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Effects of intravenous iron on fibroblast growth factor 23 (FGF23) in haemodialysis patients: a randomized controlled trial

机译:静脉铁剂对血液透析患者成纤维细胞生长因子23(FGF23)的影响:一项随机对照试验

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Background Intravenous iron affects serum levels of intact fibroblast growth factor-23 (iFGF23) and its cleavage product c-terminal FGF23 (cFGF23) in iron-deficient people with normal renal function. We hypothesized that intravenous iron modulates iFGF23 and cFGF23 in haemodialysis patients differently according to the type of iron used. Methods Prevalent, stable haemodialysis patients requiring protocol-based intravenous iron therapy were randomized to a single 200?mg dose of either ferric carboxymaltose (FCM) or iron sucrose (IS). The primary outcome was change in iFGF23 and cFGF23 from pre-infusion to Day 2 post-infusion. Serum hepcidin, ferritin and phosphate were also measured. Pair-wise comparisons utilised the Wilcoxon rank sum test; linear mixed models with an interaction term for treatment and time evaluated between-group effects. Results Forty-two participants completed the study. In those randomized to FCM ( n =?22), median (interquartile range) values pre-infusion and Day 2, respectively, were 843?pg/mL (313–1922) and 576?pg/mL (356–1296, p =?0.05) for iFGF23, 704RU/mL (475–1204) and 813RU/mL (267–1156, p =?0.04) for cFGF23, and 1.53?mmol/L (1.14–1.71) and 1.37 (1.05–1.67, p =?0.03) for phosphate. These parameters did not change following IS. Both serum ferritin ( p Conclusions Contrary to iron-deficient people with normal renal function, haemodialysis patients given protocol-driven intravenous FCM demonstrated a fall in iFGF23 and a rise in cFGF23, changes not evident with IS. This suggests a differential effect of intravenous iron treatment according to both formulation and renal function. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12614000548639 . Registered 22 May 2014 (retrospectively registered).
机译:背景技术在具有正常肾脏功能的缺铁人群中,静脉注射铁会影响完整的成纤维细胞生长因子23(iFGF23)及其裂解产物c端FGF23(cFGF23)的血清水平。我们假设,根据所用铁的类型,静脉内铁对血液透析患者中​​iFGF23和cFGF23的调节作用不同。方法将需要进行基于方案的静脉铁疗法的稳定的血液透析患者随机分为单剂量200mg的羧化麦芽糖铁(FCM)或蔗糖铁(IS)。主要结果是从输注前到输注后第2天iFGF23和cFGF23的变化。还测量了血清铁调素,铁蛋白和磷酸盐。成对比较使用Wilcoxon秩和检验;线性混合模型,其中包含用于治疗的交互作用项和评估组间效果的时间。结果42名参与者完成了研究。在那些随机分配到FCM的患者中(n =?22),输注前和第2天的中位值(四分位数范围)分别为843?pg / mL(313–1922)和576?pg / mL(356–1296,p iFGF23的== 0.05),cFGF23的704RU / mL(475–1204)和813RU / mL(267–1156,p =?0.04),1.53?mmol / L(1.14–1.71)和1.37(1.05-1.67)对于磷酸盐,p = 0.03)。这些参数在IS之后没有改变。两种血清铁蛋白(p结论与肾功能正常的铁缺乏症患者相反,接受方案驱动的静脉FCM的血液透析患者表现出iFGF23下降和cFGF23升高,IS的变化不明显。这表明静脉注射铁具有不同的作用。根据配方和肾功能进行治疗。试验注册澳大利亚和新西兰临床试验注册ACTRN12614000548639。2014年5月22日注册(回顾性注册)。

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