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【drug-news】急性冠脉综合征：Prasugrel 优于氯比格
Authors: Stephen D. Wiviott, et al.
From: n engl j med 357;20 www.nejm.org november 15, 2007
Abstract
Background
Dual-antiplatelet therapy with aspirin and a thienopyridine is a cornerstone of treatment to prevent thrombotic complications of acute coronary syndromes and percutaneous coronary intervention.
Methods
To compare prasugrel, a new thienopyridine, with clopidogrel, we randomly assigned 13,608 patients with moderate-to-high-risk acute coronary syndromes with scheduled percutaneous coronary intervention to receive prasugrel (a 60-mg loading dose and a 10-mg daily maintenance dose) or clopidogrel (a 300-mg loading dose and a 75-mg daily maintenance dose), for 6 to 15 months. The primary efficacy end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The key safety end point was major bleeding.
Results
The primary efficacy end point occurred in 12.1% of patients receiving clopidogrel and 9.9% of patients receiving prasugrel (hazard ratio for prasugrel vs. clopidogrel, 0.81; 95% confidence interval [CI], 0.73 to 0.90; P<0.001). We also found significant reductions in the prasugrel group in the rates of myocardial infarction (9.7% for clopidogrel vs. 7.4% for prasugrel; P<0.001), urgent target-vessel revascularization (3.7% vs. 2.5%; P<0.001), and stent thrombosis (2.4% vs. 1.1%; P<0.001). Major bleeding was observed in 2.4% of patients receiving prasugrel and in 1.8% of patients receiving clopidogrel (hazard ratio, 1.32; 95% CI, 1.03 to 1.68; P = 0.03). Also greater in the prasugrel group was the rate of life-threatening bleeding (1.4% vs. 0.9%; P = 0.01), including nonfatal bleeding (1.1% vs. 0.9%; hazard ratio, 1.25; P = 0.23) and fatal bleeding (0.4% vs. 0.1%; P = 0.002).
Conclusions
In patients with acute coronary syndromes with scheduled percutaneous coronary intervention, prasugrel therapy was associated with significantly reduced rates of ischemic events, including stent thrombosis, but with an increased risk of major bleeding, including fatal bleeding. Overall mortality did not differ significantly between treatment groups. (ClinicalTrials.gov number, NCT00097591.) 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领 。 Title: Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes
Prasugrel与氯比格雷在急性冠脉综合症患者的效用的比较
Authors: Stephen D. Wiviott, et al.
作者：Stephen D. Wiviott,等
From: n engl j med 357;20 www.nejm.org november 15, 2007
Abstract
摘要
Background
研究背景
Dual-antiplatelet therapy with aspirin and a thienopyridine is a cornerstone of treatment to prevent thrombotic complications of acute coronary syndromes and percutaneous coronary intervention.
在防止急性冠脉综合症和PCI术后并发症—血栓的形成治疗中，阿司匹林和一种噻吩吡啶类药物的双重抗血小板治疗是基石。
Methods
方法
To compare prasugrel, a new thienopyridine, with clopidogrel,
为了比较新的噻吩吡啶类药物—prasugrel与氯比格雷的效用
we randomly assigned 13,608 patients with moderate-to-high-risk acute coronary syndromes with scheduled percutaneous coronary intervention to receive prasugrel (a 60-mg loading dose and a 10-mg daily maintenance dose) or clopidogrel (a 300-mg loading dose and a 75-mg daily maintenance dose), for 6 to 15 months.
我们随机选了13608个患有中度到高危接受过PCI术的急性冠脉综合症患者，给予 prasugrel（60mg的负荷量和每日10mg的维持量）或者氯比格雷（300mg的负荷量和每日75mg的维持量），时间为6至15个月。
The primary efficacy end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The key safety end point was major bleeding.
首要效力观察终点是心血管事件的死亡，非致命性心肌梗死，或者非致命性中风。首要安全观察终点是大出血。
Results
结果
The primary efficacy end point occurred in 12.1% of patients receiving clopidogrel and 9.9% of patients receiving prasugrel (hazard ratio for prasugrel vs. clopidogrel, 0.81; 95% confidence interval [CI], 0.73 to 0.90; P<0.001).
首要效力观察终点在氯比格雷组的发生率是12.1%，prasugrel组是9.9%（prasugrel与氯比格雷的HR是0.81，95%的置信区间【CI】，0.73比0.90， P<0.001）。
We also found significant reductions in the prasugrel group in the rates of myocardial infarction (9.7% for clopidogrel vs. 7.4% for prasugrel; P<0.001), urgent target-vessel revascularization (3.7% vs. 2.5%; P<0.001), and stent thrombosis (2.4% vs. 1.1%; P<0.001).
我们也得出一个结论：prasugrel组在心肌梗死的发生率（氯比格雷组9.7%比prasugrel组的7.4%，P<0.001）靶血管血运重建（3.7%比2.5% P<0.001），和支架内血栓的发生率(2.4% vs. 1.1%; P<0.001)都有显著的降低。
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作者:admin@医学,生命科学 2011-04-19 17:11
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