本文選題：比伐盧定 + 普通肝素��； 參考：《首都醫(yī)科大學》2017年碩士論文

【摘要】：目的:比較比伐盧定與普通肝素在外周動脈硬化閉塞癥介入治療中的療效及安全性。方法:選擇2015年8月至2017年1月于首都醫(yī)科大學附屬北京朝陽醫(yī)院血管外科接受介入治療的外周動脈硬化閉塞癥患者共181例,隨機分為比伐盧定組(88例)和普通肝素組(93例)。采用前瞻性、隨機對照、單中心的臨床試驗設(shè)計方法。兩組患者介入治療術(shù)中使用比伐盧定或普通肝素作為唯一抗凝藥。比伐盧定先以0.4mg/kg靜脈推注,后給予1.0mg/kg/h持續(xù)靜脈滴注至手術(shù)結(jié)束。普通肝素以60U/kg靜脈推注。同時監(jiān)測兩組患者術(shù)前及首次給藥后5min的激活凝血時間。主要療效評價指標為手術(shù)成功率、術(shù)中及術(shù)后3天內(nèi)的缺血事件(包括支架內(nèi)血栓形成、卒中、肺栓塞等);主要安全性評價指標為術(shù)中及術(shù)后3天內(nèi)的出血事件(包括嚴重或威脅生命的出血、中度出血、輕微出血)和死亡。結(jié)果:比伐盧定組與普通肝素組均無血栓形成事件、嚴重或威脅生命的出血、中度出血及死亡發(fā)生,比伐盧定組手術(shù)成功率為90.91%,普通肝素組為88.17%,兩組差異無統(tǒng)計學意義(P=0.548);比伐盧定組輕微出血發(fā)生率為2.27%,普通肝素組為5.38%,差異無統(tǒng)計學意義(P=0.445)。按是否患有高血壓、糖尿病、高脂血癥、吸煙等因素分亞組比較,兩組患者輕微出血發(fā)生率差異均無統(tǒng)計學意義(P0.05)。結(jié)論:1.本研究一定程度上說明比伐盧定在外周動脈硬化閉塞癥介入治療中有效性與普通肝素相等。2.在安全性方面比伐盧定表現(xiàn)出一定的降低出血發(fā)生率的趨勢,但差異無統(tǒng)計學意義,尚不能證明比伐盧定安全性優(yōu)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.
【學位授予單位】：首都醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2017
【分類號】：R654.4

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