新型口服抗凝剂用于血流动力学稳定型肺栓塞的急性和长期治疗

L. Masotti, G. Lorenzini, G. Landini, Niccolò Bettoni, G. Panigada, R. Cappelli
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引用次数: 3

摘要

从历史上看,急性期血流动力学稳定的肺栓塞(PE)的标准治疗包括静脉注射抗凝剂与口服抗凝剂维生素K拮抗剂(VKAs)重叠至少5-7天,然后在达到治疗范围并延长至少3 - 6个月(长期期)时单独使用VKAs。然而,标准治疗有许多药理学和实践上的局限性。为了克服这些限制,新的抗凝药物具有更好的药理特征和更容易使用,已经在临床前和临床试验中进行了生产和测试,目的是与标准治疗相比至少达到无劣效性。在PE的情况下,新的口服抗凝剂(NOACs)、凝血酶直接抑制剂(达比加群)或激活因子X(阿哌沙班、依多沙班、利伐沙班)已在III期随机临床试验(RCTs)的急性和长期治疗阶段进行了测试。利伐沙班(EINSTEIN-PE研究)和阿哌沙班(AMPLIFY研究)从诊断开始直接测试,达比加群(RE-COVER I和II研究)和依多沙班(HOKUSAI研究)在标准治疗7-10天后开始测试。总的来说,这些试验表明,NOACs至少作为标准治疗是有效和安全的,有望在急性/亚急性PE治疗中提供一种基于单一药物方法或从肠外抗凝快速转换为口服抗凝的革命性方法。在本文中,作者着重于NOACs在PE治疗的急性和长期阶段的III期随机对照试验,重点是治疗的前两周。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
New Oral Anticoagulants for Acute and Long-Term Treatment of Haemodynamically Stable Pulmonary Embolism 
Historically, standard treatment of haemodynamically stable pulmonary embolism (PE) in the acute phase consists in parenteral anticoagulants overlapped with oral anticoagulants vitamin K antagonists (VKAs) for at least 5-7 days followed by VKAs alone when their therapeutic range is reached and prolonged for at least three-six months (long term phase). However standard treatment has many pharmacological and practical limitations. For overcoming these limitations, new anticoagulant drugs with better pharmacological profile and easier to use, have been manufactured and tested in pre-clinical and clinical trials with the aim to reach at least non inferiority compared to standard treatment. In the setting of PE, new oral anticoagulants (NOACs), direct inhibitors of thrombin (dabigatran) or activated factor X (apixaban, edoxaban, rivaroxaban) have been tested in the acute and long-term phases of treatment in phase III randomized clinical trials (RCTs). Rivaroxaban (EINSTEIN-PE study) and apixaban (AMPLIFY study) have been tested directly from diagnosis, dabigatran (RE-COVER I and II studies) and edoxaban (HOKUSAI study) starting after 7-10 days of standard treatment. Overall, these trials have demonstrated that NOACs are effective and safe at least as standard treatment, promising a revolutionary approach to PE treatment in acute/sub-acute PE based on single drug approach or rapid switch from parenteral to oral anticoagulation. In this paper the Authors focus on phase III RCTs on NOACs in the acute and long-term phases of PE treatment, highlighting the first two weeks of treatment. 
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