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对于淀粉样蛋白斑块降至最低水平后，再次接受多奈单抗 治疗的安全性和风险特征，目前尚未开展系统研究，因此尚不清楚。

包括 多奈单抗 在内的治疗 β 淀粉样蛋白的单克隆抗体可能导致

• 淀粉样蛋白相关性影像异常 (ARIA)，以及
• 输液相关反应 (IRR)。^1-4

淀粉样蛋白相关性影像异常包括

• 淀粉样蛋白相关性影像异常 - 水肿 (ARIA-E)，在磁共振成像上观察到血管源性脑水肿或脑沟积液，以及
• 淀粉样蛋白相关性影像异常 - 含铁血黄素沉积 (ARIA-H)，包括微出血和皮质表面铁沉积。^5,6

淀粉样蛋白相关性影像异常通常无症状，很少发生严重且危及生命的事件。 除了 ARIA 之外，接受 多奈单抗 治疗的患者还出现了直径大于 1 cm 的脑内出血（即大出血）。⁷

上次审阅日期： 2024年2月8日

参考文献

1. Cummings J, Rabinovici GD, Atri A et al; Alzheimer’s Disease and Related Disorders Therapeutics Working Group. Aducanumab: appropriate use recommendations update. J Prev Alzheimers Dis. 2022;9(2):221-230. https://doi.org/10.14283/jpad.2022.34

2. Cummings J, Apostolova L, Rabinovici GD, et al; Alzheimer’s Disease and Related Disorders Therapeutics Working Group. Lecanemab: appropriate use recommendations. J Prev Alzheimers Dis. 2023;10(3):362-377. https://doi.org/10.14283/jpad.2023.30

3. Salloway S, Pain A, Ferguson MB, et al. TRAILBLAZER-ALZ 4: directly comparing donanemab to aducanumab on amyloid lowering in early, symptomatic Alzheimer's disease - results from 18-months. Presented at: International Conference on Alzheimer's and Parkinson's Disease; March 5-9, 2024; Lisbon, Portugal.

4. Sims JR, Zimmer JA, Evans CD, et al; TRAILBLAZER-ALZ 2 Investigators. Donanemab in early symptomatic Alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA. 2023;330(6):512-527. https://doi.org/10.1001/jama.2023.13239

5. Cogswell PM, Barakos JA, Barkhof F, et al. Amyloid-related imaging abnormalities with emerging Alzheimer disease therapeutics: detection and reporting recommendations for clinical practice. AJNR Am J Neuroradiol. 2022;43(9):E19-E35. https://doi.org/10.3174/ajnr.A7586

6. Sperling RA, Jack Jr CR, Black SE, et al. Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: recommendations from the Alzheimer’s Association Research Roundtable Workgroup. Alzheimers Dement. 2011;7(4):367-385. https://doi.org/10.1016/j.jalz.2011.05.2351

7. Data on file, Eli Lilly and Company and/or one of its subsidiaries.