Efficacy of Short-term Immunosuppressive Therapy and Anti-allergenic Therapy in Severe Acute Exacerbation of Chronic Hepatitis B
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Child-Pugh degree
Study Overview
Brief Summary
The investigators will investigate the clinicopathological features of chronic hepatitis B patients with severe exacerbation selected by uniform criteria, and treated with early introduction or reintroduction of corticosteroids and anti-allergenic therapy, in order to clarify the benefits and limitations of the effects of corticosteroids and anti-allergenic therapy for amelioration of clinically severe exacerbation of chronic hepatitis B. The investigators also observe the immune index in the change before and after the treatment, in order to searching for some prognostic index.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •serum hepatitis B surface antigen(HBsAg) positive for at least 6 months;
- •All patients had a poor general condition, manifested as general malaise, fatigue, jaundice and so on;
- •serum T-Bil of 85.5 mmol/L or more; or serum T-Bil rises 17.1 mmol/L or more per day; or PTA of less than 60%;
- •serum ALT of 20 times or more the ULN.
Exclusion Criteria
- •superinfection or co-infection with hepatitis A, C, D, E, cytomegalovirus and HIV, or Epstein-Barr virus;
- •other liver diseases such as alcoholic liver disease, drug-induced hepatitis, Wilson disease and autoimmune hepatitis;
- •ascites or gastrointestinal bleeding or peptic ulcer or esophageal varix by electronic gastroscope examination;
- •decompensated liver cirrhosis;
- •severe bacterial or fungal infections;
- •a history of diabetes or cardiac disease or hypertension or nephrosis.
Arms & Interventions
glucocorticoid treatment group
Intervention: methylprednisolone (Drug)
Outcomes
Primary Outcomes
Child-Pugh degree
Time Frame: eight weeks
model for end-stage liver disease
Time Frame: eight weeks
survival rate
Time Frame: eight weeks
HBV-DNA
Time Frame: eight weeks
liver function
Time Frame: eight weeks
ALT,albumin,bilirubine,
prothrombin activity
Time Frame: eight weeks
Secondary Outcomes
- length of patient stay(eight weeks)
- hospitalization costs(eight weeks)
Investigators
Zhe-bin Wu
Principal Investigator
Third Affiliated Hospital, Sun Yat-Sen University