摘要
目的系统评价冠状旁路移植术(coronary artery bypass grafting,CABG)患者术前服用氯吡格雷抗血小板治疗对围手术期的影响,为临床指导此类患者合理用药提供依据。方法计算机检索PubMed、EMbase、Highwire、CENTRAL及其下属各临床注册试验数据中心、CBM、CNKI等数据库。收集关于实施CABG患者术前使用氯吡格雷的随机对照试验(RCT)和非随机的临床对照试验,检索时限均为2003~2012年11月,并追溯纳入研究的参考文献。由两名评价者按照纳入和排除标准独立筛选文献,提取资料和评价质量后,采用RevMan5.0软件进行Meta分析。结果纳入18个研究(10个RCT,8个非随机的临床对照试验),共14 592例患者。Meta分析结果显示:RCT的Meta分析结果显示,CABG患者术前服用氯吡咯雷抗血小板与空白对照比较,能明显降低术后心梗的发生率[RR=0.63,95%CI(0.48,0.83),P=0.000 9],且两组在术后24小时的出血量[MD=130,95%CI(–6.21,266.22),P=0.06]、因出血二次手术人数[RR=1.42,95%CI(0.92,2.20),P=0.12]和术后短期内的死亡风险增加[RR=1.19,95%CI(0.89,1.58),P=0.24]方面差异无统计学意义。但非随机的临床对照试验的Meta分析结果显示,CABG患者术前服用氯吡咯雷抗血小板与空白对照比较,在降低术后心梗的发生率方面差异无统计学意义[RR=0.83,95%CI(0.30,2.26),P=0.71],且氯吡咯雷组术后24小时的出血量[MD=82.42,95%CI(35.18,129.66),P=0.000 6]、因出血二次手术人数[RR=1.71,95%CI(1.07,2.75),P=0.03]和术后短期内的死亡风险明显增加[RR=1.89,95%CI(1.15,3.12),P=0.01]。结论目前证据显示,CABG术前服用氯吡咯雷抗血小板治疗能减少术后心梗的发生,但需谨慎考虑可能带来的出血、二次开胸手术和术后短期内死亡风险的增加。RCT与非随机的临床对照试验的结果存在矛盾,可能因纳入研究的论证强度、数量及样本量偏倚所致。上述结论需未来开展大规模高质量RCT结果予以证实。
Objective To systematically evaluate impact of perioperative use of clopidogrel on coronary bypass grafting(CABG) patients for anti-platelet treatment,in order to provide evidence for the rational drug use of such patients in the perioperative period.Methods PubMed,EMbase,HighWire,CENTRAL and its affiliated clinical trial registered data center,CBM and CNKI were electronically searched from 2003 to November,2012.Randomized controlled trials(RCTs) and non-randomized clinical trials on perioperative use of clopidogrel of CABG patients were collected.References of included studies were also retrieved.Two reviewers independently screened studies according to exclusion and inclusion criteria,extracted data,and assessed the methodological quality.Then,meta-analysis was performed using RevMan 5.0 software.Results 18 studies(including 10 RCTs and 8 non-randomized clinical trials) involving 14 592 patients were included.The results of meta-analysis showed that: a) Among 10 included RCTs,preoperative use of clopidogrel for anti-platelet treatment reduced the incidence of myocardial infarction obviously,compared with the blank control group(RR=0.63,95%CI 0.48 to 0.83,P=0.000 9),but there is no significant difference between the two groups in blood loss amount within 24 hours after operation(MD=130,95%CI –6.21 to 266.22,P=0.06),the number of reoperation patients because of bleeding(RR=1.42,95%CI 0.92 to 2.20,P=0.12),and risk of postoperative short-term death(RR=1.19,95%CI 0.89 to 1.58,P=0.24);b) Among 8 non-randomized clinical trials,there was no significant difference between the two groups in reducing the incidence of myocardial infarction(RR=0.83,95%CI 0.30 to 2.26,P=0.71),but preopera-tive use of clopidogrel for anti-platelet treatment significantly increased blood loss amount within 24 hours after operation(MD=82.42,95%CI 35.18 to 129.66,P=0.000 6),the number of reoperation patients because of bleeding(RR=1.71,95%CI 1.07 to 2.75,P=0.03),and risk of postoperative short-term
出处
《中国循证医学杂志》
CSCD
2013年第7期827-835,共9页
Chinese Journal of Evidence-based Medicine
关键词
冠状旁路移植术
氯吡格雷
系统评价
META分析
随机对照试验
Coronary artery bypass grafting
Clopidogrel
Systematic Review
Meta-analysis
Randomized controlled trial