Case Definition and Phenotype Standardization in Drug-Induced Liver Injury

被引：761

作者：

Aithal, G. P. ^{[1
]}

Watkins, P. B. ^{[2
]}

Andrade, R. J. ^{[3
,4
]}

Larrey, D. ^{[5
]}

Molokhia, M. ^{[6
]}

Takikawa, H. ^{[7
]}

Hunt, C. M. ^{[8
]}

Wilke, R. A. ^{[9
]}

Avigan, M. ^{[10
]}

Kaplowitz, N. ^{[11
]}

Bjornsson, E. ^{[12
]}

Daly, A. K. ^{[13
]}

机构：

[1] Nottingham Univ Hosp Natl Hlth Serv Trust, Natl Inst Hlth Res Biomed Res Unit, Nottingham Digest Dis Ctr, Nottingham, England

[2] Univ N Carolina Hosp, Hamner Univ N Carolina Inst Drug Safety Sci, Res Triangle Pk, NC USA

[3] Hosp Univ Virgen de la Victoria, Hepatol Unit, Malaga, Spain

[4] CIBERehd, Barcelona, Spain

[5] Hop St Eloi, Serv Hepatogastroenterol & Transplantat, Montpellier, France

[6] Kings Coll London, Div Hlth & Social Care Res, Dept Primary Care & Publ Hlth Sci, London WC2R 2LS, England

[7] Teikyo Univ Sch Med, Dept Med, Tokyo, Japan

[8] GlaxoSmithKline, Clin Safety Syst, Res Triangle Pk, NC USA

[9] Vanderbilt Univ, Dept Med, Div Clin Pharmacol, Nashville, TN USA

[10] US FDA, Off Surveillance & Epidemiol, Ctr Drug Evaluat & Res, Silver Spring, MD USA

[11] Univ So Calif, Keck Sch Med, USC Res Ctr Liver Dis, Los Angeles, CA 90033 USA

[12] Landspitali Univ Hosp, Div Gastroenterol & Hepatol, Reykjavik, Iceland

[13] Newcastle Univ Med Sch, Inst Cellular Med, Newcastle Upon Tyne, Tyne & Wear, England

来源：

CLINICAL PHARMACOLOGY & THERAPEUTICS | 2011年 / 89卷 / 06期

基金：

英国惠康基金;

关键词：

TERM-FOLLOW-UP; HEPATITIS-E; CAUSALITY ASSESSMENT; NONALCOHOLIC STEATOHEPATITIS; PSORIASIS PATIENTS; ADVERSE EVENTS; GENOME-WIDE; HEPATOTOXICITY; DIAGNOSIS; FAILURE;

D O I：

10.1038/clpt.2011.58

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Drug-induced liver injury (DILI) is the most frequent reason cited for the withdrawal of approved drugs from the market and accounts for up to 15% of the cases of acute liver failure. Investigators around the globe have begun to identify and study patients with DILI; several large registries and tissue banks are being established. In order to gain the maximum scientific benefit from these efforts, the definitions and terminology related to the clinical phenotypes of DILI must be harmonized. For this purpose, an international DILI Expert Working Group of clinicians and scientists reviewed current DILI terminology and diagnostic criteria so as to develop more uniform criteria that would define and characterize the spectrum of clinical syndromes that constitute DILI. Consensus was established with respect to the threshold criteria for definition of a case as being DILI, the pattern of liver injury, causality assessment, severity, and chronicity. Consensus was also reached on approaches to characterizing DILI in the setting of chronic liver diseases, including autoimmune hepatitis (AIH).

引用

页码：806 / 815

页数：10

共 76 条

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