Guidance for the clinical evaluation of traditional Chinese medicine-induced liver injury Issued by China Food and Drug Administration
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摘要
<正>1. Introduction Drug-induced liver injury (DILI), defined as liver injury caused by a drug and/or its metabolites, is a common clinical adverse drug reaction~(1–4). This type of injury can cause acute liver failure and even death in severe cases5. DILI accounts for many drug
引文
1.China Association of Chinese Medicine.Guideline for diagnosis and treatment of herb-induced liver injury(T/CACM 005-2016).Beijing:China Press of Traditional Chinese Medicine;2016.
2.China Society of Hepatology.Chinese Medical Association.CSHclinical guideline:the diagnosis and management of drug-induced liver injury.Shanghai:Shanghai Scientific&Technical Publishers;2015.
3.Bj?rnsson ES,Bergmann OM,Bj?rnsson HK,Kvaran RB,Olafsson S.Incidence,presentation,and outcomes in patients with drug-induced liver injury in the general population of Iceland.Gastroenterology2013;144:1419-25.
4.Miguel A,Azevedo LF,Araújo M,Pereira AC.Frequency of adverse drug reactions in hospitalized patients:a systematic review and metaanalysis.Pharmacoepidemiol Drug Saf 2012;21:1139-54.
5.Andrade RJ,Lucena MI,Kaplowitz N,García MB,Borraz Y,Pachkoria K,et al.Outcome of acute idiosyncratic drug-induced liver injury:long-term follow-up in a hepatotoxicity registry.Hepatology2006;44:1581-8.
6.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.2009.Available from:?http://www.fda.gov/downloads/Drugs/.../Gui dances/UCM174090.pdf?.
7.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 good pharmacovigilance practices and pharmacoepidemiologic assessment.2005.Available from:?https://www.fda.gov/down loads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071696.pdf?.
8.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 postmarketing studies and clinical trialsimplementation of section 505(o)(3)of the Federal Food,Drug,and Cosmetic Act.2011.Available from:?https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf?.
9.Zhang P,Ye YA,Yang XZ,Jiao Y.Systematic review on Chinese herbal medicine induced liver injury.Evid Based Complement Altern Med 2016;2016:3560812.
10.Chalasani NP,Hayashi PH,Bonkovsky HL,Navarro VJ,Lee WM,Fontana RJ,et al.ACG clinical guideline:the diagnosis and management of idiosyncratic drug-induced liver injury.Am J Gastroenterol2014;109:950-67.
11.Farah MH,Edwards R,Lindquist M,Leon C,Shaw D.International monitoring of adverse health effects associated with herbal medicines.Pharmacoepidemiol Drug Saf 2000;9:105-12.
12.Wang JB,Zhu Y,Bai ZF,Wang FS,Li XH,Xiao XH,et al.Guidelines for the diagnosis and management of herb-induced liver injury.Chin J Integr Med 2018;24:696-706.
13.Larrey D.Epidemiology and individual susceptibility to adverse drug reactions affecting the liver.Semin Liver Dis 2002;22:145-55.
14.Bjornsson ES.Epidemiology and risk factors for idiosyncratic druginduced liver injury.Semin Liver Dis 2014;34:115-22.
15.López-Gil S,Nu?o-Lámbarri N,Chávez-Tapia N,Uribe M,BarberoBecerra VJ.Liver toxicity mechanisms of herbs commonly used in Latin America.Drug Metab Rev 2017;49:338-56.
16.Valdivia-Correa B,Gómez-Gutiérrez C,Uribe M,Méndez-Sánchez N.Herbal medicine in Mexico:a cause of hepatotoxicity.Int J Mol Sci2016;17:235.
17.Medina-Caliz I,Garcia-Cortes M,Gonzalez-Jimenez A,Cabello MR,Robles-Diaz M,Sanabria-Cabrera J,et al.Herbal and dietary supplement-induced liver injuries in the Spanish DILI registry.Clin Gastroenterol Hepatol 2018;16:1495-502.
18.Vega M,Verma M,Beswick D,Bey S,Hossack J,Merriman N,et al.The incidence of drug-and herbal and dietary supplement-induced liver injury:preliminary findings from gastroenterologist-based surveillance in the population of the state of Delaware.Drug Saf2017;40:783-7.
19.Jing J,Teschke R.Traditional Chinese medicine and herb-induced liver injury:comparison with drug-induced liver injury.J Clin Transl Hepatol 2018;6:57-68.
