参考文献
[1]Li X,Tang J,Mao Y.Incidence and risk factors of drug-induced liver injury[J].Liver Int,2022,42(9):1999-2014.DOI:10.1111/liv.15262.
[2]Sgro C,Clinard F,Ouazir K,et al.Incidence of drug-induced hepatic injuries:a French population-based study[J].Hepatology,2002,36(2):451-455.DOI:10.1053/jhep.2002.34857.
[3]Björnsson ES,Bergmann OM,Björnsson 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).DOI:10.1053/j.gastro.2013.02.006.
[4]De Valle MB,Av Klinteberg V,Alem N,et al.Drug-induced liver injury in a Swedish University Hospital out-patient hepatology clinic [J].Aliment Pharmacol Ther,2006,24(8):1187-1195.DOI:10.1111/j.1365-2036.2006.03117.x.
[5]Andrade RJ,Lucena MI,Fern′andez 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.DOI:10.1016/j.gastro.2005.05.006.
[6]Vega M,Verma M,Beswick D,et al.The incidence of drug and herbal and dietary supplement-induced liver injury:preliminary findings from gastroenterologistbased surveillance in the population of The State of Delaware[J].Drug Saf,2017,40(9):783-787.DOI:10.1007/s40264-017-0547-9.
[7]Suk KT,Kim DJ,Kim CH,et al.A prospective nationwide study of druginduced liver injury in Korea[J].Am J Gastroenterol,2012,107(9):1380-1387.DOI:10.1038/ajg.2012.138.
[8]Shen T,Liu Y,Shang J,et al.Incidence and etiology of drug-induced liver injury in mainland China[J].Gastroenterology,2019,156(8).DOI:10.1053/j.gastro.2019.02.002.
[9]Vuppalanchi R,Liangpunsakul S,Chalasani 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).DOI:10.1111/j.1572-0241.2006.01019.x.
[10]Li L,Jiang W,Wang J.Clinical analysis of 275 cases of acute drug-induced liver disease[J].Front Med China,2007,1(1):58-61.DOI:10.1007/s11684-007-0012-8.
[11]Tujios SR,Lee WM.Acute liver failure induced by idiosyncratic reaction to drugs:challenges in diagnosis and therapy[J].Liver Int,2018,38(1).DOI:10.1111/liv.13535.
[12]茅益民.HepaTox: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(8):575-576.
[13]Bethesda,Maryland:National Institute of Diabetes and Digestive and Kidney Diseases.Categorization of the likelihood of drug induced liver injury[J].Clinical and Research Information on Drug-Induced Liver Injury[Internet].2012.
[14]Chalasani N,Bonkovsky HL,Fontana R,et al.Features and outcomes of 899 patients with drug-induced liver injury:the DILIN prospective study [J].Gastroenterology,2015,148(7).DOI:10.1053/j.gastro.2015.03.006.
[15]Devarbhavi H,Dierkhising R,Kremers WK,et al.Single-center experience with drug-induced liver injury from India:causes,outcome,prognosis,and predictors of mortality[J].Am J Gastroenterol,2010,105(11):2396-2404.DOI:10.1038/ajg.2010.287.
[16]Hoofnagle JH,Björnsson ES.Drug-induced liver injury-types and phenotypes[J].N Engl J Med,2019,381(3):264-273.DOI:10.1056/NEJMra1816149.
[17]A Consensus by a CIOMS Working Group.Drug-induced liver injury(DILI):current status and future directions for drug development and the post-market setting[J].Geneva,Switzerland:Council for International Organizations of Medical Sciences(CIOMS)2020.
[18]Takikawa H,Murata Y,Horiike N,et al.Drug-induced liver injury in Japan:an analysis of 1676 cases between 1997 and 2006[J].Hepatol Res,2009,39(5):427-431.DOI:10.1111/j.1872-034X.2008.00486.x.
[19]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.DOI:10.1038/clpt.2011.58.
[20]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.
[21]Lammert C,Einarsson S,Saha C,et al.Relationship between daily dose of oral medications and idiosyncratic drug-induced liver injury:search for signals[J].Hepatology,2008,47(6):2003-2009.DOI:10.1002/hep.22272.
[22]Carrascosa MF,Salcines-Caviedes JR,Lucena MI,et al.Acute liver failure following atorvastatin dose escalation:is there a threshold dose for idiosyncratic hepatotoxicity? [J].J Hepatol,2015,62(3):751-752.DOI:10.1016/j.jhep.2014.11.019.
[23]Hughes JD,Blagg J,Price DA,et al.Physiochemical drug properties associated with in vivo toxicological outcomes[J].Bioorg Med Chem Lett,2008,18(17):4872-4875.DOI:10.1016/j.bmcl.2008.07.071.
[24]Chen M,Borlak J,Tong W.High lipophilicity and high daily dose of oral medications are associated with significant risk for drug-induced liver injury[J].Hepatology,2013,58(1):388-396.DOI:10.1002/hep.26208.
[25]Aleo MD,Luo Y,Swiss R,et al.Human drug-induced liver injury severity is highly associated with dual inhibition of liver mitochondrial function and bile salt export pump[J].Hepatology,2014,60(3):1015-1022.DOI:10.1002/hep.27206.
