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<正>1背景药物性肝损伤(drug-induced liver injury,DILI)是指由各类处方或非处方的化学药物、生物制剂、传统中药(TCM)、天然药(NM)、保健品(HP)、膳食补充剂(DS)及其代谢产物乃至辅料等所诱发的肝损伤[1-4]。TCM是指在我国中医等传统民族医药学理论指导下生产和使用的各种草药和非草药类的中药材、饮片和中成药,NM是指应用现代医药理论和技术制备的天然药
Abstract:[1]BJRNSSON ES,BERGMANN OM,BJRNSSON HK,et al.Incidence,presentation,and outcomes in patients with drug-induced liver injury in the general population of Iceland[J].Gastroenterology,2013,144(7):1419-1425.
[2]FONTANA RJ,WATKINS PB,BONKOVSKY HL,et al.Drug-Induced Liver Injury Network(DILIN)prospective study:rationale,design and conduct[J].Drug Saf,2009,32(1):55-68.
[3]CHALASANI NP,HAYASHI PH,BONKOVSKY HL,et al.ACG Clinical Guideline:the diagnosis and management of idiosyncratic drug-induced liver injury[J].Am J Gastroenterol,2014,109(7):950-966.
[4]DEVARBHAVI H.An update on drug-induced liver injury[J].J Clin Exp Hepatol,2012,2(3):247-259.
[5]MIGUEL A,AZEVEDO LF,ARAU'JO M,et al.Frequency of adverse drug reactions in hospitalized patients:a systematic review and meta-analysis[J].Pharmacoepidemiol Drug Saf,2012,21(11):1139-1154.
[6]LI L,JIANG W,WANG JY.Clinical analysis of 275 cases of acute drug-induced liver disease[J].Front Med China,2007,1(1):58-61.
[7]HOOFNAGLE JH,SERRANO J,KNOBEN JE,et al.Liver Tox:a website on drug-induced liver injury[J].Hepatology,2013,57(3):873-874.
[8]MAO YM.Hepa Tox:A professional network platform to promote clinical and translational research of drug-induced liver injury in China[J].Chin Hepatol,2014,19(8):575-576.(in Chinese)茅益民.Hepa Tox:促进中国药物性肝损伤临床和转化研究的专业网络平台[J].肝脏,2014,19(8):575-576.
[9]LARREY D.Epidemiology and individual susceptibility to adverse drug reactions affecting the liver[J].Semin Liver Dis,2002,22(2):145-155.
[10]BJORNSSON ES.Epidemiology and risk factors for idiosyncratic drug-induced liver injury[J].Semin Liver Dis,2014,34(2):115-122.
[11]LAI RT,WANG H,GUI HL,et al.Clinical and pathological features in 138 cases of drug-induced liver injury[J].Chin J Hepatol,2012,20(3):185-189.(in Chinese)赖荣陶,王晖,桂红莲,等.138例药物性肝损伤患者的临床特征及肝脏组织学改变[J].中华肝脏病杂志,2012,20(3):185-189.
[12]HAO KY,YU YC,HE CL,et al.RUCAM scale-based diagnosis,clinical features and prognosis of 140 cases of drug-induced liver injury[J].Chin J Hepatol,2014,22(12):82-85.(in Chinese)郝坤艳,于乐成,何长伦,等.基于Roussel uclaf因果关系评估量表的药物性肝损伤140例诊治分析[J].中华肝脏病杂志,2014,22(12):82-85.
[13]RUSSO MW,GALANKO JA,SHRESTHA R,et al.Liver transplantation for acute liver failure from drug induced liver injury in the United States[J].Liver Transpl,2004,10(8):1018-1023.
[14]BJORNSSON E,JERLSTAD P,BERGQVIST A,et al.Fulminant drug-induced hepatic failure leading to death or liver transplantation in Sweden[J].Scand J Gastroenterol,2005,40(9):1095-1101.
[15]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.
[16]STINE JG,LEWIS JH.Drug-induced liver injury:a summary of recent advances[J].Expert Opin Drug Metab Toxicol,2011,7(7):875-890.
[17]HOOFNAGLE JH,NAVARRO VJ.Drug-induced liver injury:Icelandic lessons[J].Gastroenterology,2013,144(7):1335-1336.
