α-干扰素伍用益血生胶囊治疗慢性乙型肝炎的持续疗效

目的:对比观察α-干扰素(interferon-alpha,IFN-α)伍用益血生胶囊与IFN-α单药治疗慢性乙型肝炎疗效之差异。方法:288例经肝穿刺活检证实的HBeAg阳性慢性乙型肝炎患者,给予IFN-α1b皮下注射,5 mU/次,每周3次,疗程个体化。依患者意愿,其中125例伍用益血生胶囊口服(联合治疗组),1.0 g/次,3次/d,疗程3个月。163例未伍用益血生胶囊(IFN-α单药治疗组)。治疗结束后随访至少24个月。统计学分析采用意向治疗分析。结果:2组性别、年龄、血清丙氨酸氨基转移酶水平、HBV DNA水平、肝组织炎症活动度分级、肝组织纤维化分期以及IFN-α疗程之差异均无统计学意义。联合治疗组112例、IFN-α单药治疗组141例完成治疗和24月随访。联合治疗组、IFN-α单药治疗组完全应答率在治疗结束时、随访12月时、随访24月时分别为48.0%(60/125)和35.0%(57/163)(x2=4.980,P=0.026),45.6%(57/125)和33.1%(54/163)(x2=4.645,P=0.031),38.4%(48/125)和32.5%(53/163)(x2=1.076,P=0.300)。结论:IFN-α伍用益血生胶囊比IFN-α单药治疗能够适当提高对HBeAg阳性慢性乙型肝炎持续疗效。

Sustained efficacy of alpha-interferon therapy combined with Yixuesheng Capsule in treatment of chronic hepatitis B

Objective:To observe the difference between the combination therapy of α-interferon(IFN-α) therapy Yixuesheng Capsule and the monotherapy of IFN-α in treatment of chronic hepatitis B.Method:A total of 288 patients with HBeAg-positive chronic hepatitis B proven by liver biopsy were included in this study.During the individualized therapy,they received hypodermic injection of IFN-α 1b,with 5 MU·time-1 and three times·w-1.Of them,125 patients received combination therapy with Yixuesheng Capsule for three months,with 1.0 g/time and three times/d;and 163 patients received only IFN-α 1b(the IFN-α monotherapy group).After the course of therapy,all patients were followed up for at least 24 months.The intention-to-treat analysis was adopted for statistic analysis.Result:The two groups showed no statistical significance by gender,age,liver necroinflammation grading,liver fibrosis staging,serum ALT levels,serum HBV DNA levels and IFN-α therapy course.The whole course and the 24-month follow-up visit cover all of 112 patients in the combination treatment group and 141 cases in the IFN-α monotherapy group.The response rates of the combination treatment group and the IFN-α monotherapy group were 48.0%(60/125) and 35.0%(57/163)(x2=4.980,P=0.026) at the end of treatment,respectively,45.6%(57/125) and 33.1%(54/163)(x2=4.645,P=0.031) at the end of 12-month-follow-up period,respectively,and 38.4%(48/125) and 32.5%(53/163)(x2=1.076,P=0.300) at the end of 24-month follow-up period,respectively.Conclusion:The combination treatment with IFN-α and Yixuesheng Capsule shows a slightly better sustained efficacy on HBeAg-positive chronic hepatitis B patients compared with IFN-α monotherapy.