Souza Alcidésio, Santos Djanilson, Fonseca Said, Medeiros Marina, Batista Lívia, Turner Mark, Coelho Helena
Mother and Child Hospital of Brasilia, SGAS, Av. L2 Sul, Quadra 608, Módulo A Asa Sul, Brasília, Federal District, Brazil,
Eur J Pediatr. 2014 Jul;173(7):935-45. doi: 10.1007/s00431-014-2272-z. Epub 2014 Feb 6.
The aim was to describe the exposure to excipients among neonates hospitalised in the neonatal intensive care unit (NICU) of a public hospital in Brasilia, Brazil. This was a retrospective study based on medicines that were prescribed electronically to neonates (≤28 days) who were admitted to the NICU of a hospital in Brasilia between January 1 and March 31, 2012. Excipients were identified from the medicine package leaflets and were classified according to toxicity. Seventy-nine infants received a total of 1,303 prescriptions comprising 77 formulations and 70 active drugs. Eighty-six excipients were identified, of which, 9 were harmful excipients (HE) and 48 were potentially harmful excipients (PHE). Almost all the neonates (98.7 %) were exposed to at least one HE and PHE. Preterm neonates (n = 64; 1,502 neonate days) presented high risk of exposure to polysorbate 80 (3.26/100 neonate days), sodium hydroxide (3.39), PG (3.19) and propylparaben (3.06). Full-term neonates (n = 15; 289 neonate days) presented risks in relation to phenol (4.84), ethanol (3.8) and sodium citrate (3.46).
Neonates in NICUs in Brazil are exposed to a wide variety of HE and PHE with unpredictable results. Safer alternatives are needed, as well as further studies on the subject.
目的是描述巴西巴西利亚一家公立医院新生儿重症监护病房（NICU）住院新生儿的辅料暴露情况。这是一项回顾性研究，基于2012年1月1日至3月31日期间入住巴西利亚一家医院NICU的≤28天新生儿的电子处方药物。从药品说明书中识别辅料，并根据毒性进行分类。79名婴儿共收到1303张处方，包括77种制剂和70种活性药物。识别出86种辅料，其中9种为有害辅料（HE），48种为潜在有害辅料（PHE）。几乎所有新生儿（98.7%）都暴露于至少一种HE和PHE。早产儿（n = 64；1502个新生儿日）暴露于聚山梨酯80（3.26/100个新生儿日）、氢氧化钠（3.39）、丙二醇（3.19）和对羟基苯甲酸丙酯（3.06）的风险较高。足月儿（n = 15；289个新生儿日）存在与苯酚（4.84）、乙醇（3.8）和柠檬酸钠（3.46）相关的风险。
巴西NICU中的新生儿暴露于多种HE和PHE，结果难以预测。需要更安全的替代品，以及对此主题的进一步研究。
