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REGAIN:一项关于草酰乙酸改善长期新冠症状的随机对照临床试验。

REGAIN: a randomized controlled clinical trial of oxaloacetate for improving the symptoms of long COVID.

作者信息

Vernon Suzanne D, Rond Candace, Bell Jennifer, Butler Brindisi, Isolampi Sara, Otteson Annaleah, Phalwane Pearl, Mower Samantha, Roundy Shad, Kaufman David L, Cash Alan B, Bateman Lucinda

机构信息

Bateman Horne Center, Salt Lake City, UT, United States.

Department of Mechanical Engineering, University of Utah, Salt Lake City, UT, United States.

出版信息

Front Neurosci. 2025 Jul 18;19:1627462. doi: 10.3389/fnins.2025.1627462. eCollection 2025.

Abstract

BACKGROUND

Long COVID is characterized by fatigue, cognitive dysfunction, and other persistent symptoms. This randomized, double-blind, controlled trial evaluated the efficacy of oral oxaloacetate (OAA) in improving fatigue and cognitive function in adults with long COVID.

METHODS

A total of 69 participants were randomized to receive either 2,000 mg/day of OAA or the control for 42 days. The primary outcome was fatigue reduction, measured by the Chalder Fatigue Questionnaire (CFQ). The secondary and exploratory outcomes included the DePaul Symptom Questionnaire Short Form (DSQ-SF), health-related quality of life (RAND-36), cognitive function (Defense Automated Neurobehavioral Assessment (DANA) Brain Vital), and time upright (UP Time).

RESULTS

No significant difference in the CFQ-measured fatigue reduction was observed between the groups. However, the OAA group showed significantly greater improvements in the DSQ-SF-measured fatigue and total symptom burden at day 21 of the trial. Cognitive performance improved significantly in the OAA group, with strong correlations between symptom response and cognitive gains. OAA was well tolerated.

CONCLUSION

OAA may contribute to earlier improvements in symptom burden and cognitive function in individuals with long COVID. Further studies are warranted.

摘要

背景

新冠后综合征的特征是疲劳、认知功能障碍和其他持续症状。这项随机、双盲、对照试验评估了口服草酰乙酸(OAA)对改善新冠后综合征成年患者疲劳和认知功能的疗效。

方法

共有69名参与者被随机分为两组,一组每天接受2000毫克OAA,另一组作为对照组,为期42天。主要结局是通过查尔德疲劳问卷(CFQ)测量的疲劳减轻情况。次要结局和探索性结局包括德保罗症状问卷简表(DSQ-SF)、健康相关生活质量(RAND-36)、认知功能(国防自动化神经行为评估(DANA)脑活力)和直立时间(UP Time)。

结果

两组之间在CFQ测量的疲劳减轻方面未观察到显著差异。然而,在试验的第21天,OAA组在DSQ-SF测量的疲劳和总症状负担方面有显著更大的改善。OAA组的认知表现显著改善,症状反应与认知改善之间存在强相关性。OAA耐受性良好。

结论

OAA可能有助于新冠后综合征患者更早地减轻症状负担和改善认知功能。有必要进行进一步研究。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d867/12313680/eb99470cc4fe/fnins-19-1627462-g001.jpg

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