Clinical study on using anti-HBV therapeutic vaccine in the treatment of chronic HBV carriers / 解放军医学杂志

ABSTRACT

Objective To evaluate prove the clinical efficacy of anti HBV therapeutic vaccine in the treatment of chronic HBV carriers. Methods 600 patients diagnosed as chronic HBV carrier based on the criteria formulated by the National Conference of Viral Hepatitis in 1997 were enrolled for the study. The patients were randomly assigned into 2 groups. In the first group, 300 patients were given anti HBV therapeutic vaccine subcutaneously once a month, tagether with vitamin C 500mg p o. once a day for 12 months. Patients in the second group received normal saline 2 ml/month by subcutaneous injection and vitamin C 500mg/day p o. for 12months. There were no significant deferences in the age, sex, duration of the illness and the positive rate of serum HBV markers between the 2 groups. At the week 12, 24 and 48 after treatment, the patients were reexamined in the hospital. Serum HBsAg, HBeAg, HBV DNA, anti HBe, anti HBs and ALT were assayed before the treatment and at week 12, 24 and 48 during the course of the therapy. The efficacy of the treatment was evaluated on basis of the results of the assessment of parameters described above at week 48. After completion of the treatment, 208 patients in the treatment group and 196 cases in the control group were followed up for 12 months, and serum HBV markers were checked at the 12th month. The changes in HBV markers during the follow up study were analysed to evaluate the sustained effect after the therapy was ceased. Results The seronegative rates of serum HBsAg, HBeAg and HBV DNA in the treatment group were 14 7%, 32 0% and 37 3%, respectively, and they were significantly higher compared with the control group ( P