两种药物不良反应因果关系判断方法的比较与分析

Comparison and Analysis of Two Judgment Methods for Causality of Adverse Drug Reactions

运用Naranjo提出的药物不良反应因果关系判定标准 ,对所收集到的 39例次雷公藤不良反应病例报告进行再次分析判断 ,并与运用卫生部药物不良反应监察中心制定的药品与药物不良反应 (ADRs)因果关系判断标准判断结果进行比较。结果显示 :运用此两种方法进行药物不良反应判断 ,其结果存在不一致性(Kappa =0 .0 9) ,Naranjo法更有利于不良反应的发现 ,尤其是罕见的不良反应 ,但可使报告的不良反应发生率偏高 ,研究者可根据研究目的选择相应的判断方法。

Thirty_nine case reports of adverse drug reactions(ADRs) caused by Tripterygium wilfordii were reanalyzed and reassessed by using the judgment criteria of the causation of ADRs proposed by Naranjo.And then the results were compared with those obtained through using the criteria established by the Center for Monitoring ADRs under the Chinese Ministry of Public Health.It was shown there was inconsistency(Kappa=0.09)between the two methods in assessing ADRs.The Naranjo method was more suitable for the finding of ADRs,especially the infrequent ones.But it tended to result in higher reported ADRs incidence.It is suggested that researchers can choose the proper judgment method according to the objectives of studies.