A Prognostic Model for Drug-induced Liver Injury in China

A Prognostic Model for Drug-induced Liver Injury in China : A Multi-center, Prospective Cohort Study

A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and screen novel serum markers.

A prognostic model incorporating with the novel serum marker(s) for DILI would be established and validated to imporve the prognosis of patients in China .

Research Objectives:

1. To establish a standardized multi-center, prospective DILI cohort nationwide and obtain long-term prognostic data.
2. To establish and verify prognostic model(s) of DILI in China.
3. To explore novel serum biomarkers for the prognosis of DILI.

Inclusion Criteria:

1. RUCAM ≥6 and met one of the following biochemical conditions: (1) ALT≥5 ULN, (2) or ALP ≥2 ULN, (3) or ALT≥3 ULN and TBil≥2 ULN.
2. RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis.
3. Onset to enrollment ≤3 months.

Exclusion Criteria:

1. Hepatotropic viral infection: hepatitis A, B, C, D and E.
2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.
3. Hypoxic ischemic hepatitis and congestive liver disease.
4. Alcohol consumption: male >40g/d, female >20g/d, and ≥5 years.
5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.
6. Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG) simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment.
7. Parasitic infection.
8. Sepsis.
9. Previous liver transplantation or bone marrow transplantation.
10. Pregnancy or lactation.
11. Genetic and metabolic liver diseases.