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

被引：832

作者：

Shen, Tao ^{[1
,2
]}

Liu, Yingxia ^{[3
]}

Shang, Jia ^{[4
]}

Xie, Qing ^{[5
]}

Li, Jun ^{[6
]}

Yan, Ming ^{[7
]}

Xu, Jianming ^{[8
]}

Niu, Junqi ^{[9
]}

Liu, Jiajun ^{[10
]}

Watkins, Paul B. ^{[11
,12
]}

Aithal, Guruprasad P. ^{[13
,14
]}

Andrade, Raul J. ^{[15
,16
]}

Dou, Xiaoguang ^{[17
]}

Yao, Lvfeng ^{[18
]}

Lv, Fangfang ^{[19
]}

Wang, Qi ^{[20
]}

Li, Yongguo ^{[21
]}

Zhou, Xinmin ^{[22
]}

Zhang, Yuexin ^{[23
]}

Zong, Peilan ^{[24
]}

Wan, Bin ^{[25
]}

Zou, Zhengsheng ^{[26
]}

Yang, Dongliang ^{[27
]}

Nie, Yuqiang ^{[28
]}

Li, Dongliang ^{[29
]}

Wang, Yuya ^{[1
,2
]}

Han, Xi'an ^{[30
]}

Zhuang, Hui ^{[1
,2
]}

Mao, Yimin ^{[31
,32
]}

Chen, Chengwei ^{[33
]}

机构：

[1] Peking Univ, Dept Microbiol, Sch Basic Med Sci, Hlth Sci Ctr, Beijing, Peoples R China

[2] Peking Univ, Ctr Infect Dis, Hlth Sci Ctr, Beijing, Peoples R China

[3] Third Peoples Hosp Shenzhen, Dept Liver Dis, Shenzhen, Peoples R China

[4] Henan Prov Peoples Hosp, Dept Infect Dis, Zhengzhou, Henan, Peoples R China

[5] Shanghai Jiao Tong Univ, Dept Infect Dis, Ruijin Hosp, Sch Med, Shanghai, Peoples R China

[6] Jiangsu Prov Hosp, Dept Infect Dis, Nanjing, Jiangsu, Peoples R China

[7] Shandong Univ, Dept Elderly Digest Syst, Qilu Hosp, Jinan, Shandong, Peoples R China

[8] Med Univ Anhui, Dept Gastroenterol, Affiliated Hosp 1, Hefei, Anhui, Peoples R China

[9] Jilin Univ, Dept Hepatol, Affiliated Hosp 1, Changchun, Jilin, Peoples R China

[10] Xiamen Univ, Dept Infect Dis, Affiliated Hosp 1, Xiamen, Peoples R China

[11] Univ North Carolina Chapel Hill, Inst Drug Safety Sci, Res Triangle Pk, NC USA

[12] UNC Eshelman Sch Pharm, Div Pharmacotherapy & Expt Therapeut, Chapel Hill, NC USA

[13] Nottingham Univ Hosp NHS Trust, NIHR Nottingham Biomed Res Ctr, Nottingham, England

[14] Univ Nottingham, Nottingham, England

[15] Univ Malaga, Unidad Gest Clin Enfermedades Digest, Inst Invest Biomed Malaga IBIMA, Hosp Univ Virgen de la Victoria, Malaga, Spain

[16] Ctr Invest Biomed Red Enfermedades Hepat & Digest, Madrid, Spain

[17] China Med Univ, Dept Infect Dis, Shengjing Hosp, Shenyang, Liaoning, Peoples R China

[18] Fujian Med Univ, Dept Gastroenterol, Mengchao Hepatobiliary Hosp, Fuzhou, Fujian, Peoples R China

[19] Zhejiang Univ, Dept Liver Infect, Sir Run Shaw Hosp, Sch Med, Hangzhou, Zhejiang, Peoples R China

[20] Shanxi Med Univ, Dept Gastroenterol, Hosp 2, Taiyuan, Shanxi, Peoples R China

[21] Harbin Med Univ, Dept Infect Dis, Affiliated Hosp 1, Harbin, Heilongjiang, Peoples R China

[22] Fourth Mil Med Univ, Dept Hepatol, Xijing Hosp, Xian, Shaanxi, Peoples R China

[23] Xinjiang Med Univ, Dept Infect Dis, Affiliated Hosp 1, Urumqi, Peoples R China

[24] Chest Hosp Jiangxi Prov, Dept Cardiol, Nanchang, Jiangxi, Peoples R China

[25] Publ Hlth Clin Ctr Chengdu, Chengdu, Sichuan, Peoples R China

[26] 302 Mil Hosp China, Ctr Noninfect Liver Dis, Beijing, Peoples R China

[27] Huazhong Univ Sci & Technol, Dept Infect Dis, Tongji Med Coll, Union Hosp, Wuhan, Hubei, Peoples R China

[28] Guangzhou First Peoples Hosp, Dept Gastroenterol, Guangzhou, Guangdong, Peoples R China

[29] Nanjing Mil Command, Dept Hepatobiliary Dis, Fuzhou Gen Hosp, Fuzhou, Fujian, Peoples R China

[30] Unimed Sci, Wuxi, Peoples R China

[31] Shanghai Jiao Tong Univ, Div Gastroenterol & Hepatol, Shanghai Inst Digest Dis, Renji Hosp,Sch Med, Shanghai 200001, Peoples R China

[32] Shanghai Jiao Tong Univ, Clin Res Ctr, Sch Med, Shanghai 200001, Peoples R China

[33] Shanghai Jiao Tong Univ, Shanghai Liver Dis Res Ctr, Nanjing Mil Command, Hosp 85,Tongren Hosp,Sch Med, Shanghai, Peoples R China

来源：

GASTROENTEROLOGY | 2019年 / 156卷 / 08期

基金：

中国国家自然科学基金;

关键词：

Jaundice; RUCAM; Asia; Epidemiology; CAUSALITY ASSESSMENT; ADVERSE REACTIONS; BREAST-CANCER; POPULATION; EPIDEMIOLOGY; CYCLOPHOSPHAMIDE; TRANSPLANTATION; SURVEILLANCE; DIAGNOSIS; OUTCOMES;

D O I：

10.1053/j.gastro.2019.02.002

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

100201 [内科学];

摘要：

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.

引用

页码：2230 / +

页数：23

共 47 条

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