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阿司匹林对痴呆和认知能力下降影响的随机安慰剂对照试验。

Randomized placebo-controlled trial of the effects of aspirin on dementia and cognitive decline.

机构信息

From the School of Public Health and Preventive Medicine (J.R., E.S., R.L.W., R.W., C.M.R., S.A.W., J.E.L., S.G.O., R.T., J.J.M.) and the Turner Institute for Brain and Mental Health (T.T.J.C.), Monash University, Melbourne, Australia; Berman Center for Outcomes and Clinical Research (A.M.M., B.K.), Hennepin Health Research Institute; Division of Geriatrics, Department of Medicine (A.M.M., B.K.), Hennepin Healthcare, Minneapolis, MN; School of Public Health (C.M.R.), Curtin University, Perth; Menzies Institute for Medical Research (M.R.N.), University of Tasmania, Hobart, Australia; Sticht Center on Aging and Alzheimer's Prevention, Section on Gerontology and Geriatric Medicine, Department of Internal Medicine (J.D.W.), Wake Forest School of Medicine, Winston-Salem, NC; Center for Aging and Population Health (A.B.N.), University of Pittsburgh, PA; Department of Pharmacy Practice and Science, College of Pharmacy, and the Department of Family Medicine, Carver College of Medicine (M.E.E.), University of Iowa, Iowa City; and Department of Family Medicine and Rush Alzheimer's Disease Center (R.C.S.), Rush University Medical Center, Chicago, IL.

出版信息

Neurology. 2020 Jul 21;95(3):e320-e331. doi: 10.1212/WNL.0000000000009277. Epub 2020 Mar 25.

DOI:10.1212/WNL.0000000000009277
PMID:32213642
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7455352/
Abstract

OBJECTIVE

To determine the effect of low-dose aspirin vs placebo on incident all-cause dementia, incident Alzheimer disease (AD), mild cognitive impairment (MCI), and cognitive decline in older individuals.

METHODS

Aspirin in Reducing Events in the Elderly (ASPREE) was a double-blind, placebo-controlled trial of low-dose aspirin. In the United States and Australia, community-dwelling individuals aged ≥70 years (US minorities ≥65 years) and free of cardiovascular disease, physical disability, and diagnosed dementia were enrolled. Participants were randomized 1:1-100 mg daily aspirin or placebo. The Modified Mini-Mental State Examination, Hopkins Verbal Learning Test-Revised, Symbol Digit Modalities Test, and Controlled Oral Word Association Test assessed cognition at baseline and over follow-up. Additional cognitive testing was performed in participants with suspected dementia ("trigger") based on within-study assessments or clinical history. Dementia was adjudicated according to DSM-IV criteria. National Institute on Aging-Alzheimer's Association criteria were used for AD and MCI subclassification.

RESULTS

A total of 19,114 participants were followed over a median 4.7 years and 964 triggered further dementia assessments. There were 575 adjudicated dementia cases, and 41% were classified as clinically probable AD. There was no substantial difference in the risk of all dementia triggers (hazard ratio [HR], 1.03; 95% confidence interval [CI], 0.91-1.17), probable AD (HR, 0.96; 95% CI, 0.74-1.24), or MCI (HR, 1.12; 95% CI, 0.92-1.37) between aspirin and placebo. Cognitive change over time was similar in the aspirin and placebo groups.

CONCLUSIONS

There was no evidence that aspirin was effective in reducing risk of dementia, MCI, or cognitive decline. Follow-up of these outcomes after initial exposure is ongoing.

CLASSIFICATION OF EVIDENCE

This study provides Class II evidence that for healthy older individuals, low-dose aspirin does not significantly reduce the incidence of dementia, probable AD, MCI, or cognitive decline.

CLINICALTRIALSGOV IDENTIFIER

NCT01038583.

摘要

目的

确定小剂量阿司匹林与安慰剂相比对老年人全因痴呆、阿尔茨海默病(AD)、轻度认知障碍(MCI)和认知能力下降的影响。

方法

阿司匹林减少老年人事件(ASPREE)是一项小剂量阿司匹林的双盲、安慰剂对照试验。在美国和澳大利亚,纳入了社区居住的年龄≥70 岁的个体(美国少数民族≥65 岁),且无心血管疾病、身体残疾和诊断性痴呆。参与者以 1:1-100mg 每日阿司匹林或安慰剂随机分组。在基线和随访期间,使用改良的简易精神状态检查、霍普金斯词语学习测试修订版、符号数字模态测试和连续口头词语联想测试评估认知能力。根据研究中的评估或临床病史,对疑似痴呆的参与者(“触发”)进行额外的认知测试。根据 DSM-IV 标准进行痴呆的判定。采用国家老龄化研究所-阿尔茨海默病协会标准对 AD 和 MCI 进行分类。

结果

共有 19114 名参与者中位随访 4.7 年,964 名参与者触发进一步的痴呆评估。共诊断出 575 例痴呆病例,其中 41%被归类为临床可能的 AD。阿司匹林组与安慰剂组在全因痴呆触发(风险比 [HR],1.03;95%置信区间 [CI],0.91-1.17)、可能的 AD(HR,0.96;95% CI,0.74-1.24)或 MCI(HR,1.12;95% CI,0.92-1.37)的风险方面没有显著差异。阿司匹林组和安慰剂组的认知随时间变化相似。

结论

没有证据表明阿司匹林能降低痴呆、MCI 或认知能力下降的风险。正在对初始暴露后的这些结果进行随访。

证据分类

本研究提供了 II 级证据,表明对于健康的老年人,小剂量阿司匹林并不能显著降低痴呆、可能的 AD、MCI 或认知能力下降的发生率。

临床试验注册号

NCT01038583。

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