Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass Randomized Controlled Trial
Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass Randomized Controlled Trial
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DOI：
10.1016/j.jacc.2019.05.060
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发表时间：
2019-08-06
影响因子：
24
通讯作者：
Atz, Andrew M.
中科院分区：
文献类型：
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作者：
Graham, Eric M.;Martin, Renee H.;Atz, Andrew M.
背景：术中使用皮质类固醇改善先天性心脏手术后结果的有效性仍存在争议。
目的：本研究旨在确定术中使用甲泼尼龙是否能改善接受心脏手术的新生儿的术后恢复情况。
方法：在两个中心，接受体外循环心脏手术的新生儿在麻醉诱导后被纳入一项甲泼尼龙（30mg/kg）或安慰剂的双盲随机对照试验。主要结局是先前经过验证的发病率 - 死亡率复合指标，包括出院前手术后的以下任何事件：死亡、机械循环支持、心脏骤停、肝损伤、肾损伤或乳酸水平升高（>5mmol/L）。
结果：在纳入的190名受试者中，176名（甲泼尼龙组n = 81，安慰剂组n = 95）被纳入此分析。甲泼尼龙组共有27名（33%）受试者和安慰剂组40名（42%）受试者达到主要研究终点（优势比[OR]：0.63；95%置信区间[CI]：0.31 - 1.3；p = 0.21）。甲泼尼龙与姑息性手术受试者的血管活性正性肌力药物需求减少以及复合终点发生率降低相关（OR：0.38；95%CI：0.15 - 0.99；p = 0.048）。治疗效果和中心之间存在显著的相互作用。在此分析中，甲泼尼龙在一个中心具有保护作用，OR为0.35（95%CI：0.15 - 0.84；p = 0.02），而在另一个中心则不然，OR为5.13（95%CI：0.85 - 30.90；p = 0.07）。
结论：术中使用甲泼尼龙未能在复合主要研究终点的发生率上显示出总体显著益处。然而，在接受姑息性手术的患者中有一定益处，并且治疗效果和中心之间存在显著相互作用，这表明可能存在一些中心或患者特征使得预防性使用甲泼尼龙有益。（C）2019美国心脏病学会基金会
BACKGROUND The efficacy of intraoperative corticosteroids to improve outcomes following congenital cardiac operations remains controversial.OBJECTIVES The purpose of this study was to determine whether intraoperative methylprednisolone improves postoperative recovery in neonates undergoing cardiac surgery.METHODS Neonates undergoing cardiac surgery with cardiopulmonary bypass at 2 centers were enrolled in a double-blind randomized controlled trial of methylprednisolone (30 mg/kg) or placebo after the induction of anesthesia. The primary outcome was a previously validated morbidity-mortality composite that included any of the following events following surgery before discharge: death, mechanical circulatory support, cardiac arrest, hepatic injury, renal injury, or rising lactate level (>5 mmol/l).RESULTS Of the 190 subjects enrolled, 176 (n = 81 methylprednisolone, n = 95 placebo) were included in this analysis. A total of 27 (33%) subjects in the methylprednisolone group and 40 (42%) in the placebo group reached the primary study endpoint (odds ratio [OR]: 0.63; 95% confidence interval [CI]: 0.31 to 1.3; p = 0.21). Methylprednisolone was associated with reductions in vasoactive inotropic requirements and in the incidence of the composite endpoint in subjects undergoing palliative operations (OR: 0.38; 95% CI: 0.15 to 0.99; p = 0.048). There was a significant interaction between treatment effect and center. In this analysis, methylprednisolone was protective at 1 center, with an OR: 0.35 (95% CI: 0.15 to 0.84; p = 0.02), and not so at the other center, with OR: 5.13 (95% CI: 0.85 to 30.90; p = 0.07).CONCLUSIONS Intraoperative methylprednisolone failed to show an overall significant benefit on the incidence of the composite primary study endpoint. There was, however, a benefit in patients undergoing palliative procedures and a significant interaction between treatment effect and center, suggesting that there may be center or patient characteristics that make prophylactic methylprednisolone beneficial. (C) 2019 by the American College of Cardiology Foundation.