Fisher S, Bryant S G
Department of Psychiatry and Behavioral Sciences, University of Texas Medical Branch, Galveston 77550.
Clin Pharmacol Ther. 1990 Jul;48(1):102-7. doi: 10.1038/clpt.1990.123.
Data from two samples of ambulatory patients participating in a postmarketing surveillance study, one receiving antibiotics and another receiving tricyclic antidepressant agents, are presented, indicating that patients appear to be capable of correctly discriminating probable adverse drug reactions from other adverse clinical events. However, attribution accuracy depended both on the surveillance method and on how reports of the adverse clinical events were obtained. Discrimination was better when patients were reporting adverse clinical events spontaneously than when the interviewer probed for recall in a systematic inquiry. Discrimination was also better when the adverse clinical events were obtained from a staff-initiated surveillance method than from a self-monitoring, patient-initiated telephone-reporting method--probably because the latter method generates an excessively strong tendency to report mainly those adverse clinical events suspected of being drug related.
本文展示了来自参与上市后监测研究的两组门诊患者的数据，一组接受抗生素治疗，另一组接受三环类抗抑郁药治疗，结果表明患者似乎能够正确区分可能的药物不良反应与其他不良临床事件。然而，归因准确性既取决于监测方法，也取决于不良临床事件报告的获取方式。当患者自发报告不良临床事件时，辨别能力优于访谈者在系统询问中进行回忆探查时。当不良临床事件通过工作人员发起的监测方法获取时，辨别能力也优于自我监测、患者发起的电话报告方法——这可能是因为后一种方法产生了一种过度强烈的倾向，主要报告那些怀疑与药物相关的不良临床事件。
