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研究低铁异构麦芽糖铁(FDI)对缺铁但无贫血的慢性肾脏病患者自我报告的生活质量结局指标的影响。

Investigating the Impact of Ferric Derisomaltose (FDI) on Patient-Reported Quality-of-Life Outcome Measures in Iron-Deficient but Not Anaemic Patients with Chronic Kidney Disease.

作者信息

Jafri Alisha, Youlden Charlotte, Spencer Sebastian, Bhandari Sunil

机构信息

King's College Hospital NHS Foundation Trust, London SE5 9RS, UK.

North Cumbria Integrated Care NHS Foundation Trust, Carlisle CA2 7HY, UK.

出版信息

Biomedicines. 2025 Jul 31;13(8):1860. doi: 10.3390/biomedicines13081860.

DOI:10.3390/biomedicines13081860
PMID:40868115
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12383970/
Abstract

: Iron deficiency without anaemia (IDNA) is common in non-dialysis-dependent chronic kidney disease (CKD) and contributes to fatigue, reduced exercise tolerance, and impaired quality of life (QoL). While intravenous (IV) iron replacement is known to benefit anaemic patients, its role in IDNA remains uncertain. This study aimed to evaluate the impact of ferric derisomaltose (FDI) on patient-reported QoL outcomes in CKD patients with IDNA. This was a post hoc analysis of the double-blind, multicentre Iron and the Heart randomised controlled trial. Fifty-four participants with IDNA (ferritin < 100 µg/L or transferrin saturation < 20% and haemoglobin 110-150 g/L) and CKD stages G3b-G5 were randomised 1:1 to receive either 1000 mg FDI ( = 26) or placebo ( = 28). An additional 10 iron-replete CKD patients served as controls. SF-36v2 QoL surveys were collected at baseline, 1 month, and 3 months. : SF-36v2 scores declined across all domains, but deterioration was consistently milder in the FDI group. Role physical declined by 3% in the FDI group versus 12% with placebo and 4% in controls. Bodily pain improved by 2.8% with FDI but worsened by 1.5% in the placebo group. Mental health improved by 3.4 points with FDI and declined by 2.7 points in the placebo group, creating a 6.1-point separation. While differences did not reach statistical significance, likely due to small sample size, the consistent trends favour FDI. : IV iron may attenuate QoL decline in non-dialysis-dependent CKD patients with IDNA. These findings support the need for larger, adequately powered trials to assess patient-centred outcomes in this population.

摘要

缺铁但无贫血(IDNA)在非透析依赖的慢性肾脏病(CKD)中很常见,会导致疲劳、运动耐量降低和生活质量(QoL)受损。虽然静脉注射(IV)铁剂替代疗法已知对贫血患者有益,但其在IDNA中的作用仍不确定。本研究旨在评估异麦芽糖铁(FDI)对IDNA的CKD患者报告的QoL结局的影响。这是对双盲、多中心铁与心脏随机对照试验的事后分析。54名IDNA(铁蛋白<100μg/L或转铁蛋白饱和度<20%且血红蛋白110 - 150g/L)且CKD分期为G3b - G5的参与者按1:1随机分组,分别接受1000mg FDI(n = 26)或安慰剂(n = 28)。另外10名铁充足的CKD患者作为对照。在基线、1个月和3个月时收集SF - 36v2 QoL调查问卷。:所有领域的SF - 36v2评分均下降,但FDI组的恶化程度始终较轻。FDI组角色功能 - 身体维度下降3%,而安慰剂组为12%,对照组为4%。FDI使身体疼痛改善2.8%,而安慰剂组恶化1.5%。FDI使心理健康改善3.4分,安慰剂组下降2.7分,差距为6.1分。虽然差异未达到统计学显著性,可能是由于样本量小,但一致的趋势有利于FDI。:静脉注射铁剂可能会减轻非透析依赖的IDNA的CKD患者的QoL下降。这些发现支持需要进行更大规模、有足够效力的试验来评估该人群以患者为中心的结局。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1edb/12383970/6b0f08a81376/biomedicines-13-01860-g008.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1edb/12383970/6b0f08a81376/biomedicines-13-01860-g008.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1edb/12383970/2d187d3c6b4e/biomedicines-13-01860-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1edb/12383970/afd32c84f911/biomedicines-13-01860-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1edb/12383970/6b0f08a81376/biomedicines-13-01860-g008.jpg

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UK kidney association clinical practice guideline: update of anaemia of chronic kidney disease.英国肾脏协会临床实践指南:慢性肾脏病贫血的更新
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