 01)、阴道干涩缓解(SMD=-0.38,95%CI:-0.55,-0.21,P<0.000 1)、不良反应发生率增加(OR=1.49,95%CI:1.28,1.74,P<0.000 01)。结论 奥培米芬可增厚子宫内膜、降低阴道p H值及缓解阴道干涩,虽然在一定程度上增加不良反应的发生率,但仍是治疗外阴阴道萎缩的可靠方法。

Objective To evaluate the efficacy of Ospemifene in the treatment of postmenopausal vulvovaginal atrophy,in order to provide theoretical support for the clinical treatment of vulvovaginal atrophy.Methods Chinese and English literatures on the treatment of postmenopausal vulvovaginal atrophy were searched from CNKI,Wanfang Data,VIP,China Biomedical Database,Pub Med,Embase,Cochrane Library,and Web of Science core collection databases.The search period was from the establishment of the database to April 2023.The literature quality evaluation was conducted using the Cochrane Handbook's randomized controlled trial bias risk assessment tool;Review Manager 5.3 was used for meta-analysis of the included literature.Results Seven randomized controlled trials were included,including 2 649 patients,including1 624 cases in Ospemifene group and 1 025 cases in placebo group.There was no significant difference in endometrial increment between two groups(OR=3.74,95%CI:0.79,17.75,P=0.10).Compared with placebo group,the incidence of endometrial thickening increased(OR=1.22,95%CI:1.01,1.47,P=0.03) and vaginal p H decreased(SMD=-1.22,95%CI:-1.45,-0.98,P<0.000 01),vaginal dryness relieved(SMD=-0.38,95%CI:-0.55,-0.21,P<0.000 1),and the incidence of adverse reactions increased(OR=1.49,95% CI:1.28,1.74,P <0.000 01).Conclusion Ospemifene can thicken the endometrium,reduce vaginal p H,and relieve vaginal dryness,although it increases the incidence of adverse reactions to a certain extent,it is still a reliable treatment for vulvovaginal atrophy.