[Case-controlled study of entecavir treatment for chronic severe hepatitis B].

OBJECTIVE: To evaluate the efficacy and safety of entecavir (ETV) treatment for chronic severe hepatitis B. METHODS: 78 patients with chronic severe hepatitis B and positive HBV DNA were divided into ETV group and control group, each group had 39 patients. ETV group was given the same conventional therapy as control group, and was treated with ETV. The change of liver function, PTA, HBV DNA level were observed, and adverse events were recorded. The effective rate of treatment between ETV group and control group, the baseline characteristics between the effective cases and non-responsive cases after ETV treatment were compared at week 12. RESULTS: The baseline characteristics were well balanced between ETV group and control group. The effective rate of ETV group was 56.41% versus 33.33% of control group at week 12 (P = 0.0405). The effective rate of ETV group was higher than that of control group, in the early stage of chronic severe hepatitis B (P = 0.0275), but there was no statistically significant in the middle or late stage (P = 0.4687). The comparison result of baseline characteristics between the effective and non-responsive cases after ETV treatment showed: there were statistically different in age, bilirubin level, HBV DNA level and stage of the severe hepatitis, proportion of cirrhosis, but no statistically different in cholinesterase level, alpha-fetoprotein level and sex ratio, the proportion of ascites, positive HBeAg (P > 0.05). No serious adverse events occurred. CONCLUSIONS: ETV improves the curative effect when used in the early stage of chronic severe hepatitis B, and may not in the middle and late stage. The curative effect of ETV may be affected by age, bilirubin level, HBV DNA level and stage of the severe hepatitis, cirrhosis. ETV has good security in the treatment for chronic severe hepatitis B.