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Biosite公司诊断栓塞的TriageD二聚体检测方法面世

【 2004-12-21 发布 】 美迪医讯
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一种新型检测方法被设计用于帮助诊断与评估那些易于发生血栓栓塞事件的患者,包括肺栓塞。这种检测方法叫做Triage D二聚体检测,已经获得了美国药品食品管理局的许可。

这种床边诊断检测方法是一种十分方便的检测方法,能够在急诊科或者患者床边进行。根据一项发表在《急诊医学年报》(2004:490-502)上的研究报道,在一项评估肺栓塞的床边检测临床试验方案中,使用当前正在使用的乳胶凝集试验检测D二聚体,评估肺栓塞的患者的数量增加一倍,而急诊室观察时间下降,无需进一步进行血管造影检查。当前被漏诊的肺栓塞病例比实际诊断病例要多,这是由于患者临床症状模糊而且缺乏特异性。肺栓塞漏诊率最高的是住院患者。尸体解剖结果显示,多达60%的院内死亡患者有肺栓塞,但是这些患者中有70%都没有能够诊断出来。

Biosite公司(San Diego, CA, USA)首席科学官员、总拆Ken Buechler博士评论说:“肺栓塞会产生致命的后果,我们相信Triage D二聚体检测,做为一种床边检测项目,能够很好地帮助急诊科医生快速评估疑似肺栓塞患者,从而改进对患者的治疗处理。”正是Biosite公司进行了Triage D二聚体检测进行了商品化操作。

Test Aids Diagnosis of Embolism
 
A new test is intended as an aid in the assessment and evaluation of patients suspected of having thromboembolic events, including pulmonary embolism (PE). The test, called Triage D-Dimer test, has been cleared by the U.S. Food and Drug Administration (FDA).

This point-of-care (POC) diagnostic test is portable and can be used in the emergency department (ED) or at the patient’s beside. According to a study published in the Annals of Emergency Medicine (2004:490-502), a POC clinical protocol for the evaluation of PE, using an available latex-agglutination test for D-Dimer, doubled the number of patients evaluated for PE and decreased length of stay in the ED, without increasing the need for vascular imaging. Currently, more cases of PE are missed than are actually diagnosed because of vague and nonspecific symptoms. The highest incidence of unrecognized PE occurs in hospitalized patients. Autopsy results show that as many as 60% of patients dying in the hospital have had a PE, but the diagnosis has been missed in about 70% of the cases.

“Pulmonary embolism can be a highly lethal condition,” commented Ken Buechler, Ph.D., president and chief scientific officer of Biosite, Inc. (San Diego, CA, USA), which is commercializing the Triage D-Dimer test. “We believe the Triage D-Dimer test, used at the point of care, can play an important role in helping emergency department physicians rapidly evaluate patients with suspected pulmonary embolism, which should result in better patient management.”

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