1.上海交通大学医学院附属仁济医院神经内科,上海 200127
2.上海交通大学医学院附属瑞金医院神经内科, 上海 200025
3.同济大学附属东方医院医学影像科,上海 200120
4.浙江大学医学院附属第一医院神经内科, 杭州 310003
5.广州医科大学附属第二医院神经内科,广州 511436
6.河北医科大学第一医院神经内科,石家庄 050000
7.山东大学齐鲁医院老年科,青岛 266000
8.河北省沧州中西医结合医院脑病科,沧州 061001
9.上海交通大学医学院 附属精神卫生中心,上海 200030
10.复旦大学附属华东医院神经内科,上海 200040
11.金华市中心医院神经内科, 金华 321000
12.南通市第一人民医院神经内科,南通 226001
13.贵州医科大学附属医院神经内科, 贵阳 550001
14.宁波市第二医院神经内科,宁波 3150101
15.南京医科大学附属脑科医院神经内科,南京 210029
16.天津医科大学总医院神经内科,天津 300052
17.南京大学医学院附属南京鼓楼医院神经内科,南京 210008
18.四川大学华西医院神经内科,成都 610041
19.首都医科大学宣武医院神经内科,北京 1000531
20.福建医科大学附属协和医院神经内科,福州 350001
Received:06 June 2025,
Revised:2025-06-27,
Accepted:07 July 2025,
Published:28 September 2025
移动端阅览
支楠,肖金雯,任汝静,等.抗Aβ单克隆抗体临床应用建议(2025版)[J].重庆医科大学学报,2025,50(9):1133-1140.
Zhi Nan,Xiao Jinwen,Ren Rujing,et al.Recommendations for the clinical use of anti-amyloid-β monoclonal antibody for Alzheimer’s disease(2025)[J].Journal of Chongqing Medical University,2025,50(9):1133-1140.
支楠,肖金雯,任汝静,等.抗Aβ单克隆抗体临床应用建议(2025版)[J].重庆医科大学学报,2025,50(9):1133-1140. DOI: 10.13406/j.cnki.cyxb.003898.
Zhi Nan,Xiao Jinwen,Ren Rujing,et al.Recommendations for the clinical use of anti-amyloid-β monoclonal antibody for Alzheimer’s disease(2025)[J].Journal of Chongqing Medical University,2025,50(9):1133-1140. DOI: 10.13406/j.cnki.cyxb.003898.
近年来阿尔茨海默病免疫治疗领域迎来重要突破,中国已与国际同步批准至少2种抗Aβ单克隆抗体上市,并应用于临床。其中,仑卡奈单抗、多奈单抗分别于2024年6月和2025年4月正式应用于国内临床。基于以上背景,为促进抗Aβ单克隆抗体在国内阿尔茨海默病治疗中的规范、合理和安全应用,本文结合作者团队及国内同行对上述单抗的临床试验数据及临床应用经验,在2024年版本的基础上,继续总结更新抗Aβ单克隆抗体的临床应用建议,包括临床用药指征、用药前评估与准备、用药时医嘱及注意事项、用药后临床监测,旨在为临床医师提供翔实的用药指导和建议。
In recent years,significant breakthroughs have been achieved in the immunotherapy for Alzheimer’s disease. In line with global advancements,two anti-amyloid-β monoclonal antibodies have been approved and successfully launched in China for clinical use. Lecanemab and Donanemab were officially used in June 2024 and April 2025 in China,respectively. In order to standardize the rational and safe application of anti-amyloid-β monoclonal antibodies for Alzheimer’s disease in China,this article integrates recommendations from the clinical trials and real-world experience from the author’s team and domestic peers to further update the recommendations for the clinical use of anti-amyloid-β monoclonal antibody based on the 2024 version. It includes indications for therapy,pre-treatment evaluation and preparation,administration protocols and safety measures during treatment,and post-treatment monitoring strategies.
Jia LF , Du YF , Chu L , et al . Prevalence,risk factors,and management of dementia and mild cognitive impairment in adults aged 60 years or older in China:a cross-sectional study [J ] . Lancet Public Health , 2020 , 5 ( 12 ): 661 - 671 .
