乌梅丸治疗女性早发性卵巢功能不全临床研究

Clinical study of the curative effect and limitations of TCM compound Wumei Pill in the treatment of premature ovarian insufficiency

目的:评估中药复方乌梅丸治疗早发性卵巢功能不全(Premature ovarian insufficiency,POI)的疗效和局限性.方法:采用回顾性队列研究,共146例患者入选(2013~2017),按个人意愿分为两组,其中一组(73例)口服乌梅丸(wumei pills,WMP),另一组(73例)使用激素替代治疗(hormone replacement treatment,HRT),连续用药24周后,评估POI患者排卵率(Ovulation rate,OR)、阳性妊娠率(positive pregnancy rate,PPR)、临床妊娠率(Clinical pregnancy rate,CPR)及早期流产率(Early miscarriage rate,EMR).结果:WMP组排卵率与阳性妊娠率较HRT组均有显著升高(47.3%vs 39.1%,29.5%vs 20.1%),差异具有统计学意义(P=0.025,P=0.036).在之后的随访中发现,WMP组与HRT组对比,临床妊娠率较高(25.1%vs 17.2%),早期流产率较低(30.8%vs 43.3%),但未见统计学差异(P=0.062,P=0.252).结论:POI患者通过口服乌梅丸,不仅增加了卵泡发生发育的机会,一定程度上还改善了患者阳性妊娠率.虽然此研究并未在临床妊娠率和早期流产率上出现显著的差异,但却提示乌梅丸对POI患者的干预是有益处的.

Objective:To evaluate the curative effect and limitations of TCM compound Wumei Pill(复方乌梅丸)in the treatment of premature ovarian insufficiency(POI).Methods:A total of 146 patients were enrolled(2013~2017)in the retrospective cohort study.They were divided into 2 groups according to their wishes.One group(73 cases)was treated with Wumei Pill(WMP),while the other group(73 cases)was treated with hormone replacement treatment(HRT).POI patients were evaluated for ovulation rate(OR),positive pregnancy rate(PPR),clinical pregnancy rate(CPR)and early abortion rate(EMR).Results:Ovulation rate and positive pregnancy rate in WMP group were significantly higher than those in HRT group(47.3%vs.39.1%,29.5%vs.20.1%),which were with statistically signi ficant differences(P=0.025,P 0.036).In the subsequent follow-up,it was found that the WMP group had a higher clinical pregnancy rate(25.1%vs.17.2%)and a lower early abortion rate(30.8%vs.43.3%)than the HRT group,but no statistical di fference was found(P=0.062,P=0.252).Conclusion:POI patients not only increased the chances of developing follicles by taking WMP orally,but also improved the positive pregnancy rate to some extent.Although this study did not show significant differences in clinical pregnancy rate and early abortion rate,it suggested that Wumei Pill was beneficial for the intervention of POI patients.