关键词: 慢性乙型肝炎；干扰素&alpha, -2b；阿德福韦酯；队列观察 

Abstract: Objective  To explore the efficacy, safety, compliance and correlation factors of domestic adefovir dipivoxil (AD) and interferonα-2b (IFNα-2b) in the treatment of hepatitis B e antigen (HBeAg)-positive chronic hepatitis B (CHB) for 48 weeks. Methods  A total of 68 patients who were screened from hepatitis B prevention and treatment comprehensive demonstration zones in Shandong Province were enrolled in this prospective open cohort study, randomly receiving antiviral treatment with IFNα-2b (33 cases) and ADV (35 cases). The biochemical, virological, serological response, toxicity and compliance were observed and correlation factors analysis was investigated after 48 weeks. Results  At the 48th week, normalization rates of ALT in IFNα-2b and ADV groups were 24.2% and 85.7% (ITT analysis), 57.1% and 88.2% (PP analysis); HBV DNA undetectable rates were 24.2% and 88.6% (ITT analysis),57.1% and 91.2% (PP analysis); normalization rate of ALT and HBV DNA undetectable rates in ADV group were higher than those in IFNα-2b group (P<0.05). The rates of HBeAg loss were 12.1% and 31.4% (ITT analysis), 28.6% and 32.4% (PP analysis); HBeAg seroconversion rates were 6.1% and 2.9% (ITT analysis), 14.3% and 2.9% (PP analysis); the differences had no statistical significance (P＞0.05). The toxicity of IFNα-2b group was common. The drop-out rates of IFNα-2b and ADV were 18.2% and 2.9%(P=0.044). Univariate analysis found that HBV DNA undetection in the two groups was associated with baseline AST and no factors were related to HBeAg loss. Multi-factor analysis showed that ADV and baseline AST level were predictive factors for HBV DNA undetection, and the independent predictive factor of HBeAg loss was ADV.  Conclusion  Both domestic ADV and IFNα-2b can treat chronic hepatitis B (CHB) patients effectively, while the efficacy, safety and compliance of domestic ADV is inferior to IFNα-2b.

Key words: Chronic hepatitis B, Adefovir dipivoxil, Cohort observation, Interferon α-2b