关键词: 药品不良反应, 因果关系评价

Abstract: 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.

Key words: adverse drug reaction, causality assessment