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争议性批准新型药物治疗老年痴呆症。

Controversial Approval of New Drug to Treat Alzheimer's Disease.

机构信息

Diane S. Aschenbrenner is a former member of the faculty at Notre Dame of Maryland University and the Johns Hopkins University School of Nursing. She coordinates Drug Watch :

出版信息

Am J Nurs. 2021 Oct 1;121(10):22-23. doi: 10.1097/01.NAJ.0000794244.40800.99.

Abstract

Aducanumab (Aduhelm), the first new drug to treat Alzheimer's disease since 2003, has received accelerated approval from the Food and Drug Administration (FDA).This drug's approval has been highly contentious in the medical and scientific community owing to contradictory study findings and the FDA's advisory panel not recommending its approval.

摘要

阿杜卡玛单抗(Aduhelm)是自 2003 年以来首个获批用于治疗阿尔茨海默病的新药,已获得美国食品药品监督管理局(FDA)的加速批准。由于研究结果相互矛盾,且 FDA 顾问小组不建议批准该药物,该药物的获批在医学和科学界引起了广泛争议。

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