纳豆激酶补充对无症状颅内/颈动脉狭窄的认知增强：一项随机对照试验。

IF 2.1 4区医学 Q3 NEUROSCIENCES

Journal of Stroke & Cerebrovascular Diseases Pub Date : 2026-01-01 Epub Date: 2025-11-29 DOI:10.1016/j.jstrokecerebrovasdis.2025.108511

Kemeng Zhang MD , Xuting Zhang MD , Anni Wang MD , Wansi Zhong MD , Yingjian Pei MD , Haidi Jin MS , Ziyu Zhou MD , Cong Chen MD , Shuyue Wang PhD , Min Lou MD, PhD

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引用次数: 0

摘要

目的：纳豆激酶改善无症状颅内/颈动脉狭窄患者脑血流量和认知功能（ICC-PACS）试验是一项单中心、双盲、安慰剂对照研究，旨在评估补充6个月纳豆激酶（NK）对无症状颅内/颈动脉狭窄患者认知功能的影响。方法：共有120名参与者按1:1的比例随机分配，接受口服NK （8000 FU/天）或安慰剂治疗，为期6个月。在基线和6个月随访时进行认知评估和多模态脑磁共振成像（MRI）。结果：最终共纳入120名受试者（NK组60名，安慰剂组60名），两组基线特征平衡（平均年龄58.3岁，女性40.9%）。88例患者按要求服药6个月并完成随访（NK组45例，安慰剂组43例）。按方案分析结果发现蒙特利尔认知评估（MoCA）评分变化在组间无显著差异（平均差异：0.038;95% CI: -1.109, 1.163; P = 0.948）。然而，探索性分析显示NK组与安慰剂组的视觉空间功能评分变化具有显著性差异（组间差异：0.350;95% CI: 0.056, 0.649; P = 0.024），NK组的视觉空间功能下降风险降低（OR: 0.35; 95% CI: 0.127, 0.966）。此外，意向治疗分析的结果是一致的。结论：六个月NK补充不能改善无症状颅内/颈动脉狭窄患者的整体认知。然而，视觉空间功能的区域特异性增强提示潜在的选择性神经保护作用。

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Nattokinase supplementation for cognitive enhancement in asymptomatic intracranial/carotid stenosis: A randomized controlled trial

Objectives

The Improving Cerebral Blood Flow and Cognitive Function in Patients with Asymptomatic Intracranial/Carotid Stenosis with Nattokinase (ICC-PACS) trial was a single-center, double-blind, placebo-controlled study, aiming to evaluate the effects of 6-month nattokinase (NK) supplementation on cognitive function in patients with asymptomatic intracranial/carotid artery stenosis.

Methods

A total of 120 participants were randomized 1:1 to receive oral NK (8000 FU/day) or placebo for six months. Cognitive assessments and multimodal brain magnetic resonance imaging (MRI) were performed at baseline and 6-month follow-up.

Results

A total of 120 subjects were ultimately included (60 in the NK group and 60 in the placebo group), with balanced baseline characteristics between the two groups (average age 58.3 years, female 40.9 %). A total of 88 patients took the medication as required for 6 months and completed follow-up (45 in the NK group and 43 in the placebo group). Per-protocol analysis results found no significant between-group differences in the Montreal Cognitive Assessment (MoCA) score changes (mean difference: 0.038; 95 % CI: -1.109, 1.163; P = 0.948). However, exploratory analysis revealed significant difference in the changes of visuospatial function scores between the NK group and the placebo group (intergroup difference: 0.350; 95 % CI: 0.056, 0.649; P = 0.024), with reduced risk of visuospatial function decline in the NK group (OR: 0.35; 95 % CI: 0.127, 0.966). Besides, results were consistent in intention-to-treat analyses.

Conclusion

Six-month NK supplementation did not improve global cognition in asymptomatic intracranial/carotid stenosis patients. However, domain-specific enhancement in visuospatial function suggests potential selective neuroprotective effects.

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来源期刊

Journal of Stroke & Cerebrovascular Diseases Medicine-Surgery

CiteScore

5.00

自引率

4.00%

发文量

583

审稿时长

62 days

期刊介绍： The Journal of Stroke & Cerebrovascular Diseases publishes original papers on basic and clinical science related to the fields of stroke and cerebrovascular diseases. The Journal also features review articles, controversies, methods and technical notes, selected case reports and other original articles of special nature. Its editorial mission is to focus on prevention and repair of cerebrovascular disease. Clinical papers emphasize medical and surgical aspects of stroke, clinical trials and design, epidemiology, stroke care delivery systems and outcomes, imaging sciences and rehabilitation of stroke. The Journal will be of special interest to specialists involved in caring for patients with cerebrovascular disease, including neurologists, neurosurgeons and cardiologists.