Venning G R
Br Med J (Clin Res Ed). 1982 Jan 23;284(6311):249-52. doi: 10.1136/bmj.284.6311.249.
Suspected adverse drug reactions first reported in 1963 in the "British Medical Journal," the "Lancet," the "Journal of the American Medical Association," and the "New England Journal of Medicine" were reviewed 18 years later to assess their initial validity and subsequent verification. Of 52 first reports, five were deliberate investigations into potential or predictable reactions, and in each case causality was reasonably established; the other 47 reports were essentially anecdotal. Of these 47 reports, 14 related to categories of adverse reaction where false-positive reports were unlikely: immediate reactions, local reactions, and known reactions caused by a different mode of administration or a brand previously thought or claimed to be safe. The problem of false alarms rose in the remaining types of reactions: general reactions that did not occur immediately after administration and arose for the first time with a new chemical entity. Of 33 reports of such suspected adverse reactions, validity was satisfactorily established in 14 cases on the basis of rechallenge, predictability from known pharmacology, or the unique nature of the reaction. Of the remaining 19 reports, further verification still has not been satisfactorily established in 12. Seven of these possible false alarms were haematological reactions.Although 35 of the 47 anecdotal reports were clearly correct, of the 19 reports that were not reasonably validated at the time of the report, only seven were subsequently verified. This suggests that agencies monitoring adverse drug reactions should adopt criteria for assessing the validity of first reports of suspected adverse reactions. Such criteria should include: reactions on rechallenge, a pharmacological basis for the adverse reaction, immediate acute reactions, local reactions at the site of administration, reactions with a new route of administration of a drug known to provoke such reactions by another route, and the repeated occurrence of very rare events.
对1963年首次发表于《英国医学杂志》《柳叶刀》《美国医学会杂志》和《新英格兰医学杂志》上的疑似药物不良反应报告在18年后进行了回顾，以评估其最初的有效性及后续的验证情况。在52份首次报告中，有5份是对潜在或可预测反应的刻意调查，且在每种情况下因果关系都得到了合理确立；其他47份报告本质上属于轶事性报道。在这47份报告中，有14份涉及不太可能出现假阳性报告的不良反应类别：即时反应、局部反应以及由不同给药方式或先前认为或声称安全的品牌所引起的已知反应。在其余类型的反应中出现了误报问题：给药后未立即发生且首次与新化学实体一起出现的一般反应。在33份此类疑似不良反应报告中，基于再激发试验、已知药理学的可预测性或反应的独特性质，有14例的有效性得到了令人满意的确立。在其余19份报告中，有12份的进一步验证仍未令人满意地完成。其中7例可能的误报是血液学反应。虽然47份轶事性报告中有35份显然是正确的，但在报告时未得到合理验证的19份报告中，只有7份后来得到了验证。这表明监测药物不良反应的机构应采用评估疑似药物不良反应首次报告有效性的标准。此类标准应包括：再激发试验时的反应、不良反应的药理学依据、即时急性反应、给药部位的局部反应、已知通过另一种途径可引发此类反应的药物采用新给药途径时的反应，以及非常罕见事件的反复发生。
