重组复合干扰素——干复津治疗慢性丙型肝炎随机对照临床试验结果

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目的为了研证美国安进公司研制生产的重组复合干扰素,比较15μg和9μg干复津与11.1μg(3MU)罗扰素治疗慢性丙型肝炎的疗效和安全性。材料和方法 67例确诊为慢性丙型肝炎的患者,随机分为A组(干复津15μg)20例,B组(干复津9μg)23例,C组(罗扰素)24例。每周32次皮下注射连用24周,停药后继续观察24周。定期检查肝、肾功能、血象、凝血酶原时间、甲状腺功能、抗HCV和HCV-RNA。结果治疗24周时A、B、C三组的ALT复常率分别为75.0%、73.9%和58.3%,HCV-RNA阴转率分别为80.0%,73.7%和61.9%,显效率(ALT正常,HCV-RNA亦阴转者)三组分别为65.0%、57.9%和33.3%。A、C组间差异显著。48周时ALT正常率分别为70.0%、63.6%和70.8%,HCV-RNA阴性率则为75.0%、61.1%和71.4%,显效率分别为50.0%、44.4%和61.9%,但无统计学差异,引起的不良反应三组间亦无差异。结论 15μg和9μg的干复津为治疗慢性丙型肝炎是有效而且安全的药物。 Objective To study the efficacy and safety of recombinant interferon (IFN) developed and manufactured by Amgen in the United States in the treatment of chronic hepatitis C with 15μg and 9μg of dry Fujin and 11.1μg (3MU) of lorazone. Materials and Methods 67 patients diagnosed with chronic hepatitis C were randomly divided into group A (n = 20), group B (n = 23) and group C (n = 24). 32 times a week hypodermic injection for 24 weeks, continue to observe the withdrawal after 24 weeks. Regular liver, renal function, blood, prothrombin time, thyroid function, anti-HCV and HCV-RNA. Results The ALT normalization rates in group A, B and C were 75.0%, 73.9% and 58.3% respectively at 24 weeks, and the HCV-RNA negative conversion rates were 80.0%, 73.7% and 61.9% And HCV-RNA were also negative) were 65.0%, 57.9% and 33.3% respectively in the three groups. A, C significant difference between groups. At 48 weeks, the normal rates of ALT were 70.0%, 63.6% and 70.8%, respectively. The negative rates of HCV-RNA were 75.0%, 61.1% and 71.4%, respectively. The effective rates were 50.0%, 44.4% and 61.9% Differences, caused by adverse reactions no difference between the three groups. Conclusion 15μg and 9μg of Qianfujin is an effective and safe drug for the treatment of chronic hepatitis C.
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