36 Weeks Short-Term Optimization Treatment of Glucocorticosteroid 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, Short-term
Eligibility Criteria
Inclusion Criteria:
- Meet with ACG clinic guidelines for diagnostic criteria of chronic DILI;
The time of recurrence is 1 or more than 1;
The definition of recurrence, meet any of the following conditions:
- the level of serum AST or ALT is elevated more than 5 fold ULN;
- the level of serum AST or ALT is two times higher than before;
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.
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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
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
36 Weeks Methylprednisolone
48 Weeks Methylprednisolone
Participants in 36 weeks of glucocorticoid treatment group will receive methylprednisolone, 48mg/d for the 1st week, 32mg/d for the 2nd week, 24mg/d for the next two weeks, followed by 16mg/d for 20 weeks and reduction in doses of methylprednisolone by 4 mg per 4 weeks until drug withdrawal. Participants in 36 weeks of glucocorticoid treatment group also will receive standard treatment including reduced glutathione, glycyrrhizin, ademetionine, alprostadil, or ursodeoxycholic acid (UDCA). Participants will then be followed for 24 weeks.
Participants in 48 weeks of glucocorticoid treatment group will receive methylprednisolone, 48mg/d for the 1st week, 32mg/d for the 2nd week, 24mg/d for the next two weeks, followed by 16mg/d for 32 weeks and reduction in doses of methylprednisolone by 4 mg per 4 weeks until drug withdrawal. Participants in glucocorticoid 48 weeks of treatment group also will receive standard treatment including reduced glutathione, glycyrrhizin, ademetionine, alprostadil, or ursodeoxycholic acid (UDCA). Participants will then be followed for 24 weeks.