[1] FDA. FDA Guidance for Industry Drug-Induced Liver Injury: Premarketing Clinical Evaluation[EB/OL].[2023-09-12]. https://www.fda.gov/media/ 116737/download. [2] HILLMAN L, GOTTGRIED M, WHITSETT M, et al.Clinical features and outcomes of complementary and alternative medicine induced acute liver failure and injury[J]. American Journal of Gastroenterology, 2016, 111(7): 958-965. [3] WAI CT, TAN BH, CHAN CL, et al.Drug-induced liver injury at an Asian center: a prospective study[J]. Liver International, 2007, 27(40): 465-474. [4] SHEN T, LIU Y, SHANG J, et al.Incidence and etiology of drug-induced liver injury in China[J]. Gastroenterology, 2019, 156(8): 2230-2241. [5] MOSEDALE M, WATKINS P.Drug-induced liver injury: advances in mechanistic understanding that will inform risk management[J]. Clinical Pharmacology and Therapeutics, 2017, 101(4): 469-480. [6] GARCIA-CORTES M, ROBLES-DIAZ M, STEPHENS C, et al.Drug induced liver injury: an update[J]. Archives of Toxicology, 2020, 94: 3381-3407. [7] ZIMMERMAN HJ.Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver[M]. New York: Appleton-Century-Crofts, 1978. [8] BJORNSSON E, OLSSON R.Outcome and prognostic markers in severe drug-induced liver disease[J]. Hepatology, 2005, 42(2): 481-489. [9] ANDRADE RJ, LUCENA MI, FERNANDEZ MC, et al.Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period[J]. Gastroenterology, 2005, 129(2): 512-521. [10] SENIOR JR.Evolution of the Food and Drug Administration approach to liver safety assessment for new drugs: current status and challenges[J]. Drug Safety, 2014, 37(Suppl 1): S9-S17. [11] American Statistical Association’s Biopharmaceutical Working Group. Interactive Safety Graphics[EB/OL].[2023-12-04]. https://safetygraphics.github.io/. [12] BENICHOU C.Criteria of drug-induced liver disorders: report of an international consensus meeting[J]. Journal of Hepatology, 1990, 11: 272-276. [13] AITHAL GP, WATKINS PB, ANDRADE RJ, et al.Case definition and phenotype standardization in drug-induced liver injury[J]. Clinical Pharmacology and Therapeutics, 2011, 89(6): 806-815. [14] CHALASANI NP, HAYASHI PH, BONKOVSKY HL, et al.ACG clinical guideline: the diagnosis and management of idiosyncratic drug-induced liver injury[J]. American Journal of Gastroenterology, 2014, 109: 950-966. [15] ROBLES-DIAZ M, LUCENA MI, KAPLOWITZ N, et al.Use of Hy’s law and a new composite algorithm to predict acute liver failure in patients with drug-induced liver injury[J]. Gastroenterology, 2014, 147(1): 109-118. [16] MOLLER HJ, GRONBAEK H, SCHIODT FV, et al.Soluble CD163 from activated macrophages predicts mortality in acute liver failure[J]. Journal of Hepatology, 2007, 47(5): 671-676. [17] HAYASHI PH, ROCKEY DC, FONTANA RJ, et al.Death and liver transplantation within 2 years of onset of drug-induced liver injury[J]. Hepatology, 2017, 66(4): 1275-1285. [18] Interactive Safety Working Group Taskforce. Safety Graphics[EB/OL].[2023-12-04]. https://github.com/SafetyGraphics/hep-explorer. [19] MERZ M, LEE KR, KULLAK-UBLICK GA, et al.Methodology to assess clinical liver safety data[J]. Drug Safety, 2014, 37(Suppl 1): S33-S45. [20] Simulations-Plus.DILI-sim Initiative[EB/OL].[2023-12-04].https://www.simulations-plus.com/dilisym-services/dili-sim-initiative/. [21] CHUNG JY, LONGO DM, WATKINS PB.A rapid method to estimate hepatocyte loss due to drug-induced liver injury[J]. Clinical Pharmacology and Therapeutics, 2019, 105(3): 746-753. |