Day R O, Quinn D I, Conaghan P G, Tett S E
Department of Clinical Pharmacology and Toxicology, St. Vincent's Hospital, Darlinghurst, NSW, Australia.
J Rheumatol. 1995 May;22(5):983-8.
Drugs administered as therapy for rheumatological disorders are a relatively common cause of adverse events. Important data regarding the effects of drugs on patients with rheumatological conditions is being lost or rendered inaccessible because of deficiencies in classification, measurement, and collection methods for adverse drug reactions. A significant number of adverse reactions to drugs will not be known before marketing, and hence vigilance on the part of clinicians and patients in observing and documenting these reactions is paramount in building our knowledge and modifying our practice accordingly. A variety of systems and methods for detecting adverse drug reactions are described, critically evaluated, and compared for cost, potential bias, ethical concerns, and subject recruitment required for necessary statistical power. Systems need to be developed to give access to the wealth of clinical experimental data available in the individual practices of a broad spectrum of clinicians. To facilitate this, representative organizations need to make adverse drug reactions a high priority as well as contributing expertise and finance to database formulation and accessibility.
作为治疗风湿性疾病的药物是不良事件的相对常见原因。由于药物不良反应的分类、测量和收集方法存在缺陷,有关药物对风湿性疾病患者影响的重要数据正在丢失或无法获取。大量药物不良反应在上市前是未知的,因此临床医生和患者在观察和记录这些反应方面保持警惕,对于积累我们的知识并据此调整我们的实践至关重要。本文描述、批判性评估并比较了多种检测药物不良反应的系统和方法,涉及成本、潜在偏差、伦理问题以及获得必要统计效力所需的受试者招募情况。需要开发系统,以便能够获取广泛临床医生个人实践中可用的大量临床实验数据。为此,代表性组织需要将药物不良反应作为高度优先事项,并为数据库的建立和可及性贡献专业知识和资金。