Nellis Georgi, Metsvaht Tuuli, Varendi Heili, Toompere Karolin, Lass Jana, Mesek Inge, Nunn Anthony J, Turner Mark A, Lutsar Irja
Institute of Microbiology, Tartu University, Tartu, Tartumaa, Estonia Neonatal Unit, Tartu University Hospital, Childreńs Clinic, Tartu, Tartumaa, Estonia.
Institute of Microbiology, Tartu University, Tartu, Tartumaa, Estonia Paediatric Intensive Care Unit, Tartu University Hospital, Clinic of Anaesthesiology and Intensive Care, Tartu, Tartumaa, Estonia.
Arch Dis Child. 2015 Jul;100(7):694-9. doi: 10.1136/archdischild-2014-307793. Epub 2015 Apr 8.
We aimed to describe administration of eight potentially harmful excipients of interest (EOI)-parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol and benzalkonium chloride-to hospitalised neonates in Europe and to identify risk factors for exposure.
All medicines administered to neonates during 1 day with individual prescription and demographic data were registered in a web-based point prevalence study. Excipients were identified from the Summaries of Product Characteristics. Determinants of EOI administration (geographical region, gestational age (GA), active pharmaceutical ingredient, unit level and hospital teaching status) were identified using multivariable logistical regression analysis.
Overall 89 neonatal units from 21 countries participated. Altogether 2095 prescriptions for 530 products administered to 726 neonates were recorded. EOI were found in 638 (31%) prescriptions and were administered to 456 (63%) neonates through a relatively small number of products (n=142; 27%). Parabens, found in 71 (13%) products administered to 313 (43%) neonates, were used most frequently. EOI administration varied by geographical region, GA and route of administration. Geographical region remained a significant determinant of the use of parabens, polysorbate 80, propylene glycol and saccharin sodium after adjustment for the potential covariates including anatomical therapeutic chemical class of the active ingredient.
European neonates receive a number of potentially harmful pharmaceutical excipients. Regional differences in EOI administration suggest that EOI-free products are available and provide the potential for substitution to avoid side effects of some excipients.
我们旨在描述欧洲住院新生儿使用8种潜在有害的目标辅料（EOI）——对羟基苯甲酸酯类、聚山梨醇酯80、丙二醇、苯甲酸盐、糖精钠、山梨醇、乙醇和苯扎氯铵的情况，并确定暴露的风险因素。
在一项基于网络的点患病率研究中，记录了某一天给新生儿使用的所有药品及其个体处方和人口统计学数据。从产品特性摘要中识别辅料。使用多变量逻辑回归分析确定EOI使用的决定因素（地理区域、胎龄（GA）、活性药物成分、单位级别和医院教学状况）。
来自21个国家的89个新生儿科室参与了研究。共记录了给726名新生儿使用的530种产品的2095份处方。在638份（31%）处方中发现了EOI，通过相对较少数量的产品（n = 142；27%）给456名（63%）新生儿使用了EOI。对羟基苯甲酸酯类在给313名（43%）新生儿使用的71种（13%）产品中被发现，使用最为频繁。EOI的使用因地理区域、胎龄和给药途径而异。在对包括活性成分的解剖治疗化学分类等潜在协变量进行调整后，地理区域仍然是对羟基苯甲酸酯类、聚山梨醇酯80、丙二醇和糖精钠使用的一个重要决定因素。
欧洲新生儿会接触到多种潜在有害的药物辅料。EOI使用的区域差异表明存在不含EOI的产品，并且有进行替代以避免某些辅料副作用的可能性。
