氯吡格雷治疗冠心病合并慢性肾病的系统评价

Systematic Review in Clopidogrel Therapy Coronary Heart Disease with Chronic Nephropathy

目的评价氯吡格雷治疗冠心病合并慢性肾病的疗效及安全性。方法计算机检索MEDLINE(1977-2009)、EMBASE(1989-2009)、Cochrane图书馆(2009年第6期)、中国生物医学文献光盘数据库(CBMd isc,1978-2009)和中国期刊网全文专题数据库(CNK I,1994-2009),并辅以手工检索,采用Cochrane协作网提供的RevM an 5.0软件进行M eta分析。结果经检索和筛选,将3篇随机对照试验(RCT)、质量为A级共29 858例患者,纳入本系统评价。结果显示,氯吡格雷可明显降低终点事件的发生,但增加出血的风险,差异有显著的统计学意义[(OR)=0.88,95%C I(0.82,0.95),P<0.01],[OR=1.59,95%C I(1.42,1.77),P<0.000 01]。慢性肾病(CKD)1、2期患者,治疗组比安慰剂组出现的终点事件减少。CKD 3期的患者,治疗组比安慰剂组终点事件发生率高,差异没有统计学意义[OR=1.12,95%C I(0.99,1.27),P=0.08]。CKD 1、2及3期的患者出血的发生率高于对照组。结论氯吡格雷治疗冠心病合并慢性肾病及CKD 1、2期的患者尽管出血风险增加了,但却降低了心血管死亡、心肌梗死或脑卒中终点事件的发生率;对于CKD 3期的患者,氯吡格雷治疗的终点事件的发生率增高,同时出血风险也增加,治疗上弊大于利,尽量避免使用。

OBJECTIVE To evaluate the safety and effect of clopidogel in coronary artery disease with chronic nephropathy. METHODS Data were reviewed in MEDLINE （ 1977 - 2009）, EMBASE （ 1989 - 2009 ）, Cochrane library 2009 （6）, CBMdisc （1978 -2009） and CNKI （1994- 2009 ）. Meta analysis was performed with RevMan 5.0 software supplied by Cochrane Collaboration. RESULTS 29 858 cases were ontained from three Randomized controlled trials （RCTs）. The difference between clopidogel- treated and control groups was statistical significance, for stochastic effect model [ OR = 0. 88,95% CI（0. 82,0. 95 ） ,P 〈 0. 01 ]. Combination analysis of bleeding in the end of follow-up period showed there was statistical significance, OR = 1.59,95% CI（ 1.42,1.77 ） , P 〈0. 000 01. Less events happed in treatment group in stage 1 and stage 2 among CKD patients. More bleed cases were obtained in clopidogrel treated group than those in control group during stage 3 CKD[ OR = 1.12,95% CI（0. 99,1.27 ） ,P = 0. 08 ]. Bleed cases in Stage 1, 2, 3 CKD showed higher incidence rate in elopidogrel treated group than those in placebo group. CONCLUSION Higher incidence rate of cardiovascular death, myocardial infarction, apoplexy and bleeding were found in clopidogrel treated CHD patients during stage 3 CKD.