磺达肝癸钠对急性心肌梗死阿替普酶溶栓的疗效及安全性研究

Efficacy and safety of fondaparinux in thrombolytic therapy in acute ST-elevated myocardial infarction patients

目的观察磺达肝癸钠对急性ST段抬高心肌梗死(STEMI)患者应用重组组织型纤溶酶原激活剂(rt-PA)溶栓过程中的疗效和安全性。方法 2011年11月至2012年4月住院的急性STEMI发病6 h患者62例,全部患者给予阿替普酶溶栓,溶栓前随机给予磺达肝癸钠(2.5 mg,皮下注射)或普通肝素(60 U/kg,最大剂量4000 U),溶栓后3 h行冠状动脉造影及经皮冠状动脉介入治疗(PCI)。主要疗效指标为溶栓治疗3 h梗死相关动脉TIMI3级血流的患者百分数。其他指标包括住院期间12个月的病死率、中重度大出血及小出血的发生率。结果 (1)溶栓血管开通情况:两组患者溶栓后3 h冠状动脉造影TIMI 3级血流率磺达肝癸钠组81.25%(26/32),肝素组为76.67%(23/30),P=0.658;(2)PCI手术情况:所有患者手术即刻成功率为100%。PCI患者每例平均(1.7±0.9)枚支架,支架直径/长度为(3.0±0.7)mm/(20.9±2.6)mm。(3)安全性:无论是住院期间,还是12个月,两组均无危机生命的大出血,住院期间磺达肝癸钠组轻微出血发生率比肝素组减少[6.25%(2/32)对26.67%(8/30),P=0.029]。(4)院内及远期[平均随访(11.3±3.8)个月]全因死亡率:①住院期间,磺达肝癸钠组死亡率发生率较肝素组降低,但差异无统计学意义[18.75%(6/32)对26.67%(8/30),P=0.456];②磺达肝癸钠组的远期死亡率与肝素组比较差异无统计学意义(P>0.05)。结论在STEMI治疗中,溶栓前使用磺达肝癸钠与肝素比较,可使缺血心肌获得尽早再灌注,为进一步血运重建赢得时间,且降低出血事件和死亡率,取得较好的近、远期疗效,是一种简便、实用、有效的治疗方法。

Objective To assess efficacy and safety of Fondaparinux in thrombolytic therapy in acute ST-elevated myocardi- al infarction patients. Methods From November 2011 to April 2012,patients with acute ST-elevated myocardial infarction and pain to hospital time within 6 hours received thrombolytic therapy by Aheplase. Before thrombolytic therapy, patients were randomly assigned to Fondaparinux group （2. 5 rag, n = 32 ） or standard heparin group （ 60 U/kg, maximum 4000 U, n = 30）. Coronary angiography or percutaneous coronary intervention （PCI） was performed at 3 hour after initiating study drugs. Primary endpoints of the trial were the rate of TIMI grade 3 flow at 3 hours. Other endpoints included incidence of all cause mortality at in-hospital and 12 months, major bleeding and minor bleeding at in-hospital and 12 months. Results （1）There were no difference of primary endpoints （Fondapm＇inux group vs heparin group,81.25% （26/32） vs 76. 67% （23/39） ,P = 0. 658 ）. （2）PCI procedure：Successful rate of immediate post-procedure was 100%. The average number of stents per patient was 1.7 -＋ 0. 9 and the average diameter and length of stent were （3.0±0. 7 ） mm and （20. 9±2. 6 ） mm. （3） Safety：No significant difference existed between fondaparinux group and heparin group in major bleeding （in-hospital and 12 months,P 〉 0. 05 ）. However, the fondaparinux group had a lower prevalence of mild bleeding than heparin group in- hospital （6. 25 % [ 2/32 ] ,26. 67 % [ 8/30 ], P = 0. 029）. （4） In-hospital and all cause mortality at 30 d and 12 months （ Av- erage follow-up time was [ 11.3±3.8 ] months） ： ① Fondaparinux group had a lower mortality of in-hospital but with no sta-tistical difference（ 18. 75% [ 6/32 ] vs 26. 67% [ 8/30 ], P = 0. 456 ）.②Mortality rates at 12 months were all similar in Fondaparinux treated patients compared to heparin treated patients （ P 〉 0. 05 ）. Conclusion Fondaparinux, which can re- duce the time of reperfusion with decreasing mortality and mild hemorrhage,is feasible and safe for the patients with STEMI during thrombolysis therapy.