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心肌梗死后应用小剂量秋水仙碱的疗效和安全性
Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction


Jean-Claude Tardif ... 心脑血管疾病 • 2019.12.26
相关阅读
• 《NEJM 期刊荟萃:心脏病学》2019年头条文章 • 急性心肌梗死 • 急性感染和心肌梗死

老树新花——秋水仙碱或将成为冠心病二级预防新要素

 

高霏,史冬梅*

首都医科大学附属北京安贞医院心内科

*通讯作者

 

2019年美国AHA会议刚刚公布一项冠心病二级预防领域的重磅研究——COLCOT试验,其结果显示秋水仙碱能够显著降低新近心肌梗死患者的心血管事件风险,该结果或将对临床实践带来深远影响。这一结果也在同期发表于《新英格兰医学杂志》1

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摘要


背景

实验和临床证据支持炎症在动脉粥样硬化及其并发症中的作用。秋水仙碱是一种用于治疗痛风和心包炎的口服强效抗炎药。

 

方法

我们开展了一项随机双盲试验,本试验纳入心肌梗死后30日内的患者。患者被随机分配接受小剂量秋水仙碱(每日1次,每次0.5 mg)或安慰剂治疗。主要疗效终点是由心血管原因死亡、复苏成功的心脏停搏、心肌梗死、卒中或需要冠状动脉血运重建的心绞痛紧急住院所构成的复合结局。本试验还评估了主要终点的各构成部分和安全性。

 

结果

共计4,745例患者被纳入试验;2,366例患者被分配到秋水仙碱组,2,379例被分配到安慰剂组。患者的中位随访期为22.6个月。秋水仙碱组5.5%的患者和安慰剂组7.1%的患者发生了主要终点(风险比,0.77;95%置信区间[CI],0.61~0.96;P=0.02)。心血管原因死亡的风险比为0.84(95% CI,0.46~1.52),复苏成功的心脏停搏的风险比为0.83(95% CI,0.25~2.73),心肌梗死的风险比为0.91(95% CI,0.68~1.21),卒中的风险比为0.26(95% CI,0.10~0.70),需要冠状动脉血运重建的心绞痛紧急住院的风险比为0.50(95% CI,0.31~0.81)。据报告,秋水仙碱组9.7%的患者和安慰剂组8.9%的患者发生了腹泻(P=0.35)。秋水仙碱组0.9%的患者和安慰剂组0.4%的患者发生了被报告为严重不良事件的肺炎(P=0.03)。

 

结论

在近期发生心肌梗死的患者中,每日0.5 mg剂量的秋水仙碱与安慰剂相比显著降低了缺血性心血管事件的风险(由加拿大魁北克省政府等资助;COLCOT在ClinicalTrials.gov注册号为NCT02551094)。





作者信息

Jean-Claude Tardif, M.D., Simon Kouz, M.D., David D. Waters, M.D., Olivier F. Bertrand, M.D., Ph.D., Rafael Diaz, M.D., Aldo P. Maggioni, M.D., Fausto J. Pinto, M.D., Ph.D., Reda Ibrahim, M.D., Habib Gamra, M.D., Ghassan S. Kiwan, M.D., Colin Berry, M.D., Ph.D., José López-Sendón, M.D., Petr Ostadal, M.D., Ph.D., Wolfgang Koenig, M.D., Denis Angoulvant, M.D., Jean C. Grégoire, M.D., Marc-André Lavoie, M.D., Marie-Pierre Dubé, Ph.D., David Rhainds, Ph.D., Mylène Provencher, Ph.D., Lucie Blondeau, M.Sc., Andreas Orfanos, M.B., B.Ch., Philippe L. L’Allier, M.D., Marie-Claude Guertin, Ph.D., and François Roubille, M.D., Ph.D.
From the Montreal Heart Institute (J.-C.T., R.I., J.C.G., M.-A.L., M.-P.D., D.R., P.L.L.) and the Montreal Health Innovations Coordinating Center (M.P., L.B., A.O., M.-C.G.), Montreal, Centre Hospitalier Régional de Lanaudière, Joliette (S.K.), and Institut de Cardiologie et Pneumologie de Québec, Quebec City (O.F.B.) — all in Canada; San Francisco General Hospital, San Francisco (D.D.W.); Estudios Clínicos Latinoamérica, Rosario, Argentina (R.D.); Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy (A.P.M.); Santa Maria University Hospital (Centro Hospitalar Universitário Lisboa Norte), Centro Académico de Medicina de Lisboa, Centro Cardiovascular da Universidade de Lisboa, Faculdade de Medicina da Universidade de Lisboa, Lisbon, Portugal (F.J.P.); Fattouma Bourguiba University Hospital, Monastir, Tunisia (H.G.); Bellevue Medical Center, Beirut, Lebanon (G.S.K.); Institute of Cardiovascular and Medical Sciences, University of Glasgow, and NHS Greater Glasgow and Clyde, Glasgow, United Kingdom (C.B.); Hospital Universitario La Paz, Universidad Autónoma de Madrid, Instituto de Investigación La Paz, Centro de Investigación Biomédica en Red–Enfermedades Cardiovasculares, Madrid (J.L.-S.); Cardiovascular Center, Na Homolce Hospital, Prague, Czech Republic (P.O.); Deutsches Herzzentrum München, Technische Universität München, and DZHK (German Center for Cardiovascular Research), partner site Munich Heart Alliance, Munich, and Institute of Epidemiology and Medical Biometry, University of Ulm, Ulm — all in Germany (W.K.); Centre Hospitalier Universitaire (CHU) de Tours and Équipe d’Accueil 4245 Transplantation Immunité Inflammation Loire Valley Cardiovascular Collaboration, Tours University, Tours (D.A.), and PhyMedExp (Physiologie et Médecine Expérimentale du Cœur et des Muscles), Université de Montpellier, INSERM, Centre National de la Recherche Scientifique, Cardiology Department, CHU de Montpellier, Montpellier (F.R.) — all in France. Address reprint requests to Dr. Tardif at the Montreal Heart Institute, 5000 Belanger St., Montreal, PQ H1T 1C8, Canada, or at jean-claude.tardif@icm-mhi.org.

 

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