急性冠脉综合征经皮冠状动脉介入术中不同给药途径应用替罗非班的疗效与安全性的meta分析

摘要

目的 评价我国急性冠脉综合征(ACS)患者经皮冠状动脉介入治疗(PCI)时替罗非班经冠状动脉(IC)或经静脉(IV)不同给药途径的有效性及安全性.方法 检索从2006年1月至2012年1月纳入的国内外文献中公开发表的我国ACS[包括急性ST段抬高心肌梗死(STEMI)和非ST段抬高型ACS(NSTE-ACS)]患者PCI术中IC与IV不同给药途径应用替罗非班的临床随机对照试验(RCT)的所有学术论文35篇.根据文献异质性检验结果行meta分析,对不同纳入标准的结果进行了敏感性分析,并评价发表性偏倚.结果 经筛选后纳入meta分析的文献16篇,共计1314例患者,其中IC组658例,IV组656例.meta 分析结果显示:与替罗非班IV组比较,IC组PCI术后达心肌梗死溶栓治疗(TIMI)3级血流的比率{RR=1.13,95％ CI[1.05,1.23],P＜0.01}、TMP心肌灌注(TMP)达3级的比率{RR=1.28,95％ CI[1.12,1.46],P=0.0002}明显增加；术后7 d心脏超声左室射血分数(LVEF)值平均增加2.33％{WMD=2.33％,95％ CI[0.88％,3.78％],P=0.002},与IV组比较有统计学差异(P＜0.05),但长期临床意义尚需进一步研究观察；出血{RR=0.99,95％ CI[0.76,1.30],P=0.96)和血小板减少症{RR=0.79,95％ CI[0.42,1.51],P=0.48}的发生率与IV组比较无统计学差异(P＞0.05).结论 与单纯静脉注射比较,冠状动脉内注射替罗非班可能对改善我国ACS患者PCI术后心肌血流灌注有一定的意义,且不增加出血和血小板减少的风险.%Objective To evaluate the curative efficacy and safety of tirofiban intraeoronary versus intravenous administration during percutaneous coronary intervention for patients with acute coronary syndrome in China. Methods Randomized controlled trials (RCT) comparing the effects of IV administration of tirofiban to those of IC administration between January 2006 and January 2012 in Chinese population were systematically searched. Fixed-effect or random-effect models were used, which accounts for within-study and between-study variability, to estimate pooled RR or WMD with their 95% CI. Results Totally 16 RCT were selected in this study,which involved 1 314 patients. Compared with subjects with IV administration, those with IC administration were more likely to reach TIMI grade 3 flow {RR = 1.13 ,95% CI [ 1.05 , 1.23 ], P < 0.01) and TMP grade 3 {RR=1.28,95% CI I 1.12,1.46] ,P =0.0002) ;more LVEF was observed (WMD=2.33% ,95% CI [0.88% ,3.78% ] ,P =0.002) but without clinical significance;no significant difference was observed in the frequency of short-term bleeding events{RR=0.99,95% CI[0.76,1.30],P =0.96) and thromlxx:ytopenia(RR=0.79,95% CI[0.42,1.51 ],P =0.48). Conclusion Compared with IV administration, IC administration may improve the perfusion after PCI in ACS patients and do not increase the risk of bleeding and thrombocytopenia.