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目的探讨小剂量聚乙二醇干扰素对慢性C型病毒性肝炎的长效应用效果。方法接受聚乙二醇干扰素治疗患者732例,未接受治疗者323例。采用随机、对照研究,以聚乙二醇干扰素α-2a90μg,每周1次连续用药4年。根据纤维化分期,分别与1年和4年进行活检。主要终点为疾病的进展,包括死亡、肝细胞癌、肝功能失代偿、或纤维化较基础上升≥2点(Ishak纤维化评分)。结果治疗组血清转氨酶水平、血清肝炎病毒C RNA水平、组织学坏死性炎症评分均显著下降(P<0.001),但是,组间比较任何主要终点(治疗组34.5%,对照组35.2%;危险比1.01,95%CI 0.82~1.28,P=0.88)差异无统计学意义。至少出现1种严重不良事件病人的百分率治疗组为38.8%,对照组为31.5%(P=0.07)。结论长期应用聚乙二醇干扰素不能降低慢性C型病毒性肝炎和纤维化病人的疾病进展。
Objective To investigate the long-term effect of low-dose pegylated interferon on chronic type C viral hepatitis. Methods 732 patients were treated with pegylated interferon, 323 patients were not treated. A randomized, controlled study of peginterferon alfa-2a 90μg, once a week for 4 consecutive years of medication. According to fibrosis staging, respectively, with 1 year and 4 years biopsy. The primary endpoint was progression of the disease, including death, hepatocellular carcinoma, decompensated liver function, or fibrosis basal rise ≥2 points (Ishak Fibrosis score). Results Serum aminotransferase levels, serum hepatitis C virus C RNA levels, and histological necrotizing inflammation scores were significantly decreased in the treatment group (P <0.001), however, any of the primary end points was compared between treatment groups (34.5% in the treatment group and 35.2% in the control group; hazard ratio 1.01, 95% CI 0.82-1.28, P = 0.88), the difference was not statistically significant. The percentage of patients who had at least one serious adverse event was 38.8% in the treatment group and 31.5% in the control group (P = 0.07). Conclusions Chronic use of pegylated interferon does not reduce the disease progression in patients with chronic viral hepatitis C and fibrosis.