NEJM：一种新药抗凝血效果更好 但会增加严重出血风险

　　美国《新英格兰医学杂志》（NEJM）网络版11月4日发表一份最新研究报告说，一种名为Prasugrel的新药具有比某种主流药物更好的抗凝血效果，可用于心脏病等相关疾病的治疗。但该药同时会增加严重出血的风险。

　　研究报告说，许多心脏病患者需要使用抗凝血药物来稀释血液和减少血栓，Prasugrel在这方面比目前的主流药物Plavix更有效果。与后者相比，服用新药的病人心脏病发作、中风、因心脏病死亡的综合风险要低20%，并且见效更快，服药3天后就有较好的效果。

　　另一方面，新药增加了严重出血的风险，这意味着它对于老人等人群来说更有风险。但美国克利夫兰诊所的心脏病专家迪帕克·巴特评论说，这是为取得更好的抗凝血效果“需付的代价”。

　　这种新药是美国礼来公司和一家日本公司联合开发的。（新华网）

［原文］：Published at www.nejm.org November 4, 2007 (10.1056/NEJMoa0706482)

Prasugrel versus Clopidogrel in Patients with Acute Coronary Syndromes

Stephen D. Wiviott, M.D., Eugene Braunwald, M.D., Carolyn H. McCabe, B.S., Gilles Montalescot, M.D., Ph.D., Witold Ruzyllo, M.D., Shmuel Gottlieb, M.D., Franz-Joseph Neumann, M.D., Diego Ardissino, M.D., Stefano De Servi, M.D., Sabina A. Murphy, M.P.H., Jeffrey Riesmeyer, M.D., Govinda Weerakkody, Ph.D., C. Michael Gibson, M.D., Elliott M. Antman, M.D., for the

TRITON–TIMI 38 Investigators

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).