Efficacy of Short-term Immunosuppressive Therapy and Anti-allergenic Therapy in Severe Acute Exacerbation of Chronic Hepatitis B
Not Applicable
- Conditions
- Severe Acute Exacerbation of Chronic Hepatitis B
- Interventions
- Registration Number
- NCT01627236
- Lead Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description glucocorticoid treatment group methylprednisolone -
- Primary Outcome Measures
Name Time Method Child-Pugh degree eight weeks model for end-stage liver disease eight weeks survival rate eight weeks HBV-DNA eight weeks liver function eight weeks ALT,albumin,bilirubine,
prothrombin activity eight weeks
- Secondary Outcome Measures
Name Time Method length of patient stay eight weeks hospitalization costs eight weeks
Trial Locations
- Locations (1)
Deparment of Infectious Diseases, the Second Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China