摘要
运用卫生部药品不良反应监察中心制定的不良反应(ADRs)判断标准,对所收集到的29篇38例(共39例次)雷公藤不良反应病例报告进行分析。雷公藤的不良反应常累及二个以上系统,发生在血液系统ADRs是其主要的、严重的ADRs;发生ADRs的病例以服用雷公藤多甙片为多。两位判断者应用判断方法具有较好的一致性(Kappa=0.6336,U=6.13,P<0.01);不一致情况的分析表明。
With the application of judgement criteria for causality of adverse drug reactions (ADRs)established by Chinese Center for Monitoring ADRs, 38 published case reports of ADRs caused by Tripterygium wilfordii were reviewed. It was found that most ADRs of Tripterygium wilfordii involved more than two body systems,especially the blood system.The ADRs_causing drug type was mainly wilfordine tablet.The inter_rater agreement for causality judgement of ADRs was quite well in independent application of the judgement criteria by two individuals (Kappa=0.6336,u= 6.13 ,P<0.01).Analysis of inconsistency of assessment revealed that integration of the detailed description of the case report of ADRs would be most important for the correct evaluation of the causality of ADRs.
出处
《中药新药与临床药理》
CAS
CSCD
1999年第1期50-53,共4页
Traditional Chinese Drug Research and Clinical Pharmacology
关键词
雷公藤
副作用
因果关系
Tripterygium wilfordii/adverse effects
Causation