20.Navarro VJ,Khan I,Bj?rnsson E,Seeff LB,Serrano J,Hoofnagle JH.Liver injury from herbal and dietary supplements.Hepatology2017;65:363-73.
21.Cho JH,Oh DS,Hong SH,Ko H,Lee NH,Park SE,et al.Anationwide study of the incidence rate of herb-induced liver injury in Korea.Arch Toxicol 2017;91:4009-15.
22.Xu JM.A multicenter survey on hospital inpatients with drug-induced acute liver injury in China.Chin J Dig 2007;27:439-42.
23.Chinese Pharmacopoeia Commission.Guidelines for clinical use of pharmacopoeia of the People's Republic.Beijing:China Medical Science Press;2010.
24.China Association of Chinese Medicine.Chinese herbal medicine quality evaluation methodology guidance.(T/CACM 001-2017).2017.
25.Liu CH,Zhu CW.Epidemic features,major causes,and diagnostic evaluation of herb-induced liver injury.Chin J Clin Hepatol2017;33:829-32.
26.Li CY,Niu M,Bai ZF,Zhang CN,Zhao YL,Li RY,et al.Screening for main components associated with the idiosyncratic hepatotoxicity of a tonic herb Polygonum multiflorum.Front Med 2017;11:253-65.
27.Bai ZF,Gao Y,Zuo XB,Wang JB,Xiao XH.Progress in research on the pathogenesis of immune regulation and idiosyncratic drug-induced liver injury.Acta Pharm Sin 2017;52:1019-26.
28.Pais R,Rusu E,Ratziu V.The impact of obesity and metabolic syndrome on chronic hepatitis B and drug-induced liver disease.Clin Liver Dis 2014;18:165-78.
29.Lucena MI,Andrade RJ,Kaplowitz N,García-Cortes M,Fernández MC,Romero-Gomez M,et al.Phenotypic characterization of idiosyncratic drug-induced liver injury:the influence of age and sex.Hepatology 2009;49:2001-9.
30.Suzman DL,Pelosof L,Rosenberg A.Hepatotoxicity of immune checkpoint inhibitors:an evolving picture of risk associated with a vital class of immunotherapy agents.Liver Int 2018;38:976-87.
31.He LZ,Yin P,Meng YK,Tang JF,He TT,Niu M,et al.Immunological synergistic mechanisms of trans-/cis-stilbene glycosides in Heshouwu related idiosyncratic liver injury.Sci Bull 2017;62:748-51.
32.Amin MD,Harpavat S,Leung DH.Drug-induced liver injury in children.Curr Opin Pediatr 2015;27:625-33.
33.Chalasani N,Regev A.Drug-induced liver injury in patients with preexisting chronic liver disease in drug development:how to identify and manage?.Gastroenterology 2016;151:1046-51.
34.Qian Y,Wang XJ.Rational use of traditional Chinese medicine in the treatment of liver disease and common Chinese medicine related liver injury.Beijing:People's Medical Publishing House;2008.
35.Wang JB,Zhao HP,Zhao YL,Jin C,Liu DJ,Kong WJ,et al.Hepatotoxicity or hepatoprotection pattern recognition for the paradoxical effect of the Chinese herb Rheum palmatum L.in treating rat liver injury.PLoS One 2011;6:e24498.
36.Xing XY,Zhao YL,Kong WJ,WangJB,Jia L,Zhang P,et al.Investigation of the"dose-time-response"relationships of rhubarb on carbon tetrachloride-induced liver injury in rats.J Ethnopharmacol2011;135:575-81.
37.Chen CW,Ma HN,Fu QC,Mao YM,Xie Q,Yu YC.Drug-induced and toxic liver disease.Shanghai:Shanghai Science and Technology Press;2013.
38.Zhu Y,Li YG,Wang Y,Wang LP,Wang JB,Wang RL,et al.Analysis of clinical characteristics in 595 patients with herb-induced liver injury.Chin J Integr Med 2016;36:44-8.
39.Zhu Y,Niu M,Chen J,Zou ZS,Ma ZJ,Liu SH,et al.Comparison between Chinese herbal medicine and Western medicine-induced liver injury of 1985 patients.J Gastroenterol Hepatol 2016;31:1476-82.
40.Lou WQ,Chen CW.Recent advances in the diagnosis and risk assessment of drug-induced liver injury.Liver 2017;22:774-8.
41.Clarke JI,Dear JW,Antoine DJ.Recent advances in biomarkers and therapeutic interventions for hepatic drug safety-false dawn or new horizon?.Exp Opin Drug Saf 2016;15:625-34.
