氟代脱氧葡萄糖（18F）正电子发射断层扫描脑淀粉样蛋白：欧洲上市许可的重点。

Florbetapir (18F) for brain amyloid positron emission tomography: highlights on the European marketing approval.

机构信息

Pharmacology and Clinical Evaluation Division, Agencia Española de Medicamentos y Productos Sanitarios, Madrid, Spain.

出版信息

Alzheimers Dement. 2014 Oct;10(5 Suppl):S395-9. doi: 10.1016/j.jalz.2013.09.007. Epub 2014 Jan 10.

DOI:10.1016/j.jalz.2013.09.007

Abstract

Florbetapir (18F) for brain amyloid positron emission tomography (PET) imaging has been recently approved in Europe to estimate β-amyloid neuritic plaque density in the brain when the subject is still alive. Such density is one of the key issues for the definitive diagnosis of Alzheimer's disease (AD) at autopsy. This capability of florbetapir (18F) is regarded as a significant improvement in the diagnostic procedures for adult patients with cognitive impairment who are being evaluated for AD and other causes of cognitive impairment. The current paper highlights the specific characteristics of the European marketing authorization of florbetapir (18F).

摘要

氟[18F]脱氧葡萄糖（Florbetapir (18F)）正电子发射断层扫描（PET）脑成像技术最近在欧洲获得批准，用于在受检者仍存活时评估大脑中的β-淀粉样蛋白神经纤维缠结密度。这种密度是对尸检时阿尔茨海默病（AD）进行明确诊断的关键问题之一。氟[18F]脱氧葡萄糖（Florbetapir (18F)）的这种能力被认为是对正在接受 AD 和其他认知障碍原因评估的认知障碍成年患者的诊断程序的重大改进。本文重点介绍了氟[18F]脱氧葡萄糖（Florbetapir (18F)）在欧洲上市许可的具体特点。