Sustained Response To Combination Therapy With Interferon-alpha And Yixuesheng Capsule For Chronic Hepatitis B

Objective:To assess the sustained response and the patients'differences of living quality to interferon-alpha(IFNa) combined with YiXueSheng capsule versus to IFNa alone in HBeAg-positive chronic hepatitis B and to investigate the way to improve the therapeutic effects on chronic hepatitis B.Methods:A total of 335 consecutive patients with HBeAg-positive chronic hepatitis B proven by liver biopsy were enrolled in this study. Of them,163 patients received combination therapy with 5 MU of IFNalb subcutaneously thrice weekly for a tailored and prolonged course and 1.Og of YiXueSheng capsule orally thrice per day for the first 3 months (combination treatment group), and 172 patients received IFNalb alone (IFN-a monotherapy group). All patients were treatment-freely followed-up at least 12 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 alanine aminotransferase (ALT) levels, serum HBV DNA levels and IFNa treatment courses in the two respective groups.The HBeAg seroconversion rates in combination treatment group and in IFNa monotherapy group were 50.3%(82/163) and 36.6%(63/172)(X2=6.379, p=0.012) at the end of treatment, respectively, and were 44.2%(72/163) and 31.4%(54/172)(x2=5.822, p=0.016) at the end of at least 12-months follow-up period, respectively. The undetectable HBV DNA rates in combination treatment group and in IFNa monotherapy group were 51.5%(84/163)and 35.5%(61/172)(x2=8.802,P=0.003) at the end of treatment, respectively, and were 44.8%(73/163) and 31.4%(54/172)(x2=6.375,P=0.012) at the end of at least 12-months follow-up period, respectively.Normalization of ALT level rates in combination treatment group and in IFNa monotherapy group were 51.5%(84/163) and 36.0%(62/172)(x2=8.164,P=0.004) at the end of treatment, respectively, and were 57.1%(93/163) and 34.3%(59/172)(x2=17.480,P=0.000) at the end of at least 12-months follow-up period, respectively.The complete response rates in combination treatment group and in IFNa monotherapy group were 48.5%(79/163) and 35.5%(61/172)(x2=5.815,P=0.016) at the end of treatment, respectively, and were 43.6%(71/163) and 30.8%(53/172)(x2=5.830,P=0.016) at the end of at least 12-months follow-up period, respectively.The recurrence rate in combination treatment group and in IFNa monotherapy group were 17.9%(14/78) and 31.1%(19/61)(x2=3.294,P=0.070), respectively, The delayed response rate in combination treatment group and in IFNa monotherapy group were 9.4%(8/85)and 9.9%(11/111)(x2=0.014, p=0.907), respectively. Living quality:the all dimensions scores of both groups were similar and there was no significant difference. When the follow-up has been finished, the scores of general health (t=3.435, p=0.001), activity(t=2.785,P=0.008), social function (t=2.602, p=0.012) and mental health (t=5.120,P=0.000) in combined treatment group were better than those of IFNa treatment group and the differences were significantly different.Conclusion:In HBeAg-positive chronic hepatitis B patients, combination treatment with IFNa and YiXueSheng capsule may lead to a higher sustained response rate and it also can improve patients" living quality.