干扰素联合阿德福韦酯治疗HBeAg(+)慢性乙型肝炎疗效观察

Clinical Observation of Interferon Combined with Adefovir Dipivoxil in the Treatment of Patients with HBeAg(+) Chronic Hepatitis B

目的:观察普通干扰素(IFN)和阿德福韦酯(ADV)联合治疗HBeAg(+)慢性乙型肝炎(CHB)的疗效。方法:100名HBeAg(+)的CHB患者随机分为联合治疗组(IFN+ADV组)及单药治疗组(IFN组)。IFN组予500MU普通IFNα-2b隔日1次皮下注射,IFN+ADV组在IFN组治疗基础上加服ADV 10 mg·d-1;所有患者均治疗48周,随访24周。治疗前筛查、治疗后每4周血常规、每12周检测HBV DNA,乙肝两对半定量、肝功能、肾功能、甲状腺功能。记录不良反应。结果:治疗24周,IFN+ADV组与IFN组HBV DNA水平分别下降(3.67±0.96)log10IU·ml-1和(2.85±1.14)log10IU·ml-1,较基线均显著降低(P=0.000),两组比较,IFN+ADV组优于IFN组(P=0.000);两组HBV DNA低于检测下线比例分别为46.0%vs 24.0%(P=0.021),ALT复常率分别为76.0%vs 56.0%(P=0.035),IFN+ADV组均高于IFN组;两组HBeAg转阴率及HBeAg血清转换率分别为30.0%vs 28.05%(P=0.826),21.2%vs 17.6%(P=0.653),差异无统计学意义。IFN+ADV组脱落2例,IFN组脱落4例,两组不良反应相似,均无严重不良事件发生,未影响治疗。结论:干扰素联合阿德福韦酯或干扰素单用治疗对HBeAg(+)的CHB患者均有效,安全性良好;治疗24周,联合治疗可提高患者病毒学应答率及生化学应答率,未能提高患者HBeAg血清转换率及联合应答率。

Objective：To observe the clinical effect of standard interferon （IFN） and adefovir dipivoxil （ADV） in the treatment of patients with HBeAg（＋） chronic hepatitis B （CHB）.Methods：Totally 100 patients were randomly divided into the IFN and ADV group （IFN ＋ ADV group,50 cases） and the IFN group （IFN group,50 cases）.The IFN group was injected with IFNα-2b subcutaneously,qod,and the IFN ＋ ADV group was treated with ADV 10 mg · d-1 additionally.The treatment course was 48 weeks and the follow-up course was 24 weeks.Blood routine examination was determined every 4 weeks,HBV DNA was determined every 12 weeks,two pairs of semi-hepatitis B,liver function,renal function and thyroid function were determined before and after the treatment.The adverse reactions were compared.Results：In the 24th week,the HBV DNA level of IFN ＋ ADV group and IFN group was decreased with （3.67 ± 0.96） log10 IU · ml-1 and （2.85 ± 1.14） log10 IU · ml-1,respectively,both were lower than that of the base level （P =0.000）,and that of IFN ＋ ADV group was the lowest （P =0.000） ; the ratio of HBV DNA level lower than the detection line was 46.0% and 24.0%,respectively （P =0.021） ; the normalization rate of ALT were 76.0% and 56.0%,respectively （P =0.035）,and there were significant differences between the two groups.The negative conversion rate of HBeAg and the seroconversion rate of HBeAg was 30.0% and 28.05% （P =0.826）,21.2% and 17.6%,respectively（P =0.653）,while there were no significant differences between the two groups.Two cases lost in the IFN ＋ ADV group and 4 cases lost in the IFN group.The incidence of adverse reactions between the two groups was similar,and there was no serious adversereaction occurred.Conclusion：Interferon with adefovir dipivoxil or interferon alone is effective and safe in the treatment of patients with HBeAg（＋） chronic hepatitis B.After the 24-week treatment,the combination therapy can increase the rate of virological response and biochemical response,while the seroconversion rate of HBeAg and the combined response are unchanged.