Background In gastroenterological disorders, iron deficiency (ID) is often treated with intravenous iron. This real-world study assessed the effectiveness and safety of iron isomaltoside (IIM), a high-dose intravenous iron, for the treatment of ID in patients with gastroenterological disorders, as part of a service evaluation and improvement process. Methods Medical records of 117 patients with gastroenterological disorders, who received IIM, were examined retrospectively. Study outcomes included dose of IIM (estimated iron need versus actual dose received), number of appointments required to deliver the dose and changes in haemoglobin (Hb) and ferritin at ~1 month and ~6 months post-treatment. Safety was assessed through adverse drug reactions (ADRs). Results Overall, 76.1% of patients received their estimated iron need; 23.9% were underdosed. The mean (SD) iron dose was 1317 (409.7) mg; 62.4% of patients received their dose in one appointment. From baseline, mean (SD) Hb increased by 20.9 (15.4) g/L at 1 month post-treatment (p<0.0001) and by 22.0 (17.9) g/L at 6 months post-treatment (p<0.0001). Mean (SD) baseline ferritin was 26.6 (37.8) μg/L, which increased to 234.6 (142.9) μg/L at 1 month post-treatment (p<0.0001), and remained increased at 6 months post-treatment (122.8 (99.2) μg/L; p<0.0001). A substantial proportion of patients were non-anaemic at 1 month (57.5%) and 6 months (61.8%) post-treatment. At both post-treatment timepoints, the proportion of non-anaemic patients was higher in those receiving their total iron need versus those who were underdosed. No serious ADRs were reported. Conclusion IIM was efficacious and well tolerated in patients with gastroenterological disorders. This real-world study highlights the importance of administering the full iron need to maximise treatment response. Data are available on reasonable request.

中文翻译：

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静脉补铁治疗肠胃疾病患者缺铁的真实世界评价

背景 在胃肠道疾病中，缺铁 (ID) 通常用静脉补铁治疗。作为服务评估和改进过程的一部分，这项真实世界研究评估了高剂量静脉注射铁异麦芽糖苷 (IIM) 治疗胃肠疾病患者 ID 的有效性和安全性。方法对117例接受IIM治疗的胃肠病患者的病历进行回顾性检查。研究结果包括 IIM 剂量（估计的铁需求与实际接受的剂量）、给药所需的预约次数以及治疗后约 1 个月和约 6 个月时血红蛋白 (Hb) 和铁蛋白的变化。通过药物不良反应 (ADR) 评估安全性。结果 总体而言，76.1% 的患者接受了估计的铁需求；23.9% 剂量不足。平均 (SD) 铁剂量为 1317 (409.7) mg；62.4% 的患者在一次预约中接受了剂量。从基线开始，平均 (SD) Hb 在治疗后 1 个月增加了 20.9 (15.4) g/L (p<0.0001)，在治疗后 6 个月增加了 22.0 (17.9) g/L (p<0.0001)。平均 (SD) 基线铁蛋白为 26.6 (37.8) μg/L，在治疗后 1 个月增加到 234.6 (142.9) μg/L (p<0.0001)，并在治疗后 6 个月保持增加 (122.8 (99.2) ) μg/L；p<0.0001)。很大一部分患者在治疗后 1 个月（57.5%）和 6 个月（61.8%）没有贫血。在两个治疗后时间点，接受总铁需求的患者中非贫血患者的比例高于剂量不足的患者。没有报告严重的 ADR。结论 IIM对胃肠道疾病患者有效且耐受性良好。这项真实世界的研究强调了满足全部铁需求以最大限度地提高治疗反应的重要性。可根据合理要求提供数据。