[18]LUCENA MI,ANDRADE RJ,KAPLOWITZ N,et al.Phenotypic characterization of idiosyncratic drug-induced liver injury:the influence of age and sex[J].Hepatology,2009,49(6):2001-2009.
[19]ELINAV E,PINSKER G,SAFADI R,et al.Association between consumption of Herbalife nutritional supplements and acute hepatotoxicity[J].J Hepatol,2007,47(4):514-520.
[20]AZIZI F,AMOUZEGAR A.Management of hyperthyroidism during pregnancy and lactation[J].Eur J Endocrinol,2011,164(6):871-876.
[21]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.
[22]SAADI T,WATERMAN M,YASSIN H,et al.Metformin-induced mixed hepatocellular and cholestatic hepatic injury:case report and literature review[J].Int J Gen Med,2013,6:703-706.
[23]SORIANO V,PUOTI M,GARCIA-GASCO P,et al.Antiretroviral drugs and liver injury[J].AIDS,2008,22(1):1-13.
[24]ANDRADE RJ,LUCENA MI,KAPLOWITZ N,et al.Outcome of acute idiosyncratic drug-induced liver injury:long-term follow-up in a hepatotoxicity registry[J].Hepatology,2006,44(6):1581-1588.
[25]PAIS R,RUSU E,RATZIU V.The impact of obesity and metabolic syndrome on chronic hepatitis B and drug-induced liver disease[J].Clin Liver Dis,2014,18(1):165-178.
[26]SHARMA SK,BALAMURUGAN A,SAHA PK,et al.Evaluation of clinical and immunogenetic risk factors for the development of hepatotoxicity during antituberculosis treatment[J].Am J Respir Crit Care Med,2002,166(7):916-919.
[27]PUKENYTE E,LESCURE FX,REY D,et al.Incidence of and risk factors for severe liver toxicity in HIV-infected patients on anti-tuberculosis treatment[J].Int J Tuberc Lung Dis,2007,11(1):78-84.
[28]MITCHELL JR,LONG MW,THORGEIRSSON UP,et al.Acetylation rates and monthly liver function tests during one year of isoniazid preventive therapy[J].Chest,1975,68(2):181-190.
[29]SHAYIQ RM,ROBERTS DW,ROTHSTEIN K,et al.Repeat exposure to incremental doses of acetaminophen provides protection against acetaminophen-induced lethality in mice:an explanation for high acetaminophen dosage in humans without hepatic injury[J].Hepatology,1999,29(2):451-63.
[30]WATKINS PB,ZIMMERMAN HJ,KNAPP MJ,et al.Hepatotoxic effects of tacrine administration in patients with Alzheimer's disease[J].JAMA,1994,271(13):992-998.
[31]ZAMOR PJ,RUSSO MW.Liver function tests and statins[J].Curr Opin Cardiol,2011,26(4):338-341.
[32]PADDA MS,SANCHEZ M,AKHTAR AJ,et al.Drug-induced cholestasis[J].Hepatology,2011,53(4):1377-1387.
[33]KHANDELWAL N,JAMES LP,SANDERS C,et al.Unrecognized acetaminophen toxicity as a cause of indeterminate acute liver failure[J].Hepatology,2011,53(2):567-576.
[34]GUENGERICH FP.Cytochrome P450 activation of toxins and hepatotoxicity[M]//KAPLOWITZ N,DELEVE LD.Drug induced liver disease.3rd ed.Nederland:Elsevier,2013:15-33.
[35]DALY AK,DAY CP.Genetic association studies in drug-induced liver injury[J].Drug Metab Rev,2012,44(1):116-126.
[36]RUSSMANN S,JETTER A,KULLAK-UBLICK GA.Pharmacogenetics of drug-induced liver injury[J].Hepatology,2010,52(2):748-761.
[37]WEI CY,LEE MTM,CHEN YT.Pharmacogenomics of adverse drug reactions:implementing personalized medicine[J].Hum Mol Genet,2012,21(R1):r58-r65.
