Efficacy of Short-term Immunosuppressive Therapy and Anti-allergenic Therapy in Severe Acute Exacerbation of Chronic Hepatitis B

Sun Yat-sen University

Status

Unknown

Conditions

Severe Acute Exacerbation of Chronic Hepatitis B

Treatments

Drug: methylprednisolone

Study type

Interventional

Funder types

Other

Identifiers

NCT01627236

zssywzb01

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.