Pegylated interferon-α2b:: Pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy data
Pegylated interferon-α2b:: Pharmacokinetics, pharmacodynamics, safety, and preliminary efficacy data
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DOI：
10.1067/mcp.2000.110973
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发表时间：
2000-11-01
影响因子：
6.7
通讯作者：
Jacobs, S
中科院分区：
文献类型：
--
作者：
Glue, P;Fang, JWS;Jacobs, S
目的：本研究的目的是评估聚乙二醇化干扰素- α 2b单药治疗慢性丙型肝炎患者的安全性、药代动力学和药效学特征以及抗病毒疗效。方法：58名代偿性慢性丙型肝炎患者（38名男性，20名女性，年龄范围25至65岁）参加了这项开放标签、随机、主动对照研究。患者每周皮下注射0.035 ~ 2.0马克/千克聚乙二醇化干扰素- α 2b或主动对照组，干扰素- α 2b 300万TU皮下注射3次/周，持续24周。在治疗期间和随后的4周随访期间进行安全性和抗病毒疗效评估。在第1周和第4周进行详细的药代动力学评估。结果：聚乙二醇化的干扰素- α 2b使白细胞、中性粒细胞和血小板呈剂量相关降低，并使口腔温度、血清新巢蛋白和血清2'5'-寡腺苷酸合成酶活性呈剂量相关升高，其质量与非聚乙二醇化的干扰素- α 2b相似。聚乙二醇化干扰素- α 2b治疗组和非聚乙二醇化干扰素- α 2b治疗组报告的不良事件（流感样症状、虚弱）在质量上相似。剂量相关的抗病毒活性，通过血清中可检测的丙型肝炎病毒RNA (
Aims: The objectives of this study were to assess the safety, pharmacokinetic and pharmacodynamic profiles, and antiviral efficacy of pegylated interferon-alpha 2b monotherapy in patients with chronic hepatitis C.Methods: Fifty-eight patients (38 men, 20 women; age range, 25 to 65 years) with compensated chronic hepatitis C were enrolled in this open-label, randomized, active controlled study. Patients received 0.035 to 2.0 mug/kg pegylated interferon-alpha 2b subcutaneously weekly or the active control, interferon-alpha 2b 3 million TU subcutaneously three times/week, for 24 weeks. Safety and antiviral efficacy assessments were performed during treatment and in a subsequent 4-week follow-up period. Detailed pharmacokinetic assessments were performed at weeks 1 and 4.Results: Pegylated interferon-alpha 2b produced dose-related reductions in white blood cells, neutrophils, and platelets, and dose-related increases in oral temperature, serum neopterin, and serum 2'5'-oligoadenylate synthetase activity, which were qualitatively similar to those produced by nonpegylated interferon-alpha 2b. Reported adverse events (flu-like symptoms, asthenia) were qualitatively similar in pegylated interferon-alpha 2b- and nonpegylated interferon-alpha 2b-treated groups. Dose-related antiviral activity, as measured by loss of detectable serum hepatitis C virus RNA (