[38]ALFIREVIC A,GONZALEZ-GALARZA F,BELL C,et al.In silico analysis of HLA associations with drug-induced liver injury use of a HLA-genotyped DNA archive from healthy volunteers[J].Genome Med,2012,4(6):51.
[39]KINDMARK A,JAWAID A,HARBRON CG,et al.Genomewide pharmacogenetic investigation of a hepatic adverse event without clinical signs of immunopathology suggests an underlying immune pathogenesis[J].Pharmacogenomics J,2008,8(3):186-195.
[40]SINGER JB,LEWITZKY S,LEROY E,et al.A genome-wide study identifies HLA alleles associated with lumiracoxib-related liver injury[J].Nature,2010,42(8):711-714.
[41]PESSAYRE D,FROMENTY B,BERSON A,et al.Central role of mitochondria in drug-induced liver injury[J].Drug Metab Rev,2012,44(1):34-87.
[42]GONCALVES RL,ROTHSCHILD DE,QUINLAN CL,et al.Sources of superoxide/H2O2 during mitochondrial proline oxidation[J].Redox Biol,2014,2:901-909.
[43]FAN JG,ZENG MD,LI JQ,et al.Correlation between hepatic fat,lipid peroxidation and hepatic fibrosis in rats chronically fed with ethanol and/or high fat diet[J].Chin J Intern Med,1997,36(12):808-811.(in Chinese)范建高,曾民德,李继强,等.肝内脂肪和脂质过氧化与肝纤维化关系的实验研究[J].中华内科杂志,1997,36(12):808-811.
[44]FINKEL T.Signal transduction by reactive oxygen species[J].J Cell Biol,2011,194:7-15.
[45]CHOUMAR A,TARHUNI A,LETTE'RON P,et al.Lipopolysaccharide-induced mitochondrial DNA depletion[J].Antioxid Redox Signal,2011,15:2837-2854.
[46]KIM JS,HE L,QIAN T,et al.Role of the mitochondrial permeability transition in apoptotic and necrotic death after ischemia/reperfusion injury to hepatocytes[J].Curr Mol Med,2003,3(6):527-535.
[47]NAKAGAWA H,MAEDA S,HIKIBA Y,et al.Deletion of apoptosis signal-regulating kinase 1 attenuates acetaminophen-induced liver injury by inhibiting c-Jun N-terminal kinase activation[J].Gastroenterology,2008,135(4):1311-1321.
[48]JAESCHKE H,MCGILL MR,WILLIAMS CD,et al.Current issues with acetaminophen hepatotoxicity—a clinically relevant model to test the efficacy of natural products[J].Life Sci,2011,88(17-18):737-745.
[49]MARTIN-MURPHY BV,HOLT MP,JU C.The role of damage associated molecular pattern molecules in acetaminophen induced liver injury in mice[J].Toxicol Lett,2010,192(3):387-394.
[50]JANSSENS S,PULENDRAN B,LAMBRECHT BN.Emerging functions of the unfolded protein response in immunity[J].Nat Immunol,2014,15(10):910-919.
[51]LILY DARA,CHENG JI,NEIL KAPLOWITZ.The contribution of endoplasmic reticulum stress to liver diseases[J].Hepatology,2011,55(5):1752-1763.
[52]FREDRIKSSON L,WINK S,HERPERS B,et al.Drug-induced endoplasmic reticulum and oxidative stress responses independently sensitize toward TNFα-mediated hepatotoxicity[J].Toxicol Sci,2014,140(1):144-159.
[53]LAI R,XIANG X,MO R,et al.Protective effect of Th22 cells and intrahepatic IL-22 in drug induced hepatocellular injury[J].J Hepatol,2015,63(1):148-155.
[54]MASSON MJ,COLLINS LA,POHL LR.The role of cytokines in the mechanism of adverse drug reactions[J].Handb Exp Pharmacol,2010,196:195-231.
[55]UETRECHT J.Immunoallergic drug-induced liver injury in humans[J].Semin Liver Dis,2009,29(4):383-392.
[56]VANDENABEELE P,GALLUZZI L,VANDEN BERGHE T,et al.Molecular mechanisms of necroptosis:an ordered cellular explosion[J].Nat Rev Mol Cell Biol,2010,11(10):700-714.
