Department of Anaesthesia, Royal Victoria Infirmary, The Newcastle Upon Tyne Hospitals NHS Foundations Trust, Newcastle Upon Tyne, UK.
Royal National Orthopaedic Hospital NHS Trust, London, UK.
Sci Rep. 2022 Nov 7;12(1):18859. doi: 10.1038/s41598-022-23581-3.
Ferric derisomaltose (FDI; Monofer) is used in clinical practice to treat iron deficiency, but the safety and efficacy of FDI has not been robustly evaluated in a large real-world study. This retrospective, multicentre, audit-based, observational study provides pragmatic information about safety and clinical responses with FDI across therapy areas and patient populations, helping to facilitate treatment decisions. Participating sites provided data from the medical records of adults who had received ≥ 1 FDI infusion. The primary outcome was the incidence of adverse reactions within 24 hours of the FDI infusion. Secondary outcomes included the change from baseline in haemoglobin and ferritin up to 12 months post infusion. In total, 19 sites provided data for a total of 7354 FDI-treated patients; 64.3% of patients were female, and 42.2% were aged ≥ 70 years. Surgery was the main hospital specialty (34.5%). The incidence of any recorded adverse reactions, hypersensitivity reactions, and anaphylaxis were 1.7%, 0.4%, and < 0.1%, respectively, regardless of baseline anaemia status. Statistically significant increases in haemoglobin and ferritin were observed between baseline and Month 4 following FDI treatment (p < 0.0001). Improvements in haemoglobin were more pronounced for hospital specialties where operative blood loss is expected (surgery/obstetrics) compared with those where blood loss is not expected. This study provides real-world clinical evidence for the low risk of adverse reactions with FDI across diverse patient populations, providing reassurance that intravenous iron is not associated with serious toxicity. These findings may inform changes in intravenous iron delivery to provide effective therapy to more patients in need.
三价柠檬酸铁复合物（FDI；Monofer）在临床上用于治疗缺铁症，但在一项大型真实世界研究中，尚未对 FDI 的安全性和疗效进行稳健评估。这项回顾性、多中心、基于审计的观察性研究提供了关于 FDI 在治疗领域和患者人群中的安全性和临床反应的实用信息，有助于促进治疗决策。参与研究的机构提供了接受≥1 次 FDI 输注的成年患者的病历数据。主要结局是 FDI 输注后 24 小时内不良反应的发生率。次要结局包括从基线到输注后 12 个月时血红蛋白和铁蛋白的变化。共有 19 个机构提供了数据，总计 7354 例 FDI 治疗患者；64.3%的患者为女性，42.2%的患者年龄≥70 岁。手术是主要的医院专科（34.5%）。任何记录的不良反应、过敏反应和过敏反应的发生率分别为 1.7%、0.4%和<0.1%，无论基线贫血状态如何。FDI 治疗后第 4 个月，血红蛋白和铁蛋白均观察到统计学上显著增加（p<0.0001）。在预计有手术失血的医院专科（外科/妇产科），与预计无失血的医院专科相比，血红蛋白的改善更为明显。这项研究提供了 FDI 在不同患者人群中不良反应风险低的真实世界临床证据，使人们放心，静脉铁不会引起严重毒性。这些发现可能会改变静脉铁输送方式，为更多有需要的患者提供有效治疗。
