比伐芦定在急性心肌梗死经皮冠状动脉介入治疗中的应用研究

发布时间：2018-05-15 17:52

本文选题：急性心肌梗死 + 比伐芦定　；参考：《大连医科大学》2013年硕士论文

【摘要】：目的：评价新型抗凝药物比伐芦定在急性心肌梗死（acute myocardio infarction,AMI）患者经皮冠状动脉介入治疗（percutaneous coronary interventions, PCI）围术期应用的有效性和安全性。方法：本研究为随机、对照研究，自2012年5月至2013年2月，在沈阳军区总医院共入选200例AMI住院患者（包括ST段抬高和非抬高AMI）。按照方案1:1随机分为两组：（1）比伐芦定组（n=100），在导管室中，开始PCI术前给予比伐芦定0.75mg/kg静脉推注作为负荷剂量，后立即以1.75mg/kg/h持续输注至手术结束（静脉滴注至少维持30min以上）；（2）普通肝素联合替罗非班组（n=100），本组患者在病房或急诊室中即开始应用替罗非班静脉内推注并持续静脉滴注，起始推注剂量为10μg/kg，在3min内推注完毕，继以0.15μg/kg/min的速率维持静脉滴注，该组患者在导管室中，于开始PCI术前给予普通肝素60U/kg静脉推注。主要疗效评价指标：观察两组患者住院期间及术后30天内主要不良心脑血管事件（major adverse cardiac and cerebral events, MACCE），包括心性死亡、非致死性AMI、急诊靶血管血运重建和缺血性卒中。主要安全性观察指标为住院期间和术后30天内的出血事件。出血事件评判依照出血学术研究联合会(BleedingAcademic Research Consortium, BARC)的评级标准。结果：两组患者性别、年龄、吸烟、糖尿病史、卒中史、心肌梗死史等临床基线资料均匹配，两组间无统计学差异（P值均0.05)。住院期间及至30天随访时，比伐芦定组与普通肝素联合替罗非班组MACCE事件的发生率分别为2.0%（2例）和4.0%（4例），两组间无统计学差异（P=0.683）；比伐芦定组BARC定义出血评级1~5型出血事件总和显著低于普通肝素联合替罗非班组（2.0%vs10.0%，2例vs10例，P=0.033）。比伐芦定组BARC出血评级1~2型轻微出血发生率2%，普通肝素联合替罗非班组轻微出血发生率8.0%，，无统计学差异（P=0.101）。结论：与普通肝素联合替罗非班组相比，AMI患者在PCI围术期应用比伐芦定可以达到良好的抗凝效果，并且具有更好的安全性。
[Abstract]:Objective: to evaluate the efficacy and safety of a new anticoagulant, bivaldine, in percutaneous coronary intervention (PCI) for percutaneous coronary intervention (coronary interventions, PCI) in patients with acute myocardial infarction (AMI). Methods: from May 2012 to February 2013, 200 AMI inpatients (including St segment elevation and non-elevation AMI) were enrolled in a randomized, controlled study in Shenyang military region General Hospital. According to the 1:1 plan, two groups were randomly divided into two groups: 1) Bivaludine group (n = 100). In the catheterization room, intravenous injection of bivaludine 0.75mg/kg was given before PCI as a loading dose. Immediately after the operation, 1.75mg/kg/h was continuously infused until the end of the operation (intravenously) heparin combined with tirofiban group was administered intravenously and continuously in the ward or emergency room. The initial injection dose was 10 渭 g / kg, and then the intravenous infusion was maintained at a rate of 0.15 渭 g/kg/min. The patients were given ordinary heparin 60U/kg intravenous infusion before PCI at the beginning of PCI. Main outcome measures: major adverse cardiovascular and cerebrovascular events, including cardiac death, non-fatal AMI, emergency target vessel revascularization and ischemic stroke, were observed during hospitalization and 30 days after operation. The main safety indexes were bleeding events during hospitalization and 30 days after operation. Bleeding events were judged according to the rating criteria of the bleeding academic Research Consortium, BARC). Results: the baseline data such as sex, age, smoking, diabetes, stroke and myocardial infarction were matched in the two groups, and there was no significant difference between the two groups (P < 0.05). During the stay in hospital and up to 30 days of follow-up, The incidence of MACCE events in the bivaldine group and the common heparin combined tirofiban group was 2.0 and 4.0, respectively. There was no statistical difference between the two groups (P < 0. 683), and the total number of bleeding events defined by BARC in the bivarudine group was significantly lower than that in the normal group. Heparin combined with tirofiban group 2. 0 vs 10. 0 demonstrated 2 cases of vs10. The incidence of mild hemorrhage in the group of BARC hemorrhage rating type 1 and type 2 was 2%, and that in the group of common heparin combined with tirofiban was 8.0. There was no statistical difference between the two groups. Conclusion: compared with conventional heparin combined with tirofiban group, patients with acute myocardial infarction can achieve better anticoagulant effect and better safety in perioperative period of PCI.
【学位授予单位】：大连医科大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：R542.22

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