42.Nicoletti P,Aithal GP,Bjornsson ES,Andrade RJ,Sawle A,Arrese M,et al.Association of liver injury from specific drugs,or groups of drugs,with polymorphisms in hla and other genes in a genome-wide association study.Gastroenterology 2017;152:1078-89.
43.Church RJ,Kullak-Ublick GA,Aubrecht J,Bonkovsky HL,Chalasani N,Fontana RJ,et al.,Candidate biomarkers for the diagnosis and prognosis of drug-induced liver injury:Hepatology 2018.Available from:https://doi.org/10.1002/hep.29802.
44.Zhang L,Wong LY,He Y,Wong IC.Pharmacovigilance in China:current situation,successes and challenges.Drug Saf 2014;37:765-70.
45.Tan EH,Low EXS,Dan YY,Tai BC.Systematic review and metaanalysis of algorithms used to identify drug-induced liver injury(DILI)in health record databases.Liver Int 2017.Available from:https://doi.org/10.1111/liv.13646.
46.China Food and Drug Administration.Technical guidelines for acute toxicity study of traditional Chinese medicine and natural medicine.2007.Available from:?http://www.cde.org.cn/zdyz.do?Method?largePage&id?2086?.
47.China Food and Drug Administration.Technical guidelines for longterm toxicity study of traditional Chinese medicine and natural medicine.2007.Available from:?http://www.cde.org.cn/zdyz.do?Method?largePage&id?1498?.
48.Jiang ZZ,Wang XZ,Sun LX,Wang T,Zhang PH,Huang X,et al.Technical methods and application of traditional Chinese medicine toxicity evaluation.Prog Pharm Sci 2013;37:545-7.
49.Wang JB,Cui HR,Bai ZF,Xiao XH.Precision medicine-oriented safety assessment strategy for traditional Chinese medicines:diseasesyndrome-based toxicology.Acta Pharm Sin 2016;51:1681-8.
50.Suzuki A,Brunt EM,Kleiner DE,Miquel R,Smyrk TC,Andrade RJ,et al.The use of liver biopsy evaluation in discrimination of idiopathic autoimmune hepatitis versus drug-induced liver injury.Hepatology2011;54:931-9.
51.Kullak-Ublick GA,Andrade RJ,Merz M,End P,Benesic A,Gerbes AL,et al.Drug-induced liver injury:recent advances in diagnosis and risk assessment.Gut 2017;66:1154-64.
52.Shahbaz O,Mahajan S,Lewis JH.Highlights of drug-and herbinduced liver injury in the literature from 2016:how best to translate new information into clinical practice?.Exp Opin Drug Metab Toxicol2017;13:935-51.
53.Dakhoul L,Ghabril M,Chalasani N.Drug-induced chronic liver injury.J Hepatol 2018;69:248-50.
54.China Food and Drug Administration.General principles of clinical research on traditional Chinese medicine.2015.Available from:?http://samr.cfda.gov.cn/WS01/CL0087/134581.html?.
55.Wang JB,Li CY,Zhu Y,Song HB,Bai ZF,Xiao XH.Integrated evidence chain-based identification of Chinese herbal medicineinduced hepatotoxicity and rational usage:exemplification by Polygonum Multiflorum(He shou wu).Chin Sci Bull 2016;61:971-80.
56.He TT,Gomg M,Bai YF,Zhu Y,Wang JB,Niu M,et al.Clinical analysis of two diagnosis methods for herb-induced liver injury.Chin JChin Mat Med 2016;41:3096-9.
57.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 Clin Epidemiol 1993;46:1323-30.
58.Danan G,Teschke R.RUCAM in drug and herb induced liver injury:the update.Int J Mol Sci 2016;17:14-46.
59.Wang J,Ma Z,Niu M,Zhu Y,Liang Q,Zhao Y,et al.Evidence chainbased causality identification in herb-induced liver injury:exemplification of a well-known liver-restorative herb Polygonum multiflorum.Front Med 2015;9:457-67.
60.Wang JB,Zhang L,Guo YM,Bai ZF,Xiao XH.Causality assessment strategies and methods for Chinese medicines-induced liver injury.Acta Pharm Sin 2018;53:920-8.
61.Xiao XH.Pharmaceutical diseases and their risk prevention and control.Prog Pharm Sci 2018;42:161-3.
62.Ministry of Health of the People’s Republic of China.Administrative measures for the reporting and monitoring of adverse drug reactions.2011.Available from:?http://www.nhc.gov.cn/zwgkzt/wsbysj/201105/51770.shtml?.
