A dose-ranging study of pegylated interferon alfa-2b and ribavirin in chronic hepatitis C
A dose-ranging study of pegylated interferon alfa-2b and ribavirin in chronic hepatitis C
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DOI：
10.1053/jhep.2000.16661
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发表时间：
2000-09-01
期刊：
影响因子：
13.5
通讯作者：
Clement, RP
中科院分区：
文献类型：
--
作者：
Glue, P;Rouzier-Panis, R;Clement, RP
本研究的目的是评估聚乙二醇干扰素α-2b（PEG-Intron）联合利巴韦林治疗慢性丙型肝炎患者的安全性、药代动力学和疗效。共有72例临床代偿性慢性丙型肝炎病毒（HCV）患者（35例男性/37例女性，年龄范围20-68岁）入组这项开放标签、随机、活性对照研究。患者接受PEG-Intron 0.35、0.7或1.4 μ g/kg皮下注射，每周一次，持续24周，或与利巴韦林600、800或1，000至1，200 mg联合口服，每日一次。在治疗期间和24周随访期后评估患者的安全性和有效性。在第1周和第4周进行详细的药代动力学评估。PEG-内含子单独给药可使白色细胞、中性粒细胞和血小板出现预期的剂量相关性减少。添加利巴韦林以剂量相关的方式降低血红蛋白水平，并没有进一步减少PEG-内含子诱导的中性粒细胞或白色细胞计数的减少，以及血小板计数的增加。神经元功能试验（C5 a和FMLP迁移、杀伤曲线）未改变。所有剂量组报告的不良事件（流感样症状、虚弱）在性质上相似。抗-HCV活性，如通过可检测的血清HCV RNA的损失（即，
The objectives of this study were to assess the safety, pharmacokinetics, and efficacy of pegylated interferon alfa-2b (PEG-Intron) plus ribavirin in patients with chronic hepatitis C. A total of 72 patients (35 men/37 women, age range 20-68 years) with clinically compensated chronic hepatitis C virus (HCV) were enrolled into this open-label, randomized, active controlled study. Patients received either PEG-Intron 0.35, 0.7, or 1.4 mu g/kg subcutaneously weekly for 24 weeks alone, or in combination with ribavirin 600, 800, or 1,000 to 1,200 mg orally daily. Patients were evaluated during treatment and after a 24-week follow-up period for safety and efficacy. Detailed pharmacokinetic assessments were performed at weeks 1 and 4. PEG-Intron alone produced expected dose-related reductions in white cells, neutrophils and platelets. Addition of ribavirin reduced hemoglobin levels in a dose-related manner, did not further reduce PEG-Intron-induced decreases in neutrophil or white cell count, and increased platelet counts. Neutrophil function tests (C5a and FMLP migration, killing curves) were unaltered. Reported adverse events (flu-like symptoms, asthenia) were qualitatively similar in all dose groups. Anti-HCV activity, as measured by loss of detectable serum HCV RNA (i.e.