JOURNAL OF PRACTICAL HEPATOLOGY ›› 2014, Vol. 17 ›› Issue (4): 372-376.doi: 10.3969/j.issn.1672-5069.2014.04.010

• Orignal Article • Previous Articles     Next Articles

Multi-centered randomized controlled trial of clinical observation of interferon-α2b and adefovir dipivoxil in the treatment of patients with HBeAg positive chronic hepatitis B

Wang Bing, Jia Hongyu, Liang Zhushi   

  1. nstitute of Biology,Hefei 230088,Anhui Province,China
  • Received:2014-02-18 Online:2014-08-30 Published:2016-04-11

Abstract: Objective To investigate the therapeutic effect of standard interferon plus adefovir dipivoxil for patients with HBeAg-positive chronic hepatitis B. Methods In this randomized multi-centered controlled clinical trial,87 patients with HBeAg-positive chronic hepatitis B were randomly divided into interferon α-2b monotherapy group(32 cases,with injection of 6 million units of interferon α-2b every other days for 48 weeks),adefovir dipivoxil monotherapy group(27 cases,with oral 10 mg per day for 72 weeks)and combinational treatment group(28 cases,with interferon α-2b 6 MU every other day for 48 weeks and 10 mg of adefovir dipivoxil per day for 72 weeks). Serum ALT,serum HBV markers and HBV DNA levels in these patients were tested every 12 weeks. Results The average ages of patients receiving interferon α-2b alone,adefovir dipivoxil alone or the combinational treatment were(31.8±6.6),(34.2±6.4) and (30.5±7.2) years,respectively,and the baseline serum HBV DNA levels in the three groups were(7.68±1.56)log10 IU/ml,(7.61±2.00)log10IU/ml and(7.80±1.79) log10IU/ml,respectively,and there were no significant difference in average age and baseline HBV DNA level among three groups(P>0.05),either gender composition or the baseline ALT level(P>0.05);At the end of week 72,the HBeAg seroconversion rates were 41% and 19%,the rates of HBV DNA loss were 53% and 63%,the ALT normalization rates were 63% and 67%,and HBsAg seroclearance rates were 0% in interferon or adefovir dipivoxil monotherapy patients,all of which were significantly lower than those in patients receiving combinational treatment(57%,89%,93% and 14,respectively,P<0.05). Conclusion In terms of viral suppression,ALT normalization,and HBeAg or HBsAg seroconversion rates,the therapy of standard interferon α-2b plus adefovir dipivoxil for 48 weeks is significantly better than using them alone.

Key words: Chronic hepatitis B, Standard interferon, Adefovir dipivoxil, Seroconversion, Efficacy