恩替卡韦治疗的慢性乙型肝炎患者加用聚乙二醇干扰素α-2a的临床疗效与安全性

Clinical Efficacy and Safety of Pegylated Interferon α-2a in Chronic Hepatitis B Patients Treated with Entecavir

目的探讨恩替卡韦(ETV)治疗的慢性乙型肝炎患者加用聚乙二醇干扰素(PegIFN)α-2a治疗的临床疗效与安全性,为寻求慢性乙型肝炎的临床治愈目标提供更加有效、合理的治疗方案。方法收集50例恩替卡韦治疗的慢性乙型肝炎患者,已实现病毒学阴转(HBV DNA<500copies·mL-1)但未达到临床治愈目标,根据患者自愿原则分为恩替卡韦联合聚乙二醇干扰素α-2a治疗组(观察组)和恩替卡韦单药治疗组(对照组),每组25例。对照组患者继续口服恩替卡韦抗病毒治疗,0.5mg·次-1·d-1;观察组在恩替卡韦治疗基础上联合PegIFNα-2a皮下注射抗病毒治疗,180μg·0.5mL-1·次-1,1次·周-1;2组均治疗48周。观察2组患者治疗0、12、24、48周后HBeAg转阴率、HBeAg血清学转换率、HBsAg水平、HBsAg转阴率及治疗期间不良反应发生情况。结果完成48周随访记录患者共49例,其中观察组24例,对照组25例。2组患者治疗24周、48周时的HBeAg转阴率、HBeAg血清学转换率、HBsAg转阴率比较差异均无统计学意义(P>0.05),但观察组HBsAg水平下降幅度在治疗12周、24周、48周时均较对照组明显增大,差异均具有统计学意义(P<0.05)。观察组治疗期间不良反应发生率较对照组显著升高(P<0.05)。结论恩替卡韦治疗的慢性乙型肝炎患者加用PegIFNα-2a治疗可有效降低患者的HBsAg水平,但临床上需综合患者的药物不良反应情况及经济水平合理选择抗病毒治疗方案。

Objective To evaluate the efficacy and safety of pegylated interferon(pegIFN)α-2a in chronic hepatitis B(CHB)patients treated with entecavir(ETV),and to provide a more effective and reasonable treatment plan for the clinical cure of CHB.Methods Fifty CHB patients treated with ETV were enrolled in this study.In these patients,virological negative conversion had been realized(HBV DNA<500copies·mL-1),but the clinical cure goal had not been reached.According to the voluntary principle,patients were treated with oral ETV alone(0.5mg once daily)(control group,n=25)or in combination with subcutaneous pegIFNα-2a injection(180μg·0.5mL-1once weekly)(observation group,n=25)for48weeks.The negative conversion rate of HBeAg,serological conversion rate of HBeAg,level of HBsAg,negative conversion rate of HBsAg and adverse reactions were observed in both groups after treatment for0,12,24and48weeks.ResultsA total of49patients completed the follow-up,including24patients in observation group and25patients in control group.There were no significant differences between two groups in the negative conversion rate of HBeAg,serological conversion rate of HBeAg and negative conversion rate of HBsAg after24and48weeks of treatment(P>0.05).The decrease in HBsAg level in observation group was more obvious than that in control group after treatment for12,24and48weeks(P<0.05).In addition,the incidence of adverse reactions in observation group was higher than that in control group(P<0.05).Conclusion Sequential combination of pegIFNα-2a and ETV can effectively reduce HBsAg level in CHB patients.However,adverse drug reactions and economic level should be considered to select a reasonable antiviral treatment plan.