Clinical diagnosis of Chinese-herbal-induced liver injury

doi:10.19803/j.1672-8629.20230021

Abstract

Abstract: Objective To provide a roadmap based on modular evidence chains for the clinical diagnosis of herbal induced liver injury (HILI). Methods Four modules of information were investigated, including the temporal relationship between the application of Chinese herbal medicine and the occurrence of liver injury, the related liver toxicity information of the herbals itself, the possibility of drug combination as the cause of liver injury, and the potential non-drug factors of liver injury. All these information were incorporated to form an logistically structured chain of evidence for the diagnosis of HILI. Results and Conclusion The clinical diagnostic principle of HILI is similar to that of liver injury caused by modern drugs (including chemical drugs and biomedicine), but it has its own characteristics and difficulties. After analyzing the variability of temporal relationship between Chinese herbal medicine and liver injury, the following information were detailedly evaluated in multiple dimensions, including the liver toxicity information related to Chinese herbal medicine itself, the corresponding information of concomitant drugs, and the existent status of liver injury caused by other pathogens. Then a revised roadmap based on the evidence chain was proposed. Rousse Uclaf Causality Assessment Method (RUCAM) scale is advisable in the diagnosis of HILI, yet the diagnostic value of Revised Electronic Causality Assessment Method (RECAM) scale for HILI needs to be further investigated in real world clinic. If necessary, the diagnosis of HILI should be further confirmed with the Structured Expert Opinion Progress (SEOP). Some pathological features of liver biopsy may be helpful for the confirmation of HILI, and specific biomarkers of HILI need to be further explored.

Key words: Chinese herbal medicine, liver injury, clinical diagnosis, evidence chain, roadmap

CLC Number:

R961
R994.11

YU Lecheng, HAO Kunyan, FAN Ye. Clinical diagnosis of Chinese-herbal-induced liver injury[J]. Chinese Journal of Pharmacovigilance, 2023, 20(5): 481-488.

