Kramer M S, Lane D A, Hutchinson T A
Department of Epidemiology, McGill University Faculty of Medicine, Montreal, Quebec, Canada.
J Chronic Dis. 1987;40(12):1073-85. doi: 10.1016/0021-9681(87)90073-7.
The International Agranulocytosis and Aplastic Anemia Study (IAAAS) of analgesic-induced risks of blood dyscrasias represents the current "state of the art" in case-control pharmacoepidemiology. We present a conceptual framework for examining the goal, methods, and analysis of an epidemiologic study of drug risks and review the IAAAS within this framework. In our view, the new risk estimates reported by the IAAAS are not inherently more accurate than existing ones, nor have they been measured in clinically and sociodemographically relevant groups of patients over the anticipated course of therapy. Thus, the reported risks cannot be used to guide clinical or regulatory decisions concerning available treatment options for such patients. Furthermore, we believe that the IAAAS methods for selection of cases and controls, ascertainment of exposure, and data analysis may well have led to invalid estimates even for those risks that are reported. We hope that closer attention to the conceptual framework we suggest and the methodologic issues we raise will enable future case-control pharmacoepidemiologic studies to provide more useful and accurate answers to questions concerning the adverse effects of drugs.
国际粒细胞缺乏症和再生障碍性贫血研究（IAAAS）关于镇痛药引起血液系统疾病风险的研究代表了病例对照药物流行病学的当前“先进水平”。我们提出了一个概念框架，用于审视药物风险流行病学研究的目标、方法和分析，并在此框架内回顾IAAAS。我们认为，IAAAS报告的新风险估计在本质上并不比现有估计更准确，而且它们也不是在治疗预期疗程内对临床和社会人口统计学相关患者群体进行测量得到的。因此，报告的风险不能用于指导针对此类患者现有治疗选择的临床或监管决策。此外，我们认为，IAAAS选择病例和对照、确定暴露情况以及数据分析的方法很可能导致即使是所报告的那些风险估计也是无效的。我们希望对我们提出的概念框架和所提出的方法学问题给予更密切关注，将使未来的病例对照药物流行病学研究能够为有关药物不良反应的问题提供更有用和准确的答案。
