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替罗非班在冠状动脉支架植入术中应用的安全性及耐受性评价
http://www.100md.com 《中华实用医药杂志》 2004年第18期
安全性和耐受性,替罗非班,冠状动脉支架,安全性和耐受性,1试验设计和方法,2试验结果,3讨论,参考文献
     【摘要】 目的 评价替罗非班在冠心病患者支架植入术中与肝素和阿司匹林合用的安全性和耐受性。 方法 随机、双盲、安慰剂对照的国际多中心协作研究,国内共入选30例冠心病需植入支架的患者,随机进入安慰剂和替罗非班组。 结果 替罗非班组患者18例,安慰剂组12例。替罗非班组患者中不稳定型心绞痛7例(38.9%),稳定型心绞痛9例(50%),急性心肌梗死2例(11%)。安慰剂组不稳定型心绞痛6例(50.0%),稳定型心绞痛2例(16.7%),急性心肌梗死3例(25.0%)。替罗非班组共植入支架21只,安慰剂组植入支架12只。两组手术全部成功,患者血红蛋白、血球压积、血小板计数在用药前后比较无明显变化,两组间比较差异无显著性(P>0.05)。替罗非班组出现过敏反应1例,未停药;两组均无出血并发症发生,替罗非班组有1例穿刺部位止血时间延长,但未发生血肿。两组30天随访时均无心肌梗死、CABG、再次PTCA和死亡等终点事件发生。 结论 替罗非班在国人中用于PTCA及支架术是安全的,耐受性良好,无严重并发症发生,与阿司匹林和肝素、噻氯匹啶合用未增加出血并发症。

    关键词 替罗非班 冠状动脉支架 安全性和耐受性

    The evaluation of safety and tolerability of tirofiban in application of intracoronary stent placement

    Chen Yu,Qiao Shubin,Wu Yuan,et al.

    Diagnosis and Therapy Center of Coronary Artery Disease,Fuwai Cardiovascular Disease Hospital,Beijing100037.

    【Abstract】 Objective To evaluate the safety sand tolerability of tirofiban together with aspirin and heparin applied in patients who are undergoing intracoronary stent placement.Methods This is a multicenter randomized,controlled,double-blind trial towards30patients with coronary artery disease on a domestic study.Results There were18cases in tirofiban group and12cases in controlled group.There were7cases with unstable angina and9cases with stable angina and2cases with AMI in tirofiban group;6cases with unstable angina and2cases with stable angina and3cases with AMI in controlled group.Six cases have OMI history in tirofiban group and3cases in controlled group.21stents were placed in coronary artery in tirofiban group and12stents were placed in controlled group.All pa-tients in two groups have no change about RBC and platelet acount before and after using study drug.There is no sta-tistical significance between two groups.One patient got skin allergy in tirofiban group.Patients in two groups didn't experience bleeding adverse events.There were no end points such as MI ......

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