磺达肝癸钠对急性ST段抬高心肌梗死接受直接PCI患者的疗效和安全性研究  

Efficacy and safety of fondaparinux in patients with acute ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention

作　　者：朱梦云[1] 于学靖[1] 彭文辉[1] 唐恺[1] 李伟明[1] 徐亚伟[1] 

机构地区：[1]同济大学附属第十人民医院心内科,上海200072

出　　处：《同济大学学报（医学版）》2011年第6期48-52,共5页Journal of Tongji University(Medical Science)

基　　金：上海市科委重大科研项目(05DZ19503)

摘　　要：目的评价磺达肝癸钠对急性ST段抬高心肌梗死(ST-segment e1evation myocardia1 infarction,STEMI)患者接受直接经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)的疗效和安全性。方法 STEMI并且接受直接PCI患者160例,随机分成观察组(82例)和对照组(78例)。观察组使用磺达肝癸钠+类普通肝素(unfractionated heparin,UFH)安慰剂,对照组使用UFH+类磺达肝癸钠安慰剂,采用随机双盲平行对照法。主要观测指标为第9天的死亡或再梗死率及出血事件,以及随访第3天、第30天、1年和3年时二次评估。结果磺达肝癸钠组第9天出血事件4.9%(4/82),显著低于对照组出血事件14.1%(11/78),P<0.05,两者有统计学差异;同样结果见于随访的第30天。磺达肝癸钠组第9天死亡或再梗死率8.5%(7/82),对照组7.7%(6/78),P>0.05,两者无统计学差异;同样结果见于第3天、第30天、1年和3年。磺达肝癸钠组中2例患者PCI术期间发现导管内血栓,且直接PCI术前均未接UFH。结论与UFH相比,磺达肝癸钠在STEMI接受直接PCI治疗的人群中,明显减少出血事件,且未增加死亡和再梗死率。单用磺达肝癸钠有发生导管内血栓事件的趋向,可考虑联合应用UFM。Objective To evaluate the efficacy and safety of fondaparinux in patients with acute ST-segment elevation myocardial infarction（STEMI） undergoing primary percutaneous coronary intervention（PCI）.Methods One hundred and sixty patients with STEMI undergoing primary PCI were randomly divided into two groups：82 patients in fondaparinux group and 78 patients in control group.Patients in fondaparinux group were assigned to receive fondaparinux plus unfractionated heparin（UFH） placebo;those in the control group received UFH plus fondaparinux placebo.Main outcome measures were death,reinfarction or bleeding at 9 d;the secondary assessments were carried out at 3 d,30 d,ly and 3y during follow-up.Results The rate of bleeding at 9 d in fondaparinux group was 4.9%（4/82）,significantly lower than that in control group（14.1%,11/78,P 0.05）. The same result was observed at 30 d.The rate of death or reinfarction at 9 d in fondaparinux group was 8.5%（7/82）,while in control group was 7.7%（6/78）（P 0.05）.The same result was observed at 3 d,30 d,1 y and 3 y follow-up.Guiding catheter thrombosis was found in 2 patients in fondaparinux group,who did not receive UFH before primary PCI.Conclusion Compared with UFH, fondaparinux significantly reduces bleeding in patients with STEMI undergoing primary PCI,and does not increase death or reinfarction.There is a trend toward more events of guiding catheter thrombosis in patients with fondaparinux administration alone,which suggest that the combined administration of fondaparinux with UFH may be considered.

关 键 词：心肌梗死 血管成形术 抗凝药 

分 类 号：R541[医药卫生—心血管疾病]