一种新的冠心病风险评估方法获美批准

2014-12-17 小田 译 医学论坛网

美国食品与药物管理局(FDA)近日批准了可评估血浆脂蛋白相关的磷脂酶A2(Lp-PLA2)筛选检测法用于评估目前无冠状动脉性心脏病(CHD)的CHD风险和冠状动脉粥样硬化人群的卒中风险。 这种检测方法名为PLAC检测,是一种特定的血管炎性酶,可用于预测女性CHD风险,尤其是非裔美国女性人群。 FDA是基于“卒中地理和种族差异的原因”亚组研究结果批准该种检测方法的。该研究纳入了459

美国食品与药物管理局(FDA)近日批准了可评估血浆脂蛋白相关的磷脂酶A2(Lp-PLA2)筛选检测法用于评估目前无冠状动脉性心脏病(CHD)的CHD风险和冠状动脉粥样硬化人群的卒中风险。

这种检测方法名为PLAC检测,是一种特定的血管炎性酶,可用于预测女性CHD风险,尤其是非裔美国女性人群。

FDA是基于“卒中地理和种族差异的原因”亚组研究结果批准该种检测方法的。该研究纳入了4598例年龄45岁至92岁的目前无CHD的受试者。在中位随访5年后,那些Lp-PLA2水平>225 nmol/min/mL的个体CHD事件发生率为7.0%,而那些<225 nmol/min/mL 的个体这种事件发生率则为3.3%。当Lp-PLA2>225 nmol/min/mL时,黑人女性的CHD事件发生率显著升高。因此,PLAC检测说明书含有单独的黑人男性和女性、白人男性和女性的工作数据。

英文链接:FDA Approves Lp-PLA2 Test for Patients Without Existing Coronary Disease




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