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Incidence and Etiology of Drug-Induced Liver Injury in Mainland China

Shen, Tao; Liu, Yingxia; Shang, Jia; Xie, Qing; Li, Jun; Yan, Ming; Xu, Jianming; Niu, Junqi; Liu, Jiajun; Watkins, Paul B.; Aithal, Guruprasad P.; Andrade, Raúl J.; Dou, Xiaoguang; Yao, Lvfeng; Lv, Fangfang; Wang, Qi; Li, Yongguo; Zhou, Xinmin; Zhang, Yuexin; Zong, Peilan; Wan, Bin; Zou, Zhengsheng; Yang, Dongliang; Nie, Yuqiang; Li, Dongliang; Wang, Yuya; Han, Xi’an; Zhuang, Hui; Mao, Yimin; Chen, Chengwei

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Tao Shen

Yingxia Liu

Jia Shang

Qing Xie

Jun Li

Ming Yan

Jianming Xu

Junqi Niu

Jiajun Liu

Paul B. Watkins

Raúl J. Andrade

Xiaoguang Dou

Lvfeng Yao

Fangfang Lv

Qi Wang

Yongguo Li

Xinmin Zhou

Yuexin Zhang

Peilan Zong

Bin Wan

Zhengsheng Zou

Dongliang Yang

Yuqiang Nie

Dongliang Li

Yuya Wang

Xi’an Han

Hui Zhuang

Yimin Mao

Chengwei Chen


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% 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 anti-tuberculosis 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 drug-induced liver injury (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 anti-tuberculosis drugs were the leading causes of DILI in mainland China

Journal Article Type Article
Acceptance Date Feb 5, 2019
Online Publication Date Feb 8, 2019
Publication Date 2019-06
Deposit Date Feb 18, 2019
Publicly Available Date Feb 19, 2019
Journal Gastroenterology
Print ISSN 2308-2097
Electronic ISSN 1528-0012
Publisher Publishing House Zaslavsky
Peer Reviewed Peer Reviewed
Volume 156
Issue 8
Pages 2230-2241.e11
Keywords Gastroenterology
Public URL
Publisher URL


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