Supplementary Material for: Ultrarapid Iron Polymaltose Infusions Are Safe for Management of Iron Deficiency

<b><i>Introduction:</i></b> Iron deficiency is a common condition, especially among patients with kidney and heart failure and inflammatory bowel disease. Intravenous iron is the preferred method of treatment in these patients, but it usually requires prolonged iron polymaltose infusions or multiple administrations of alternative preparations. The aim of the study was to confirm the safety and patient acceptance of ultrarapid iron polymaltose infusions as an alternative to slower treatments and ferric carboxymaltose. <b><i>Method:</i></b> An open-label, phase 4 safety study was conducted at a tertiary hospital, with consenting participants diagnosed with iron deficiency and requiring iron polymaltose up to 1,500 mg receiving the infusion over 15 min. The acute adverse event (AE) rates and their severities were compared to historical controls of 1- and 4-h iron polymaltose infusions from a retrospective study of 648 patients from the same study site. Delayed AEs as well as participant infusion acceptability were also studied. <b><i>Results:</i></b> Three hundred participants over a 2-year period received ultrarapid infusions of iron polymaltose with an acute AE rate of 18.7% and severe AE rate of 1.0%. The total and mild infusion AE rates were higher compared to those of slower infusions (<i>p</i> &lt; 0.001), but comparable for moderate and severe AEs. Delayed reactions occurred in 12.5% of participants, with over 95% of them preferring repeat ultrarapid infusions if required again. <b><i>Conclusion:</i></b> Iron polymaltose can be safely infused at ultrarapid rates when compared to slower infusions, with similar safety to ferric carboxymaltose, offering greater convenience for patients and reduced healthcare costs.

**引言：** 缺铁症（iron deficiency）是一种常见病症，尤其高发于心肾衰竭与炎症性肠病患者群体中。此类患者的首选治疗方案为静脉补铁（intravenous iron），但通常需要长期输注麦芽糖铁（iron polymaltose），或是多次使用其他替代补铁制剂。本研究旨在验证超快输注麦芽糖铁方案作为常规慢速输注疗法及羧基麦芽糖铁（ferric carboxymaltose）的替代方案的安全性与患者接受度。
**方法：** 本研究为一项开放标签（open-label）IV期（phase 4）安全性临床试验，在某三级医院开展，纳入确诊缺铁症且需输注麦芽糖铁剂量不超过1500mg的知情同意受试者，给药时长为15分钟。将急性不良事件（acute adverse event, AE）的发生率与严重程度，与同一研究中心既往一项纳入648名患者的回顾性研究中，接受1小时及4小时麦芽糖铁输注的历史对照组数据进行对比。同时本研究还对迟发性不良事件（delayed AEs）及受试者的输注接受度进行了评估。
**结果：** 为期2年的研究周期内，共计300名受试者接受了超快输注麦芽糖铁治疗，其急性不良事件发生率为18.7%，严重不良事件发生率为1.0%。总输注相关不良事件发生率及轻度输注相关不良事件发生率均高于慢速输注组（p<0.001），但中度与重度不良事件发生率两组间无显著差异。12.5%的受试者出现迟发性不良反应，其中超过95%的受试者表示，若后续仍需补铁，更愿意接受再次超快输注。
**结论：** 与慢速输注方案相比，麦芽糖铁可安全地以超快速率输注，且安全性与羧基麦芽糖铁相当，可为患者带来更高的治疗便利性，并降低医疗成本。