Bidu Nadielle S, Fernandes Bruno J D, Dias Eduardo J C, Filho Jucelino N C, Bastos Regina E A, Godoy Ana L P C, Azeredo Francine J, Pedreira Joice N R, Couto Ricardo D
Pharmacy Postgraduate Program, Faculty of Pharmacy, Federal University of Bahia/UFBA, Salvador, Bahia, Brazil.
Clinical Biochemistry Laboratory, Department of Clinical and Toxicological Analysis, Faculty of Pharmacy, Federal University of Bahia/UFBA, Salvador, Bahia, Brazil.
Curr Pharm Biotechnol. 2019;20(4):346-351. doi: 10.2174/1389201020666190319161511.
Vancomycin is used mostly to overcome infections caused by methicillinresistant microorganisms. There are no well-established administration protocols for neonates and infants, so the leak of a specific administration regime in that population may lead to serum concentrations beyond the specified range.
This case series evaluated the pharmacokinetics adjustment from a vancomycin therapeutic regimen prescribed to neonates and infants with bacterial infection at a neonatal public hospital intensive- care-unit, with the primary purpose to verify cases of nephrotoxicity.
Three neonates and four infants taking vancomycin therapy, hospitalized in a public hospital from November 2014 to March 2015, were included in the study. Vancomycin serum concentrations were determined by particle-enhanced-turbidimetric inhibition-immunoassay. The vancomycin concentrations were used for dose adjustment by USC*Pack-PC-Collection®, a non-parametric maximization program. The trough serum concentration range of 10 to 20mg.L-1 was considered therapeutic.
Three patients had serum concentration outside the reference-range, one with subtherapeutic, and two with supratherapeutic concentrations. All patients had concomitant use of drugs which interfered with vancomycin distribution and excretion pharmacokinetics parameters, including drugs that may enhance nephrotoxicity. One patient showed signs of acute renal damage, by low vancomycin and creatinine estimated clearances.
The pharmacokinetic adjustment has been proven to be a useful and necessary tool to increase therapeutic efficacy and treatment benefits. The standard dose of vancomycin can be used to initiate therapy in neonates and infants admitted to the ICU, but after reaching the drug steady state, the dosing regimen should be individualized and guided by pharmacokinetic parameters.
万古霉素主要用于治疗耐甲氧西林微生物引起的感染。对于新生儿和婴儿，目前尚无成熟的给药方案，因此该人群中特定给药方案的遗漏可能导致血清浓度超出规定范围。
本病例系列评估了一家新生儿公立医院重症监护病房为细菌感染的新生儿和婴儿开具的万古霉素治疗方案的药代动力学调整情况，主要目的是核实肾毒性病例。
本研究纳入了2014年11月至2015年3月在一家公立医院住院接受万古霉素治疗的3名新生儿和4名婴儿。采用颗粒增强比浊抑制免疫测定法测定万古霉素血清浓度。通过非参数最大化程序USC*Pack-PC-Collection®使用万古霉素浓度进行剂量调整。10至20mg.L-1的谷血清浓度范围被认为是治疗性的。
3例患者的血清浓度超出参考范围，1例低于治疗浓度，2例高于治疗浓度。所有患者均同时使用了干扰万古霉素分布和排泄药代动力学参数的药物，包括可能增强肾毒性的药物。1例患者因万古霉素和肌酐估计清除率低而出现急性肾损伤迹象。
药代动力学调整已被证明是提高治疗效果和治疗效益的有用且必要的工具。万古霉素的标准剂量可用于开始对入住重症监护病房的新生儿和婴儿进行治疗，但在达到药物稳态后，给药方案应个体化并以药代动力学参数为指导。
