冠状动脉内支架病人使用替罗非班的安全性和耐受性评价

The Safety and Tolerability of Tirofiban in Patients Undergoing Intracoronary Stent Placement

目的:评价新的血小板GP Ⅱb/Ⅲa拮机剂替罗非班(Tirofiban)对接受冠状动脉内支架治疗的病人在使用肝素和阿司匹林基础上的安全性和耐受性。方法:此研究为一随机、双盲试验。15例行冠状动脉支架的病人随机分成两组,分别给予替罗非班和安慰剂。首先以10μg/kg的剂量在3分钟内注入,然后以0.1μg·kg^(-1)·min^(-1)的速度维持给予36小时,在此期间进行安全性监测,并在30天进行随访,观察临床事件的发生。结果:9例替罗非班组和6例安慰剂组的病人在给药后的30天内无死亡、心肌梗死或大出血的临床事件发生,也无因反复缺血而进行急诊冠状动脉旁路移植术或急诊重复PTCA。替罗非班组患者有1例出现CK-MB一过性增高,安慰剂组有2例一过性增高。与药物相关的不良反应(皮肤过敏反应)1人。结论:本试验的有限资料显示:血小板GP Ⅱb/Ⅲa拮抗剂替罗非班对接受冠状动脉内支架治疗的病人应用安全,有效,病人耐受性好。

Objective: To assess the safety and tolerability of a new platelet GP lib/Ilia antagonist Tirofiban on a background of heparin and aspirin in patients undergoing percutaneous intervention with intracoronary stent placement. Methods: this was a randomized and double blind trial, 15 patients undergoing percutaneous intervention with intracoronary sir.nl placement were randomized into two groups and given Tirofiban or placebo, respectively. Tirofiban or placebo IV bolus of 10 fig/kg over 3 minutes followed by a Tirofihan or placebo IV maintenance infusion of 0. 1μg ·kg-1· min-1 for 36 hours and assessed the safety and clinical evemts during this time and 30 days. Results: there were no death, inyocardial infarction or major bleeding in Tirofiban(9 patients) or placebot6 patients) group, and no urgent coronary artery bypass grafting or urgent percutaneous intervention for recurrent ischemia. One patient occurred CK - MB elevated in Tirofiban group and two in placebo group. The adverse drug effect was one patient with skin allergy. Conclusion: defined data showed that Tirofiban was a effective antagonist of platelet GP Ⅱb/Ⅲa, safety and tolerability in patients undergoing percutaneous intervention with intracoronary stent placement.