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在非糖尿病的中国 CKD 患者中,非奈利酮的疗效和安全性:一项回顾性、真实世界研究。

Effectiveness and safety of finerenone in Chinese CKD patients without diabetes: a retrospective, real-world study.

机构信息

Department of Nephropathy, China-Japan Friendship Hospital, Beijing, 100029, China.

出版信息

Int Urol Nephrol. 2024 Dec;56(12):3877-3885. doi: 10.1007/s11255-024-04142-1. Epub 2024 Jul 10.

Abstract

BACKGROUND

Finerenone, a non-steroidal mineralocorticoid receptor antagonist, has previously demonstrated its efficacy and safety in chronic kidney disease (CKD) associated with diabetes mellitus. Given its therapeutic potential, finerenone has been preliminarily explored in clinical practice for non-diabetic CKD patients. The effectiveness and safety in this population require further investigation in a real-world setting.

METHODS

This retrospective, real-world analysis included non-diabetic CKD patients receiving finerenone. The main clinical outcomes assessed were changes in urinary albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate (eGFR). Serum potassium (sK) levels were also monitored. Data were collected at baseline, and then at 1 month and 3 months following treatment initiation.

RESULTS

Totally, 16 patients were included. There was a notable decrease in UACR from 1-month post-treatment, with a further reduction at 3 months, resulting in a median reduction of 200.41 mg/g (IQR, 84.04-1057.10 mg/g; P = 0.028; percent change, 44.52% [IQR, 31.79-65.42%]). The average eGFR at baseline was 80.16 ml/min/1.73m, with no significant change after 1 month (80.72 ml/min/1.73m, P = 0.594) and a slight numerical increase to 83.45 ml/min/1.73m (P = 0.484) after 3 months. During the 3-month follow-up, sK levels showed only minor fluctuations, with no significant differences compared to baseline, and remained within the normal range throughout the treatment period. No treatment discontinuation or hospitalization due to hyperkalemia was observed.

CONCLUSION

In non-diabetic CKD patients, finerenone showed good effectiveness and safety within a 3-month follow-up period. This study provides valuable real-world evidence supporting the use of finerenone in non-diabetic CKD and highlights the need for future large-scale prospective research to further validate its efficacy.

摘要

背景

非甾体类盐皮质激素受体拮抗剂费来尼酮先前已证实其在糖尿病相关慢性肾脏病(CKD)中的疗效和安全性。鉴于其治疗潜力,费来尼酮已初步在非糖尿病 CKD 患者的临床实践中进行探索。在真实世界环境中,该药物在该人群中的疗效和安全性仍需进一步研究。

方法

本回顾性真实世界分析纳入了接受费来尼酮治疗的非糖尿病 CKD 患者。主要评估的临床结局为尿白蛋白与肌酐比值(UACR)和估算肾小球滤过率(eGFR)的变化。还监测血清钾(sK)水平。数据在基线时采集,然后在治疗开始后 1 个月和 3 个月时采集。

结果

共纳入 16 例患者。治疗 1 个月后 UACR 显著下降,3 个月时进一步下降,中位数降低 200.41mg/g(IQR,84.04-1057.10mg/g;P=0.028;百分比变化,44.52%[IQR,31.79-65.42%])。基线时平均 eGFR 为 80.16ml/min/1.73m,治疗 1 个月后无显著变化(80.72ml/min/1.73m,P=0.594),3 个月后略有增加至 83.45ml/min/1.73m(P=0.484)。在 3 个月随访期间,sK 水平仅略有波动,与基线相比无显著差异,且整个治疗期间均在正常范围内。未观察到因高钾血症而停止治疗或住院。

结论

在非糖尿病 CKD 患者中,费来尼酮在 3 个月的随访期间显示出良好的疗效和安全性。本研究提供了有价值的真实世界证据,支持在非糖尿病 CKD 中使用费来尼酮,并强调需要进一步开展大规模前瞻性研究来验证其疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/946c/11534878/0a16e57bc163/11255_2024_4142_Fig1_HTML.jpg

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