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非透析3/4期慢性肾脏病患者中,非布司他对高尿酸血症及估计肾小球滤过率的疗效以及心脏功能评估:一项为期12个月的干预性研究。

Efficacy of febuxostat on hyperuricemia and estimated glomerular filtration rate in patients with non-dialysis stage 3/4 chronic kidney disease and assessment of cardiac function: a 12-month interventional study.

作者信息

Waheed Yousuf Abdulkarim, Yang Fan, Liu Jie, Almayahe Shifaa, Selvam Karthick Kumaran Munisamy, Wang Disheng, Sun Dong

机构信息

Department of Nephrology, Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.

Clinical Research Center for Kidney Disease, Xuzhou Medical University, Xuzhou, China.

出版信息

Front Nephrol. 2025 Mar 26;5:1526182. doi: 10.3389/fneph.2025.1526182. eCollection 2025.

Abstract

OBJECTIVES

Febuxostat, an oral medication for treating hyperuricemia (HUA), is a non-purine xanthine oxidase inhibitor that regulates serum uric acid (SUA) metabolism in patients with chronic kidney disease (CKD). However, the drug's effectiveness in improving renal function in patients with non-dialysis stage 3/4 CKD remains unclear. Our aim is to investigate the efficacy of febuxostat on kidney function. In addition, the cardiac function will be assessed.

METHOD

We conducted a single-center, interventional, randomized, controlled, open-label study. A total of 316 patients with non-dialysis stage 3/4 CKD, with SUA ≥6mg/dL in women and ≥7mg/dL in men, were assigned to either the febuxostat group (n=156) or the control group (n=160). The primary endpoint was the evaluation of changes in kidney biomarkers from baseline to 12 months of treatment, and any changes in cardiac biomarkers and echocardiographs were the secondary endpoint.

RESULTS

The primary endpoint was a comparison between the two groups from baseline to 12 months of treatment. SUA was significantly decreased in patients treated with febuxostat 40 mg (6.85 ± 0.41mg/dL at baseline and 5.27 ± 0.70mg/dL at 12 months of treatment, ) and this was associated with increased eGFR (34.48 ± 8.42ml/min at baseline and 38.46 ± 8.87ml/min at 12 months of treatment, ). There were significant decreases in high-sensitivity troponin T (19.50 ± 7.24ng/L at baseline and 16.98 ± 7.32ng/L at 12 months of treatment, and N-terminal-pro brain natriuretic peptide (941.35 ± 374.30pg/ml at baseline and 762.22 ± 303.32 pg/ml at 12 months of treatment, in the febuxostat group. These changes were also associated with increased left ventricular ejection fraction in the febuxostat group (50.47 ± 3.95% at baseline and 51.12 ± 3.96% at the end of the study, ).

CONCLUSION

In the interventional group, febuxostat was well-tolerated and demonstrated a reduction in SUA associated with an increase in eGFR. This slowed down the progression of renal disease in patients with non-dialysis stage 3/4 CKD and improved cardiac function.

摘要

目的

非布司他是一种用于治疗高尿酸血症(HUA)的口服药物,是一种非嘌呤类黄嘌呤氧化酶抑制剂,可调节慢性肾脏病(CKD)患者的血清尿酸(SUA)代谢。然而,该药物在改善非透析3/4期CKD患者肾功能方面的有效性仍不明确。我们的目的是研究非布司他对肾功能的疗效。此外,还将评估心脏功能。

方法

我们进行了一项单中心、干预性、随机、对照、开放标签研究。共有316例非透析3/4期CKD患者,女性SUA≥6mg/dL,男性SUA≥7mg/dL,被分为非布司他组(n=156)或对照组(n=160)。主要终点是评估从基线到治疗12个月时肾脏生物标志物的变化,心脏生物标志物和超声心动图的任何变化为次要终点。

结果

主要终点是两组从基线到治疗12个月的比较。接受40mg非布司他治疗的患者SUA显著降低(基线时为6.85±0.41mg/dL,治疗12个月时为5.27±0.70mg/dL),这与估算肾小球滤过率(eGFR)增加有关(基线时为34.48±8.42ml/min,治疗12个月时为38.46±8.87ml/min)。非布司他组高敏肌钙蛋白T(基线时为19.50±7.24ng/L,治疗12个月时为16.98±7.32ng/L)和N末端脑钠肽前体(基线时为941.35±374.30pg/ml,治疗12个月时为762.22±303.32pg/ml)显著降低。这些变化也与非布司他组左心室射血分数增加有关(基线时为50.47±3.95%,研究结束时为51.12±3.96%)。

结论

在干预组中,非布司他耐受性良好,SUA降低,同时eGFR增加。这减缓了非透析3/4期CKD患者肾病的进展并改善了心脏功能。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0649/11979189/20aa0ff4d62d/fneph-05-1526182-g001.jpg

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