Bukit Tinggi Medical Centre, Bandar Bukit Tinggi 1, Klang, Selangor, Malaysia.
Med J Malaysia. 2024 Sep;79(5):517-524.
Up to 24.2% Malaysians are estimated to be affected by anaemia. Iron deficiency is the most common nutritional deficiency leading to anaemia. Oral iron therapy may not be well tolerated or efficient. Ferric carboxymaltose (FCM), a non-dextran intravenous iron formulation, may be an appealing alternative for iron replacement therapy. This retrospective study aimed to investigate the efficacy and safety of intravenous FCM infusion for the management of iron deficiency anaemia in a single centre in Malaysia.
All patients who received at least one dose of 500 mg intravenous FCM infusion from January to December 2023 in Bukit Tinggi Medical Centre (BTMC) were identified from the electronic medical record database. Inclusion criteria were patients: (1) ≥ 14 years old and (2) with iron deficiency anaemia. The primary outcome was the mean change in haemoglobin level before treatment and 30 day after treatment. Secondary outcomes included reasons for intravenous FCM infusion, median dose, adverse drug reactions, mean change in haemoglobin levels for different subgroups and percentage of patients with normalised haemoglobin after treatment. The efficacy outcome was analysed using per-protocol analysis while the safety outcome used intention-to-treat analysis. Paired t-test was used to compare the mean difference between the haemoglobin measurements before and 30-day after treatment.
A total of 144 administrations were given to 141 patients requiring intravenous iron replacement therapy during the 1-year study period in BTMC. Intravenous FCM infusion was administered for the management of iron deficiency related to: (1) increased blood loss, including menorrhagia, haemorrhoids and GI-related surgery, (2) low iron intake, including poor nutrition and gastrointestinalrelated malabsorption and (3) haematological disorders, including autoimmune haemolytic anaemia, myelodysplastic syndrome, diffuse large B-cell lymphoma and idiopathic thrombocytopaenia purpura. The median dose of intravenous FCM infusion was 1000 mg. At 30 day post-infusion, the mean haemoglobin level increased significantly from 8.9 g/L to 11.6 g/L (p < 0.05), an increase of 2.68 g/L (95% CI: 2.45 - 2.90 g/L). No adverse drug reactions were reported. Subgroup analysis showed that patients with haematological disorders had significantly higher improvement in haemoglobin levels after intravenous iron infusion compared to those without. At 7-day, 14-day, 21-day post-infusion, 33% (33/99), 34% (34/99) and 36% (36/99) patients had a normalised haemoglobin level, respectively. The proportion of patients with a normalised haemoglobin level increased to 36% (36/99) and 42% (42/99) at 30-day and 90-day post-infusion.
Within the limit of this single-centre retrospective study, intravenous FCM infusion was well tolerated and effective in increasing the haemoglobin level among patients with iron deficiency anaemia.
据估计，多达 24.2%的马来西亚人受到贫血的影响。铁缺乏是导致贫血的最常见营养缺乏症。口服铁剂治疗可能无法耐受或有效。羧基麦芽糖铁（FCM）是一种非右旋糖酐的静脉内铁制剂，可能是铁替代治疗的一种有吸引力的选择。本回顾性研究旨在调查静脉内 FCM 输注在马来西亚一家中心治疗铁缺乏性贫血的疗效和安全性。
从电子病历数据库中确定了 2023 年 1 月至 12 月期间在武吉丁宜医疗中心（BTMC）接受至少一剂 500 毫克静脉内 FCM 输注的所有患者。纳入标准为：（1）≥14 岁；（2）患有铁缺乏性贫血。主要结局是治疗前和治疗后 30 天血红蛋白水平的平均变化。次要结局包括静脉内 FCM 输注的原因、中位数剂量、药物不良反应、不同亚组的血红蛋白水平平均变化以及治疗后血红蛋白正常化的患者比例。疗效结果采用方案治疗分析，安全性结果采用意向治疗分析。配对 t 检验用于比较治疗前后血红蛋白测量值的平均差异。
在 BTMC 的 1 年研究期间，共进行了 144 次治疗，共 141 例患者需要静脉内铁补充治疗。静脉内 FCM 输注用于治疗与以下原因相关的铁缺乏症：（1）失血增加，包括月经过多、痔疮和胃肠道相关手术；（2）铁摄入量低，包括营养不良和胃肠道相关吸收不良；（3）血液系统疾病，包括自身免疫性溶血性贫血、骨髓增生异常综合征、弥漫性大 B 细胞淋巴瘤和特发性血小板减少性紫癜。静脉内 FCM 输注的中位数剂量为 1000 毫克。输注后 30 天，血红蛋白水平从 8.9 克/升显著增加到 11.6 克/升（p<0.05），增加了 2.68 克/升（95%CI：2.45-2.90 克/升）。未报告药物不良反应。亚组分析显示，与无血液系统疾病的患者相比，有血液系统疾病的患者在静脉补铁后血红蛋白水平的改善更显著。在输注后 7 天、14 天和 21 天，分别有 33%（33/99）、34%（34/99）和 36%（36/99）的患者血红蛋白水平正常化。在输注后 30 天和 90 天，血红蛋白水平正常化的患者比例分别增加至 36%（36/99）和 42%（42/99）。
在这项单中心回顾性研究的范围内，静脉内 FCM 输注在铁缺乏性贫血患者中耐受良好且有效，可以提高血红蛋白水平。
