磺达肝癸钠治疗非急诊血运重建急性心肌梗死的效果与安全性

Short-term effects of fondaparinux and enoxaparin in patients with non-revascularization in the early stage of myocardial infarction

目的探讨急性心肌梗死且未行急诊血运重建患者使用磺达肝癸钠的近期疗效和安全性。方法480例急性心肌梗死患者（未接受急诊再灌注治疗）按随机数随机分为依诺肝素组和磺达肝癸钠组，各240例。依诺肝素组给予依诺肝素1mg／kg（年龄〈75岁）或0．75mg／kg皮下注射（年龄≥75岁），1次／12h；磺达肝癸钠组给予磺达肝癸钠2．5mg／kg皮下注射，1次／24h，均连用5～9d。比较2组治疗9d内主要不良心脏事件（MACE）、严重出血发生率和30d及6个月随访情况。结果治疗9d轻微出血和总出血磺达肝癸钠组均较依诺肝素组减少[19例（7．9％）比44例（18．3％）和25例（10．4％）比57例（23．7％），风险比（HR）分别为0．412、0．413，95％置信区间（CI）0．241～0．706、0．258～0．662，P=0．001、P=0．000]。随访1个月，磺达肝癸钠组MACE发生率低于依诺肝素组[37例（15．4％）比59例（24．6％），HR=0．600，95％CI为0．398～0．905，P=0．015]，至6个月时差异无统计学意义[62例（25．8％）比77例（32．1％），HR=0．751，95％C10．537～1．049，P=0．098]。结论磺达肝癸钠治疗早期未行血运重建急性心肌梗死患者近期疗效优于依诺肝素，且出血并发症少。

Objective To explore the short-term clinical efficacy and safety of fondaparinux in non-revascularization in the early stage of myocardial infarction patients. Methods A total of 480 acute myocardial infarction patients （without undergoing early revascularization） were randomly divided into two groups： enoxapafin group （received enoxaparin 1 mg/kg q12 h or 0.75 mg/kg q12 h, if 〉75 years） and fondaparinux group （received fondaparinux 2.5 mg daily）. The clinical effectiveness included major adverse cardiac events （MACE） and bleedings during 9 days, with the follow-up at 30 days and six months. Results Both the minor bleeding and total bleeding events were markedly fewer in fondapafinux group than those in enoxaparin group after 9 days treatment （7.9% vs 18.3% , 10.4% vs 23.7% , HR： O. 412,0. 413, 95% CI： O. 241-0. 706, 0. 258-0. 662, P =0. 001 , P =0. 000）. Fondaparinux was associated with a significantly reduction of MACE at one month （15.4% vs 24.6%, HR ：0. 600, 95%CI： 0. 398-0. 905, P =0. 015） and a downward trend for MACE at six months （25.8% vs 32. 1%, HR： 0. 75l, 95%CI： O. 537-1. 049, P =0. 098）. Conclusion Fondapafinux can effectively improve the short-term clinical efficacy in patients with non-revascularization in the early stage of myocardial infarction than enoxaparin, with lower bleeding incidence.