Diagnostic values of integrated evidence chain, Roussel Uclaf Causality Assessment Method, and Structured Expert Opinion Process method for drug-induced liver injury

Tingting HE; Qingsheng LIANG; Liping WANG; Longxin LIANG; Xiaohan LI; Yanfei CUI; Jing JING; Zhaofang BAI; Man GONG; Ruilin WANG

doi:10.3969/j.issn.1001-5256.2022.01.022

Volume 38 Issue 1

Jan. 2022

Turn off MathJax

Article Contents

Article Navigation > Journal of Clinical Hepatology > 2022 > 38(1): 141-147

PDF( 2269 KB)

Diagnostic values of integrated evidence chain, Roussel Uclaf Causality Assessment Method, and Structured Expert Opinion Process method for drug-induced liver injury

DOI: 10.3969/j.issn.1001-5256.2022.01.022

Tingting HE^1a,
Qingsheng LIANG^1b,
Liping WANG^1a,
Longxin LIANG^{1c, 2},
Xiaohan LI^1d,
Yanfei CUI^1a,
Jing JING^1a,
Zhaofang BAI^{1c, 3},
Man GONG^{1a
,
,},
Ruilin WANG^{1a
,
,}

1a.
Department of Traditional Chinese Medicine Hepatology of Department of Liver Disease, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China
1b.
The Fifth Ward of Department of Liver Disease, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China
1c.
Institute of Liver Diseases, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China
1d.
Department of Clinical Laboratory, The Fifth Medical Center of Chinese PLA General Hospital, Beijing 100039, China
2.
College of Pharmacy, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China
3.
PLA Institute of Traditional Chinese Medicine, Beijing 100039, China

Research funding:

Major Scientific Research and Difficult Medical Technology Research Project (2020KTY001);

National Science and Technology Major Project (2018ZX10303502-002-019);

National Science and Technology Major Project (2018ZX10725506-002);

Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine (ZYYCXTD-C-202005)

Received Date: 2021-06-13
Accepted Date: 2021-09-06
Published Date: 2022-01-20

Abstract

Abstract

Objective To investigate the clinical applicability and different characteristics of three commonly used diagnostic methods for drug-induced liver injury from the two aspects of liver injury induced by Western medicine and liver injury induced by traditional Chinese medicine. Methods A prospective cohort study was performed for 289 hospitalized patients with acute drug-induced liver injury who were admitted to The Fifth Medical Center of Chinese PLA General Hospital from January 2015 to December 2020 and did not receive integrated traditional Chinese and Western medicine therapy, among whom 187 patients had herb-induced liver injury and 102 had Western medicine-induced liver injury. The 289 patients were diagnosed by the integrated evidence chain (IEC), Roussel Uclaf Causality Assessment Method (RUCAM), and the Structured Expert Opinion Process (SEOP) method, and related data at acute onset were collected, including general information, latency period, detailed medication, and laboratory markers such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transpeptidase, alkaline phosphatase, and total bilirubin. A statistical analysis was performed to investigate the consistency between IEC, RUCAM, and SEOP in the diagnosis of Western medicine-induced liver injury and herb-induced liver injury and their own applicability. The Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data; the chi-square was used for comparison of categorical data. Results The hepatocellular type was the main type of clinical liver injury in both Western medicine-induced liver injury and herb-induced liver injury, accounting for 81.4% and 74.3%, respectively, and laboratory examination showed higher levels of ALT and AST. Western medicine-induced liver injury cases were diagnosed by IEC, RUCAM, and SEOP, with a clinical diagnosis rate of 65.7%, 100%, and 63.7%, respectively, and the constituent ratio of Western medicine-induced liver injury was 23.2%, 35.3%, and 22.5%, respectively. Herb-induced liver injury cases were diagnosed by these three methods, with a clinical diagnosis rate of 47.6%, 100%, and 29.9%, respectively, and the constituent ratio of herb-induced liver injury was 30.8%, 64.7%, and 19.4%, respectively. The consistency test of the three diagnostic methods showed that in the diagnosis of Western medicine-induced liver injury cases, there was good consistency between IEC and SEOP (Kappa=0.785, P < 0.05), while there was poor consistency between RUCAM and IEC (Kappa=0.149, P > 0.05) and between RUCAM and SEOP (Kappa=0.117, P > 0.05); in the diagnosis of herb-induced liver injury cases, there was poor consistency between RUCAM and SEOP (Kappa=0.066, P > 0.05), while there was good consistency between RUCAM and IEC (Kappa=0.026, P < 0.05) and between IEC and SEOP (Kappa=0.437, P < 0.05). Conclusion The IEC method shows good applicability for both Western medicine-induced liver injury and herb-induced liver injury, and there is good consistency between IEC and SEOP in the diagnosis of Western medicine-induced liver injury cases, while there is a relatively low level of consistency between IEC and SEOP in the diagnosis of herb-induced liver injury. There is poor consistency between RUCAM and the other two methods. In the clinical diagnosis of Western medicine-induced liver injury, IEC, RUCAM, and SEOP should be used in combination to accurately judge the causal relationship between drugs and liver injury.
- Chemical and Drug Induced Liver Injury,
- Diagnosis,
- Disease Attributes

