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阿尔茨海默病Aβ免疫治疗的临床获益OA

Clinical benefits of Aβ immunotherapy for Alzheimer's disease

中文摘要英文摘要

β淀粉样蛋白(β-amyloid,Aβ)在脑内沉积是阿尔茨海默病(Alzheimer's disease,AD)发病的关键环节,应用抗Aβ单克隆抗体清除Aβ是AD最重要的疾病修饰治疗.仑卡奈单抗和多奈单抗是目前批准上市的两种抗Aβ抗体.本文通过系统回顾两药的关键Ⅲ期临床试验,尤其关注治疗过程中淀粉样蛋白PET-CT及脑脊液或血浆生物标志物的改变以及疗效评估,总结不同患者临床疗效的异质性及其可能的影响因素,同时结合中国西北地区真实世界研究的初步随访数据,系统综述了靶向Aβ的单克隆抗体作为AD的疾病修饰疗法的临床获益,并提出应采用"有意义的获益"(meaningful benefit)这一新概念进行评估,强调AD疾病修饰疗法治疗的目标并非短期症状改善,而是长期治疗的累积效应,即治疗时间越长,延缓认知和功能衰退的效果越明显,从而推迟患者进入疾病更严重阶段的时间.这为临床医师治疗决策、疗效评估和患者管理提供重要依据.

The deposition of β-amyloid(Aβ)in the brain is a key step in the pathogenesis of Alzheimer's disease(AD).The clearance of Aβ using anti-Aβ monoclonal antibodies is the most important disease modification therapy(DMT)for AD.Lecanemab and Donanemab are currently two approved anti-Aβ antibodies.This article systematically reviews the results of phase Ⅲ clinical trials for these two drugs,with a particular focus on the changes in biomarkers(amyloid PET-CT and cerebrospinal fluid or plasma biomarkers)during treatment,as well as efficacy evaluation.It summarizes the heterogeneity of clinical efficacy among different patients and its possible influencing factors.Combined with preliminary follow-up data from real-world studies in Northwest China,the review systematically summarizes the clinical benefits of targeted Aβ monoclonal antibodies as DMT for AD.It proposes the adoption of a new concept"meaningful benefit"for evaluation,emphasizing that the goal of DMT for AD is not short-term symptom improvement,but the cumulative effect of long-term treatment.Specifically,the longer the treatment duration,the more pronounced the effect in delaying cognitive and functional decline,thereby postponing the time when patients progress to more severe stages of the disease.This provides important evidence for clinicians in treatment decision-making,efficacy evaluation,and patient management.

刘洁;刘佩杰;高玲;党亮君;魏珊;屈秋民;王瑾

西安交通大学第一附属医院神经内科,陕西西安 710061西安交通大学第一附属医院神经内科,陕西西安 710061西安交通大学第一附属医院神经内科,陕西西安 710061西安交通大学第一附属医院神经内科,陕西西安 710061西安交通大学第一附属医院神经内科,陕西西安 710061西安交通大学第一附属医院神经内科,陕西西安 710061西安交通大学第一附属医院神经内科,陕西西安 710061

医药卫生

阿尔茨海默病(AD)β淀粉样蛋白(Aβ)免疫治疗淀粉样蛋白单克隆抗体临床获益

Alzheimer's disease(AD)β-amyloid(Aβ)immunotherapyamyloid monoclonal antibodyclinical benefit

《西安交通大学学报(医学版)》 2026 (1)

18-24,7

西安交通大学第一附属医院横向课题(No.HXIIT2024089)Supported by the Lateral Research Project of The First Affiliated Hospital of Xi'an Jiaotong University(No.HXIIT2024089)

10.7652/jdyxb202601003

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