Karch F E, Lasagna L
JAMA. 1975 Dec 22;234(12):1236-41.
The data on adverse drug reactions (ADRs) are incomplete, unrepresentative, uncontrolled, and lacking in operational criteria for identifying ADRs. No quantitative conclusions can be drawn from the reported data in regard to morbidity, mortality, or the underlying causes of ADRs, and attempts to extrapolate the available data to the general population would be invalid and perhaps misleading. To evaluate the impact as well as the causes of ADRs, representative populations, including general hospital and ambulatory patients of all medical specialties, must be studied, and operationally defined criteria must be used to establish the presence of an ADR in a prospective study that incorporates appropriate control populations. Similar studies on the benefits of drug use are needed to provide perspective on the risk-benefit aspects of drug therapy. Until such studies are performed, estimates of the nature and scope of the ADR problem can be only guesses.
关于药物不良反应（ADR）的数据不完整、缺乏代表性、不受控制，且缺乏识别ADR的操作标准。从报告的数据中无法就发病率、死亡率或ADR的潜在原因得出定量结论，将现有数据外推至普通人群的尝试将是无效的，甚至可能产生误导。为了评估ADR的影响及其原因，必须研究具有代表性的人群，包括综合医院和各医学专科的门诊患者，并在纳入适当对照人群的前瞻性研究中使用可操作定义的标准来确定ADR的存在。还需要对药物使用的益处进行类似研究，以便从药物治疗的风险效益方面提供视角。在进行此类研究之前，对ADR问题的性质和范围的估计只能是猜测。
