急性心肌梗死患者行经皮冠状动脉介入术前应用尼可地尔的有效性与安全性的Meta分析

Meta-analysis on efficacy and safety of nicorandil prior to primary percutaneous coronary intervention in patients with acute myocardial infarction

目的:系统评价急性心肌梗死经皮冠状动脉介入术(PCI)之前应用尼可地尔的疗效和安全性。方法:计算机检索PubMed,EMBASE,Cochrane Central Register of Controlled Trials,MEDLINE,CBM,CNKI,Wanfang Database和VIP citation databases等数据库关于急性心肌梗死PCI术前应用尼可地尔的随机对照试验(RCT),同时检索纳入文献的参考文献,检索时限为1982年1月-2022年2月。采用改良Jadad评分方法对文献质量进行评价,采用RevMan5.2.0进行统计学分析。结果:共纳入24个RCT,急性心肌梗死患者2426例。Meta分析结果显示:术后试验组患者无复流现象(NRP)发生率显著低于对照组[RR=0.45,95%CI(0.33~0.62),P<0.00001];术后试验组患者校正后心肌梗死溶栓试验帧数(cTFC)显著低于对照组[WMD=-5.02,95%CI(-7.28~-2.76),P<0.0001];试验组患者的室壁运动积分(WMS)与对照组比较差异无统计学意义[WMD=0.04,95%CI(-0.71~0.80),P=0.91];术后试验组患者的左心室射血分数(LVEF)显著高于对照组[WMD=1.89,95%CI(1.08~2.71),P<0.00001];术后试验组患者的心力衰竭(HF)发生率显著低于对照组[RR=0.44,95%CI(0.26~0.72),P<0.05];术后试验组患者的主要不良心血管事件(MACE)发生率显著低于对照组[RR=0.64,95%CI(0.52~0.79),P<0.0001]。结论:对于急性心肌梗死患者行PCI之前应用尼可地尔可进一步改善患者的冠状动脉血流和心脏收缩功能,改善患者PCI术后左心室功能,降低主要不良心血管事件发生率,且不增加出血事件的发生,具有较好的临床疗效。

Objective:To evaluate the efficacy and safety of nicorandil prior to primary percutaneous coronary intervention(PCI)in patients with acute myocardial infarction.Methods:PubMed,EMBASE,Cochrane Central Register of Controlled Trials,MEDLINE,CBM,CNKI,Wanfang Database and VIP citation databases were searched for RCTs.All eligible studies were randomized controlled trials assessing efficacy and safety of nicorandil prior to PCI in patients with acute myocardial infarction.The data were analyzed by RevMan 5.2 software.Results:Tweenty RCTs with 2426 patients were finally included.The Meta-analysis results showed,treatment of nicorandil prior to PCI significantly reduced the incidence of NRP([RR=0.45,95%CI(0.33~0.62),P<0.0001]and reduced corrected TIMI framecount(cTFC)[WMD=-5.02,95%CI(-7.28~-2.76),P<0.0001]immediately after PCI.Moreover,although nicorandil did not significantly affect WMS(WMD=0.04,95%CI(-0.71~0.80),P=0.91),treatment of nicorandil significantly increased left ventricular ejection fraction(LVEF)in STEMI patients undergoing primary PCI[WMD=1.89,95%CI(1.08~2.71),P<0.00001].In addition,nicorandil significantly reduced the risk of Heart Failure(HF)exacerbation or rehospitalization[RR=0.44,95%CI(0.26~0.72),P<0.05]and the incidence of MACE[RR=0.64,95%CI(0.52~0.79),P<0.0001].Further analyses showed that effects of nicorandil on LVEF,HF exacerbation and MACE were consistent within one month after PCI and during follow-up.Conclusions:Periprocedural nicorandil improves coronary blood flow,cardiac systolic function and prognosis in STEMI patients receiving primary PCI.