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阿尔茨海默病患者接受白蛋白置换的血浆置换治疗后的神经心理学、神经精神和生活质量评估:来自随机 AMBAR 研究的结果。

Neuropsychological, neuropsychiatric, and quality-of-life assessments in Alzheimer's disease patients treated with plasma exchange with albumin replacement from the randomized AMBAR study.

机构信息

Research Center and Memory Clinic, Fundació ACE, Institut Català de Neurociències Aplicades-Universitat Internacional de Catalunya, Barcelona, Spain.

Centro de Investigación Biomédica en Red de Enfermedades Neurodegenerativas (CIBERNED), Instituto de Salud Carlos III, Madrid, Spain.

出版信息

Alzheimers Dement. 2022 Jul;18(7):1314-1324. doi: 10.1002/alz.12477. Epub 2021 Nov 2.

Abstract

INTRODUCTION

We report the effects of plasma exchange (PE) with albumin replacement on neuropsychological, neuropsychiatric, and quality-of-life (QoL) outcomes in mild-to-moderate Alzheimer's disease (AD) patients in a phase 2b/3 trial (Alzheimer's Management by Albumin Replacement [AMBAR] study).

METHODS

Three hundred forty-seven patients were randomized into placebo (sham-PE) and three PE-treatment arms with low/high doses of albumin, with/without intravenous immunoglobulin (IVIG). Specific test measurements were performed at baseline; month 2 (weekly conventional PE); months 6, 9, and 12 (monthly low-volume PE [LVPE]); and month 14.

RESULTS

The PE-treated mild-AD cohort improved their language fluency and processing speed versus placebo at month 14 (effect sizes: >100%; P-values: .03 to .001). The moderate-AD cohort significantly improved short-term verbal memory (effect sizes: 94% to >100%; P-values: .02 to .003). The progression of the neuropsychiatric symptoms of PE-treated was similar to placebo. Mild-AD patients showed improved QoL (P-values: .04 to .008).

DISCUSSION

PE-treated AD patients showed improvement in memory, language abilities, processing speed, and QoL-AD. No worsening of their psychoaffective status was observed.

摘要

简介

我们报告了在轻度至中度阿尔茨海默病(AD)患者的 2b/3 期试验(白蛋白替代治疗阿尔茨海默病管理[AMBAR]研究)中,用白蛋白替代物进行血浆置换(PE)对神经心理学、神经精神和生活质量(QoL)结果的影响。

方法

347 名患者被随机分为安慰剂(假 PE)和 3 个 PE 治疗组,分别接受低/高剂量白蛋白、有/无静脉注射免疫球蛋白(IVIG)治疗。在基线时、第 2 个月(每周常规 PE)、第 6、9 和 12 个月(每月低容量 PE [LVPE])以及第 14 个月进行特定的测试测量。

结果

与安慰剂相比,PE 治疗的轻度 AD 队列在第 14 个月时提高了语言流畅性和处理速度(效应大小:>100%;P 值:.03 至.001)。中度 AD 队列的短期语言记忆显著改善(效应大小:94%至>100%;P 值:.02 至.003)。PE 治疗的神经精神症状进展与安慰剂相似。轻度 AD 患者的 QoL 得到改善(P 值:.04 至.008)。

讨论

PE 治疗的 AD 患者在记忆、语言能力、处理速度和 QoL-AD 方面有改善。未观察到其心理情感状态恶化。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8a09/9540900/dca3235f3d20/ALZ-18-1314-g004.jpg

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