[26]Tazuma S.Cyclosporin A and cholestasis:its mechanism(s)and clinical relevancy[J].Hepatol Res,2006,34(3):135-136.DOI:10.1016/j.hepres.2005.12.009.
[27]Morgan RE,Trauner M,van Staden CJ,et al.Interference with bile salt export pump function is a susceptibility factor for human liver injury in drug development[J].Toxicol Sci,2010,118(2):485-500.DOI:10.1093/toxsci/kfq269.
[28]Yu K,Geng X,Chen M,et al.High daily dose and being a substrate of cytochrome P450 enzymes are two important predictors of drug-induced liver injury[J].Drug Metab Dispos,2014,42(4):744-750.DOI:10.1124/dmd.113.056267.
[29]Molleston JP,Fontana RJ,Lopez MJ,et al.Characteristics of idiosyncratic drug-induced liver injury in children:results from the DILIN prospective study[J].J Pediatr Gastroenterol Nutr,2011,53(2):182-189.DOI:10.1097/MPG.0b013e31821d6cfd.
[30]deLemos AS,Foureau DM,Jacobs C,et al.Drug-induced liver injury with autoimmune features[J].Semin Liver Dis,2014,34(2):194-204.DOI:10.1055/s-0034-1375959.
[31]Zimmerman HJ.Effects of alcohol on other hepatotoxins[J].Alcohol Clin Exp Res,1986,10(1).DOI:DOI:10.1111/j.1530-0277.1986.tb05605.x.
[32]Kunelis CT,Peters JL,Edmondson HA.Fatty liver of pregnancy and its relationship to tetracycline therapy[J].Am J Med,1965,38:359-377.DOI:10.1016/0002-9343(65)90145-2.
[33]Bruno S,Maisonneuve P,Castellana P,et al.Incidence and risk factors for non-alcoholic steatohepatitis:prospective study of 5408 women enrolled in Italian tamoxifen chemoprevention trial[J].BMJ,2005,330(7497):932.DOI:10.1136/bmj.38391.663287.E0.
[34]Rosenberg P,Urwitz H,Johannesson A,et al.Psoriasis patients with diabetes type 2 are at high risk of developing liver fibrosis during methotrexate treatment[J].J Hepatol,2007,46(6):1111-1118.DOI:10.1016/j.jhep.2007.01.024.
[35]Stephens C,Lucena MI,Andrade RJ.Genetic risk factors in the development of idiosyncratic drug-induced liver injury[J].Expert Opin Drug Metab Toxicol,2021,17(2):153-169.DOI:10.1080/17425255.2021.1854726.
[36]Zanger UM,Schwab M.Cytochrome P450 enzymes in drug metabolism:regulation of gene expression,enzyme activities,and impact of genetic variation[J].Pharmacol Ther,2013,138(1):103 141.DOI:10.1016/j.pharmthera.2012.12.007.
[37]Cirulli ET,Nicoletti P,Abramson K,et al.A missense variant in PTPN22 is a risk factor for drug-induced liver injury[J].Gastroenterology,2019,156(6).DOI:10.1053/j.gastro.2019.01.034.
[38]Kardaun SH,Sidoroff A,Valeyrie-Allanore L,et al.Variability in the clinical pattern of cutaneous side-effects of drugs with systemic symptoms:does a DRESS syndrome really exist[J].Br J Dermatol,2007,156(3):609-611.DOI:10.1111/j.1365-2133.2006.07704.x.
[39]Kleiner DE.The pathology of drug-induced liver injury[J].Semin Liver Dis,2009,29(4):364-372.DOI:10.1055/s-0029-1240005.
[40]Kleiner DE,Chalasani NP,Lee WM,et al.Hepatic histological findings in suspected drug-induced liver injury:systematic evaluation and clinical associations[J].Hepatology,2014,59(2):661-670.DOI:10.1002/hep.26709.
[41]Tian QJ,Zhao XY,Wang Y,et al.Histologic pattern is better correlated with clinical outcomes than biochemical classification in patients with drug-induced liver injury[J].Mod Pathol,2019,32(12):1795-1805.DOI:10.1038/s41379-019-0314-9.
[42]Ahmad J,Barnhart HX,Bonacini M,et al.Value of liver biopsy in the diagnosis of drug-induced liver injury[J].J Hepatol,2022,76(5):1070-1078.DOI:10.1016/j.jhep.2021.12.043.
[43]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.DOI:10.14309/ajg.0000000000001259.
[44]Garc′ıa-Cort′es M,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.DOI:10.1111/j.1365-2036.2008.03655.x.
[45]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.DOI:10.1053/jhep.2001.20645.
[46]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.DOI:10.1016/0895-4356(93)90101-6.
[47]Danan G,Teschke R.RUCAM in drug and herb induced liver injury:the update[J].Int J Mol Sci,2015,17(1).DOI:10.3390/ijms17010014.
[48]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.
[49]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.
[50]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.DOI:10.1002/hep.23577.
[51]Björnsson E,Olsson R.Outcome and prognostic markers in severe druginduced liver disease[J].Hepatology,2005,42(2):481-489.DOI:10.1002/hep.20800.
[52]Koch DG,Tillman H,Durkalski V,et al.Development of a model to predict transplant-free survival of patients with acute liver failure[J].Clin Gastroenterol Hepatol,2016,14(8):1199-1206.DOI:10.1016/j.cgh.2016.03.046.
