Mayo Clinic, Rochester, MN, United States.
Sleep Med. 2013 Nov;14(11):1100-4. doi: 10.1016/j.sleep.2013.06.006. Epub 2013 Aug 28.
An alternative treatment approach is needed for children who cannot tolerate oral iron preparations or when there is a need for rapid replenishment of iron stores. We report on the safety, adverse effects, and efficacy of intravenous iron sucrose in a retrospective sample of children with restless legs syndrome (RLS) or periodic limb movement disorder (PLMD).
Sixteen children with RLS/PLMD who received intravenous iron sucrose at our institution between 2005 and 2011 were identified. The diagnosis of RLS/PLMD was established after formal sleep consultation and nocturnal polysomnography (PSG). Serum ferritin was assayed in all 16 subjects prior to iron sucrose infusion and in 14 subjects after infusion. The medical records were reviewed for treatment-related details.
The mean age of subjects was 6.6 years (range, 2-16 y; 5/16 girls). The mean periodic limb movement index (PLMI) was 18.2±12.8. Fifteen of the 16 subjects (93.7%) had systemic or neurologic comorbidities. Fourteen of 16 (87.5%) subjects had received prior oral iron supplementation for sleep-related concerns, with the majority of the subjects either having gastrointestinal (GI) side effects or insufficient benefits. Intravenous iron sucrose therefore was provided to these 16 subjects through our outpatient pediatric infusion therapy center. The average dose of intravenous iron sucrose of 3.6 mg/kg was infused over 2 h. The baseline mean serum ferritin was 16.4±6.6 ng/mL. After infusion with intravenous iron sucrose, the mean serum ferritin rose to 45.7±22.4 ng/mL (n=14; [95% confidence interval, 17.2-41.3]; P<.0001). Parental assessment of response to iron sucrose therapy was conducted on follow-up clinic visits or via telephone calls. There was improved sleep in 62.5% (n=10) of subjects and no improvement in 12.5% (n=2) of subjects. No follow-up information was available for 25% (n=4) of subjects. Minor adverse events occurred in 25% (n=4) of subjects--two subjects experienced difficulty with peripheral intravenous catheter placement, while two had transient GI symptoms, such as anorexia, nausea, and vomiting. None of the subjects had anaphylaxis.
Intravenous iron sucrose appears to be a relatively effective therapy for patients with childhood-onset RLS/PLMD and iron deficiency who do not tolerate or respond to oral iron supplements. Side effects were transient. The most common adverse events were difficulty with intravenous line placement and GI disturbance. There is a need for systematic prospective studies on the safety and efficacy of intravenous iron sucrose in RLS/PLMD in children.
对于不能耐受口服铁制剂或需要快速补充铁储存的儿童，需要一种替代治疗方法。我们报告了静脉注射蔗糖铁在一组患有不安腿综合征（RLS）或周期性肢体运动障碍（PLMD）的儿童中的安全性、不良反应和疗效。
在 2005 年至 2011 年期间，我们机构确定了 16 名接受静脉注射蔗糖铁的 RLS/PLMD 儿童。在进行正式的睡眠咨询和夜间多导睡眠图（PSG）后，诊断为 RLS/PLMD。在静脉注射蔗糖铁之前，对所有 16 名受试者进行了血清铁蛋白检测，在 14 名受试者进行了静脉注射蔗糖铁后进行了检测。对病历进行了回顾，以了解与治疗相关的细节。
受试者的平均年龄为 6.6 岁（范围，2-16 岁；5/16 名女孩）。平均周期性肢体运动指数（PLMI）为 18.2±12.8。16 名受试者中的 15 名（93.7%）存在系统性或神经科合并症。16 名受试者中的 14 名（87.5%）因睡眠相关问题接受了先前的口服铁补充剂治疗，大多数受试者存在胃肠道（GI）副作用或获益不足。因此，我们通过我们的儿科门诊输液治疗中心向这 16 名受试者提供了静脉铁蔗糖。平均 3.6mg/kg 的静脉铁蔗糖剂量在 2 小时内输注。基线时的平均血清铁蛋白为 16.4±6.6ng/mL。静脉注射蔗糖铁后，平均血清铁蛋白升高至 45.7±22.4ng/mL（n=14；[95%置信区间，17.2-41.3]；P<.0001）。通过随访门诊就诊或电话随访，对父母进行了对蔗糖铁治疗反应的评估。10 名受试者（62.5%）的睡眠得到改善，2 名受试者（12.5%）没有改善。4 名受试者（25%）的随访信息不可用。25%（n=4）的受试者出现轻微不良反应——2 名受试者外周静脉置管困难，2 名受试者出现短暂的胃肠道症状，如食欲不振、恶心和呕吐。没有受试者发生过敏反应。
静脉注射蔗糖铁似乎是一种相对有效的治疗方法，适用于不能耐受或不能耐受口服铁补充剂的儿童期起病的 RLS/PLMD 和缺铁患者。副作用是短暂的。最常见的不良反应是静脉置管困难和胃肠道紊乱。需要对儿童 RLS/PLMD 中静脉注射蔗糖铁的安全性和疗效进行系统的前瞻性研究。