[57]KE PY,CHEN SS.Hepatitis C virus and cellular stress response:implications to molecular pathogenesis of liver diseases[J].Viruses,2012,4(10):2251-2290.
[58]HENKEL A,GREEN RM.The unfolded protein response in fatty liver disease[J].Semin Liver Dis,2013,33(4):321-329.
[59]FONTANA RJ.Pathogenesis of idiosyncratic drug-induced liver injury and clinical perspectives[J].Gastroenterology,2014,146(4):914-928.
[60]HUSSAINI SH,FARRINGTON EA.Idiosyncratic drug-induced liver injury:an update on the 2007 overview[J].Expert Opin Drug Saf,2014,13(1):67-81.
[61]JU C,REILLY T.Role of immune reactions in drug-induced liver injury(DILI)[J].Drug Metab Rev,2012,44(1):107-115.
[62]CZAJA AJ.Drug-induced autoimmune-like hepatitis[J].Dig Dis Sci,2011,56(4):958-976.
[63]CHALASANI N,BJRNSSON E.Risk factors for idiosyncratic drug-induced liver injury[J].Gastroenterology,2010,138(7):2246-2259.
[64]EISENBERG-LERNER A,KIMCHI A.PKD is a kinase of Vsp34that mediates ROS-induced autophagy downstream of DAPk[J].Cell Death Differ,2012,19(5):788-797.
[65]DING WX,MANLEY S,NI HM.The emerging role of autophagy in alcoholic liver disease[J].Exp Biol Med,2011,236(5):546-556.
[66]ROTH RA,GANEY PE.Role of Inflammation in Drug-Induced Liver Injury[M]//KAPLOWITZ N,DELEVE LD.Drug-induced liver disease.3rd ed.San Diego:Academic Press,2013:157-173.
[67]WU MH,ZANG P,HUANG X.Toll-like receptors in innate immunity and infectious diseases[J].Front Med in China,2010,4(4):385-93.
[68]HANSEN JD,VOJTECH LN,LAING KJ.Sensing disease and danger:a survey of vertebrate PRRs and their origins[J].Dev Comp Immunol,2011,35(9):886-897.
[69]KAPLOWITZ N.Idiosyncratic drug hepatotoxicity[J].Nat Rev Drug Discov,2005,4(6):489-499.
[70]MEHENDALE HM.Tissue repair:an important determinant of final outcome of toxicant-induced injury[J].Toxicol Pathol,2005,33(1):41-51.
[71]KLEINER DE.Histopathological evaluation of drug-inducend liver disease[M]//KAPLOWTTZ N,DELEVE LD,ed.Drug-Induced Liver Disease.3rd Ed.San Diego:Academic Press,2013:241-261.
[72]GOODMAN ZD.Drug hepatotosicity[J].Clin Liver Dis,2002,6(2):381-397.
[73]RAMACHANDRAN R,KAKAR S.Histological patterns in drug-induced liver disease[J].J Clin Pathol,2009,62(6):481-492.
[74]KLEINER DE.The pathology of drug-induced liver injury[J].Semin Liver Dis,2009,29(4):364-372.
[75]LABBE G,PESSAYRE D,FROMENTY B.Drug-induced liver injury through mitochondrial dysfunction:mechanisms and detection during preclinical safety studies[J].Fundam Clin Pharmacol,2008,22(4):335-353.
[76]TANG W.Drug metabolite profiling and elucidation of drug-induced hepatotoxicity[J].Expert Opin Drug Metab Toxicol,2007,3(3):407-420.
[77]HAYASHI PH,FONTANA RJ.Clinical features,diagnosis,and natural history of drug-induced liver injury[J].Semin Liver Dis,2014,34(2):134-144.
[78]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.
[79]FONTANA RJ,SEEFF LB,ANDRADE RJ,et al.Standardization of nomenclature and causality assessment in drug-induced liver injury:summary of a clinical research workshop[J].Hepatology,2010,52(2):730-742.
[80]FONTANA RJ,HAYASHI PH,GU J,et al.Idiosyncratic druginduced liver injury is associated with substantial morbidity and mortality within 6 months from onset[J].Gastroenterology,2014,147(1):96-108.
