Kane Robert C
Venice Oncology Center, Venice, Florida, USA.
Curr Ther Res Clin Exp. 2003 Apr;64(4):263-8. doi: 10.1016/S0011-393X(03)00038-9.
When oral iron replacement therapy is ineffective, IV or IM iron dextran products have been used successfully in many patients. However, adverse events, including urticaria, anaphylaxis, and death, sometimes are associated with the use of these products.
The aim of this study was to assess the efficacy and tolerability of sodium ferric gluconate complex (SFGC) in sucrose in the treatment of adults with iron deficiency anemia.
This was a single-center, open-label, uncontrolled study. Consecutive adults in need of IV iron replacement who experienced severe reactions to generic IV iron dextran and who had previously failed to respond to oral iron products were treated with a single dose of IV SFGC (312, 375, or 500 mg) infused over 2 hours. A second dose of SFGC could be administered 6 to 8 weeks later, if needed.
Six patients (3 men, 3 women; mean [SD] age, 77.0 [10.4] years) were enrolled. All patients received a single-dose infusion of SFGC, and 2 patients received a second dose. No adverse events were observed at the lower doses (312 and 375 mg); however, both patients given the 500-mg dose reported transient nausea, and 1 had pruritus and the other had transient hypertension.
The results of this study show that SFGC is a satisfactory alternative when IV iron replacement is needed by adults with iron deficiency anemia.
当口服铁剂替代疗法无效时，静脉注射或肌肉注射右旋糖酐铁产品已成功用于许多患者。然而，这些产品的使用有时会伴有不良事件，包括荨麻疹、过敏反应和死亡。
本研究旨在评估蔗糖铁葡聚糖钠复合物（SFGC）治疗缺铁性贫血成人患者的疗效和耐受性。
这是一项单中心、开放标签、非对照研究。连续的需要静脉补铁且对普通静脉注射右旋糖酐铁有严重反应、先前口服铁剂治疗无效的成人患者接受单剂量静脉注射SFGC（312、375或500mg），输注时间为2小时。如有需要，可在6至8周后给予第二剂SFGC。
共纳入6例患者（3例男性，3例女性；平均[标准差]年龄，77.0[10.4]岁）。所有患者均接受单剂量SFGC输注，2例患者接受了第二剂。较低剂量（312和375mg）未观察到不良事件；然而，接受500mg剂量的2例患者均报告有短暂恶心，其中1例有瘙痒，另1例有短暂高血压。
本研究结果表明，对于缺铁性贫血成人患者需要静脉补铁时，SFGC是一种令人满意的替代药物。
