关于中药相关药物性肝损伤的规范化报告程序的探讨  

Exploration of the standardized reporting procedure for drug-induced liver injury related to Chinese materia medica

作　　者：刘玉娟[1] 冉姗 陈志东[2] 施晓琳[3] 黄海茵[3] 方忠宏[1] LIU Yujuan;RAN Shan;CHEN Zhidong;SHI Xiaolin;HUANG Haiyin;FANG Zhonghong(Jinshan Hospital of Fudan University,Shanghai 201508,China;Shanghai Jiao Tong University Affiliated Sixth People’s Hospital,Shanghai 200233,China;Yueyang Hospital of Integrated Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China)

机构地区：[1]复旦大学附属金山医院,上海201508 [2]上海交通大学医学院附属第六人民医院 [3]上海中医药大学附属岳阳中西医结合医院

出　　处：《北京中医药大学学报》2023年第11期1582-1586,共5页Journal of Beijing University of Traditional Chinese Medicine

基　　金：上海市进一步加快中医药事业发展三年行动计划项目[No.ZY(2018-2020)-ZYBZ-08]。

摘　　要：近年来,关于中药引起的药物性肝损伤报道日益增多,给中医药的健康发展带来诸多负面影响。本文旨在通过分析当前文献数据库中有关中药药物性肝损伤报道的概况,论证中药药物性肝损伤报告过程中存在的问题和不足,并为中药药物性肝损伤的合理报告程序提出建议。研究结果显示,已发表的中药药物性肝损伤研究报告中存在中药药源信息不全,无合并用药、饮酒、服用保健品史关联分析等问题,报告程序明显违背药物不良反应报告基本原则,导致目前中药药物性肝损伤过度报道。此外,为明确病因药物,本文提出中药相关药物性肝损伤的定义,并建议制定中药相关药物性肝损伤的规范化报告程序方案。本文在厘清药物性肝损伤的真实病因基础上,通过参考国内外规范的处置不良反应报告规则和程序,规范中药相关药物性肝损伤报告程序,进一步优化中药的临床应用,以促进中医药行业的健康发展。In recent years,an increasing number of reports have been made on drug-induced liver injury(DILI)caused by Chinese materia medica,which has negatively influenced the development of traditional Chinese medicine(TCM).This article aims to analyze the current literature database on DILI reports related to Chinese materia medica,highlight the problems and deficiencies in the process of reporting DILI by Chinese materia medica,and suggest recommendations for a rational reporting procedure for this complication.Research findings indicated that published studies on DILI by Chinese materia medica contain incomplete information on Chinese materia medica sources,an absence of analysis of concurrent medication,alcohol consumption,and use of dietary supplements,and a clear violation of the basic principles of adverse drug reaction(ADR)reporting,leading to excessive reporting of DILI by Chinese materia medica.Additionally,to clarify the causative drugs,this article proposes the definition of Chinese materia medica-related DILI,and suggests a standardized reporting procedure for Chinese materia medica-related DILI.This article clarifies the true etiology of DILI and by referring to both domestic and international standards for handling ADR reporting,establishes standardized procedures for reporting Chinese materia medica-related DILI.These efforts are intended to further optimize the clinical application of Chinese materia medica and promote the healthy development of the TCM.

关 键 词：中医 中药 药物性肝损伤 药物不良反应 

分 类 号：R259.953[医药卫生—中西医结合]