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当前位置:药品说明书与价格首页 >> 神经内科 >> 帕金森病 >> 药品推荐 >> 氟潘(Ioflupan I-123,DaTscan)

氟潘(Ioflupan I-123,DaTscan)

2011-06-08 09:45:51  作者:新特药房  来源:中国新特药网天津分站  浏览次数:248  文字大小:【】【】【
简介:DaTscan由通用医疗公司研发,于1月14日获FDA批准,用于帕金森综合征的诊断。DaTscan是一种在单光子计算机断层扫描时作为显影剂对颅内纹状体区域的多巴胺转运蛋白成像的放射性药物,以辅助医生鉴别和诊断 ...

近日,美国FDA已经批准了DaTscan用于检测帕金森综合征(PS)疑似成年患者大脑内的多巴胺转运蛋白(DaT)。DaTscan作为多巴胺转运蛋白客观和准确的指标将能更好地帮助医生做出诊断决策。
 
DaTscan为一种用于单光子发射计算机断层显像(SPECT)成像的放射性药剂。这是首个获得FDA批准的帮助医生评估如特发性(原因不明)的帕金森氏病(PD)等神经退行性运动障碍的诊断显像剂,DaTscan可作为帮助鉴别特发性震颤(一种手、头、脸的不自主颤动)与PS所致震颤的诊断评估的一种辅助手段。DaTscan无法区分PS的不同类型。
 
德拉姆杜克大学医学中心杜克运动障碍诊断主任、神经病学家Mark Stacy博士说,碘[123I]氟潘[DaTscan]可能是一个帮助医师鉴别帕金森氏症与特发性震颤病的重要新型显像剂。
 
FDA批准DaTscan是基于两项证实DaTscan用于大脑内部纹状体区域DaT分布可视化有效性的III期临床试验的结果。这些研究对284例震颤成人患者进行了评估,研究结果显示,大脑中DaT分布可视化检测中的DaTscan的作用与一种参考临床诊断相一致。
 
FDA优先评估后采取的行动标志着首个检测大脑内DAT分布的放射性药剂的批准。大脑内DaT分布的可视化可能有助于减少对疑似PS成人患者诊断的不确定性。FDA同意DaTscan优先审查,是因为协助医生依据多巴胺的特点管理患者的临床需求未能被满足。

DaTscan常见不良反应是头痛、头晕、食欲增加和蚁走感等。

Your doctor has prescribed a DaTscan imaging test for you or someone for whom you care. This test will give your doctor information to help him or her understand the symptoms you or your loved one is experiencing.
DaTscan is an imaging drug that will be injected into the bloodstream to help your doctor assess a chemical in your brain called dopamine. A special device, called a gamma camera, will take pictures of your brain. These pictures and a report will be sent to your doctor, who can discuss the test results with you. The DaTscan results may help determine if the symptoms you are experiencing are the result of a Parkinsonian syndrome.
Parkinsonian syndromes occur when your brain is not getting enough of the dopamine it needs to perform certain functions. This affects the brain’s ability to control movement and other muscle functions.
There are different types of Parkinsonian syndromes. The most common is Parkinson’s disease, also known as PD. Other types include multiple system atrophy and progressive supranuclear palsy. DaTscan cannot distinguish between these different syndromes. In combination with other tests, DaTscan may help your doctor determine if you are suffering from a Parkinsonian syndrome.
The DaTscan test will be performed in the nuclear medicine department of a hospital or in an outpatient clinic.
DaTscan is for adult patients who have signs or symptoms of Parkinsonian syndromes, such as shaking or stiffness. DaTscan is available only with a prescription from your doctor, and only your doctor can decide if this test is right for you.
This test is NOT for:
  •  Patients with a known allergy or sensitivity to iodine
  •  Patients with a known sensitivity to DaTscan
  •  Children
This test may not be right for:
  •  Patients who are pregnant
  •  Patients who are nursing
  •  Patients with reduced kidney or liver funtion
Sensitivity reactions (such as rash or itching) have been reported after DaTscan administration. In clinical trials, the most common side effects were headache, nausea, dry mouth, or dizziness.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online  or by phone [1-800-332-1088].

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