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氯吡格雷对心血管疾病患者重要结局的增量效应:随机试验的荟萃分析

Incremental effect of clopidogrel on important outcomes in patients with cardiovascular disease: a meta-analysis of randomized trials.

作者信息

Helton Thomas J, Bavry Anthony A, Kumbhani Dharam J, Duggal Sandeep, Roukoz Henri, Bhatt Deepak L

机构信息

Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio, USA.

出版信息

Am J Cardiovasc Drugs. 2007;7(4):289-97. doi: 10.2165/00129784-200707040-00006.

DOI:10.2165/00129784-200707040-00006
PMID:17696569
Abstract

OBJECTIVES

To quantify the impact of clopidogrel plus aspirin on the individual outcomes of death, myocardial infarction, or stroke in patients with established cardiovascular disease, or in patients with multiple risk factors for vascular disease.

BACKGROUND

Randomized trials have demonstrated a reduction in composite outcomes when clopidogrel is added to aspirin therapy in patients with coronary artery disease; however, the magnitude of benefit on individual outcomes is unknown.

METHODS

We conducted a meta-analysis on randomized, controlled trials that compared aspirin plus clopidogrel with aspirin plus placebo for the treatment of coronary artery disease.

RESULTS

This analysis included five randomized trials (CURE, CREDO, CLARITY, COMMIT, and CHARISMA) in 79 624 patients. The incidence of all-cause mortality was 6.3% in the aspirin plus clopidogrel group versus 6.7% in the aspirin group (odds ratio [OR] 0.94; 95% CI 0.89, 0.99; p = 0.026). The incidence of myocardial infarction was 2.7% and 3.3% (OR 0.82; 95% CI 0.75, 0.89; p < 0.0001), and stroke was 1.2% and 1.4% (OR 0.82; 95% CI 0.73, 0.93; p = 0.002). Similarly, the incidence of major bleeding was 1.6% and 1.3% (OR 1.26; 95% CI 1.11, 1.41; p < 0.0001), and fatal bleeding was 0.28% and 0.27% (OR 1.04; 95% CI 0.76, 1.43; p = 0.79).

CONCLUSION

The addition of clopidogrel to aspirin results in a small reduction in all-cause mortality in patients with ST-elevation myocardial infarction and a modest reduction in myocardial infarction and stroke in patients with cardiovascular disease. The overall incidence of major bleeding however is increased, although there is no excess of fatal bleeds or hemorrhagic strokes.

摘要

目的

量化氯吡格雷联合阿司匹林对已确诊心血管疾病患者或具有多种血管疾病危险因素患者的死亡、心肌梗死或中风等个体结局的影响。

背景

随机试验表明,在冠状动脉疾病患者中,阿司匹林治疗基础上加用氯吡格雷可降低复合结局;然而,对个体结局的获益程度尚不清楚。

方法

我们对比较阿司匹林联合氯吡格雷与阿司匹林联合安慰剂治疗冠状动脉疾病的随机对照试验进行了荟萃分析。

结果

该分析纳入了5项随机试验(CURE、CREDO、CLARITY、COMMIT和CHARISMA),共79624例患者。阿司匹林联合氯吡格雷组的全因死亡率为6.3%,阿司匹林组为6.7%(比值比[OR]0.94;95%置信区间0.89,0.99;p = 0.026)。心肌梗死发生率分别为2.7%和3.3%(OR 0.82;95%置信区间0.75,0.89;p < 0.0001),中风发生率分别为1.2%和1.4%(OR 0.82;95%置信区间0.73,0.93;p = 0.002)。同样,严重出血发生率分别为1.6%和1.3%(OR 1.26;95%置信区间1.11,1.41;p < 0.0001),致命性出血发生率分别为0.28%和0.27%(OR 1.04;95%置信区间0.76,1.43;p = 0.79)。

结论

阿司匹林加用氯吡格雷可使ST段抬高型心肌梗死患者的全因死亡率略有降低,使心血管疾病患者的心肌梗死和中风发生率适度降低。然而,严重出血的总体发生率增加,尽管致命性出血或出血性中风并无增多。

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