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目的初步评价高负荷剂量替罗非班在急性ST段抬高型心肌梗死(ST-segment elevation myocardial infarction,STEMI)患者直接经皮冠状动脉介入(primary percutaneous coronary intervention,PPCI)治疗中的有效性及安全性。方法根据PPCI治疗中替罗非班用量的不同,将入选的104名STEMI患者随机均分为标准剂量组[替罗非班先予10μg/kg于3 min内静脉弹丸注射,继之以0.15μg/(kg·min)维持,SD组,n=52]和高剂量组[替罗非班以20μg/kg静脉弹丸注射,维持剂量为0.225μg/(kg·min),HD组,n=52]。观察介入治疗后90 min心电图ST段抬高总和回落百分比(sum-ST segment resolution,sum STR),以及住院期间和出院90 d后左室射血分数(left ventricular ejection fraction,LVEF)。90 d内出现任何出血事件及主要不良心脏事件(major adverse cardiac events,MACE)(心脏性死亡、靶血管的再次血运重建、再梗)。结果 HD组在PPCI治疗后90 min sum STR完全回落高于SD组(P=0.013);HD组术后90 d的LVEF高于SD组(P=0.008);HD组术后90 d内MACE发生率和全因死亡率明显低于SD组(P=0.022,P=0.017);对于MACE事件的Cox多因素回归分析显示,高剂量替罗非班可以减少MACE的发生(HR=0.115,95%CI:0.019~0.682,P=0.017);HD组和SD组出院后90 d内,累积MACE发生Kaplan-Meier曲线比较,HD组明显低于SD组(P=0.028);两组累积出血发生率Kaplan-Meier曲线比较无统计学意义(P=0.343)。结论对于进行PPCI治疗的STEMI患者,应用高剂量替罗非班可能有助于改善短期预后,并不增加严重出血风险。
Objective To evaluate the efficacy of high-dose tirofiban in primary percutaneous coronary intervention (PPCI) in patients with acute ST-segment elevation myocardial infarction (STEMI) safety. Methods According to the amount of tirofiban used in PPCI treatment, 104 selected STEMI patients were randomly divided into standard dose group [Tirofiban 10 μg / kg given intravenously within 3 min, followed by 0.15 μg (kg · min), SD group (n = 52) and high-dose group [Tirofiban was injected at a dose of 0.225μg / (kg · min) ]. The sum-ST segment resolution (sum STR) and the left ventricular ejection fraction (LVEF) during hospitalization and 90 days after discharge were observed at 90 min after interventional therapy. Any bleeding events and major adverse cardiac events (MACE) occurred within 90 days (cardiac death, revascularization of the target vessel, reinfarction). Results Compared with SD group, the sum STR decreased completely at 90 min after PPCI treatment in HD group (P = 0.013). The LVEF in HD group 90 d after operation was significantly higher than that of SD group (P = 0.008) Rates and all-cause mortality were significantly lower in SD group than in SD group (P = 0.022, P = 0.017). Cox regression analysis of MACE events showed that high dose of tirofiban reduced MACE (HR = 0.115, 95% CI: 0.019-0.682, P = 0.017). The Kaplan-Meier curves of cumulative MACE in HD group and SD group were significantly lower than those in SD group (P = 0.028) within 90 days after discharge from hospital. The cumulative incidence of hemorrhage Kaplan-Meier curve was not statistically significant (P = 0.343). Conclusions For patients with STEMI treated with PPCI, the use of high-dose tirofiban may improve short-term prognosis without increasing the risk of severe bleeding.