中国大陆药物性肝损伤的发病率和病因

StephenW

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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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.

StephenW

中国大陆药物性肝损伤的发病率和病因
陶申1，*
，刘迎霞2，*
，贾尚3，*
，清谢4
，Jun Li5
，明艳6
，徐建明7
，Junqi Niu8
，刘嘉俊9
，Paul B. Watkins10
，Guruprasad P. Aithal11
，RaúlJ。Andrade12
，晓光豆13
，吕凤瑶14
，方方吕15
，齐王16
，Yongguo Li17
，新民周18
，岳新章19
，Peilan Zong20
，宾万21
，郑胜邹22
，梁梁亮23
，余强强24
，梁亮亮25
，Yuya Wang1
，西安汉26
，惠壮1
，伊敏懋27，*，'作者信息关于作者伊敏懋电子邮件作者伊敏毛
，Chengwei Chen28，**，'作者陈成伟的通讯信息，电子邮件作者陈成伟
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DOI：https：//doi.org/10.1053/j.gastro.2019.02.002 |
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文章大纲

材料和方法
3年回顾性多中心研究（“DILI-R”）
案例发现和数据收集
因果关系评估
临床表现
DILI的严重程度和结果
统计分析
结果
人口统计特征
临床报告
年龄，性别和种族的影响
DILI的原因
DILI发病率的估算
讨论
补充材料
参考

背景与目的

我们进行了一项全国性的回顾性研究，以确定中国大陆药物性肝损伤（DILI）的发生率和原因。
方法

我们收集了总共25,927例确诊DILI病例的数据，这些病例于2012年至2014年在中国大陆的308个医疗中心住院。我们收集了所有患者的人口统计学，病史，治疗，实验室，疾病严重程度和死亡率数据。根据Roussel Uclaf因果关系评估方法，每个站点的研究人员被要求完成因出院时诊断为DILI（n = 29,478）的每个病例的因果关系评估。
结果

大多数DILI病例表现为肝细胞损伤（51.39％; 95％置信区间[CI] 50.76-52.03），其次为混合性损伤（28.30％; 95％CI 27.73-28.87）和胆汁淤积性损伤（20.31％; 95％CI 19.80） -20.82）。涉及药物的主要单一类别是传统中药或草药和膳食补充剂（26.81％）和抗结核药物（21.99％）。慢性DILI发生率为13.00％，虽然44.40％的肝细胞DILI病例符合Hy's Law标准，但仅有280例（1.08％）发展为肝功能衰竭，2例接受肝移植（0.01％），102例患者死亡（0.39％）。在死亡人数中，DILI被认为在72人（70.59％）中起主要作用，在21人（20.59％）中起作用，在9人（8.82％）中没有任何作用。假设在中国整个住院人群中DILI的比例由DILI捕获完成的66个中心观察到，我们估计一般人口的年发病率为每10万人23.80（95％CI 20.86-26.74） ）。该分析仅包括住院患者，因此真实发病率可能更高。
结论

在一项确定中国大陆DILI发病率和原因的回顾性研究中，一般人群的年发病率估计为每10万人23.80人;高于西方国家的报道。中药，中草药和膳食补充剂以及抗结核药物是中国大陆DILI的主要原因。

StephenW

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