A NOVEL POINT-OF-CARE PLATELET FUNCTION ANALYZER

描述（由申请人提供）：冠心病（CHD）和中风仍然是美国发病率和死亡率的主要原因之一，血小板在冠心病/中风中起着重要作用。因此，使用抗血小板药物有助于预防或治疗这类血管疾病。尽管大量患者常规使用抗血小板药物，但很少监测每位患者的抗血小板治疗效果。大多数患者的处方是固定剂量，没有努力建立治疗效果，缺乏适当的策略，妨碍了个人监测和调整剂量，以确保充分的保护。多达30%的患者可能对标准剂量的常用抗血小板药物（如阿司匹林和氯吡格雷）有耐药性，这一事实进一步强调了监测抗血小板治疗的必要性。目前评估血小板功能的方法繁琐且耗时（实验室方法），或者相对昂贵、不可靠，并且只能提供间接/不完整的测量（目前的即时护理仪器），因此缺乏灵敏度。在NIH的资助下，Thrombodyne公司开发了一种评估全血血小板功能的新方法。功能版的血小板功能分析仪（TPFA）经受住了严格的实验室和有限的临床测试，检测血小板功能异常并识别可能对标准剂量抗血小板药物耐药的患者。通过这一申请，研究人员要求支持他们继续努力：1)使TPFA成为一种成本效益高、方便和多功能的护理点仪器，2)寻求FDA批准，准备上市，3)证明单独定制抗血小板药物（或药物组合）的剂量会带来更好的治疗效果，减少副作用，并取得更好的结果。申请人在其发展道路上处于一个独特的点，所要求的资金将允许他们将设备推向市场。这种方便、成本效益高的即时血小板功能分析仪的引入，将使为每个人量身定制抗血小板治疗成为可能，并改善结果。

DESCRIPTION (provided by applicant): Coronary heart disease (CHD) and stroke remain 1 of the major causes of morbidity and mortality in the US, and platelets play a major role in CHD/stroke. Thus, the use of antiplatelet drugs is helpful in the prevention or treatment of such vascular disorders. Despite routine use of antiplatelet agents in a large number of patients, the efficacy of antiplatelet therapy is rarely monitored in each patient. Most patients are prescribed a fixed dose with no effort to establish therapeutic efficacy, and the lack of suitable strategies precludes individual monitoring and adjustment of dosage to ensure adequate protection. The need for monitoring antiplatelet therapy is further accentuated by the fact that as many as 30% of patients may be resistant to standard dosages of commonly used antiplatelet drugs such as aspirin and clopidogrel. The current methods for the assessment of platelet function are cumbersome and time-consuming (laboratory methods), or relatively expensive, unreliable and offer only an indirect/incomplete measure (current point-of care instruments), and therefore lack sensitivity. Thrombodyne Inc. has developed, with funding from NIH, a novel approach to assess platelet function in whole blood. A functional version of the Thrombodyne Platelet Function Analyzer (TPFA) has withstood the rigors of laboratory and limited clinical testing, and detects platelet function abnormalities and identifies patients who may be resistant to standard doses of antiplatelet agents. Through this application, the investigators request support to sustain their efforts to: 1) make TPFA a cost-effective, convenient and versatile point-of-care instrument, 2) to seek FDA approvals to prepare it for marketing, and 3) to demonstrate that individually tailored dosing of antiplatelet agent (or combination of agents) would lead to better therapeutic efficacy, reduce side effects, and result in better outcomes. The applicants are at a unique point in their development path where the requested funding would allow them to take the device to market. The introduction of this convenient, cost-effective point-of-care platelet function analyzer would make it possible to tailor antiplatelet therapy for each individual and improve outcomes.