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直接口服抗凝剂与华法林在心房颤动合并肝硬化患者中的疗效和安全性比较

Efficacy and Safety of Direct Oral Anticoagulants Versus Warfarin in Patients With Atrial Fibrillation and Liver Cirrhosis.

作者信息

Chou Tien-Shin, Lin Yuan, Tsai Ming-Lung, Tseng Chin-Ju, Dai Jhih-Wei, Yang Ning-I, Lin Chih-Lang, Chen Li-Wei, Hung Ming-Jui, Chen Tien-Hsing

机构信息

Division of Gastroenterology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan.

College of Medicine, Chang Gung University, Taoyuan, Taiwan.

出版信息

J Clin Gastroenterol. 2025 Oct 1;59(9):901-909. doi: 10.1097/MCG.0000000000002089.

Abstract

OBJECTIVE

Comparing direct oral anticoagulants (DOACs) and warfarin's efficacy and safety in patients with nonvalvular atrial fibrillation (AF) and liver cirrhosis (LC).

BACKGROUND

Evidence of the pharmacodynamics of DOACs is limited in patients with AF and LC.

METHODS

A retrospective cohort study was conducted in the largest hospital system in Taiwan, involving patients with AF and LC for the years 2012 to 2021. Hazards of thromboembolic events (ischemic stroke, transient ischemic attack, and systemic embolism), intracranial hemorrhage, gastrointestinal, major bleeding, and all-cause mortality were investigated with a new-user, active comparator design. Inverse probability of treatment weighting was applied to balance potential confounders between treatment groups.

RESULTS

In total, 478 DOAC users and 247 warfarin users were included. DOACs and warfarin demonstrated similar trends in preventing thromboembolic events, namely ischemic stroke [adjusted hazard ratio (aHR), 1.05 (95% CI: 0.42-2.61)], transient ischemic attack [aHR, 1.36 (95% CI: 0.18-10.31)], and systemic embolism [aHR, 0.49 (95% CI: 0.14-1.70)]. DOAC use was associated with a similar risk of intracranial hemorrhage [aHR, 0.65 (95% CI: 0.26-1.59)] and gastrointestinal bleeding [aHR, 0.64 (95% CI: 0.39-1.03)], a decreased risk of major bleeding [aHR, 0.64 (95% CI: 0.42-0.99)], and a reduction in mortality [aHR, 0.73 (95% CI: 0.54-0.99)]. DOAC users exhibited a significant reduction in major bleeding risk in patients with Child-Pugh class A (aHR, 0.48; 95% CI: 0.33-0.70).

CONCLUSIONS

DOACs showed potential safety advantages over warfarin for patients with nonvalvular AF and LC, particularly in reducing major bleeding risk in those with Child-Pugh class A.

摘要

目的

比较直接口服抗凝剂(DOACs)与华法林在非瓣膜性心房颤动(AF)合并肝硬化(LC)患者中的疗效和安全性。

背景

DOACs在AF合并LC患者中的药效学证据有限。

方法

在台湾最大的医院系统进行了一项回顾性队列研究,纳入2012年至2021年期间的AF合并LC患者。采用新用户、活性对照设计,调查血栓栓塞事件(缺血性卒中、短暂性脑缺血发作和全身性栓塞)、颅内出血、胃肠道大出血、大出血和全因死亡率的风险。应用治疗权重逆概率来平衡治疗组之间的潜在混杂因素。

结果

共纳入478名DOAC使用者和247名华法林使用者。DOACs和华法林在预防血栓栓塞事件方面表现出相似的趋势,即缺血性卒中[调整后风险比(aHR),1.05(95%CI:0.42-2.61)]、短暂性脑缺血发作[aHR,1.36(95%CI:0.18-10.31)]和全身性栓塞[aHR,0.49(95%CI:0.14-1.70)]。使用DOACs与颅内出血风险相似[aHR,0.65(95%CI:0.26-1.59)]和胃肠道出血风险相似[aHR,0.64(95%CI:0.39-1.03)],大出血风险降低[aHR,0.64(95%CI:0.42-0.99)],死亡率降低[aHR,0.73(95%CI:0.54-0.99)]。DOAC使用者在Child-Pugh A级患者中的大出血风险显著降低(aHR,0.48;95%CI:0.33-0.70)。

结论

对于非瓣膜性AF合并LC患者,DOACs显示出优于华法林的潜在安全性优势,尤其是在降低Child-Pugh A级患者的大出血风险方面。

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