[53]Ghabril M,Gu J,Yoder L,et al.Development and validation of a model consisting of comorbidity burden to calculate risk of death within 6 months for patients with suspected drug-induced liver injury[J].Gastroenterology,2019,157(5).DOI:10.1053/j.gastro.2019.07.006.
[54]Medina-Caliz I,Robles-Diaz M,Garcia-Muñoz B,et al.Definition and risk factors for chronicity following acute idiosyncratic drug-induced liver injury[J].J Hepatol,2016,65(3):532-542.DOI:10.1016/j.jhep.2016.05.003.
[55]Wang CY,Deng Y,Li P,et al.Prediction of biochemical nonresolution in patients with chronic drug-induced liver injury:a large multicenter study[J].Hepatology,2022,75(6):1373-1385.DOI:10.1002/hep.32283.
[56]Fontana RJ,Hayashi PH,Gu J,et al.Idiosyncratic drug-induced liver injury is associated with substantial morbidity and mortality within 6 months from onset[J].Gastroenterology,2014,147(1).DOI:10.1053/j.gastro.2014.03.045.
[57]Bonkovsky HL,Kleiner DE,Gu J,et al.Clinical presentations and outcomes of bile duct loss caused by drugs and herbal and dietary supplements [J].Hepatology,2017,65(4):1267-1277.DOI:10.1002/hep.28967.
[58]Björnsson E,Talwalkar J,Treeprasertsuk S,et al.Drug-induced autoimmune hepatitis:clinical characteristics and prognosis[J].Hepatology,2010,51(6):2040-2048.DOI:10.1002/hep.23588.
[59]Björnsson ES,Bergmann O,Jonasson JG,et al.Drug-induced autoimmune hepatitis:response to corticosteroids and lack of relapse after cessation of steroids[J].Clin Gastroenterol Hepatol,2017,15(10):1635-1636.DOI:10.1016/j.cgh.2017.05.027.
[60]中华医学会消化病学分会肝胆疾病协作组.吡咯生物碱相关肝窦阻塞综合征诊断和治疗专家共识意见(2017年,南京)[J].中华消化杂志,2017,37(8):513-522.
[61]Zhuge Y,Liu Y,Xie W,et al.Expert consensus on the clinical management of pyrrolizidine alkaloid-induced hepatic sinusoidal obstruction syndrome[J].J Gastroenterol Hepatol,2019,34(4):634-642.DOI:10.1111/jgh.14612.
[62]Wang X,Zhang W,Zhang M,et al.Development of a Drum Tower Severity Scoring(DTSS)System for pyrrolizidine alkaloid-induced hepatic sinusoidal obstruction syndrome[J].Hepatol Int,2022,16(3):669-679.DOI:10.1007/s12072-021-10293-5.
[63]Bonifazi F,Barbato F,Ravaioli F,et al.Diagnosis and treatment of VOD/SOS after allogeneic hematopoietic stem cell transplantation[J].Front Immunol,2020,11:489.DOI:10.3389/fimmu.2020.00489.
[64]Dignan FL,Wynn RF,Hadzic N,et al.BCSH/BSBMT guideline:diagnosis and management of veno-occlusive disease(sinusoidal obstruction syndrome)following haematopoietic stem cell transplantation[J].Br J Haematol,2013,163(4):444-457.DOI:10.1111/bjh.12558.
[65]Mohty M,Malard F,Abecassis M,et al.Sinusoidal obstruction syndrome/veno-occlusive disease:current situation and perspectives-a position statement from the European Society for Blood and Marrow Transplantation(EBMT)[J].Bone Marrow Transplant,2015,50(6):781-789.DOI:10.1038/bmt.2015.52.
[66]Sulkowski MS,Thomas DL,Chaisson RE,et al.Hepatotoxicity associated with antiretroviral therapy in adults infected with human immunodeficiency virus and the role of hepatitis C or B virus infection[J].JAMA,2000,283(1):74-80.DOI:10.1001/jama.283.1.74.
[67]N′uñez M.Clinical syndromesand consequences of antiretroviral-related hepatotoxicity[J].Hepatology,2010,52(3):1143-1155.DOI:10.1002/hep.23716.
[68]Wong WM,Wu PC,Yuen MF,et al.Antituberculosis drug-related liver dysfunction in chronic hepatitis Binfection[J].Hepatology,2000,31(1):201-206.DOI:10.1002/hep.510310129.
[69]Bessone F,Dirchwolf M,Rodil MA,et al.Review article:drug-induced liver injury in the context of nonalcoholic fatty liver disease:a physiopathological and clinical integrated view[J].Aliment Pharmacol Ther,2018,48(9):892-913.DOI:10.1111/apt.14952.
[70]Lammert C,Imler T,Teal E,et al.Patients with chronic liver disease suggestive of nonalcoholic fatty liver disease may be at higher risk for druginduced liver injury[J].Clin Gastroenterol Hepatol,2019,17(13):2814-2815.DOI:10.1016/j.cgh.2018.12.013.
[71]Massart J,Begriche K,Moreau C,et al.Role of nonalcoholic fatty liver disease as risk factor for drug-induced hepatotoxicity[J].J Clin Transl Res,2017,3(Suppl 1):212-232.DOI:10.18053/jctres.03.2017S1.006.