王 刚 , 齐金蕾 , 刘馨雅 , 等 . 中国阿尔茨海默病报告2024 [J ] . 诊断学理论与实践 , 2024 , 23 ( 3 ): 219 - 256 .
Wang G , Qi JL , Liu XY , et al . China Alzheimer report 2024 [J ] . J Diagn Concepts Pract , 2024 , 23 ( 3 ): 219 - 256 .
朱 圆 , 余小萍 , 王 刚 . 老年痴呆患者基于社区支持的居家照护的专家建议 [J ] . 阿尔茨海默病及相关病杂志 , 2023 , 6 ( 1 ): 77 - 84 .
Zhu Y , Yu XP , Wang G . Suggestions for home care of people with dementia based on community support [J ] . Chinese Journal of Alzheimer’s Disease and Related Disorders , 2023 , 6 ( 1 ): 77 - 84 .
李建平 , 任汝静 , 王 刚 . 阿尔茨海默病的临床诊治进展 [J ] . 诊断学理论与实践 , 2022 , 21 ( 1 ): 18 - 21 .
Li JP , Ren RJ , Wang G . Advance in clinical diagnosis and treatment of Alzheimer’s disease [J ] . J Diagn Concepts Pract , 2022 , 21 ( 1 ): 18 - 21 .
Imbimbo BP , Ippati S , Watling M , et al . Role of monomeric amyloid-β in cognitive performance in Alzheimer’s disease:Insights from clinical trials with secretase inhibitors and monoclonal antibodies [J ] . Pharmacol Res , 2023 , 187 : 106631 .
肖金雯 , 任汝静 , 王 刚 . 论Aβ单抗治疗阿尔茨海默病的临床实践和进展 [J ] . 阿尔茨海默病及相关病杂志 , 2023 , 6 ( 1 ): 7 - 11 .
Xiao JW , Ren RJ , Wang G . Anti-Amyloid-β monoclonal antibodies for Alzheimer’s disease: clinical practice and progress [J ] . Chinese Journal of Alzheimer’s Disease and Related Disorders , 2023 , 6 ( 1 ): 7 - 11 .
Budd Haeberlein S , Aisen PS , Barkhof F , et al . Two randomized phase 3 studies of aducanumab in early Alzheimer’s disease [J ] . J Prev Alzheimers Dis , 2022 , 9 ( 2 ): 197 - 210 .
van Dyck CH , Swanson CJ , Aisen P , et al . Lecanemab in early Alzheimer’s disease [J ] . N Engl J Med , 2023 , 388 ( 1 ): 9 - 21 .
Sims JR , Zimmer JA , Evans CD , et al . Donanemab in early symptomatic Alzheimer disease:the TRAILBLAZER-ALZ 2 randomized clinical trial [J ] . JAMA , 2023 , 330 ( 6 ): 512 - 527 .
ADUHELM ™(aducanumab-avwa) injection , for intravenous use Initial U . S. Approval: 2021 [EB/OL ] . [ 2025-05-28 ] . https://www. accessdata. fda. gov/drugsatfda_docs/label/2021/761178s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761178s000lbl.pdf .
LEQEMBI®(lecanemab-irmb) injection,for intravenous use Ini⁃tial U. S. Approval: 2023,Revised 2025 [EB/OL]. [2025-05-28]. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761269s005lbl.pdf.
KISUNLA(donanemab azbt) injection , for intravenous use Initial U.S. Approval: 2024 [EB/OL ] . [ 2025-05-28 ] . https://www. accessdata. fda. gov/drugsatfda_docs/label/2024/761248s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761248s000lbl.pdf .
《早期阿尔茨海默病疾病修饰治疗专家共识》编审委员会 . 早期阿尔茨海默病疾病修饰治疗专家共识 [J ] . 中华内科杂志 , 2025 , 64 ( 5 ): 385 - 395 .
Expert Consensus Review Committee on Disease-Modifying Treatments for Early Alzheimer’s Disease . Recommendations for the disease-modifying treatments of early Alzheimer’s disease [J ] . Chin J Intern Med , 2025 , 64 ( 5 ): 385 - 395 .
