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: This study evaluated the safety and efficacy of Ruiparin sodium in the use of catheterization. Methods: 270 patients underwent coronary angiography (CAG) and / or PCI without heparin or unfractionated heparin at 12 h before surgery were enrolled. 67 patients received unfractionated heparin as control group and 203 patients were randomly divided into control group In the group of 50IU · kg ~ (-1) and 70IU · kg ~ (-1) of RuI heparin sodium, single dose of heparin sodium or unfractionated heparin was injected through the sheath during CAG / PCI. Preoperative, intraoperative 10 min, immediately after angiography, 2h after surgery anti-factor Xa activity and APTT, immediately after removal of the arterial sheath. Endpoints were perioperative anti-factor Xa activity and death at 30 days, myocardial infarction, emergency revascularization and bleeding events. Results: The anti-Xa activity of Rui Hexin 50IU · kg ~ (-1) and 70IU · kg ~ (-1) groups reached the peak at 10min after operation, and then decreased gradually. The peak value of anti-factor Xa (1.26 ± 0.29 IU · mL -1) in 70 IU · kg -1 group was significantly higher than that in 50 IU · kg -1 group (1.04 ± 0.30 IU · mL -1) ~ (-1))] (P <0.001). In the two groups, 95.1% (96 cases) and 99% (101 cases) patients had peak anti-factor Xa> 0.5 IU · mL -1. At the end of the 30-day follow-up, two patients (1.9%) in the 50 IU · kg -1 group had minor hemorrhage (hematoma at the femoral artery puncture site), and one patient (70 IU · kg -1) (P = 0.061). One patient in the 50 IU · kg ~ (-1) group had a severe bleeding event (on the day after the operation), a slight bleeding occurred in 5 patients in the unfractionated heparin group Cardiac rupture, pericardial tamponade). In the PCI subgroup analysis, 1 patient (2.9%) in each of 50 IU · kg -1 and 70 IU · kg -1 groups (emergency coronary bypass) / (2.2%) (acute anterior wall infarction ) End point event; unfractionated heparin group no end point event, no significant difference between the three groups (P = 0.570). CONCLUSION: The single transcatheter arterial injection of Ruibuxu sodium is the safe and effective for central catheterization and treatment. The 70 IU · kg -1 group is more suitable for the Chinese population and can be used immediately after surgery Removal of arterial sheath without monitoring APTT, minor bleeding event rate is also lower than unfractionated heparin.