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目的观察国产替罗非班对急诊经皮冠状动脉介入治疗(PCI)患者血小板聚集率和临床结果的影响,进而评价其在急诊PCI中的疗效和安全性。方法2005年9月至2006年3月30例在中南大学湘雅二医院行急诊PCI的患者(均为ST段抬高心肌梗死患者)入选替罗非班组,同期相匹配的30例行择期PCI的患者入选对照组。替罗非班组在PCI术前第10~30分静脉注射替罗非班10μg/kg(3min注完),然后以0.15μg/(kg.min)静脉滴注维持36h,对照组以相同的方法输注安慰剂。所有患者均接受静脉注射普通肝素及口服二磷酸腺酐(ADP)受体拮抗剂和阿司匹林。观察两组血小板聚集率、7d和30d复合终点事件发生率(死亡、顽固性心肌缺血、再发心肌梗死和靶血管重建术)和出血事件。结果与对照组相比,替罗非班组血小板聚集率明显下降[(19±8)%比(54±7)%,P<0.001];7d和30d复合终点事件发生率未见差别(16.7%比6.7%,P=0.42;30.0%比13.3%,P=0.21);替罗非班组出血事件有增多趋势(26.7%比3.3%,P=0.026),主要是穿刺点出血,二组均无颅内出血等严重出血事件发生。结论替罗非班对急诊PCI患者是安全有效的。
Objective To observe the effect of domestic tirofiban on platelet aggregation rate and clinical outcome in patients undergoing emergency percutaneous coronary intervention (PCI), and to evaluate its efficacy and safety in emergency PCI. Methods From September 2005 to March 2006, 30 patients with acute PCI in Xiangya Second Hospital of Central South University (all patients with ST-segment elevation myocardial infarction) were enrolled in the Tirofiban group. The matched 30 patients underwent elective PCI Of patients were enrolled in the control group. The tirofiban group was injected with tirofiban 10 μg / kg intravenously 10 min to 30 min before PCI (3 min injection) and then maintained for 36 h at 0.15 μg / (kg · min) by intravenous drip. The control group was treated with the same method Infusion placebo. All patients received intravenous unfractionated heparin and oral diphosphate (ADP) receptor antagonists and aspirin. The platelet aggregation rate, the composite end point events (death, refractory myocardial ischemia, recurrent myocardial infarction and target revascularization) and bleeding events on the 7th and 30th days were observed. Results Compared with the control group, the platelet aggregation rate was significantly decreased in the tirofiban group ([19 ± 8]% vs (54 ± 7)%, P <0.001]. There was no difference in the composite end point events between the 7th and 30th days (16.7% P = 0.42; 30.0% vs 13.3%, P = 0.21). There was an increasing trend of bleeding in the tirofiban group (26.7% vs. 3.3%, P = 0.026), mainly bleeding at the puncture point, Intracranial hemorrhage and other serious bleeding occurred. Conclusion Tirofiban is safe and effective for emergency PCI.