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磺达肝癸钠用于中国初次经皮冠状动脉介入治疗后的抗凝治疗:一项单中心随机试验。

Fondaparinux Sodium for Anticoagulant Therapy After Primary Percutaneous Coronary Intervention: A Single-Center Randomized Trial in China.

机构信息

Departments of Cardiology.

General Practice.

出版信息

J Cardiovasc Pharmacol. 2024 Sep 1;84(3):331-339. doi: 10.1097/FJC.0000000000001596.

Abstract

In this study, we investigated the safety and efficacy of fondaparinux sodium in postpercutaneous coronary intervention (PCI) anticoagulation therapy for patients with ST-segment elevation myocardial infarction. There are a total of 200 patients with ST segment elevation myocardial infarction underwent PCI and anticoagulation therapy. They were randomly split into experimental (n = 108) and control groups (n = 92). The experimental group received postoperative fondaparinux sodium (2.5 mg q.d), while the control group received enoxaparin (4000 IU q12 h). We did not use a loading dose for enoxaparin. Bleeding incidence and major adverse cardiovascular/cerebrovascular events were monitored during hospitalization, and at 1, 3, and 6 months postsurgery. The primary end points, including bleeding, mortality, and myocardial infarction during hospitalization, were not significantly different between the 2 groups. For secondary end points, the incidence of combined end point events at 1 month, 3 months, and 6 months after surgery in the experimental group was lower than in the control group (P < 0.05). According to Cox regression analysis, the risk of bleeding in the experimental group was significantly lower than that in the control group [hazard ratios: 0.506, 95% confidence interval (CI): 0.284-0.900] (P = 0.020). The risk of mortality in the experimental group was significantly lower than in the control group (hazard ratio: 0.188, 95% CI: 0.040-0.889) (P = 0.035). In summary, perioperative use of fondaparinux sodium during PCI in patients with STEMI in this study was associated with a lower risk of bleeding and death compared with enoxaparin use in the absence of loading dose.

摘要

在这项研究中,我们调查了磺达肝癸钠在经皮冠状动脉介入治疗(PCI)后 ST 段抬高型心肌梗死患者抗凝治疗中的安全性和有效性。共有 200 例 ST 段抬高型心肌梗死患者接受了 PCI 和抗凝治疗。他们被随机分为实验组(n = 108)和对照组(n = 92)。实验组接受术后磺达肝癸钠(2.5 mg q.d),对照组接受依诺肝素(4000 IU q12 h)。我们对依诺肝素不使用负荷剂量。在住院期间和手术后 1、3 和 6 个月监测出血发生率和主要不良心血管/脑血管事件。主要终点包括住院期间出血、死亡率和心肌梗死,两组间无显著差异。次要终点方面,实验组术后 1 个月、3 个月和 6 个月联合终点事件发生率低于对照组(P < 0.05)。根据 Cox 回归分析,实验组出血风险显著低于对照组[风险比:0.506,95%置信区间(CI):0.284-0.900](P = 0.020)。实验组死亡率风险显著低于对照组(风险比:0.188,95% CI:0.040-0.889)(P = 0.035)。综上所述,与不使用负荷剂量的依诺肝素相比,本研究中 STEMI 患者 PCI 围手术期使用磺达肝癸钠与出血和死亡风险降低相关。

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