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一项前瞻性随机、双盲、安慰剂对照研究,旨在评估使用功能脑 MRI 对新冠后慢性疲劳综合征患者进行神经保护治疗的有效性。

A prospective randomized, double-blind placebo-controlled study to evaluate the effectiveness of neuroprotective therapy using functional brain MRI in patients with post-covid chronic fatigue syndrome.

机构信息

Research Center of Neurology, Moscow, Russia.

出版信息

Biomed Pharmacother. 2023 Dec;168:115723. doi: 10.1016/j.biopha.2023.115723. Epub 2023 Oct 18.

DOI:10.1016/j.biopha.2023.115723
PMID:37862966
Abstract

BACKGROUND AND PURPOSE

to assess executive network using resting-state fMRI and patterns of brain activation using task fMRI with a cognitive paradigm, against the background of taking the drug in comparison with placebo in patients with post-COVID asthenic syndrome.

METHODS

The study employed a prospective, randomized, double-blind, placebo-controlled trial approach to assess the efficacy of utilizing functional MRI of the brain as a neuroprotective therapy for treating patients with chronic fatigue syndrome following COVID-19. The study included 30 patients matched by sex and age with post-COVID asthenic syndrome. All patients were examined with MFI-20, MoCA, FAS-10 scales, MRI using a Siemens MAGNETOM Prisma 3 T scanner before and after a course of therapy with coordination complex with succinate acid anion (CCSA) or placebo (15 patients each) using resting state fMRI and with cognitive paradigm.

RESULTS

The changes obtained as a result of the treatment of post-Covid asthenic syndrome demonstrated clinical superiority in the reduction of asthenic symptoms for the group of patients treated with CCSA (MFI-20 scores: -20·0 points in the CCSA group compared to -12 points in the placebo group, p = 0·043). The data obtained also correlate with the analysis of task fMRI and resting state fMRI may indicate an increase in the functional cognitive status after a course of therapy with CCSA. Clinically, this correlates with a statistically significant improvement in the MoCA score (2 points in the CCSA group compared to 1 point in the placebo group, p < 0·05).

CONCLUSIONS

the study demonstrates the potential effectiveness of CCSA therapy in relation to a wide range of symptoms (chronic fatigue syndrome/ asthenic syndrome and cognitive impairment) in patients with post-COVID syndrome. The first time demonstrated the effectiveness of neuroprotective therapy after post-COVID asthenic syndrome with the use of high-tech neuroimaging techniques.

摘要

背景与目的

评估使用静息态 fMRI 的执行网络和使用认知范式的任务 fMRI 的脑激活模式,背景是在患有 COVID-19 后虚弱综合征的患者中与安慰剂相比使用药物。

方法

该研究采用前瞻性、随机、双盲、安慰剂对照试验方法,评估使用脑功能磁共振成像作为 COVID-19 后慢性疲劳综合征患者神经保护治疗的疗效。该研究纳入了 30 名性别和年龄匹配的 COVID-19 后虚弱综合征患者。所有患者均在接受治疗前后进行 MFI-20、MoCA、FAS-10 量表检查、使用西门子 MAGNETOM Prisma 3T 扫描仪进行 MRI,治疗方案为使用顺丁烯二酸阴离子配位复合物(CCSA)或安慰剂(每组 15 名患者),使用静息态 fMRI 和认知范式。

结果

COVID-19 后虚弱综合征治疗后的变化显示,CCSA 治疗组虚弱症状减轻具有临床优势(CCSA 组 MFI-20 评分:-20·0 分,安慰剂组-12 分,p=0·043)。获得的数据还与任务 fMRI 的分析相关,静息态 fMRI 可能表明在接受 CCSA 治疗后功能认知状态的提高。临床上,这与 MoCA 评分的统计学显著改善相关(CCSA 组增加 2 分,安慰剂组增加 1 分,p<0·05)。

结论

该研究表明 CCSA 治疗在 COVID-19 后综合征患者的广泛症状(慢性疲劳综合征/虚弱综合征和认知障碍)方面具有潜在的有效性。首次使用高科技神经影像学技术证明 COVID-19 后虚弱综合征后的神经保护治疗有效。

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