拉米夫定与IFNα-1b序贯治疗HBeAg阳性慢性乙肝患者临床疗效观察

Clinic Efficacy of Sequential Therapy with Lamivudine and Recombinant Human Interferon α-1b Combination Compared to Lamivudine or Recombinant Human Interferon α-1b Monotherapy in HBeAg Positive Chronic Hepatitis B Patients

目的:观察比较拉米夫定联合IFNα-1b的序贯疗法与拉米夫定、IFNα-1b的单药疗法在治疗HBeAg阳性的慢性乙型肝炎方面的疗效差异。方法:将98例HBeAg阳性慢乙肝患者随机分为序贯治疗组、拉米夫定治疗组和IFNα-1b治疗组。序贯治疗组33例,年龄37.85±7.70岁,男/女:18/15,首先使用拉米夫定(100mg一日一次口服疗程24周),序贯使用IFNα-1b(60ug隔日一次皮下注射疗程28周),在第20周至24周同时使用拉米夫定和IFNα-1b,总疗程48周;拉米夫定治疗组34例,年龄39.42±6.88岁,男/女:20/14,仅口服拉米夫定,100mg一日一次口服,疗程48周;IFNα-1b治疗组31例,年龄35.71±6.14岁,男/女:14/17,仅皮下注射IFNα-lb,60ug隔日一次,疗程48周。治疗12周、24周、48周时检测肝功能、乙肝两对半、HBV-DNA等指标变化。结果:在治疗12周、24周时三组间肝功复常率、HBeAg阴转率无差异,序贯治疗组、拉米夫定组HBV-DNA阴转率优于IFNα-1b治疗组;实验疗程结束时序贯治疗组HBeAg阴转率、抗-HBe转换率及HBV-DNA阴转率显著高于其他两组,P<0.05,但在HBV-DNA阴转率方面序贯治疗组与拉米夫定治疗组差异不显著。结论:拉米夫定和IFNα-lb序贯疗法在HBV-DNA阴转率、HBeAg阴转率和抗HBe转换率三方面的疗效优于拉米夫定、IFNα-lb单一用药。

Objective： To compare the efficacy of sequential lamivudine and 1FNα-1b therapy versus lamivudine or IFNα-1b monotherapy in HBeAg positive chronic hepatitis B patients. Methods： 98 CHB with HBeAg positive patients were randomly divided into three groups： observation group was treated with combined lamivudine and IFNα-1b, （n=33,age：37.85 ± 7.70 years old, Male/Female： 18±15）received lamivudine （100 mg qd po）monotherapy from 1 st day to 24th weeks, then added IFNα-1b （6 MIU qod ih ） from 20th weeks to 48weeks; lamivudine group （n=34, age：39.42± 6.88 years old, Male/Female：20/14）was treated with lamivudine for 48 weeks; IFNα-1b group （n=31, age：35.71± 6.14 years old, Male/Female： 14/17 ）was treated with IFNα-1b（6 MIU qod ih）for 48 weeks. Exam the liver function, HBsAg, HBsAb,HBeAg,HBeAb,HBcAb and HBV-DNA at 12th weeks,24th weeks and 48th weeks. Results： The rates of liver function normalization and HBeAg loss were not statistically significant among three groups at 12th and 24th weeks,but rate of HBV-DNA suppression （〈1000 copies / ml）in observation group and lamivudine group were higher significant than IFNα-1b group, P〈0.05; Rates of HBeAg loss and anti-HBe appearance in sequential therapy group were higher significant than other groups at end of experiment ,P〈0.05; but the rate of HBV-DNA suppression（〈1000 copies / ml） wasn＇t statistically significant between observation group and lamivudine group. Conclusions： The results demonstrate that sequential therapy is superior to lamivudine or IFNα-1b monotherapy in rates of HBV-DNA suppression, HBeAg loss and anti-HBe appearance.