国产比伐卢定用于急性ST段抬高型心肌梗死患者急诊介入治疗术中的临床研究

Clinical Effect of Domestic Bivalirudin During Emergent Percutaneous Coronary Intervention in Patients With Acute ST-segment Elevation Myocardial Infarction

目的:探讨国产注射用比伐卢定对急性ST段抬高型心肌梗死(STEMI)患者急诊介入治疗(PCI)术中凝血功能的影响及安全性评价。方法:随机选择75例STEMI行急诊PCI的患者,术中用普通肝素(肝素组,n=35)或国产注射用比伐卢定(比伐卢定组,n=40)抗凝。分别于PCI术前、用药后5 min、术后即刻、停药后30 min、1h、2 h检测激活全血凝固时间(ACT)。用药前、用药结束后6、24、72 h静脉采血,检测凝血功能四项指标即活化部分凝血酶时间(APTT)、凝血酶原时间(PT)、凝血酶时间(TT)和纤维蛋白原(FIB)。结果:比伐卢定组用药后5 min测定的ACT均能达到PCI手术所要求的ACT>225 s,而肝素组有1例患者未能达到要求需要追加剂量。PCI术中两组均能维持ACT>225 s。停药后,比伐卢定组较肝素组ACT降低,停药30min、1 h、2 h的ACT值比伐卢定组均低于肝素组,差异均有统计学意义(P<0.05)。比伐卢定组与肝素组比较,术后凝血功能四项指标、PCI术后30 d无心脏事件生存率差异均无统计学意义(P均>0.05),PCI术后24 h内轻度出血的发生率降低(0 vs 11.43%),差异有统计学意义(P<0.05)。结论:与常规肝素抗凝相比,国产注射用比伐卢定作为抗凝剂应用于STEMI患者急诊介入治疗中,起效更快,效果更强,而且半衰期更短,提示国产比伐卢定可以安全有效地应用于急诊PCI术中的抗凝治疗。

Objective： To evaluate the safety and anticoagulant efficacy of domestic bivalirudin injection during emergent percutaneous coronary intervention （PCI） in patients with ST-segment elevation myocardial infarction （STEMI）.Methods： A total of 75 STEMI patients were randomly divided into 2 groups according to anticoagulant used in emergent PCI procedure. Bivalirudin group, the patients received intravenous domestic bivalirudin, n=40 and Heparin group, n=35. The activated clotting time （ACT） was tested at pre-PCI, 5 minutes after medication, immediately after PCI, 30 minutes, 1 hour and 2 hours after medication respectively. The activated partial thromboplastin time （APTT）, prothrombin time （PT）, thrombin time （TT） and ifbrinogen （FIB） level were measured at before medication and 6, 24, 72 hours after medication. Results： All patients in Bivalirudin group had ACT〉225s at 5min after medication as PCI requirement, while 1 patient in Heparin group could not reach the requirement and the extra dose was added. Both groups maintained ACT〉225s during PCI procedure. Bivalirudin group had the lower ACT levels than those in Heparin group at 30 min, 1-and 2-hour after the medication, P〈0.05. The post-PCI levels of APTT, PT, TT and FIB were similar between 2 groups, all P〉0.05. The no-cardiac event surviving rate at 30 days after PCI in Bivalirudin group and in Heparin group were similar P＆gt;0.05 and the mild bleeding at 24 hours after PCI in Bivalirudin group was lower （0 vs 11.43）%, P〈0.05. 〈br〉 Conclusion： Compared with heparin, domestic bivalirudin may take faster effect, with shorter half-life period for anticoagulation during emergent PCI procedure in STEMI patients.