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秋水仙碱用于心血管疾病二级预防:随机对照试验的系统评价和荟萃分析。

Colchicine for Secondary Prevention of Cardiovascular Disease: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

机构信息

Montréal Heart Institute, Université de Montréal, Montréal, Québec, Canada.

Montréal Heart Institute, Université de Montréal, Montréal, Québec, Canada.

出版信息

Can J Cardiol. 2021 May;37(5):776-785. doi: 10.1016/j.cjca.2020.10.006. Epub 2020 Oct 17.

Abstract

BACKGROUND

Reduction of inflammation with colchicine has emerged as a therapeutic option for secondary prevention of cardiovascular disease (CVD) in patients with coronary artery disease (CAD). Our objective was to consolidate evidence from randomized controlled trials (RCTs) evaluating the efficacy and safety of low-dose colchicine for secondary prevention of CVD among patients with CAD on standard medical therapy.

METHODS

RCTs comparing the incidence of cardiovascular (CV) events between patients with clinically manifest CAD randomized to colchicine vs placebo (or no colchicine) were included. The primary composite efficacy endpoint included CV mortality, myocardial infarction (MI), ischemic stroke, and urgent coronary revascularization. The DerSimonian and Laird random-effects model was used to calculate pooled hazard ratios (HRs) and 95% confidence intervals (CIs).

RESULTS

Four RCTs, with a pooled sample size of 11,594 patients, were included (colchicine n = 5774; placebo/no colchicine n = 5820). Included RCTs studied populations with stable CAD (N = 2) and acute coronary syndrome (N = 2). Compared with placebo or no colchicine, colchicine was associated with a statistically significant reduction in the incidence of the primary composite endpoint (pooled HR, 0.68; 95% CI, 0.54-0.81; I = 37.7%). The reduction in CV events among patients randomized to colchicine was driven by statistically significant reductions in MIs, ischemic strokes, and urgent coronary revascularizations (P < 0.05 for all) and was relatively consistent among subgroups. The incidence of safety outcomes did not differ between groups (P > 0.05).

CONCLUSIONS

In secondary prevention of CV events, the addition of low-dose colchicine to standard medical therapy reduces the incidence of major CV events-except CV mortality-when compared with standard medical therapy alone.

摘要

背景

秋水仙碱减少炎症已成为冠心病患者心血管疾病(CVD)二级预防的治疗选择。我们的目的是整合评估低剂量秋水仙碱用于标准药物治疗的 CAD 患者二级预防 CVD 的疗效和安全性的随机对照试验(RCT)的证据。

方法

纳入比较临床上表现为 CAD 的患者随机分为秋水仙碱与安慰剂(或无秋水仙碱)的 RCT,比较心血管(CV)事件发生率。主要复合疗效终点包括 CV 死亡率、心肌梗死(MI)、缺血性卒中和紧急冠状动脉血运重建。采用 DerSimonian 和 Laird 随机效应模型计算合并危险比(HR)和 95%置信区间(CI)。

结果

纳入 4 项 RCT,共纳入 11594 例患者(秋水仙碱 n = 5774;安慰剂/无秋水仙碱 n = 5820)。纳入的 RCT 研究了稳定型 CAD(N = 2)和急性冠脉综合征(N = 2)的人群。与安慰剂或无秋水仙碱相比,秋水仙碱与主要复合终点发生率降低具有统计学意义(合并 HR,0.68;95%CI,0.54-0.81;I = 37.7%)。随机分配到秋水仙碱组的患者 CV 事件减少归因于 MI、缺血性卒中和紧急冠状动脉血运重建的发生率降低(所有 P < 0.05),且在亚组中相对一致。两组间安全性结局的发生率无差异(P > 0.05)。

结论

在二级预防 CV 事件中,与单独标准药物治疗相比,标准药物治疗中添加低剂量秋水仙碱可降低主要 CV 事件的发生率-除 CV 死亡率外。

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