63.Raschi E,De Ponti F.Drug-and herb-induced liver injury:progress,current challenges and emerging signals of post-marketing risk.World J Hepatol 2015;7:1761-71.
2.China Society of Hepatology.Chinese Medical Association.CSHclinical guideline:the diagnosis and management of drug-induced liver injury.Shanghai:Shanghai Scientific&Technical Publishers;2015.
3.Bj?rnsson ES,Bergmann OM,Bj?rnsson HK,Kvaran RB,Olafsson S.Incidence,presentation,and outcomes in patients with drug-induced liver injury in the general population of Iceland.Gastroenterology2013;144:1419-25.
4.Miguel A,Azevedo LF,Araújo M,Pereira AC.Frequency of adverse drug reactions in hospitalized patients:a systematic review and metaanalysis.Pharmacoepidemiol Drug Saf 2012;21:1139-54.
5.Andrade RJ,Lucena MI,Kaplowitz N,García MB,Borraz Y,Pachkoria K,et al.Outcome of acute idiosyncratic drug-induced liver injury:long-term follow-up in a hepatotoxicity registry.Hepatology2006;44:1581-8.
6.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.2009.Available from:?http://www.fda.gov/downloads/Drugs/.../Gui dances/UCM174090.pdf?.
7.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 good pharmacovigilance practices and pharmacoepidemiologic assessment.2005.Available from:?https://www.fda.gov/down loads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071696.pdf?.
8.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 postmarketing studies and clinical trialsimplementation of section 505(o)(3)of the Federal Food,Drug,and Cosmetic Act.2011.Available from:?https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf?.
9.Zhang P,Ye YA,Yang XZ,Jiao Y.Systematic review on Chinese herbal medicine induced liver injury.Evid Based Complement Altern Med 2016;2016:3560812.
10.Chalasani NP,Hayashi PH,Bonkovsky HL,Navarro VJ,Lee WM,Fontana RJ,et al.ACG clinical guideline:the diagnosis and management of idiosyncratic drug-induced liver injury.Am J Gastroenterol2014;109:950-67.
11.Farah MH,Edwards R,Lindquist M,Leon C,Shaw D.International monitoring of adverse health effects associated with herbal medicines.Pharmacoepidemiol Drug Saf 2000;9:105-12.
12.Wang JB,Zhu Y,Bai ZF,Wang FS,Li XH,Xiao XH,et al.Guidelines for the diagnosis and management of herb-induced liver injury.Chin J Integr Med 2018;24:696-706.
13.Larrey D.Epidemiology and individual susceptibility to adverse drug reactions affecting the liver.Semin Liver Dis 2002;22:145-55.
14.Bjornsson ES.Epidemiology and risk factors for idiosyncratic druginduced liver injury.Semin Liver Dis 2014;34:115-22.
15.López-Gil S,Nu?o-Lámbarri N,Chávez-Tapia N,Uribe M,BarberoBecerra VJ.Liver toxicity mechanisms of herbs commonly used in Latin America.Drug Metab Rev 2017;49:338-56.
16.Valdivia-Correa B,Gómez-Gutiérrez C,Uribe M,Méndez-Sánchez N.Herbal medicine in Mexico:a cause of hepatotoxicity.Int J Mol Sci2016;17:235.
17.Medina-Caliz I,Garcia-Cortes M,Gonzalez-Jimenez A,Cabello MR,Robles-Diaz M,Sanabria-Cabrera J,et al.Herbal and dietary supplement-induced liver injuries in the Spanish DILI registry.Clin Gastroenterol Hepatol 2018;16:1495-502.
18.Vega M,Verma M,Beswick D,Bey S,Hossack J,Merriman N,et al.The incidence of drug-and herbal and dietary supplement-induced liver injury:preliminary findings from gastroenterologist-based surveillance in the population of the state of Delaware.Drug Saf2017;40:783-7.
19.Jing J,Teschke R.Traditional Chinese medicine and herb-induced liver injury:comparison with drug-induced liver injury.J Clin Transl Hepatol 2018;6:57-68.
20.Navarro VJ,Khan I,Bj?rnsson E,Seeff LB,Serrano J,Hoofnagle JH.Liver injury from herbal and dietary supplements.Hepatology2017;65:363-73.
21.Cho JH,Oh DS,Hong SH,Ko H,Lee NH,Park SE,et al.Anationwide study of the incidence rate of herb-induced liver injury in Korea.Arch Toxicol 2017;91:4009-15.
