Salford Royal NHS Foundation Trust, Salford, UK.
Hull University Teaching Hospitals NHS Trust, Hull, UK.
BMC Nephrol. 2020 Dec 10;21(1):539. doi: 10.1186/s12882-020-02180-2.
Intravenous iron is often used to treat iron deficiency anaemia in non-dialysis chronic kidney disease (ND-CKD), but the optimal dosing regimen remains unclear. We evaluated the impact of high- versus low-dose intravenous iron isomaltoside on the probability of retreatment with intravenous iron in iron-deficient ND-CKD patients.
This real-world, prospective, observational study collected data from 256 ND-CKD patients treated for anaemia in the UK. Following an initial course of iron isomaltoside, patients were followed for ≥12 months. Iron dose and the need for retreatment were determined at the investigators' discretion. The primary study outcome was the need for retreatment at 52 weeks compared between patients who received >1000 mg of iron during Course 1 and those who received ≤1000 mg. Safety was evaluated through adverse drug reactions.
The probability of retreatment at Week 52 was significantly lower in the >1000 mg iron group (n = 58) versus the ≤1000 mg group (n = 198); hazard ratio (95% confidence interval [CI]): 0.46 (0.20, 0.91); p = 0.012. Mean (95% CI) haemoglobin increased by 6.58 (4.94, 8.21) g/L in the ≤1000 mg group and by 10.59 (7.52, 13.66) g/L in the >1000 mg group (p = 0.024). Changes in other blood and iron parameters were not significantly different between the two groups. Administering >1000 mg of iron isomaltoside saved 8.6 appointments per 100 patients compared to ≤1000 mg. No serious adverse drug reactions were reported. Of the patients who received ≤1000 mg of iron in this study, 82.3% were eligible for a dose >1000 mg.
The >1000 mg iron isomaltoside regimen reduced the probability of retreatment, achieved a greater haemoglobin response irrespective of erythropoiesis-stimulating agent treatment, and reduced the total number of appointments required, compared to the ≤1000 mg regimen. Many of the patients who received ≤1000 mg of iron were eligible for >1000 mg, indicating that there was considerable underdosing in this study.
ClinicalTrials.gov NCT02546154 , 10 September 2015.
静脉铁常用于治疗非透析慢性肾脏病（ND-CKD）患者的缺铁性贫血，但最佳剂量方案仍不清楚。我们评估了高剂量与低剂量静脉铁异麦芽糖对缺铁性 ND-CKD 患者再次静脉铁治疗概率的影响。
本真实世界、前瞻性、观察性研究收集了英国 256 例接受贫血治疗的 ND-CKD 患者的数据。在初始铁异麦芽糖疗程后，对患者进行了≥12 个月的随访。根据研究者的判断，确定铁剂量和再治疗的需要。主要研究结果是在第 1 疗程中接受>1000mg 铁的患者与接受≤1000mg 铁的患者在 52 周时需要再治疗的情况。通过不良反应评估安全性。
第 52 周时，>1000mg 铁组（n=58）再治疗的概率显著低于≤1000mg 组（n=198）；风险比（95%置信区间[CI]）：0.46（0.20，0.91）；p=0.012。≤1000mg 组的平均血红蛋白增加 6.58（4.94，8.21）g/L，>1000mg 组增加 10.59（7.52，13.66）g/L（p=0.024）。两组间其他血液和铁参数的变化无显著差异。与≤1000mg 相比，每 100 例患者使用>1000mg 铁异麦芽糖可节省 8.6 次就诊。未报告严重药物不良反应。在这项研究中，接受≤1000mg 铁的患者中，82.3%适合使用>1000mg 的剂量。
与≤1000mg 方案相比，>1000mg 铁异麦芽糖方案降低了再治疗的概率，无论是否使用促红细胞生成素刺激剂治疗，血红蛋白反应都更大，并减少了所需的总就诊次数。在这项研究中，许多接受≤1000mg 铁的患者适合使用>1000mg 铁，这表明存在相当大的剂量不足。
ClinicalTrials.gov NCT02546154，2015 年 9 月 10 日。
