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更新药品不良反应因果关系评估的法国方法。

Updating the French method for the causality assessment of adverse drug reactions.

机构信息

Cellule Plan de Gestion de risque, ANSM, Saint-Denis, France.

出版信息

Therapie. 2013 Mar-Apr;68(2):69-76. doi: 10.2515/therapie/2013016. Epub 2013 Jun 18.

Abstract

The Imputability Working Group (CRI) updated the French drug reaction causality assessment method. This tripartite group is made up of staff from the French network of regional pharmacovigilance centres, pharmaceutical companies, and the French National Agency for the Safety of Medicines and Health Products (ANSM). After reviewing the strengths and weaknesses of the previous method, several ideas for improvement were proposed: a better-worded and more discriminating scale for certain chronological and semiological criteria, a larger scale for the intrinsic score (increased from 5 to 7 levels), a new bibliographical scale to differentiate between expected and unexpected adverse drug reactions, and a new informativeness scale.

摘要

归因工作组(CRI)更新了法国药物反应因果关系评估方法。该三方小组由法国区域药物警戒中心网络、制药公司和法国国家药品与健康产品安全局(ANSM)的工作人员组成。在审查了先前方法的优缺点后,提出了一些改进建议:对某些时间和症状标准的用词和区分度更好的量表,内在评分的更大范围(从 5 级增加到 7 级),区分预期和非预期药物不良反应的新文献量表,以及新的信息量量表。

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