高剂量盐酸替罗非班在急性ST段抬高型心肌梗死患者直接经皮冠状动脉介入治疗中的应用

Application of High-loading-dose Tirofiban in Patients with Acute ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

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 investigate the effecticacy and safety of a high-loading-dose of tirofiban in acute ST-segment elevation myocardial infarction（STEMI）patients undergoing primary percutaneous coronary intervention（PPCI）.Methods A total of 104 patients with STEMI were randomly divided into the standard-dose group（10μg/kg tirofiban was intravenous projectile injected within 3 min and followed by 0.15μg/（kg·min）for maintenance,SD group,n=52）and the high-dose group（20μg/kg tirofiban was intravenous projectile injected and followed by 0.225μg/（kg·min）for maintenance,HD group,n=52）.The sum of ST-segment elevation resolution（sum STR）at 90 minutes after PPCI,the left ventricular ejection fraction（LVEF）in the hospital and at 90 days follow-up were observed.Any bleeding events,cardiac death,target vessel revascularization,re-infarction within 90 days and the combination of these were as major adverse cardiac events（MACE）.Results The complete sum STR of HD group was higher than that of SD group in 90 minutes after PPCI treatment（P=0.013）.HD group showed higher LVEF in 90 days compared with SD group（P=0.008）.At 90 days,the incidence of MACE and all-cause mortality in HD group was significantly lower than SD group（P=0.022,P=0.017）.Cox multivariate regression analysis of MACE events showed a high-dose of tirofiban may reduce the incidence of MACE events（HR=0.115,95%CI：0.019-0.682,P=0.017）.Within 90 days after discharge,the incidence of MACE in SD group was significantly higher than that in HD group（P=0.028）,while the incidence of bleeding was not significantly differnet between two groups in the KM curve.Conclusion High-dose tirofiban may improve the short-term clinical outcomes without increasing risk of major bleeding to the STEMI patients undergoing PPCI.