雷帕霉素药物洗脱支架与紫杉醇药物洗脱支架治疗冠心病疗效的Meta分析

A Meta-analysis on curative effect of sirolimus-eluting stent and paclitaxel-eluting stent in treatment coronary heart disease

目的比较雷帕霉素药物洗脱支架(sirolimus-eluting stent,SES)与紫杉醇药物洗脱支架(paclitaxel-eluting stent,PES)治疗冠心病的疗效与安全性。方法计算机检索PubMed、MEDLINE、Cochrane Central Register of Controlled Trials、CNKI全文数据库,收集2006年1月至2011年10月公开发表的有关SES和PES疗效和安全性比较的随机对照试验(RCTs)。对文献质量进行严格评价后,符合要求的RCTs进行资料提取及采用RevMen5.1软件进行Meta分析。结果共纳入9项RCTs,Meta分析显示:SES组与PES组病死率(OR=0.98,95%CI:0.74～1.31,P>0.05)、心肌梗死率(OR=0.86,95%CI:0.69～1.07,P>0.05)和支架内血栓发生率(OR=0.94,95%CI:0.67～1.32,P>0.05)均无统计学差异,但靶病变血运重建(TLR)率(OR=0.67,95%CI:0.51～0.89,P<0.05)、主要心脏不良事件(MACE)发生率(OR=0.08,95%CI:0.68～0.94,P<0.05)和支架内再狭窄率(OR=0.44,95%CI:0.24～0.79,P<0.05)的差异有统计学意义。结论两种药物洗脱支架治疗冠心病患者的病死率、心肌梗死率和支架内血栓发生率相似,但与PES比较,SES能明显降低支架术后TLR、MACE和支架内再狭窄的发生率。

Objective To compare the curative effect and safety of sirolimus-eluting stent （SES） and paclitax- el-eluting stent （PES） in the treatment of coronary heart disease （CHD）. Methods The database of PubMed,MED- LINE, Cochrane Central Register of Controlled Trials and CNKI were retrieved for collecting the randomized controlled trials （RCT） about the comparison of the curative effect and safety between SES and PES published from Jan. 2006 to Oct. 2011. After the critical evaluation on the quality of literature, the data were extracted from valid RCT and given Meta-analysis by using RevMen 5.1 software. Results There were totally 9 RCT enclosed and Meta-analysis showed that there was no statistical difference between two groups in mortality （OR = 0.98,95% C1：0.74 -1.31, P 〉 0.05 ）, the rate of myocardial infarction （ OR = 0.86,95% CI：0. 69 - 1.07 ,P 〉 0.05 ） and incidence of stent thrombosis （ OR = 0.94,95% CI：0. 67 -1.32, P 〉 0.05 ）. There was statistically significant difference between two groups in the rate of target lesion revascularization （ OR = 0.67,95 % CI： 0.51 - 0.89, P 〈 0.05 ） , incidence of major adverse cardiac e- vents （ OR = 0.08,95 % CI： 0.68 - 0.94, P 〈 0.05 ） and rate of stent coronary restenosis （ OR = 0.44,95 % CI：0. 24 0.79,P 〈 0.05）. Conclusion Two kinds of drug-eluting stents are similar in mortality, rate of myocardial infarction and incidence of stent thrombosis in the treatment of CHD. SES can significantly reduce the incidence of target lesion revascularization and major adverse cardiac events compared with PES.