当前时间:2022/12/8 5:07:35
当前位置:首页 >> 最新医学研究

美国批准阿尔茨海默氏症测试新法

发布时间:2012/4/29 7:58:43    发布者:中国中西医结合医学会    点击量:1183

图片来源:美国国立卫生研究院

近日,美国食品与药物管理局(FDA)批准用一种放射性化合物评估阿尔茨海默氏症患者的认知损伤。这种名为Amyvid的药物能够与淀粉体斑块结合在一起,后者是阿尔茨海默氏症在大脑中的名片。在进行正电子发射层析(PET)扫描之前,Amyvid使得医生能够看清淀粉体是否已经开始在大脑中积聚。FDA在其批准函中表示,一个负结果减少了病人因阿尔茨海默氏症导致认知问题的可能性,但一个正结果并非是确诊阿尔茨海默氏症所必需的。

该药物由礼来公司于2010年收购的艾威德放射性药物公司研制。2011年,一个FDA小组决定延缓批准Amyvid,并等待更多令人信服的证据,从而证明不同的医生会从扫描数据中读出相同的结果来。为此,礼来公司随后为神经放射专家举行了一个在线培训班,以保证一致的读数结果。

阿尔茨海默氏症神经影像计划负责人、美国加利福尼亚大学旧金山分校的神经学家Michael Weiner表示,Amyvid已经用于研究,包括临床试验很多年。Weiner表示,在与其他诊断试验相结合后,这种药物将成为一种强力的工具。但它也有潜在的缺点。“这里有很多担忧——它通常可能会被滥用,它可能会被误用并产生错误的诊断结果,包括假阳性和假阴性。”Weiner说,“对于如何使用这种药物,医学界必须给出自己的标准。”

阿尔茨海默氏症是一种以进行性认知障碍和记忆力损害为主的中枢神经系统退行性疾病,患者初期出现记忆力和思维能力减退,不久就会不易辨认方向,语言表达困难,无法辨认亲人,最后丧失生活自理能力,给家庭和社会带来沉重负担。阿尔茨海默症多发生于中年或老年的早期,因德国医生阿尔茨海默最先描述而得名。(生物谷Bioon.com)

 

U.S. FDA Approves Possible Alzheimer's Test

by Greg Miller on 9 April 2012, 5:03 PM

On Friday, the U.S. Food and Drug Administration (FDA) approved a radioactive compound for evaluating people with cognitive impairment for Alzheimer's disease. The drug, called Amyvid, binds to amyloid plaques, the calling card of Alzheimer's disease in the brain. When administered before a PET scan, Amyvid allows doctors to see whether amyloid has begun to build up. A negative test reduces the likelihood that a patient's cognitive problems are due to Alzheimer's, FDA said in its approval letter, but a positive test does not necessarily confirm a diagnosis of Alzheimer's. The compound was developed by Avid Radiopharmaceuticals, which was acquired by Eli Lilly and Company in 2010. Last year, an FDA panel decided to hold off on approving Amyvid pending more compelling evidence that different doctors would read the scans consistently. Lilly subsequently developed an online training course for neuroradiologists to ensure consistent readings. Amyvid has been used in research, including clinical trials, for years, says Michael Weiner, a neurologist at the University of California, San Francisco, and principal investigator of the Alzheimer's Disease Neuroimaging Initiative. The compound will be a powerful tool for clinicians when used in combination with other diagnostic tests, Weiner says. But there are potential downsides, too. "There are many concerns: that it could be overused in general, that it could be misused and there will be false diagnoses, both false positives and false negatives," Weiner says. "The medical community is going to have to develop its own standards for how to use it."