健脾安胎方可改善不孕患者体外受精-胚胎移植的妊娠结局

Chinese medicine Jianpi Antai formula improves pregnancy outcomes of in vitro fertilization-embryo transfer in infertile women

目的:评价健脾安胎方在接受体外受精-胚胎移植(IVF-ET)患者中的有效性和安全性。方法:研究共纳入浙江大学医学院附属邵逸夫医院生殖医学中心行两枚冷冻优胚移植后的患者300例,按照随机数字表法分为观察组和对照组,观察组给予移植期常规用药+健脾安胎方,对照组仅予移植期常规用药。评估两组一般情况、胚胎种植率、临床妊娠率、活产率及血常规、肝肾功能等安全性指标。结果:277例病例(观察组134例,对照组143例)完成研究并纳入统计。与对照组比较,观察组的胚胎种植率(分别为55.9%和68.7%)、临床妊娠率(分别为44.8%和56.7%)和活产率(分别为37.8%和50.7%)均升高(均P<0.05)。亚组分析发现,高龄患者(≥35岁)中,观察组的胚胎种植率、临床妊娠率和活产率均高于对照组(均P<0.05);卵巢储备功能减退患者(抗米勒管激素<1.68 ng/mL)中,观察组的胚胎种植率、临床妊娠率和活产率均高于对照组(均P<0.05)。随访期间,两组基本生命体征均无异常;均无皮疹、腹泻等不良事件。结论:健脾安胎方能提高接受IVF-ET移植患者的胚胎着床率,降低移植胚胎流产率,改善妊娠结局,且安全性高。

Objective:To evaluate the efficacy and safety of Chinese medicine Jianpi Antai formula in infertile women undergoing in vitro fertilization-embryo transfer(IVF-ET).Methods:A total of 300 infertile women who underwent 2 frozen embryo transfer procedures at the Reproductive Medicine Center,Sir Run Run Shaw Hospital were included in the study.The participants were randomly divided into study group and control group.The study group received routine medication plus the Jianpi Antai formula during the period of embryo transfer,while the control group received routine medication only.The general condition,embryo implantation rate,clinical pregnancy rate,live birth rate,and the blood routine and liver and kidney function were evaluated and compared between two groups.Results:There were 277 cases who completed the study,including 134 in the study group and 143 in the control group.The embryo implantation rate(68.7%vs.55.9%),the clinical pregnancy rate(56.7%vs.44.8%)and the live birth rate(50.7%vs.37.8%)in the study group were all higher than those in the control group(all P<0.05).Subgroup analysis revealed that in patients of advanced age(≥35 years)and those with decreased ovarian reserve function(anti-Müllerian hormone<1.68 ng/mL),the embryo implantation rate,clinical pregnancy rate,and live birth rate in the study group were all higher than those in the control group(all P<0.05).During the follow-up period,there were no abnormalities in the basic vital signs of both groups,and no adverse events were reported.Conclusion:Jianpi Antai formula can safely improve the embryo implantation rate in infertile women undergoing IVF-ET,reduce the embryo miscarriage rate,increase the live birth rate as well as improve the clinical outcomes.