阿哌沙班和利伐沙班治疗晚期慢性肾病房颤和静脉血栓栓塞的范围综述

摘要(中文译文)

晚期慢性肾脏病（CKD）患者卒中、静脉血栓栓塞症（VTE）和出血风险升高，然而其被排除在重大试验之外，导致阿哌沙班和利伐沙班的给药剂量存在不确定性。旨在梳理现有关于阿哌沙班和利伐沙班在晚期CKD（以非透析为主）患者中用于治疗心房颤动（AF）和/或静脉血栓栓塞症（VTE）的给药实践及相关临床结局的证据，并识别该领域的知识空白。按照Arksey和O'Malley框架进行范围综述，并依据PRISMA-ScR指南报告。检索策略由医学图书馆员协助制定，检索数据库包括MEDLINE、Embase、Cochrane和CINAHL，检索截止日期为2025年5月7日。去除重复记录后，使用Covidence管理文献。两名评审员独立筛选标题、摘要和全文。纳入标准为：在患有AF或VTE的晚期CKD（以非透析为主）成人中，研究阿哌沙班或利伐沙班给药剂量并报告血栓栓塞或大出血结局的研究。排除非英文文献及特定出版类型（如摘要、病例系列、社论）。使用结构化表格提取数据，并进行总结以回答研究目的。共纳入34项研究：7项VTE研究、6项AF/VTE合并研究、21项AF研究。与华法林相比，标准剂量的阿哌沙班和利伐沙班更常被使用，且与较低的复发性VTE和大出血发生率相关，但差异无统计学意义。在阿哌沙班组中，标准剂量5 mg每日两次的VTE事件少于2.5 mg每日两次，但大出血事件更多，差异同样无统计学意义。在AF研究中，标准剂量和减量阿哌沙班（5 mg每日两次和2.5 mg每日两次）以及减量利伐沙班（15 mg每日一次）均较华法林显著降低大出血风险。卒中风险的降低未始终具有统计学意义，但阿哌沙班和利伐沙班较华法林呈降低趋势。在唯一一项比较阿哌沙班与利伐沙班的AF研究中，利伐沙班两种剂量（20 mg或15 mg每日一次）的出血率均高于阿哌沙班。四项AF研究中的一项显示，标准剂量阿哌沙班较减量阿哌沙班出血率更高。本综述总结了阿哌沙班和利伐沙班在晚期CKD患者中用于AF/VTE的给药情况，揭示了诸多空白，如剂量比较研究有限、结局指标异质性大以及非透析人群数据稀缺。迫切需要高质量的随机对照试验。

Abstract

Individuals with advanced chronic kidney disease (CKD) have elevated risks for stroke, venous thromboembolism (VTE), and bleeding, yet their exclusion from major trials leaves uncertainty about dosing of apixaban and rivaroxaban. To map existing evidence on apixaban and rivaroxaban dosing practices and associated clinical outcomes in patients with advanced CKD, predominantly not receiving dialysis, treated for atrial fibrillation (AF) and/or venous thromboembolism (VTE), and to identify knowledge gaps in this area. A scoping review was conducted following the Arksey and O'Malley framework and reported per PRISMA-ScR guidelines. The search, developed with a medical librarian, was conducted in MEDLINE, Embase, Cochrane, and CINAHL through May 7, 2025. Duplicates were removed, and records managed in Covidence. Two reviewers independently screened titles, abstracts, and full texts. We included studies of apixaban or rivaroxaban dosing in adults with advanced CKD (mostly non-dialysis) with AF or VTE reporting thromboembolic or major bleeding outcomes. Non-English articles and publication types (e.g., abstracts, case series, editorials) were excluded. Data was extracted using a structured form and summarized to address the study aim. Thirty-four studies were identified: seven VTE, six combined AF/VTE, and 21 AF. Standard-dose apixaban and rivaroxaban were more commonly used and associated with lower, though non-significant, rates of recurrent VTE and major bleeding compared to warfarin. In apixaban groups, standard-dose 5 mg BID had fewer VTE events than the 2.5 mg BID dose but more major bleeding events which were also not statistically significant. In AF studies, both standard and reduced-dose apixaban (5 mg BID and 2.5 mg BID), and reduced-dose rivaroxaban (15 mg daily), significantly reduced major bleeding risk versus warfarin. Stroke reductions were not consistently significant but trended lower with apixaban and rivaroxaban compared to warfarin. In the only AF study comparing apixaban and rivaroxaban, both doses of rivaroxaban (20 mg or 15 mg daily) had higher bleeding rates than apixaban. One of four AF studies showed higher bleeding with standard versus reduced-dose apixaban. This review summarizes apixaban and rivaroxaban dosing for AF/VTE in advanced CKD, revealing gaps such as limited dose-comparison studies, heterogeneous outcomes and sparse data in non-dialysis. Robust trials are urgently needed.

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