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慢性乙型肝炎患者聚乙二醇干扰素 α2a 的群体药代动力学。

Population pharmacokinetics of peginterferon α2a in patients with chronic hepatitis B.

机构信息

Research Center for Clinical & Translational Medicine, 302 Military Hospital, Beijing, 100039, China.

Department of Pharmacy, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100050, China.

出版信息

Sci Rep. 2017 Aug 11;7(1):7893. doi: 10.1038/s41598-017-08205-5.

DOI:10.1038/s41598-017-08205-5
PMID:28801680
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5555209/
Abstract

There were significant differences in response and pharmacokinetic characteristics to the peginterferon α2a treatment among Chronic Hepatitis B (CHB) patients. The aim of this study is to identify factors which could significantly impact the peginterferon α2a pharmacokinetic characteristics in CHB patients. There were 208 blood samples collected from 178 patients who were considered as CHB and had been treated with peginterferon α2a followed by blood concentration measurement and other laboratory tests. The covariates such as demographic and clinical characteristics of the patients were retrieved from medical records. Nonlinear mixed-effects modeling method was used to develop the population pharmacokinetic model with NONMEM software. A population pharmacokinetic model for peginterferon α2a has been successfully developed which shows that distribution volume (V) was associated with body mass index (BMI), and drug clearance (CL) had a positive correlation with creatinine clearance (CCR). The final population pharmacokinetic model supports the use of BMI and CCR-adjusted dosing in hepatitis B virus patients.

摘要

在接受聚乙二醇干扰素α2a 治疗的慢性乙型肝炎（CHB）患者中，其应答和药代动力学特征存在显著差异。本研究旨在确定可显著影响 CHB 患者聚乙二醇干扰素α2a 药代动力学特征的因素。从 178 例被认为患有 CHB 并接受聚乙二醇干扰素α2a 治疗的患者中采集了 208 份血样，并进行了血药浓度测定和其他实验室检查。从病历中检索了患者的人口统计学和临床特征等协变量。采用 NONMEM 软件的非线性混合效应建模方法建立了群体药代动力学模型。成功建立了聚乙二醇干扰素α2a 的群体药代动力学模型，结果表明分布容积（V）与体重指数（BMI）有关，药物清除率（CL）与肌酐清除率（CCR）呈正相关。最终的群体药代动力学模型支持在乙型肝炎病毒患者中使用 BMI 和 CCR 校正剂量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2861/5555209/d0fecc981adf/41598_2017_8205_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2861/5555209/60499093ece9/41598_2017_8205_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2861/5555209/0f01fd1354db/41598_2017_8205_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2861/5555209/cf6252eb99d8/41598_2017_8205_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2861/5555209/14882e6ba0d9/41598_2017_8205_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2861/5555209/d0fecc981adf/41598_2017_8205_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2861/5555209/60499093ece9/41598_2017_8205_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2861/5555209/0f01fd1354db/41598_2017_8205_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2861/5555209/cf6252eb99d8/41598_2017_8205_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2861/5555209/14882e6ba0d9/41598_2017_8205_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2861/5555209/d0fecc981adf/41598_2017_8205_Fig5_HTML.jpg

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