急性ST段抬高型心肌梗死PPCI后抗凝治疗的有效性及安全性研究

发布时间：2018-02-03 21:30

本文关键词： 急性ST段抬高型心肌梗死低分子肝素主要不良心脑血管事件生存曲线　出处：《上海交通大学》2015年博士论文　论文类型：学位论文

【摘要】：目的:本研究旨在设计一项前瞻性随机对照研究,比较急性STEMI患者急诊PCI术后抗凝治疗的安全性及有效性,为术后是否需要低分子肝素抗凝治疗提供相关参考依据。方法:收集2012年5月至2015年3月期间在上海交通大学医学院附属仁济医院成功行急诊PCI术并符合相应入排标准的急性STEMI患者377例。PCI术后随机入选低分子肝素组或非低分子肝素组(对照组)。定义有效性终点为院内、随访30天及随访6个月内主要不良心脑血管事件(MACCE)发生率,安全性终点为大出血及小出血事件。利用SPSS 16.0统计软件分析两组终点事件的发生率及有无统计学差异。并应用Kaplan-Meier法进行两组间生存分析,绘制生存曲线。然后分别收集年龄大于等于75岁的高龄患者及急诊PCI术后TIMI血流未达到3级的患者,探讨低分子肝素在这两组人群中使用的有效性及安全性。结果:1.1对于急性STEMI成功行急诊PCI且术后TIMI血流达到3级的患者,术后使用低分子肝素组的院内及远期MACCE发生率较对照组相比无统计学差异。1.2低分子肝素组总体出血事件发生率显著增加,两者差异具有统计学意义(P=0.036),提示在急诊PCI术后双联或三联口服抗血小板基础上,应用低分子肝素存在一定的出血风险。2.1高龄STEMI患者急诊PCI术后常规使用低分子肝素并未减少院内及远期MACCE发生率。生存分析显示与对照组相比,两者长期生存率无统计学差异。2.2低分子肝素组总体出血事件发生率增加,但两者差异尚未达到统计学意义。该结果提示在高龄STEMI患者中应用低分子肝素可能存在一定的出血风险。3.1心肌再灌注不良患者术后应用低分子肝素的院内及远期MACCE发生率低于对照组,但两组差异尚未达到统计学意义。3.2低分子肝素组总体出血事件发生率有所增加,但两者差异无明显统计学意义。结论:1.对于急诊PCI术后TIMI血流达到3级的急性STEMI患者,PCI术后无需常规LMWH抗凝治疗。2.对于高龄急性STEMI患者成功急诊PCI术后并不建议常规使用抗凝治疗。如需行抗凝治疗,则需要对抗凝药物的剂量及使用时间酌情进行相应的调整,并在应用过程中严密监测出血事件的发生。3.对于急诊PCI术后心肌灌注欠佳的急性STEMI患者,可以考虑在PCI术后加用低分子肝素抗凝治疗,以降低缺血性事件的发生,改善相关临床预后。
[Abstract]:Objective: to design a prospective randomized controlled trial to compare the safety and efficacy of anticoagulant therapy after emergency PCI in patients with acute STEMI. Methods: from May 2012 to March 2015, emergency PCI was successfully performed in Renji Hospital, Shanghai Jiaotong University Medical College. 377 patients with standard acute STEMI were randomly assigned to low molecular weight heparin group or non low molecular weight heparin group (control group). The incidence of major adverse cardiovascular and cerebrovascular events in 30 days and 6 months was observed. The safety endpoints were haemorrhage and small bleeding events. The incidence and statistical difference of endpoint events between the two groups were analyzed by SPSS 16.0 software. The survival of the two groups was analyzed by Kaplan-Meier method. The survival curve was drawn. Then the elderly patients aged more than 75 years and those patients whose TIMI blood flow did not reach grade 3 after emergency PCI operation were collected. To investigate the efficacy and safety of low-molecular-weight heparin (LMWH) used in these two groups. Results: 1.1.Results in patients with acute STEMI, emergency PCI was performed successfully and the blood flow of TIMI reached grade 3 after operation. The incidence of in-hospital and long-term MACCE in the low molecular weight heparin group was significantly higher than that in the control group .1.2 the overall incidence of bleeding events in the low molecular weight heparin group was significantly higher than that in the control group. The difference was statistically significant (P < 0.036), suggesting that the antiplatelet therapy was based on the combination of dual or triple oral antiplatelet therapy after emergency PCI. Low molecular weight heparin (LMWH) had a certain bleeding risk in elderly patients with STEMI. 2.1 the routine use of LMWH did not reduce the incidence of in-hospital and long-term MACCE after emergency PCI in elderly patients. Survival analysis showed that compared with the control group, LMWH did not decrease the risk of bleeding. There was no significant difference in long-term survival rate between the two groups. 2.2 the overall incidence of hemorrhage events in the low molecular weight heparin group increased. But the difference is not statistically significant. The results suggest that there may be a certain risk of bleeding in elderly patients with STEMI. 3.1 patients with myocardial reperfusion dysphoria after the application of low molecular weight heparin in hospital and in the long term. The incidence of MACCE was lower than that of control. However, the difference between the two groups was not statistically significant. 3.2 the overall incidence of bleeding events in the low molecular weight heparin group increased. But there was no significant difference between the two. Conclusion 1.Conclusion\\\%\\\. Routine anticoagulant therapy. If anticoagulant therapy is required, The dosage and duration of anticoagulant should be adjusted accordingly, and the bleeding events should be monitored closely. 3. For acute STEMI patients with poor myocardial perfusion after emergency PCI, Low molecular weight heparin anticoagulant therapy may be considered after PCI in order to reduce the occurrence of ischemic events and improve the clinical prognosis.
【学位授予单位】：上海交通大学
【学位级别】：博士
【学位授予年份】：2015
【分类号】：R542.22

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