CAUSALITY ASSESSMENT OF ADVERSE REACTIONS TO DRUGS .1. A NOVEL METHOD BASED ON THE CONCLUSIONS OF INTERNATIONAL CONSENSUS MEETINGS - APPLICATION TO DRUG-INDUCED LIVER INJURIES
CAUSALITY ASSESSMENT OF ADVERSE REACTIONS TO DRUGS .1. A NOVEL METHOD BASED ON THE CONCLUSIONS OF INTERNATIONAL CONSENSUS MEETINGS - APPLICATION TO DRUG-INDUCED LIVER INJURIES
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DOI：
10.1016/0895-4356(93)90101-6
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发表时间：
1993-11-01
影响因子：
7.2
通讯作者：
BENICHOU, C
中科院分区：
文献类型：
--
作者：
DANAN, G;BENICHOU, C
尽管已提出了大量的方法，但评估药物在不良医疗事件发生中的因果作用仍然是最有争议的问题之一。标准的限定术语，如“兼容的”、“暗示的”或“不确定的”，从未被严格定义，导致重复性较低。标准的权重通常不适合受损的器官，从而降低了方法的特异性。本文描述了一种新的药物因果关系评估方法。这些标准的内容和限度已由参加面向机关的国际协商一致会议的专家确定。引入了其他标准，并确定了权重。该方法被应用于急性肝损伤的报告。重复性由一个独立的团队进行了测试。本文在原有方法的基础上，以具有积极再挑战的报告为外部标准，研究了这种新方法的有效性。
Despite the great number of methods proposed, assessing the causal role of a drug in the occurrence of an adverse medical event remains one of the most controversial issues. Qualifying terms for criteria, such as ''compatible'', ''suggestive'' of ''inconclusive'', have never been strictly defined, leading to low reproducibility. Weights of the criteria are usually not adapted to the injured organ, decreasing the specificity of the method. In this paper, a new method for drug causality assessment is described. Contents and limits of the criteria have been defined by experts convened to organ-oriented international consensus meetings. Additional criteria have been introduced and weights attributed. The method was applied to reports of acute liver injuries. The reproducibility was tested by an independent team. The validity of this novel method is studied in the following paper, based on an original approach using reports with positive rechallenge as external standard.