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关于直接口服抗凝剂在慢性肾脏病患者中的安全性/疗效特征的立场文件。来自 SIN、FCSA 和 SISET 的共识文件。

Position paper on the safety/efficacy profile of direct oral anticoagulants in patients with chronic kidney disease. Consensus document from the SIN, FCSA and SISET.

机构信息

Thrombosis and Haemostasis Unit, Fondazione IRCCS "Casa Sollievo della Sofferenza", San Giovanni Rotondo, Italy.

Ob/Gyn Department of The First I.M. Sechenov Moscow State Medical University, Moscow, Russia.

出版信息

Blood Transfus. 2020 Nov;18(6):478-485. doi: 10.2450/2020.0156-20. Epub 2020 Aug 6.

DOI:10.2450/2020.0156-20
PMID:33000751
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7605878/
Abstract

Direct oral anticoagulants (DOAC) are mostly prescribed to prevent cardioembolic stroke in patients with non-valvular atrial fibrillation (AF). An increasing number of guidelines recommend DOAC in AF patients with preserved renal function for the prevention of thromboembolism, and an increased use of DOAC in daily practice has been recorded also in elderly patients. Ageing is associated with a reduction in glomerular filtration rate, and impaired renal function, regardless of the cause, increases the risk of bleeding. Multiple medication use (polypharmacy) for treating superimposed co-morbidities is common in both elderly and chronic kidney disease (CKD) patients and drug-drug interaction may cause accumulation of DOAC, thereby increasing the risk of bleeding. The safety profile of DOAC in patients with CKD has not been defined with any certainty, particularly in those with severely impaired renal function or end stage renal disease. This has been due to the heterogeneity of studies and the relative paucity of data. This document reports the position of three Italian scientific societies engaged in the management of patients with atrial fibrillation who are treated with DOAC and present with CKD.

摘要

直接口服抗凝剂(DOAC)主要用于预防非瓣膜性心房颤动(AF)患者的心源性卒中。越来越多的指南建议在肾功能保留的 AF 患者中使用 DOAC 预防血栓栓塞,并且在日常实践中也记录到老年患者中 DOAC 的使用增加。年龄增长与肾小球滤过率降低有关,无论病因如何,肾功能受损都会增加出血风险。同时治疗合并症的多种药物(多药治疗)在老年患者和慢性肾脏病(CKD)患者中很常见,药物相互作用可能导致 DOAC 蓄积,从而增加出血风险。DOAC 在 CKD 患者中的安全性尚未明确确定,特别是在那些肾功能严重受损或终末期肾病患者中。这是由于研究的异质性和相对缺乏数据。本文件报告了参与管理接受 DOAC 治疗且患有 CKD 的心房颤动患者的三个意大利科学协会的立场。

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Circulation. 2020 Apr 28;141(17):1384-1392. doi: 10.1161/CIRCULATIONAHA.119.044059. Epub 2020 Mar 12.
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Oral Anticoagulation for Patients With Atrial Fibrillation on Long-Term Hemodialysis.长期血液透析的心房颤动患者的口服抗凝治疗。
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Safety and Efficacy of Direct Oral Anticoagulants Versus Warfarin in Patients With Chronic Kidney Disease and Atrial Fibrillation.直接口服抗凝剂与华法林在慢性肾脏病合并心房颤动患者中的安全性和疗效。
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Multicenter Randomized Controlled Trial of Vitamin K Antagonist Replacement by Rivaroxaban with or without Vitamin K2 in Hemodialysis Patients with Atrial Fibrillation: the Valkyrie Study.多中心随机对照试验:华法林抗凝替代物利伐沙班联合或不联合维生素 K2 在血液透析合并心房颤动患者中的应用:VALKYRIE 研究。
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