Hallas Jesper, Bjerrum Lars, Støvring Henrik, Andersen Morten
Department of Clinical Pharmacology, Faculty of Health Sciences, University of Southern Denmark, DK 5000 Odense C, Denmark.
Am J Epidemiol. 2008 Oct 15;168(8):966-73. doi: 10.1093/aje/kwn191. Epub 2008 Aug 27.
Ephedrine and herbal ephedra preparations have been shown to induce a small-to-moderate weight loss. Owing to reports on serious cardiovascular events, they were banned from the US market in 2004. There have been no large controlled studies on the possible association between prescribed ephedrine/caffeine and cardiovascular events in general. The authors linked data from four different sources within Statistics Denmark, using data on 257,364 users of prescribed ephedrine/caffeine for the period 1995-2002. The data were analyzed using a case-crossover technique with a composite endpoint: death outside of a hospital, myocardial infarction, or stroke. To account for effects of chronic exposure and effects in naïve users, the authors performed a secondary case-control study nested within the cohort of ephedrine/caffeine ever users. Among 2,316 case subjects, 282 (12.2%) were current users of ephedrine/caffeine. The case-crossover analysis yielded an odds ratio of 0.84 (95% confidence interval: 0.71, 1.00); after adjustment for trends in ephedrine/caffeine use, it was 0.95 (95% confidence interval: 0.79, 1.16). Subgroup analyses revealed no strata with significantly elevated risk. In the case-control substudy, there was no increased risk among naïve users or users with large cumulative doses. Prescribed ephedrine/caffeine was not associated with a substantially increased risk of adverse cardiovascular outcomes in this study.
麻黄碱及草药麻黄制剂已被证明可导致轻度至中度体重减轻。由于有关于严重心血管事件的报道，它们于2004年被禁止在美国市场销售。总体而言，目前尚无关于处方麻黄碱/咖啡因与心血管事件之间可能关联的大型对照研究。作者将丹麦统计局四个不同来源的数据进行了关联，使用了1995 - 2002年期间257,364名处方麻黄碱/咖啡因使用者的数据。使用病例交叉技术对数据进行分析，复合终点为：院外死亡、心肌梗死或中风。为了考虑慢性暴露的影响以及初次使用者的影响，作者在曾经使用过麻黄碱/咖啡因的队列中进行了一项嵌套式二级病例对照研究。在2316例病例受试者中，282例（12.2%）为麻黄碱/咖啡因的当前使用者。病例交叉分析得出的比值比为0.84（95%置信区间：0.71, 1.00）；在对麻黄碱/咖啡因使用趋势进行调整后，该比值比为0.95（95%置信区间：0.79, 1.16）。亚组分析未发现风险显著升高的分层。在病例对照子研究中，初次使用者或累积剂量大的使用者中风险未增加。在本研究中，处方麻黄碱/咖啡因与不良心血管结局风险的大幅增加无关。