[72]Tarantino G,Saldalamacchia G,Conca P,et al.Non-alcoholic fatty liver disease:further expression of the metabolic syndrome[J].J Gastroenterol Hepatol,2007,22(3):293-303.DOI:10.1111/j.1440-1746.2007.04824.x.
[73]Chalasani N,Aljadhey H,Kesterson J,et al.Patients with elevated liver enzymes are not at higher risk for statin hepatotoxicity[J].Gastroenterology,2004,126(5):1287-1292.DOI:10.1053/j.gastro.2004.02.015.
[74]Cohen DE,Anania FA,Chalasani N.An assessment of statin safety by hepatologists[J].Am J Cardiol,2006,97(8A):77C-81C.DOI:10.1016/j.amjcard.2005.12.014.
[75]Lewis JH,Mortensen ME,Zweig S,et al.Efficacy and safety of high-dose pravastatin in hypercholesterolemic patients with well-compensated chronic liver disease:Results of a prospective,randomized,double-blind,placebo-controlled,multicenter trial[J].Hepatology,2007,46(5):1453-1463.DOI:10.1002/hep.21848.
[76]Hoofnagle JH.Hepatic decompensation during direct-acting antiviral therapy of chronic hepatitis C[J].J Hepatol,2016,64(4):763-765.DOI:10.1016/j.jhep.2016.01.007.
[77]National Institute of Diabetes and Digestive and Kidney Diseases(NIDDKD):Bethesda,MD,USA.Obeticholic acid.In:Liver Tox:clinical and research information on drug-induced liver injury[J].2012.
[78]Ungo JR,Jones D,Ashkin D,et al.Antituberculosis drug-induced hepatotoxicity:the role of hepatitis C virus and the human immunodeficiency virus[J].Am J Respir Crit Care Med,1998,157(6 Pt 1):1871-1876.DOI:10.1164/ajrccm.157.6.9711039.
[79]Dakhoul L,Ghabril M,Gu J,et al.Heavy consumption of alcohol is not associated with worse outcomes in patients with idiosyncratic drug-induced liver injury compared to non-drinkers[J].Clin Gastroenterol Hepatol,2018,16(5).DOI:10.1016/j.cgh.2017.12.036.
[80]Sobhonslidsuk A,Poovorawan K,Soonthornworasiri N,et al.The incidence,presentation,outcomes,risk of mortality and economic data of drug-induced liver injury from a national database in Thailand:a population-base study[J].BMC Gastroenterol,2016,16(1):135.DOI:10.1186/s12876-016-0550-0.
[81]Lau G,Yu ML,Wong G,et al.APASL clinical practice guideline on hepatitis B reactivation related to the use of immunosuppressive therapy[J].Hepatol Int,2021,15(5):1031-1048.DOI:10.1007/s12072-021-10239-x.
[82]Perrillo RP,Gish R,Falck-Ytter YT.American Gastroenterological Association Institute technical review on prevention and treatment of hepatitis B virus reactivation during immunosuppressive drug therapy[J].Gastroenterology,2015,148(1).DOI:10.1053/j.gastro.2014.10.038.
[83]Wang G,Duan Z.Guidelines for prevention and treatment of chronic hepatitis B[J].J Clin Transl Hepatol,2021,9(5):769-791.DOI:10.14218/JCTH.2021.00209.
[84]Liu Z,Jin Q,Zhang Y,et al.Randomised clinical trial:48 weeks of treatment with tenofovir amibufenamide versus tenofovir disoproxil fumarate for patients with chronic hepatitis B[J].Aliment Pharmacol Ther,2021,54(9):1134-1149.DOI:10.1111/apt.16611.
[85]Terrault NA,Lok ASF,Mc Mahon BJ,et al.Update on prevention,diagnosis,and treatment of chronic hepatitis B:AASLD 2018 hepatitis B guidance[J].Hepatology,2018,67(4):1560-1599.DOI:10.1002/hep.29800.
[86]Navarro VJ,Barnhart H,Bonkovsky HL,et al.Liver injury from herbals and dietary supplements in the US Drug-Induced Liver Injury Network [J].Hepatology,2014,60(4):1399-1408.DOI:10.1002/hep.27317.
[87]Bessone F,Garc′ıa-Cort′es M,Medina-Caliz I,et al.Herbal and dietary supplementsinduced liver injury in Latin America:experience from the LATINDILI network[J].Clin Gastroenterol Hepatol,2022,20(3):e548-e563.DOI:10.1016/j.cgh.2021.01.011.
[88]Robles-Diaz M,Gonzalez-Jimenez A,Medina-Caliz I,et al.Distinct phenotype of hepatotoxicity associated with illicit use of anabolic androgenic steroids[J].Aliment Pharmacol Ther,2015,41(1):116-125.DOI:10.1111/apt.13023.
[89]Aiso M,Takikawa H,Tsuji K,et al.Analysis of 307 cases with drug-induced liver injury between 2010 and 2018 in Japan[J].Hepatol Res,2019,49(1):105-110.DOI:10.1111/hepr.13288.(https://www.daowen.com)
[90]Wai CT,Tan BH,Chan CL,et al.Drug-induced liver injury at an Asian center:a prospective study[J].Liver Int,2007,27(4):465-474.DOI:10.1111/j.1478-3231.2007.01461.x.
