Tao Shen1, Yingxia Liu2, Jia Shang3, Qing Xie4, Jun Li5, Ming Yan6, Jianming Xu7, Junqi Niu8, Jiajun Liu9, Paul B Watkins10, Guruprasad P Aithal11, Raúl J Andrade12, Xiaoguang Dou13, Lvfeng Yao14, Fangfang Lv15, Qi Wang16, Yongguo Li17, Xinmin Zhou18, Yuexin Zhang19, Peilan Zong20, Bin Wan21, Zhengsheng Zou22, Dongliang Yang23, Yuqiang Nie24, Dongliang Li25, Yuya Wang1, Xi'an Han26, Hui Zhuang1, Yimin Mao27, Chengwei Chen28. 1. Department of Microbiology and Center of Infectious Disease, School of Basic Medical Sciences, Peking University Health Science Center, Beijing, China. 2. Department of Liver Disease, Third People's Hospital of Shenzhen, Shenzhen, China. 3. Department of Infectious Diseases, Henan Provincial People's Hospital, Zhengzhou, Henan, China. 4. Department of Infectious Diseases, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China. 5. Department of Infectious Diseases, Jiangsu Province Hospital, Nanjing, China. 6. Department of Elderly Digestive System, Qilu Hospital of Shandong University, 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 at Chapel Hill, Research Triangle Park, and Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, Chapel Hill, North Carolina. 11. NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS 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. 14. Department of Gastroenterology, 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, Second Hospital of Shanxi Medical University, Taiyuan, China. 17. Department of Infectious Diseases, First Affiliated Hospital of Harbin Medical 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 of Cardiology, 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. 24. Department of Gastroenterology, Guangzhou First People's Hospital, Guangzhou, China. 25. Department of Hepatobiliary Disease, Fuzhou General Hospital of Nanjing Military Command, Fuzhou, China. 26. Unimed Scientific, Wuxi, China. 27. 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. 28. 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.
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.
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: Nina Weiler; Andreas Schlotmann; Andreas Anton Schnitzbauer; Stefan Zeuzem; Martin-Walter Welker Journal: Dtsch Arztebl Int Date: 2020-01-24 Impact factor: 5.594
Authors: Helgi K Björnsson; Einar S Björnsson; Bharathi Avula; Ikhlas A Khan; Jon G Jonasson; Marwan Ghabril; Paul H Hayashi; Victor Navarro Journal: Liver Int Date: 2020-02-11 Impact factor: 5.828