比伐卢定在老年急性冠脉综合征并慢性肾脏疾病3期患者经皮冠脉介入治疗中的疗效及安全性

Efficacy and safety of bivalirudin on aged patients with acute coronary syndrome and 3rd stage of chronic kidney disease in percutaneous coronary intervention

摘要:

目的：探讨比伐卢定在老年（＞60岁）急性冠脉综合征（acute coronary syndrome，ACS）并慢性肾脏疾病（chronic kidney disease，CKD）3期患者经皮冠状动脉介入术（percutaneous coronary intervention，PCI）中抗凝的疗效及安全性。方法：2015年3月至2017年5月在焦作市人民医院心内科1病区选择72例老年ACS并CKD 3期行PCI患者，按照数字表法随机分为比伐卢定组（n=37）和肝素组（n=35）。在PCI中，比伐卢定组给予比伐卢定抗凝治疗，肝素组给予普通肝素钠（unfractionated heparin，UFH）抗凝治疗。监测2组患者用药过程中活化凝血时间（activated clotting time，ACT）值的变化，用药前后肾功能指标：肾小球滤过率、血清肌酐（serum creatinine，Scr）、血尿素氮（blood urea nitrogen，BUN），30 d内主要心脑血管不良事件（major adverse cardio and cerebral vessels events，MACCE），术后7 d内的出血事件。结果：用药后，2组患者的ACT值迅速升高，用药后5、30 min及停药即刻2组患者的ACT值比较（F=0.543、1.364、1.866，P=0.464、0.247、0.176），差异无统计学意义，用药后5、30 min及停药即刻ACT达标率比较差异无统计学意义（P=0.233、0.219、0.233）。停药后1、3、6 h，比伐卢定组ACT值均小于肝素组（F=110.084、79.462、7.572，均P=0.000）。比伐卢定组的术后拔管时间短于肝素组（t=-8.787，P=0.000）。同组患者的eGFR、Scr及BUN用药前与用药后24 ｈ比较差异无统计学意义（均P＞0.05），用药前与用药后24 ｈ 2组之间比较差异无统计学意义（均P＞0.05）。术后30 d内，2组患者MACCE发生率比较（ ?字2=0.006，P=0.983），差异无统计学意义；术后7 d内，比伐卢定组的出血事件发生率低于肝素组（5.4 % vs. 22.9 %， ?字2=4.964，P=0.026）。肝素组出现肝素诱导的血小板减少症1例。结论：在老年ACS并CKD 3期行PCI的患者中，比伐卢定与UFH抗凝疗效相当，但比伐卢定抗凝效果更稳定，半衰期更短，出血率更低，安全性更好，且不会加重肾功能不全患者的肾功能损害。

Abstract:

Objective：To study the anticoagulant efficacy and safety of bivalirudin in treatment of aged（＞60 years） patients with acute coronary syndrome（ACS） and 3rd stage of chronic kidney disease（CKD3） undergoing percutaneous coronary intervention（PCI）. Methods：Totally 72 aged patients（＞70 years） with ACS and CKD3 who received PCI from March 2015 to May 2017 in the People’s Hospital of Jiaozuo City were randomly divided into bivalirudin group（37 cases） and unfractionated heparin（UFH） group（35 cases）. Bivalirudin group were treated with bivalirudin，while UFH group were treated with UFH in PCI. The changes of ACT value in the using medication process，renal function index（glomerular filtration rate，Scr，BUN） before and after using medication，major adverse cardio and cerebral vessels events（MACCE） within 30 days after operation，bleeding events within 7 d after surgery were monitored in two groups. Results：After treatment，the ACT values of two groups increased rapidly；the difference was not statistically significant in the ACT values on 5 min and 30 min after using drugs and immediate withdrawal（F=0.543，1.364，1.866；P=0.464，0.247，0.176）；the difference was not statistically significant in the standard-reaching rate of ACT values on 5 min and 30 min after using drugs and immediate withdrawal（P=0.233，0.219，0.233）；at 1，3，6 h after stopping the drug，the ACT value in the bivalirudin group was less than that in UFH group（F=110.084，79.462，7.572，all P=0.000）. The extubation time in the bivalirudin group was shorter than that in UFH group（t=-8.787，P=0.000）. The difference was not statistically significant between before and 24 h after administration in eGFR，Scr and BUN within the same group（all P>0.05），there was no statistical difference between two groups before and 24 h after administration（all P>0.05）. There was no significant difference in the incidence of MACCE between the two groups within 30 d after operation（ ?字2=0.006，P=0.983）. The incidence of bleeding events in the bivalirudin group was lower than that in UFH group within 30 d after operation（5.4% vs. 22.9%， ?字2=4.964，P=0.026）. Heparin group showed heparin induced throm－bocytopenia（HIT） one patient. Conclusion：In treatment of aged patients with ACS and CKD3 undergoing PCI，bivalirudin and UFH show similar anticoagulant efficacy. But the effect of anticoagulant efficacy of bivalirudin is more stable，the half-life is shorter，the rate of bleeding is lower，the safety is better，it does not aggravate the impairment of renal function in patients with renal insufficiency.