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阿哌沙班与低分子量肝素或维生素K拮抗剂用于严重肾衰竭患者静脉血栓栓塞治疗的安全性和有效性:一项系统评价和荟萃分析。

Safety and efficacy of apixaban versus low-molecular weight heparin or vitamin-K antagonists for venous thromboembolism treatment in patients with severe renal failure: A systematic review and meta-analysis.

作者信息

Almajdi Anwar, Almutairi Sara, Alharbi Maha

机构信息

College of Pharmacy, Kuwait University, Kuwait.

Department of Pharmacy Practice, College of Pharmacy, Kuwait University, Kuwait.

出版信息

Thromb Res. 2023 Sep;229:77-85. doi: 10.1016/j.thromres.2023.06.027. Epub 2023 Jul 4.

Abstract

INTRODUCTION

Chronic kidney disease is an independent risk factor for venous thromboembolism (VTE). Traditionally, Low Molecular Weight Heparin (LMWH) followed by warfarin has been the conventional therapy for VTE treatment. Direct oral anticoagulants (DOACs), including apixaban, have shown several advantages over the traditional therapy in individuals with normal kidney function. This meta-analysis aims to review the safety and efficacy of apixaban compared to warfarin or LMWH for the treatment of VTE in severe renal failure.

METHOD

We conducted literature search in PubMed, Embase, and Cochrane databases. Retrospective observational studies involving clinical effectiveness and safety outcomes of apixaban compared to warfarin in adult patients with an estimated glomerular filtration rate (eGFR) <30 mL/min/m or on dialysis were included.

RESULTS

Eight studies were included in the analysis. Significant reduction in VTE recurrence observed in apixaban compared to warfarin (RR, 0.65; 95 % CI, 0.43-0.98; P = 0.04; I2 = 78 %). No significant difference in all-cause mortality between apixaban and warfarin (RR, 0.99; 95 % CI, 0.91-1.07; P = 0.74; I2 = 0 %). Apixaban showed a significantly lower rate of major bleeding (RR, 0.72; 95 % CI, 0.62-0.84; P < 0.0001; I2 = 34 %) and minor bleeding events (RR, 0.42; 95 % CI, 0.21-0.86; P = 0.02; I2 = 10 %) compared to warfarin. No significant difference observed in clinically relevant non-major bleeding between apixaban and warfarin (RR, 0.81; 95 % CI, 0.65-1.00; P = 0.05; I2 = 67 %).

CONCLUSION

Apixaban was favored over warfarin for treating VTE in severe renal failure, reducing VTE recurrence and bleeding risk. No differences were observed in all-cause mortality and CRNMB events. More evidence is required due to limited RCTs and prospective studies.

摘要

引言

慢性肾脏病是静脉血栓栓塞症(VTE)的独立危险因素。传统上,低分子量肝素(LMWH)继以华法林一直是VTE治疗的传统疗法。直接口服抗凝剂(DOACs),包括阿哌沙班,在肾功能正常的个体中已显示出优于传统疗法的若干优势。本荟萃分析旨在比较阿哌沙班与华法林或LMWH治疗严重肾衰竭患者VTE的安全性和有效性。

方法

我们在PubMed、Embase和Cochrane数据库中进行了文献检索。纳入了涉及估计肾小球滤过率(eGFR)<30 mL/min/m²或正在接受透析的成年患者中阿哌沙班与华法林临床有效性和安全性结果的回顾性观察性研究。

结果

八项研究纳入分析。与华法林相比,阿哌沙班治疗的VTE复发率显著降低(RR,0.65;95%CI,0.43 - 0.98;P = 0.04;I² = 78%)。阿哌沙班与华法林的全因死亡率无显著差异(RR,0.99;95%CI,0.91 - 1.07;P = 0.74;I² = 0%)。与华法林相比,阿哌沙班的大出血发生率显著更低(RR,0.72;95%CI,0.62 - 0.84;P < 0.0001;I² = 34%),小出血事件发生率也更低(RR,0.42;95%CI,0.21 - 0.86;P = 0.02;I² = 10%)。阿哌沙班与华法林在临床相关非大出血方面无显著差异(RR,0.81;95%CI,0.65 - 1.00;P = 0.05;I² = 67%)。

结论

在治疗严重肾衰竭患者的VTE方面,阿哌沙班优于华法林,可降低VTE复发率和出血风险。在全因死亡率和临床相关非大出血事件方面未观察到差异。由于随机对照试验(RCT)和前瞻性研究有限,需要更多证据。

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