关于中药相关药物性肝损伤的规范化报告程序的探讨

刘玉娟; 冉姗; 陈志东; 施晓琳; 黄海茵; 方忠宏

doi:10.3969/j.issn.1006-2157.2023.11.013

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关于中药相关药物性肝损伤的规范化报告程序的探讨

临床研究 | 更新时间：2023-12-08

- 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
- 北京中医药大学学报 2023年46卷第11期页码：1582-1586
- 作者机构：
  
  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
- 作者简介：
  
  刘玉娟，女，主管药师
  # 方忠宏，男，主任药师，主要研究方向：药源性疾病的预防与治疗，E-mail：selfcareno1@163.com
- 基金信息：
  
  上海市进一步加快中医药事业发展三年行动计划项目(ZY（2018-2020）-ZYBZ-08)
- DOI：10.3969/j.issn.1006-2157.2023.11.013
  中图分类号： R259.953
- 纸质出版日期：2023-11-30，
  
  网络出版日期：2023-09-08，
  
  收稿日期：2023-05-04，
- 稿件说明：
移动端阅览
刘玉娟, 冉姗, 陈志东, 等. 关于中药相关药物性肝损伤的规范化报告程序的探讨[J]. 北京中医药大学学报, 2023,46(11):1582-1586.

LIU Yujuan, RAN Shan, CHEN Zhidong, et al. Exploration of the standardized reporting procedure for drug-induced liver injury related to Chinese materia medica[J]. Journal of Beijing University of Traditional Chinese Medicine, 2023,46(11):1582-1586.
刘玉娟, 冉姗, 陈志东, 等. 关于中药相关药物性肝损伤的规范化报告程序的探讨[J]. 北京中医药大学学报, 2023,46(11):1582-1586. DOI： 10.3969/j.issn.1006-2157.2023.11.013.

LIU Yujuan, RAN Shan, CHEN Zhidong, et al. Exploration of the standardized reporting procedure for drug-induced liver injury related to Chinese materia medica[J]. Journal of Beijing University of Traditional Chinese Medicine, 2023,46(11):1582-1586. DOI： 10.3969/j.issn.1006-2157.2023.11.013.

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。

Abstract

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

Keywords

traditional Chinese medicineChinese materia medicadrug-induced liver injuryadverse drug reaction

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