实用肝脏病杂志 ›› 2014, Vol. 17 ›› Issue (4): 372-376.doi: 10.3969/j.issn.1672-5069.2014.04.010

• 乙型肝炎 • 上一篇    下一篇

普通干扰素-α2b联合阿德福韦酯治疗HBeAg阳性慢性乙型肝炎患者多中心随机开放对照临床观察*

王兵, 贾红宇, 梁柱石, 陆春燕, 盛海, 宋礼华   

  1. 230088 合肥市 安徽省生物研究所(王兵,陆春燕,盛海,宋礼华); 浙江大学医学院第一附属医院感染病科(贾红宇); 梧州东湖人民医院(梁柱石)
  • 收稿日期:2014-02-18 出版日期:2014-08-30 发布日期:2016-04-11
  • 作者简介:王兵,男,42岁,大学本科,助理研究员。主要从事基因工程药物的研发与推广。E-mail:wancin@163.com
  • 基金资助:
    安徽省科技厅长三角联合攻关项目(编号:10140702027)

Multi-centered randomized controlled trial of clinical observation of interferon-α2b and adefovir dipivoxil in the treatment of patients with HBeAg positive chronic hepatitis B

Wang Bing, Jia Hongyu, Liang Zhushi   

  1. nstitute of Biology,Hefei 230088,Anhui Province,China
  • Received:2014-02-18 Online:2014-08-30 Published:2016-04-11

摘要: 目的观察普通干扰素α-2b联合阿德福韦酯治疗HBeAg阳性慢性乙型肝炎患者的疗效和安全性。方法采用随机、开放、多中心对照临床试验研究,纳入87例HBeAg阳性慢性乙型肝炎患者,将其随机分为普通干扰素α-2b治疗组32例,给予注射600万单位普通干扰素α-2b, 1次/隔日,疗程48w;阿德福韦酯治疗组27例,给予阿德福韦酯10 mg口服,1次/d,疗程72w;和联合治疗组28 例,同时给予普通干扰素α-2b,48w和阿德福韦酯72w。每隔12w检测各组患者ALT、血清HBV标志物和HBV DNA 水平。结果干扰素单药治疗、阿德福韦酯单药治疗和联合治疗组患者平均年龄分别为(31.8±6.6)岁、(34.2±6.4)岁和(30.5±7.2)岁,基线HBV DNA水平分别为(7.68±1.56)log10IU/ml、(7.61±2.00)log10IU/ml和(7.80±1.79)log10IU/ml,三组患者间两指标无统计学差异(P>0.05); 三组间性别构成和基线ALT水平亦无显著统计学差异(P>0.05);在治疗72w时,干扰素单药治疗和阿德福韦酯单药治疗患者HBeAg转阴率分别为41%和19%,HBV DNA转阴率分别为53%和63%,ALT复常率分别为63%和67%,HBsAg血清学转换率为0.0%,均显著低于联合治疗组患者(57%、89%、93%和14%,P<0.05)。结论在病毒抑制、转氨酶复常和血清学转换率方面,普通干扰素α-2b 与阿德福韦酯联合治疗HBeAg阳性慢性乙型肝炎患者72w的疗效明显优于两药单独应用的效果。

关键词: 慢性乙型肝炎, 普通干扰素, 阿德福韦酯, 血清学转换, 疗效

Abstract: Objective To investigate the therapeutic effect of standard interferon plus adefovir dipivoxil for patients with HBeAg-positive chronic hepatitis B. Methods In this randomized multi-centered controlled clinical trial,87 patients with HBeAg-positive chronic hepatitis B were randomly divided into interferon α-2b monotherapy group(32 cases,with injection of 6 million units of interferon α-2b every other days for 48 weeks),adefovir dipivoxil monotherapy group(27 cases,with oral 10 mg per day for 72 weeks)and combinational treatment group(28 cases,with interferon α-2b 6 MU every other day for 48 weeks and 10 mg of adefovir dipivoxil per day for 72 weeks). Serum ALT,serum HBV markers and HBV DNA levels in these patients were tested every 12 weeks. Results The average ages of patients receiving interferon α-2b alone,adefovir dipivoxil alone or the combinational treatment were(31.8±6.6),(34.2±6.4) and (30.5±7.2) years,respectively,and the baseline serum HBV DNA levels in the three groups were(7.68±1.56)log10 IU/ml,(7.61±2.00)log10IU/ml and(7.80±1.79) log10IU/ml,respectively,and there were no significant difference in average age and baseline HBV DNA level among three groups(P>0.05),either gender composition or the baseline ALT level(P>0.05);At the end of week 72,the HBeAg seroconversion rates were 41% and 19%,the rates of HBV DNA loss were 53% and 63%,the ALT normalization rates were 63% and 67%,and HBsAg seroclearance rates were 0% in interferon or adefovir dipivoxil monotherapy patients,all of which were significantly lower than those in patients receiving combinational treatment(57%,89%,93% and 14,respectively,P<0.05). Conclusion In terms of viral suppression,ALT normalization,and HBeAg or HBsAg seroconversion rates,the therapy of standard interferon α-2b plus adefovir dipivoxil for 48 weeks is significantly better than using them alone.

Key words: Chronic hepatitis B, Standard interferon, Adefovir dipivoxil, Seroconversion, Efficacy