环氧化酶-2选择性非甾体抗炎药与严重冠心病风险

COX-2 selective non-steroidal anti-inflammatory drugs and risk of serious coronary heart disease.

作者信息

Ray Wayne A, Stein C Michael, Daugherty James R, Hall Kathi, Arbogast Patrick G, Griffin Marie R

机构信息

Department of Preventive Medicine, Vanderbilt University School of Medicine, Nashville, TN 37232, USA.

出版信息

Lancet. 2002 Oct 5;360(9339):1071-3. doi: 10.1016/S0140-6736(02)11131-7.

DOI:10.1016/S0140-6736(02)11131-7

PMID:12383990

Abstract

Results of premarketing and postmarketing trials have raised doubts about the cardiovascular safety of the non-steroidal anti-inflammatory drug (NSAID) rofecoxib, especially at doses greater than 25 mg. Between Jan 1, 1999, and June 30, 2001, we did a retrospective cohort study of individuals on the expanded Tennessee Medicaid programme (TennCare), in which we assessed occurrence of serious coronary heart disease (CHD) in non-users (n=202916) and in users of rofecoxib and other NSAIDs (rofecoxib n=24 132, other n=151 728). Participants were aged 50-84 years, lived in the community, and had no life-threatening non-cardiovascular illness. Users of high-dose rofecoxib were 1.70 (95% CI 0.98-2.95, p=0.058) times more likely than non-users to have CHD; among new users this rate increased to 1.93 (1.09-3.42, p=0.024). By contrast, there was no evidence of raised risk of CHD among users of rofecoxib at doses of 25 mg or less or among users of other NSAIDs.

摘要

上市前和上市后试验的结果引发了人们对非甾体抗炎药（NSAID）罗非昔布心血管安全性的质疑，尤其是剂量大于25毫克时。在1999年1月1日至2001年6月30日期间，我们对田纳西州扩大医疗补助计划（TennCare）中的个体进行了一项回顾性队列研究，评估了非使用者（n = 202916）以及罗非昔布和其他非甾体抗炎药使用者（罗非昔布n = 24132，其他n = 151728）中严重冠心病（CHD）的发生率。参与者年龄在50 - 84岁之间，居住在社区，且没有危及生命的非心血管疾病。高剂量罗非昔布使用者患冠心病的可能性是非使用者的1.70倍（95%可信区间0.98 - 2.95，p = 0.058）；在新使用者中，这一比率增至1.93（1.09 - 3.42，p = 0.024）。相比之下，没有证据表明剂量为25毫克或更低的罗非昔布使用者或其他非甾体抗炎药使用者患冠心病的风险增加。