Establishment of Drug-induced Liver Injury Databases and Application of Circulating miRNA
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- histological features of drug-induced liver injury obtained by liver biopsy
研究概览
简要总结
The purpose of the study is to establish drug-induced liver injury databases in China, make criteria for Chinese drug-induced liver injury patients and evaluate the application of certain circulating miRNA in diagnosis or treatment of drug-induced liver injury.
详细描述
Firstly, this study collects some retrospective data. Analyse these data and establish certain unique diagnostic criteria for Chinese. Then collect prospective data and validate the criteria. Otherwise,collect blood sample or other sample of the patients and study certain miRNA in diagnosis or treatment of drug-induced liver injury.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females between the age of 18 to 70 years
- •Women in child-bearing period taking some contraception measures
- •Patients with onset of acute liver injury attributed to antituberculosis drugs or antineoplastic drugs, Roussel Uclaf Causality Assessment Method（RUCAM ） score≥6
- •Written informed consent can be obtained, some patients agree with liver biopsy
排除标准
- •Viral hepatitis
- •Alcoholic liver disease or non-alcoholic liver disease
- •Wilson's disease or other inherited metabolic liver diseases
- •Auto-immune liver diseases
- •Any dysfunction of liver
- •Malnutrition
- •Chronic diseases such as HIV,severe heart diseases, severe brain diseases or chronic kidney diseases
- •Patients who can not complete follow-ups on time
结局指标
主要结局
histological features of drug-induced liver injury obtained by liver biopsy
时间窗: within six months of the DILI onset date
Liver biopsy is the main method
clinical features of drug-induced liver injury assessed by serum parameters of liver function
时间窗: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
serum parameters of liver function is the focus
次要结局
未报告次要终点
研究者
Wen Xie
head of department
Beijing Ditan Hospital