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我们从静脉血栓栓塞治疗的真实世界 NOAC 研究中学到了什么?

What have we learned from real-world NOAC studies in venous thromboembolism treatment?

机构信息

Thrombosis Research Unit, Department of Medicine I, Division Hematology, University Hospital "Carl Gustav Carus" Dresden, Fetscherstrasse 74; D-01307 Dresden, Germany; Kings Thrombosis Service, Department of Hematology, Kings College London, UK.

出版信息

Thromb Res. 2018 Mar;163:83-91. doi: 10.1016/j.thromres.2018.01.034. Epub 2018 Feb 6.

Abstract

Venous thromboembolism (VTE) remains a substantial clinical and health-economic burden worldwide and effective anticoagulant treatment is necessary immediately after VTE is suspected to reduce short- and long-term VTE related morbidity and mortality. For decades, low molecular weight heparin (LMWH), fondaparinux and Vitamin K antagonists (VKAs) have been the standard of anticoagulant therapy for VTE patients but these treatment options had clinically relevant drawbacks and limitations. The introduction of non-VKA oral anticoagulants (NOACs) that specifically inhibit either thrombin or factor Xa have resolved many of these drawbacks because these new compounds exhibit a rapid onset and offset of action, fewer food and drug interactions and a predictable anticoagulant effect. All NOACs have successfully completed their respective phase-III trial programs consisting of many large randomized controlled trials, leading to approval for acute VTE treatment around the world. Nevertheless, their introduction into daily care practice is challenging and a careful evaluation of the effectiveness and safety of NOACs in less selected cohorts outside carefully monitored clinical trials is essential. This review introduces the different types of real-world evidence (RWE) and explores the available data for VTE treatment with NOACs, based on a literature search using the key words "venous thromboembolism" or "VTE" in combination with "NOAC", "DOAC", "apixaban", "dabigatran", "edoxaban" and "rivaroxaban" on June 30; 2017, followed by data extraction from studies that reported real-world outcome data for VTE treatment with NOACs, although available evidence is almost exclusively limited to rivaroxaban.

摘要

静脉血栓栓塞症(VTE)仍然是全球范围内一个重大的临床和健康经济负担,需要在怀疑 VTE 后立即进行有效的抗凝治疗,以降低短期和长期与 VTE 相关的发病率和死亡率。几十年来,低分子肝素(LMWH)、磺达肝素和维生素 K 拮抗剂(VKAs)一直是 VTE 患者抗凝治疗的标准,但这些治疗方案存在临床相关的缺点和局限性。非维生素 K 拮抗剂口服抗凝剂(NOACs)的引入,专门抑制凝血酶或因子 Xa,解决了许多这些缺点,因为这些新化合物具有快速起效和消除作用、较少的食物和药物相互作用以及可预测的抗凝作用。所有的 NOACs都已成功完成各自的 III 期试验项目,其中包括许多大型随机对照试验,从而在全球范围内获得了急性 VTE 治疗的批准。然而,将其引入日常护理实践具有挑战性,需要仔细评估 NOAC 在临床试验以外的选择较少的队列中的有效性和安全性。本综述介绍了不同类型的真实世界证据(RWE),并根据 2017 年 6 月 30 日使用关键字“venous thromboembolism”或“VTE”与“NOAC”、“DOAC”、“apixaban”、“dabigatran”、“edoxaban”和“rivaroxaban”结合进行文献检索,探索了用于 VTE 治疗的 NOAC 的可用数据,随后从报告了用于 VTE 治疗的 NOAC 的真实世界结果数据的研究中提取数据,但现有证据几乎完全限于利伐沙班。

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