[81]CHALASANI N,FONTANA RJ,BONKOVSKY HL,et al.Causes,clinical features,and outcomes from a prospective study of drug-induced liver injury in the United States[J].Gastroenterology,2008,135(6):1924-1934.
[82]BORRAZ Y,FERNANDEZ MC,GARCIA-MUHOZ B,et al.Would it be desirable to modify the cut-off point for definition of chronicity in drug-induced liver injury(DILI)?[C].61st Annual Meeting of the American Association for the Study of Liver Diseases,2010:a270.
[83]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.
[84]LEISE MD,POTERUCHA JJ,TALWALKAR JA.Drug-induced liver injury[J].Mayo Clin Proc,2014,89(1):95-106.
[85]GAO H,LI N,WANG JY,et al.Definitive diagnosis of hepatic sinusoidal obstruction syndrome induced by pyrrolizidine alkaloids[J].J Dig Dis,2012,13(1):33-39.
[86]FAN CQ,CRAWFORD JM.Sinusoidal obstruction syndrome(hepatic veno-occlusive disease)[J].J Clin Exp Hepatol,2014,4(4):332-346.
[87]KOOTTE AM,SIEGEL AM,KOORENHOF M.Generalised peliosis hepatis mimicking metastases after long-term use of oral contraceptives[J].Neth J Med,2015,73(1):41-43.
[88]YU CY,CHANG LC,CHEN LW,et al.Peliosis hepatis complicated by portal hypertension following renal transplantation[J].World J Gastroenterol,2014,20(9):2420-2425.
[89]GREEN RM,FLAMM S.AGA technical review on the evaluation of liver chemistry tests[J].Gastroenterology,2002,123(4):1367-1384.
[90]WATKINS PB,DESAI M,BERKOWITZ SD,et al.Evaluation of drug-induced serious hepatotoxicity(e DISH):application of this data organization approach to phaseⅢclinical trials of rivaroxaban after total hip or knee replacement surgery[J].Drug Saf,2011,34(3):243-252.
[91]EGUCHI A,WREE A,FELDSTEIN AE.Biomarkers of liver cell death[J].J Hepatol,2014,60(5):1063-1074.
[92]WATKINS PB,SELIGMAN PJ,PEARS JS,et al.Using controlled clinical trials to learn more about acute drug-induced liver injury[J].Hepatology,2008,48(5):1680-1689.
[93]FANNIN RD,RUSSO M,O'CONNELL TM,et al.Acetaminophen dosing of humans results in blood transcriptome and metabolome changes consistent with impaired oxidative phosphorylation[J].Hepatology,2010,51(1):227-236.
[94]SU YW,CHEN X,JIANG ZZ,et al.A panel of serum microRNAs as specific biomarkers for diagnosis of compound-and herb-induced liver injury in rats[J].PLo S One,2012,7(5):e37395.
[95]BALA S,PETRASEK J,MUNDKUR S,et al.Circulating microRNAs in exosomes indicate hepatocyte injury and inflammation in alcoholic,drug-induced,and inflammatory liver diseases[J].Hepatology,2012,56(5):1946-1957.
[96]ANTOINE DJ,DEAR JW,LEWIS PS,et al.Mechanistic biomarkers provide early and sensitive detection of acetaminophen-induced acute liver injury at first presentation to hospital[J].Hepatology,2013,58(2):777-787.
[97]WATKINS PB.Biomarkers for drug-induced liver injury[M]//KAPLOWITZ N,DELEVE LD.Drug-Induced Liver Disease.3rd ed.San Diego:Academic Press,2013:275-286.
[98]KENNA JG.Current concepts in drug-induced bile Salt Export Pump(BSEP)Interference[J].Curr Protoc Toxicol,2014,61:23.7.1-23.7.15.
[99]LIN G,WANG JY,LI N,et al.Hepatic sinusoidal obstruction syndrome associated with consumption of Gynura segetum[J].J Hepatol,2011,54(4):666-673.
[100]STEPHENS C,ANDRADE RJ,LUCENA MI.Mechanisms of drug-induced liver injury[J].Curr Opin Allergy Clin Immunol,2014,4(4):286-292.