[91]朱春雾,王海南,袁继丽,等.445例药物性肝损伤的临床分析[J].临床肝胆病杂志,2018,34(2):354-358.
[92]Zhou Y,Yang L,Liao Z,et al.Epidemiology of drug-induced liver injury in China:a systematic analysis of the Chinese literature including 21,789 patients[J].Eur J Gastroenterol Hepatol,2013,25(7):825-829.DOI:10.1097/MEG.0b013e32835f6889.
[93]Lin L,Li H,Lin H,et al.A new perspective on liver injury by traditional Chinese herbs such as:the geographical area of harvest as an important contributory factor[J].Front Pharmacol,2017,8:349.DOI:10.3389/fphar.2017.00349.
[94]崔鹤蓉,柏兆方,宋海波,等.从古今炮制方法演变探讨何首乌毒性的潜在影响因素[J].中国中药杂志,2016,41(02):333-339.
[95]Teschke R.Traditional Chinese medicine induced liver injury[J].J Clin Transl Hepatol,2014,2(2):80-94.DOI:10.14218/JCTH.2014.00003.
[96]Fasinu PS,Bouic PJ,Rosenkranz B.An overview of the evidence and mechanisms of herb-drug interactions[J].Front Pharmacol,2012,3(69).DOI:10.3389/fphar.2012.00069.
[97]Geneva:World Health Organization.Key technical issues of herbal medicines with reference to interaction with other medicines[J].2021.
[98]宋海波,韩玲.中药肝损伤的流行特点、风险因素及评价[J].中国药理学与毒理学杂志,2016,30(4):291-305.
[99]吴淑馨,孙宏峰,杨晓晖,等.从柴胡制剂不良事件论如何围绕“有因再评价”开展中药上市后临床研究[J].中国中药杂志,2014,39(15):2983-2988.
[100]田代华.黄帝内经·素问[M].北京:人民卫生出版社,2005,189-190.
[101]Rao A,Rule JA,Hameed B,et al.Secular trends in severe idiosyncratic druginduced liver injury in North America:an update from the acute liver failure study group registry[J].Am J Gastroenterol,2022,117(4):617-626.DOI:10.14309/ajg.0000000000001655.
[102]国家药品监督管理局.中药药源性肝损伤临床评价技术指导原则[J].临床肝胆病杂志,2018,34(7):1403-1409.
[103]中华医学会结核病学分会.抗结核药物性肝损伤诊治指南(2019年版)[J].中华结核和呼吸杂志,2019,42(5):343-356.
[104]Devarbhavi H,Choudhury AK,Sharma MK,et al.Drug-induced acute-onchronic liver failure in Asian patients[J].Am J Gastroenterol,2019,114(6):929-937.DOI:10.14309/ajg.0000000000000201.
[105]Nicoletti P,Devarbhavi H,Goel A,et al.Genetic risk factors in drug-induced liver injury due to isoniazid-containing antituberculosis drug regimens[J].Clin Pharmacol Ther,2021,109(4):1125-1135.DOI:10.1002/cpt.2100.
[106]Devarbhavi H,Singh R,Patil M,et al.Outcome and determinants of mortality in 269 patients with combination anti-tuberculosis drug-induced liver injury[J].J Gastroenterol Hepatol,2013,28(1):161-167.DOI:10.1111/j.1440-1746.2012.07279.x.
[107]Abbara A,Chitty S,Roe JK,et al.Drug-induced liver injury from antituberculous treatment:a retrospective study from a large TB centre in the UK[J].BMC Infect Dis,2017,17(1):231.DOI:10.1186/s12879-017-2330-z.
[108]Nahid P,Dorman SE,Alipanah N,et al.Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America clinical practice guidelines:treatment of drug-susceptible tuberculosis[J].Clin Infect Dis,2016,63(7):e147-e195.DOI:10.1093/cid/ciw376.
[109]Mok TS,Wu YL,Thongprasert S,et al.Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma[J].N Engl J Med,2009,361(10):947-957.DOI:10.1056/NEJMoa0810699.
[110]Mitsudomi T,Morita S,Yatabe Y,et al.Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405):an open label,randomised phase 3 trial[J].Lancet Oncol,2010,11(2):121-128.DOI:10.1016/S1470-2045(09)70364-X.
[111]Maemondo M,Inoue A,Kobayashi K,et al.Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR[J].N Engl J Med,2010,362(25):2380-2388.DOI:10.1056/NEJMoa0909530.
[112]Rosell R,Carcereny E,Gervais R,et al.Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre,open-label,randomised phase 3 trial[J].Lancet Oncol,2012,13(3):239-246.DOI:10.1016/S1470-2045(11)70393-X.
[113]Wu YL,Zhou C,Hu CP,et al.Afatinib versus cisplatin plus gemcitabine for first-line treatment of Asian patients with advanced non-small-cell lung cancer harbouring EGFR mutations(LUX-Lung 6):an open-label,randomised phase 3 trial[J].Lancet Oncol,2014,15(2):213-222.DOI:10.1016/S1470-2045(13)70604-1.
[114]Shi YK,Wang L,Han BH,et al.First-line icotinib versus cisplatin/pemetrexed plus pemetrexed maintenance therapy for patients with advanced EGFR mutation-positive lung adenocarcinoma(CONVINCE):a phase 3,open-label,randomized study[J].Ann Oncol,2017,28(10):2443-2450.DOI:10.1093/annonc/mdx359.
