主页 > 医学文档 >
【medical-news】FDA：FDA Approves New Medical Use for Plav
今天选了一篇：
FDA Approves New Medical Use for Plavix
Drug Benefits Patients with Common Form of Heart Attack
The Food and Drug Administration (FDA) today approved the use of Plavix (clopidogrel bisulfate) for patients who have had a type of heart attack called acute ST-segment elevation myocardial infarction (STEMI), who are not going to have coronary artery repair (angioplasty).
A STEMI is a severe heart attack caused by the sudden, total blockage of an artery. In STEMI patients, Plavix prevents subsequent blockage in the already-damaged heart vessel, which could lead to more heart attacks, stroke - and possibly death.
FDA approved Plavix in November 1997 to decrease platelet function in people who suffer from acute coronary syndrome (ACS). Platelets are the sticky blood cells that help to form a clot and can contribute to blocked coronary arteries
According to the American Heart Association, each year an estimated 500,000 Americans have a STEMI heart attack.
"Plavix has demonstrated that it can help reduce these post-STEMI events for patients who suffer certain kinds of heart attacks," said Steven Galson, MD, Director of FDA's Center for Drug Evaluation and Research.
Two studies support the effectiveness of Plavix in treating STEMI heart attack patients. A large trial, the Clopidogrel and Metoprolol in Myocardial Infarction Trial (COMMIT) study, demonstrated that Plavix, when combined with other standard treatments including thrombolysis, a procedure to dissolve clots, reduced mortality and also reduced the combined number of recurrent heart attacks, strokes and deaths. COMMIT was a randomized, double-blind, placebo-controlled trial of 46,000 patients conducted in China.
The findings in COMMIT in China are supported by the results of the Clopidogrel as Adjunctive Reperfusion Therapy (CLARITY) study. CLARITY was a clinical trial of 3,500 patients undergoing thrombolysis for STEMI heart attacks. CLARITY showed that the coronary artery blood flow was better with clopidogrel treatment compared to placebo.
Serious side effects of Plavix include bleeding and, rarely, low white blood cell counts or thrombotic thrombocytopenic purpura (low platelet counts with spontaneous bleeding and clotting). \Plavix is manufactured by Sanofi Aventis of Bridgewater, NJ.
####
来源：http://www.fda.gov/bbs/topics/NEWS/2006/NEW01431.html
我的翻译：
美国食品药品监督管理局(FDA)今天批准了波立维® (硫酸氢氯吡格雷)用于患有被称为ST段抬高的心肌梗塞(STEMI)的病人，患有STEMI的患者无法进行冠状动脉修复（及进行血管成形术）。
STEMI是一种由突然,完全的动脉堵塞引起的严重的心脏疾病，对STEMI患者，波立维能够阻止动脉堵塞随后发上受损心血管的堵塞，如果发生这种堵塞，会造成严重的心脏疾病，中风甚至死亡。
1997年11月FDA批准玻立维用于降低急性冠状动脉综合征（ACS）患者的血小板，血小板是粘稠血细胞，能够形成血凝块，阻塞冠状动脉。
据美国心脏协会统计，美国每年有约500，000人发生STEMI心脏疾病。
FDA'药品审评和研究中心主任，医学博士，Steven Galson说“玻立维已经显示了它能够帮助患有某种心脏疾病的患者，降低随STEMI后的进一步病状。”
两项研究证明了玻立维对STEMI心脏疾病患者有效。在中国进行了有46.000例病例的用来研究硫酸氢氯吡格雷和美托洛尔治疗心肌梗塞(COMMIT)的随机，双盲，安慰剂做对照的临床试验 COMMIT实验结果显示，结合其他的标准治疗手段，比如溶解血凝块的溶栓治疗，玻立维降低了死亡率，也降低再发性心脏病造成的中风和死亡率.
硫酸氢氯吡格雷作为再通疗法的辅助治疗(CLARITY)研究结果也支持了在中国进行的COMMIT实验的结果发现 . CLARITY是一项对3,500例STEMI心脏疾病患者进行的溶栓治疗,结果显示,对比使用安慰剂, 接受硫酸氢氯吡格雷治疗的患者的冠状动脉血流状况更好.
玻立维的副反应包括出血,以及罕见的白血细胞记数降低或血栓性血小板减少性紫癜.该产品由新泽西洲桥水市的塞诺菲.安万特公司生产.
欢迎各位指正！ 还有什么新闻？ [标签:content1][标签:content2]
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-10-14 05:17
医学,生命科学网