[101]VUPPALANCHI R,IANGPUNSAKUL S,CHALSANI N.Etiology of new-onset jaundice:how often is it caused by idiosyncratic drug-induced liver injury in the United States[J].Am J Gastroenterol,2007,102(3):558-562.
[102]LORAS C,GISBER JP,MINGUEZ M,et al.Liver dysfunction related to hepatitis B and C in patients with inflammatory bowel disease treated with immunosuppressive therapy[J].Gut,2010,59(10):1340-1346.
[103]MAKAR GA,WEINER MG,KIMMEL SE,et al.Incidence and prevalence of abnormal liver associated enzymes in patients with atrial fibrillation in a routine clinical care population[J].Pharmacoepidemiol Drug Saf,2008,17(1):43-51.
[104]AITHAL GP,WATKINS PB,ANDRADE RJ,et al.Case definition and phenotype standardization in drug-induced liver injury[J].Clin Pharmacol Ther,2011,89(6):806-815.
[105]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.
[106]MARIA VAJ,VICTORINO RMM.Development and validation of a clinical scale for the diagnosis of drug induced hepatitis[J].Hepatology,1997,26(3):664-669.
[107]HAYASHI PH.Causality assessment in drug-induced liver injury[J].Semin Liver Dis,2009,29(4):348-356.
[108]Roussel Uclaf Causality Assessment Method(RUCAM)in drug induced liver injury[DB/OL].http://www.livertox.nih.gov/rucam.html.
[109]LUCENA MI,CAMARGO R,ANDRADE RJ,et al.Comparison of two clinical scales for causality assessment in hepatotoxicity[J].Hepatology,2001,33(1):123-130.
[110]GARCA-CORTSM,LUCENA MI,PACHKORIA K,et al.Evaluation of naranjo adverse drug reactions probability scale in causality assessment of drug-induced liver injury[J].Aliment Pharmacol Ther,2008,27(9):780-789.
[111]滝川一,恩地森一,高森賴雪.DDW-J2004ヮ—クショツプ药物性肝障害诊断基准の提案[J].肝臓,2005,46(2):85-90.
[112]Cooperative Group for Hepatic and Gall Diseases,Chinese Society of Gastroenterology,Chinese Medical Association.Recommendations on the diagnosis and treatment of acute drug-induced liver injury(Draft)[J].Chin J Dig,2007,27(11):765-767.(in Chinese)中华医学会消化病学分会肝胆疾病协作组.急性药物性肝损伤诊治建议(草案)[J].中华消化杂志,2007,27(11):765-767.
[113]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.
[114]Severity grading in drug induced liver injury[DB/OL].http://livertox.nih.gov/Severity.html.
[115]Liver Failure and Artificial Liver Group,Chinese Society of Infectious Diseases,Chinese Medical Association,Severe Liver Diseases and Artificial Liver Group,Chinese Society of Hepatology,Chinese Medical Association.Diagnostic and treatment guidelines for liver failure(2012 version)[J].Chin J Hepatol,2013,21(3):178-179.(in Chinese)中华医学会感染病学分会肝衰竭与人工肝学组,中华医学会肝病学分会重型肝病与人工肝学组.肝衰竭诊治指南(2012年版)[J].中华肝脏病杂志,2013,21(3):178-179.
[116]PALMORE TN,SHAH NL,LOOMBA R,et al.Reactivation of hepatitis B with reappearance of hepatitis B surface antigen after chemotherapy and immunosuppression[J].Clin Gastroenterol Hepatol,2009,7(10):1130-1137.
[117]SUZUKI A,BRUNT EM,KLEINER DE,et al.The use of liver biopsy evaluation in discrimination of idiopathic autoimmune hepatitis versus drug-induced liver injury[J].Hepatology,2011,54(3):931-939.
[118]MIAO Q,BIAN Z,TANG R,et al.Emperipolesis mediated by CD8 T cells is a characteristic histopathologic feature of autoimmune hepatitis[J].Clin Rev Allergy Immunol,2015,48(2-3):226-235.
[119]BJORNSSON E,TALWALKAR J,TREEPRASERTSUK S,et al.Drug-induced autoimmune hepatitis:clinical characteristics and prognosis[J].Hepatology,2010,51(6):2040-2048.
