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目的评估高病毒载量的HBeAg阳性慢性乙型肝炎(CHB)的抗病毒治疗效果。方法采用前瞻性、多中心、非随机、开放的研究方法,将120例高病毒载量的HBeAg阳性的入选病例均分为三组,分别采用恩替卡韦(ETV,A组)、聚乙二醇干扰素α-2a(PegIFNα-2a,B组)和两者联合应用(C组)治疗48周。分别在治疗24、48周及随访24周时进行疗效观察及安全性评估。结果在治疗48周及停药随访24周时,C组的病毒学应答疗效和HBeAg血清学应答均优于A、B组(P<0.05、P<0.01)。在24周时,B、C组ALT恢复正常率高于A组(52.6%、56.4%vs.27.8%)(P<0.05)。结论联合应用PegIFNα-2a和ETV治疗高病毒载量的HBeAg阳性CHB患者的疗效优于单药治疗。
Objective To evaluate the antiviral effect of HBeAg-positive chronic hepatitis B (CHB) with high viral load. Methods A prospective, multicenter, non-randomized and open study was conducted to divide 120 HBeAg positive cases with high viral load into three groups, which were treated with entecavir (ETV, group A), with polyethylene glycol Therapeutic effect of α-2a (PegIFNα-2a, B group) and combination of both (C group) for 48 weeks. Efficacy and safety assessment were performed at 24, 48 weeks and 24 weeks respectively. Results The virological response and HBeAg seroclearance in group C were better than those in group A and B at 48 weeks of treatment and at the 24th week of follow - up (P <0.05, P <0.01). At 24 weeks, the recovery rates of ALT in groups B and C were higher than those in group A (52.6%, 56.4% vs.27.8%, P <0.05). Conclusions The combination of PegIFNα-2a and ETV is superior to monotherapy in the treatment of HBeAg-positive CHB patients with high viral load.