Hughes Kaitlin M, Johnson Peter N, Anderson Michael P, Sekar Kris C, Welliver Robert C, Miller Jamie L
J Pediatr Pharmacol Ther. 2017 Jan-Feb;22(1):33-40. doi: 10.5863/1551-6776-22.1.33.
The primary aim was to compare attainment of goal serum amikacin concentrations using two dosage regimens in patients admitted to a neonatal intensive care unit. Secondary objectives included comparison of percentages of supratherapeutic trough concentrations, and subtherapeutic and supratherapeutic peak concentrations.
This was an Institutional Review Board-approved, retrospective study of neonates receiving amikacin during January-December 2013 (group 1) and January-December 2014 (group 2). Group 1 received amikacin dosage consistent with published recommendations, whereas group 2 was dosed using a modified protocol that was based on postmenstrual and postnatal age. Goal serum amikacin peak concentration was defined as 20 to 35 mg/L; hence, subtherapeutic and supratherapeutic peak concentrations were defined as <20 mg/L and >35 mg/L, respectively. Supratherapeutic trough concentrations were >8 mg/L. Between-group analysis was performed using Wilcoxon-Mann-Whitney test, Student -test or χ, or Fisher exact analysis as appropriate with a p value <0.05.
A total of 278 neonates were included (group 1: n = 144; group 2: n = 134). Most patients were male (60%) and were admitted for prematurity or respiratory distress (77%). The median gestational age in group 1 was 34.4 weeks (range, 30.0-37.9 weeks) versus group 2 at 36.9 weeks (range, 31.4-38.9 weeks), whereas the postnatal age was similar between both groups at 4 days. There was a significant increase in attaining goal peak amikacin concentrations between groups 1 and 2, 34% versus 84%, p < 0.001, and decrease in supratherapeutic peak concentrations, 65% versus 12%, p < 0.001. There was no significant difference in subtherapeutic peak or supratherapeutic trough concentrations.
A modified neonatal amikacin dosage protocol resulted in increased peak amikacin serum concentration compared with published dosage recommendations. Future research should focus on determination of the optimal dosage regimen in neonates.
主要目的是比较新生儿重症监护病房收治的患者使用两种给药方案时达到目标血清阿米卡星浓度的情况。次要目的包括比较超治疗谷浓度、亚治疗峰浓度和超治疗峰浓度的百分比。
这是一项经机构审查委员会批准的回顾性研究，研究对象为2013年1月至12月（第1组）和2014年1月至12月（第2组）接受阿米卡星治疗的新生儿。第1组接受的阿米卡星剂量符合已发表的推荐剂量，而第2组使用基于月经龄和出生后年龄的改良方案给药。目标血清阿米卡星峰浓度定义为20至35mg/L；因此，亚治疗峰浓度和超治疗峰浓度分别定义为<20mg/L和>35mg/L。超治疗谷浓度>8mg/L。组间分析采用Wilcoxon-Mann-Whitney检验、Student检验或χ²检验，或根据适当情况采用Fisher精确分析，p值<0.05。
共纳入278例新生儿（第1组：n = 144；第2组：n = 134）。大多数患者为男性（60%），因早产或呼吸窘迫入院（77%）。第1组的中位胎龄为34.4周（范围30.0 - 37.9周）；第2组为36.9周（范围31.4 - 38.9周），而两组出生后年龄相似，均为4天。第1组和第2组之间达到目标峰阿米卡星浓度的比例有显著增加，分别为34%和84%，p < 0.001；超治疗峰浓度有所下降，分别为65%和12%，p < 0.001。亚治疗峰浓度或超治疗谷浓度无显著差异。
与已发表的给药推荐相比，改良的新生儿阿米卡星给药方案使阿米卡星血清峰浓度升高。未来的研究应侧重于确定新生儿的最佳给药方案。
