Akinmboni T O, Davis N L, Falck A J, Bearer C F, Mooney S M
Division of Neonatology, Department of Pediatrics, University of Maryland School of Medicine, Baltimore MD, USA.
J Perinatol. 2018 Feb;38(2):169-174. doi: 10.1038/jp.2017.165. Epub 2017 Nov 2.
The excipients benzyl alcohol, propylene glycol and ethanol are present in medications used in the neonatal intensive care unit. Exposure to high levels can have adverse effects in a neonatal population. The objective was to quantify excipient exposure in very low birth weight (VLBW) neonates and identify risk factors associated with greater exposure.
A retrospective record review of VLBW infants admitted over 1 year. Excipient exposures were calculated and multivariable regression analyses identified risk factors for increasing exposure.
In total, 98% of subjects were exposed to at least one excipient. A total of 5 to 9% received doses higher than recommended for adults. Necrotizing enterocolitis, seizure, bronchopulmonary dysplasia and longer stay predicted higher excipient exposure.
The excipients examined are in medications commonly prescribed for VLBW neonates, and cumulative doses may exceed recommended exposures for adults. Although safety profiles have not been established, judicious use of medication containing these excipients is warranted for this population.
新生儿重症监护病房使用的药物中含有辅料苯甲醇、丙二醇和乙醇。高剂量接触这些辅料可能会对新生儿产生不良影响。本研究的目的是量化极低出生体重（VLBW）新生儿的辅料接触量，并确定与较高接触量相关的风险因素。
对1年内收治的VLBW婴儿进行回顾性记录审查。计算辅料接触量，并通过多变量回归分析确定接触量增加的风险因素。
总体而言，98%的受试者接触过至少一种辅料。共有5%至9%的受试者接受的剂量高于成人推荐剂量。坏死性小肠结肠炎、癫痫、支气管肺发育不良和住院时间延长预示着辅料接触量较高。
所检测的辅料存在于VLBW新生儿常用的药物中，累积剂量可能超过成人推荐接触量。尽管尚未确定其安全性，但对于该人群，谨慎使用含有这些辅料的药物是必要的。
