缺血后处理在急性心肌梗死患者中应用的功能磁共振影像学评价:Meta及试验序贯分析

Functional Cardiac Magnetic Resonance Imaging Assessment of Ischemic Postconditioning in Acute Myocardial Infarction:A Trial Sequential Analysis

目的对缺血后处理(IPoC)在急性心肌梗死(AMI)患者中应用的左心室收缩功能磁共振影像学(cMRI)的随机对照试验(RCT)进行Meta及试验序贯分析(TSA)。方法纳入PubMed,EMBase,and Cochrane Library数据库(截止2019年9月)发表的相应RCT。临床研究终点为cMRI评估的左心室射血分数(LVEF)。将随访周期分为三个类别:①1周之内;②3~6月;③6~12月。由于存在潜在的临床异质性所有分析采用随机效应模型。对纳入的所有RCT行发表偏倚和试验序贯分析以评估其可信度。采用Stata v12.0和TSA v0.9进行统计分析。结果本研究纳入14篇RCTs共计1820例患者。与对照组相比,IPoC并不明显改善LVEF[加权均差(WMD)=1.62;P=0.12;I2=90.0%]。本研究终点并不存在明显的发表偏倚(Begg检验,P=0.87;Egger检验,P=0.69)。亚组分析结果显示,无论是术后1周左右(WMD=2.55,P=0.11),术后3~6月(WMD=0.53,P=0.63),还是术后6~12月(WMD=1.60,P=0.57),其效果均无显著统计学意义。TSA分析结果显示在接近达到期望信息量(RIS)之前(n=1732 vs RIS=1897)已经获得了确切的结论,可信度较高。结论本Meta分析的研究有关cMRI评价的结果显示,IPoC并不能明显改善术后LVEF。TSA显示此阴性结果可信度高。

Objective To evaluate the effect of ischemic postconditioning(IPoC)on left ventricular ejection fraction(LVEF)assessed by cardiac magnetic resonance imaging(cMRI)using meta analysis and trial sequential analysis(TSA)in patients with acute myocardial infarction(AMI).Methods A meta-analysis was conducted based on the evidence of randomized controlled trials(RCT)from PubMed,EMBase,and Cochrane Library(up to September 2019).The clinical endpoint of interest was LVEF assessed by cMRI.The follow-up period was divided into three categories:①within 1 week;②3 months to 6 months;③6 months to 12 months.Random-effect model was used for the potential clinical inconsistency in the pooled analysis.Publication bias assessment and TSA were also performed to evaluate the reliability.All statistical analyses were performed in Stata(v12.0;Stata Corporation,College Station,TX)and TSA v0.9 Beta(Copenhagen Trial Unit,Copenhagen,Denmark).Results Fourteen trials with a total of 1820 AMI patients were searched and selected.Compared with controls,IPoC did not significantly improve the LVFE[weighted mean difference(WMD)=1.62;P=0.12;I2=90.0%].No obvious evident of significant publication bias was observed(Begg’s test,P=0.87;Egger’s test,P=0.69).Subgroup analysis revealed that the effects were all nonsignificant during three follow-up periods(1 week,WMD=2.55,P=0.11;3~6 months,WMD=0.53,P=0.63;6-12 months,WMD=1.60;P=0.57).The TSA showed that the pooled result has reached the reliability before the required information size(RIS)(n=1732 vs RIS=1897).Conclusion The current meta analysis suggests that IPoC fails to improve LVEF assessed by cMRI,which could be confirmed in the reliability by TSA.