Department of Pediatrics, Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA.
Pediatrics. 2012 Feb;129(2):e385-91. doi: 10.1542/peds.2011-2034. Epub 2012 Jan 23.
Recent studies have called into question the benefit of perioperative corticosteroids in children undergoing heart surgery, but have been limited by the lack of placebo control, limited power, and grouping of various steroid regimens together in analysis. We evaluated outcomes across methylprednisolone regimens versus no steroids in a large cohort of neonates.
Clinical data from the Society of Thoracic Surgeons Database were linked to medication data from the Pediatric Health Information Systems Database for neonates (≤30 days) undergoing heart surgery (2004-2008) at 25 participating centers. Multivariable analysis adjusting for patient and center characteristics, surgical risk category, and within-center clustering was used to evaluate the association of methylprednisolone regimen with outcome.
A total of 3180 neonates were included: 22% received methylprednisolone on both the day before and day of surgery, 12% on the day before surgery only, and 28% on the day of surgery only; 38% did not receive any perioperative steroids. In multivariable analysis, there was no significant mortality or length-of-stay benefit associated with any methylprednisolone regimen versus no steroids, and no difference in postoperative infection. In subgroup analysis by surgical-risk group, there was a significant association of methylprednisolone with infection consistent across all regimens (overall odds ratio 2.6, 95% confidence interval 1.3-5.2) in the lower-surgical-risk group.
This multicenter observational analysis did not find any benefit associated with methylprednisolone in neonates undergoing heart surgery and suggested increased infection in certain subgroups. These data reinforce the need for a large randomized trial in this population.
最近的研究对围手术期皮质类固醇在接受心脏手术的儿童中的益处提出了质疑，但由于缺乏安慰剂对照、效力有限以及在分析中将各种类固醇方案分组在一起，这些研究受到了限制。我们评估了大样本新生儿接受不同甲泼尼龙方案与不使用类固醇的结果。
将胸外科医师学会数据库中的临床数据与儿科健康信息系统数据库中的药物数据相链接，以评估 25 个参与中心的新生儿（≤30 天）接受心脏手术（2004-2008 年）的情况。使用多变量分析调整患者和中心特征、手术风险类别以及中心内聚类，以评估甲泼尼龙方案与结局的关系。
共纳入 3180 例新生儿：22%的患者在手术前一天和手术当天接受甲泼尼龙治疗，12%的患者仅在手术前一天接受甲泼尼龙治疗，28%的患者仅在手术当天接受甲泼尼龙治疗；38%的患者未接受任何围手术期皮质类固醇治疗。多变量分析显示，与不使用任何皮质类固醇相比，任何甲泼尼龙方案在死亡率或住院时间方面均无显著获益，术后感染发生率也无差异。在按手术风险组进行的亚组分析中，所有方案均显示甲泼尼龙与感染之间存在显著关联（整体优势比 2.6，95%置信区间 1.3-5.2），低手术风险组更为明显。
这项多中心观察性分析未发现接受心脏手术的新生儿使用甲泼尼龙有任何获益，并提示某些亚组的感染风险增加。这些数据强调了在该人群中进行大型随机试验的必要性。
