摘要
本研究应用基因工程干扰素α1b进行多中心第Ⅲ期临床研究,慢性丙型肝炎患者共318例,其中249例应用干扰素α1b治疗,第1—4周每日肌注30μg,第5—16周隔日肌注30μg,对照组69例。ALT完全应答率分别为163/249(65.46％);2/69(2.90％),P<0.05。血HCV RNA(PCR法)转阴率分别为48/171(28.07％);2/69(2.90％),P<0.05。治疗前后两次肝穿活检病理学比较,两组明显改善者分别为8/19(42.11％);0/2(0％)。干扰素α1b对HCV RNA各型ALT完全应答率Ⅰ型9/11(81.82％),Ⅱ型11/22(50.00％),Ⅲ型5/7(71.43％),Ⅰ型Ⅲ型的疗效高于Ⅱ型,P<0.05,血中HCV RNA(PCR法)转阴率Ⅰ型7/9(77.78％),Ⅱ型1/11(9.09％),Ⅲ型4/5(80.00％),Ⅰ与Ⅲ型的转阴率高于Ⅱ型,P<0.05.α1b型干扰素的不良反应有发热伴流感样症状为70/249(28.12％),红斑点皮疹,脱发,WBC减少,BPC减少各2例,各占0.80％,全未影响治疗。总之,干扰素α1b对慢性丙型肝炎患者的ALT复常、HCV-RNA转阴、肝活检病理的改善皆有显著疗效,不良反应率比其他基因工程干扰素α-2a、α-2b少而轻。
The aim of the multi-central study was to evaluate the effects of recombinant human interferon a-lb (rhlFNa-lb)for the treatment of chronic hepatitis C.Two hundred and Fourty-nine patients with hepatitis C were treated with rhIFNa-lb (at a dose of 3Mu,IM,qdX4w,then 3Mu,IM,qodX 16w) for 20 weeks; and other sixty-nine patients for control.The normality rate of serum alanine aminotransferase (ALT) levels was 65.5% in the treated group,much higher than in control group (2.9% ,P<0.05) ;the serum conversion rate from hepatitis C vinus (HCV) RNA positive to negative were 28.1% and 2.9% (P< 0.05) and histological improvement was found in 42.l%(8/19)and 0%(0/2) of cases, respectively, in the two group.The complete response rate in patients with HCV RNA type I and I infection (81.8% and 71.4% ) were higher than with type I infection (50.0% ,P<0.05).The side effects were fever with common cold-like symptoms (28.1%) and other uncommon ones included red macular rash,mild alopecia and leukothrombopenia (about 0.
出处
《实用肝脏病杂志》
CAS
1997年第1期14-17,共4页
Journal of Practical Hepatology
