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目的:在应用肝素和阿司匹林的基础上,研究替罗非班治疗急性冠状动脉综合征的疗效和安全性。方法:本试验是一项多中心、随机、双盲、安慰剂对照临床研究。入选急性冠状动脉综合症患者200例。在均使用阿司匹林和肝素的基础上,试验组101例给予替罗非班(负荷量0.4μg.kg-1.min-1×30min,然后0.1μg.kg-1.min-1,静脉滴注),对照组99例给予安慰剂,疗程2~5d。结果:试验组30d内复合终点事件(顽固性心绞痛/新的心肌梗死/死亡)的发生率较对照组显著降低(P<0.01);试验组ST段下移程度和缺血导联数明显减少,血小板聚集率明显降低,两组比较均有显著差异(P<0.01)。5d内和30d内试验组死亡、新的心肌梗死和顽固性缺血等终点事件的发生率亦有降低趋势,但两组比较无显著差异(P>0.05)。替罗非班组主要不良反应为出血(发生率13%),与对照组(发生率7%)比较无统计差异(P>0.05)。结论:在阿司匹林和肝素治疗基础上,替罗非班可明显降低急性冠状动脉综合征患者心肌缺血相关事件的发生率,改善心电图心肌缺血表现,且安全性较好。
OBJECTIVE: To study the efficacy and safety of tirofiban in the treatment of acute coronary syndrome (ACS) on the basis of heparin and aspirin. METHODS: This trial is a multicenter, randomized, double-blind, placebo-controlled clinical study. Selected patients with acute coronary syndrome in 200 cases. On the basis of both aspirin and heparin, 101 patients in the test group were given tirofiban (loading 0.4μg.kg-1.min-1 × 30min, then 0.1μg.kg-1.min-1, intravenous infusion ), The control group of 99 patients given placebo, treatment of 2 ~ 5d. Results: The incidence of composite end point (refractory angina / new myocardial infarction / death) within 30 days in experimental group was significantly lower than that in control group (P <0.01). The degree of ST segment depression and the number of ischemic leads in experimental group were significantly decreased , Platelet aggregation rate was significantly lower, the two groups were significantly different (P <0.01). The incidence of endpoints such as new myocardial infarction and intractable ischemia also decreased in the 5-day and 30-day experimental groups, but there was no significant difference between the two groups (P> 0.05). Tirofiban major adverse reactions were bleeding (incidence 13%), compared with the control group (incidence 7%) no significant difference (P> 0.05). CONCLUSIONS: Based on aspirin and heparin therapy, tirofiban significantly reduces the incidence of myocardial ischemic-related events in patients with acute coronary syndrome and improves myocardial electrocardiographic myocardial ischemia with better safety.