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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >The influence of renal function on hydroxyurea pharmacokinetics in adults with sickle cell disease.
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The influence of renal function on hydroxyurea pharmacokinetics in adults with sickle cell disease.

机译：肾功能对镰状细胞病成人的羟基脲药代动力学的影响。

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摘要

This was an open-label, nonrandomized, 2-center study conducted to assess the influence of renal function on the pharmacokinetics of hydroxyurea in adults with sickle cell disease (SCD). Seventeen patients were divided into 5 groups: normal renal function (n = 7), mild renal impairment (n = 2), moderate renal impairment (n = 3), severe renal impairment (n = 2), and end-stage renal disease (ESRD, n = 3). Except for patients with ESRD, all the patients received a 15-mg/kg single oral dose of hydroxyurea. Patients with ESRD received a 15-mg/kg oral dose of hydroxyurea on 2 occasions. Blood and urine samples were collected for the assessment of hydroxyurea pharmacokinetics. The results indicate that the systemic exposure increases and the urinary recovery decreases as the degree of renal insufficiency worsens. On the basis of the exposure and the apparent clearance from the current and 2 historical studies, the authors have proposed an initial dosing regimen of hydroxyurea (7.5 mg/kg/day) for SCD patients with CL(cr) <60 mL/min. This dosing strategy is anticipated to provide a safe dose for SCD patients with renal impairment.
机译：这是一项开放标签，非随机，2中心研究，旨在评估肾功能对镰状细胞病（SCD）成人的羟基脲药代动力学的影响。 17位患者分为5组：正常肾功能（n = 7），轻度肾功能不全（n = 2），中度肾功能不全（n = 3），严重肾功能不全（n = 2）和终末期肾脏疾病（ESRD，n ＝ 3）。除ESRD患者外，所有患者均接受15 mg / kg的单次口服羟基脲剂量。 ESRD患者有2次口服15 mg / kg羟基脲。收集血液和尿液样本以评估羟基脲的药代动力学。结果表明，随着肾功能不全程度的加重，全身暴露增加，尿恢复降低。根据目前和2个历史研究的暴露量和表观清除率，作者提出了CL（cr）<60 mL / min的SCD患者的羟基脲初始给药方案（7.5 mg / kg /天）。预期这种给药策略可为患有肾功能不全的SCD患者提供安全剂量。

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