Karha Juhana, Rajagopal Vivek, Kottke-Marchant Kandice, Bhatt Deepak L
Department of Cardiovascular Medicine, Cleveland Clinic Foundation, Cleveland, OH 44195, USA.
Am Heart J. 2006 May;151(5):976.e7-11. doi: 10.1016/j.ahj.2006.02.017.
Aspirin inhibits platelet aggregation and is widely used in the treatment of cardiovascular disease. Some individuals are less responsive to aspirin's antiplatelet effect, a phenomenon termed aspirin resistance. It is not known whether the antiplatelet effect is fully preserved with the enteric-coated (EC) formulation.
We performed a prospective randomized trial of 50 healthy volunteers using a crossover design to compare the EC with the standard aspirin formulations. The subjects received a 7-day course of each aspirin formulation (81-mg) (Bayer Corporation, Morristown, NJ) separated by a 3-week washout period. Platelet function was measured before and after each course using optical aggregometry (with arachidonic acid and adenosine diphosphate as agonists) and a point-of-care platelet assay.
The assays were reproducible, and the variation in baseline platelet function was small to moderate between the subjects. There was no difference in the extent of platelet inhibition between the EC and standard formulations with any of the 3 assays. With the point-of-care platelet assay, the mean aspirin effect favoring the standard formulation (more aggregation inhibition) compared with the EC formulation was 1.6% +/- 15.8% (P = .60 for difference between the formulations). The corresponding optical aggregometry values were -3.4% +/- 39.5% (P = .97) and -1.4% +/- 16.6% (P = .75) for arachidonic acid and adenosine diphosphate, respectively.
Compared with standard aspirin, EC aspirin appears to exhibit similar inhibition of platelet aggregation in healthy volunteers. Furthermore, point-of-care platelet assessment correlated well with the gold standard of laboratory-based optical platelet aggregometry.
阿司匹林可抑制血小板聚集,广泛用于心血管疾病的治疗。一些个体对阿司匹林的抗血小板作用反应较弱,这种现象称为阿司匹林抵抗。肠溶包衣(EC)制剂的抗血小板作用是否能完全保留尚不清楚。
我们采用交叉设计对50名健康志愿者进行了一项前瞻性随机试验,以比较EC制剂与标准阿司匹林制剂。受试者接受每种阿司匹林制剂(81毫克)(拜耳公司,新泽西州莫里斯敦)为期7天的疗程,中间间隔3周的洗脱期。在每个疗程前后,使用光学聚集测定法(以花生四烯酸和二磷酸腺苷作为激动剂)和即时血小板检测法测量血小板功能。
检测具有可重复性,受试者之间基线血小板功能的差异为小到中度。在3种检测方法中的任何一种中,EC制剂和标准制剂之间的血小板抑制程度均无差异。使用即时血小板检测法,与EC制剂相比,标准制剂的平均阿司匹林效应(更多的聚集抑制)为1.6%±15.8%(制剂之间差异的P值为0.60)。花生四烯酸和二磷酸腺苷对应的光学聚集测定值分别为-3.4%±39.5%(P值为0.97)和-1.4%±16.6%(P值为0.75)。
与标准阿司匹林相比,EC阿司匹林在健康志愿者中似乎表现出相似的血小板聚集抑制作用。此外,即时血小板评估与基于实验室的光学血小板聚集测定的金标准相关性良好。