比伐卢定在体外膜肺氧合中的抗凝效果

Anticoagulation effect of bivalirudin during extracorporeal membrane oxygenation

目的评估体外膜肺氧合(extracorporeal membrane oxygenation,ECMO)期间应用比伐卢定抗凝治疗的临床效果。方法连续入选2020年6月至2021年10月期间在兰州大学第一医院心脏中心接受ECMO治疗的心血管危重患者64例为研究对象,根据ECMO辅助期间抗凝方案分为比伐卢定组(n=29)和肝素组(n=35),比较不同抗凝策略对患者的疗效和安全性。主要抗凝疗效指标为活化部分凝血活酶时间(APTT)稳定性、APTT达标率及栓塞事件。主要安全性指标为血液制品输注、严重出血事件、院内死亡及随访180天死亡事件。结果比伐卢定组血红蛋白(Hb)和红细胞计数(RBC)高于肝素组Hb(g/L):156.85±21.39 vs.133.84±22.61,P=0.005;RBC(×10^(12)/L):4.88±0.54 vs.4.16±0.65,P=0.002,其余基线资料差异均无统计学意义(P>0.05)。比伐卢定组APTT变异系数低于肝素组(21.48±11.77 vs.34.97±17.94,P=0.002),APTT达标率高于肝素组(72.97±25.74 vs.46.85±31.37,P=0.001)。两组血栓事件、严重出血事件、血液制品输注、撤机存活率、院内死亡及随访180天死亡事件差异均无统计学意义(P>0.05)。两组患者ECMO上机后第1个24 h、第2个24 h纤维蛋白原、D-二聚体、凝血酶原时间和血小板计数差异均无统计学意义(P>0.05)。结论在ECMO辅助过程中比伐卢定抗凝效果较肝素更加稳定,且未增加血栓和严重出血事件,表明比伐卢定相比肝素是有效且安全的。

Objective To evaluate the clinical effect of bivalirudin for anticoagulation therapy during extracorporeal membrane oxygenation(ECMO).Methods Cardiovascular critically ill patients(64 cases)who received ECMO treatment at the Heart Center of the First Hospital of Lanzhou University from June 2020 to October 2021 were consecutively selected as the research subjects and divided into bivalirudin group(n=29)and heparin group(n=35).The efficacy and safety of different anticoagulation strategies were compared in the patients.The main anticoagulation efficacy indicators were activated partial thromboplastin time(APTT)stability,percentage within target range,and embolic events.The primary safety indexes were blood product transfusion,major bleeding events,in-hospital death,and the mortality after 180 days follow-up.Results The hemoglobin(Hb)and red blood cell(RBC)counts in the bivalirudin group were higher than those in the heparin group[Hb(g/L)156.85±21.39 vs.133.84±22.61,P=0.005;RBC(×10^(12)/L):4.88±0.54 vs.4.16±0.65,P=0.002,respectively].There were no significant difference in other baseline data between the two groups(P>0.05).The bivalirudin group had a significantly lower APTT variation coefficient than the heparin group(21.48±11.77 vs.34.97±17.94,P=0.002),and the percentage within the target range in the bivalirudin group was higher than that in heparin group(72.97±25.74 vs.46.85±31.37,P=0.001).There were no significant differences in thrombotic events,serious bleeding events,blood product transfusion,cancellation survival rate,in-hospital deaths and 180-day follow-up deaths between the two groups(P>0.05).There were no significant differences in fibrinogen,D-dimer,prothrombin time and platelet count between the two groups in the first 24 hours and the second 24 hours after ECMO(P>0.05).Conclusion The anticoagulation effect of bivalirudin was more stable during the adjuvant ECMO process,and there was no increase in thrombosis and serious bleeding events,indicating that bivalirudin is effective and safe compared with heparin.