关键词: Acute Lymphoblastic Leukemia (ALL) Gentamicin Pediatric Pharmacokinetics (PK) Therapeutic Drug Monitoring (TDM)

来  源:   DOI:10.1016/j.jsps.2024.102060   PDF(Pubmed)

Abstract:
Understanding the pharmacokinetics of gentamicin is essential in special populations, such as pediatric patients with acute lymphoblastic leukemia (ALL), in light of previous studies indicating that ALL patients have a lower volume of distribution than non-ALL patients. Furthermore, validation of such results is needed to ensure their clinical application. Accordingly, this single-center, retrospective, cross-sectional study compares the pharmacokinetic parameters of volume of distribution and clearance (Cl) of gentamicin between ALL and non-ALL patients. Inclusion criteria were pediatric patients aged between 1 and 14 years with or without ALL and receiving intravenous gentamicin for treatment courses > 72 h. Patients\' characteristics, such as age, sex, height, serum albumin, diagnosis, serum creatinine (Scr) concentration, dosing, and pharmacokinetic information, including peak and trough concentrations, were retrieved. The study scrutinized a total of 115 pediatric patients, comprising toddlers (15.7 %), children (76.5 %), and adolescents (7.8 %). All patients received gentamicin every 8 h, with an average dose of 2.50 (0.64) mg/kg. Patients were divided into two groups based on disease state, with 45.2 % (n = 52) in the non-ALL group and 54.8 % (n = 63) in the ALL group. Both groups had similar characteristics in terms of gender, weight, body surface area, and dose. The only significant covariates identified were weight and creatinine clearance (Clcr) for volume of distribution (Vd). A significant difference was found in Scr, Clcr, and blood urea nitrogen (BUN); however, no significant difference between ALL and non-ALL patients emerged in the volume of distribution or Cl. In conclusion, the study findings indicate that dosing requirements were similar between the two groups. Further prospective studies with larger sample sizes are warranted.
摘要:
了解庆大霉素的药代动力学在特殊人群中至关重要,例如急性淋巴细胞白血病(ALL)的儿科患者,鉴于先前的研究表明,ALL患者的分布体积低于非ALL患者。此外,需要对这些结果进行验证,以确保其临床应用。因此,这个单一的中心,回顾性,横断面研究比较了ALL和非ALL患者中庆大霉素的分布容积和清除率(Cl)的药代动力学参数.纳入标准为1至14岁有或无ALL且接受静脉庆大霉素治疗疗程>72h的儿科患者。比如年龄,性别,高度,血清白蛋白,诊断,血清肌酐(Scr)浓度,给药,和药代动力学信息,包括峰谷浓度,被检索。这项研究共检查了115名儿科患者,包括幼儿(15.7%),儿童(76.5%),青少年(7.8%)。所有患者每8小时接受庆大霉素,平均剂量为2.50(0.64)mg/kg。根据疾病状态将患者分为两组,非ALL组为45.2%(n=52),ALL组为54.8%(n=63)。两组在性别方面有相似的特点,体重,体表面积,和剂量。唯一确定的显著协变量是体重和肌酐清除率(Clcr)的分布体积(Vd)。在Scr中发现了显著差异,Clcr,和血尿素氮(BUN);然而,ALL和非ALL患者之间的分布体积或Cl没有显着差异。总之,研究结果表明,两组的给药要求相似.有必要进行更大样本量的进一步前瞻性研究。
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