Pineda Leslie C, Watt Kevin M
Department of Pediatrics, Duke University Medical Center, Duke University, Box 2739, 2424 Erwin Road, Hock Plaza Suite 504, Durham, NC 27710, USA.
Department of Pediatrics, Duke Clinical Research Institute, Duke University Medical Center, Duke University, Box 3046, 2300 Erwin Road, Durham, NC 27710, USA.
Clin Perinatol. 2015 Mar;42(1):167-76, ix-x. doi: 10.1016/j.clp.2014.10.009. Epub 2014 Nov 27.
To prevent the devastating consequences of infection, most infants admitted to the neonatal intensive care unit are exposed to antibiotics. However, dosing regimens are often extrapolated from data in adults and older children, increasing the risk for drug toxicity and lack of clinical efficacy because they fail to account for developmental changes in infant physiology. However, newer technologies are emerging with minimal-risk study designs, including ultra-low-volume assays, pharmacokinetic modeling and simulation, and opportunistic drug protocols. With minimal-risk study designs, pharmacokinetic data and dosing regimens for infants are now available for ampicillin, clindamycin, meropenem, metronidazole, and piperacillin/tazobactam.
为防止感染带来的灾难性后果,大多数入住新生儿重症监护病房的婴儿都要接受抗生素治疗。然而,给药方案往往是根据成人和大龄儿童的数据推断而来,由于没有考虑婴儿生理发育的变化,增加了药物毒性和临床疗效不佳的风险。不过,包括超微量检测、药代动力学建模与模拟以及机会性用药方案在内的低风险研究设计的新技术正在不断涌现。通过低风险研究设计,现已获得了氨苄西林、克林霉素、美罗培南、甲硝唑和哌拉西林/他唑巴坦用于婴儿的药代动力学数据和给药方案。