药品不良反应报告因果关系评价方法概述  

Review of Adverse Drug Reaction Reports Causality Assessment Methods

作　　者：魏晶[1] 王瑜歆[1] 

机构地区：[1]辽宁省药品不良反应监测中心,辽宁沈阳110003

出　　处：《中国药物警戒》2011年第10期600-603,共4页Chinese Journal of Pharmacovigilance

摘　　要：药品不良反应因果关系的评价方法是药物警戒过程中比较重要的一种工具,该研究提供一个这些方法总的概述,并阐述他们的特点。药品不良反应因果关系评价方法大致分为三种:专家判断或全面内省法、计分推算法、概率法或贝叶斯法。专家判断法是基于先前已有的知识和经验的非标准化方法对个案进行评估,以得出因果关系的结论;计分推算法是设计一系列的问题,通过计算回答问题的分数来判断因果关系的可能性;贝叶斯法是通过使用个例报告的相关信息把药品因果关系的先验概率转化为后验概率的过程。先验概率是用流行病学信息计算得来,后验概率与这个背景信息相比得出因果关系的可能性。另外,不同的评价方法因果关系的分类也不同,因果关系评价的标准也不同。总之,目前仍然没有一种通用的因果关系评价方法。ADR causality assessment method is an important tool in the process of pharmacovigilance. The aim of this review is to provide an overview of these methods and discuss their strengths and weaknesses. The methods were found, falling into three broad categories： expert judgement/global introspection, algorithms and probabilistic methods（Bayesian approaches）. Expert judgements are individual assessments based on previous knowledge and experience in the field using no standardized tool to arrive at conclusions regarding causality. Algorithms are sets of specific questions with associated scores for calculating the likelihood of a cause-effect relationship. Bayesian approaches use specific findings in a case to transform the prior estimate of probability into a posterior estimate of probability of drug causation. The prior probability is calculated from epidemiological information and the posterior probability combines this background information with the evidence in the individual case to come up with an estimate of causation. Different causality categories are adopted in each method, and the categories are assessed using different criteria. In conclusion, there is still no method universally accepted for causality assessment of ADRs.

关 键 词：药品不良反应 因果关系评价 

分 类 号：R95[医药卫生—药学]