中医药孕前干预治疗复发性流产疗效的Meta分析

Meta-Analysis of Prepregnancy Intervention of Traditional Chinese Medicine in the Treatment of Recurrent Spontaneous Abortion

目的评价中医药孕前干预治疗复发性流产的疗效优势,为中医药“预培其损”理论治疗复发性流产提供证据与参考。方法检索PubMed、Embase、Web of Science、Cochrane Library、中国知网、维普期刊数据库、中国生物医学文献数据库及万方数据库,检索时间为建库至2021年10月。采用RevMan 5.4、Stata 14.0软件对符合纳入标准的随机对照试验进行Meta分析。结果纳入随机对照研究文献13篇,共1021例病例。Meta分析结果显示:中药孕前干预治疗复发性流产可以提高妊娠成功率(RR=1.35,95%CI[1.24,1.47],P<0.00001),对提高保胎成功率(RR=1.32,95%CI[1.21,1.45],P<0.00001)、提高活产率(RR=1.50,95%CI[1.22,1.83],P<0.00001)、改善凝血功能、孕后性激素(β-HCG、P)水平方面可能存在一定疗效优势,而对妊娠率、早产率及免疫相关指标的改善可能不具有明显的疗效优势。结论当前有限证据显示,中医药孕前干预治疗可能使复发性流产患者获益,但需更多进一步的作用机制研究,同样也需要纳入更多大样本、高质量的随机对照试验来加以验证。

Objective To evaluate the efficacy of the prepregnancy intervention of Traditional Chinese Medicine(TCM)in the treatment of recurrent spontaneous abortion(RSA)and thereby provide medical evidence and reference for the clinical application of"tonifying the deficiency before disease onset"theory in the treatment of RSA.Methods Randomized controlled trials(RCTs)on the prepregnancy intervention of TCM in the treatment of RSA were retrieved from PubMed,Web of Science,Embase,Cochrane Library,China National Knowledge Infrastructure(CNKI),VIP,Wanfang Data,and China Biology Medicine disc(CBMdisc)(from inception to October 2021)and Revman 5.4 and Stata 14.0 were used for the statistical analysis of the eligible RCTs.Results A total of 13 RCTs were included,involving 1021 patients.Meta-analysis suggested that prepregnancy intervention of TCM can improve the pregnancy rate(RR=1.35,95%CI[1.24,1.47],P<0.00001).Moreover,it was advantageous in improving thesuccess rate of miscarriage prevention(RR=1.32,95%CI[1.21,1.45],P<0.00001),the live birth rate(RR=1.50,95%CI[1.22,1.83],P<0.00001),and coagulation function and levels of sex hormones(β-HCG,P)after pregnancy.Conclusion Current limited evidence shows that prepregnancy intervention of TCM may benefit patients with RSA.However,the mechanism should be further studied and more high-quality and double-blind RCTs with large samples should be carried out to further verify the conclusion.