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  首頁(yè) > 美迪醫(yī)訊 > Mallinckrodt公司含釓造影劑OptiMark  

Mallinckrodt公司含釓造影劑OptiMark

【?2005-04-05 發(fā)布?】 美迪醫(yī)訊
美迪網(wǎng)領(lǐng)先的醫(yī)療器械電子商務(wù)平臺(tái)

一種使用新型造影劑的II期臨床試驗(yàn)已經(jīng)成功完成,在試驗(yàn)中檢測(cè)了使用OptiMark(釓弗塞胺)造影劑在檢測(cè)心肌梗塞表現(xiàn)、位置與程度方面的安全性與有效性。

這項(xiàng)首次大規(guī)模多中心國(guó)際臨床試驗(yàn)結(jié)果在美國(guó)奧蘭多(FL, USA)舉行的美國(guó)心臟病學(xué)院(ACC)年會(huì)上進(jìn)行了報(bào)道。從這些劑量范圍探索試驗(yàn)中獲取的信息確證了在疑似心臟病發(fā)作患者中的最佳劑量,而且顯示了在這個(gè)患者人群中藥物的安全性。

這項(xiàng)II期臨床試驗(yàn)包括了23個(gè)國(guó)際醫(yī)療中心的600多位患者與26名研究人員。OptiMark是由Mallinckrodt公司研制開(kāi)發(fā)的,這是Tyco健康保健(Mansfield, MA, USA)的商業(yè)機(jī)構(gòu)。其它用于檢測(cè)有活力心肌的不同造影方法包括鉈核素造影、氟-18去氧葡萄糖(FDG)正電子發(fā)射斷層攝影(PET)以及超聲心動(dòng)圖。盡管已經(jīng)在臨床實(shí)踐中使用,這項(xiàng)技術(shù)有著一些局限性包括造影窗口較差、缺乏足夠的清晰度、人工衰減導(dǎo)致模糊影像以及缺乏待機(jī)途徑。

核磁共振能夠鑒別出有活力心臟組織與已經(jīng)發(fā)生疤痕改變的組織或者心臟病發(fā)作導(dǎo)致死亡的組織之間的區(qū)別。使用釓為基質(zhì)的對(duì)比造影劑例如OptiMark能夠增強(qiáng)疤痕組織或者無(wú)活力組織區(qū)域。
 
Imaging Agent to Detect Heart Attacks
 
A new imaging agent has successfully completed two phase II studies using the OptiMark (gadoversetamide) imaging agent to determine the safety and effectiveness in detecting the presence, location, and extent of myocardial infarctions.

The findings of these first large, multicenter international trials were presented in March 2005 at the annual meeting of the American College of Cardiology (ACC) in Orlando (FL, USA). The information retrieved from these dose-ranging studies demonstrated the optimal dose to use in patients with a suspected heart attack and also showed the safety of the agent in this patient population.

The phase II trials included more than 600 patients and 26 researchers at 23 international medical centers. OptiMark was developed by Mallinckrodt, a business unit of Tyco Healthcare (Mansfield, MA, USA). Other imaging methods used to detect viable myocardium include thallium nuclear imaging, fluorodeoxyglucose (FDG) positron emission tomography (PET), and echocardiography. Although used clinically, these techniques have several limitations including poor imaging windows, lack of adequate resolution, attenuation artifacts causing blurred images, and lack of ready access.

MRI is able to identify the difference between living heart tissue and tissue that has become scarred or has died as a result of a heart attack. The use of gadolinium-based contrast agents such as OptiMark has been found to enhance areas of scarred or nonviable tissue.

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