[120]NAVARRO VJ,SENIOR JR.Drug-related hepatotoxicity[J].N Engl J Med,2006,354(7):731-739.
[121]WU S,XIA Y,LV X,et al.Preventive use of hepatoprotectors yields limited efficacy on the liver toxicity of anti-tuberculosis agents in a large cohort of Chinese patients[J].J Gastroenterol Hepatol,2015,30(3):540-545.
[122]FORD R,SCHWARTZ L,DANCEY J,et al.US 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[J].Eur J Cancer,2009,45(2):268-274.
[123]MAO YM,LIU XL,CHEN CW.Introduction of 2013 FDA Guidelines for drug-induced liver injury[J].Chin Hepatol,2013,18(5):325-330.(in Chinese)茅益民,刘晓琳,陈成伟.2013年美国FDA药物性肝损伤指南介绍[J].肝脏,2013,18(5):325-330.
[124]HEARD KJ.Acetylcysteine for acetaminophen poisoning[J].N Engl J Med,2008,359(3):285-292.
[125]MASUBUCHI Y,NAKAYAMA J,SADAKATA Y.Protective effects of exogenous glutathione and related thiol compounds against drug-induced liver injury[J].Biol Pharm Bull,2011,34(3):366-370.
[126]BERK M,MALHI GS,GRAY LJ,et al.The promise of N-acetylcysteine in neuropsychiatry[J].Trends Pharmacol Sci,2013,34(3):167-177.
[127]ZWINGMANN C,BILODEAU M.Metabolic insights into the hepatoprotective role of N-acetylcysteine in mouse liver[J].Hepatology,2006,43(3):454-463.
[128]REUBEN A,KOCH DG,LEE WM.Drug-induced acute liver failure:results of a U.S.multicenter,prospective study[J].Hepatology,2010,52(6):2065-2076.
[129]LEE WM,HYNAN LS,ROSSARO L,et al.Intravenous N-acetylcysteine improves transplant-free survival in early stage nonacetaminophen acute liver failure[J].Gastroenterology,2009,137(3):856-864.
[130]BATEMAN DN,DEAR JW,THANACOODY HK,et al.Reduction of adverse effects from intravenous acetylcysteine treatment for paracetamol poisoning:a randomised controlled trial[J].Lancet,2014,383(9918):697-704.
[131]SINGH S,HYNAN LS,LEE WM,Acute Liver Failure Study Group.Improvements in hepatic serological biomarkers are associated with clinical benefit of intravenous N-acetylcysteine in early stage non-acetaminophen acute liver failure[J].Dig Dis Sci,2013,58(5):1397-1402.
[132]LEE WM,STRAVITZ RT,LARSON AM.Introduction to the revised American Association for the Study of Liver Diseases Position Paper on acute liver failure 2011[J].Hepatology,2012,55(3):965-967.
[133]MAO YM,ZENG MD,CHEN Y,et al.Magnesium isoglycyrrhizinate in the treatment of chronic liver diseases:a randomized,double-blind,multi-doses,active drug controlled,muitl-center study[J].Chin J Hepatol,2009,17(11):847-851.(in Chinese)茅益民,曾民德,陈勇,等.异甘草酸镁治疗ALT升高的慢性肝病的多中心、随机、双盲、多剂量、阳性药物平行对照研究[J].中华肝脏病杂志,2009,17(11):847-851.
[134]LI X,ZHOU J,CHEN S,et al.Role of bicyclol in preventing chemotherapeutic agent-induced liver injury in patients over 60years of age with cancer[J].J Int Med Res,2014,42(4):906-914.
[135]CHU NH,LI L,ZHANG X,et al.Role of bicyclol in preventing drug-induced liver injury in tuberculosis patients with liver disease[J].Int J Tuberc Lung Dis,2015,19(4):475-480.
[136]ZHANG QH,SHI GF,LI Q.Diammonium glycyrrhizinate enteric-coated capsules in treatment of chronic hepatitis[J].Chin J Infect Dis,2007,25(3):175-176.(in Chinese)张琼华,施光峰,李谦.甘草酸二胺肠溶胶囊治疗慢性肝炎2396例[J].中华传染病杂志,2007,25(3):175-176.
