HBV-ACLF
Conditions
Interventions
Methylprednisolone group:common medical treatment, combined with methylprednisolone 40mg intravenously once a day, discontinued after 5 days
Zidaxian group:common medical treatment, combined with the Zidaxian 1.6mg subcutaneous injection once a day, discontinued after 5 days.
Control group:Routine medical treatment.
Sponsors
Zhejiang University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) The patient agrees to participate in the study and sign the informed consent form; 2) Male and female aged 18-65 years old; 3) HBsAg positive for more than 6 months and positive for HBV DNA (higher than 1000copies/ml or 200 IU/ml); 4) Extremely weak, and have obvious gastrointestinal symptoms such as anorexia, abdominal distension, nausea, and vomiting; 5) The jaundice is progressively deepened in the short term (the serum total bilirubin is greater than 10 times the upper limit of normal or daily increase is >=17.1umol/L); 6) The bleeding tendency is obvious, PTA<=40%, and other reasons are excluded; 7) Less than or equal to 1 organ dysfunction except for criteria 5) and 6) above; 8) The disease is on the rise phrase, ALT/TB has not reached its peak, and ALT is greater than 500 U/L, TB is less than 204 umol/L (12 mg/dl, SOFA score 4); 9) Patients with chronic liver disease based on chronic liver disease have not been diagnosed with cirrhosis.
Exclusion criteria
Exclusion criteria: 1) Acute pregnancy fatty liver; 2) drug-induced liver damage; 3) Alcoholic liver disease; 4) autoimmune liver disease; 5) Congenital metabolic liver disease, such as wilson disease, hemochromatosis, etc.; 6) Hepatitis B recurrence after transplantation leads to severe hepatitis; 7) Concomitant with other viral infections (anti-HAV IgM, anti-HCV, anti-HEV IgM, anti-HEV-IgG, anti-HDV-IgM, and anti-HIV antibodies); 8) Associated with severe underlying diseases, including uncontrolled clinically significant heart, lung, kidney, digestive, neurological, psychiatric, immunological, metabolic, or malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complication rate; | — |
Countries
China
Contacts
Public ContactJianrong Huang
The First Affiliated Hospital, College of Medicine, Zhejiang University
Outcome results
None listed