胎儿镜下气管球囊阻塞术治疗先天性膈疝效果的系统评价

目的:系统评价胎儿镜下气管球囊阻塞术(FETO)对先天性膈疝(CDH)的治疗作用。方法:计算机全面检索相关文献数据库关于FETO对CDH胎儿治疗作用的相关文献,检索英文数据库:Embase、Pub Med、Cochrane Central Register of Controlled Trials(CCRT)、Web of Science、ACP、Medline及Ovid;检索中文数据库:中国生物医学文献数据库(CBM)、中国期刊全文数据库(CNKI)、维普(VIP),万方;手工检索相关会议资料、论文集及学位论文汇编等。检索时间为自建库至2016年9月,检索内容为FETO对CDH胎儿治疗作用的随机对照试验(randomized controlled trial,RCT)。采用Cochrane系统评价法,对检索文献进行质量评价和Meta分析,参照PRISMA报告规范进行报告。其异质性采用I~2检验,I~2≤50%采用固定效应模型,I250%采用随机效应模型;采用Mantel-Haenszel法评估RR和95%CI。结果:检索相关文献,共两篇符合本研究纳入标准,纳入受试者孕妇共65例。对纳入研究文献的方法学质量评价结果显示纳入文献质量适中。FETO组和对照组均未发生孕产妇死亡和输血。FETO组与对照组妊娠结局的Meta分析结果示:FETO明显增加早产(RR 1.99,95%CI 1.09~3.61,P=0.02)和未足月胎膜早破(RR 2.41,95%CI 1.26~4.61,P=0.01)的发病风险,而胎盘早剥(RR 3.55,95%CI 0.43~29.42,P=0.24)、母体感染(RR 3.32,95%CI 0.36~30.21,P=0.29)和新生儿存活(RR 2.86,95%CI 0.10~80.82,P=0.54)的发生率两组比较差异无统计学意义。结论:FETO增加早产和未足月胎膜早破的发病风险,不增加胎盘早剥、母体感染、孕产妇死亡的发病风险,其治疗作用有待进一步评估。

Foetal Endoscopic Tracheal Occlusion for the Treatment of Congenital Diaphragmatic Hernia:A Systematic Review and Meta-analysis

Objective:The aim of our study was to evaluate the effectiveness and safety of foetal endoscopic tracheal occlusion(FETO) in foetuses with congenital diaphragmatic hernia(CDH).Methods:Based on the principles and methods of Cochrane systematic reviews,we searched the Embase,PubMed,Cochrane Central Register of Controlled Trials,Web of Science,American College of Physicians(ACP),and Ovid-Medline databases for randomized controlled trials(RCTs) evaluating FETO for the treatment of CDH from the date of database inception to Sep 2016.Related conference papers and dissertations were also searched manually.The methodological quality and data extraction of the included studies were assessed independently by two reviewers followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses(PRISMA),and a meta-analysis was conducted using RevMan 5.0 software.The heterogeneity of the treatment was evaluated with the I2 statistic.Risk ratios(RR) and 95％ confidence intervals (CI) were computed for dichotomous data and were combined with a fixed-effects model(I2 ＜50％) using the Mantel-Haenszel method.A random-effects model was used to analyse the results(with values of I2 ＞50％).Results:2 RCTs involving 65 pregnancies met the inclusion criteria.We graded the methodological quality of included studies as moderate.The pregnancies treated with FETO showed a significant increase in the incidence of preterm delivery(RR 1.99,95％ CI 1.09 ～ 3.61,P =0.02) and preterm premature rupture of membranes(PPROM) (RR 2.41,95％ CI 1.26 ～ 4.61,P =0.01).There were no significant differences in the rates of maternal infection (RR 3.32,95％ CI 0.36 ～ 30.21,P =0.29),neonatal survival (RR 2.86,95％ CI 0.10 ～ 80.82,P =0.54),or placental abruption (RR 3.55,95％ CI 0.43 ～ 29.42,P =0.24) between the FETO and control groups.Conclusions:Our analysis showed that FETO was associated with the increase risk of preterm delivery and PPROM,but did not improve risk of placental abruption,maternal infection and maternal mortality.These results suggest that FETO may be a promising and challengeable treatment strategy to severe CDH,and well-organized multicentre RCTs should be conducted to evaluate the benefit of FETO.