调经促孕丸联合常规西药治疗不孕症的系统评价及试验序贯分析

Systematic Evaluation and Trial Sequential Analysis of Tiaojing Cuyun Pills Combined with Conventional Western Medicine in Treatment of Infertility

目的 系统评价调经促孕丸联合常规西药治疗不孕症的有效性和安全性。方法 检索PubMed、EMbase、Cochrane Library、Medline、维普中文科技期刊数据库(VIP)、中国知网数据库(CNKI)、万方数据库(Wanfang)、中国生物医学文献服务系统(SinoMed)建库至2021年8月15日收录的关于调经促孕丸联合常规西药治疗不孕症的随机对照试验,根据纳排标准筛选文献,采用RevMan 5.4软件进行Meta分析。结果 共纳入19项随机对照试验,1734例患者。Meta分析结果显示,调经促孕丸联合常规西药在提高不孕症患者妊娠率[RR=1.67,95%CI(1.51,1.86),P<0.000 01]、排卵率[RR=1.13,95%CI(1.02,1.25),P=0.02]、总有效率[RR=3.04,95%CI(1.75,5.28),P<0.0001]、宫颈黏液评分[MD=1.79,95%CI(1.45,2.13),P<0.000 01],增加内膜厚度[MD=0.89,95%CI(0.02,1.76),P=0.04],降低早期流产率[RR=0.20,95%CI(0.08,0.50),P=0.000 05]、不良反应/事件的发生[RR=0.60,95%CI(0.42,0.88),P=0.008],调节女性体内血清激素水平等方面的作用优于对照组,亚组分析结果显示在提高妊娠率方面,使用调经促孕丸联合枸橼酸氯米芬药物的作用更明显。并进一步试验序贯分析相应指标。结论 调经促孕丸对不孕症患者临床症状的改善具有一定的疗效和安全性。

Objective To systematically evaluate the efficacy and safety of Tiaojing Cuyun Pills combined with conventional western medicine in treatment of infertility.Methods Clinical randomized controlled trials(RCTs)on the treatment of infertility with Tiaojing Cuyun Pills combined with conventional western medicines were searched in PubMed, EMbase, Cochrane Library, Medline, VIP,CNKI,Wanfang Data, and SinoMed since theestablishment of the databases to August 15 th, 2021 based on inclusion and exclusion criteria, and Meta-analysis was conducted by RevMan 5.4.Results Nineteen RCTs were included, involving 1734 patients in total.Meta-analysis showed that Tiaojing Cuyun Pills combined with conventional western medicine were superior to the control group in improving pregnancy rate[RR=1.67,95%CI(1.51,1.86),P<0.000 01],ovulation rate[RR=1.13,95%CI(1.02,1.25),P=0.02],total efficiency[RR=3.04,95%CI(1.75,5.28),P<0.000 1]and cervical mucus score[MD=1.79,95%CI(1.45,2.13),P<0.000 01],increasing endometrial thickness[MD=0.89,95%CI(0.02,1.76),P=0.04],and reducing early abortion rate[RR=0.20,95%CI(0.08,0.50),P=0.000 05]and drug-related adverse reactions[RR=0.60,95%CI(0.42,0.88),P=0.008]as well as regulating female hormone levels.The subgroup analysis revealed that the effect of Tiaojing Cuyun Pills combined with clomifene citrate was more obvious in elevating pregnancy rate.Trial sequential analysis was performed by TSA0.9,and a reliable therapeutic effect of the experimental group was observed.Conclusion Tiaojing Cuyun Pills can effectively improve the clinical symptoms of infertile patients.