Incidence and Etiology of Drug-Induced Liver Injury in Mainland China
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,∗,'Correspondence information about the author Yimin MaoEmail the author Yimin Mao
, Chengwei Chen28,∗∗,'Correspondence information about the author Chengwei ChenEmail the author Chengwei Chen
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DOI: https://doi.org/10.1053/j.gastro.2019.02.002 |
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Abstract
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Article Outline
Materials and Methods
A 3-Year Retrospective Multicentric Study (“DILI-R”)
Case finding and data collection
Causality assessment
Clinical presentation
Severity of DILI and outcomes
Statistical Analysis
Results
Demographic Features
Clinical Presentations
Effect of Age, Gender, and Ethnicity
Causes of DILI
Estimation of Incidence of DILI
Discussion
Supplementary Material
References
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.作者: StephenW 时间: 2019-5-29 21:07