CAJ | 학술논문

目的：研究磺达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（2．5 mg皮下注射，1次/d）或依诺肝素（60 mg皮下注射，2次/d）皮下注射2 d，术前12 h停用，术中使用普通肝素（80～100 U/kg），术后继续给予磺达肝癸钠（2．5 mg皮下注射，1次/d）或依诺肝素（60 mg皮下注射，每12小时1次）皮下注射3 d，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，临床应用上更安全。
목적：연구광체간계납여의낙간소재중국인급성관맥종합정（ACS）경피관상동맥개입치료（PCI）술후적료효급안전성。방법：수집2012년2월지2013년2월재하남성인민의원심내과행경PCI적ACS환자1060례，기중불은정성심교통환자945례，급성심기경사환자115례，수궤분배위광체간규납조화의낙간소조。소유환자균재구복아사필림＋록필격뢰적기출상，술전분별급여광체간계납（2．5 mg피하주사，1차/d）혹의낙간소（60 mg피하주사，2차/d）피하주사2 d，술전12 h정용，술중사용보통간소（80～100 U/kg），술후계속급여광체간계납（2．5 mg피하주사，1차/d）혹의낙간소（60 mg피하주사，매12소시1차）피하주사3 d，관찰병수방환자주원기간、술후2주、4주내출혈、혈전급주요불양심장사건（MACE）적발생솔。결과：광체간계납여의낙간소재PCI술후적항응료효기본상동，술후MACE발생솔량조간무명현차이（P＞0．05）。단광체간규납조교의낙간소조출혈발생솔강저（P＜0．05）。결론：광체간계납여의낙간소재중국인급성관맥종합정PCI술후항응료효상당，단응용광체간계납교의낙간소출혈발생솔강저，림상응용상경안전。
Objective To study efficiency and safety of fondaparinux and Enoxaparin in treatment of Chinese patients with acute coronary syndrome (ACS) having undergone percutaneous 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 anticoagulation 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.