Low Yee Shan, Tan Sin Li, Wan Angeline Sl
Department of Pharmacy, Sultanah Fatimah Specialist Hospital, Muar, Johor.
Department of Pediatrics, Sultanah Fatimah Specialist Hospital, Muar, Johor.
J Pediatr Pharmacol Ther. 2015 Mar-Apr;20(2):119-27. doi: 10.5863/1551-6776-20.2.119.
To evaluate the usefulness of extended-interval gentamicin dosing practiced in neonatal intensive care unit (NICU) and special care nursery (SCN) of a Malaysian hospital.
Cross-sectional observational study with pharmacokinetic analysis of all patients aged ≤28 days who received gentamicin treatment in NICU/SCN. Subjects received dosing according to a regimen modified from an Australian-based pediatric guideline. During a study period of 3 months, subjects were evaluated for gestational age, body weight, serum creatinine concentration, gentamicin dose/interval, serum peak and trough concentrations, and pharmacokinetic parameters. Descriptive percentages were used to determine the overall dosing accuracy, while analysis of variance (ANOVA) was conducted to compare the accuracy rates among different gestational ages. Pharmacokinetic profile among different gestational age and body weight groups were compared by using ANOVA.
Of the 113 subjects included, 82.3% (n = 93) achieved therapeutic concentrations at the first drug-monitoring assessment. There was no significant difference found between the percentage of term neonates who achieved therapeutic concentrations and the premature group (87.1% vs. 74.4%), p = 0.085. A total of 112 subjects (99.1%) achieved desired therapeutic trough concentration of <2 mg/L. Mean gentamicin peak concentration was 8.52 mg/L (95% confidence interval [Cl], 8.13-8.90 mg/L) and trough concentration was 0.54 mg/L (95% CI, 0.48-0.60 mg/L). Mean volume of distribution, half-life, and elimination rate were 0.65 L/kg (95% CI, 0.62-0.68 L/kg), 6.96 hours (95% CI, 6.52-7.40 hours), and 0.11 hour(-1) (95% CI, 0.10-0.11 hour(-1)), respectively.
The larger percentage of subjects attaining therapeutic range with extended-interval gentamicin dosing suggests that this regimen is appropriate and can be safely used among Malaysian neonates.
评估马来西亚一家医院新生儿重症监护病房（NICU）和特殊护理病房（SCN）中延长间隔给予庆大霉素的有效性。
对在NICU/SCN接受庆大霉素治疗的所有年龄≤28天的患者进行药代动力学分析的横断面观察性研究。受试者根据基于澳大利亚儿科指南修改的方案给药。在3个月的研究期间，对受试者的胎龄、体重、血清肌酐浓度、庆大霉素剂量/间隔、血清峰浓度和谷浓度以及药代动力学参数进行评估。使用描述性百分比来确定总体给药准确性，同时进行方差分析（ANOVA）以比较不同胎龄之间的准确率。通过ANOVA比较不同胎龄和体重组之间的药代动力学特征。
在纳入的113名受试者中，82.3%（n = 93）在首次药物监测评估时达到治疗浓度。足月儿达到治疗浓度的百分比与早产儿组之间无显著差异（87.1%对74.4%），p = 0.085。共有112名受试者（99.1%）达到了<2 mg/L的理想治疗谷浓度。庆大霉素平均峰浓度为8.52 mg/L（95%置信区间[Cl]，8.13 - 8.90 mg/L），谷浓度为0.54 mg/L（95% CI，0.48 - 0.60 mg/L）。平均分布容积、半衰期和消除率分别为0.65 L/kg（95% CI，0.62 - 0.68 L/kg）、6.96小时（95% CI，6.52 - 7.40小时）和0.11小时⁻¹（95% CI，0.10 - 0.11小时⁻¹）。
延长间隔给予庆大霉素时达到治疗范围的受试者比例较高，表明该方案是合适的，可在马来西亚新生儿中安全使用。
