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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。
Naranjo put forward the adverse drug reaction causality criteria, the collected 39 cases of triptolide adverse reactions reported again to determine the case, and with the application of the Ministry of Health Adverse Drug Reaction Monitoring Center developed drug and drug adverse reactions (ADRs ) Causality judgment criteria Judgment results are compared. The results showed that there were some inconsistencies in the determination of ADRs by these two methods (Kappa = 0.09). The Naranjo method was more favorable for the detection of adverse reactions, especially for rare adverse reactions, but the reported The incidence of adverse reactions is high, researchers can choose the appropriate judging method according to the purpose of the study.