Department of Pediatrics, Division of Pediatric Hematology and Oncology, University of Minnesota Medical School, Minneapolis, Minnesota, USA.
Division of Pharmacy, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.
Pediatr Blood Cancer. 2021 Jul;68(7):e29024. doi: 10.1002/pbc.29024. Epub 2021 Mar 26.
Iron deficiency anemia (IDA) affects millions of children worldwide. Oral iron replacement is effective but often poorly tolerated. Intravenous iron has been demonstrated to have utility in all ages, but pediatric use remains limited. Low molecular weight iron dextran (LMWID) has a dosing range capable of replacing iron deficits in a single infusion and has been evaluated in small pediatric cohorts, but additional safety and efficacy data are limited. Here, we evaluate the safety and efficacy of LMWID in association with an electronic medical record (EMR)-based effort to optimize dosing.
A retrospective IRB-approved investigation of LMWID utilization at a tertiary pediatric hospital between January 1, 2016 and March 31, 2020 was undertaken to evaluate the therapeutic efficacy and frequency/severity of infusion-related adverse event (AE) in children and adolescents receiving LMWID. Patient demographics and LMWID dosing characteristics were collected, and primary outcome measures included laboratory response and the incidence/severity of any infusion-related events. The utilization of an EMR-based nomogram for LMWID dosing was also evaluated.
A total of 254 infusions for 191 patients were included (ages 0.7-20.9 years), most with IDA. LMWID replaced at least 75% of the estimated iron deficit in a single infusion for 76% of patients. The mean hemoglobin and ferritin increases were 2.1 g/dl and >100 ng/ml, respectively. Infusion-related AEs were rare, occurring in only 12/254 (4.7%) of infusions and 67% during the test dose; each rapidly resolved without long-term sequelae. No AEs occurred in those <10 years of age. Premedication use markedly decreased with nomogram use without a change in AE rate.
In a large institutional cohort, LMWID was well tolerated in children and adolescents, with most patients having their total iron deficits relieved in a single infusion. These data support expanded use of LMWID in the management of pediatric iron deficiency.
缺铁性贫血（IDA）影响着全球数以百万计的儿童。口服铁补充剂是有效的，但往往耐受性差。静脉铁已被证明在所有年龄段都有疗效，但儿科应用仍然有限。低分子右旋糖酐铁（LMWID）的剂量范围能够在单次输注中替代铁缺乏，并已在小的儿科队列中进行了评估，但安全性和疗效数据有限。在这里，我们评估了 LMWID 的安全性和疗效，并结合电子病历（EMR）进行了优化剂量的努力。
对 2016 年 1 月 1 日至 2020 年 3 月 31 日期间在一家三级儿科医院使用 LMWID 的情况进行了回顾性 IRB 批准的调查，以评估接受 LMWID 的儿童和青少年的治疗效果和输注相关不良反应（AE）的频率/严重程度。收集了患者的人口统计学和 LMWID 剂量特征，主要观察指标包括实验室反应和任何输注相关事件的发生率/严重程度。还评估了基于 EMR 的 LMWID 剂量计算图表的应用。
共纳入 191 例患者的 254 次输注（年龄 0.7-20.9 岁），大部分为 IDA。LMWID 在单次输注中至少替代了 75%的估计铁缺乏，占 76%的患者。平均血红蛋白和铁蛋白增加分别为 2.1g/dl 和>100ng/ml。输注相关 AE 罕见，仅 254 次输注中的 12 次（4.7%）和 67%的测试剂量中发生；每个都迅速解决，没有长期后遗症。10 岁以下患者无 AE 发生。使用计算图表后，预处理药物的使用明显减少，而 AE 发生率没有变化。
在一项大型机构队列研究中，LMWID 在儿童和青少年中耐受性良好，大多数患者在单次输注中就能缓解其全部铁缺乏。这些数据支持在儿童缺铁症的治疗中扩大使用 LMWID。
