指南解读

《抗Aβ单克隆抗体临床应用建议(2025版)》解读

  • 支楠 ,
  • 耿介立 ,
  • 曹雯炜 ,
  • 宋雅颖 ,
  • 王刚
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  • 上海交通大学医学院附属仁济医院神经内科上海 200127
王刚 E-mail:wanggang@renji.com

收稿日期: 2025-11-06

  修回日期: 2025-12-09

  录用日期: 2026-01-06

  网络出版日期: 2026-04-25

基金资助

科技创新2023重大项目(2021ZD0201804)

Interpretation of clinical application recommendations for anti-Aβ monoclonal antibodies (2025 Edition)

  • ZHI Nan ,
  • GENG Jieli ,
  • CAO Wenwei ,
  • SONG Yaying ,
  • WANG Gang
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  • Department of Neurology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China

Received date: 2025-11-06

  Revised date: 2025-12-09

  Accepted date: 2026-01-06

  Online published: 2026-04-25

摘要

《抗Aβ单克隆抗体临床应用建议(2025版)》(以下简称2025版建议)系统整合了阿杜卡单抗、仑卡奈单抗、多奈单抗的Ⅲ期临床试验数据,参考相关药物说明书、国内真实世界证据及临床实践经验,重点围绕仑卡奈单抗和多奈单抗对2024版建议进行了全面更新。2025版建议从用药前患者筛选、治疗方案评估、用药流程规范、不良反应监测、停药指征及特殊人群管理等多个方面提出了细化建议,特别在个体化停药标准方面取得重要进展,明确仑卡奈单抗推荐采用18个月固定疗程;而多奈单抗则以β-淀粉样蛋白(amyloid β-protein, Aβ)-正电子发射断层显像(positron emission tomography,PET)检测的Centiloid值达到预设阈值作为治疗完成标准,即单次Centiloid值≤11,或连续2次Centiloid值均处于11~25区间。在安全性管理方面,2025版建议进一步完善了淀粉样蛋白相关影像学异常(amyloid-related imaging abnormalities,ARIA)的分层监测与处理流程,并对接受抗凝治疗、载脂蛋白E(apolipoprotein E,APOEε4/ε4纯合子等特殊人群制定了精准风险管理策略。当前抗Aβ单抗的临床应用仍面临若干关键挑战,多维度生物标志物的整合应用体系尚未系统建立,制约了个体化治疗路径的构建;中国人群长期用药的真实世界证据仍显不足,影响治疗方案的本地化优化与风险精细管理。未来需围绕上述方向加强研究,以推动抗Aβ单抗治疗从标准化模式,向基于生物标志物与临床表型的个体化精准医疗持续发展。

本文引用格式

支楠 , 耿介立 , 曹雯炜 , 宋雅颖 , 王刚 . 《抗Aβ单克隆抗体临床应用建议(2025版)》解读[J]. 诊断学理论与实践, 2026 , 25(02) : 148 -156 . DOI: 10.16150/j.1671-2870.2026.02.005

Abstract

The Clinical Application Recommendations for Anti-Aβ Monoclonal Antibodies (2025 Edition) systema-tically integrates Phase Ⅲ clinical trial data for aducanumab, lecanemab, and donanemab, referencing relevant drug labels, domestic real-world evidence, and clinical practice experience. With a focus on lecanemab and donanemab, it provides a comprehensive update to the 2024 edition. The recommendations provide detailed guidance on patient screening before treatment, treatment regimen evaluation, medication protocol standardization, adverse event monitoring, discontinuation criteria, and management of special populations, with significant progress in individualizing discontinuation criteria, specif-ying that lecanemab is recommended as an 18-month fixed course. For donanemab, the treatment completion criterion is defined as achieving a Centiloid value measured by amyloid-β positron emission tomography (Aβ-PET) that reaches a preset threshold, specifically a single Centiloid value ≤11 or two consecutive Centiloid values both in the range of 11-25. Regarding safety management, the recommendations further refine the stratified monitoring and management protocol for amyloid-related imaging abnormalities (ARIA) and establish precise risk management strategies for special populations, including patients on anticoagulant therapy and apolipoprotein E (APOE) ε4/ε4 homozygotes. Currently, the clinical application of anti-Aβ monoclonal antibodies still faces several key challenges. The integrated application system of multidimensional biomarkers has not yet been systematically established, which constrains the development of individualized treatment pathways. Meanwhile, real-world evidence on long-term medication use in the Chinese population remains insufficient, hindering the local optimization of treatment strategies and refined risk management. Future efforts should focus on strengthe-ning research in the above directions to promote the continuous development of anti-Aβ monoclonal antibody therapy from a standardized model toward individualized precision medicine based on biomarkers and clinical phenotypes.

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