[115]Shah RR,Morganroth J,Shah DR.Hepatotoxicity of tyrosine kinase inhibitors:clinical and regulatory perspectives[J].Drug Saf,2013,36(7):491-503.DOI:10.1007/s40264-013-0048-4.
[116]Peeraphatdit TB,Wang J,Odenwald MA,et al.Hepatotoxicity from immune checkpoint inhibitors:a systematic review and management recommendation[J].Hepatology,2020,72(1):315-329.DOI:10.1002/hep.31227.
[117]雷晓红,唐颖悦,李静.肿瘤免疫检查点抑制剂相关的肝毒性[J].中华肝脏病杂志,2020,28(02):175-178.
[118]Suzman DL,Pelosof L,Rosenberg A,et al.Hepatotoxicity of immune checkpoint inhibitors:an evolving picture of risk associated with a vital class of immunotherapy agents[J].Liver Int,2018,38(6):976-987.DOI:10.1111/liv.13746.
[119]De Martin E,Michot JM,Papouin B,et al.Characterization of liver injury induced by cancer immunotherapy using immune checkpoint inhibitors[J].J Hepatol,2018,68(6):1181-1190.DOI:10.1016/j.jhep.2018.01.033.
[120]Yildirim S,Deniz K,Doˇgan E,et al.Ipilimumab-associated cholestatic hepatitis:a case report and literature review [J].Melanoma Res,2017,27(4):380-382.DOI:10.1097/CMR.0000000000000366.
[121]LoPiccolo J,Brener MI,Oshima K,et al.Nodular regenerative hyperplasia associated with immune checkpoint blockade[J].Hepatology,2018,68(6):2431-2433.DOI:10.1002/hep.30157.
[122]Huffman BM,Kottschade LA,Kamath PS,et al.Hepatotoxicity after immune checkpoint inhibitor therapy in melanoma:natural progression and management[J].Am J Clin Oncol,2018,41(8):760-765.DOI:10.1097/COC.0000000000000374.
[123]Yervoy(Ipilimumab)Prescribing Information[EB/OL].2015.Available from:https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125377s073lbl.pdf.
[124]Imfinzi(Durvalumab)Prescribing Information[EB/OL].2020.Available from:https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761069s018lbl.pdf.
[125]Tecentriq(Atezolizumab)Prescribing Information[EB/OL].2021.Available from:https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761034s042lbl.pdf.
[126]Bavencio(Avelumab)Prescribing Information[EB/OL].2019.Available from:https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761049s006lbl.pdf.
[127]Kleiner DE,Berman D.Pathologic changes in ipilimumab-related hepatitis in patients with metastatic melanoma[J].Dig Dis Sci,2012,57(8):2233-2240.DOI:10.1007/s10620-012-2140-5.
[128]Postow MA,Sidlow R,Hellmann MD.Immune-related adverse events associated with immune checkpoint blockade[J].N Engl J Med,2018,378(2):158-168.DOI:10.1056/NEJMra1703481.
[129]Johnson DB,Sullivan RJ,Ott PA,et al.Ipilimumab therapy in patients with advanced melanoma and preexisting autoimmune disorders[J].JAMA Oncol,2016,2(2):234-240.DOI:10.1001/jamaoncol.2015.4368.
[130]Menzies AM,Johnson DB,Ramanujam S,et al.Anti-PD-1 therapy in patients with advanced melanoma and preexisting autoimmune disorders or major toxicity with ipilimumab[J].Ann Oncol,2017,28(2):368-376.DOI:10.1093/annonc/mdw443.
[131]Abdel-Wahab N,Shah M,Lopez-Olivo MA,et al.Use of immune checkpoint inhibitors in the treatment of patients with cancer and preexisting autoimmune disease:a systematic review[J].Ann Intern Med,2018,168(2):121-130.DOI:10.7326/M17-2073.
[132]Li M,Wong D,Vogel AS,et al.Effect of corticosteroid dosing on outcomes in high-grade immune checkpoint inhibitor hepatitis[J].Hepatology,2022,75(3):531-540.DOI:10.1002/hep.32215.
[133]National Cancer Institute.Common terminology criteria for adverse events(CTCAE),Version 4.03[J].2009.
[134]Dear JW,Clarke JI,Francis B,et al.Risk stratification after paracetamol overdose using mechanistic biomarkers:results from two prospective cohort studies[J].Lancet Gastroenterol Hepatol,2018,3(2):104-113.DOI:10.1016/S2468-1253(17)30266-2.
[135]McGill MR,Staggs VS,Sharpe MR,et al.Serum mitochondrial biomarkers and damage-associated molecular patterns are higher in acetaminophen overdose patients with poor outcome[J].Hepatology,2014,60(4):1336-1345.DOI:10.1002/hep.27265.
[136]Clarke JI,Dear JW,Antoine DJ.Recent advances in biomarkers and therapeutic interventions for hepatic drug safety-false dawn or new horizon?[J].Expert Opin Drug Saf,2016,15(5):625-634.DOI:10.1517/14740338.2016.1160057.
[137]Church RJ,Kullak-Ublick GA,Aubrecht J,et al.Candidate biomarkers for the diagnosis and prognosis of drug-induced liver injury:an international collaborative effort[J].Hepatology,2019,69(2):760-773.DOI:10.1002/hep.29802.
