摘要
目的评估目前我国药物性肝损伤(DILI)文献病例报告的质量。方法制定了评估DILI因果关系所必须的31个要素清单,对2015年1月至2017年12月间我国科技核心期刊发表61篇DILI文献病例报告进行分析。结果 DILI文献病例报告中,患者年龄、性别、怀疑药品名称、用药原因等因素报告率较高,但是一些评估DILI因果关系所需的关键要素的报告率较低。结论目前DILI文献病例报告中常缺乏评估DILI因果关系关键性内容,建议建立DILI病例发表相关指南或专家共识,进一步提高我国DILI文献病例报告质量,对DILI信号挖掘等文献利用也具有重要作用。
Objective To assess the quality of published cases drug-induced liver injury(DILI)reports in China.Methods A list of 31 crucial elements necessary in evaluating causality of DILI was developed,then the reporting rate of the 31 crucial elements was investigated in 61 reports published from January 2015 to December 2017.Results Elements such as patients'age,sex,drug name and primary disease were widely reported,while some key elements in evaluating causality of DILI were under-reported.Conclusion Some reports of DILI lacked important or essential details.Creating guidelines of DILI reports submitted for publication is recommended to improve the quality of DILI reports in China,and it is important for the utility of these reports too,such as early detection of drug induced hepatotoxicity.
作者
朱兰
任经天
关薇
刘红亮
ZHU Lan;REN Jingtian;GUAN Wei;LIU Hongliang(Center for Drug Reevaluation,CFDA,Beijing 100022,China)
出处
《中国药物警戒》
2018年第11期663-667,共5页
Chinese Journal of Pharmacovigilance
基金
国家科技重大专项(2015ZX09501004-001-001):基于SRS系统的动态
长效中药风险信号早期发现研究
关键词
文献病例报告
药物性肝损伤
药品不良反应报告
published case report
drug-induced liver injury
adverse drug reaction report
