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

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

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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

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References(18)

References

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

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

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