[138]Li C,Rao T,Chen X,et al.HLA-B*35:01 allele is a potential biomarker for predicting polygonum multiflorum-induced liver injury in humans[J].Hepatology,2019,70(1):346-357.DOI:10.1002/hep.30660.
[139]Tu C,Niu M,Wei AW,et al.Susceptibility-related cytokine panel for prediction of polygonum multiflorum-induced hepatotoxicity in humans[J].J Inflamm Res,2021,14:645-655.DOI:10.2147/JIR.S299892.
[140]Zhang L,Niu M,Wei AW,et al.Risk profiling using metabolomic characteristics for susceptible individuals of drug-induced liver injury caused by polygonum multiflorum[J].Arch Toxicol,2020,94(1):245-256.DOI:10.1007/s00204-019-02595-3.
[141]Roth SE,Avigan MI,Bourdet D,et al.Next-generation DILI biomarkers:prioritization of biomarkers for qualification and best practices for biospecimen collection in drug development[J].Clin Pharmacol Ther,2020,107(2):333-346.DOI:10.1002/cpt.1571.
[142]US Department of Health and Human Services FDA,Center for Drug Evaluation and Research.Letter of Support for Drug-Induced Liver Injury(DILI)Biomarker(s)[EB/OL].2016.Available from:https://fda.report/media/99532/Letter-of-Support-for-Drug-Induced-Liver-Injury-%28DILI%29-Biomarker%28s%29-7-25-16.pdf.
[143]US FDA.Guidance for Industry.Drug-induced liver injury:premarketing clinical evaluation[J].2009.
[144]Navarro VJ,Senior JR.Drug-related hepatotoxicity[J].N Engl J Med,2006,354(7):731-739.DOI:10.1056/NEJMra052270.
[145]Lee WM,Hynan LS,Rossaro L,et al.Intravenous N-acetylcysteine improves transplant-free survival in early stage non-acetaminophen acute liver failure[J].Gastroenterology,2009,137:3.DOI:10.1053/j.gastro.2009.06.006.
[146]Squires RH,Dhawan A,Alonso E,et al.Intravenous N-acetylcysteine in pediatric patients with nonacetaminophen acute liver failure:a placebocontrolled clinical trial[J].Hepatology,2013,57(4):1542-1549.DOI:10.1002/hep.26001.
[147]Hu PF,Wang PQ,Chen H,et al.Beneficial effect of corticosteroids for patients with severe drug-induced liver injury[J].J Dig Dis,2016,17(9):618-627.DOI:10.1111/1751-2980.12383.
[148]Sundaram S,Vuppalanchi R,Saxena R,et al.Treatment of idiosyncratic drug-induced liver injury using steroids[J].ACG Case Rep J,2020,7(2):e00319.DOI:10.14309/crj.0000000000000319.
[149]Wree A,Dechêne A,Herzer K,et al.Steroid and ursodesoxycholic acid combination therapy in severe drug-induced liver injury[J].Digestion,2011,84(1):54-59.DOI:10.1159/000322298.
[150]Wang JB,Huang A,Wang Y,et al.Corticosteroid plus glycyrrhizin therapy for chronic drug-or herb-induced liver injury achieves biochemical and histological improvements:a randomised open-label trial [J].Aliment Pharmacol Ther,2022,55(10):1297-1310.DOI:10.1111/apt.16902.
[151]Ma JGJ,Lammert C.Characterization of steroid therapy for drug-induced liver injury[J].Gastroenterology,2020,158(6):S-1304.DOI:10.1016/S0016-5085(20)33922-6.
[152]Wan YM,Wu JF,Li YH,et al.Prednisone is not beneficial for the treatment of severe drug-induced liver injury:an observational study (STROBE compliant)[J].Medicine(Baltimore),2019,98(26):e15886.DOI:10.1097/MD.0000000000015886.
[153]Wang Y,Wang Z,Gao M,et al.Efficacy and safety of magnesium isoglycyrrhizinate injection in patients with acute drug-induced liver injury:A phase II trial[J].Liver Int,2019,39(11):2102-2111.DOI:10.1111/liv.14204.
[154]Lei X,Zhang J,Xu Q,et al.Exploring the efficacy and safety of polyene phosphatidylcholine for treatment of drug-induced liver injury using the Roussel Uclaf causality assessment method:a propensity score matching comparison[J].J Int Med Res,2021,49(8):3000605211039810.DOI:10.1177/03000605211039810.
[155]Yao L,Zhang J,Jin J,et al.An analysis of the efficacy and safety of compound glycyrrhizin injections in the treatment of drug-induced liver injury using a nationwide database[J].Int J Clin Pharm,2022,44(3):731-740.DOI:10.1007/s11096-022-01402-x.
[156]Zhang B,Jiang G,Wang L,et al.An analysis of silybin meglumine tablets in the treatment of drug-induced liver injury as assessed for causality with the updated Roussel Uclaf causality assessment method using a nationwide database[J].Br J Clin Pharmacol,2023,89(4):1329-1337.DOI:10.1111/bcp.15575.
[157]Li J,Zhang J,Xu X,et al.Hugan tablets for the treatment of RUCAM based drug-induced liver injury:a propensity score matching analysis using a nationwide database[J].Expert Rev Clin Pharmacol,2021,14(12):1543-1550.DOI:10.1080/17512433.2021.1981859.
