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Incidence and Etiology of Drug-Induced Liver Injury in Mainland China.
Gastroenterology 2019; 156(8):2230-2241.e11G

Abstract

BACKGROUND & AIMS

We performed a nationwide, retrospective study to determine the incidence and causes of drug-induced liver injury (DILI) in mainland China.

METHODS

We collected data on a total of 25,927 confirmed DILI cases, hospitalized from 2012 through 2014 at 308 medical centers in mainland China. We collected demographic, medical history, treatment, laboratory, disease severity, and mortality data from all patients. Investigators at each site were asked to complete causality assessments for each case whose diagnosis at discharge was DILI (n = 29,478) according to the Roussel Uclaf Causality Assessment Method.

RESULTS

Most cases of DILI presented with hepatocellular injury (51.39%; 95% confidence interval [CI] 50.76-52.03), followed by mixed injury (28.30%; 95% CI 27.73-28.87) and cholestatic injury (20.31%; 95% CI 19.80-20.82). The leading single classes of implicated drugs were traditional Chinese medicines or herbal and dietary supplements (26.81%) and antituberculosis medications (21.99%). Chronic DILI occurred in 13.00% of the cases and, although 44.40% of the hepatocellular DILI cases fulfilled Hy's Law criteria, only 280 cases (1.08%) progressed to hepatic failure, 2 cases underwent liver transplantation (0.01%), and 102 patients died (0.39%). Among deaths, DILI was judged to have a primary role in 72 (70.59%), a contributory role in 21 (20.59%), and no role in 9 (8.82%). Assuming the proportion of DILI in the entire hospitalized population of China was represented by that observed in the 66 centers where DILI capture was complete, we estimated the annual incidence in the general population to be 23.80 per 100,000 persons (95% CI 20.86-26.74). Only hospitalized patients were included in this analysis, so the true incidence is likely to be higher.

CONCLUSIONS

In a retrospective study to determine the incidence and causes of DILI in mainland China, the annual incidence in the general population was estimated to be 23.80 per 100,000 persons; higher than that reported from Western countries. Traditional Chinese medicines, herbal and dietary supplements, and antituberculosis drugs were the leading causes of DILI in mainland China.

Authors+Show Affiliations

Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China.Department of Liver Disease, Third People's Hospital of Shenzhen, Shenzhen, China.Department of Infectious Diseases, Henan Provincial People's Hospital, Zhengzhou, Henan, China.Department of Infectious Diseases, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.Department of Infectious Diseases, Jiangsu Province Hospital, Nanjing, China.Department of Elderly Digestive System, Qilu Hospital of Shandong University, Jinan, China.Department of Gastroenterology, First Affiliated Hospital of Medical University of Anhui, Hefei, China.Department of Hepatology, First Affiliated Hospital of Jilin University, Changchun, China.Department of Infectious Diseases, First Affiliated Hospital of Xiamen University, Xiamen, China.Institute for Drug Safety Sciences, University of North Carolina at Chapel Hill, Research Triangle Park, and Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina.NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University Of Nottingham, Nottingham, UK.Unidad de Gestión Clínica de Enfermedades Digestivas, Instituto de Investigación Biomédica de Malaga (IBIMA), Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Málaga, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.Department of Infectious Diseases, Shengjing Hospital, China Medical University, Shenyang, China.Department of Gastroenterology, Mengchao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China.Department of liver Infection, Sir Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.Department of Gastroenterology, Second Hospital of Shanxi Medical University, Taiyuan, China.Department of Infectious Diseases, First Affiliated Hospital of Harbin Medical University, Harbin, China.Department of Hepatology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.Department of Infectious Diseases, First Affiliated Hospital, Xinjiang Medical University, Urumqi, China.Department of Cardiology, Chest Hospital of Jiangxi Province, Nanchang, China.Public Health Clinical Centre of Chengdu, Chengdu, China.Center for Non-Infectious Liver Diseases, 302 Military Hospital of China, Beijing, China.Department of Infectious Diseases, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.Department of Gastroenterology, Guangzhou First People's Hospital, Guangzhou, China.Department of Hepatobiliary Disease, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China.Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China.Unimed Scientific, Wuxi, China.Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China.Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, and Clinical Research Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China. Electronic address: maoym11968@163.com.Shanghai Liver Diseases Research Center, 85th Hospital of Nanjing Military Command, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. Electronic address: ccw2@163.com.

