Iacobelli Silvia, Allamèle-Moutama Käliani, Lorrain Simon, Gouyon Béatrice, Gouyon Jean-Bernard, Bonsante Francesco
Néonatologie, Réanimation Néonatale et Pédiatrique, CHU Saint Pierre, Saint Pierre, France.
Centre d'Etudes Périnatales de l'Océan Indien (UR 7388), Université de la Réunion, Saint Pierre, France.
Front Pharmacol. 2023 Apr 5;14:1170842. doi: 10.3389/fphar.2023.1170842. eCollection 2023.
Postnatal corticosteroids (PC) are widely used in very preterm infants. International reports and national multicenter trials describe a marked variability across countries and inter-sites, in the use of PC. Few information is available on therapeutic indications and prescription characteristics of PC. The main objective of this study was to describe the exposure to PC in a large cohort of preterm infants born at less than 32 weeks of gestation, according to the prescription data of 41 tertiary-care NICUs in France. Secondary objectives were to describe therapeutic indications, day of life (DOL) of the first exposure, route of administration, duration, cumulative dose for each drug, and differences in exposure rates across centers. We conducted a prospective observational cohort analysis from January 2017 to December 2021, in 41 French tertiary-care NICUs using the same computerized order-entry system. In total, 13,913 infants [birth weight 1144.8 (±365.6) g] were included. Among them, 3633 (26.1%) were exposed to PC, 21.8% by systemic and 10.1% by inhaled route. Within the study population, 1,992 infants (14.3%) received the first corticosteroid treatment in the first week of life and 1641 (11.8%) after DOL 7. The more frequent indications were prevention and/or treatment of bronchopulmonary dysplasia, and arterial hypotension. Hydrocortisone was the more often prescribed molecule. For systemic PC the first exposure occurred in mean at DOL 9.4 (±13.5), mean duration of treatment was 10.3 (±14.3) days, and the cumulative dose (expressed as the equivalent dose of hydrocortisone) was in median [IQR] 9.0 [5.5-28.8] mg/kg. For inhaled PC, the first exposure occurred in mean at DOL 34.1 (±19.7), and mean duration of treatment 28.5 (±24.4) days. The exposure rate ranged from a minimum of 5% to a maximum of 56% among centers, and significantly increased over the study period ( < 0.0001). In this French cohort of very preterm infants, around one patient out to five was exposed to PC during hospital stay in the NICU. The exposure occurred early, starting from the first week of life. Exposure rate widely varied among centers. Pharmacoepidemiology studies are useful to increase knowledge on corticosteroid utilization patterns in preterm infants.
产后皮质类固醇(PC)广泛应用于极早产儿。国际报告和国内多中心试验表明,各国及各研究地点在PC的使用上存在显著差异。关于PC的治疗适应证和处方特征的信息很少。本研究的主要目的是根据法国41家三级护理新生儿重症监护病房(NICU)的处方数据,描述一大群孕周小于32周的早产儿中PC的暴露情况。次要目的是描述治疗适应证、首次暴露的日龄(DOL)、给药途径、持续时间、每种药物的累积剂量,以及各中心暴露率的差异。我们于2017年1月至2021年12月在法国41家使用相同计算机化医嘱录入系统的三级护理NICU中进行了一项前瞻性观察队列分析。总共纳入了13913名婴儿[出生体重1144.8(±365.6)g]。其中,3633名(26.1%)婴儿暴露于PC,全身性暴露占21.8%,吸入性暴露占1,0.1%。在研究人群中,1992名婴儿(14.3%)在出生后第一周接受了首次皮质类固醇治疗,1641名(11.8%)在出生后第7日龄后接受治疗。最常见的适应证是预防和/或治疗支气管肺发育不良以及动脉低血压。氢化可的松是最常处方的药物。对于全身性PC,首次暴露的平均日龄为9.4(±13.5),平均治疗持续时间为10.3(±14.3)天,累积剂量(以氢化可的松等效剂量表示)中位数[四分位间距]为9.0[5.5 - 28.8]mg/kg。对于吸入性PC,首次暴露的平均日龄为34.1(±19.7),平均治疗持续时间为28.5(±24.4)天。各中心的暴露率范围从最低的5%到最高的56%,且在研究期间显著增加(<0.0001)。在这个法国极早产儿队列中,NICU住院期间约五分之一的患者暴露于PC。暴露从出生后第一周就开始了。各中心的暴露率差异很大。药物流行病学研究有助于增加对早产儿皮质类固醇使用模式的了解。