Kelly William N
Department of Administrative and Clinical Sciences, School of Pharmacy, Mercer University, 3001 Mercer University Dr., Atlanta, GA 3034-4155.
Ann Pharmacother. 2003 Dec;37(12):1774-8. doi: 10.1345/aph.1D202.
Case reports of adverse drug events (ADEs) are an important source of information.
To determine what variables are reported in ADE case reports, how causality was assessed for each report, and what criteria are specified for publishing ADE case reports.
A descriptive analysis of highly significant ADE case reports published in English over a 20-year period was performed. Main outcome measures included frequency distributions for the types of variables reported. The presence of causality assessment and the criteria for submitting an ADE report to practitioner journals were also examined.
A highly significant ADE was described in 1520 published case reports during the study period. Three patient variables were reported >90% of the time, while 12 others were reported <25% of the time. Only 1 drug variable was reported >90% of the time; 6 others were reported 14-74% of the time. Most of the relevant ADE variables were reported most often. Added information for drug interactions, medication errors, and allergic drug reactions were reported 61-99% of the time. Less than 1% of ADE reporters objectively assessed the probability of the ADE. All but one journal publishing the most ADE reports did not require such assessment.
Professional journals might consider stricter requirements for publishing ADE reports. As a minimum, requirements should include an objective assessment of ADE causality, with explicit recognition in the published text and abstract of the report.
药品不良事件（ADEs）的病例报告是重要的信息来源。
确定ADE病例报告中报告了哪些变量，每份报告如何评估因果关系，以及发布ADE病例报告规定了哪些标准。
对20年间以英文发表的具有高度显著性的ADE病例报告进行描述性分析。主要观察指标包括所报告变量类型的频率分布。还检查了因果关系评估的存在情况以及向医学专业期刊提交ADE报告的标准。
在研究期间，1520份已发表的病例报告中描述了具有高度显著性的ADE。三种患者变量报告频率>90%，而其他12种报告频率<25%。只有一种药物变量报告频率>90%；其他六种报告频率为14%-74%。大多数相关的ADE变量报告频率最高。药物相互作用、用药错误和药物过敏反应的补充信息报告频率为61%-99%。不到1%的ADE报告者客观评估了ADE的可能性。除一份发表ADE报告最多的期刊外，所有期刊都没有要求进行此类评估。
专业期刊可能应考虑对发表ADE报告提出更严格的要求。至少，要求应包括对ADE因果关系的客观评估，并在报告的发表文本和摘要中明确体现。
