目的 对比普通肝素与比伐卢定应用于急性心肌梗死患者经皮冠状动脉介入治疗(PCI)的疗效及安全性.方法 连续入选2016年6月~2017年3月于河南科技大学第一附属医院治疗的急性心肌梗死患者153例,男性81例,女性72例,年龄65~87岁.按照随机数字表分为普通肝素组(76例)和比伐卢定组(77例).比伐卢定组患者术前及术中应用比伐卢定;普通肝素组术前注射肝素.用药前检测血小板计数、激活全血凝固时间(ACT),用药后1 h、4 h、24 h复测.观察两组治疗后1年内心血管不良事件以及出血发生率.结果 比伐卢定组用药后1 h的ACT值为(151.3±32.9)s,显著低于普通肝素组的(280.7±35.9)s;用药后4 h,比伐卢定组的ACT值仍低于普通肝素组[(143.5±28.9)s vs. (214.9± 39.9)s],差异有统计学意义(P均<0.05).比伐卢定组与普通肝素组各时间点的血小板计数比较,差异无统计学意义(P均>0.05).比伐卢定组共有10例(13.0%)出现心血管不良事件,普通肝素组有13例(17.1%),两组比较差异无统计学意义(P>0.05).两组患者均未发生重度出血.比伐卢定组无显著意义出血发生率为9.1%,显著低于普通肝素组的32.9%,差异有统计学意义(P<0.001).比伐卢定组总出血率为10.4%,低于普通肝素组的36.8%,差异有统计学意义(P<0.001).结论 在行PCI的急性心肌梗死患者中,与应用普通肝素相比,使用比伐卢定可获得良好的抗凝效果,且出血发生率低,不增加心血管不良事件的发生.
Objective To compare the curative effect and safety between unfractionated heparin (UFH) and bivalirudin in patients with acute myocardial infarction (AMI) during percutaneous coronary intervention (PCI). Methods AMI patients (n=153, male 81, female 72 and aged from 65 to 87) were chosen from the First Affiliated Hospital of Henan University of Science and Technology from June 2016 to Mar. 2017. All patients were divided into UFH group (n=76) and bivalirudin group (n=77) according to random digital table. The bivalirudin group was given bivalirudin before and during PCI, and UFH group was given UFH injection before PCI. Platelet count and activated clotting time (ACT) were detected before medication and re-detected after medication for 1 h, 4 h and 24 h. The incidence of major adverse cardiovascular events (MACE) and bleeding events were observed in 2 groups after treatment for 1 y. Results ACT was (151.3±32.9) s in bivalirudin group, which was significantly lower than that in UFH group [(280.7±35.9) s] after medication for 1 h, and ACT was still lower in bivalirudin group than that in UFH group [(143.5±28.9) s vs. (214.9±39.9) s] after medication for 4 h (all P<0.05). The comparison in platelet count showed the difference had no statistical significance between 2 groups at all time points (all P>0.05). There were 10 cases (13.0%) of MACE in bivalirudin group and 13 (17.1%) in UFH group (P>0.05). There were no severe bleeding events observed in 2 groups. The incidence of non-significant bleeding was 9.1% in bivalirudin group and 32.9% in UFH group (P<0.001). The total bleeding rate was 10.4% in bivalirudin group and 36.8% in UFH group (P<0.001). Conclusion Bivalirudin can obtain well anti-coagulation effect, reduce bleeding rate and not increase MACE incidence compared with UFH in AMI patients during PCI.