口服抗凝剂治疗合并心房颤动或静脉血栓栓塞的慢性肾脏病的疗效与安全性：一项系统评价和荟萃分析
Efficacy and safety of oral anticoagulants in the treatment of chronic kidney disease with atrial fibrillation or venous thromboembolism: a systematic review and meta-analysis.
作者信息
Yin Qinan, Zheng Xingyue, Ni Xiaoqing, Wang Yin, Huang Xuefei, Song Yujie, Han Lizhu, Huang Youjin, Bian Yuan
机构信息
Department of Pharmacy, Personalized Drug Research and Therapy Key Laboratory of Sichuan Province, Sichuan Provincial People's Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
Department of Pharmacy, Chengdu Women's and Children's Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Chengdu, China.
出版信息
Front Pharmacol. 2025 Aug 29;16:1615284. doi: 10.3389/fphar.2025.1615284. eCollection 2025.
BACKGROUND
The choice of oral anticoagulants for patients with Chronic Kidney Disease (CKD) combined with venous thromboembolism (VTE) or atrial fibrillation (AF) remains controversial.
OBJECTIVE
To compare the efficacy and safety of warfarin and direct oral anticoagulants (DOACs) in the treatment of CKD with atrial fibrillation or venous thromboembolism.
METHODS
Relevant publications were sourced from databases like PubMed, Embase, Web of Science, Cochrane Library, and ClinicalTrials.gov up to 30 June 2024. Only RCTs assessing the efficacy and safety of warfarin and DOACs for treating CKD with AF or VTE were included in the meta-analysis. The review outcomes are thrombosis recurrence or VTE-related deaths and major bleeding for CKD patients with VTE, and stroke or systemic embolism and major bleeding for CKD patients with AF. The risk of bias in all included studies was evaluated using the Cochrane Collaboration's tool.
RESULTS
After reviewing 540 studies, 15 randomized controlled trials (RCTs) with 16,361 participants were included. The study found that DOACs reduced the risk of hemorrhagic stroke compared to warfarin in patients with AF and CKD (RR = 0.455, 95% CI: 0.275-0.752, P = 0.002). There was no significant difference in ischemic stroke incidence between the two. DOACs also lowered the risk of major bleeding in patients with AF and CKD compared to warfarin (RR = 0.604, 95% CI: 0.442-0.825, P = 0.002), and significantly reduced the risk of intracranial bleeding (RR = 0.424, 95% CI: 0.287-0.626, P < 0.001). All five studies reported recurrent VTE or VTE-related deaths, showing no significant difference between warfarin and DOAC groups (RR = 0.663, 95% CI: 0.409-1.073, P = 0.094), Patients with renal dysfunction on either treatment had similar risks of major bleeding events (RR = 0.543, 95% CI: 0.209-1.407, P = 0.208).
CONCLUSION
DOACs demonstrate superior efficacy and safety compared to warfarin in patients with AF and CKD. Additionally, DOACs exhibit comparable efficacy and safety to warfarin in patients with VTE and CKD.
SYSTEMATIC REVIEW REGISTRATION
http://www.clinicaltrials.gov, identifier (CRD42024510727).
背景
对于慢性肾脏病（CKD）合并静脉血栓栓塞症（VTE）或心房颤动（AF）的患者，口服抗凝剂的选择仍存在争议。
目的
比较华法林和直接口服抗凝剂（DOACs）治疗CKD合并心房颤动或静脉血栓栓塞症的疗效和安全性。
方法
截至2024年6月30日，从PubMed、Embase、Web of Science、Cochrane图书馆和ClinicalTrials.gov等数据库中获取相关出版物。纳入荟萃分析的仅为评估华法林和DOACs治疗CKD合并AF或VTE疗效和安全性的随机对照试验（RCT）。审查结果包括CKD合并VTE患者的血栓形成复发或VTE相关死亡以及大出血，以及CKD合并AF患者的中风或全身性栓塞和大出血。使用Cochrane协作工具评估所有纳入研究的偏倚风险。
结果
在审查了540项研究后，纳入了15项随机对照试验（RCT），共16361名参与者。研究发现，在CKD合并AF的患者中，与华法林相比，DOACs降低了出血性中风的风险（RR = 0.455，95% CI：0.275 - 0.752，P = 0.002）。两者在缺血性中风发生率上无显著差异。与华法林相比，DOACs也降低了CKD合并AF患者大出血的风险（RR = 0.604，95% CI：0.442 - 0.825，P = 0.002），并显著降低了颅内出血的风险（RR = 0.424，95% CI：0.287 - 0.626，P < 0.001）。所有五项研究均报告了复发性VTE或VTE相关死亡，显示华法林组和DOAC组之间无显著差异（RR = 0.663，95% CI：0.409 - 1.073，P = 0.094），接受任何一种治疗的肾功能不全患者发生大出血事件的风险相似（RR = 0.543，95% CI：0.209 - 1.407，P = 0.208）。
结论
在CKD合并AF的患者中，DOACs在疗效和安全性方面优于华法林。此外，在CKD合并VTE的患者中，DOACs在疗效和安全性方面与华法林相当。
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