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直接口服抗凝剂与华法林治疗肝硬化患者血栓或心房颤动的比较:一项回顾性队列研究。

Direct Oral Anticoagulants Versus Warfarin for Treatment of Thrombosis or Atrial Fibrillation in Patients With Cirrhosis: A Retrospective Cohort Study.

机构信息

Ochsner Health, New Orleans, LA, USA.

出版信息

Ann Pharmacother. 2022 May;56(5):533-540. doi: 10.1177/10600280211025050. Epub 2021 Sep 1.

DOI:10.1177/10600280211025050
PMID:34470525
Abstract

BACKGROUND

Evidence for direct oral anticoagulants (DOACs) in patients with cirrhosis is limited. Few patients with Child-Turcotte-Pugh (CTP) class B and C cirrhosis have been studied.

OBJECTIVE

To compare major bleeding rates in patients with cirrhosis receiving a DOAC versus warfarin.

METHODS

A retrospective cohort study was conducted in adults with cirrhosis receiving a DOAC versus warfarin for venous thromboembolism, portal-vein thrombosis, or atrial fibrillation. The primary outcome was the rate of major bleeding. Secondary outcomes included time to major bleeding, clinically relevant nonmajor bleeding, all bleeding, gastrointestinal bleeding, intracranial bleeding, and new thromboembolic events. The study was approved by the Ochsner Health System Institutional Review Board.

RESULTS

A total of 44 patients receiving a DOAC and 41 patients receiving warfarin were included. Major bleeding occurred in 4 patients receiving a DOAC and 6 patients receiving warfarin (9.1% vs 14.6%; = 0.881). Rates of major bleeding were similar in 24 DOAC and 17 warfarin patients with CTP Class B (4.2% vs 17.6%; = 0.37) and 8 DOAC and 9 warfarin patients with CTP Class C (37.5% vs 11.1%; = 0.41) cirrhosis. Secondary bleeding and efficacy outcomes were similar between cohorts. The study was limited by a small sample size.

CONCLUSION AND RELEVANCE

Treatment with DOACs in patients with cirrhosis was associated with a similar rate of major bleeding compared with warfarin. Inclusion of CTP class C patients in future studies remains valuable to evaluate safety and efficacy of DOACs in this population.

摘要

背景

关于肝硬化患者直接口服抗凝剂(DOAC)的证据有限。仅有少数 Child-Turcotte-Pugh(CTP)分级为 B 和 C 的肝硬化患者接受过相关研究。

目的

比较接受 DOAC 与华法林治疗的肝硬化患者的主要出血率。

方法

一项回顾性队列研究纳入了接受 DOAC 或华法林治疗静脉血栓栓塞、门静脉血栓形成或心房颤动的肝硬化成人患者。主要结局为主要出血率。次要结局包括主要出血时间、临床相关非大出血、所有出血、胃肠道出血、颅内出血和新的血栓栓塞事件。该研究获得了奥克斯纳健康系统机构审查委员会的批准。

结果

共纳入 44 例接受 DOAC 和 41 例接受华法林治疗的患者。4 例接受 DOAC 治疗的患者和 6 例接受华法林治疗的患者发生了主要出血(9.1% vs. 14.6%;=0.881)。在 CTP 分级为 B 的 24 例 DOAC 和 17 例华法林患者中(4.2% vs. 17.6%;=0.37)和 CTP 分级为 C 的 8 例 DOAC 和 9 例华法林患者中(37.5% vs. 11.1%;=0.41),主要出血率相似。两组间的次要出血和疗效结局相似。该研究受到样本量小的限制。

结论和相关性

在肝硬化患者中,DOAC 治疗与华法林相比,主要出血率相似。在未来的研究中纳入 CTP 分级为 C 的患者,对于评估 DOAC 在该人群中的安全性和疗效仍然具有重要意义。

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Comparison of the Efficacy and Safety of Direct Oral Anticoagulants and Warfarin in Cirrhotic Patients: A Systematic Review and Meta-Analysis.直接口服抗凝剂与华法林在肝硬化患者中的疗效和安全性比较:系统评价和荟萃分析。
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