阿尔茨海默病体液标志物临床应用中国指南(2024版)

Chinese guideline for clinical application of fluid biomarkers for Alzheimer′s disease(2024 edition)

阿尔茨海默病是最常见的导致认知障碍的神经退行性疾病,其病程隐匿、早期识别困难,随着疾病修饰疗法的发展,对于阿尔茨海默病早期精准诊断的需求越来越紧迫。阿尔茨海默病体液标志物是指在体液样本中检测到的与疾病密切相关的生物分子,可用于阿尔茨海默病的筛查、诊断、分期、疾病进展预测和临床试验,在临床实践中发挥着越来越关键的作用。本指南系统检索和评价了阿尔茨海默病的体液标志物,提出了体液采集和处理的标准化操作流程,细化了不同类型体液标志物在疾病筛查、诊断、分期、预测疾病进展以及临床试验等场景中的应用规范,并制订24条推荐意见。本指南的发布旨在规范体液标志物在临床实践中的应用,推进阿尔茨海默病体液标志物的研究。

Alzheimer′s disease is the most prevalent neurodegenerative disorder leading to cognitive impairment,but its progression is subtle and the early recognition is difficult.With advancements in disease-modifying therapies,the need for precise early diagnosis of Alzheimer′s disease is increasingly pressing.Fluid biomarkers of Alzheimer′s disease,detectable in bodily fluid samples,are intricately associated with the disease.It can be used for screening,diagnosis,staging,prediction of disease progression,and clinical trials,playing an increasingly critical role in clinical practice..This guideline systematically reviews and evaluates the spectrum of fluid biomarkers for Alzheimer′s disease,propose standardized protocols for sample collection and processing,and delineates the application standards of fluid biomarkers in disease screening,diagnosis,staging,prognosis of disease progression,and clinical trials.A total of 24 recommendations have been formulated.The publication of this guideline aims to standardize the application of fluid biomarkers in clinical practice,thereby advancing research in Alzheimer′s disease fluid biomarkers.