FullText(HTML)

References(18)

References

[1]	SHEN T, LIU Y, SHANG J, et al. Incidence and etiology of drug-induced liver injury in mainland China[J]. Gastroenterology, 2019, 156(8): 2230-2241. e11. DOI: 10.1053/j.gastro.2019.02.002.
[2]	CHI F, WANG XJ, ZHANG YY, et al. Clinical characteristics and misdiagnosis of drug-induced liver injury with extraphepatic manifestation as initial symptom[J]. Clin Misdiagn Misther, 2018, 31(10): 49-52. DOI: 10.3969/j.issn.1002-3429.2018.10.013. 池菲, 王晓静, 张媛媛, 等. 以肝外表现首发的药物性肝损伤临床特征及误诊分析[J]. 临床误诊误治, 2018, 31(10): 49-52. DOI: 10.3969/j.issn.1002-3429.2018.10.013.
[3]	HE XJ, PI MM, GUO CH, et al. No β Lipoproteinemia misdiagnosed as drug-induced liver injury: A case report[J]. Chin J Mod Med, 2020, 30(6): 123-124. DOI: 10.3969/j.issn.1005-8982.2020.06.024. 贺小金, 皮明明, 郭朝慧, 等. 无β脂蛋白血症误诊为药物性肝损伤1例[J]. 中国现代医学杂志, 2020, 30(6): 123-124. DOI: 10.3969/j.issn.1005-8982.2020.06.024.
[4]	XIAO XH. Combination of medicine and pharmacy assists for precise prevention and control of drug-induced liver injury[J]. J Clin Hepatol, 2020, 36(3): 489-490. DOI: 10.3969/j.issn.1001-5256.2020.03.001. 肖小河. 医药结合, 助力药物性肝损伤精准防控[J]. 临床肝胆病杂志, 2020, 36(3): 489-490. DOI: 10.3969/j.issn.1001-5256.2020.03.001.
[5]	Branch of Hepatobiliary Diseases, China Association of Chinese Medicine, Branch of Chinese Patent Medicine, China Association of Chinese Medicine. Guideline for diagnosis and treatment of herb-induced liver injury[J]. J Clin Hepatol, 2016, 32(5): 835-843. DOI: 10.3969/j.issn.1001-5256.2016.05.003. 中华中医药学会肝胆病分会, 中华中医药学会中成药分会. 中草药相关肝损伤临床诊疗指南[J]. 临床肝胆病杂志, 2016, 32(5): 835-843. DOI: 10.3969/j.issn.1001-5256.2016.05.003.
[6]	Drug-induced Liver Disease Study Group, Chinese Society of Hepatology, Chinese Medical Association. Guidelines for the management of drug-induced liver injury[J]. J Clin Hepatol, 2015, 31(11): 1752-1769. DOI: 10.3969/j.issn.1001-5256.2015.11.002. 中华医学会肝病学分会药物性肝病学组. 药物性肝损伤诊治指南[J]. 临床肝胆病杂志, 2015, 31(11): 1752-1769. DOI: 10.3969/j.issn.1001-5256.2015.11.002.
[7]	DANAN G, BENICHOU C. Causality assessment of adverse reactions to drugs—I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries[J]. J Clin Epidemiol, 1993, 46(11): 1323-1330. DOI: 10.1016/0895-4356(93)90101-6.
[8]	DANAN G, TESCHKE R. RUCAM in drug and herb induced liver injury: The update[J]. Int J Mol Sci, 2015, 17(1): 14. DOI: 10.3390/ijms17010014.
[9]	CHALASANI NP, HAYASHI PH, BONKOVSKY HL, et al. ACG clinical guideline: The diagnosis and management of idiosyncratic drug-induced liver injury[J]. Am J Gastroenterol, 2014, 109(7): 950-966; quiz 967. DOI: 10.1038/ajg.2014.131.
[10]	YU LC, CHEN CW. New version of rucam: An important assessment tool for drug and herbal induced liver injury[J]. Chin Hepatol 2016, 21(6): 493-500. DOI: 10.14000/j.cnki.issn.1008-1704.2016.06.019. 于乐成, 陈成伟. 新版RUCAM: 药物和草药诱导性肝损伤的重要评估工具[J]. 肝脏, 2016, 21(6): 493-500. DOI: 10.14000/j.cnki.issn.1008-1704.2016.06.019.
[11]	HE TT, JING J, BO ZF, et al. Constituent ratio and changing trend of non-infectious liver diseases in The Fifth Medical Center of Chinese PLA General Hospital from 2002 to 2018[J]. J Clin Hepatol, 2020, 36(8): 1773-1777. DOI: 10.3969/j.issn.1001-5256.2020.08.019. 何婷婷, 景婧, 柏兆方, 等. 解放军总医院第五医学中心2002年-2018年常见非感染性肝病构成比及变化趋势分析[J]. 临床肝胆病杂志, 2020, 36(8): 1773-1777. DOI: 10.3969/j.issn.1001-5256.2020.08.019.
[12]	SUN Y, XIE H, WANG CH, et al. Advance of causality assessment and biomarker of idiosyncratic drug-induced liver injury[J]. Infect Dis Info, 2017, 30(4): 203-208. DOI: 10.3969/j.issn.1007-8134.2017.04.005. 孙颖, 谢欢, 王春红, 等. 特异质型药物性肝损伤病因评估及生物标志物的研究进展[J]. 传染病信息, 2017, 30(4): 203-208. DOI: 10.3969/j.issn.1007-8134.2017.04.005.
[13]	ROCKEY DC, SEEFF LB, ROCHON J, et al. Causality assessment in drug-induced liver injury using a structured expert opinion process: Comparison to the Roussel-Uclaf causality assessment method[J]. Hepatology, 2010, 51(6): 2117-2126. DOI: 10.1002/hep.23577.
[14]	DANAN G, TESCHKE R. Drug-induced liver injury: Why is the Roussel Uclaf causality assessment method (RUCAM) still used 25 years after its launch?[J]. Drug Saf, 2018, 41(8): 735-743. DOI: 10.1007/s40264-018-0654-2.
[15]	ZHU PS, ZHENG GZ, LONG AH. Study on dynamic change of liver and renal function of in trahepatic cholestasis in rats induced by ANIT[J]. J Medical Forum, 2010, 31(14): 6-8. https://www.cnki.com.cn/Article/CJFDTOTAL-HYYX201014002.htm 朱平生, 郑贵珍, 龙爱华. ANIT诱发大鼠肝内胆汁淤积的肝肾功能动态变化研究[J]. 医药论坛杂志, 2010, 31(14): 6-8. https://www.cnki.com.cn/Article/CJFDTOTAL-HYYX201014002.htm
[16]	HE TT, GONG M, BAI YF, et al. Clinical analysis of two diagnosis methods for herb-induced liver injury[J]. China J Chin Mater Med, 2016, 41(16): 3096-3099. DOI: 10.4268/cjcmm20161626. 何婷婷, 宫嫚, 白云峰, 等. 2种药物性肝损伤诊断指南的应用分析[J]. 中国中药杂志, 2016, 41(16): 3096-3099. DOI: 10.4268/cjcmm20161626.
[17]	ROCKEY DC, SEEFF LB, ROCHON J, et al. Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf causality assessment method[J]. Hepatology, 2010, 51(6): 2117-2126. DOI: 10.1002/hep.23577.
[18]	YU YC, FAN Y. Advances in Roussel Uclaf causality assessment method for diagnosis of drug－induced liver injury and its comparison with structured expert opinion process[J]. J Clin Hepatol, 2016, 32(9): 1706-1713. DOI: 10.3969/j.issn.1001-5256.2016.09.014. 于乐成, 范晔. RUCAM诊断药物性肝损伤的进展及其与结构化专家观点评估法的比较[J]. 临床肝胆病杂志, 2016, 32(9): 1706-1713. DOI: 10.3969 /j.issn.1001-5256.2016.09.014.

