Efficacy and Safety of Glucocorticosteroid Treatment in the Patients With Chronic Recurrent DILI
Drug-induced Liver Injury,Chronic
About this trial
This is an interventional treatment trial for Drug-induced Liver Injury,Chronic focused on measuring Drug-induced Liver Injury, Recurrence, Methylprednisolone
Eligibility Criteria
Inclusion Criteria:
- Meet with ACG clinic guidelines for diagnostic criteria of chronic DILI;
Meet any of the following conditions:
- serum AST or ALT ≥ 10 fold ULN;
- serum AST or ALT ≥ 5 fold ULN and TBIL ≥ 2 fold ULN;
- liver histology indicates bridging necrosis or multiacinar necrosis or moderate or more inflammation or inflammation G3 or more;
- Women of childbearing age had a negative urine pregnancy test, and the subjects are willing to have no family planning during the study and to take effective measures;
- Voluntary participation, understanding and signing of informed consent, comply with the requirements of the research;
Exclusion Criteria:
- Patients with serious pre-existent comorbid conditions (vertebral compression fractures,psychosis,active peptic ulcer, brittle diabetes,uncontrolled hypertension;
- Patients with intolerances to prednisone;
- Patients with severe infection receiving antibiotics, anti-fungal,anti-viral therapy;
- Viral hepatitis,alcoholic or non-alcoholic liver disease,Wilson's disease or other inherited metabolic liver diseases.
- Pregnancy or desire of pregnancy;
- Breast-feeding;
- Liver cancer or other malignant tumor;
Sites / Locations
- Beijing 302 hospital,China
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Methylprednisolone
Standard Treatment
Participants will receive methylprednisolone from week 0 through week 48 study visit in combination with standard treatment including reduced glutathione, glycyrrhizin, ademetionine, alprostadil,or ursodeoxycholic acid (UDCA) in the first 12 weeks. Participants will then be followed until week 72 study visit.
Participants will only receive standard treatment (namely,routine liver protection drugs) including reduced glutathione, glycyrrhizin, ademetionine, alprostadil,or ursodeoxycholic acid (UDCA) from week 0 through week 12 study visit. Participants will then be followed until week 72 study visit.