澳大利亚GenesisCare医疗公司联合荷兰Meander医疗中心Arend Mosterd团队研究了秋水仙碱治疗慢性冠心病的疗效。2020年8月31日，《新英格兰医学杂志》发表了这项成果。

最近一项试验证据表明，秋水仙碱的抗炎作用可降低近期心肌梗塞患者发生心血管事件的风险，但证据有限。

在这项随机、对照、双盲试验中，研究组招募了5522例慢性冠心病患者，将其随机分配，其中2762例接受秋水仙碱治疗，2760例接受安慰剂治疗。主要终点是心血管死亡、自发性（非过程性）心肌梗塞、缺血性中风或缺血驱动的冠状动脉血运重建的综合结局。关键次要终点是心血管死亡、自发性心肌梗塞或缺血性中风的综合结局。

中位随访28.6个月后，秋水仙碱组中有187例患者（6.8％）发生主要终点事件，显著低于安慰剂组（264例，9.6％）。秋水仙碱组中有115例患者（4.2％）发生关键次要终点，亦显著低于安慰剂组（157例，5.7％）。

秋水仙碱组中自发性心肌梗塞或缺血驱动的冠状动脉血运重建的复合终点、心血管死亡或自发性心肌梗死的复合终点、缺血驱动的冠状动脉血运重建和自发性心肌梗死的发生率均显著低于安慰剂组。秋水仙碱组中非心血管原因死亡率为每100人年0.7起，显著高于安慰剂组（每100人年0.5起）。

研究结果表明，慢性冠心病患者服用秋水仙碱可显著降低心血管事件风险。

附：英文原文

Title: Colchicine in Patients with Chronic Coronary Disease | NEJM

Author: Stefan M. Nidorf, M.D.,, Aernoud T.L. Fiolet, M.D.,, Arend Mosterd, M.D.,, John W. Eikelboom, M.D.,, Astrid Schut, M.Sc.,, Tjerk S.J. Opstal, M.D.,, Salem H.K. The, M.D.,, Xiao-Fang Xu, M.D.,, Mark A. Ireland, M.D.,, Timo Lenderink, M.D.,, Donald Latchem, M.D.,, Pieter Hoogslag, M.D.,, Anastazia Jerzewski, M.D.,, Peter Nierop, M.D.,, Alan Whelan, M.D.,, Randall Hendriks, M.D.,, Henk Swart, M.D.,, Jeroen Schaap, M.D.,, Aaf F.M. Kuijper, M.D.,, Maarten W.J. van Hessen, M.D.,, Pradyot Saklani, M.D.,, Isabel Tan, M.D.,, Angus G. Thompson, M.D.,, Allison Morton, M.D.,, Chris Judkins, M.D.,, Willem A. Bax, M.D.,, Maurits Dirksen, M.D.,, Marco M.W. Alings, M.D.,, Graeme J. Hankey, M.D.,, Charley A. Budgeon, Ph.D.,, Jan G.P. Tijssen, Ph.D.,, Jan H. Cornel, M.D.,, and Peter L. Thompson, M.D.

Issue&Volume: 2020-08-31

Abstract:

Background

Evidence from a recent trial has shown that the antiinflammatory effects of colchicine reduce the risk of cardiovascular events in patients with recent myocardial infarction, but evidence of such a risk reduction in patients with chronic coronary disease is limited.

Methods

In a randomized, controlled, double-blind trial, we assigned patients with chronic coronary disease to receive 0.5 mg of colchicine once daily or matching placebo. The primary end point was a composite of cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemic stroke, or ischemia-driven coronary revascularization. The key secondary end point was a composite of cardiovascular death, spontaneous myocardial infarction, or ischemic stroke.

Results

A total of 5522 patients underwent randomization; 2762 were assigned to the colchicine group and 2760 to the placebo group. The median duration of follow-up was 28.6 months. A primary end-point event occurred in 187 patients (6.8%) in the colchicine group and in 264 patients (9.6%) in the placebo group (incidence, 2.5 vs. 3.6 events per 100 person-years; hazard ratio, 0.69; 95% confidence interval [CI], 0.57 to 0.83; P<0.001). A key secondary end-point event occurred in 115 patients (4.2%) in the colchicine group and in 157 patients (5.7%) in the placebo group (incidence, 1.5 vs. 2.1 events per 100 person-years; hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P=0.007). The incidence rates of spontaneous myocardial infarction or ischemia-driven coronary revascularization (composite end point), cardiovascular death or spontaneous myocardial infarction (composite end point), ischemia-driven coronary revascularization, and spontaneous myocardial infarction were also significantly lower with colchicine than with placebo. The incidence of death from noncardiovascular causes was higher in the colchicine group than in the placebo group (incidence, 0.7 vs. 0.5 events per 100 person-years; hazard ratio, 1.51; 95% CI, 0.99 to 2.31).

Conclusions

In a randomized trial involving patients with chronic coronary disease, the risk of cardiovascular events was significantly lower among those who received 0.5 mg of colchicine once daily than among those who received placebo.

DOI: 10.1056/NEJMoa2021372

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2021372