临床试验中的药物性肝损伤识别、处理及评价指导原则

国家药品监督管理局药品审评中心

doi:10.3969/j.issn.1001-5256.2023.08.007

临床试验中的药物性肝损伤识别、处理及评价指导原则

DOI: 10.3969/j.issn.1001-5256.2023.08.007

国家药品监督管理局药品审评中心

本文首次发表于[国家药品监督管理局药品审评中心官方网站www.cde.org.cn]

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出版历程
- 收稿日期: 2023-07-10
- 录用日期: 2023-07-15
- 出版日期: 2023-08-20

Guidelines for identification, management, and assessment of drug-induced liver injury in clinical trials

Center for Drug Evaluation, National Medicine Products Administration

摘要

- 化学性与药物性肝损伤 /
- 临床试验 /
- 诊疗准则
- Chemical and Drug Induced Liver Injury /
- Clinical Trial /
- Practice Guideline

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参考文献(11)

[1]	U.S. Department of Health and Human Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Guidance for Industry; Drug-Induced Liver Injury: Premarketing Clinical Evaluation[R/OL]. (2009-07). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-induced-liver-injury-premarketing-clinical-evaluation.
[2]	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. DOI: 10.1055/s-0039-1685519.
[3]	European Association for the Study of the Liver. EASL clinical practice guidelines: Drug-induced liver injury[J]. J Hepatol, 2019, 70(6): 1222-1261. DOI: 10.1016/j.jhep.2019.02.014.
[4]	DEVARBHAVI H, AITHAL G, TREEPRASERTSUK S, et al. Drug-induced liver injury: Asia Pacific Association of Study of Liver consensus guidelines[J]. Hepatol Int, 2021, 15(2): 258-282. DOI: 10.1007/s12072-021-10144-3.
[5]	EMA. Reflection paper on non-clinical evaluation of drug-induced liver injury (DILI)
[6]	REGEV A, PALMER M, AVIGAN MI, et al. Consensus: guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury during clinical trials in patients with nonalcoholic steatohepatitis[J]. Aliment Pharmacol Ther, 2019, 49(6): 702-713. DOI: 10.1111/apt.15153.
[7]	PALMER M, REGEV A, LINDOR K, et al. Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury occurring during clinical trials in adults with chronic cholestatic liver disease[J]. Aliment Pharmacol Ther, 2020, 51(1): 90-109. DOI: 10.1111/apt.15579.
[8]	TREEM WR, PALMER M, LONJON-DOMANEC I, et al. Consensus guidelines: best practices for detection, assessment and management of suspected acute drug-induced liver injury during clinical trials in adults with chronic viral hepatitis and adults with cirrhosis secondary to hepatitis B, C and nonalcoholic steatohepatitis[J]. Drug Saf, 2021, 44(2): 133-165. DOI: 10.1007/s40264-020-01014-2.
[9]	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. DOI: 10.1002/hep.32327.
[10]	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.
[11]	CIOMS Working Group. Drug-induced liver injury (DILI): Current status and future directions for drug development and the post-market setting[R]. Deneva, Switzerland: Council for International Organizations of Medical Sciences (CIOMS), 2020.