Pejović Biljana, Ranković-Janevski Milica, Bozinović-Prekajski Niveska
Srp Arh Celok Lek. 2010 Jan-Feb;138(1-2):50-5. doi: 10.2298/sarh1002050p.
Drug safety depends on trough levels.
Objective of the study was to measure gentamicin and amikacin trough levels in neonates and to identify risk groups by gestational and postnatal age.
Gentamicin and amikacin were applied according to the clinical practice guidelines. Trough levels (mg/l) were determined using fluorescence polarization immunoassay methodology. Target trough levels were <2 mg/l for gentamicin, and <10 mg/l for amikacin. Patients were divided in 3 groups by gestational age: I < or =32, II 33-36, and III > or =37 gestational weeks and, by postnatal age, in 2 groups: < or =7 and >7 days.
Out of 163 neonates, 111 were receiving gentamicin and 52 amikacin. Mean amikacin trough level was 7.8 +/- 4.8 mg/l and, in group 110.5 +/- 4.9 mg/l, which was above the target range and significantly higher than in group II (LSD, p < 0.05). In the amikacin group, 26 patients were 7 and less, and 26 more than 7 days old, without significant differences in trough levels between the groups. In the gentamicin group, 52.3% of neonates had trough values within the target range. Gentamicin trough level in group I was above the trough range, 3.7 +/- 1.8, 2.3 +/- 1.5 in group II and, 1.8 +/- 1.4 mg/l in group III. The difference in trough levels among the groups was highly significant (F = 9.015, p < 0.001, chi2 = 17.576, p < 0.001). Further analysis revealed that differences between groups I and II (LSD, p = 0.002) and between I and III (LSD, p = 0.000) were highly significant.
Obtained gentamicin and amikacin trough levels are high. Inverse correlation has been confirmed between trough level and gestational age, with highly significant difference, and the risk group has been identified. There is obviously a need to change the dosing regimen in terms of those with extended intervals, particularly for neonates of the lowest gestational age, along with pharmacokinetic measurements.
药物安全性取决于谷浓度。
本研究旨在测定新生儿庆大霉素和阿米卡星的谷浓度，并根据胎龄和出生后年龄确定风险组。
按照临床实践指南应用庆大霉素和阿米卡星。采用荧光偏振免疫分析法测定谷浓度（mg/l）。庆大霉素的目标谷浓度<2mg/l，阿米卡星的目标谷浓度<10mg/l。患者按胎龄分为3组：I组≤32周，II组33 - 36周，III组≥37孕周；按出生后年龄分为2组：≤7天和>7天。
163例新生儿中，111例接受庆大霉素治疗，52例接受阿米卡星治疗。阿米卡星的平均谷浓度为7.8±4.8mg/l，II组为10.5±4.9mg/l，高于目标范围，且显著高于II组（LSD，p<0.05）。在阿米卡星组中，26例患者年龄≤7天，26例患者年龄>7天，两组间谷浓度无显著差异。在庆大霉素组中，52.3%的新生儿谷浓度值在目标范围内。I组庆大霉素谷浓度高于谷浓度范围，II组为3.7±1.8，III组为2.3±1.5mg/l，I组为1.8±1.4mg/l。各组间谷浓度差异高度显著（F = 9.015，p<0.001，χ2 = 17.576，p<0.001）。进一步分析显示，I组与II组（LSD，p = 0.002）以及I组与III组（LSD，p = 0.000）之间的差异高度显著。
所测得的庆大霉素和阿米卡星谷浓度较高。已证实谷浓度与胎龄呈负相关，差异高度显著，并确定了风险组。显然有必要改变给药方案，延长给药间隔，特别是对于最低胎龄的新生儿，并进行药代动力学测量。
