安达芬治疗慢性乙型肝炎多中心研究

随访观察安达芬(3MU,肌注,每日一次,两周后改为隔日一次,疗程3个月)治疗慢性乙型肝炎的疗效,以进口干扰能作对照。住院治疗的140例慢性乙型肝炎,分成国产rIFN-α-2b治疗组(A组)和干扰能治疗组(B组)及国产rIFNα-2b开放性试验组(C组)。A、B两组在病情轻重、年龄、性别、病程及血清ALT等方面皆具可比性。治疗前所有病例HBsAg、HBeAg、HBV DNA均阳性。结果发现A组在治疗完成时、治疗后随访3个月、6个月及1年的HBeAg阴转率分别为50.0％、59.4％、58.1％和53.6％;HBV DNA阴转率分别为65.6％、65.6％、64.5％和57.1％,均高于B组,但P>0.05。另外C组10例治疗前后肝脏病理检查结果示,干扰素治疗后其病理改变得到不同程度改善。因此安达芬同进口干扰能疗效相似。

THE MULTI - CENTRAL STUDY OF DOMESTIC RECOMBINANT INTERFERON ALPHA - 2B IN TREATMENT OF CHRONIC HEPATITIS B

The efficacy of recombinant interferon alpha-2b(r-1FN-o2b) in treatment of chronic hepatitis B was evaluated.One hundred and forty patients with chronic hepatitis B were divided into three groups,including group A N group B.and open trial group (group C)-Group A was administered with domestic rIFN-2b while group B was given Intron A as a control group.Group C was treated with the same rIFN-2b as in group A but without control.Group A and group B were comparable in their clinical type,age,sex, course of disease and ALT levels.All cases had serum positive HBsAg,HBeAg and HBV DNA before treatment.In group A, the rate of HBeAg disappearance was 50.0% at the completion of therapy.At 3 mon,6 mon and one year after termination of the therapy, the rates of HBeAg disappearance were 59.4% ,58.1 % and 53.6% , respectively.The rates of HBV DNA clearance were 65.6% ,65.6% ,64.5% and 57.1 % , respectively.These parameters were not different from in group B (P>0.05).Seven out of ten patients in group C had their liver histological changes improved after treatment as compared with before rIFN-2b therapy.These results suggest that the efficacy of domestic r~ IFN-a2b is similar to that of Intron A in treatment of chronic hepatitis B.