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阿哌沙班预防动静脉移植物血栓形成的疗效与安全性。

Efficacy and safety of Apixaban for the prevention of thrombosis in arteriovenous grafts.

作者信息

Hedayat Arash, Soltani Aidin Esrafilian, Hakiminezhad Mahdi, Zareian Fateme, Saneian Mandana, Moradmand Mohamad, Abrishami Sahand, Nodoushan Mohamad Hosein Tabatabaei, Pouriayevali Ali, Mohebbi Mahdi, Ghorbani Helia

机构信息

Hematology Oncology Division, Internal Medicine Department, Isfahan University of Medical Sciences, Isfahan.

Department of General Surgery, School of Medicine, Shahid Beheshti University of Medical Sciences, Tehran.

出版信息

Eur J Transl Myol. 2024 Jan 15;34(1):12029. doi: 10.4081/ejtm.2024.12029.

Abstract

This research aims to fill a vital gap in existing studies by evaluating the efficacy and safety of Apixaban, a direct oral anticoagulant, in the prevention of arteriovenous graft (AVG) thrombosis, thereby offering substantial insights into alternative anticoagulant options for hemodialysis patients. Conducted as a multi-center, randomized, double-blind, placebo-controlled trial, this study involved end-stage renal disease (ESRD) patients who had recently received polytetrafluoroethylene grafts. Participants were assigned to receive either Apixaban at a dose of 2.5 mg twice daily or a placebo. The primary outcome measure was the occurrence of graft thrombosis, while secondary outcomes focused on the incidence and severity of bleeding. Analytical methods included Kaplan-Meier estimates, Cox proportional hazards models, and conventional statistical tests. With 96 patients enrolled, the study found that Apixaban significantly reduced the incidence of AVG thrombosis compared to placebo (16.7% vs. 62.5%, P < 0.0001). Notably, this reduction in thrombosis incidence was not accompanied by an increase in bleeding events, thus affirming the safety profile of Apixaban as established in prior research. Apixaban is identified as an efficacious alternative to traditional anticoagulants in the prevention of AVG thrombosis among hemodialysis patients, representing a notable advancement in the care of individuals with ESRD. The results of this study support further investigations into the optimal dosing strategies specifically tailored for this patient demographic.

摘要

本研究旨在通过评估直接口服抗凝剂阿哌沙班预防动静脉移植物(AVG)血栓形成的疗效和安全性,填补现有研究中的一个重要空白,从而为血液透析患者的替代抗凝方案提供重要见解。作为一项多中心、随机、双盲、安慰剂对照试验,本研究纳入了近期接受聚四氟乙烯移植物的终末期肾病(ESRD)患者。参与者被分配接受每日两次2.5毫克剂量的阿哌沙班或安慰剂。主要结局指标是移植物血栓形成的发生情况,次要结局则关注出血的发生率和严重程度。分析方法包括Kaplan-Meier估计、Cox比例风险模型和传统统计检验。该研究共纳入96名患者,结果发现,与安慰剂相比,阿哌沙班显著降低了AVG血栓形成的发生率(16.7%对62.5%,P<0.0001)。值得注意的是,血栓形成发生率的降低并未伴随着出血事件的增加,从而证实了阿哌沙班在先前研究中确立的安全性。阿哌沙班被确定为血液透析患者预防AVG血栓形成的传统抗凝剂的有效替代品,代表了ESRD患者护理方面的一项显著进展。本研究结果支持进一步研究专门针对该患者群体的最佳给药策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/991e/11017168/33485ce113b2/ejtm-34-1-12029-g001.jpg

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