比伐蘆定在急性心肌梗死經(jīng)皮冠狀動(dòng)脈介入治療中的應(yīng)用研究
發(fā)布時(shí)間:2018-05-15 17:52
本文選題:急性心肌梗死 + 比伐蘆定; 參考:《大連醫(yī)科大學(xué)》2013年碩士論文
【摘要】:目的:評(píng)價(jià)新型抗凝藥物比伐蘆定在急性心肌梗死(acute myocardio infarction,AMI)患者經(jīng)皮冠狀動(dòng)脈介入治療(percutaneous coronary interventions, PCI)圍術(shù)期應(yīng)用的有效性和安全性。 方法:本研究為隨機(jī)、對(duì)照研究,自2012年5月至2013年2月,在沈陽(yáng)軍區(qū)總醫(yī)院共入選200例AMI住院患者(包括ST段抬高和非抬高AMI)。按照方案1:1隨機(jī)分為兩組:(1)比伐蘆定組(n=100),在導(dǎo)管室中,開(kāi)始PCI術(shù)前給予比伐蘆定0.75mg/kg靜脈推注作為負(fù)荷劑量,后立即以1.75mg/kg/h持續(xù)輸注至手術(shù)結(jié)束(靜脈滴注至少維持30min以上);(2)普通肝素聯(lián)合替羅非班組(n=100),本組患者在病房或急診室中即開(kāi)始應(yīng)用替羅非班靜脈內(nèi)推注并持續(xù)靜脈滴注,起始推注劑量為10μg/kg,在3min內(nèi)推注完畢,繼以0.15μg/kg/min的速率維持靜脈滴注,該組患者在導(dǎo)管室中,于開(kāi)始PCI術(shù)前給予普通肝素60U/kg靜脈推注。主要療效評(píng)價(jià)指標(biāo):觀察兩組患者住院期間及術(shù)后30天內(nèi)主要不良心腦血管事件(major adverse cardiac and cerebral events, MACCE),包括心性死亡、非致死性AMI、急診靶血管血運(yùn)重建和缺血性卒中。主要安全性觀察指標(biāo)為住院期間和術(shù)后30天內(nèi)的出血事件。出血事件評(píng)判依照出血學(xué)術(shù)研究聯(lián)合會(huì)(BleedingAcademic Research Consortium, BARC)的評(píng)級(jí)標(biāo)準(zhǔn)。 結(jié)果:兩組患者性別、年齡、吸煙、糖尿病史、卒中史、心肌梗死史等臨床基線資料均匹配,兩組間無(wú)統(tǒng)計(jì)學(xué)差異(P值均0.05)。住院期間及至30天隨訪時(shí),比伐蘆定組與普通肝素聯(lián)合替羅非班組MACCE事件的發(fā)生率分別為2.0%(2例)和4.0%(4例),兩組間無(wú)統(tǒng)計(jì)學(xué)差異(P=0.683);比伐蘆定組BARC定義出血評(píng)級(jí)1~5型出血事件總和顯著低于普通肝素聯(lián)合替羅非班組(2.0%vs10.0%,2例vs10例,P=0.033)。比伐蘆定組BARC出血評(píng)級(jí)1~2型輕微出血發(fā)生率2%,普通肝素聯(lián)合替羅非班組輕微出血發(fā)生率8.0%,,無(wú)統(tǒng)計(jì)學(xué)差異(P=0.101)。 結(jié)論:與普通肝素聯(lián)合替羅非班組相比,AMI患者在PCI圍術(shù)期應(yīng)用比伐蘆定可以達(dá)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.
【學(xué)位授予單位】:大連醫(yī)科大學(xué)
【學(xué)位級(jí)別】:碩士
【學(xué)位授予年份】:2013
【分類號(hào)】:R542.22
【參考文獻(xiàn)】
相關(guān)期刊論文 前1條
1 張成;;替羅非班治療急性冠脈綜合征介入術(shù)后無(wú)復(fù)流的臨床研究[J];實(shí)用心腦肺血管病雜志;2011年04期
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