[137]Ministry of Health,Labour and Welfare,Japan.Clinical guidelines for severe side effects-drug-induced liver injury[S].2008.(in Chinese)日本厚生劳动省.重症副作用临床指导手册——药物性肝损害[S].2008.
[138]ABENAVOLI L,CAPASSO R,MILIC N,et al.Milk thistle in liver diseases:past,present,future[J].Phytother Res,2010,24(10):1423-1432.
[139]NATHWANI RA,KAPLOWITZ N.Drug hepatotoxicity[J].Clin Liver Dis,2006,10(2):207-217.
[140]NI LD,XIE Q,LI HW,et al.Ursodeoxycholic acid in the treatment of drug-induced liver injury:an open controlled clinical trial[J].Chin Hepatol,2009,14(4):278-280.(in Chinese)倪鎏达,谢青,李捍卫,等.熊去氧胆酸治疗药物性肝损伤开放对照临床试验[J].肝脏,2009,14(4):278-280.
[141]ZHAO P,DUAN GF,DU L,et al.Systematic evaluation on the emcacy of ademetionine in patients with drug-induced lier injury[J].Chin J Gastroenterol Hepatol,2011,20(4):341-344.(in Chinese)赵攀,段光锋,杜丽,等.腺苷蛋氨酸治疗药物性肝损伤效果的系统评价[J].胃肠病学和肝病学杂志,2011,20(4):341-344.
[142]MATO JM,LU SC.Role of S-adenosyl-L-methionine in liver health and injury[J].Hepatology,2007,45(5):1306-1312.
[143]VINCENZI B,SANTINI D,FREZZA AM,et al.The role of Sadenosyl methionine in preventing FOLFOX-induced liver toxicity:a retrospective analysis in patients affected by resected colorectal cancer treated with adjuvant FOLFOX regimen[J].Expert Opin Drug Saf,2011,10(3):345-349.
[144]JEONG R,LEE YS,SOHN C,et al.Model for end-stage liver disease score as a predictor of short-term outcome in patients with drug-induced liver injury[J].Scand J Gastroenterol,2015,50(4):439-446.
[145]YU YC,CHEN CW.Interpretation of ACG guidelines for the clinical diagnosis and treatment of idiosyncratic drug-induced liver injury[J].Chin Hepatol,2014,19(8):570-574.(in Chinese)于乐成,陈成伟.ACG特异质性药物性肝损伤临床诊治指南解读[J].肝脏,2014,19(8):570-574.
[146]ZHANG L,YANG XH.Pharmacovigilance idea should be introduced sufficiently into the safety monitoring and evaluation process of chinese drugs[J].Chin J Integr Tradit West Med,2009,29(9):863-866.(in Chinese)张力,杨晓晖.在中药安全性监测和评价过程中充分引入药物警戒理念[J].中国中西医结合杂志,2009,29(9):863-866.
[147]ZHANG L,WONG LY,HE Y,et al.Pharmacovigilance in China:current situation,successes and challenges[J].Drug Saf,2014,37(10):765-770.
[148]GRAHAM DJ,MOSHOLDER AD,GELPERIN K,et al.Pharmacoepidemiology and risk management[M]//STROM BL.Pharmacoepidemiology.4th ed.West Sussex,England:John Wiley&Sons,Ltd.,2005:51530.
[149]WATKINS PB,BLOOM J,HUNT C.Biomarkers of acute idiosyncratichepatocellular injury in clinical trials[M]//OLSON S,ROBINSON S,GIFFIN R.Accelerating the development of biomarkers for drug safety:workshop summary.Washington:National Academies Press,2009:4257.
[150]WILLY M,LI Z.What is prescription labeling communicating to doctors about hepatotoxic drugs?A study of FDA-approved product labeling[J].Pharmacoepidemiol Drug Saf,2004,13(4):201-206.
基本信息:
中图分类号:R595.3
引用信息:
[1]于乐成,茅益民,陈成伟.药物性肝损伤诊治指南[J].临床肝胆病杂志,2015,31(11):1752-1769.
基金信息:
国家“十二五”重大专项课题(2012ZX09303-001)
2015-11-15
2015-11-15