比伐卢定与普通肝素在外周动脉硬化闭塞症介入治疗中的对照性研究

发布时间：2018-05-15 22:20

本文选题：比伐卢定 + 普通肝素　；参考：《首都医科大学》2017年硕士论文

【摘要】：目的:比较比伐卢定与普通肝素在外周动脉硬化闭塞症介入治疗中的疗效及安全性。方法:选择2015年8月至2017年1月于首都医科大学附属北京朝阳医院血管外科接受介入治疗的外周动脉硬化闭塞症患者共181例,随机分为比伐卢定组(88例)和普通肝素组(93例)。采用前瞻性、随机对照、单中心的临床试验设计方法。两组患者介入治疗术中使用比伐卢定或普通肝素作为唯一抗凝药。比伐卢定先以0.4mg/kg静脉推注,后给予1.0mg/kg/h持续静脉滴注至手术结束。普通肝素以60U/kg静脉推注。同时监测两组患者术前及首次给药后5min的激活凝血时间。主要疗效评价指标为手术成功率、术中及术后3天内的缺血事件(包括支架内血栓形成、卒中、肺栓塞等);主要安全性评价指标为术中及术后3天内的出血事件(包括严重或威胁生命的出血、中度出血、轻微出血)和死亡。结果:比伐卢定组与普通肝素组均无血栓形成事件、严重或威胁生命的出血、中度出血及死亡发生,比伐卢定组手术成功率为90.91%,普通肝素组为88.17%,两组差异无统计学意义(P=0.548);比伐卢定组轻微出血发生率为2.27%,普通肝素组为5.38%,差异无统计学意义(P=0.445)。按是否患有高血压、糖尿病、高脂血症、吸烟等因素分亚组比较,两组患者轻微出血发生率差异均无统计学意义(P0.05)。结论:1.本研究一定程度上说明比伐卢定在外周动脉硬化闭塞症介入治疗中有效性与普通肝素相等。2.在安全性方面比伐卢定表现出一定的降低出血发生率的趋势,但差异无统计学意义,尚不能证明比伐卢定安全性优于普通肝素。
[Abstract]:Objective: to compare the efficacy and safety of bivaludine and heparin in interventional treatment of peripheral arteriosclerosis obliterans. Methods: from August 2015 to January 2017, 181 patients with peripheral arteriosclerosis obliterans received interventional therapy in vascular surgery department of Beijing Chaoyang Hospital affiliated to Capital Medical University. They were randomly divided into two groups (88 patients in Bivaludine group) and 93 patients in general heparin group (n = 93). Prospective, randomized, single-center clinical trial design was used. Patients in both groups were treated with bivaludine or heparin as the only anticoagulant during interventional therapy. Intravenous injection of 0.4mg/kg was performed before continuous intravenous infusion of 1.0mg/kg/h until the end of the operation. Ordinary heparin was injected intravenously with 60U/kg. At the same time, the activated coagulation time of 5min was monitored before and after the first administration in both groups. The main outcome measures were the success rate of operation, ischemic events (including stent thrombosis, stroke) during operation and 3 days after operation. The main safety indexes were bleeding events (including severe or life-threatening bleeding, moderate bleeding, mild bleeding) and death during operation and 3 days after operation. Results: there were no thrombotic events, severe or life-threatening bleeding, moderate bleeding and death in both Bivaldine group and ordinary heparin group. The successful rate of operation was 90.91 in the group of bivarudine and 88.17 in the group of common heparin. There was no significant difference between the two groups in the incidence of slight hemorrhage in the group of bivaludine (2.27%) and that in the group of common heparin (5.38%), there was no significant difference between the two groups (P = 0.445). According to the subgroup of hypertension, diabetes, hyperlipidemia and smoking, there was no significant difference in the incidence of slight hemorrhage between the two groups (P 0.05). Conclusion 1. To some extent, the efficacy of bivaludine in the interventional treatment of peripheral arteriosclerosis obliterans is equal to that of heparin. In the aspect of safety, Bivalodine showed a tendency to reduce the incidence of hemorrhage, but the difference was not statistically significant, and it could not be proved that the safety of bivaludine was superior to that of heparin.
【学位授予单位】：首都医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R654.4

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