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

LIU Yujuan; RAN Shan; CHEN Zhidong; SHI Xiaolin; HUANG Haiyin; FANG Zhonghong

doi:10.3969/j.issn.1006-2157.2023.11.013

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

Clinical Studies | 更新时间：2023-12-08

- Exploration of the standardized reporting procedure for drug-induced liver injury related to Chinese materia medica
- Journal of Beijing University of Traditional Chinese Medicine Vol. 46, Issue 11, Pages: 1582-1586(2023)
- 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：
  
  FANG Zhonghong, Chief Pharmacist.Jinshan Hospital of Fudan University, No.1508, Longhang Road, Jinshan District, Shanghai 201508.E-mail: selfcareno1@163.com
- 基金信息：
  
  Shanghai Municipality’s Three-year Action Plan for Further Accelerating the Development of Traditional Chinese Medicine(ZY（2018-2020）-ZYBZ-08)
- DOI：10.3969/j.issn.1006-2157.2023.11.013
  CLC： R259.953
- Received：04 May 2023，
  
  Published Online：08 September 2023，
  
  Published：30 November 2023
- 稿件说明：
移动端阅览
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：

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

Keywords

references

王蜀．药物性肝损伤临床分析 [J]. 实用肝脏病杂志， 2008 ， 11 ( 6 )： 413 - 414 .

冉姗，方忠宏，黄海茵，等．中药药物性肝损伤报告中存在的问题及建议 [J]. 中医杂志， 2021 ， 62 ( 7 )： 581 - 584 .

STEEN DL , BHATT DL . Statin potency associated with incident diabetes in a real-world evaluation [J/OL]. Evid Based Med , 2014 , 19 ( 2 )： 68 [ 2023-05-01 ]. https://ebm.bmj.com/content/19/2/68.long .

CHITTURI S , GEORGE J . Hepatotoxicity of commonly used drugs: nonsteroidal anti-inflammatory drugs, antihypertensives, antidiabetic agents, anticonvulsants, lipid-lowering agents, psychotropic drugs [J]. Semin Liver Dis , 2002 , 22 ( 2 )： 169 - 183 .

LEE LM , CARIAS DC , GOSSER R , et al . ASHP Guidelines on Adverse Drug Reaction Monitoring and Reporting [J]. Am J Health Syst Pharm , 2022 , 79 ( 1 )： 83 - 89 .

FERNER RE , MCGETTIGAN P . Adverse drug reactions [J/OL]. BMJ ， 2018 , 363 ： k4051 [ 2023-05-01 ]. https://www.bmj.com/content/363/bmj.k4051.long .

ELDRIDGE N , WANG Y , METERSKY M , et al . Trends in Adverse Event Rates in Hospitalized Patients, 2010-2019 [J]. JAMA , 2022 ， 328 ( 2 )： 173 - 183 .

LAZAROU J , POMERANZ BH , COREY PN . Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies [J]. JAMA , 1998 , 279 ( 15 )： 1200 - 1205 .

SHEN T , LIU YX , SHANG J , et al . Incidence and etiology of drug-induced liver injury in mainland China [J]. Gastroenterology , 2019 ， 156 ( 8 )： 2230 - 2241 .

DAI N , YU YC , REN TH , et al . Gynura root induces hepatic veno-occlusive disease: a case report and review of the literature [J]. World J Gastroenterol , 2007 ， 13 ： 1628 - 1631 .

LIU CX , FAN HR , LI YZ , et al . Research Advances on Hepatotoxicity of Herbal Medicines in China [J/OL]. Biomed Res Int ， 2016 , 2016 ： 7150391 [ 2023-05-01 ]. https://www.hindawi.com/journals/bmri/2016/7150391/ .

PADULA WV , PRONOVOST PJ . Improvements in Hospital Adverse Event Rates: Achieving Statistically Significant and Clinically Meaningful Results [J]. JAMA ， 2022 ， 328 ( 2 )： 148 - 150 .

薛寿征，曾广先．马兜铃酸肾病：研究及启示 [J]. 科学， 2018 ， 70 ( 4 )： 27 - 31 .

范文瀚，李成忠，万谟彬，等 . 三种诊断标准对药物性肝损害诊断的比较与分析 [J]. 肝脏， 2012 , 17 ( 1 )： 17 - 20 .

肖云卿．口服中药三七致肝肾功能受损1例 [J]. 中国危重病急救医学， 1993 ， 5 ( 4 )： 217 .

蒋淼，方忠宏，刘玉娟，等．药(含中药)源性肝损伤的病因溯源 [J]. 北京中医药大学学报， 2019 , 42 ( 2 )： 149 - 159 .

徐媛，方忠宏，冉姗 . 1例多因素所致药物性肝损伤病例的病因论证与药学监护 [J]. 药物流行病学杂志， 2023 ， 32 ( 3 )： 350 - 355 .

姜华侨，王飞，吕小群，等 . 1例药源性肝损伤的病因药物鉴别报告 [J]. 中医杂志， 2020 ， 61 ( 9 )： 824 - 826 .

COLEMAN JJ , PONTEFRACT SK . Adverse drug reactions [J]. Clin Med , 2016 , 16 ( 5 )： 481 - 485 .

EDWARDS IR , ARONSON JK . Adverse drug reactions: definitions, diagnosis, and management [J]. Lancet , 2000 , 356 ( 9237 )： 1255 - 1259 .

NAVARRO VJ , LUCENA MI . Hepatotoxicity induced by herbal and dietary supplements [J]. Semin Liver Dis , 2014 , 34 ( 2 )： 172 - 193 .

ARONSON D , FERNER RE . Clarification of Terminology in Drug Safety [J]. Drug Safety , 2005 , 28 ( 10 )： 851 - 870 .

European Association for the Study of the Liver . EASL Clinical Practice Guidelines: Drug-induced liver injury [J]. J Hepatol , 2019 ， 70 ( 6 )： 1222 - 1261 .

国家药典委员会 . 中药饮片卷 [M]// 国家药典委员会．临床用药须知．北京：中国医药科技出版社， 2017 ： 3 .

RAMSAY HM , GODDARD W , GILL S , et al . Herbal creams used for atopic eczema in Birmingham, UK illegally contain potent corticosteroids [J]. Arch Dis Child , 2003 , 88 ( 12 )： 1056 - 1057 .

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