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重新思考在血栓性抗磷脂综合征患者中使用直接口服抗凝剂进行二级血栓预防的问题。

Rethinking the use of direct oral anticoagulants for secondary thromboprophylaxis in patients with thrombotic antiphospholipid syndrome.

机构信息

Department of Internal Medicine, Venous Thromboembolism Unit, Hospital Universitario Infanta Leonor, Madrid, Spain.

Department of Internal Medicine, Venous Thromboembolism Unit, Hospital Universitario de Fuenlabrada, Madrid, Spain.

出版信息

Drug Discov Ther. 2024 Sep 19;18(4):213-219. doi: 10.5582/ddt.2024.01050. Epub 2024 Aug 28.

Abstract

Patients with thrombotic antiphospholipid syndrome (APS) are at high risk for recurrent thrombosis, and indefinite anticoagulation is recommended. Patients with APS merit indefinite anticoagulation, and vitamin K antagonists (VKAs) have historically been the standard treatment. Direct oral anticoagulants (DOACs) present an appealing alternative to VKAs. Due to their pharmacokinetic and pharmacodynamic characteristics, DOACs offer advantages over VKAs, namely the lack of need for laboratory monitoring, the usage of a fixed dosage, and the absence of significant interaction with dietary components and drugs. The efficacy and safety of DOACs in patients with APS have been studied in four phase II/III clinical trials (three with rivaroxaban and one with apixaban). These studies showed DOACs' inferiority compared to VKAs in preventing recurrent thrombosis. Recurrence was significantly greater in patients with arterial thrombotic events and a triple positivity for antiphospholipid antibodies. No differences were observed in the incidence of venous thromboembolism between both groups. Major bleeding was similar in patients treated with DOACs or VKAs. Several observational studies have reported similar results. This review aims to analyse the existing evidence on the efficacy and safety of DOACs for secondary prevention in patients with APS.

摘要

患有血栓性抗磷脂综合征 (APS) 的患者存在反复血栓形成的高风险,建议进行无限期抗凝治疗。APS 患者需要无限期抗凝治疗,维生素 K 拮抗剂 (VKA) 一直是标准治疗方法。直接口服抗凝剂 (DOAC) 是 VKA 的一种有吸引力的替代方法。由于其药代动力学和药效学特征,DOAC 优于 VKA,即无需实验室监测、使用固定剂量以及与饮食成分和药物无明显相互作用。四项 II/III 期临床试验(三项使用利伐沙班,一项使用阿哌沙班)研究了 DOAC 在 APS 患者中的疗效和安全性。这些研究表明,DOAC 在预防复发性血栓形成方面不如 VKA。动脉血栓事件和抗磷脂抗体三重阳性的患者复发率明显更高。两组之间静脉血栓栓塞事件的发生率无差异。DOAC 治疗组和 VKA 治疗组的大出血发生率相似。几项观察性研究报告了类似的结果。本综述旨在分析 DOAC 在 APS 患者二级预防中的疗效和安全性的现有证据。

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