22.Xu JM.A multicenter survey on hospital inpatients with drug-induced acute liver injury in China.Chin J Dig 2007;27:439-42.
23.Chinese Pharmacopoeia Commission.Guidelines for clinical use of pharmacopoeia of the People's Republic.Beijing:China Medical Science Press;2010.
24.China Association of Chinese Medicine.Chinese herbal medicine quality evaluation methodology guidance.(T/CACM 001-2017).2017.
25.Liu CH,Zhu CW.Epidemic features,major causes,and diagnostic evaluation of herb-induced liver injury.Chin J Clin Hepatol2017;33:829-32.
26.Li CY,Niu M,Bai ZF,Zhang CN,Zhao YL,Li RY,et al.Screening for main components associated with the idiosyncratic hepatotoxicity of a tonic herb Polygonum multiflorum.Front Med 2017;11:253-65.
27.Bai ZF,Gao Y,Zuo XB,Wang JB,Xiao XH.Progress in research on the pathogenesis of immune regulation and idiosyncratic drug-induced liver injury.Acta Pharm Sin 2017;52:1019-26.
28.Pais R,Rusu E,Ratziu V.The impact of obesity and metabolic syndrome on chronic hepatitis B and drug-induced liver disease.Clin Liver Dis 2014;18:165-78.
29.Lucena MI,Andrade RJ,Kaplowitz N,García-Cortes M,Fernández MC,Romero-Gomez M,et al.Phenotypic characterization of idiosyncratic drug-induced liver injury:the influence of age and sex.Hepatology 2009;49:2001-9.
30.Suzman DL,Pelosof L,Rosenberg A.Hepatotoxicity of immune checkpoint inhibitors:an evolving picture of risk associated with a vital class of immunotherapy agents.Liver Int 2018;38:976-87.
31.He LZ,Yin P,Meng YK,Tang JF,He TT,Niu M,et al.Immunological synergistic mechanisms of trans-/cis-stilbene glycosides in Heshouwu related idiosyncratic liver injury.Sci Bull 2017;62:748-51.
32.Amin MD,Harpavat S,Leung DH.Drug-induced liver injury in children.Curr Opin Pediatr 2015;27:625-33.
33.Chalasani N,Regev A.Drug-induced liver injury in patients with preexisting chronic liver disease in drug development:how to identify and manage?.Gastroenterology 2016;151:1046-51.
34.Qian Y,Wang XJ.Rational use of traditional Chinese medicine in the treatment of liver disease and common Chinese medicine related liver injury.Beijing:People's Medical Publishing House;2008.
35.Wang JB,Zhao HP,Zhao YL,Jin C,Liu DJ,Kong WJ,et al.Hepatotoxicity or hepatoprotection pattern recognition for the paradoxical effect of the Chinese herb Rheum palmatum L.in treating rat liver injury.PLoS One 2011;6:e24498.
36.Xing XY,Zhao YL,Kong WJ,WangJB,Jia L,Zhang P,et al.Investigation of the"dose-time-response"relationships of rhubarb on carbon tetrachloride-induced liver injury in rats.J Ethnopharmacol2011;135:575-81.
37.Chen CW,Ma HN,Fu QC,Mao YM,Xie Q,Yu YC.Drug-induced and toxic liver disease.Shanghai:Shanghai Science and Technology Press;2013.
38.Zhu Y,Li YG,Wang Y,Wang LP,Wang JB,Wang RL,et al.Analysis of clinical characteristics in 595 patients with herb-induced liver injury.Chin J Integr Med 2016;36:44-8.
39.Zhu Y,Niu M,Chen J,Zou ZS,Ma ZJ,Liu SH,et al.Comparison between Chinese herbal medicine and Western medicine-induced liver injury of 1985 patients.J Gastroenterol Hepatol 2016;31:1476-82.
40.Lou WQ,Chen CW.Recent advances in the diagnosis and risk assessment of drug-induced liver injury.Liver 2017;22:774-8.
41.Clarke JI,Dear JW,Antoine DJ.Recent advances in biomarkers and therapeutic interventions for hepatic drug safety-false dawn or new horizon?.Exp Opin Drug Saf 2016;15:625-34.
42.Nicoletti P,Aithal GP,Bjornsson ES,Andrade RJ,Sawle A,Arrese M,et al.Association of liver injury from specific drugs,or groups of drugs,with polymorphisms in hla and other genes in a genome-wide association study.Gastroenterology 2017;152:1078-89.
