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ω-3 脂肪酸预防术后心房颤动(OPERA)试验中,鱼油补充剂对心脏手术患者的认知结局没有影响。

Fish Oil Supplementation Does Not Affect Cognitive Outcomes in Cardiac Surgery Patients in the Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA) Trial.

机构信息

Department of Medicine, Divisions of Allergy, Pulmonary and Critical Care Medicine.

Friedman School of Nutrition Science & Policy, Tufts University, Boston, MA.

出版信息

J Nutr. 2018 Mar 1;148(3):472-479. doi: 10.1093/jn/nxx002.

DOI:10.1093/jn/nxx002
PMID:29546292
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6454465/
Abstract

BACKGROUND

Cognitive decline has been reported following cardiac surgery, leading to great interest in interventions to minimize its occurrence. Long-chain n-3 (ω-3) polyunsaturated fatty acids (PUFAs) have been associated with less cognitive decline in observational studies, yet no trials have tested the effects of n-3 PUFAs on cognitive decline after surgery.

OBJECTIVE

We sought to determine whether perioperative n-3 PUFA supplementation reduces postoperative cognitive decline in patients postcardiac surgery.

METHODS

The study comprised a randomized, double-blind, placebo-controlled, multicenter, clinical trial conducted on cardiac surgery recipients at 9 tertiary care medical centers across the United States. Patients were randomly assigned to receive fish oil (1-g capsules containing ≥840 mg n-3 PUFAs as ethyl esters) or placebo, with preoperative loading of 8-10 g over 2-5 d followed postoperatively by 2 g/d until hospital discharge or postoperative day 10, whichever came first. Global cognition was assessed using in-person testing over 30 d with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (primary outcome), Mini-Mental State Exam (secondary outcome), and Trails A and B (secondary outcome) tests. All end points were prespecified. Statistical methods were employed, including descriptive statistics, logistic regression, and various sensitivity analyses.

RESULTS

A total of 320 US patients were enrolled in the Omega-3 Fatty Acids for Prevention of Post-Operative Atrial Fibrillation (OPERA) Cognitive Trial (OCT), a substudy of OPERA. The median age was 62 y (IQR 53, 70 y). No differences in global cognition were observed between placebo and fish oil groups at day 30 (P = 0.32) for the primary outcome, a composite neuropsychological RBANS score. The population demonstrated resolution of initial 4-d cognitive decline back to baseline function by 30 d on the RBANS.

CONCLUSION

Perioperative supplementation with n-3 PUFAs in cardiac surgical patients did not influence cognition ≤30 d after discharge. Modern anesthetic, surgical, and postoperative care may be mitigating previously observed long-term declines in cognitive function following cardiac surgery. This trial was registered at clinicaltrials.gov as NCT00970489.

摘要

背景

心脏手术后会出现认知能力下降,这引起了人们对减少其发生的干预措施的极大兴趣。长链 n-3(ω-3)多不饱和脂肪酸(PUFAs)与观察性研究中的认知能力下降减少有关,但尚无试验测试 n-3 PUFAs 对手术后认知能力下降的影响。

目的

我们旨在确定围手术期补充 n-3 PUFAs 是否可减少心脏手术后患者的术后认知能力下降。

方法

这项研究包括在美国 9 家三级护理医疗中心进行的一项随机、双盲、安慰剂对照、多中心临床试验。患者被随机分配接受鱼油(1 克胶囊,含≥840 毫克 n-3 PUFAs 作为乙酯)或安慰剂,术前 2-5 天内给予 8-10 克负荷量,然后术后每天给予 2 克,直至出院或术后第 10 天,以先到者为准。使用 30 天内的面对面测试使用重复性电池评估神经心理状态(RBANS)(主要结局)、简易精神状态检查(次要结局)和 A 和 B 测试(次要结局)来评估整体认知。所有终点均为预设。采用描述性统计、逻辑回归和各种敏感性分析等统计方法。

结果

共有 320 名美国患者参加了预防术后心房颤动的 ω-3 脂肪酸(OPERA)认知试验(OCT),这是 OPERA 的一项亚研究。中位年龄为 62 岁(IQR 53,70 岁)。在第 30 天,主要结局即 RBANS 综合神经心理评分,在安慰剂和鱼油组之间未观察到认知能力的差异(P = 0.32)。该人群在 RBANS 上的认知功能最初 4 天的下降在 30 天内恢复到基线功能。

结论

心脏外科患者围手术期补充 n-3 PUFAs 并未影响出院后≤30 天的认知功能。现代麻醉、手术和术后护理可能减轻了心脏手术后观察到的长期认知功能下降。该试验在 clinicaltrials.gov 上注册为 NCT00970489。

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