[158]刘文,陈兆辉,陈靖责.五灵丸在门诊抗结核药物治疗过程中的保肝疗效观察[J].中西医结合肝病杂志,2012,22(02):122-123.
[159]Niu H,Sanabria-Cabrera J,Alvarez-Alvarez I,et al.Prevention and management of idiosyncratic drug-induced liver injury:systematic review and meta-analysis of randomised clinical trials[J].Pharmacol Res,2021,164:105404.DOI:10.1016/j.phrs.2020.105404.
[160]Li X,Zhou J,Chen S,et al.Role of bicyclol in preventing chemotherapeutic agent-induced liver injury in patients over 60 years of age with cancer[J].JInt Med Res,2014,42(4):906-914.DOI:10.1177/0300060514527058.
[161]Chen Y,Ye P,Ren C,et al.Pharmacoeconomics of three therapeutic schemes for anti-tuberculosis therapy induced liver injury in China[J].Open Med(Wars),2018,13:53-63.DOI:10.1515/med-2018-0010.
[162]吴玉娇,张晶,杨艳玲.异甘草酸镁预防恶性肿瘤化疗药致肝损伤的有效性和安全性的系统评价[J].中国医院用药评价与分析,2021,21(03):333-337.
[163]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.DOI:10.5588/ijtld.14.0579.
[164]冷楠楠,刘永军,邱玉.5种保肝药物治疗药物性肝损伤的网状meta分析[J].中国医药科学,2022,12(08):42-47,106.
[165]李特,陈蓉,李静蓉.保肝降酶方案治疗丙氨酸氨基转移酶升高的慢性乙型肝炎的经济学评价[J].中国药房,2013,24(46):4321-4324.
[166]李国辉,陈任安,王文清.异甘草酸镁注射液预防血液肿瘤化疗相关肝损伤多中心临床协作研究[J].陕西医学杂志,2019,48(06):787-790.
[167]秦叔逵,杨柳青,王科明.异甘草酸镁注射液预防抗肿瘤化疗相关性急性肝损伤的随机对照、全国多中心临床研究[J].临床肿瘤学杂志,2017,22(02):97-106.
[168]闫玉兰,莫永森,张冬梅.异甘草酸镁对化疗药物致初治胃肠道肿瘤患者肝损害的预防作用[J].中华肝脏病杂志,2015,23(3):204-208.
[169]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.DOI:10.1002/hep.29283.
[170]Reuben A,Koch DG,Lee WM.Drug-induced acute liver failure:results of a USmulticenter,prospective study[J].Hepatology,2010,52(6):2065-2076.DOI:10.1002/hep.23937.
[171]Goh ET,Stokes CS,Sidhu SS,et al.L-ornithine L-aspartate for prevention and treatment of hepatic encephalopathy in people with cirrhosis[J].Cochrane Database Syst Rev,2018,5(5):CD012410.DOI:10.1002/14651858.CD012410.pub2.
[172]Schmid M,Peck-Radosavljevic M,König F,et al.A double-blind,randomized,placebo-controlled trial of intravenous L-ornithine-L-aspartate on postural control in patients with cirrhosis[J].Liver Int,2010,30(4):574-582.DOI:10.1111/j.1478-3231.2010.02213.x.
[173]Jain A,Sharma BC,Mahajan B,et al.L-ornithine L-aspartate in acute treatment of severe hepatic encephalopathy:a double-blind randomized controlled trial[J].Hepatology,2022,75(5):1194-1203.DOI:10.1002/hep.32255.
[174]Sidhu SS,Sharma BC,Goyal O,et al.L-ornithine L-aspartate in bouts of overt hepatic encephalopathy[J].Hepatology,2018,67(2):700-710.DOI:10.1002/hep.29410.
[175]Acharya SK,Bhatia V,Sreenivas V,et al.Efficacy of L-ornithine L-aspartate in acute liver failure:a double-blind,randomized,placebo-controlled study[J].Gastroenterology,2009,136(7):2159-2168.DOI:10.1053/j.gastro.2009.02.050.
[176]McPhail MJW,Farne H,Senvar N,et al.Ability of King's College Criteria and Model for End-Stage Liver Disease Scores to predict mortality of patients with acute liver failure:a meta-analysis[J].Clin Gastroenterol Hepatol,2016,14(4):516-525.DOI:10.1016/j.cgh.2015.10.007.
[177]Larsen FS,Schmidt LE,Bernsmeier C,et al.High-volume plasma exchange in patients with acute liver failure:an open randomised controlled trial[J].J Hepatol,2016,64(1):69-78.DOI:10.1016/j.jhep.2015.08.018.
[178]Xiong G,Yang Z,Yi J,et al.DDInter:an online drug-drug interaction database towards improving clinical decision-making and patient safety[J].Nucleic Acids Res,2022,50(D1):D1200-D1207.DOI:10.1093/nar/gkab880.
[179]He N,Su S,Ye Z,et al.Evidence-based guideline for therapeutic drug monitoring of vancomycin:2020 update by the Division of Therapeutic Drug Monitoring,Chinese Pharmacological Society[J].Clin Infect Dis,2020,71(Suppl 4):S363-S371.DOI:10.1093/cid/ciaa1536.