铁制剂治疗缺铁性贫血的随机对照临床研究

Comparitive study on three iron preparations for treatment of iron deficiency anemia: A randomized-controlled trial

目的 了解硫酸亚铁控释片、琥珀酸亚铁、多糖铁复合物治疗缺铁性贫血的疗效及不良反应。方法 将 10 5例就诊于血液科门诊的缺铁性贫血患者 ,按照入选标准 ,以随机区组的方法随机分入 3个治疗组 ,分别予以硫酸亚铁控释片 (福乃得 ,5 0 0mg ,每日 1次 )、琥珀酸亚铁 (速力菲 ,0 .1g ,每日 3次 )、多糖铁复合物 (力蜚能 ,0 .15g ,每日 2次 )治疗 8周 .每 1～ 2周随访 1次 ,随访血常规、网织红细胞计数及药物的不良反应。治疗前及治疗结束检查血清铁、总铁结合力、血清铁蛋白等有关铁参数。结果与结论 以血红蛋白和血清铁蛋白恢复正常作为完全缓解的标准 ,硫酸亚铁控释片、琥珀酸亚铁、多糖铁复合物 3种药治疗 8周 ,缺铁性贫血的完全缓解率分别为 74%、76 %、40 % (P =0 .0 0 4) ,总的有效率分别为 81%、89%、76 % (P >0 .0 5 )。主要的不良反应为胃肠道反应 ,3种药中以多糖铁复合物的不良反应最少 ,其次为琥珀酸亚铁 ,硫酸亚铁控释片的不良反应最常见 。

Objective To compare the clinical efficacy and side effects of Niferrix, Ferroid and Ferrous succinate for treatment of iron deficiency anemia (IDA). Methods One hundred and five IDA patients ( male 11,famale 94,age 40.8±12.6yrs) were studied in our outpatient department. Those who had malignancy, connective tissue diseases, uncontrolled blood loss, and those who received iron preparations or blood transfusion within one month were excluded. These patients were randomly divided into three treatment groups. Niferrix (Polysaccharide iron complex) 0.15g twice a day; Ferroid (Ferrous sulfate controlled release tablets) 0.5g per day; Ferrous succinate 0.1g three times a day. These patients were followed up every other week for 8 weeks, and Hb and some iron parameters were examined. Restoration to normal Hb level was considered complete remission (CR). Results The CR of Niferrix, Ferroid and Ferrous succinate for IDA are 0.4 (95%CI: 0.22～0.58), 0.74 (0.58～0.90), 0.76 (0.6～0.92) respectively ( P =0.004). Conclusion Ferrous succinate and Ferriod are more effective than Niferrix, but the side effects of Ferriod is higher than that of the others and those of Niferrix the least.