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非透析慢性肾脏病患者中羧基麦芽糖铁的疗效及其对肾功能的影响:一项前瞻性观察性研究。

Efficiency of ferric carboxymaltose in non-dialysis CKD patients and its impact on kidney function: a prospective observational study.

作者信息

Roldão Marisa, Escoli Rachele, Gonçalves Hernâni, Lobos Ana Vila

机构信息

Department of Nephrology, Centro Hospitalar do Médio Tejo, Av. Xanana Gusmão 45, 2350-754, Torres Novas, Portugal.

出版信息

Int Urol Nephrol. 2023 Apr;55(4):953-959. doi: 10.1007/s11255-022-03360-9. Epub 2022 Sep 29.

DOI:10.1007/s11255-022-03360-9
PMID:36173535
Abstract

BACKGROUND

Iron deficiency anemia occurs in most patients with non-dialysis chronic kidney disease (ND-CKD). Previous studies have suggested that intravenous (IV) iron therapy is more effective than oral iron in these patients. Clinical evidence relating the effects of IV iron on renal function is, however, limited.

METHODS

Prospective observational study of adult patients with ND-CKD, anemia, iron deficiency, and estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m, treated with a single dose of 500 mg or 1000 mg of ferric carboxymaltose (FCM) and followed-up for 24 weeks. Primary outcome was FCM efficacy, assessed by comparing Hb, TSAT and ferritin at 24 weeks with those at baseline. Secondary outcome was FCM impact on renal function, evaluated by comparing eGFR over the same period.

RESULTS

One hundred and forty patients were recruited: seventy-eight (55.7%) were treated with 1000 mg and 62 (44.3%) with 500 mg of FCM. 24 weeks after FCM administration, Hb increased 1.54 ± 1.99 g/dL (95% CI 1.09-1.99, p = 001) in the group treated with 1000 mg and 0.86 ± 1.4 g/dL (95% CI 0.53-1.22, p = 0.001) in those treated with 500 mg. TSAT increased in both groups but more in those treated with 1000 mg, and ferritin only increased in the latter. Estimated GFR showed a significant increase of 1.55 ± 6.86 mL/min/m (95% CI 0.05-3.09, p = 0.049), from a baseline of 27.73 ± 17.23 to 28.88 ± 18.02 mL/min/m in the group treated with 1000 mg.

CONCLUSIONS

Our findings suggested that IV FCM therapy was effective in improving serum iron levels and anemia in ND-CKD stage 3 to 5 patients. Higher doses seem to be necessary to replace depleted iron stores. In our cohort, IV FCM therapy was associated with an improvement in renal function, particularly in those treated with higher doses of FCM.

摘要

背景

大多数非透析慢性肾脏病(ND-CKD)患者会发生缺铁性贫血。既往研究表明,对于这些患者,静脉注射铁剂治疗比口服铁剂更有效。然而,关于静脉注射铁剂对肾功能影响的临床证据有限。

方法

对成年ND-CKD、贫血、缺铁且估计肾小球滤过率(eGFR)<60 mL/min/1.73 m²的患者进行前瞻性观察研究,给予单次剂量500 mg或1000 mg的羧麦芽糖铁(FCM)治疗,并随访24周。主要结局是FCM的疗效,通过比较24周时的血红蛋白(Hb)、转铁蛋白饱和度(TSAT)和铁蛋白与基线水平来评估。次要结局是FCM对肾功能的影响,通过比较同一时期的eGFR来评估。

结果

共招募了140例患者:78例(55.7%)接受1000 mg FCM治疗,62例(44.3%)接受500 mg FCM治疗。FCM给药24周后,接受1000 mg治疗组的Hb升高1.54±1.99 g/dL(95%CI 1.09 - 1.99,p = 0.001),接受500 mg治疗组的Hb升高0.86±1.4 g/dL(95%CI 0.53 - 1.22,p = 0.001)。两组的TSAT均升高,但接受1000 mg治疗组升高更多,且铁蛋白仅在接受1000 mg治疗组中升高。接受1000 mg治疗组的估计GFR从基线的27.73±17.23显著升高至28.88±18.02 mL/min/m²,升高了1.55±6.86 mL/min/m²(95%CI 0.05 - 3.09,p = 0.049)。

结论

我们的研究结果表明,静脉注射FCM治疗对于改善3至5期ND-CKD患者的血清铁水平和贫血有效。似乎需要更高剂量来补充耗尽的铁储备。在我们的队列中,静脉注射FCM治疗与肾功能改善相关,尤其是在接受更高剂量FCM治疗的患者中。

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本文引用的文献

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Ferric Carboxymatose in Non-Hemodialysis CKD Patients: A Longitudinal Cohort Study.非血液透析慢性肾脏病患者使用羧麦芽糖铁:一项纵向队列研究
J Clin Med. 2021 Mar 23;10(6):1322. doi: 10.3390/jcm10061322.
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Quality of care and practice patterns in anaemia management at specialist kidney clinics in Ireland: a national study.爱尔兰专科肾脏诊所贫血管理的护理质量与实践模式:一项全国性研究。
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A randomized trial of intravenous and oral iron in chronic kidney disease.
慢性肾脏病静脉和口服铁剂的随机试验
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The impact of intravenous ferric carboxymaltose on renal function: an analysis of the FAIR-HF study.静脉注射羧麦芽糖铁对肾功能的影响:FAIR-HF研究分析
Eur J Heart Fail. 2015 Mar;17(3):329-39. doi: 10.1002/ejhf.229. Epub 2015 Feb 11.
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FIND-CKD: a randomized trial of intravenous ferric carboxymaltose versus oral iron in patients with chronic kidney disease and iron deficiency anaemia.FIND-CKD:一项针对慢性肾脏病合并缺铁性贫血患者比较静脉注射羧麦芽糖铁与口服铁剂的随机试验。
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Erythropoiesis-stimulating agents increase the risk of acute stroke in patients with chronic kidney disease.促红细胞生成素类药物会增加慢性肾脏病患者发生急性中风的风险。
Kidney Int. 2011 Aug;80(3):288-94. doi: 10.1038/ki.2011.49. Epub 2011 Mar 9.
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