瑞肝素钠在导管室中应用的安全性和有效性研究  

Comparison of the efficacy and safety between intra-sheath reviparin and unfractionated heparin in cardiac catheter laboratory

作　　者：孙志军[1] 贾三庆[1] 王雷[1] 李虹伟[1] 严松彪[1] 赵敏[1] 陈晖[1] 张宇晨[1] 王宇朋[1] 张潇伊[2] 

机构地区：[1]首都医科大学附属北京友谊医院心血管疾病诊治研究中心,北京100050 [2]复旦大学附属中山医院老年科,上海200032

出　　处：《中国新药杂志》2007年第21期1801-1804,共4页Chinese Journal of New Drugs

摘　　要：目的:本研究对瑞肝素钠在导管室中运用的安全性和有效性进行评价。方法:入选术前12h未用低分子肝素或普通肝素的行冠状动脉造影(CAG)和/或冠状动脉介入治疗(PCI)患者270例,67例使用普通肝素为对照组,203例随机分为瑞肝素钠50IU·kg^(-1)及70 IU·kg^(-1)组,在CAG/PCI过程中经鞘管单次注射不同剂量瑞肝素钠或普通肝素,所有瑞肝素钠组患者监测术前、术中10 min、造影结束即刻、术后2h的血抗Xa因子活性及APTT,术后即刻拔除动脉鞘管。观察终点为围手术期抗Xa因子活性和30d时的死亡、心梗、急诊血运重建和出血事件。结果:瑞肝素钠50IU·kg^(-1)和70IU·kg^(-1)组术中10min抗Xa因子活性均达到最高峰,而后逐渐下降。70IU·kg^(-1)组抗Xa因子峰值[(1.26±0.29)IU·mL^(-1))]显著高于50IU·kg^(-1)组[(1.04±0.30)IU·mL^(-1))](P<0.001)。两组分别有95.1%(96例)和99%(101例)的患者术中抗Xa因子峰值>0.5 IU·mL^(-1)。至30d随访结束,50IU·kg^(-1)组有2例(1.9%)术后出现轻微出血事件(股动脉穿刺部位血肿),70 IU·kg^(-1)组有1例(1%)出现轻微出血事件,而普通肝素组有5例出现轻微出血事件(7.5%)(P=0.061);50 IU·kg^(-1)组有1例患者出现严重出血事件(术后当天出现心脏破裂,心包填塞)。PCI亚组分析:50 IU·kg^(-1)和70 IU·kg^(-1)组各有1例(2.9%)(急诊冠脉搭桥)/(2.2%)(急性前壁再梗)发生终点事件;普通肝素组无终点事件,3组之间无显著差异(P=0.570)。结论:行心导管检查及治疗中单次经动脉鞘管注射瑞肝素钠与普通肝素是一样安全有效的,且70 IU·kg^(-1)组更适于中国人群,并可术后即刻拔除动脉鞘管无需监测APTT,轻微出血事件发生率也低于普通肝素。Objective： To assess anticoagulant effect and safety of intra-sheath reviparin and unfractionated heparin （UFH） in the procedure of CAG/PCI. Methods： Totally 270 patients admitted for CAG/PCI were enrolled and randomly divided into groups. Control patients received UFH （n = 67） ; while other 203 patients received either 70 IU·kg^-1 （ n = 102） or 50 IU·kg^-1 reviparin （ n = 101 ） through sheaths. The sheaths were removed immediately at the end of the procedure in the reviparin groups. All the patients received the loading dose of clopidogrel （300 mg） before CAG/PCI. Serial blood samples were taken to measure the anti-Xa and APTT before CAG, 10 min after the bolus, at the end of the CAG/PCI, 2 h after CAG/PCI. Results： All the patients obtained the peak anti-Xa level 10min after bolus. The peak anti-Xa level was higher in the patients with 70 IU ·kg^-1 reviparin [ （ 1. 26 ±0. 29） IU·mL^-1] than with 50IU·kg^-1 reviparin [（1.04±0.30）IU·mL^-1, p〈0.001]. The percentage of patients who had a peak anti-Xa 〉 0.5 IU·mL^-1 was higher in 70 IU·kg^-1 group （101 patients, 99% ） than in 50 IU·kg^-1 group （96 patients, 95. 1% ）. At 30-day follow-up, 2 （1.9%）, 1 （1%） and 5 （7.5%） minor bleeding events were detected in 50 IU·kg^-1, 70 IU·kg^-1 and UFH groups , respectively （P =0. 061 ）. There was 1 major bleeds event in 50 IU·kg^-1 group： 1 patient got cardiac rupture and pericardial tamponade. In PCI subgroup, 1 patients （2.9%） had undergone an urgent revascularization in 50 IU·kg^-1 group ; 1 patient （2.2%） had cardiovascular events in 70 IU·kg^-1group. There was no primary endpoint event in UFH group, and no significant difference among 3 groups （P = 0. 570）. Conclusions： A single bolus of 50 IU ·kg^-1 or 70 IU·kg^-1 reviparin in patients undergoing CAG/PCI is as safe and effective as UFH.

关 键 词：低分子肝素 普通肝素 冠状动脉介入治疗 抗XA因子 

分 类 号：R973.2[医药卫生—药品] R969.4[医药卫生—药学]