蔗糖铁注射液治疗肿瘤相关性贫血的前瞻性随机对照研究

Intravenous iron sucrose injection in treatment of patients with tumor-related anemia:a prospective randomized controlled clinical trial

目的比较蔗糖铁（森铁能）静脉注射与口服琥珀酸亚铁薄膜衣片（速力菲）治疗恶性肿瘤患者缺铁性贫血的疗效与安全性。方法采用前1性、随机对照研究,将60例恶性肿瘤患者随机分为两组。实验组（蔗糖铁）：将100-200 mg蔗糖铁稀释于生理盐水100 ml,每周2-3次,连续应用4周。对照组（琥珀酸亚铁薄膜衣片）：一次0.2 g,一日3次。全部病例都合并使用红细胞生成素（EPO）治疗。观察并比较两组患者治疗贫血的效果、铁代谢指标变化及不良反应发生情况。结果经治疗后,试验组与对照组的Hb均较治疗前显著升高,Hct也较治疗前明显升高,而试验组的上升幅度大于对照组（P〈0.05）。治疗后两组铁蛋白和转铁蛋白饱合度均明显高于治疗前,试验组的上升幅度大于对照组（P〈0.05）。两组患者均无严重不良反应发生。结论蔗糖铁是治疗伴有缺铁的恶性肿瘤患者相关性贫血的一种安全而有效的药物。

Objective To investigate and compare the efficacy and safety of intravenous injection of iron sucrose and per oral ferrous succinate for the treatment of iron deficiency anemia in patients with tumor.Methods In this prospective randomized controlled clinical study,60 patients with advanced cancer were divided into two groups： treatment group（iron sucrose group,n=30）,the patients were treated with iron sucrose,100 mg intravenous,2-3 times a week for 4 weeks,the control group（ferrous succinate group,n=30）, the patients were treated with per oral ferrous succinate,0. 2 g, tid. Erythropoietin（ EPO）was used in both groups. The efficacy and safety were assessed by evaluating the changes in Hb, Hct, ferritin, transferrin saturation and side effects in both groups after treatment. Results Compared with before treatment,the Hb level and Hct level in both groups significantly increased after treatment, the increament rates of Hb and Hct in iron sucrose group were higher than those in per oral ferrous succinate group（ P 〈0. 05 ）. The levels of ferritin and transferrin saturation increased significantly in both groups and the increment rates in iron sucrose group were higher than those in per oral ferrous succinate group（P 〈0.05）. There were no severe adverse events in both groups. Conclusion Intravenous iron sucrose is an effective and safe agent for the treatment of iron deficiency anemia in patients with advanced cancer.