Kaserer Alexander, Braun Julia, Mair Alexander, Akbas Samira, Rössler Julian, Bischoff-Ferrari Heike A, Turina Matthias, Clavien Pierre-Alain, Opitz Isabelle, Hülsmeier Andreas, Karsai Gergely, Gasciauskaite Greta, Spahn Gabriela H, Schläpfer Martin, Spahn Donat R
Institute of Anesthesiology, University of Zurich and University Hospital Zurich, Zurich, Switzerland.
Departments of Epidemiology and Biostatistics, Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland.
J Clin Anesth. 2025 Feb;101:111727. doi: 10.1016/j.jclinane.2024.111727. Epub 2024 Dec 12.
Iron deficiency anemia in the perioperative setting is treated predominantly with intravenous iron formulation, of which ferric carboxymaltose may induce hypophosphatemia by modulating fibroblast growth factor 23.
In this single-center, prospective, randomized, double-blind trial, we consented 92 adult patients scheduled for elective major abdominal or thoracic surgery. These patients either had isolated iron deficiency (plasma ferritin <100 ng/mL or transferrin saturation < 20 %) or iron deficiency anemia (hemoglobin (Hb) 100-130 g/L with plasma ferritin <100 ng/mL or transferrin saturation < 20 %). Preoperatively, participants received a single preoperative intravenous dose of ferric carboxymaltose and were then randomly assigned to receive either phosphate or placebo, administered orally three times a day for 30 days corresponding to an 18 mmol dose of daily phosphate supplementation in the intervention group. The primary endpoint was the minimum serum phosphate concentration during follow-up visits. The key secondary efficacy endpoint was mean perioperative hemoglobin concentration of postoperative days 0, 2 and 4, assessing the non-inferiority of additional phosphate supplementation.
We randomly consented 46 patients in each group (mean ± SD age 56 ± 17 years, 57 % female). Minimal phosphate concentration was 0.49 ± 0.21 mmol/L in the treatment group and 0.42 ± 0.17 mmol/L in the placebo group (p = 0.12, two-sided p-value). Average mean hemoglobin was 110 ± 16 g/L in the treatment and 113 ± 13 g/L in the placebo group (p = 0.023, one-sided p-value for non-inferiority). Hypophosphatemia occurred in 32 patients (70 %) of the treatment group and in 39 patients (85 %) of the placebo group (odds ratio 0.15, 95 % CI from 0.02 to 0.77, p = 0.014). Secondary outcomes, such as rescue medication use, core muscle strength and MOCA test scores, did not differ between groups.
Co-administration of oral phosphate supplementation to ferric carboxymaltose cannot prevent hypophosphatemia. However, hypophosphatemia occurs in fewer patients. Phosphate co-administration did not impede the treatment of iron deficiency anemia with ferric carboxymaltose.
围手术期缺铁性贫血主要采用静脉铁制剂治疗，其中羧麦芽糖铁可能通过调节成纤维细胞生长因子23诱导低磷血症。
在这项单中心、前瞻性、随机、双盲试验中，我们纳入了92例计划进行择期腹部或胸部大手术的成年患者。这些患者要么患有单纯缺铁（血浆铁蛋白<100 ng/mL或转铁蛋白饱和度<20%），要么患有缺铁性贫血（血红蛋白（Hb）100 - 130 g/L，血浆铁蛋白<100 ng/mL或转铁蛋白饱和度<20%）。术前，参与者接受单次术前静脉注射羧麦芽糖铁，然后随机分配接受磷酸盐或安慰剂治疗，每天口服3次，持续30天，干预组相当于每日补充18 mmol剂量的磷酸盐。主要终点是随访期间的最低血清磷酸盐浓度。关键的次要疗效终点是术后第0、2和4天的围手术期平均血红蛋白浓度，评估额外补充磷酸盐的非劣效性。
我们每组随机纳入46例患者（平均±标准差年龄56±17岁，57%为女性）。治疗组的最低磷酸盐浓度为0.49±0.21 mmol/L，安慰剂组为0.42±0.17 mmol/L（p = 0.12，双侧p值）。治疗组的平均血红蛋白为110±16 g/L，安慰剂组为113±13 g/L（p = 0.023，非劣效性的单侧p值）。治疗组32例患者（70%）发生低磷血症，安慰剂组39例患者（85%）发生低磷血症（比值比0.15，95%置信区间为0.02至0.77，p = 0.014）。其他次要结局，如急救药物使用、核心肌肉力量和蒙特利尔认知评估量表（MOCA）测试分数，两组之间无差异。
羧麦芽糖铁联合口服补充磷酸盐不能预防低磷血症。然而，发生低磷血症的患者较少。联合使用磷酸盐并不妨碍羧麦芽糖铁治疗缺铁性贫血。
