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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 influences of renal function and maturation on vancomycin elimination in newborns and infants.
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The influences of renal function and maturation on vancomycin elimination in newborns and infants.

机译：肾功能和成熟对万古霉素消除新生儿和婴儿的影响。

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摘要

The purpose of this study was to describe the maturation of vancomycin (V) clearance and the influence of altered renal function in infants on vancomycin using population pharmacokinetic methods. A population pharmacokinetic model was developed using NONMEM from clinical data obtained from 374 newborns and infants < 2 years of age (median age = 27 days) from four institutions. A total of 1103 serum V concentrations were used in the model development, including 311 with elevated serum creatinine (CR) (> 0.8 mg/dl) and more than 104 evaluations in infants older than 2 months of age. The final model was evaluated against a second data set of 160 concentrations from 67 infants at one of the institutions and then used to develop dosing guidelines. The data were best described by a two-compartment model. Weight and CR greatly influenced vancomycin elimination, while postnatal age and prematurity (< 28 weeks) were significant but less important predictors of V elimination. For the typical study infant (age = 27 days, CR = 0.6, WT= 1.8 kg, gestational age = 33.5 weeks), this results in VdSS = 0.79 l/kg and Cl = 0.066 l/h/kg. The validation data set showed the model to be unbiased. Dosing guidelines from this model, based on serum creatinine and gestational age at birth, performed better than published guidelines based on postconceptional age. Vancomycin clearance is initially reduced in premature infants and increases with postnatal age. Most of the age-related changes could be predicted by the concomitant fall in serum creatinine. Dosing guidelines that incorporate these factors are more likely to produce therapeutic V concentrations in infants.
机译：这项研究的目的是使用群体药代动力学方法描述万古霉素（V）清除的成熟度以及婴儿肾脏功能改变对万古霉素的影响。使用NONMEM，从四个机构的374名新生儿和2岁以下（中位年龄= 27天）的婴儿中获得临床数据，建立了群体药代动力学模型。在模型开发中总共使用了1103个血清V浓度，其中311个血清肌酐（CR）升高（> 0.8 mg / dl），并且对2个月以上的婴儿进行了104次以上的评估。根据其中一个机构的67名婴儿的160个浓度的第二个数据集评估了最终模型，然后将其用于制定剂量指南。最好用两室模型描述数据。体重和CR极大地影响了万古霉素的消除，而出生后的年龄和早产（<28周）则是重要的指标，但V消除的预测指标却不那么重要。对于典型的研究婴儿（年龄= 27天，CR = 0.6，WT = 1.8千克，胎龄= 33.5周），这导致VdSS = 0.79 l / kg和Cl = 0.066 l / h / kg。验证数据集显示该模型是无偏的。该模型基于出生时的血清肌酐和胎龄的用药指导要比已发表的基于受孕后年龄的指导要好。万古霉素清除率最初在早产儿中降低，并随出生后年龄增加。大多数与年龄有关的变化可以通过血清肌酐的下降来预测。包含这些因素的剂量指南更可能在婴儿中产生治疗性V浓度。

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