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【目的】评价聚乙二醇化干扰素α-2a(PEG-IFN-α2a)治疗慢性乙型肝炎(CHB)的临床疗效和安全性。【方法】66例CHB患者随机分配到治疗组和对照组。治疗组(33例)予PEG-IFNα-2a 180μg皮下注射,每周1次,疗程48周。对照组(33例)予普通干扰素(IFN-α2a)300万U,皮下注射,隔日1次,疗程48周,治疗结束后随访48周。【结果】①ALT复常率在各时间段(治疗24周、治疗48周及随访48周)治疗组(84.8%、90.9%及87.9%)均分别显著高于对照组(63.6%、69.7%及63.6%)(P<0.05);两组HBV-DNA阴转率在治疗期间无显著性差异(P>0.05),而随访48周时治疗组(63.6%)显著高于对照组(39.4%)(P<0.05),HBV-DNA阳性复发率治疗组22.2%(6/27)显著低于对照组43.5%(10/23)(P<0.05)。②HBeAg阴转率在各时间段治疗组(45.5%、57.6%及54.5%)均分别显著高于对照组(15.2%、21.2%及18.2%)(P<0.05);HBeAg/抗HBe血清转化率在各时间段治疗组(33.3%、51.5%及45.5%)也均分别显著高于对照组(9.1%、21.2%及18.2%)(P<0.05)。③两组不良反应的发生率差异无统计学意义(P>0.05)。【结论】PEG-IFNα-2a治疗慢性乙型肝炎优于普通干扰素,具有较持久的病毒学和血清学应答率,停药后HBV-DNA阳性复发率抵,每周1次给药方式,可使患者具有更好的依从性。
【Objective】 To evaluate the clinical efficacy and safety of peginterferon α-2a (PEG-IFN-α2a) in the treatment of chronic hepatitis B (CHB). 【Methods】 Sixty-six CHB patients were randomly assigned to treatment group and control group. The treatment group (33 cases) was given PEG-IFNα-2a 180μg subcutaneously once a week for 48 weeks. The control group (33 cases) received IFN-α2a 3 million U, subcutaneously, once every other day for 48 weeks. After the treatment, the patients were followed up for 48 weeks. 【Results】 ① The rate of ALT normalization in the treatment group (84.8%, 90.9% and 87.9%, respectively) was significantly higher than that in the control group (63.6%, 69.7% and 24.6% 63.6%) (P <0.05). There was no significant difference in the negative conversion rate of HBV DNA between the two groups (P> 0.05), but the treatment group (63.6%) was significantly higher than the control group (39.4% (P <0.05). The positive relapse rate of HBV-DNA in treatment group was significantly lower than that in control group (22.2%, 6/27, 43.5%, P <0.05). ② The negative conversion rate of HBeAg was significantly higher in the treatment group (45.5%, 57.6% and 54.5%) than that in the control group (15.2%, 21.2% and 18.2%, P <0.05) The treatment groups (33.3%, 51.5% and 45.5%) were also significantly higher than the control group (9.1%, 21.2% and 18.2%, respectively) at all time points (P <0.05). ③ There was no significant difference in the incidence of adverse reactions between the two groups (P> 0.05). 【Conclusion】 PEG-IFNα-2a is superior to ordinary interferon in the treatment of chronic hepatitis B, with longer lasting virological and serological response rate, positive relapse rate of HBV-DNA after drug withdrawal, weekly administration mode, Patients can have better compliance.