Pub Type(s)

Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

30742832

Citation

Shen, Tao, et al. "Incidence and Etiology of Drug-Induced Liver Injury in Mainland China." Gastroenterology, vol. 156, no. 8, 2019, pp. 2230-2241.e11.
Shen T, Liu Y, Shang J, et al. Incidence and Etiology of Drug-Induced Liver Injury in Mainland China. Gastroenterology. 2019;156(8):2230-2241.e11.
Shen, T., Liu, Y., Shang, J., Xie, Q., Li, J., Yan, M., ... Chen, C. (2019). Incidence and Etiology of Drug-Induced Liver Injury in Mainland China. Gastroenterology, 156(8), pp. 2230-2241.e11. doi:10.1053/j.gastro.2019.02.002.
Shen T, et al. Incidence and Etiology of Drug-Induced Liver Injury in Mainland China. Gastroenterology. 2019;156(8):2230-2241.e11. PubMed PMID: 30742832.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Incidence and Etiology of Drug-Induced Liver Injury in Mainland China. AU - Shen,Tao, AU - Liu,Yingxia, AU - Shang,Jia, AU - Xie,Qing, AU - Li,Jun, AU - Yan,Ming, AU - Xu,Jianming, AU - Niu,Junqi, AU - Liu,Jiajun, AU - Watkins,Paul B, AU - Aithal,Guruprasad P, AU - Andrade,Raúl J, AU - Dou,Xiaoguang, AU - Yao,Lvfeng, AU - Lv,Fangfang, AU - Wang,Qi, AU - Li,Yongguo, AU - Zhou,Xinmin, AU - Zhang,Yuexin, AU - Zong,Peilan, AU - Wan,Bin, AU - Zou,Zhengsheng, AU - Yang,Dongliang, AU - Nie,Yuqiang, AU - Li,Dongliang, AU - Wang,Yuya, AU - Han,Xi'an, AU - Zhuang,Hui, AU - Mao,Yimin, AU - Chen,Chengwei, Y1 - 2019/02/08/ PY - 2018/09/14/received PY - 2019/02/04/revised PY - 2019/02/05/accepted PY - 2019/2/12/pubmed PY - 2019/6/30/medline PY - 2019/2/12/entrez KW - Asia KW - Epidemiology KW - Jaundice KW - RUCAM SP - 2230 EP - 2241.e11 JF - Gastroenterology JO - Gastroenterology VL - 156 IS - 8 N2 - BACKGROUND & AIMS: We performed a nationwide, retrospective study to determine the incidence and causes of drug-induced liver injury (DILI) in mainland China. METHODS: We collected data on a total of 25,927 confirmed DILI cases, hospitalized from 2012 through 2014 at 308 medical centers in mainland China. We collected demographic, medical history, treatment, laboratory, disease severity, and mortality data from all patients. Investigators at each site were asked to complete causality assessments for each case whose diagnosis at discharge was DILI (n = 29,478) according to the Roussel Uclaf Causality Assessment Method. RESULTS: Most cases of DILI presented with hepatocellular injury (51.39%; 95% confidence interval [CI] 50.76-52.03), followed by mixed injury (28.30%; 95% CI 27.73-28.87) and cholestatic injury (20.31%; 95% CI 19.80-20.82). The leading single classes of implicated drugs were traditional Chinese medicines or herbal and dietary supplements (26.81%) and antituberculosis medications (21.99%). Chronic DILI occurred in 13.00% of the cases and, although 44.40% of the hepatocellular DILI cases fulfilled Hy's Law criteria, only 280 cases (1.08%) progressed to hepatic failure, 2 cases underwent liver transplantation (0.01%), and 102 patients died (0.39%). Among deaths, DILI was judged to have a primary role in 72 (70.59%), a contributory role in 21 (20.59%), and no role in 9 (8.82%). Assuming the proportion of DILI in the entire hospitalized population of China was represented by that observed in the 66 centers where DILI capture was complete, we estimated the annual incidence in the general population to be 23.80 per 100,000 persons (95% CI 20.86-26.74). Only hospitalized patients were included in this analysis, so the true incidence is likely to be higher. CONCLUSIONS: In a retrospective study to determine the incidence and causes of DILI in mainland China, the annual incidence in the general population was estimated to be 23.80 per 100,000 persons; higher than that reported from Western countries. Traditional Chinese medicines, herbal and dietary supplements, and antituberculosis drugs were the leading causes of DILI in mainland China. SN - 1528-0012 UR - https://www.unboundmedicine.com/medline/citation/30742832/Incidence_and_Etiology_of_Drug_Induced_Liver_Injury_in_Mainland_China_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5085(19)30364-6 DB - PRIME DP - Unbound Medicine ER -