43.Church RJ,Kullak-Ublick GA,Aubrecht J,Bonkovsky HL,Chalasani N,Fontana RJ,et al.,Candidate biomarkers for the diagnosis and prognosis of drug-induced liver injury:Hepatology 2018.Available from:https://doi.org/10.1002/hep.29802.
44.Zhang L,Wong LY,He Y,Wong IC.Pharmacovigilance in China:current situation,successes and challenges.Drug Saf 2014;37:765-70.
45.Tan EH,Low EXS,Dan YY,Tai BC.Systematic review and metaanalysis of algorithms used to identify drug-induced liver injury(DILI)in health record databases.Liver Int 2017.Available from:https://doi.org/10.1111/liv.13646.
46.China Food and Drug Administration.Technical guidelines for acute toxicity study of traditional Chinese medicine and natural medicine.2007.Available from:?http://www.cde.org.cn/zdyz.do?Method?largePage&id?2086?.
47.China Food and Drug Administration.Technical guidelines for longterm toxicity study of traditional Chinese medicine and natural medicine.2007.Available from:?http://www.cde.org.cn/zdyz.do?Method?largePage&id?1498?.
48.Jiang ZZ,Wang XZ,Sun LX,Wang T,Zhang PH,Huang X,et al.Technical methods and application of traditional Chinese medicine toxicity evaluation.Prog Pharm Sci 2013;37:545-7.
49.Wang JB,Cui HR,Bai ZF,Xiao XH.Precision medicine-oriented safety assessment strategy for traditional Chinese medicines:diseasesyndrome-based toxicology.Acta Pharm Sin 2016;51:1681-8.
50.Suzuki A,Brunt EM,Kleiner DE,Miquel R,Smyrk TC,Andrade RJ,et al.The use of liver biopsy evaluation in discrimination of idiopathic autoimmune hepatitis versus drug-induced liver injury.Hepatology2011;54:931-9.
51.Kullak-Ublick GA,Andrade RJ,Merz M,End P,Benesic A,Gerbes AL,et al.Drug-induced liver injury:recent advances in diagnosis and risk assessment.Gut 2017;66:1154-64.
52.Shahbaz O,Mahajan S,Lewis JH.Highlights of drug-and herbinduced liver injury in the literature from 2016:how best to translate new information into clinical practice?.Exp Opin Drug Metab Toxicol2017;13:935-51.
53.Dakhoul L,Ghabril M,Chalasani N.Drug-induced chronic liver injury.J Hepatol 2018;69:248-50.
54.China Food and Drug Administration.General principles of clinical research on traditional Chinese medicine.2015.Available from:?http://samr.cfda.gov.cn/WS01/CL0087/134581.html?.
55.Wang JB,Li CY,Zhu Y,Song HB,Bai ZF,Xiao XH.Integrated evidence chain-based identification of Chinese herbal medicineinduced hepatotoxicity and rational usage:exemplification by Polygonum Multiflorum(He shou wu).Chin Sci Bull 2016;61:971-80.
56.He TT,Gomg M,Bai YF,Zhu Y,Wang JB,Niu M,et al.Clinical analysis of two diagnosis methods for herb-induced liver injury.Chin JChin Mat Med 2016;41:3096-9.
57.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 Clin Epidemiol 1993;46:1323-30.
58.Danan G,Teschke R.RUCAM in drug and herb induced liver injury:the update.Int J Mol Sci 2016;17:14-46.
59.Wang J,Ma Z,Niu M,Zhu Y,Liang Q,Zhao Y,et al.Evidence chainbased causality identification in herb-induced liver injury:exemplification of a well-known liver-restorative herb Polygonum multiflorum.Front Med 2015;9:457-67.
60.Wang JB,Zhang L,Guo YM,Bai ZF,Xiao XH.Causality assessment strategies and methods for Chinese medicines-induced liver injury.Acta Pharm Sin 2018;53:920-8.
61.Xiao XH.Pharmaceutical diseases and their risk prevention and control.Prog Pharm Sci 2018;42:161-3.
62.Ministry of Health of the People’s Republic of China.Administrative measures for the reporting and monitoring of adverse drug reactions.2011.Available from:?http://www.nhc.gov.cn/zwgkzt/wsbysj/201105/51770.shtml?.
63.Raschi E,De Ponti F.Drug-and herb-induced liver injury:progress,current challenges and emerging signals of post-marketing risk.World J Hepatol 2015;7:1761-71.