基因B/C型HBeAg(+)慢性乙型肝炎患者初始拉米夫定、阿德福韦酯联合治疗疗效

A randomized study of de novo combination therapy lamivudine plus adefovir in HBe Ag-positive chronic hepatitis B patients with genotype B / C

目的:观察初始拉米夫定(LAM)和阿德福韦酯(ADV)联合与LAM、恩替卡韦(ETV)单药治疗基因B/C型HBe Ag(+)慢性乙型肝炎(慢乙肝)患者的疗效。方法:招募182例符合中国慢乙肝防治指南中治疗标准的基因B/C型HBe Ag(+)慢乙肝初始治疗患者,随机分为3组,分别以LAM和ADV联合、LAM或ETV单药治疗48周,观察疗效。结果:基线水平无差异的3组患者分别经过3种方案治疗后,联合治疗组生化学应答率(12周P<0.01,24周P<0.01,48周P<0.01)、HBe Ag血清学应答率(12周P<0.01,24周P<0.05,48周P<0.05)、完全病毒学应答率(12周P<0.05,24周P<0.05,48周P<0.05)均高于LAM组。联合治疗组在生化学应答方面较ETV组存在一定优势。结论:LAM和ADV初始联合治疗是我国以B/C型基因为主的慢乙肝患者抗病毒治疗的优良策略。

Objective To observe the efficacy of de novo combination therapy lamivudine plus adefovir, lamivudine monotherapy and entecavir monotherapy in HBeAg-positive CHB patients with genotype B/C. Methods A total of 182 treatment-naive CHB patients in line with treatment standards of Chinese CHB prevention and treatment guidelines were randomly assigned to three groups and treated with lamivudine plus adefovir or lamivudine monotherapy or entecavir monotherapy for 48 weeks. Results Patients in three groups presented no difference in baseline levels. After treatment by three therapies, the group of lamivudine plus adefovir showed a higher biochemical response rates （12 week P 〈 0.01, 24 week P 〈 0.01, 48 week P 〈 0.01）, HBeAg- serological rates（12 week P 〈 0.01, 24 week P 〈 0.05, 48 week P 〈 0.05） and completely virological response rates （12 week P 〈 0.05, 24 week P 〈 0.05, 48 week P 〈 0.05） than lamivudine group. In terms of biochemical response rates, the group of lamivudine plus adefovir had certain advantages when compared with entecavir group. Conclusion De novo combination therapy lamivudine plus adefovir is a good antiviral strategy for chronic hepatitis B patients with B/C genotype viral infection in China.