Atwood Craig S, Perry George
Geriatric Research, Education and Clinical Center, Veterans Administration Hospital and Department of Medicine, University of Wisconsin, Madison, WI, USA.
Department of Neuroscience, Development and Regenerative Biology, University of Texas at San Antonio, San Antonio, TX, USA.
J Alzheimers Dis. 2023;92(3):799-801. doi: 10.3233/JAD-230040.
The questionable approval of aducanumab and the recent approval of lecanemab (Leqembi; Eisai and Biogen) by the FDA has raised the issue of safety (stroke, meningitis, and encephalitis) over efficacy (slowing of cognitive decline). This communication recounts the important physiological functions of amyloid-β as a barrier protein with unique sealant and anti-pathogenic activities important for maintaining vascular integrity coupled with innate immune functions that prevent encephalitis and meningitis. The approval of a drug that obviates both of these purposive functions increases the risk of hemorrhage, edema and downstream pathogenic outcomes and should be clearly outlined to patients.
阿杜卡努单抗的可疑获批以及美国食品药品监督管理局(FDA)近期对仑卡奈单抗(Leqembi;卫材和百健)的批准引发了关于安全性(中风、脑膜炎和脑炎)而非疗效(认知衰退减缓)的问题。本通讯叙述了β淀粉样蛋白作为一种屏障蛋白的重要生理功能,其具有独特的密封和抗病原活性,对于维持血管完整性以及预防脑炎和脑膜炎的固有免疫功能至关重要。批准一种消除这两种目的性功能的药物会增加出血、水肿及下游致病后果的风险,应向患者明确说明。