OBJECTIVE: To investigate the anti-HBV efficacy of bifendate in treatment of chronic hepatitis B. METHODS: A total of 119 patients with chronic hepatitis B were randomly divided into treatment group (n = 65, aged 24 +/- 12) and control group (n = 54, aged 25 +/- 11). In the treatment group every patient was given higher doses bifendate pills (</= 12 age, 30 approximately 45 mg/d; > 12 age, 45 approximately 67.5 mg/d) for up to 12 months. Hepatic function test was performed and HBeAg, HBeAband HBV DNA were detected at regular intervals in all patients. RESULTS: The serum alanine amonotransferase (ALT) decreased to normal only one month later in 70.76% of patients in the treatment group and decreased to normal at least in 2 approximately 3 months in the control group (P < 0.01). The serum conversion rates of HBeAg, HBeAband HBV DNA in the treatment group were 44.4%, 29.3%, 38.5%, respectively, which were significantly higher than those in the control group (P < 0.01). No noticeable side effect was observed. CONCLUSION: Higher doses of bifendate taken for a long term has remarkable anti-HBV efficacy in treatment of chronic hepatitis B.
RCT Entities:
OBJECTIVE: To investigate the anti-HBV efficacy of bifendate in treatment of chronic hepatitis B. METHODS: A total of 119 patients with chronic hepatitis B were randomly divided into treatment group (n = 65, aged 24 +/- 12) and control group (n = 54, aged 25 +/- 11). In the treatment group every patient was given higher doses bifendate pills (</= 12 age, 30 approximately 45 mg/d; > 12 age, 45 approximately 67.5 mg/d) for up to 12 months. Hepatic function test was performed and HBeAg, HBeAb and HBV DNA were detected at regular intervals in all patients. RESULTS: The serum alanine amonotransferase (ALT) decreased to normal only one month later in 70.76% of patients in the treatment group and decreased to normal at least in 2 approximately 3 months in the control group (P < 0.01). The serum conversion rates of HBeAg, HBeAb and HBV DNA in the treatment group were 44.4%, 29.3%, 38.5%, respectively, which were significantly higher than those in the control group (P < 0.01). No noticeable side effect was observed. CONCLUSION: Higher doses of bifendate taken for a long term has remarkable anti-HBV efficacy in treatment of chronic hepatitis B.