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重组复合干扰素治疗慢性丙型肝炎的临床研究 |
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s treatment, ALT normalization rate for 15 μg CIFN, 9 μg and 3MU IFN α-2a were 76.9%, 68.3% and 57.4%. HCV RNA seroconversion rate were 89.6%, 73.6% and 60.4%. There were significant statistical difference of both ALT normalization rate and HCV RNA seroconversion rate between CIFN 15 μg and IFN α-2a 3MU treated patients (P<0.05 and P<0.01). After 48 weeks therapy, ALT normalization rate for those three groups were 78.8%, 63.9% and 55.0%, the HCV RNA seroconversion rate were 75.0%, 65.4% and 54.7%. It also showed significant statistical difference between CIFN 15 μg and 3MU IFN α-2a group (P<0.01 and P<0.05). The short-term and long-term complete response rate in the patients treated with CIFN 15 μg (70.8% and 64.6%, respectively) were higher than in the patients treated with IFN α-2a 3 MU (34.0% and 43.4%, respectively; P<0.01 and P<0.05). The category, incidence and severity of adverse events were similar in 3 groups. Conclusion CIFN is safe and effective at both 9 μg and 15 μg doses in the treatment of chronic hepatitis C. Futhermore, the results suggest the short-term as well as long-term efficacy of 15 μg to be more effective than IFN α-2a (3 MU) without increasing toxicity.
【Key words】Chronic hepatitis C; Consensus Interferon; Interferon alpha-2a; Alanine aminotransferase; Hepatitis C virus RNA
α干扰素是目前公认治疗慢性丙型肝炎(丙肝)有效的药物。文献报告其治疗结束时的丙氨酸转氨酶(ALT)应答率为40%～50%，而ALT持久应答率为20%～25%［1，2］。重组复合α干扰素(Consensus Interferon, CIFN)是非天然存在的Ⅰ型干扰素。它是通过对已知的α干扰素亚型序列筛选，采用每个位点上最常出现的氨基酸决定簇，用基因重组技术复合而成。本研究遵循中国药物临床试验管理规范(GCP)的准则，采用随机对照研究比较两种剂量的CIFN和重组α-2a干扰素(IFN α-2a)治疗慢性丙肝初治患者的结果，评价CIFN的疗效和安全性。
材料和方法
一、病例选择
凡病程在6个月以上，血清丙型肝炎病毒抗体(抗-HCV)和HCV RNA阳性，血清ALT大于正常值高限1.5倍，年龄为18～65岁，男、女两性患者，作为入选标准。凡合并有乙型肝炎病毒(HBV)、丁型肝炎病毒(HDV)、人类免疫缺陷病毒(HIV)、自身免疫性肝炎、遗传性肝病，恶性肿瘤或其他全身病患者，失代偿肝病(胆红素>35 μmol/L，白蛋白<35 g/L，凝血酶原时间比正常延长3 s，有腹水，消化道出血，肝性脑病的病史)，骨髓抑制，血清肌上一页 [1] [2] [3] 下一页
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