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目的前瞻性评价急性 ST 段抬高性心肌梗死(STEMI)患者急诊经皮冠状动脉介入治疗(PCI)联合应用国产替罗非班治疗的临床疗效及安全性。方法入选连续160例接受急诊 PCI 治疗的急性 STEMI 患者,随机分为替罗非班组(80例)和对照组(80例)。比较两组基础临床情况、介入治疗结果、术后即刻疗效、术后30天和180天主要心脏不良事件(MACE,包括死亡、再梗死、再次靶血管重建)发生率及左室射血分数(LVEF)。结果两组基础临床情况、介入治疗结果差异均无统计学意义。与对照组相比,替罗非班组术后即刻心肌梗死溶栓试验(TIMI)3级复流血流差异无统计学意义(95.0%比87.5%,P>0.05),但即刻心肌组织灌注(TMP)3级(75.0%比56.3%,P<0.05)、校正 TIMI 帧数[(23.56±5.19)帧比(31.05±6.92)帧,P<0.01)]、ST 段抬高总和回落[(6.51±3.56)mm 比(4.53±2.47)mm,P<0.01]、肌酸激酶同工酶(CK-MB)峰值[(225.02±105.81)μg/L比(269.20±110.88)μg/L,P<0.05)、肌钙蛋白 I(TnI)峰值[(45.25±33.00)μg/L 比(56.46±29.48)μg/L,P<0.05]及平均住院天数[(11.38±4.63)天比(14.68±6.90)天,P<0.01]均显著优于对照组。替罗非班组术后 MACE 发生率30天(5.0%比16.3%,P<0.05)和180天(7.5%比18.8%,P<0.05)明显降低,LVEF(术后30天:53%±7%比49%±9%,P<0.01;术后180天:59%±8%比53%±9%,P<0.01)显著提高。多因素 logistic 回归分析表明,年龄>65岁[比值比(OR)=3.42,P<0.01]、替罗非班治疗(OR=0.56,P<0.05)、住院期 LVEF<0.5(OR=2.56,P<0.01)是术后180天 MACE 发生率的主要决定因素。替罗非班组术后出血并发症发生率高于对照组(16.3%和7.5%),但差异无统计学意义(P>0.05)。结论急诊冠状动脉支架术联合应用国产替罗非班治疗STEMI 能显著提高相关梗死区域再灌注水平,明显改善术后即刻、术后30天及180天临床预后和左心室收缩功能。
Objective To prospectively evaluate the clinical efficacy and safety of domestic Tirofiban in the treatment of acute ST-segment elevation myocardial infarction (STEMI) combined with emergency percutaneous coronary intervention (PCI). Methods A total of 160 acute STEMI patients undergoing emergency PCI were included in the study. Tirofiban (n = 80) and control group (n = 80) were randomly divided into two groups. The incidences of major adverse cardiac events (MACE, including death, reinfarction, and target revascularization) and the incidence of left ventricular ejection fraction (LVEF) at 30 and 180 days after surgery were compared between the two groups based on clinical outcomes, interventional outcomes, LVEF). Results The two groups of basic clinical situation, interventional treatment differences were not statistically significant. Compared with the control group, there was no significant difference in TIMI grade 3 resuscitation blood flow between the immediate and immediate groups (95.0% vs 87.5%, P> 0.05), but immediate myocardial perfusion (P <0.01). The sum of TIMI frame number [(23.56 ± 5.19) frame ratio (31.05 ± 6.92) frames, P <0.01) (225.02 ± 105.81) μg / L (269.20 ± 110.88) μg / L, P <0.01), P < 0.05), the peak value of TnI was (45.25 ± 33.00) μg / L (56.46 ± 29.48) μg / L, P <0.05] and the average length of hospital stay was (11.38 ± 4.63) days ) Days, P <0.01] were significantly better than the control group. The incidence of postoperative MACE in tirofiban group was significantly lower after 30 days (5.0% vs 16.3%, P <0.05) and 180 days (7.5% vs 18.8%, P <0.05) % Vs 49% ± 9%, P <0.01; 180 days after operation: 59% ± 8% vs 53% ± 9%, P <0.01). Multivariate logistic regression analysis showed that LVEF <0.5 (OR = 2.56, P <0.01) was significantly higher in patients with age> 65 years (odds ratio = 3.42, P <0.01) was the major determinant of MACE incidence at 180 days postoperatively. The incidence of postoperative bleeding complications in tirofiban group was higher than that in control group (16.3% and 7.5%), but the difference was not statistically significant (P> 0.05). Conclusions The combination of emergency coronary stent and domestic tirofiban in treatment of STEMI can significantly improve the reperfusion level in the relevant infarction area and significantly improve the clinical prognosis and left ventricular systolic function immediately after operation, 30 days and 180 days after operation.