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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Utility of sparse concentration sampling for citalopram in elderly clinical trial subjects.
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Utility of sparse concentration sampling for citalopram in elderly clinical trial subjects.

机译：西酞普兰稀疏浓度采样在老年临床试验受试者中的效用。

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摘要

The objective of this study was to evaluate whether the disposition of the selective serotonin reuptake inhibitor, citalopram, could be robustly captured using 1 to 2 concentration samples per subject in 106 patients participating in 2 clinical trials. Nonlinear mixed-effects modeling was used to evaluate the pharmacokinetic parameters describing citalopram's disposition. Both a prior established 2-compartment model and a de novo 1-compartment pharmacokinetic model were used. Covariates assessed were concomitant medications, race, sex, age (22-93 years), and weight. Covariates affecting disposition were assessed separately and then combined in a stepwise manner. Pharmacokinetic characteristics of citalopram were well captured using this sparse sampling design. Two covariates (age and weight) had a significant effect on the clearance and volume of distribution in both the 1- and 2-compartment pharmacokinetic models. Clearance decreased 0.23 L/h for every year of age and increased 0.14 L/h per kilogram body weight. It was concluded that hyper-sparse sampling designs are adequate to support population pharmacokinetic analysis in clinically treated populations. This is particularly valuable for populations such as the elderly, who are not typically available for pharmacokinetic studies.
机译：这项研究的目的是评估参加2个临床试验的106名患者中每位受试者使用1至2个浓度的样品是否可以稳健地捕获选择性5-羟色胺再摄取抑制剂西酞普兰的处置。非线性混合效应模型用于评估描述西酞普兰处置的药代动力学参数。使用先前建立的2室模型和从头1室药代动力学模型。评估的协变量是药物，种族，性别，年龄（22-93岁）和体重。分别评估影响处置的协变量，然后逐步进行合并。使用这种稀疏采样设计可以很好地捕获西酞普兰的药代动力学特征。在1室和2室药代动力学模型中，两个协变量（年龄和体重）对清除率和分布体积有显着影响。清除率每岁降低0.23 L / h，每千克体重增加0.14 L / h。结论是，超稀疏采样设计足以支持在临床治疗人群中进行人群药代动力学分析。这对于通常无法进行药代动力学研究的人群（如老年人）特别有价值。

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