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在高血管风险患者中,阿司匹林联合氯吡格雷预防卒中的疗效与安全性:一项随机对照试验的荟萃分析

Efficacy and safety of adding clopidogrel to aspirin on stroke prevention among high vascular risk patients: a meta-analysis of randomized controlled trials.

作者信息

Chen Shuying, Shen Qingyu, Tang Yamei, He Lei, Li Yi, Li Hui, Li Mei, Peng Ying

机构信息

Department of Neurology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, China.

Department of Neurology, Affiliated Boji Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, China.

出版信息

PLoS One. 2014 Aug 11;9(8):e104402. doi: 10.1371/journal.pone.0104402. eCollection 2014.

DOI:10.1371/journal.pone.0104402
PMID:25110930
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4128803/
Abstract

OBJECTIVES

Whether clopidogrel should be added to aspirin for stroke prevention remained controversial for the risk of hemorrhagic complications. This meta-analysis was aimed to assess the efficacy and safety of adding clopidogrel to aspirin on stroke prevention in high vascular risk patients, and to provide evidence for a suitable duration of dual antiplatelet therapy.

METHODS

We searched PubMed, EMBase, OVID and Cochrane Central Register of Controlled Trials (up to June, 2013) for randomized controlled trials evaluating the efficacy and safety of clopidogrel plus aspirin versus aspirin alone in high vascular risk patients. Comparisons of stroke and hemorrhagic complications between treatment groups were expressed by the pooled Relative Risks (RRs) with 95% Confidence Intervals (CIs).

RESULTS

Fifteen trials with a total of 97692 intention-to-treat participants were included with duration of follow-up ranging from 7 days to 3.6 years. Dual antiplatelet therapy reduced all stroke by 21% (RR: 0.79, 95% CI: 0.73-0.85) with no evidence of heterogeneity across the trials (P = 0.27, I2 = 17%).The effects were consistent between short-term subgroup (≤1 month, RR: 0.76, 95% CI: 0.67-0.85) and long-term subgroup (≥3 months, RR: 0.81, 95% CI: 0.73-0.89). The risk of major bleeding was not significantly increased by dual antiplatelet therapy in short-term subgroup (RR: 1.11, 95% CI: 0.91-1.36), while significantly increased in long-term subgroup (RR: 1.52, 95% CI: 1.36-1.69). Long-term dual antiplatelet therapy substantially increased the risk of intracranial bleeding (RR: 1.76, 95% CI: 1.22-2.54).

CONCLUSIONS

This meta-analysis demonstrates that short-term combination of clopidogrel and aspirin is effective and safe for stroke prevention in high vascular risk patients. Long-term combination therapy substantially increases the risk of major bleeding and intracranial bleeding.

摘要

目的

对于高血管风险患者,在预防卒中时是否应在阿司匹林基础上加用氯吡格雷,因存在出血并发症风险仍存在争议。本荟萃分析旨在评估在阿司匹林基础上加用氯吡格雷对高血管风险患者预防卒中的有效性和安全性,并为合适的双联抗血小板治疗疗程提供证据。

方法

我们检索了PubMed、EMBase、OVID和Cochrane对照试验中心注册库(截至2013年6月),以查找评估氯吡格雷联合阿司匹林与单用阿司匹林在高血管风险患者中有效性和安全性的随机对照试验。治疗组间卒中与出血并发症的比较用合并相对危险度(RR)及95%置信区间(CI)表示。

结果

纳入15项试验,共97692例意向性治疗参与者,随访时间从7天至3.6年。双联抗血小板治疗使所有卒中风险降低21%(RR:0.79,95%CI:0.73 - 0.85),各试验间无异质性证据(P = 0.27,I² = 17%)。短期亚组(≤1个月,RR:0.76,95%CI:0.67 - 0.85)和长期亚组(≥3个月,RR:0.81,95%CI:0.73 - 0.89)的效果一致。短期亚组中,双联抗血小板治疗未显著增加大出血风险(RR:1.11,95%CI:0.91 - 1.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d892/4128803/591fd0ce7381/pone.0104402.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d892/4128803/92e4f4129999/pone.0104402.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d892/4128803/8d26b03e3a09/pone.0104402.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d892/4128803/5a02474f7c91/pone.0104402.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d892/4128803/591fd0ce7381/pone.0104402.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d892/4128803/92e4f4129999/pone.0104402.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d892/4128803/8d26b03e3a09/pone.0104402.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d892/4128803/5a02474f7c91/pone.0104402.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d892/4128803/591fd0ce7381/pone.0104402.g004.jpg

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