Department of Pediatrics, Division of Neonatology, Erasmus University Medical Center - Sophia Children's Hospital, Rotterdam, The Netherlands.
Department of Pharmacy and Radboud Institute of Health Sciences (RIHS), Radboudumc, Nijmegen, The Netherlands.
Br J Clin Pharmacol. 2018 Jun;84(6):1313-1323. doi: 10.1111/bcp.13563. Epub 2018 Apr 17.
Evidence for drug use in newborns is sparse, which may cause large differences in drug prescriptions. We aimed to investigate the differences between neonatal intensive care units (NICUs) in the Netherlands in currently prescribed drugs.
This multicentre study included neonates admitted during 12 months to four different NICUs. Drugs were classified in accordance with the Anatomical Therapeutic Chemical (ATC) classification system and assessed for on/off-label status in relation to neonatal age. The treatment protocols for four common indications for drug use were compared: pain, intubation, convulsions and hypotension.
A total of 1491 neonates (GA range 23 -42 weeks) were included with a total of 32 182 patient days, 181 different drugs and 10 895 prescriptions of which 23% was off-label in relation to neonatal age. Overall, anti-infective drugs were most frequently used with a total of 3161 prescriptions, of which 4% was off-label in relation to neonatal age. Nervous system drugs included 2500 prescriptions of which 31% was off-label in relation to neonatal age. Nervous system drugs, blood and blood forming organs, and cardiovascular drugs showed the largest differences between NICUs with ranges of 919-2278, 554-1465, and 238-952 total prescriptions per 1000 patients per ATC class, respectively.
We showed that drug use varies widely in neonatal clinical practice. The drug classes with the highest proportion of off-label drugs in relation to neonatal age showed the largest differences between NICUs, i.e. cardiovascular and nervous system drugs. Drug research in neonates should receive high priority to guarantee safe and appropriate medicines and optimal treatment.
新生儿用药证据稀缺，这可能导致药物处方存在较大差异。我们旨在调查荷兰不同新生儿重症监护病房（NICU）之间目前开具的药物的差异。
这项多中心研究纳入了 4 家不同 NICU 中 12 个月内收治的新生儿。药物按解剖治疗化学（ATC）分类系统进行分类，并根据新生儿年龄评估其是否为标签外用药。比较了使用药物的 4 种常见适应证（疼痛、插管、抽搐和低血压）的治疗方案。
共纳入 1491 例新生儿（胎龄范围为 23-42 周），共 32182 个患者日，使用了 181 种不同的药物和 10895 张处方，其中 23%与新生儿年龄有关的药物为标签外用药。总体而言，抗感染药物使用最频繁，共有 3161 张处方，其中 4%与新生儿年龄有关的药物为标签外用药。神经系统药物包括 2500 张处方，其中 31%与新生儿年龄有关的药物为标签外用药。NICU 之间差异最大的药物类别是神经系统药物、血液和造血器官药物以及心血管药物，分别为每 1000 名患者每 ATC 类别的总处方数为 919-2278、554-1465 和 238-952。
我们发现新生儿临床实践中的用药差异很大。与新生儿年龄相关的标签外用药比例最高的药物类别，即心血管和神经系统药物，在 NICU 之间差异最大。新生儿药物研究应受到高度重视，以确保安全和适当的药物治疗和最佳治疗效果。
