使用药物计量学方法评估万古霉素在儿科重症监护患者中达到 24 小时浓度-时间曲线下面积与最低抑制浓度之比大于或等于 400 时所需的剂量。

Dawoon Jung, Omayma A Kishk, Adnan T Bhutta, Ginny E Cummings, Hana M El Sahly, Manpreet K Virk, Brady S Moffett, Jennifer L Morris Daniel, Amy Watanabe, Nicholas Fishbane, Karen L Kotloff, Kenan Gu, Varduhi Ghazaryan, Jogarao V S Gobburu, Ayse Akcan-Arikan, James D Campbell
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引用次数: 0

摘要

目的:研究哪些独立因素会影响重症儿童万古霉素的药代动力学:研究哪些独立因素会影响重症患儿体内万古霉素的药代动力学,建立从谷浓度预测24小时浓度-时间曲线下面积的方程,并评估可能实现24小时浓度-时间曲线下面积与最小抑制浓度比值(AUC24/MIC)大于或等于400的给药方案:万古霉素的前瞻性群体药代动力学研究:环境: 四级护理 PICU 的重症患者:马里兰大学儿童医院和德克萨斯儿童医院重症监护病房接受万古霉素静脉注射治疗的 90 天或以上至 18 岁以下的儿童,无论其使用指征如何:干预措施:万古霉素的剂量和间隔由主治临床医生决定:在首次用药后的长达 7 天内,收集了每位患者万古霉素血清浓度的中位数,以及其他变量。这些数据用于描述万古霉素的药代动力学特征,并评估影响未接受体外疗法的重症监护病房患者达到 AUC24/MIC 比值大于或等于 400 的变异性因素。共有 302 名中位数年龄为 6.0 岁的儿童参与了这项研究。两室模型描述了万古霉素的药代动力学,体重 20 公斤的典型患者的清除率为 2.76 升/小时。使用床旁施瓦茨方程或儿童慢性肾脏病方程估算的肾小球滤过率是所评估变量中唯一具有统计学意义的清除率预测指标,其预测效果相当。当 MIC = 1 μg/mL 时,达到 AUC24/MIC = 400 的谷值水平为 5.6-10.0 μg/mL。采用每 6 小时和 8 小时 15 毫克/千克(q6h 和 q8h)的典型给药方案,分别有 60.4% 和 36.5% 的患者达到 AUC24/MIC 大于或等于 400 的目标:万古霉素在重症儿童中的药代动力学仅取决于估计的肾小球滤过率。低浓度可准确预测 AUC24。典型的小儿万古霉素给药方案为 15 mg/kg q6h 和 q8h,其 AUC24/MIC 通常低于 400。
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Evaluation of Vancomycin Dose Needed to Achieve 24-Hour Area Under the Concentration-Time Curve to Minimum Inhibitory Concentration Ratio Greater Than or Equal to 400 Using Pharmacometric Approaches in Pediatric Intensive Care Patients.

Objectives: To investigate which independent factor(s) have an impact on the pharmacokinetics of vancomycin in critically ill children, develop an equation to predict the 24-hour area under the concentration-time curve from a trough concentration, and evaluate dosing regimens likely to achieve a 24-hour area under the concentration-time curve to minimum inhibitory concentration ratio (AUC24/MIC) greater than or equal to 400.

Design: Prospective population pharmacokinetic study of vancomycin.

Setting: Critically ill patients in quaternary care PICUs.

Patients: Children 90 days old or older to younger than 18 years who received IV vancomycin treatment, irrespective of the indication for use, in the ICUs at the University of Maryland Children's Hospital and Texas Children's Hospital were enrolled.

Interventions: Vancomycin was prescribed at doses and intervals chosen by the treating clinicians.

Measurements and main results: A median of four serum levels of vancomycin per patient were collected along with other variables for up to 7 days following the first administration. These data were used to characterize vancomycin pharmacokinetics and evaluate the factors affecting the variability in achieving AUC24/MIC ratio greater than or equal to 400 in PICU patients who are not on extracorporeal therapy. A total of 302 children with a median age of 6.0 years were enrolled. A two-compartment model described the pharmacokinetics of vancomycin with the clearance of 2.76 L/hr for a typical patient weighing 20 kg. The glomerular filtration rate estimated using either the bedside Schwartz equation or the chronic kidney disease in children equation was the only statistically significant predictor of clearance among the variables evaluated, exhibiting equal predictive performance. The trough levels achieving AUC24/MIC = 400 were 5.6-10.0 μg/mL when MIC = 1 μg/mL. The target of AUC24/MIC greater than or equal to 400 was achieved in 60.4% and 36.5% with the typical dosing regimens of 15 mg/kg every 6 and 8 hours (q6h and q8h), respectively.

Conclusions: The pharmacokinetics of vancomycin in critically ill children were dependent on the estimated glomerular filtration rate only. Trough concentrations accurately predict AUC24. Typical pediatric vancomycin dosing regimens of 15 mg/kg q6h and q8h will often lead to AUC24/MIC under 400.

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