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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Population pharmacokinetics of ceftaroline in patients with acute bacterial skin and skin structure infections or community-acquired bacterial pneumonia
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Population pharmacokinetics of ceftaroline in patients with acute bacterial skin and skin structure infections or community-acquired bacterial pneumonia

机译：头孢洛林在急性细菌性皮肤和皮肤结构感染或社区获得性细菌性肺炎患者中的群体药代动力学

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Ceftaroline, the active form of ceftaroline fosamil, is a broad]spectrum cephalosporin antibiotic. A population pharmacokinetic (PPK) model for ceftaroline was developed in NONMEMR using data from 185 healthy subjects and 92 patients with acute bacterial skin and skin structure infection (ABSSSI). Data from 128 patients with community-acquired bacterial pneumonia (CABP) were used for external model validation. Healthy subjects received 50.2,000 mg ceftaroline fosamil via intravenous (IV) infusion over 1 hour or intramuscular (IM) injection q12h or q24h. ABSSSI and CABP patients received 600 mg of ceftaroline fosamil IV over 1 hour q12h. A three-compartment model with zero-order IV or parallel first-order IM input and first-order elimination described ceftaroline fosamil PK. A two-compartment model with first-order conversion of prodrug to ceftaroline and parallel linear and saturable elimination described ceftaroline PK. Creatinine clearance was the primary determinant of ceftaroline exposure. Good agreement between the observed data and both population (r2.0.93) and individual post-hoc (r2.0.98) predictions suggests the PPK model can adequately approximate ceftaroline PK using covariate information. Such a PPK model can evaluate dose adjustments for patients with renal impairment and generate ceftaroline exposures for use in pharmacokinetic.pharmacodynamic assessments of efficacy in patients with ABSSSI or CABP.
机译：头孢洛林是头孢洛林磷酰胺的活性形式，是一种广谱头孢菌素抗生素。在NONMEMR中使用来自185名健康受试者和92例急性细菌性皮肤和皮肤结构感染（ABSSSI）患者的数据开发了头孢洛林的群体药代动力学（PPK）模型。来自128例社区获得性细菌性肺炎（CABP）患者的数据用于外部模型验证。健康受试者在1小时内通过静脉（IV）输注或肌肉（IM）注射q12h或q24h接受50.2,000 mg ceftaroline fosamil。 ABSSSI和CABP患者在12小时1小时内接受了600毫克的头孢洛林fosamil IV。具有零阶IV或并行一阶IM输入和一阶消除的三室模型描述了头孢洛林fosamil PK。具有前药到头孢洛林的一级转化以及平行线性和饱和消除的两室模型描述了头孢洛林PK。肌酐清除率是头孢洛林暴露的主要决定因素。观察到的数据与总体（r2.0.93）和事后预测（r2.0.98）之间的良好一致性表明，PPK模型可以使用协变量信息充分近似头孢洛林PK。这种PPK模型可以评估肾功能不全患者的剂量调整并产生头孢洛林暴露量，用于ABSSSI或CABP患者的药代动力学，药效动力学评估。

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