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目的观察比伐卢定和肝素用于高危急性冠脉综合征(ACS)患者经皮冠状动脉介入(PCI)治疗中的疗效。方法选择2014年1月至2016年6月收治的ACS行PCI治疗的患者85例,随机分为两组,其中比伐卢定组41例,肝素组44例。比伐卢定组患者首剂静脉注射0.75 mg/kg的比伐卢定,之后以1.75 mg·kg-1·h-1维持静脉滴注至手术结束后;肝素组患者首剂静脉注射100 IU/kg的肝素,之后继续推注,以维持活化全血凝固时间(ACT)在225~300 s范围内。观察记录两组主要不良心脑血管事件(MACCE)的发生率以及两种药物的抗凝效果。结果在MACCE(包括全因死亡、心源性死亡、再次心肌梗死、靶血管血运重建及脑卒中)、支架内血栓及出血学术研究会出血分级标准(BARC)3-5级出血事件发生率比较,两组无统计学差异(P均>0.05);在总出血及BARC2-5型出血事件中,比伐卢定组的发生率有较肝素组降低趋势,但差异无统计学意义(P均>0.05);在PCI术前及术中,两组的ACT相当(P均>0.05),但在停药后30 min、1 h、2 h,比伐卢定的ACT明显低于肝素(P均<0.05)。结论在实施PCI的高危ACS患者中,与使用肝素比较,比伐卢定可有效抗凝,不增加30 d的MACCE发生率,能否有效降低出血事件发生率有待扩大样本量进一步研究。
Objective To observe the efficacy of bivalirudin and heparin in percutaneous coronary intervention (PCI) in patients with high-risk acute coronary syndrome (ACS). Methods A total of 85 ACS patients undergoing PCI from January 2014 to June 2016 were randomly divided into two groups: 41 in the bivalirudin group and 44 in the heparin group. Patients in the bivalirudin group received the first intravenous infusion of 0.75 mg / kg bivalirudin, followed by intravenous infusion at 1.75 mg · kg-1 · h-1 until the end of the operation. The first dose of heparin received 100 IU / kg of heparin, followed by bolus injection to maintain an activated whole blood clotting time (ACT) in the 225-300 s range. The incidence of major adverse cardiovascular and cerebrovascular events (MACCE) and the anticoagulation effects of the two drugs were observed and recorded. Results In the MACCE (including all-cause death, cardiogenic death, reoccurrence of myocardial infarction, target revascularization and stroke), stent thrombosis and hemorrhage, the bleeding grade 3-5 (BARC) grade 3-5 bleeding event rate (P> 0.05). In the total bleeding and BARC2-5 hemorrhage, the incidence of bivalirudin decreased compared with heparin group, but the difference was not statistically significant (P> 0.05) (All P> 0.05). Before and during PCI, ACT was comparable in both groups (P> 0.05), but the ACT of bivalirudin at 30 min, 1 h and 2 h after drug withdrawal was significantly lower than that of heparin P <0.05). Conclusions Bivalirudin is effective in anticoagulation compared with heparin in patients with high-risk ACS for PCI, and does not increase the incidence of MACCE by 30 days. Whether this can effectively reduce the incidence of hemorrhage remains to be further studied.