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秋水仙碱用于血管事件二级预防的长期试验:一项荟萃分析。

Long-term trials of colchicine for secondary prevention of vascular events: a meta-analysis.

作者信息

Samuel Michelle, Berry Colin, Dubé Marie-Pierre, Koenig Wolfgang, López-Sendón José, Maggioni Aldo Pietro, Pinto Fausto J, Roubille François, Tardif Jean-Claude

机构信息

University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.

Dalhousie University, Halifax, Canada.

出版信息

Eur Heart J. 2025 Jul 7;46(26):2552-2563. doi: 10.1093/eurheartj/ehaf174.

Abstract

BACKGROUND AND AIMS

Colchicine has emerged as a safe and inexpensive anti-inflammatory medication to target the residual risk of cardiovascular events in the secondary prevention of coronary artery disease. Two recently published randomized controlled trials (RCTs) investigating colchicine in the post-stroke and post-myocardial infarction (MI) populations warrant a re-evaluation of colchicine. New evidence was synthesized in a systematic review and meta-analysis to determine the long-term efficacy and safety of colchicine for the secondary prevention of vascular disease.

METHODS

Randomized controlled trials comparing the incidence of cardiovascular events between patients with clinically manifest vascular disease randomized to colchicine vs. placebo and ≥12-month follow-up were included. The primary efficacy endpoint is major adverse cardiovascular events (MACE) and includes cardiovascular mortality, MI, ischaemic stroke, and urgent coronary revascularization. The DerSimonian and Laird random effects model was used to calculate pooled effect estimates.

RESULTS

Six RCTs, with a pooled sample size of 21 800 patients, were included (colchicine n = 10 871; placebo n = 10 929). Over a follow-up of 12-34 months, colchicine reduced the incidence of MACE compared with placebo [pooled hazard ratio .75, 95% confidence interval (CI) .56-.93]. The reduction in cardiovascular events among colchicine patients was driven by reductions in MIs, ischaemic strokes, and urgent coronary revascularizations (P < .05 for all). No differences were detected for safety outcomes (P > .05 for all), including non-cardiovascular deaths (risk ratio 1.08, 95% CI .76-1.54).

CONCLUSIONS

This updated meta-analysis of RCTs demonstrated a substantial reduction in MACE, MI, ischaemic stroke, and recurrent coronary revascularization with colchicine compared with placebo. Therefore, the results support the use of colchicine to reduce recurrent cardiovascular events.

摘要

背景与目的

秋水仙碱已成为一种安全且廉价的抗炎药物,用于降低冠状动脉疾病二级预防中心血管事件的残余风险。最近发表的两项关于秋水仙碱在中风后和心肌梗死(MI)人群中的随机对照试验(RCT),促使人们对秋水仙碱进行重新评估。在一项系统评价和荟萃分析中综合了新证据,以确定秋水仙碱在血管疾病二级预防中的长期疗效和安全性。

方法

纳入了比较临床诊断为血管疾病的患者随机接受秋水仙碱与安慰剂治疗且随访时间≥12个月时心血管事件发生率的随机对照试验。主要疗效终点是主要不良心血管事件(MACE),包括心血管死亡、心肌梗死、缺血性中风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效应估计值。

结果

纳入了6项RCT,合并样本量为21800例患者(秋水仙碱组n = 10871;安慰剂组n = 10929)。在12 - 34个月的随访中,与安慰剂相比,秋水仙碱降低了MACE的发生率[合并风险比0.75,95%置信区间(CI)0.56 - 0.93]。秋水仙碱组患者心血管事件的减少是由心肌梗死、缺血性中风和紧急冠状动脉血运重建的减少所驱动的(所有P < 0.05)。在安全结局方面未检测到差异(所有P > 0.05),包括非心血管死亡(风险比1.08,95% CI 0.76 - 1.54)。

结论

这项更新的RCT荟萃分析表明,与安慰剂相比,秋水仙碱可显著降低MACE、心肌梗死、缺血性中风和复发性冠状动脉血运重建的发生率。因此,结果支持使用秋水仙碱来减少复发性心血管事件。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cc1b/12233006/701fc151b533/ehaf174_sga.jpg

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