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依诺肝素与肝素对比:从急诊医学角度看SYNERGY试验

Enoxaparin versus heparin: the SYNERGY trial from an emergency medicine perspective.

作者信息

Rokos Ivan C

出版信息

Drugs. 2005;65(10):1313-6. doi: 10.2165/00003495-200565100-00001.

DOI:10.2165/00003495-200565100-00001
PMID:15977965
Abstract

The SYNERGY (Superior Yield of the New strategy of Enoxaparin, Revascularisation, and GlYcoprotein inhibitors) trial, involving almost 10,000 patients, is a landmark cardiology study published in 2004. The study compared two anticoagulants used as part of a modern early invasive strategy involving angiographic triage of high-risk non-ST-elevation acute coronary syndrome patients. The trial as a whole showed similar efficacy between unfractionated heparin and enoxaparin. Regarding safety, two of the three in-hospital bleeding endpoints reported were similar between the two anticoagulants. Importantly, because of the high rate of pre-enrolment anticoagulant administration, many study participants required an anticoagulant change after randomisation. Thus, close attention is warranted to a prespecified subanalysis of >6000 patients who received 'consistent therapy'; that is, the same anticoagulant was administered pre- and post-enrolment based on intention to treat. In this large 'consistent therapy' cohort, the efficacy endpoint favoured enoxaparin and, as in the overall study population, two of the three reported bleeding endpoints were similar between the two anticoagulants. Finally, the rate of peri-procedural thrombotic complications that occurred during percutaneous coronary intervention was equal for both anticoagulants. Thus, since both anticoagulants have a similar efficacy and safety profile, then the simplicity of the enoxaparin regimen (i.e. no monitoring of activated partial thromboplastin time and easy dose calculation of 1 mg/kg subcutaneously) provides an important and desirable feature relevant to a busy emergency medicine practitioner.

摘要

协同(依诺肝素、血管重建和糖蛋白抑制剂新策略的卓越疗效)试验纳入了近10000名患者,是2004年发表的一项具有里程碑意义的心脏病学研究。该研究比较了两种抗凝剂,它们是现代早期侵入性策略的一部分,该策略涉及对高危非ST段抬高急性冠状动脉综合征患者进行血管造影分诊。整个试验显示普通肝素和依诺肝素之间疗效相似。在安全性方面,报告的三个院内出血终点中的两个在两种抗凝剂之间相似。重要的是,由于入组前抗凝剂使用率高,许多研究参与者在随机分组后需要更换抗凝剂。因此,对于>6000名接受“持续治疗”患者的预先指定亚组分析值得密切关注;也就是说,根据意向性治疗,入组前后使用相同的抗凝剂。在这个大型“持续治疗”队列中,疗效终点有利于依诺肝素,并且与整个研究人群一样,报告的三个出血终点中的两个在两种抗凝剂之间相似。最后,两种抗凝剂在经皮冠状动脉介入治疗期间发生的围手术期血栓并发症发生率相等。因此,由于两种抗凝剂具有相似的疗效和安全性,那么依诺肝素方案的简单性(即无需监测活化部分凝血活酶时间,皮下注射1mg/kg剂量计算简便)为忙碌的急诊医学从业者提供了一个重要且理想的特征。

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本文引用的文献

1
Enoxaparin vs unfractionated heparin in high-risk patients with non-ST-segment elevation acute coronary syndromes managed with an intended early invasive strategy: primary results of the SYNERGY randomized trial.依诺肝素与普通肝素用于采用早期侵入性策略治疗的高危非ST段抬高型急性冠脉综合征患者:SYNERGY随机试验的主要结果
JAMA. 2004 Jul 7;292(1):45-54. doi: 10.1001/jama.292.1.45.
2
ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction--summary article: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on the Management of Patients With Unstable Angina).美国心脏病学会/美国心脏协会2002年不稳定型心绞痛和非ST段抬高型心肌梗死患者管理指南更新——总结篇:美国心脏病学会/美国心脏协会实践指南特别工作组(不稳定型心绞痛患者管理委员会)报告
J Am Coll Cardiol. 2002 Oct 2;40(7):1366-74. doi: 10.1016/s0735-1097(02)02336-7.