地屈孕酮治疗先兆流产的系统评价

摘要

目的:评价地屈孕酮治疗先兆流产的有效性和安全性.方法:计算机检索PubMed、Embase、Cochrane Central、中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、维普中文科技期刊全文数据库(VIP)、ClinicalTrials.gov和世界卫生组织国际临床试验注册平台(WHO ICTRP),获得地屈孕酮治疗先兆流产已发表和未发表的随机对照试验(RCT).2名研究者独立筛选文献、提取资料和评估偏倚风险,采用RevMan 5.0软件进行Meta分析.结果:共纳入8个RCT,包括1185名受试者.地屈孕酮vs.保守治疗:纳入4个RCT,Meta分析结果显示,地屈孕酮组流产率低于保守治疗组[RR=0.46,95％CI(0.32,0.65),P＜0.0001],2组早产(P=0.77)、产前出血(P=0.57)及胎儿先天畸形(P=0.71)发生率差异均无统计学意义；地屈孕酮vs.黄体酮:纳入2个RCT,因偏倚较大未进行Meta分析,均报道2组流产率差异无统计学意义(P=1.000和P=0.630);地屈孕酮vs.人绒毛膜促性腺激素(HCG):纳入1个RCT,2组流产(P=0.711)、早产(P=0.727)和胎儿畸形(P=0.461)发生率差异均无统计学意义；地屈孕酮联合中药治疗:纳入2个RCT,地屈孕酮联合滋肾育胎丸与单服地屈孕酮组流产率分别为8％和13％,差异无统计学意义(P=0.655),地屈孕酮联合补肾活血安胎方与黄体酮组流产率分别为7.5％和15％,差异无统计学意义(P=0.390).结论:地屈孕酮较单纯保守治疗流产率低,但现有研究方法学质量均较低,有待高质量研究验证其疗效；尚缺乏证据证明母亲或胎儿的不良结局与孕期服用地屈孕酮有关；现有研究尚不能提示地屈孕酮与黄体酮、HCG疗效有差异；现有证据尚不能提示地屈孕酮联合中药治疗有益.%OBJECTIVE: To evaluate the efficacy and safety of dydrogesterone in the treatment of threatened miscarriage. METHODS: Randomized controlled trials (RCT) involving dydrogesterone in the treatment of threatened miscarriage were identified from PubMed, Embase, Cochrane Central, CBM, CNKI, VIP, ClinicalTrials.gov and WHO ICTRP. Published and unpublished RCTs were obtained on dydrogesterone in the treatment of threatened miscarriage. Included literatures were extracted and bias risks were evaluated independently by two reviewers. RevMan 5.0 software was used for Meta-analysis. RESULTS: A total of 8 RCT involving 1185 participants were included. Dydrogesterone vs. Conservative treatment: 4 RCT were included, the results of Meta-analysis showed that participants treated with dydrogesterone had a lower risk of miscarriage, compared with conservative treatment [RR=0.46,95%CI(0.32,0.65) ,P<0.0001]; no statistical significance was found in the incidence of premature birth (P= 0.77), antepartum haemorrhage (P=0.57) and congenital malformation (P= 0.71).Dydrogesterone vs. Progesterone: 2 RCT were included. We did not conduct Meta-analysis as included studies were in high risk of bias. No statistical significance was reported between two groups in the incidence of miscarriage (P= 1.000 and P= 0.630). Dydrogesterone vs. HCG: 1 RCT was included. No statistical significance was reported between two groups regarding to the incidence of miscarriage (P=0.711), premature birth (P= 0.727) and congenital malformation (P=0.461). Dydrogesterone combined with TCM treatment: 2 RCT were included, the incidences of miscarriage in dydrogesterone combined with Zishen yutai pills group and dydrogesterone alone group were 8% and 13% , there was no statistical significance (P=0.655) ; miscarriage occurred in 7.5% of women treated with dydrogesterone combined with Bushen huoxue antai prescription, and in 15% of that treated with progesterone, without statistical significance, neither (P=0.390). CONCLUSION: Dydrogesterone group has a lower incidence of miscarriage than conservative treatment only, but further studies with good methodological design are still needed to investigate its efficacy. There is no sufficient evidence to show any negative outcomes occurred in mothers or children related to dydrogesterone. Current studies with poor methodological quality show rnno difference in the efficacy between dydrogesterone and progesterone or HCG. There is insufficient evidence to show the benefit of dydrogesterone combined with TCM.