Preliminary Study On Hepatitis B Vaccine In The Treatment Of Convalescent Chronic Hepatitis B Patients

ObjectiveTo study the efficacy,safety and feasibility of hepatitis B vaccine in the treatment of convalescent chronic hepatitis B patients.Methods54 cases of convalescent chronic hepatitis B were divided into Treatment group(25 cases)and Control group(29 cases)randomly.Treatment group patients were given hepatitis B vaccine by intramuscular injection,20 ug every 4 weeks,24 weeks for a course of treatment;Control group patients were not given hepatitis B vaccine.In two groups the patients with liver dysfunction were given conventional liver drug treatment.All the patients were tested by the routine blood analysis,liver and kidney function,liver spectrum,alpha-fetoprotein,hepatitis B serological markers,HBV DNA,abdominal ultrasound before treatment and after 12 weeks?24 weeks treatment,and analyzed using SAS version 9.2 statistical method.ResultsFirstly,there was no significant difference in the age and sex between Treatment group and Control group(P> 0.05).Secondly,the levels of alanine aminotransferase(ALT),aspartate aminotransferase(AST)and ?-glutamyl transferase(GGT)were measured before and after treatment.In Treatment group abnormal ALT was found in 2 cases before treatment,2 cases after 12 weeks treatment,2 cases after 24 weeks treatment;Abnormal AST was found in 2 cases,2 cases and 2 cases respectively;Abnormal GGT was found in 2 cases,2 cases and 3 cases respectively.In Control group abnormal ALT was found in 3 cases,1 case and 4 cases respectively;Abnormal AST was found in 4 cases,2 cases and 3 cases respectively;Abnormal GGT was found in 7 cases,11 cases and 8 cases respectively.At different time points,the abnormality rates of ALT and AST were no significant difference(P value >0.05)between Treatment group and Control group.The abnormality rate of GGT of Control group was much higher than that of Treatment group after 12 weeks treatment,P value <0.05.Thirdly,before treatment the serum mean concentration and positive rate of hepatitis B surface antibody(HBs Ab)of Treatment group were 125.9±210.86 IU/ml and 88%,and those of Control group were 28.29±87.48 IU/ml and 79.31%,respectively.There was no significant difference between the two groups,P value>0.05.After 12 weeks and 24 weeks treatment the serum mean concentration and positive rate of HBs Ab of Treatment group were 887.5±761.24 IU/ml and 96%,1000±554.2 IU/ml and 96%,and those of Control group were 30.26±112.46 IU/ml and 68.87%,28.6±106.99 IU/ml and 65.52%,respectively.Both of the serum mean concentration and positive rate of HBs Ab of Treatment group were much higher than those of Control group,P value <0.01.In Treatment group both of the serum mean concentration and positive rate of HBs Ab After 12 weeks and 24 weeks treatment were much higher than those before treatment,P value<0.05.But there was no significant difference between HBs Ab after 12 weeks and 24 weeks treatment,P value>0.05.In Control group there was no significant difference between HBs Ab of different time point,P value>0.05.Both of the serum mean concentration and positive rate of hepatitis B core antibody(HBc Ab)and hepatitis B e antibody(HBe Ab)were no significant difference between Treatment group and Control group at the different time points,P value>0.05.In two groups the serum hepatitis B surface antigen and e antigen were not found positive all the time.Fourthly,In two groups the serum hepatitis B virus DNA(HBV DNA)was not found positive all the time,and that showed there was no viral replication.Fifthly,liver failure,liver fibrosis,liver cirrhosis and hepatocellular carcinoma(HCC)were not found in Treatment group and Control group at different time points.Moreover,routine blood analysis and renal function remained normal.There was no hepatitis B vaccine-related adverse reaction,such as fever,rash,nausea and vomiting occured during the observation period.ConclusionHepatitis B vaccine significantly improved the serum HBs Ab levels of patients in Treatment group.During 24 weeks treatment period there was no hepatitis B virus clearance and other hepatitis B virus related liver diseases occurred in both group.Hepatitis B vaccine was safe.