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口服直接Xa因子抑制剂在肾病综合征患者中的安全性和有效性:一项全国性回顾性研究的结果

Safety and Efficacy of Oral Direct Factor Xa Inhibitors in Patients With Nephrotic Syndrome: Results From a National Retrospective Study.

作者信息

Arches Caroline, Jalal-Eddine Arwa, Titeca-Beauport Dimitri, Dao Myriam, Lobbedez Thierry, Zaoui Philippe, Masset Christophe, Bertrand Dominique, El Karoui Khalil, Brenier Henri, Sakhi Hamza, Peiffer Bastien, Audard Vincent, Joher Nizar

机构信息

Département de Néphrologie et Transplantation, Centre de Référence Maladie Rare Syndrome Néphrotique Idiopathique, Hôpitaux Universitaires Henri Mondor, Assistance Publique-Hôpitaux de Paris AP-HP, Créteil, France.

Université Paris Est Créteil, Institut National de Recherche Médicale (INSERM) U88. Institut Mondor de Recherche Biomédicale (IMRB), Créteil, France.

出版信息

Kidney Int Rep. 2025 Feb 3;10(4):1188-1195. doi: 10.1016/j.ekir.2025.01.042. eCollection 2025 Apr.

DOI:10.1016/j.ekir.2025.01.042
PMID:40303208
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12034858/
Abstract

INTRODUCTION

The optimal management of thromboembolism (TE) in patients with nephrotic syndrome (NS) remains challenging. Until now, anticoagulation therapy for NS consisted of vitamin K antagonists (VKAs) or heparin. Data on direct oral anticoagulant (DOAC) use in NS are limited, and their safety and convenience have been well-demonstrated in other indications.

METHODS

We conducted a multicenter retrospective study of adult patients with NS treated with therapeutic-dose anticoagulation between 2014 and 2022. We compared the incidences of bleeding and TE events between patients receiving DOAC and those receiving VKAs or heparin (standard-of-care [SOC]). Patients with end-stage kidney disease were excluded.

RESULTS

The overall population consisted of 144 patients (median [interquartile range] age of 54 [38-67] years, 34.7% women) with a median albumin level at 1.5 (1.2-1.8) g/dl and a median urinary protein-to-creatinine ratio of 8.8 (5.5-12.3)g/g. Membranous nephropathy was the main NS etiology (45.8%). No significant differences were observed between the DOAC ( = 72) and the SOC ( = 72) groups. The anticoagulant strategy was primary prophylaxis in 79.2% of patients taking DOAC and 83.3% of patients with SOC ( = 0.67). DOAC use was not associated with an increased rate of TE (4.2% vs. 0%,  = 0.25) or bleeding events (6.9% vs. 13.9%,  = 0.28) compared with the SOC group. Univariate analysis identified female sex, age > 75 years, and anticoagulant exposure > 90 days as risk factors for bleeding.

CONCLUSION

This study suggests that DOAC are safer and more effective than conventional anticoagulant strategies for both primary and secondary prophylaxis in patients with NS.

摘要

引言

肾病综合征(NS)患者血栓栓塞(TE)的最佳管理仍然具有挑战性。到目前为止,NS的抗凝治疗包括维生素K拮抗剂(VKA)或肝素。关于NS中使用直接口服抗凝剂(DOAC)的数据有限,并且它们的安全性和便利性在其他适应症中已得到充分证明。

方法

我们对2014年至2022年间接受治疗剂量抗凝治疗的成年NS患者进行了一项多中心回顾性研究。我们比较了接受DOAC的患者与接受VKA或肝素(标准治疗 [SOC])的患者之间出血和TE事件的发生率。排除终末期肾病患者。

结果

总体人群包括144例患者(中位年龄[四分位间距]为54 [38 - 67]岁,34.7%为女性),中位白蛋白水平为1.5(1.2 - 1.8)g/dl,中位尿蛋白与肌酐比值为8.8(5.5 - 12.3)g/g。膜性肾病是NS的主要病因(45.8%)。DOAC组(n = 72)和SOC组(n = 72)之间未观察到显著差异。79.2%服用DOAC的患者和83.3%接受SOC的患者的抗凝策略是一级预防(P = 0.67)。与SOC组相比,使用DOAC与TE发生率增加(4.2%对0%,P = 0.25)或出血事件增加(6.9%对13.9%,P = 0.28)无关。单因素分析确定女性、年龄>75岁和抗凝暴露>90天为出血的危险因素。

结论

本研究表明,对于NS患者的一级和二级预防,DOAC比传统抗凝策略更安全、更有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebe6/12034858/2a1d8ca1ffe6/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebe6/12034858/2a1d8ca1ffe6/ga1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ebe6/12034858/2a1d8ca1ffe6/ga1.jpg

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Pharmacokinetics and Pharmacodynamics of Apixaban in Nephrotic Syndrome: Findings From a Phase 1a Trial.阿哌沙班在肾病综合征中的药代动力学和药效学:1a期试验结果
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