重组干扰素α-2b治疗慢性乙型肝炎的疗效、影响因素及预后研究

Study of therapeutic efficiency, efficient factor and prognostic value of recombinant interferon α-2b for chronic hepatitis B

目的观察重组干扰素α 2b(干扰能)治疗慢性乙型肝炎的疗效、影响疗效的因素和对长期预后的影响。方法88例慢性乙型肝炎病例配对分为治疗组和对照组各44例。治疗组用重组干扰素α 2b3×106U ,每周3次 ,皮下注射 ,疗程3个月 ,对照组不用抗病毒治疗。42例开放病例根据治疗剂量分为3×106U和6×106U2组,治疗方法为每周3次或隔日1次,深皮下或肌肉注射,疗程3个月。结果用重组干扰素α 2b治疗的全部病例在治疗完成时、随访6个月、1～7年的有效应答率(完全应答 +部分应答,分别为55.8 %、58.8 %、61.9 %、57.9 %、58.5 %、56.1 %、52.6 %、45.5 %和50.0 %)均显著高于对照组(分别为13.6 %、13.6 %、15.9 %、15.9 %、13.6 %、15.0 %、15.2 %、11.1 %和7.7 %),P<0.05或P<0.01。6×106 U和3×106 U治疗组间有效应答率差异无显著性(P>0.05)。中度慢性肝炎、治疗前ALT>100IU/L、病程短于3年、女性病人和治疗开始后有发热者的疗效较好(P<0.05)。治疗组的长期预后明显优于对照组(P<0.05),有效应答病例的长期预后显著优于无应答病例(P<0.05)。结论重组干扰素α 2b是一种肯定有效的抗乙型肝炎病毒药物。干扰素治疗可改善慢性乙型肝炎病人的长期预后。

Objective To observe the therapeutic efficiency of recombinant interferon α-2b(rIFNα-2b, Intron A) and to investigate the therapeutic efficient factor and prognostic value of rIFNα-2b in patients with chronic hepatitis B. Methods 88 cases of chronic hepatitis B were equally divided into treatment and control group. In the treatment group,44 patients were subcutaneous injected with 3 million units (3×10 6 U) of rIFNα-2b, three times weekly for 3 months. No antivirus treatment was adminstrated for patients of the control group. 42 cases of opening group were divided into 3×106 U group and 6×106 U group with rIFNα-2b injection, three times weekly or once another day for three months. Results The efficientive rate was significantly higher in the treatment group than in the control. At the end of treatment and after follow-up of 6 months and 1 to 7 years, the efficient rate in the treatment group was 55.8%, 58.8%, 61.9%, 57.9%, 58.5%, 56.1%, 52.6%, 45.5% and 50.0% respectively and that in the control was 13.6%, 13.6%,15.9%, 15.9%, 13.6%, 15.0%, 15.2%, 11.1% and 7.7% respectively ( P<0.05 or P<0.01). The effective response rates were also significantly higher in patients with chronic active hepatitis, higher initial ALT level (more than 100 IU/L), shorter disease course (less than 3 years), female sex and pyrexia side effect than in the corresponding patients (P<0.05). The long period prognosis was better in rIFNα-2b treated patients and effective response cases than in the control group and no response cases (P<0.05). Conclusions Our results suggest that rIFNα-2b is certainly an effective anti-hepatitis drug. IFN treatment can improve the long period prognosis of patients with chronic hepatitis B.