滋肾育胎丸对比安慰剂在进行新鲜胚胎移植周期的妇女中提高活产率的作用——一项随机对照临床试验  

Effects of Zishen Yutai Pill compared with placebo on live births among women in a fresh embryo transfer cycle:a randomized controlled trial

作　　者：陈晓莉(翻译)[1] 杨冬梓(审校)[1] XiaoliChen;Dongzi Yang(Center for Reproductive Medicine,Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University,Guangzhou 510020,China)

机构地区：[1]中山大学孙逸仙纪念医院生殖医学中心,广州510020

出　　处：《中华生殖与避孕杂志》2022年第10期1065-1074,共10页Chinese Journal of Reproduction and Contraception

基　　金：广东省名优中成药二次开发项目(20174002);广州市科技计划项目(20170402048)。

摘　　要：目的评价滋肾育胎丸对新鲜胚胎移植周期妇女活产率的影响。方法采用多中心、随机、双盲、安慰剂对照临床试验设计方法,研究服用滋肾育胎丸是否能改善行体外受精/卵胞质内单精子注射(in vitro fertilization/intracytoplasmic sperm injection,IVF/ICSI)的新鲜胚胎移植周期妇女的妊娠结局。主要结局指标为活产率。次要结局指标为种植率、生化妊娠率、临床妊娠率、流产率、取消周期率,以及孕妇、胎儿、新生儿并发症发生率。按1∶1比例纳入2265例受试者,比较滋肾育胎丸组与安慰剂组之间活产率的差异。受试者入组后,采用区组随机法随机分配接受滋肾育胎丸或安慰剂治疗;在试验过程中,药物服用剂量为一日3次,一次5 g。结果招募于2014年4月至2017年6月期间进行。随访于2018年6月完成。2265例患者进入随机分配,其中,1131例患者进入滋肾育胎丸组,1134例患者分配到安慰剂组。两组间人口学特征相近。在意向性分析中,滋肾育胎丸组及安慰剂组的活产率分别为26.8%(303/1131)、23.0%(261/1134),差异有统计学意义(RR=1.16,95%CI=1.01~1.34,P=0.038);种植率分别为36.8%(482/1310)、32.6%(410/1256),差异有统计学意义(RR=1.13,95%CI=1.01~1.25,P=0.027)。滋肾育胎丸组及安慰剂组的生化妊娠率分别为35.5%(402/1131)、31.1%(353/1134),差异有统计学意义(RR=1.14,95%CI=1.02~1.28,P=0.026),临床妊娠率则分别为31.2%(353/1131)、27.3%(310/1134),差异有统计学意义(RR=1.14,95%CI=1.00~1.30,P=0.043)。两组间的流产率及孕妇、胎儿、新生儿并发症发生率差异均无统计学意义(均P>0.05)。结论滋肾育胎丸能有效提高新鲜胚胎移植周期妇女的活产率。Objective To assess the efficacy of Zishen Yutai Pill compared with placebo on live birth rate among women following fresh embryo transfer cycles.Methods We conducted a double-blind,multicenter,placebo-controlled,randomized trial to investigate whether administration of Zishen Yutai Pill would improve pregnancy outcomes among women undergoing fresh embryo transfer following in vitro fertilization or intracytoplasmic sperm injection.The primary outcome was live birth rate.Secondary outcomes were rates of implantation,biochemical pregnancy,clinical pregnancy,pregnancy loss,cycle cancellation,maternal,fetal and neonatal complications.A total of 2265 sample size(1∶1 in two groups)was used to detect a live birth rate difference between Zishen Yutai Pill and placebo.Participants were enrolled and randomized to receive 5 g of Zishen Yutai Pill or placebo orally,three times per day during the study using block randomization method.Results Recruitment was completed between April 2014 and June 2017,with 2580 patients screened.Follow-up was completed in June 2018.Totally 2265 patients were randomized,1131 to Zishen Yutai Pill group and 1134 to placebo group.Characteristics were similar between the two groups.In intention-to-treat analysis,the rates of live birth in Zishen Yutai Pill group and placebo group were 26.8%(303/1131)and 23.0%(261/1134),respectively,the difference was statistically significant(RR=1.16,95%CI=1.01-1.34,P=0.038).The implantation rates were 36.8%(482/1310)and 32.6%(410/1256)in Zishen Yutai Pill group and placebo group,respectively,the difference was statistically significant(RR=1.13,95%CI=1.01-1.25,P=0.027).The biochemical pregnancy rate in Zishen Yutai Pill group was 35.5%(402/1131)vs.31.1%(353/1134)in placebo group,the difference was statistically significant(RR=1.14,95%CI=1.02-1.28,P=0.026).The rates of clinical pregnancy in Zishen Yutai Pill group and placebo group were 31.2%(353/1131)and 27.3%(310/1134),respectively,the difference was statistically significant(RR=1.14,95%CI=1.00-1.30,P=0.043).Th

关 键 词：生殖技术 辅助 中药 不孕症 妊娠结局 

分 类 号：R271.9[医药卫生—中西医结合]