比伐卢定对急性冠脉综合征患者介入术后出血影响的临床分析

目的评价国产注射用比伐卢定和普通肝素在急性冠状动脉综合征(ACS)患者冠状动脉介入术(PCI)后的出血风险。方法择期行PCI的ACS患者95例,随机分为肝素组(n=46)和比伐卢定组(n=49),其中肝素组脱落5例,比伐卢定组脱落3例,2组各剔除6例。2组分别采用国产注射用比伐卢定和肝素抗凝。于用药前和停药后1 h测定凝血酶原时间(PT)、凝血酶时间(TT)、纤维蛋白原(Fib),并比较试验期间各项凝血指标的变化。PCI术后随访30 d比较2组患者出血事件发生率和主要心血管不良事件(MACE)发生率。结果 2组患者基线资料相当,比伐卢定组和肝素组用药前和停药后1 h凝血指标无显著性差异(P>0.05)。PCI术后30 d内2组出血事件发生率、MACE发生率及不良反应比较差异无统计学意义(P均>0.05)。结论与常规肝素抗凝相比,比伐卢定在PCI术中抗凝效果安全稳定。

The clinical analysis of bleeding risk of domestic bivalirudin during percutaneous coronary intervention in acute coronary syndrome patients

Objective To compared the bleeding risk of bivalirudin and unfractionated heparin(UFH) in acute coronary syndrome(ACS) patients who received percutaneous coronary intervention(PCI).Methods A total of 95 ACS patients receiving PCI were enrolled in our study and randomly allocated into UFH group(n = 46) and bivalirudin group(re =49). There were 5 and 3 missed patients in group UFH and bivalirudin,respectively,and then 6 patients in each group were excluded from present study.The blood clotting related parameters,including PT,TT,and Fib were detected before administration, 5 min post administration,30 min after the first dosage,1 h and 6 h after stopping infusion.Then the comparison of the above parameters and the rate of reaching the target were analyzed between the two groups.The primary composite end point was 30 day to observe the incidence of death,myocardial infarction,urgent repeat revascularization,or in hospital major bleeding.Results The baseline data of the two groups were not significantly different(P > 0.05).At 1 h after administration, the index of PT,TT and Fib of the two groups were not significantly different(P >0.05).The primary composite end point was not significantly different between the two groups(P >0.05).In addition,adverse reaction was not significantly different between the two groups(P >0.05).Conclusion Compared with UFH,the more stable anti-coagulation effects can be obtained by using bivalirudin in PCI procedures.