干扰素α-1b治疗慢性乙型肝炎的疗效及其预测因素分析

The therapeutic efficacy of recombinant interferon alfa-1b for the treatment of chronic hepatitis B and its predictive factors

目的 探讨不同剂量干扰素 (IFN)α 1b治疗慢性乙型肝炎 (CHB)的近、远期疗效、不良反应及其疗效预测因素。方法 146例CHB患者被随机分为 4组 (IFNα 1b 3MU组、5MU组、10MU组及对照组 )。观察 4组的近、远期疗效和不良反应 ;并对宿主、病毒和药物等 19项可能影响疗效的因素作单变量分析及多元回归分析。结果 应用干扰素α 1b 5MU和 10MU治疗组的疗效(5 5 .3%、5 8.1% )优于 3MU组 (32 .6 % )和对照组 (5 .9% ) (P <0 .0 1或P <0 .0 5 ) ;但 5MU组和 10MU组之间疗效差异无显著性。 10MU组的不良反应发生率明显高于 5MU组和 3MU组 (P <0 .0 1或P <0 .0 5 )。治疗 8周内血清HBVDNA及HBeAg的含量下降。 结论 干扰素α 1b的推荐剂量为 5MU/次 ,疗效预测因素为药物剂量及IL

Objective To study the short term and long term response and the safety of the different doses of recombinant interferon alfa 1b(IFNα 1b) for the treatment of the patients with chronic hepatitis B and the predictive factors of the response. Methods 146 Chinese patients with chronic hepatitis B entered randomly into four groups. Three groups were given with IFN α 1b 3 million unit (MU), 5 MU and 10 MU respectively. The control group was given placebo. The short term(ETR) and long term(SR 12) responses and side effect were observed. Selected nineteen items (host related, drugs related and virus related), which affected the response of IFN alfa 1b probably (host, virus and drugs, et al) were analyzed. Results The end treatment response (ETR) of the IFN α 1b 5 MU therapy was 55.3%, and 10 MU was 58.1%. Both efficacy were higher than the group of 3 MU IFN alfa 1b (32.6%) and control therapy group (5.9%, P <0.01). There were not a significant difference between 5 MU and 10 MU therapy groups. The side effects were more frequent in IFN α 1b 10 MU group than in 5 MU group and 3 MU group ( P <0.05). The quantitative assessment of serum HBV DNA and HBeAg levels showed the decreasing of more than 50% within 8 weeks of treatment. Conclusions The predominant predictive factors, which affected response of IFN alfa 1b were the drug doses, the peak level of interleukin 12 (IL 12) during IFN α 1b treatment.