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靶向降低血清谷浓度:一种针对疑似新生儿早发型败血症的新庆大霉素给药策略。

Targeting Lower Serum Trough Concentrations: A New Gentamicin Dosing Strategy for Suspected Neonatal Early-Onset Sepsis.

作者信息

Kayser Nicholas, Cunningham Kelli, Alabsi Samir, Smith Hayden

机构信息

Department of Pharmacy (NK, KC), UnityPoint Des Moines-Blank Children's Hospital, Des Moines, IA.

Neonatal Intensive Care Unit (SA), UnityPoint Des Moines-Blank Children's Hospital, Des Moines, IA.

出版信息

J Pediatr Pharmacol Ther. 2023;28(1):71-77. doi: 10.5863/1551-6776-28.1.71. Epub 2023 Feb 3.

Abstract

OBJECTIVE

Neonatal gentamicin dosing algorithms are not designed to achieve serum trough concentrations ≤1 mcg/mL. The purpose of our study was to evaluate a new gentamicin algorithm based on serum creatinine (SCr) and gestational age (GA) designed to achieve serum gentamicin trough concentrations ≤1 mcg/mL.

METHODS

A retrospective cohort study was conducted in a level IIIB neonatal intensive care unit. The incidence of elevated serum gentamicin troughs for this study was compared with the center's previously published results to evaluate the proposed dosing algorithm. Patients were included if gentamicin was administered within the first 7 days of life and a serum gentamicin trough concentration and a baseline SCr concentration were obtained. Patients were further subdivided into groups based on GA for data analysis: ≤30 weeks (group 1), 30-34 weeks (group 2), and ≥35 weeks (group 3). The SCr was considered mildly elevated (0.81-0.99 mg/dL) or elevated (≥1 mg/dL). The respective outcomes between the post-algorithm and control groups were examined using intention-to-treat analysis and Bayesian modeling to calculate rate differences.

RESULTS

Of the 2377 patients evaluated, 366 met the inclusion criteria. Significantly lower percentages of elevated serum gentamicin troughs were noted in groups 2 and 3 subsequent to the implementation of the dosing algorithm with 16% and 15% lower rate differences, respectively. Regardless of GA, there were significantly fewer elevated serum troughs in the post-implementation groups than in the control with mildly elevated and elevated SCr p < 0.001.

CONCLUSIONS

Using a dosing algorithm based on SCr significantly reduced the number of elevated serum trough rates in neonates with a GA greater than 30 weeks.

摘要

目的

新生儿庆大霉素给药算法并非旨在使血清谷浓度≤1 mcg/mL。我们研究的目的是评估一种基于血清肌酐(SCr)和胎龄(GA)的新型庆大霉素算法,该算法旨在使血清庆大霉素谷浓度≤1 mcg/mL。

方法

在一家三级B级新生儿重症监护病房进行了一项回顾性队列研究。将本研究中血清庆大霉素谷值升高的发生率与该中心之前发表的结果进行比较,以评估所提出的给药算法。如果在出生后7天内给予庆大霉素且获得了血清庆大霉素谷浓度和基线SCr浓度,则纳入患者。为了进行数据分析,根据胎龄将患者进一步分为几组:≤30周(第1组)、30 - 34周(第2组)和≥35周(第3组)。SCr被认为轻度升高(0.81 - 0.99 mg/dL)或升高(≥1 mg/dL)。使用意向性分析和贝叶斯模型来计算率差,检查算法实施后组与对照组之间的各自结果。

结果

在评估的2377例患者中,366例符合纳入标准。在实施给药算法后,第2组和第3组血清庆大霉素谷值升高的百分比显著降低,率差分别降低了16%和15%。无论胎龄如何,实施后组血清谷值升高的情况均显著少于SCr轻度升高和升高的对照组(p < 0.001)。

结论

使用基于SCr的给药算法可显著降低胎龄大于30周新生儿血清谷值升高率的数量。

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Gentamicin Dosing in Neonates with Normal Renal Function: Trough and Peak Levels.肾功能正常的新生儿的庆大霉素给药:谷浓度和峰浓度
Eur J Drug Metab Pharmacokinet. 2021 Sep;46(5):677-684. doi: 10.1007/s13318-021-00708-x. Epub 2021 Aug 9.

本文引用的文献

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Maturation of glomerular filtration rate in neonates and infants: an overview.新生儿和婴儿肾小球滤过率的成熟:综述
Pediatr Nephrol. 2021 Jun;36(6):1439-1446. doi: 10.1007/s00467-020-04632-1. Epub 2020 Jun 11.
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Therapeutic drug monitoring of aminoglycosides in neonates.新生儿氨基糖苷类药物的治疗药物监测
Clin Pharmacokinet. 2009;48(2):71-88. doi: 10.2165/00003088-200948020-00001.

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