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大剂量亚硒酸钠对心脏手术患者的影响:一项随机对照的双中心试验。

Effect of high-dose sodium selenite in cardiac surgery patients: A randomized controlled bi-center trial.

机构信息

Department for Anesthesia, Intensive Care Medicine and Rescue Medicine, Lucerne Cantonal Hospital, Lucerne, Switzerland.

Department of Anesthesiology, Operative Intensive Care, Preclinical Emergency Medicine and Pain Management, University Hospital Basel, Switzerland.

出版信息

Clin Nutr. 2018 Aug;37(4):1172-1180. doi: 10.1016/j.clnu.2017.04.019. Epub 2017 May 2.

DOI:10.1016/j.clnu.2017.04.019
PMID:28502744
Abstract

BACKGROUND & AIMS: Cardiac surgery is accompanied by oxidative stress and systemic inflammatory response, which may be associated with organ dysfunction and increased mortality. Selenium and selenoenzymes are important constituents of anti-oxidative defense. We hypothesized that high-dose sodium selenite supplementation can attenuate the postoperative inflammation and might, therefore, improve clinical outcome.

METHODS

Randomized, placebo-controlled, double-blinded, bi-center study on 411 adult patients undergoing elective cardiac surgery. Patients received an intravenous bolus of 4000 μg selenium (in the form of sodium selenite) or placebo after induction of anesthesia and 1000 μg/d selenium or placebo during their intensive care unit (ICU) stay. Primary outcome measure was the Sequential Organ Failure Assessment (SOFA) score on the second postoperative day. Secondary endpoints included the change in perioperative selenium levels, change of inflammatory and cardiac markers, use of vasoactive medication, incidence of acute kidney injury, ICU and hospital length of stay, and mortality.

RESULTS

The perioperative administration of high-dose sodium selenite prevented the postoperative drop of blood and serum selenium levels, reduced the number of patients depending on postoperative vasoactive support but failed to reduce the postoperative SOFA score and its related organ-specific scores compared to placebo. Except for an increase of postoperative procalcitonin and bilirubin levels in the sodium selenite group, other inflammatory markers, organ function variables and clinical endpoints remained unchanged.

CONCLUSIONS

The perioperative administration of high-dose sodium selenite in cardiac surgery patients prevented the postoperative fall of blood selenium levels and reduced the need for postoperative vasoactive support by a yet unknown mechanism.

TRIAL REGISTRATION

Registered under ClinicalTrials.gov Identifier no. NCT01141556.

摘要

背景与目的

心脏手术伴随着氧化应激和全身炎症反应,这可能与器官功能障碍和死亡率增加有关。硒和硒酶是抗氧化防御的重要组成部分。我们假设大剂量亚硒酸钠补充可以减轻术后炎症,并因此改善临床结局。

方法

这是一项在 411 名接受择期心脏手术的成年患者中进行的随机、安慰剂对照、双盲、双中心研究。患者在麻醉诱导后接受静脉注射 4000μg 硒(亚硒酸钠形式)或安慰剂,在重症监护病房(ICU)期间接受 1000μg/d 硒或安慰剂。主要观察指标是术后第 2 天的序贯器官衰竭评估(SOFA)评分。次要终点包括围手术期硒水平的变化、炎症和心脏标志物的变化、血管活性药物的使用、急性肾损伤的发生率、ICU 和住院时间以及死亡率。

结果

围手术期给予大剂量亚硒酸钠可防止术后血液和血清硒水平下降,减少术后依赖血管活性支持的患者数量,但与安慰剂相比,未能降低术后 SOFA 评分及其相关器官特异性评分。除亚硒酸钠组术后降钙素原和胆红素水平升高外,其他炎症标志物、器官功能变量和临床终点均无变化。

结论

在心脏手术患者中,围手术期给予大剂量亚硒酸钠可防止术后血硒水平下降,并通过未知机制减少术后血管活性支持的需求。

试验注册

ClinicalTrials.gov 标识符为 NCT01141556。

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