Downing Amy, Jacobsen Jacob, Sorensen Henrik T, McLaughlin Joseph K, Johnsen Soren P
Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark.
Br J Clin Pharmacol. 2006 Oct;62(4):496-501. doi: 10.1111/j.1365-2125.2006.02753.x. Epub 2006 Aug 30.
To examine the risk of angio-oedema among users of the newer cyclooxygenase (COX)-2 selective inhibitors celecoxib and rofecoxib and other non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) in a population-based case-control study.
Cases of angio-oedema were identified from hospital discharge registries from three Danish counties between 1 January 2000 and 31 December 2003 (n = 377) and 10 matched population controls per case were selected from the Civil Registration System (n = 3747). Data on newer COX-2 selective inhibitor and other NSAID use (current and former) were obtained from prescription databases. Data on potential confounding factors were also collected. Conditional logistic regression was used to compute relative risks for angio-oedema according to drug exposure.
The crude relative risks for the newer COX-2 selective inhibitors were higher than those for other NSAIDs. After adjustment for confounding, the relative risk for current use of newer COX-2 selective inhibitors was 0.96 [95% confidence interval (CI) 0.46, 2.03], whereas the risk for other NSAIDs was 1.77 (95% CI 1.23, 2.58).
Our data support the hypothesis that newer COX-2 selective inhibitors are safe in relation to angio-oedema. However, given other current health concerns related to these drugs, their use should continue to be carefully monitored.
在一项基于人群的病例对照研究中,考察新型环氧化酶(COX)-2选择性抑制剂塞来昔布和罗非昔布以及其他非阿司匹林非甾体抗炎药(NSAIDs)使用者发生血管性水肿的风险。
从丹麦三个县2000年1月1日至2003年12月31日的医院出院登记中确定血管性水肿病例(n = 377),并从民事登记系统中为每个病例选择10名匹配的人群对照(n = 3747)。从处方数据库中获取新型COX-2选择性抑制剂和其他NSAIDs使用情况(当前和既往)的数据。还收集了潜在混杂因素的数据。采用条件逻辑回归根据药物暴露情况计算血管性水肿的相对风险。
新型COX-2选择性抑制剂的粗相对风险高于其他NSAIDs。在对混杂因素进行调整后,当前使用新型COX-2选择性抑制剂的相对风险为0.96 [95%置信区间(CI)0.46, 2.03],而其他NSAIDs的风险为1.77(95% CI 1.23, 2.58)。
我们的数据支持以下假设,即新型COX-2选择性抑制剂在血管性水肿方面是安全的。然而,鉴于目前与这些药物相关的其他健康问题,应继续对其使用进行密切监测。