摘要
目的：系统评价国产氯吡格雷（泰嘉）与进口氯吡格雷（波立维）在接受冠状动脉介入术（PCI）患者中的安全性差异。方法采用Cochrane系统评价方法，计算机检索中国期刊全文数据库、中文科技期刊数据库、中国生物医学文献数据库等三大中文文献数据库，追踪检索已获得文献或相关研究提供的参考文献。对纳入文献进行质量评价和资料提取后，采用系统评价专用软件Review manager 4.2进行Meta分析。结果根据纳入标准和排除标准，最终有20个临床研究纳入Meta分析，包括4392例经皮冠状动脉介入患者，其中泰嘉组2066例,进口波立维组2326例。Meta分析主要结果显示，有11个研究报道了术后12个月的主要心血管不良事件（MACE）发生率，经异质性检验，I2=0%，表明研究结果间无统计学异质性，采用固定效应模型合并分析，泰嘉组和波立维组之间的MACE发生率无统计学差异（OR=1.00；95% CI：0.75～1.34；P=0.99）；有11个研究报道了术后12个月的不良反应发生率，经异质性检验，I2=0%，表明研究结果间无统计学异质性，采用固定效应模型合并分析，泰嘉组和波立维组之间的不良反应发生率无统计学差异（OR=1.14；95%CI：0.82～1.59；P=0.44）。结论经皮冠状动脉介入术后使用泰嘉和波立维的MACE和不良反应的发生等方面无明显差异，为泰嘉替代波立维抗血小板治疗提供了一定的循证医学证据。
Objective To compare the safety and effectiveness of domestic and imported clopidogrel in patients after percutaneous coronary intervention（PCI）. Methods The inclusion and exclusion criterias of literatures were drawn up, and the trials of domestic and imported clopidogrel applied to patients after PCI were retrieved from Chinese Journal full texdatabase（CJFD）, Chinese Academic Journal, and CBM and analyzed by Rev Man software 4.2 version. Results There were total 20 clinical studies including 4392 patients after PCI, which were divided into two groups, namely 2066 patients for Talcom group and 2326 patients for Plavix group. The main results of meta analysis showed that ,the difference in major adverse cardiac events（MACE） occurrence was not significant statistically between Talcom and Plavix groups（OR=1.00; 95% CI：0.75-1.34; P =0.99）, between which 11 studies reported the 12th month’s MACE occurrence after PCI, by choosing the fixed-effect model after heterogeneity test（I2=0%）; and the difference in the occurrence of diverse reaction was not also significant statistically between Talcom and Plavix groups（OR=1.14;95%CI：0.82-1.59;P =0.44）, between which 11 studies reported the 12th month＇s MACE occurrence after PCI, by choosing the fixed-effect model after heterogeneity test（I2=0%）. Conclusion The difference in the occurrence rate of MACE and diverse reaction for patients between domestic-made clopidogrel and imported clopidogrel groups are not obvious, so this conclusion would provide some evidence of EBM for the application of domestic clopidogrel.
出处
《中华临床医师杂志（电子版）》
CAS
2013年第14期157-160,共4页
Chinese Journal of Clinicians(Electronic Edition)
