Fisher S, Bryant S G, Kent T A, Davis J E
Department of Psychiatry and Behavioral Sciences, University of Texas Medical Branch at Galveston 77555.
Pharmacotherapy. 1994 Mar-Apr;14(2):202-9.
Although studies have shown that patients can distinguish probable adverse drug reactions (ADRs) from adverse clinical events (ACEs) caused by other factors, it is not known whether these attribution judgments add any independent validity to other accepted methods of identifying ADRs, such as physician assessments or epidemiologic data. Data from 2487 patients receiving fluoxetine and 815 receiving trazodone were used to see whether such information was redundant when added to standard statistical analysis directed toward detecting ADRs. Relative risk values for 14 trazodone or fluoxetine ADRs were selected because each was significantly identified by an innovative postmarketing surveillance system. In one analysis, all patient reports were used to compute relative risk; in the other, only reports attributed by patients to the study drug were included. Results indicate that taking into account patient attribution judgments results in a consistent, albeit modest, increase in the discriminatory power of this monitoring method.
尽管研究表明患者能够区分可能的药物不良反应（ADR）与由其他因素引起的不良临床事件（ACE），但尚不清楚这些归因判断是否能为其他公认的识别ADR的方法（如医生评估或流行病学数据）增加任何独立的有效性。研究人员使用了来自2487名服用氟西汀的患者和815名服用曲唑酮的患者的数据，以观察当将此类信息添加到旨在检测ADR的标准统计分析中时，这些信息是否多余。选择了14种曲唑酮或氟西汀ADR的相对风险值，因为每种ADR都通过创新的上市后监测系统得到了显著识别。在一项分析中，使用所有患者报告来计算相对风险；在另一项分析中，仅纳入患者归因于研究药物的报告。结果表明，考虑患者归因判断会使这种监测方法的辨别力得到一致的提高，尽管提高幅度不大。