Relative Articles

Supplements(1)

Supplements

整合证据链、Roussel Uclaf因果关系评价法、结构化专家观点程序对药物性肝损伤的诊断效用分析.pdf

Cited By

Proportional views

Proportional views

通讯作者: 陈斌, bchen63@163.com

1.
沈阳化工大学材料科学与工程学院沈阳 110142

Tables(4)

Get Citation

PDF

XML

Article Metrics

Article views (477) PDF downloads(62)

Diagnostic values of integrated evidence chain, Roussel Uclaf Causality Assessment Method, and Structured Expert Opinion Process method for drug-induced liver injury

DOI: 10.3969/j.issn.1001-5256.2022.01.022

Abstract

References

Supplements

Proportional views

Catalog

通讯作者: 陈斌, bchen63@163.com

Article Metrics

Proportional views

Related

Diagnostic values of integrated evidence chain, Roussel Uclaf Causality Assessment Method, and Structured Expert Opinion Process method for drug-induced liver injury

DOI: 10.3969/j.issn.1001-5256.2022.01.022

Abstract

References

Supplements

Proportional views

Catalog

通讯作者: 陈斌, bchen63@163.com

Article Metrics

Proportional views

Related

About Journal

Submission Guideline

Journal Online

Hepatobiliary College

Guidelines

Export File

Citation

Format

Content