黄 琪 , 任树华 , 管一晖 , 等 . 18 F-Florbetapir PET定量标准化Centiloid及其在中国临床前期阿尔茨海默病队列中的应用 [J ] . 中华核医学与分子影像杂志 , 2024 , 44 ( 5 ): 266 - 272 .
Huang Q , Ren SH , Guan YH , et al . Standardization of amyloid quantitation with 18 F-Florbetapir SUV ratio to the Centiloid scale and its application in Chinese Preclinical Alzheimer’s D isease Study [J ] . Chin J Nucl Med Mol Imaging , 2024 , 44 ( 5 ): 266 - 272 .
Cummings J , Apostolova L , Rabinovici GD , et al . Lecanemab:appropriate use recommendations [J ] . J Prev Alzheimers Dis , 2023 , 10 ( 3 ): 362 - 377 .
A Study of Donanemab(LY 3002813) in Participants With Early Alzheimer’s Disease(TRAILBLAZER-ALZ 2 )[EB/OL ] . [ 2025-05-28 ] . https://clinicaltrials.gov/ct2/show/NCT04437511 https://clinicaltrials.gov/ct2/show/NCT04437511 .
中华医学会神经病学分会痴呆与认知障碍学组 , 中华医学会核医学分会 . 淀粉样蛋白PET显像在阿尔茨海默病诊断中的应用专家共识 [J ] . 中华医学杂志 , 2023 , 103 ( 45 ): 3615 - 3626 .
Chinese Society of Dementia and Cognitive lmpairment , Chinese Society of Nuclear Medicine . Expert consensus on the application of amyloid-PET imaging in the diagnosis of Alzheimer’s disease [J ] . Natl Med J China , 2023 , 103 ( 45 ): 3615 - 3626 .
常 燕 . 重视β-淀粉样蛋白PET在新时代阿尔茨海默病诊疗中的价值 [J ] . 神经病学与神经康复学杂志 , 2025 , 21 ( 1 ): 12 - 16 .
Chang Y . Attach importance to the value of β-amyloid-PET in the diagnosis and treatment of Alzheimer’s disease in the new era [J ] . J Neurol Neurorehabil , 2025 , 21 ( 1 ): 12 - 16 .
A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer’s Disease(Clarity AD) [EB/OL ] . [ 2025-05-28 ] . https://clinicaltrials.gov/ct2/show/NCT03887455 https://clinicaltrials.gov/ct2/show/NCT03887455 .
中华医学会神经病学分会痴呆与认知障碍学组 . 阿尔茨海默病源性轻度认知障碍诊疗中国专家共识2024 [J ] . 中华神经科杂志 , 2024 , 57 ( 7 ): 715 - 737 .
Chinese Society of Dementia and Cognitive Impairment . Chinese expert consensus on the diagnosis and treatment of mild cognitive impairment due to Alzheimer’s disease 2024 [J ] . Chin J Neurol , 2024 , 57 ( 7 ): 715 - 737 .
Jeong SY , Suh CH , Kim SJ , et al . Amyloid-related imaging abnormalities in the era of anti-amyloid beta monoclonal antibodies for Alzheimer’s disease:recent updates on clinical and imaging features and MRI monitoring [J ] . Korean J Radiol , 2024 , 25 ( 8 ): 726 - 741 .
初曙光 , 王 刚 . 淀粉样蛋白相关影像学异常:一种与阿尔茨海默病治疗相关的具有影像学特征和诊断特异性的MRI表现 [J ] . 神经病学与神经康复学杂志 , 2025 , 21 ( 1 ): 6 - 11 .
Chu SG , Wang G . Amyloid-related imaging abnormalities: an MRI manifestation associated with Alzheimer’s disease-targeted therapy with imaging characteristics and diagnostic specificity [J ] . J Neurol Neurorehabil , 2025 , 21 ( 1 ): 6 - 11 .
Reish NJ , Jamshidi P , Stamm B , et al . Multiple cerebral hemorrhages in a patient receiving lecanemab and treated with t-PA for stroke [J ] . N Engl J Med , 2023 , 388 ( 5 ): 478 - 479 .
0
Views
9
下载量
0
CSCD
Publicity Resources
Related Articles
Related Author
Related Institution
京公网安备11010802024621
