Institut de Cardiologie (AP-HP), INSERM U856 and Universite Paris 6, Hopital Pitié-Salpetrière, Paris, France.
Thromb Haemost. 2010 Jan;103(1):213-23. doi: 10.1160/TH09-07-0482. Epub 2009 Oct 26.
Compared with the approved dose regimen of clopidogrel (300-mg loading dose [LD], 75-mg maintenance dose [MD]), prasugrel has been demonstrated to reduce ischaemic events in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI). In ACS, antiplatelet effects of a prasugrel MD regimen have not been previously compared with either a higher clopidogrel MD or after switching from a higher clopidogrel LD. The objective of this study was to evaluate the antiplatelet effect of a prasugrel 10-mg MD versus a clopidogrel 150-mg MD in patients with ACS who had received a clopidogrel 900-mg LD. Patients with non-ST elevation ACS, treated with aspirin and a clopidogrel 900-mg LD, were randomised within 24 hours post-LD to receive a prasugrel 10-mg or clopidogrel 150-mg MD. After 14 days of the initial MD, subjects switched to the alternative treatment for 14 days. The primary endpoint compared maximum platelet aggregation (MPA, 20 microM adenosine diphosphate [ADP]) between prasugrel and clopidogrel MDs for both periods. Responder analyses between treatments were performed using several platelet-function methods. Of 56 randomised subjects, 37 underwent PCI. MPA was 26.2% for prasugrel 10 mg and 39.1% for clopidogrel 150 mg (p<0.001). The prasugrel MD regimen reduced MPA from the post-900-mg LD level (41.2% to 29.1%, p=0.003). Poor response ranged from 0% to 6% for prasugrel 10 mg and 4% to 34% for clopidogrel 150 mg. Thus, in ACS patients a prasugrel 10-mg MD regimen resulted in significantly greater platelet inhibition than clopidogrel at twice its approved MD or a 900-mg LD.
与氯吡格雷（300 毫克负荷剂量[LD]，75 毫克维持剂量[MD]）的批准剂量方案相比，普拉格雷已被证明可降低接受经皮冠状动脉介入治疗（PCI）的急性冠状动脉综合征（ACS）患者的缺血事件。在 ACS 中，普拉格雷 MD 方案的抗血小板作用以前从未与更高剂量的氯吡格雷 MD 或从更高剂量的氯吡格雷 LD 转换后进行比较。本研究的目的是评估 ACS 患者接受氯吡格雷 900 毫克 LD 后接受普拉格雷 10 毫克 MD 与氯吡格雷 150 毫克 MD 的抗血小板作用。非 ST 段抬高型 ACS 患者，接受阿司匹林和氯吡格雷 900 毫克 LD 治疗，在 LD 后 24 小时内随机分为普拉格雷 10 毫克或氯吡格雷 150 毫克 MD。初始 MD 治疗 14 天后，患者换用另一种治疗方法 14 天。主要终点比较普拉格雷和氯吡格雷 MD 两种方案在两个时期的最大血小板聚集（MPA，20μM 二磷酸腺苷[ADP]）。使用几种血小板功能方法对两种治疗方法进行了应答分析。在 56 名随机患者中，37 名患者接受了 PCI。普拉格雷 10 毫克的 MPA 为 26.2%，氯吡格雷 150 毫克为 39.1%（p<0.001）。普拉格雷 MD 方案使从 LD 后 900 毫克水平的 MPA 降低（从 41.2%降至 29.1%，p=0.003）。普拉格雷 10 毫克的不良反应范围为 0%至 6%，氯吡格雷 150 毫克的不良反应范围为 4%至 34%。因此，在 ACS 患者中，普拉格雷 10 毫克 MD 方案的血小板抑制作用明显大于氯吡格雷，是其批准的 MD 的两倍或 900 毫克 LD。
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