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非奈利酮降低中国非糖尿病慢性肾脏病患者蛋白尿的效果及安全性:一项真实世界回顾性研究

Proteinuria reduction by and safety of finerenone in Chinese patients with CKD without diabetes: a real-world retrospective study.

作者信息

Cong Guangting, Qin Yue, Wang Xingzhi, Sui Manshu

机构信息

Department of Nephrology, the First Affiliated Hospital of Harbin Medical University, No. 23 Youzheng Road, Nangang District, Harbin, Heilongjiang, 150001, P. R. China.

出版信息

BMC Urol. 2025 Aug 2;25(1):189. doi: 10.1186/s12894-025-01897-2.

DOI:10.1186/s12894-025-01897-2
PMID:40753244
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12317585/
Abstract

BACKGROUND

This retrospective study aimed to assess the effectiveness and safety of finerenone in patients with chronic kidney disease (CKD) without diabetes mellitus (DM), as evidence from both clinical trials and real-world data remains limited.

METHODS

Patients with CKD and without DM were enrolled in this study from December 2022 to August 2023. In addition to standard CKD treatment, patients received finerenone. Twenty-four-hour urinary protein (UTP) levels, estimated glomerular filtration rate (eGFR), and serum potassium (sK⁺) levels were measured on a monthly basis for 5 months from the time of enrolment.

RESULTS

A total of 43 patients were enrolled, with a baseline 24-h UTP of 5.58 ± 7.67 g. The mean age of the patients was 50.98 ± 13.00 years, and 30 individuals (69.8%) were male. Membranous nephropathy was diagnosed in 20 patients (46.5%). During follow-up, the 24-h UTP levels significantly decreased, with a median reduction of 2.46 g (IQR: 0.2015-2.609; P < 0.01) and a percentage change of 60.86% (IQR: 35.625-87.062%) being observed. No significant changes were observed in the eGFR (P = 0.713) or sK⁺ levels (P = 0.400), which remained within a range of 3.5-5.5 mmol/L. No rehospitalizations due to hyperkalaemia occurred.

CONCLUSION

Finerenone treatment significantly reduced proteinuria over the follow-up period, with minimal effects on potassium and the eGFR being observed, thereby supporting its safety and efficacy in the treatment of CKD patients without DM.

摘要

背景

这项回顾性研究旨在评估非奈利酮在非糖尿病慢性肾病(CKD)患者中的有效性和安全性,因为来自临床试验和真实世界数据的证据仍然有限。

方法

2022年12月至2023年8月,将非糖尿病CKD患者纳入本研究。除了标准的CKD治疗外,患者接受非奈利酮治疗。从入组时起,每月测量5个月的24小时尿蛋白(UTP)水平、估计肾小球滤过率(eGFR)和血清钾(sK⁺)水平。

结果

共纳入43例患者,基线24小时UTP为5.58±7.67g。患者的平均年龄为50.98±13.00岁,30例(69.8%)为男性。20例(46.5%)诊断为膜性肾病。随访期间,24小时UTP水平显著降低,中位数降低2.46g(IQR:0.2015 - 2.609;P<0.01),观察到的百分比变化为60.86%(IQR:35.625 - 87.062%)。eGFR(P = 0.713)或sK⁺水平(P = 0.400)未观察到显著变化,其仍保持在3.5 - 5.5 mmol/L范围内。未发生因高钾血症而再住院的情况。

结论

在随访期间,非奈利酮治疗显著降低蛋白尿,对钾和eGFR的影响最小,从而支持其在治疗非糖尿病CKD患者中的安全性和有效性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/98c7/12317585/6c046f80fe2a/12894_2025_1897_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/98c7/12317585/6c046f80fe2a/12894_2025_1897_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/98c7/12317585/6c046f80fe2a/12894_2025_1897_Fig1_HTML.jpg

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本文引用的文献

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Finerenone, a Non-Steroidal Mineralocorticoid Receptor Antagonist, Reduces Vascular Injury and Increases Regulatory T-Cells: Studies in Rodents with Diabetic and Neovascular Retinopathy.非奈利酮,一种非甾体盐皮质激素受体拮抗剂,可减少血管损伤并增加调节性 T 细胞:在糖尿病和新生血管性视网膜病变的啮齿动物中的研究。
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新型抗炎抗纤维化药物治疗糖尿病肾病:从基础到临床。
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Finerenone Reduces Risk of Incident Heart Failure in Patients With Chronic Kidney Disease and Type 2 Diabetes: Analyses From the FIGARO-DKD Trial.非奈利酮降低慢性肾脏病和 2 型糖尿病患者的心力衰竭事件风险:FIGARO-DKD 试验分析。
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