黄体酮联合滋肾育胎丸治疗先兆流产的临床疗效和安全性评价

Efficacy and Safety Analysis of Zishen Yutai Pills Combined with Progesterone in the Treatment of Threatened Abortion

目的从循证医学角度评价黄体酮联合滋肾育胎丸对先兆流产患者的临床疗效和安全性。方法计算机检索中国知网、万方、维普、PubMed及EMBASE等数据库,检索时间从建库至2018年6月,检索出滋肾育胎丸联合黄体酮治疗先兆流产的随机对照研究,按照Cochrane系统评价的方法对符合纳入的研究进行筛选和质量评价,对纳入研究的结局指标用RevMan5.3软件进行Meta分析,用倒漏斗图检验和Egger检验评估发表偏倚,用TSAv0.9软件对临床总有效率和保胎成功率进行试验序贯分析。结果共纳入11项研究,涉及1216名患者。Meta分析提示:在单用黄体酮治疗的基础上,加用滋肾育胎丸能提高15%保胎成功率、20%的临床总有效率,提高孕酮、β-HCG、雌二醇水平,还能缩短治疗时间,无明显药物副作用;对总有效率和保胎成功率进行发表偏倚检验,显示不存在发表偏倚;试验序贯分析结果显示Meta分析结论可靠。结论黄体酮联合滋肾育胎丸比单用黄体酮,可显著提高先兆流产的临床疗效且无明显副作用,临床上值得推广运用。

Objective To evaluate the effectiveness and safety of Zishen Yutai Pills combined with progesterone in treatment of threatened abortion.Methods The randomized controlled trials (RCTs) about the treatment of threatened abortion with combination of Zishen Yutai pill and progesterone were retrieved from CNKI, WanFang, VIP, Pubmed and EMBASE database from the build up to June 2018 by internet.Risk assessment and quality evaluation were performed by Cochrane systematic review.Meta-analysis was performed for included studies by RevMan 5.3 software.Funnel plots and Egger's test were used to evaluate publication bias.TSA v0.9 software was used for trial sequential analysis (TSA) of the rate of pregnancy in cases of recurrent abortion and the total clinical effect.Results Eventually 11 clinical studies, 1216 cases of patients were included.Meta-analysis indicates that, compared with the treatment of pure progesterone, Zishen Yutai Pills combined with progesterone therapy could increase the 15% rate of pregnancy in cases of recurrent abortion, increase the total 20% clinical effect, improve the levels of progesterone,β-HCG, Estradiol (E2), significantly shorten treatment times and no obvious side effects were found.Publication bias test of the rate of pregnancy in cases of recurrent abortion and the total clinical effect were conducted, and the results showed that there was no publication bias.The TSA analysis showed that the evidence of Meta-analysis was reliable.Conclusion Compared with the treatment of pure progesterone, Zishen Yutai Pills combined with progesterone therapy could increase clinical effect in thetreatment of threatened abortion and no obvious side effects, which is worthy ofclinical application.