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冠心病介入治疗中应用低分子肝素与普通肝素的随机对照研究 被引量:17

A randomized comparative study of using enoxaparin or UFH adjunctive to percutaneous coronary intervention in patients with CHD (ROUTE)
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摘要 目的探讨冠心病患者经皮冠状动脉介入治疗(PCI)中应用低分子肝素(LMWH)替代普通肝素(UFH)的安全性和有效性。方法自2003年10月至2005年2月共入选966例申请一次性行PCI的患者,所有患者均签署了知情同意书。966例患者中最终完成PCI治疗者455例[包括283例为非ST段抬高急性冠脉综合征(ACS)者]。未接受PCI治疗者511例。研究采用随机对照方法,将入选患者分为LMWH组和静脉UFH组,LMWH组484例,静脉UFH组482例。LMWH组采用依诺肝素(ENOXAPARIN),按1MG/KG的剂量于PCI手术前至少给予2次皮下注射(每12H一次),PCI手术在最后1次皮下注射30MIN后开始。完成冠状动脉造影或PCI后,立即拔出鞘管。静脉UFH组的患者于手术前即刻先给予普通肝素25MG静脉推注,如果造影显示适合PCI时,再追加65MG。完成PCI后4H左右拔出鞘管。LMWH组和静脉UFH组中最终行PCI者各为227例和228例。结果(1)LMWH组中1例于PCI术中发生急性血栓形成致急性心肌梗死(AMI),PCI术后及住院期间未见急性和亚急性血栓形成。静脉UFH组术中和住院期间无急性和亚急性血栓形成。住院期间心脏事件发生率(死亡、AMI和再次血管重建)在LMWH组为0.44%,静脉UFH组为0;(2)LMWH组均于术后即刻拔出鞘管,穿刺局部发生血肿8例,静脉UFH组于术后4H左右拔出鞘管,穿刺局部发生血肿20例,前者血肿发生率明显低于后者,差异有统计学意义(P<0.05);(3)随访1个月LMWH组心脏事件发生率为0,静脉UFH组1例于院外发生亚急性血栓致AMI,再次行PCI成功,随访期间心脏事件发生率为0.43%。结论本研究结果提示对于拟行PCI的冠心病患者或非ST段抬高ACS患者术前给予至少2次依诺肝素皮下注射(1MG/KG,每12H一次),并于最后1次皮下注射的8H内行PCI是安全和有效的,术前和术中不需要给予静脉UFH,术后可即刻拔出鞘管。 Objective To evaluate the efficacy and safety of using Enoxaparin instead of UFH for patients with coronary heart disease (CHD) underwent coronary angiogram with or without percutaneous coronary intervention (PCI). Methods From Oct. 2003 to Feb. 2005, 966 patients with CHD underwent coronary angiogram (CAG) were randomized to receive enoxaparin (1 mg/kg subcutaneously, Q12 h, at least twice before CAG and the sheath was withdrawn immediately after the procedure, n = 484) or UFH (25 rag, iv, before CAG with additional 65 mg iv if PCI indicated and the sheath was withdrawn 4 hours after the procedure, n = 482). Results (1) PCI was not performed in 511 patients due to mild lesions or patients were suitable for CABG. In 455 patients underwent PCI (227 in enoxaparin and 228 in UFH group), 1 patient in enoxaparin group developed acute thrombosis and resulted in AMI during PCI and underwent successful urgent revascularization. The incidence of in-hospital major adverse cardiac events were 0. 44% in the enoxaparin group and 0 in the UFH group. (2) Hematoma at the puncture site happened in 8 patients (3.5%) in enoxaparin group and in 20 patients (8.8%, P 〈0. 05) in UFH group. (3) One patient had AMI caused by subaeute thrombosis in UFH group during 1 month follow-up. Conchlsions Our results suggest that the effects and safety are comparable for enoxaparin and UFH, it is also safe and efficient to give enoxaparin at least twice before CAG/PCI and the sheathe earl be withdrawn immediately after PCI. For ACS patients received more than twice enoxaparin and the last dose was given within 8 hours before PCI, PCI could be performed directly without additional UFH.
出处 《中华心血管病杂志》 CAS CSCD 北大核心 2006年第2期127-129,共3页 Chinese Journal of Cardiology
关键词 冠状动脉疾病 血管成形术 经腔 经皮冠状动脉 依诺肝素 Coronary disease Angioplasty ,transluminal, percutaneous coronary Enoxaparin
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