机构：[1]Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University HealthScience Center, Beijing, China[2]Department of Liver Disease, Third People’s Hospital of Shenzhen, Shenzhen, China深圳市康宁医院深圳医学信息中心[3]Department of Infectious Diseases, Henan Provincial People’s Hospital, Zhengzhou, Henan, China[4]Department of InfectiousDiseases, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China[5]Department of InfectiousDiseases, Jiangsu Province Hospital, Nanjing, China江苏省人民医院[6]Department of Elderly Digestive System, Qilu Hospital of ShandongUniversity, Jinan, China[7]Department of Gastroenterology, First Affiliated Hospital of Medical University of Anhui, Hefei, China[8]Department of Hepatology, First Affiliated Hospital of Jilin University, Changchun, China[9]Department of Infectious Diseases,First Affiliated Hospital of Xiamen University, Xiamen, China[10]Institute for Drug Safety Sciences, University of North Carolina atChapel Hill, Research Triangle Park, and Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman Schoolof Pharmacy, Chapel Hill, North Carolina[11]NIHR Nottingham Biomedical Research Centre, Nottingham University HospitalsNHS Trust and the University Of Nottingham, Nottingham, UK[12]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[13]Department of Infectious Diseases, Shengjing Hospital, China Medical University, Shenyang, China中国医科大学附属盛京医院中国医科大学盛京医院[14]Department ofGastroenterology, Mengchao Hepatobiliary Hospital, Fujian Medical University, Fuzhou, China[15]Department of liver Infection,Sir Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China[16]Department of Gastroenterology, SecondHospital of Shanxi Medical University, Taiyuan, China[17]Department of Infectious Diseases, First Affiliated Hospital of HarbinMedical University, Harbin, China[18]Department of Hepatology, Xijing Hospital, Fourth Military Medical University, Xi’an, China[19]Department of Infectious Diseases, First Affiliated Hospital, Xinjiang Medical University, Urumqi, China[20]Department ofCardiology, Chest Hospital of Jiangxi Province, Nanchang, China[21]Public Health Clinical Centre of Chengdu, Chengdu, China[22]Center for Non-Infectious Liver Diseases, 302 Military Hospital of China, Beijing, China[23]Department of Infectious Diseases,Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China华中科技大学同济医学院附属协和医院[24]Department ofGastroenterology, Guangzhou First People’s Hospital, Guangzhou, China[25]Department of Hepatobiliary Disease, FuzhouGeneral Hospital of Nanjing Military Command, Fuzhou, China[26]Unimed Scientific, Wuxi, China[27]Division ofGastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai JiaoTong University, and Clinical Research Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China[28]Shanghai Liver Diseases Research Center, 85th Hospital of Nanjing Military Command, Tongren Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China
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.
基金：
Major Project of National Twelfth Five Plan [2012ZX09303-001]; Major Project of National Thirteenth Five Plan [2017ZX09304016]; National Natural Science Foundation of ChinaNational Natural Science Foundation of China [NSFC 81670524]; Shanghai Shenkang Hospital Development Center [16CR2009A]; Clinical Research Center, Shanghai Jiao Tong University School of Medicine [DLY201607]
第一作者机构：[1]Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University HealthScience Center, Beijing, China
共同第一作者：
通讯作者：
通讯机构：[27]Division ofGastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai JiaoTong University, and Clinical Research Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China[28]Shanghai Liver Diseases Research Center, 85th Hospital of Nanjing Military Command, Tongren Hospital, Shanghai JiaoTong University School of Medicine, Shanghai, China[*1]Division of Gastroenterology and Hepatology, Shanghai Institute of Digestive Disease, Renji Hospital,School of Medicine, Shanghai Jiao Tong University, Clinical Research Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200001, China. Shanghai, China.[*2]Shanghai Liver Diseases Research Center, 85th Hospital of Nanjing Military Command, Shanghai 200235,China,Tongren Hospital, Shanghai Jiao Tong University School of Medicine,Shanghai 200050, China.
推荐引用方式(GB/T 7714)：
Tao Shen,Yingxia Liu,Jia Shang,et al.Incidence and Etiology of Drug-Induced Liver Injury in Mainland China[J].GASTROENTEROLOGY.2019,156(8):2230-+.doi:10.1053/j.gastro.2019.02.002.
APA：
Tao Shen,Yingxia Liu,Jia Shang,Qing Xie,Jun Li...&Chengwei Chen.(2019).Incidence and Etiology of Drug-Induced Liver Injury in Mainland China.GASTROENTEROLOGY,156,(8)
MLA：
Tao Shen,et al."Incidence and Etiology of Drug-Induced Liver Injury in Mainland China".GASTROENTEROLOGY 156..8(2019):2230-+
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