Sloand James A, Shelly Mark A, Feigin Andrew, Bernstein Paul, Monk Rebeca D
Department of Medicine, Nephrology Division, University of Rochester School of Medicine, Rochester, NY, USA.
Am J Kidney Dis. 2004 Apr;43(4):663-70. doi: 10.1053/j.ajkd.2003.11.021.
Restless legs syndrome (RLS) is a common disorder in patients with end-stage renal disease (ESRD) that causes motor agitation and insomnia. Because RLS has been associated with iron deficiency, we sought to investigate the effects of intravenous (IV) iron dextran on symptoms of RLS in a double-blind placebo-controlled trial.
Patients determined to have RLS by International RLS Study Group criteria were administered either iron dextran, 1,000 mg, or normal saline IV in a blinded fashion. Patient demographic data were collected, and blood chemistry tests, liver function studies, serum iron levels, ferritin levels, and total iron-binding capacity were obtained at baseline and 1, 2, and 4 weeks postinfusion. Side effects or adverse events to interventions were monitored, and RLS symptoms were assessed by a rating scale at the same intervals.
Eleven patients were randomly assigned to the administration of iron dextran, and 14 patients to the administration of saline. RLS severity scores were slightly higher in the placebo group at baseline, but hemoglobin levels, iron stores, and other biochemical parameters did not differ. Although no change in symptoms were seen in the placebo-treated group, significant improvement in RLS symptom scores in response to iron dextran was seen 1 week after infusion (-2; interquartile range [IQR], -6 to -1; P = 0.03, Wilcoxon's rank sums), but was greatest at 2 weeks (-3; IQR, -5 to -2 compared with -1 to 0; P = 0.01). Salutary effects of iron persisted at 4 weeks, but were no longer statistically significant. The significant increase in serum ferritin levels and iron saturation observed in the iron dextran-treated group was not seen in the placebo-treated group. No differences in adverse events were noted between groups.
High-dose iron dextran infusion is associated with a significant, but transient, reduction in symptoms of RLS in patients with ESRD.
不安腿综合征（RLS）是终末期肾病（ESRD）患者中的一种常见病症，可导致运动性激越和失眠。由于RLS与缺铁有关，我们试图在一项双盲安慰剂对照试验中研究静脉注射右旋糖酐铁对RLS症状的影响。
根据国际RLS研究组标准确定患有RLS的患者，以盲法接受1000毫克右旋糖酐铁或生理盐水静脉注射。收集患者人口统计学数据，并在基线以及输注后1、2和4周进行血液化学检测、肝功能研究、血清铁水平、铁蛋白水平和总铁结合力检测。监测干预措施的副作用或不良事件，并以评分量表在相同时间间隔评估RLS症状。
11名患者被随机分配接受右旋糖酐铁注射，14名患者接受生理盐水注射。安慰剂组在基线时RLS严重程度评分略高，但血红蛋白水平、铁储备和其他生化参数并无差异。虽然安慰剂治疗组症状未见变化，但输注右旋糖酐铁后1周RLS症状评分有显著改善（-2；四分位数间距[IQR]，-6至-1；P = 0.03，Wilcoxon秩和检验），但在2周时改善最大（-3；IQR，-5至-2，而安慰剂组为-1至0；P = 0.01）。铁的有益作用在4周时持续存在，但不再具有统计学意义。右旋糖酐铁治疗组观察到的血清铁蛋白水平和铁饱和度显著增加在安慰剂治疗组未观察到。两组之间不良事件无差异。
高剂量静脉注射右旋糖酐铁与ESRD患者RLS症状的显著但短暂减轻有关。