References

[1] YU YC, MAO YM, CHEN CW, et al.DILI study group, Chinese socity of hepatology. Csh guideline for the diagnosis and treatment of drug-induced liver injury[J]. Hepatol Int, 2017, 11(3): 221-241.
[2] WANG JB, ZHU Y, BAI ZF, et al.Guidelines for the diagnosis and management of herb-induced liver injury[J]. Chin J Integr Med, 2018, 24(9): 696-706.
[3] YU YC, FAN Y, CHEN CW.Research status and prospect of liver injury related to herbal and dietary supplements[J]. Chin Heptol(肝脏), 2017, 22(4): 296-300.
[4] HOOFNAGLE JH, SERRANO J, KNOBEN JE, et al.LiverTox: a website on drug-induced liver injury[J]. Hepatology, 2013, 57(3): 873-874.
[5] MAO YM.HepaTox: a professional network platform to promote clinical and translational research of drug-induced liver injury in China[J]. Chin Heptol(肝脏), 2014, 19(8): 575-576.
[6] 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.
[7] DANAN G, TESCHKE R.RUCAM in drug and herb induced liver injury: the update[J]. Int J Mol Sci, 2015, 17(1): 14.
[8] HAYASHI PH, LUCENA MI, FONTANA RJ, et al.A revised electronic version of RUCAM for the diagnosis of DILI[J]. Hepatology, 2022, 76(1): 18-31.
[9] HUANG DL, LI CP, WANG JB, et al.Correlational verification of drug-induced liver injury with HLA-B*3501 allele due to polygonum mutiflorum[J]. Chin J Hepatol(中华肝脏病杂志), 2021, 29(11): 1106-1108.
[10] ZHAO WW, SHAN W, ZHANG SW, et al.Clinical analysis of 44 cases of liver injury induced by Tripterygium wilfordii[J]. Chin J Drug Abuse Prevention and Treatment(中国药物滥用防治杂志), 2018, 24(5): 268-271.
[11] PENG MM, GE WH, ZHUGE YZ.Clinical analysis on Gynura segetum induced hepatic veno-occlusive disease[J]. Chin J Clin Pharmacol, 2018, 34(8): 938-941.
[12] WANG L, WANG Y, WEE A, et al.Clinicopathological features of Bu Gu Zhi-induced liver injury, a long-term follow-up cohort study[J]. Liver Int, 2020, 40(3): 571-580.
[13] SHEN H, ZHANG ZY.Natural Drugs and Drug-induced Liver Injury(天然药物与药物性肝损伤)[M]. Nanjing: Southeast University Press, 2020: 201-240.
[14] WANG XL, GOU XJ, CHEN L, et al.Metabolomics of Gynura segetum-induced hepatotoxicity in rats[J]. Chin Traditional Patent Medicine, 2019, 41(8): 1826-1834.
[15] LI DD, TANG XL, LONG L, et al.Research of hepatotoxicity mechanism of crude Polygonum Multiflorum and Radix Polygonum Multiflorum Preparata based on high-content screening techniques. Chin J Pharmacol Toxicol(中国药理学与毒理学杂志), 2017, 31(6): 626-635.
[16] WANG XJ, CHEN CW, FU QC.Drug-induced liver injury related with zhixue capsules: an analysis of 30 gregarious patients[J]. Chin Hepatol(肝脏), 2009, 14(4): 287-290.
[17] YU YC, CHEN CW.Pathogenesis of drug-induced liver injury:current understanding and future needs[J]. J Clin Hepatol, 37(11): 2515-2524.
[18] European Association for the Study of the Liver. EASL clinical practice guidelines: drug-induced liver injury[J]. J Hepatol, 2019, 70: 1222-1261.
[19] CHALASANI NP, MADDUR H, RUSSO MW, et al.ACG clinical guideline: diagnosis and management of idiosyncratic drug-induced liver injury[J]. Am J Gastroenterol, 2021, 116(5): 878-898.
[20] YU YC, FAN Y, CHEN CW.Rechallenge test of drug induced liver injury: Can it be intentional? How to operate? How to judge?[J]. Chin Hepatol(肝脏), 2017, 22(12): 1073-1076.
[21] General Office of the National Health Commission, State Administration of Traditional Chinese Medicine Comprehensive Department. Diagnosis and Treatment Protocol for COVID-19 (Trial version 10)[EB/OL]. General Office of the National Health Commission, State Administration of Traditional Chinese Medicine Comprehensive Department. (2023-01-05)[2023-01-16]. http://www.nhc.gov.cn//xcs/zhengcwj/202301/8e6e038fe3ef4b5c9629e0293dd3dd19.shtml.
[22] LEISE MD, POTERUCHA JJ, TALWALKAR JA.Drug-induced liver injury[J]. Mayo Clin Proc, 2014, 89(1): 95-106.
[23] MA J, XIA Q, FU PP, et al.Pyrrole-protein adducts-a biomarker of pyrrolizidine alkaloid-induced hepatotoxicity[J]. J Food Drug Anal, 2018, 26(3): 965-972.
[24] WANG LL, SUN J.Progress in diagnosis and treatment of hepatic sinus obstruction syndrome caused by pyrrole alkaloids[J]. Int J Dig Dis(国际消化病杂志), 2020, 40(2): 96-99.
[25] YU YC, HE CL, HOU JL.Biomarkers in drug-induced liver injuries[J]. J Pract Hepatol(实用肝脏病杂志), 2014, 17(6): 564-568.
[26] Asia Pacific Association of Study of Liver. Drug-induced liver injury: Asia pacific association of study of liver consensus guidelines[J]. Hepatol Int, 2021, 15(2): 258-282.
[27] ZHUGE Y, LIU Y, XIE W, et al.Chinese society of gastroenterology committee of hepatobiliary disease. expert consensus on the clinical management of pyrrolizidine alkaloid-induced hepatic sinusoidal obstruction syndrome[J]. J Gastroenterol Hepatol(中华消化杂志), 2019, 34(4): 634-642.
[28] HU XQ.Discussion on pathological scoring system of drug-induced liver injury[J]. Chin J Hepatol(中华肝脏病杂志), 2012, 20(3): 176-177.
[29] HU XQ.Restudy on pathological scoring system of drug-induced liver injury[J]. Chin Hepatol(肝脏), 2014, 19(8): 577-579.
[30] LUO Q, ZHU HR, GU HT, et al.Liver histopathological features of patients with drug-induced liver injury due to chinese herbal medicine and western medicine: a comparative analysis of 50 cases[J]. J Clin Hepatol(临床肝胆病杂志), 2020, 36(3): 596-601.
[31] JIANG ZL, LI PING, WANG JL, et al.Relationship between liver tissue iron deposition and serum biochemistry and pathology in 106 patients wiht drug-induced liver injury[J]. Chin J Dig(中华消化杂志), 2016, 36(8): 543-547.
[32] YANG RY, ZHAO XY.Significance of liver histopathological examination in diagnosis and treatment of drug-induced liver injury[J]. J Chin Hepatol(临床肝胆病杂志), 2018, 34(6): 1172-1175.
[33] SOARES PF, FERNANDES MTCF, SOUZA ADS, et al.Causality imputation between herbal products and HILI: an algorithm evaluation in a systematic review[J]. Ann Hepatol, 2021, 25: 100539.
[34] 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.
[35] LEWIS JH.Digitizing DILI: Who can? RUCAM? RECAM?[J]. Hepatology, 2022, 76(1): 3-5.
[36] DANAN G, TESCHKE R.Letter to the editor: electronic RUCAM: major pitfalls call for caution and proper validation[J]. Hepatology, 2022, 76(1): E27.
[37] BESSONE F, ROBLES-DIAZ M, HERNANDEZ N, et al.Assessment of serious acute and chronic idiosyncratic drug-induced liver injury in clinical practice[J]. Semin Liver Dis, 2019, 39(3): 381-394.
[38] HOU FQ, ZENG Z, WANG GQ.Hospital admissions for drug-induced liver injury: clinical features, therapy, and outcomes[J]. Cell Biochem Biophys, 2012, 64(2): 77-83.
[39] MARTINEZ MA, VUPPALANCHI R, FONTANA RJ, et al.Clinical and histologic features of azithromycin-induced liver injury[J]. Clin Gastroenterol Hepatol, 2015, 13(2): 369-376.
[40] LIN NH, YANG HW, SU YJ, et al.Herb induced liver injury after using herbal medicine: a systemic review and case-control study[J]. Medicine (Baltimore), 2019, 98(13): e14992.
[41] ZHU Q, ZHANG Y, XUAN J, et al.HLA-A*02:01 allele is associated with transhinone-induced cutancous adverse drug reactions[J]. Pharmacogenomics, 2019, 20(3): 408-414.
[42] 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.