国产比伐卢定在2型糖尿病并ST段抬高型心肌梗死患者冠脉介入术中抗凝疗效及安全性评价  

Evaluation of anticoagulant efficacy and safety for domestic bivalirudin during percutanous coronary intervention in patients with type 2 diabetes mellitus and ST-segment elevation myocardial infarction

作　　者：高鹏 寇广亚 武延海 

机构地区：[1]河南省新乡市第二人民医院,新乡453002

出　　处：《内科急危重症杂志》2016年第6期429-433,共5页Journal of Critical Care In Internal Medicine

基　　金：国家自然科学基金项目(No:81160046)

摘　　要：目的:评价国产比伐卢定在2型糖尿病(T2DM)合并急性ST段抬高型心肌梗死(STEMI)患者经皮冠状动脉介入术(PCI)中的抗凝疗效及安全性。方法:选择确诊T2DM并STEMI且须直接行PCI治疗患者100例,随机分为2组:比伐卢定组50例,PCI术中采用比伐卢定抗凝;肝素组50例,PCI术中采用普通肝素抗凝。比较2组用药前、后活化凝血时间(ACT)、术后6 h凝血4项、PCI疗效[术后2 h ST段回落百分比、术后7 d左心室射血分数(LVEF)]、术后30 d内出血事件及主要不良心血管事件(MACE)。结果:1用药后5、30 min及术后即刻,比伐卢定组的ACT值均高于肝素组(均P<0.05);2手术结束后,比伐卢定组ACT值下降更迅速,于术后1 h下降至用药前水平,而肝素组下降较慢,于术后6 h才下降至用药前水平;3 2组PCI疗效(术后2 h ST段回落百分比、术后7 d LVEF)及术后30 d内MACE比较,差异无统计学意义(均P>0.05);4比伐卢定组术后30 d内出血事件低于肝素组(P<0.05)。结论:与普通肝素抗凝相比,国产比伐卢定在T2DM并STEMI患者PCI术中,效果更强,疗效更稳定,出血事件发生率更低。Objective： To evaluate the effectiveness and safety for domestic bivalirudin during percutanous coronary intervention（ PCI） in patients with type 2 diabetes mellitus（ T2DM） and ST segment elevation myocardial infarction（ STEMI）. Methods： A total of 100 cases of T2 DM with STEMI undergoing PCI were chosen as the research objects,and randomly divided into two groups： the bivalirudin group（ 50 cases）,given bivalirudin anticoagulant therapy; the heparin group（ 50cases）,receiving heparin anticoagulant therapy. The activated clotting time（ ACT） before and after treatment,coagulation 4items at 6th h after operation,PCI effect [percent of ST-segment resolution at 2nd h after operation,left ventricular ejection fraction（ LVEF） at 7th day after operation],bleeding event and major adverse cardiac events（ MACE） within 30 days were compared between two groups. Results： 1At 5 and 30 min after treatment and immediately after surgery,ACT in the bivalirudin group was longer than that in the heparin group（ all P〈0. 05）; 2At the end of surgery,ACT in the bivalirudin group reduced more rapidly,decreased to the pre-medication level at 1st h after operation,while in the heparin group ACT reduced slowly,dropped to the level of pre-medication at 6th h after operation; 3There was no statistically significant difference in PCI effect（ percent of ST-segment resolution at 2nd h after operation,LVEF at 7th day after operation） and MACE within 30 days between two groups（ all P〈0. 05）; 4The incidence of bleeding event within 30 days in the bivalirudin group was lower than that in the heparin group（ P〈0. 05）. Conclusions： As compared with unfractionated heparin,domestic bivalirudin is stronger and more stable in the effectiveness in PCI of T2 DM patients with STEMI,and the incidence of bleeding events is lower.

关 键 词：比伐卢定 国产 普通肝素 2型糖尿病 ST段抬高型急性心肌梗死 经皮冠状动脉介入术 凝血功能 

分 类 号：R973.2[医药卫生—药品]