Interferon-alpha Combined With YiXueSheng Capsule For Chronic Hepatitis B

Objective:To assess the efficacy of Interferon-alpha(IFN-α) combined with YiXueSheng capsule versus IFN-αalone for treatment of HBeAg-positive chronic hepatitis B,and to investigate the efficacy of YiXueSheng capsule preventing from IFN-α-related myelosuppression.Methods:A total of 181 consecutive patients with HBeAg-positive chronic hepatitis B proven by liver biopsy were enrolled in this study.Of them,84 patients received combination therapy with 5 MU of IFN-α1b subcutaneously thrice weekly for a tailored and prolonged course and,by their intentions,1.0 of YiXueSheng capsule orally thrice per day for 3 months (combination treatment group),and 97 patients received IFN-α1b alone(IFN-αmonotherapy group).Normalization of alanine aminotransferase(ALT) level,loss of HBeAg with or without HBeAg seroconvertion,undetectable HBV DNA(below 10~3 copies/mL by fluorescent-quantitative PCR),altogether was considered as combined response.All patients were treatment-freely followed-up for at least 6 months.For statistic analysis,an intention-to-treat analysis was used in this paper.Results:There were no significant differences between baseline profiles including gender, age,liver necroinflammation grading,liver fibrosis staging,serum ALT levels,serum HBV DNA levels,peripheral white blood cell counts,neutrophil counts,blood platelet counts,and IFN-αtreatment courses in the two respective groups.The combined response rates in combination treatment group and in IFN-αmonotherapy group were 60.7%(51/84) and 47.4%(46/97) at the end of treatment(X~2=3.198,p=0.074),respectively,and were 54.8% (46/84) and 34.0%(33/97) at the end of 6-months follow-up period(X~2=7.874,p=0.005), respectively.The recurrence rate in combination treatment group and in IFN-αmonotherapy group were 11.8%(6/51 ) and 30.4%(14/46)(X~2=5.151,p=0.023 ),respectively.Leucopenia, neutropenia,and thrombocytopenia were observed in 36.9%,65.5%,and 9.5%in combination treatment group,respectively,while in 52.6%(51/97 X~2=4.462,p=0.035),83.5%(81/97 X~2=7.833,p=0.005),and 20.6%(20/97 X~2=4.238,p-0.040) in IFN-αmonotherapy group, respectively.Conclusions:In HBeAg-positive chronic hepatitis B patients,combination treatment with IFN-α1b and YiXueSheng Capsule may lead to a higher response rate,and YiXueSheng capsule treatment may be favourable to preventing from IFN-α-related myelosuppression.