磺达肝癸钠与依诺肝素在中国人急性冠脉综合征PCI术后疗效及安全性的前瞻性研究

Prospective study on efficiency and safety of fondaparinux and enoxaparin in treatment of Chinese patients with acute coronary syndrome having undergoneing PCI

目的：研究磺迭肝癸钠与依诺肝素在中国人急性冠脉综合征（ACS）经皮冠状动脉介入治疗（PCI）术后的疗效及安全性。方法：收集2012年2月至2013年2月在河南省人民医院心内科行经PCI的ACS患者1060例，其中不稳定性心绞痛患者945例，急性心肌梗死患者115例，随机分配为磺达肝葵钠组和依诺肝素组。所有患者均在口服阿司匹林＋氯吡格雷的基础上，术前分别给予磺达肝癸钠（2．5mg皮下注射，1；K／d）或依诺肝素（60mg皮下注射，2次／d）皮下注射2d，术前12h停用，术中使用普通肝素（80～100U／kg），术后继续给予磺达肝癸钠（2．5mg皮下注射，1~K／d）或依诺肝素（60mg皮下注射，每12小时1次）皮下注射3d，观察并随访患者住院期间、术后2周、4周内出血、血栓及主要不良心脏事件（MACE）的发生率。结果：磺达肝癸钠与依诺肝素在PCI术后的抗凝疗效基本相同，术后MACE发生率两组间无明显差异（P〉0．05）。但磺达肝葵钠组较依诺肝素组出血发生率降低（P〈0．05）。结论：磺达肝癸钠与依诺肝素在中国人急性冠脉综合征PCI术后抗凝疗效相当，但应用磺达肝癸钠较依诺肝素出血发生率降低，I临床应用上更安全。

Objective To study efficiency and safety of fondaparinux and Enoxaparin in treatment of Chinese patients with acute coronary syndrome （ACS） having undergone pereutaneous coronary intervention （PCI）. Methods One thousand and sixty ACS patients （945 with unstable angina, 115 with AMI） having undergone PCI in Henan provincial hospital from July 2011 to July 2013 were randomized into two groups treated with fondaparinux or enoxaparin respectively. Apart from treatment with oral aspirin and clopidogrel, those in the former group were treated with fondaparinux （2.5 mg IH QD） and the latter with enoxaparin （60 mg IH Q12H） subcutaneously for 2 days before operation, both suspended for 12 h before the operation. All of the patients were given heparin （60 IU/ kg） during the operation. After the operation, the therapies with fondaparinux （2.5 mg IH QD） and enoxaparin （60 mg IH Q12H） were resumed subcutaneously for 3 days. Perioperative observation and follow-ups were made in terms of hemorrhage, thrombosis and major adverse cardiac events （MACE） in the patients during the hospitalization period, 2 and 4 weeks after operation. Results Fondaparinux and enoxaparin are both effective on antieoagulation for the patients after PCI. There was no significant difference about the incidence of MACE between the two groups （P 〉 0.05）. But, fondaparinux group had lower incidence of hemorrhage than enoxaparin group （P 〈 0.05）. Conclusion Fondaparinux and enoxaparin both have good anticoagulant activity in Chinese patients with ACS undergoing PCI, but fondaparinux may lower the risk of hemorrhage compared to enoxaparin.