在IBD引起的缺铁性贫血患者中，不同补铁制剂导致的低磷血症风险
- ①纳入97名IBD引起的缺铁性贫血成人患者，49名接受FDI治疗，48名接受FCM治疗；
- ②从基线到第35天及到第70天，FDI组的低磷血症发生率均显著低于FCM组（8.3% vs. 51.0%，12.5% vs. 59.2%）；
- ③与FDI组相比，FCM组的完整FGF23、肾磷酸盐排泄和甲状旁腺素增加更明显，1,25-二羟基维生素D减少更明显，疲劳评分改善更缓慢，与低磷血症相关；
- ④两组铁蛋白、转铁蛋白饱和度和血红蛋白均明显增加，副作用和严重不良事件发生率相似。
主编推荐语
Gut上发表的一项随机双盲对照试验结果，在97名IBD引起的缺铁性贫血患者中，对比了两种补铁制剂——去甲麦芽糖铁（FDI）和羧基麦芽糖铁（FCM）的疗效及安全性，两组的缺铁性贫血均得到显著改善，但FCM导致的低磷血症发生率显著高于FCM。
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Hypophosphataemia following ferric derisomaltose and ferric carboxymaltose in patients with iron deficiency anaemia due to inflammatory bowel disease (PHOSPHARE-IBD): a randomised clinical trial
IBD引起的缺铁性贫血患者使用去甲麦芽糖铁和羧基麦芽糖铁后的低磷血症：一项随机临床试验
10.1136/gutjnl-2022-327897
2022-09-09, Article
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Objective: Intravenous iron—a common treatment for anaemia and iron deficiency due to inflammatory bowel disease (IBD)—can cause hypophosphataemia. This trial compared the incidence of hypophosphataemia after treatment with ferric carboxymaltose (FCM) or ferric derisomaltose (FDI).
Design: This randomised, double-blind, clinical trial was conducted at 20 outpatient hospital clinics in Europe (Austria, Denmark, Germany, Sweden, UK). Adults with IBD and iron deficiency anaemia (IDA) were randomised 1:1 to receive FCM or FDI at baseline and at Day 35 using identical haemoglobin- and weight-based dosing regimens. The primary outcome was the incidence of hypophosphataemia (serum phosphate <2.0 mg/dL) at any time from baseline to Day 35 in the safety analysis set (all patients who received ≥1 dose of study drug). Markers of mineral and bone homeostasis, and patient-reported fatigue scores, were measured.
Results : A total of 156 patients were screened; 97 (49 FDI, 48 FCM) were included and treated. Incident hypophosphataemia occurred in 8.3% (4/48) FDI-treated patients and in 51.0% (25/49) FCM-treated patients (adjusted risk difference: −42.8% (95% CI –57.1% to –24.6%) p<0.0001). Both iron formulations corrected IDA. Patient-reported fatigue scores improved in both groups, but more slowly and to a lesser extent with FCM than FDI; slower improvement in fatigue was associated with greater decrease in phosphate concentration.
Conclusion: Despite comparably effective treatment of IDA, FCM caused a significantly higher rate of hypophosphataemia than FDI. Further studies are needed to address the longer-term clinical consequences of hypophosphataemia and to investigate mechanisms underpinning the differential effects of FCM and FDI on patient-reported fatigue.
First Authors:
Heinz Zoller
Correspondence Authors:
Heinz Zoller
All Authors:
Heinz Zoller,Myles Wolf,Irina Blumenstein,Christian Primas,Stefan Lindgren,Lars L Thomsen,Walter Reinisch,Tariq Iqbal
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