| 国产比伐卢定用于冠状动脉介入治疗术中抗凝的疗效和安全性评价 |
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| 引用本文： | 比伐卢定多中心临床研究协作组. 国产比伐卢定用于冠状动脉介入治疗术中抗凝的疗效和安全性评价[J]. 中国循环杂志, 2011, 26(5). DOI: 10.3969/j.issn.1000-3614.2011.05.005 |
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| 作者姓名： | 比伐卢定多中心临床研究协作组 |
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| 作者单位： | 广州军区广州总医院,心内科,广东省广州市,510010 |
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| 摘 要： | 目的:评估国产比伐卢定应用于择期冠状动脉介入治疗术(PCI)中抗凝治疗的疗效及安全性.方法:采用随机、单盲、多中心临床试验设计,随机将接受择期PCI的患者分为比伐卢定组和肝素组,在PCI术中分别采用比伐卢定或普通肝素抗凝治疗,主要疗效评价指标为术中测定激活的全血凝固时间(ACT)、手术成功率(靶病变术后狭窄程度小于20%并24 h内无冠状动脉事件发生)及30天无心血管事件生存率,主要安全性评价指标为轻度及重度出血.结果:共有218例患者入选,实际入组完成试验207例,比伐卢定组(n=105)和肝素组(n=102).用药后5 min除肝素组2例需要追加剂量外,其余两组患者PCI术中均能维持ACT>225 s,两组差异无统计学意义(P>0.05);比伐卢定组和肝素组PCI手术成功率和30天无心脏事件生存率均分别为100%和98.04%(P>0.05),差异无统计学意义.比伐卢定组和肝素组24 h内轻度出血的发生率分别为0.95%和6.86%(P<0.05)、30天内轻度出血发生率分别为1.9%和8.8%(P<0.05),肝素组有1例发生严重消化道出血.结论:国产比伐卢定能安全有效地应用于择期PCI术中抗凝治疗,疗效不劣于肝素且出血副作用低于肝素.
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| 关 键 词： | 比伐卢定,国产 肝素 经皮冠状动脉介入治疗术 抗凝疗法 临床试验 |
Evaluation of Anticoagulant Efficacy and Safety for Domestic Bivalirudin During Percutaneous Coronary Intervention |
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| Cooperative Group of Domestic Bivalirudin Multi Center Clinical Trial. Evaluation of Anticoagulant Efficacy and Safety for Domestic Bivalirudin During Percutaneous Coronary Intervention[J]. Chinese Circulation Journal, 2011, 26(5). DOI: 10.3969/j.issn.1000-3614.2011.05.005 |
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| Authors: | Cooperative Group of Domestic Bivalirudin Multi Center Clinical Trial |
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| Affiliation: | Cooperative Group of Domestic Bivalirudin Multi Center Clinical Trial. XIANG Ding-cheng,Department of Cardiology,Liuhuaqiao Hospital,Guangzhou(510010),Guangdong,China |
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| Abstract: | Objective:To evaluate the anticoagulant efficacy and safety of domestic bivalirudin during elective percutaneous coronary intervention(PCI). Methods:A total of 218 elective PCI candidates were enrolled in this randomized,single-blind multi center clinical trial and 207 patients finished the trail.The patients were divided into two groups,Bivalirudin group,n=105 and Heparin group,n=102,they received either bivalirudin or heparin during PCI procedure.We compared the activated coagulation time(ACT),procedural ... |
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| Keywords: | Bivalirudin domestic Heparin Percutaneous coronary intervention Anticoagulant Clinical trial |
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