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阿杜卡奴单抗(商品名为 Aduhelm)的获批可能基于对 PET 成像数据的误解。

Aducanumab (Marketed as Aduhelm) Approval Is Likely Based on Misinterpretation of PET Imaging Data.

机构信息

Department of Nuclear Medicine, Odense University Hospital, Odense, Denmark.

Department of Clinical Research, University of Southern Denmark, Odense, Denmark.

出版信息

J Alzheimers Dis. 2021;84(4):1457-1460. doi: 10.3233/JAD-215275.

Abstract

According to the FDA, aducanumab (Aduhelm), the recently approved anti-Alzheimer drug, reduces the level of cerebral amyloid plaques-a hallmark finding in patients with Alzheimer's disease-and this will result in a reduction in clinical decline. The authors of this article are not convinced that amyloid deposits are a hallmark of Alzheimer's disease and are of the opinion that the apparent reduction in amyloid accumulation following aducanumab treatment is likely instead a result of continued and advanced cerebral cell death and, thus, not a sign of improvement but of an even more advanced disease.

摘要

根据 FDA 的说法,最近批准的抗阿尔茨海默病药物 aducanumab(Aduhelm)可降低脑淀粉样蛋白斑块的水平——这是阿尔茨海默病患者的一个标志性发现——并由此导致临床衰退的减少。本文的作者并不认为淀粉样沉积物是阿尔茨海默病的一个标志性特征,他们认为在接受 aducanumab 治疗后淀粉样蛋白堆积的明显减少可能是由于持续的、更严重的脑细胞死亡造成的,因此,这不是改善的迹象,而是疾病更严重的表现。

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