蛋白琥珀酸铁口服溶液与富马酸亚铁混悬液治疗小儿缺铁性贫血的疗效观察

Therapeutic effect of iron protein succinylate and ferric fumarate suspension in children with iron deficiency anemia

目的比较蛋白琥珀酸铁口服溶液与富马酸亚铁混悬液对小儿缺铁性贫血的临床治疗效果。方法本研究是随机、阳性药物平行对照、多中心试验,2016年12月—2018年1月,9家医院共纳入241例确诊缺铁性贫血儿童,随机分为2组,试验组134例,对照组107例。试验组给予蛋白琥珀酸铁口服溶液1.5mL/(kg·d),对照组给予富马酸亚铁混悬液0.9mL/(kg·d),分两次于饭前1h服用,疗程4周,4周后检测并记录各项疗效指标及不良反应。结果试验组和对照组铁剂治疗的临床总有效率分别是88.8%和78.5%(P<0.05),两组不良反应发生率无明显差异(P>0.05)。结论蛋白琥珀酸铁口服溶液对小儿缺铁性贫血的疗效较好,且具有良好的安全性,临床上值得进一步推广使用。

Objective Comparison of the clinical treatment effect of iron protein succinylate and ferric fumarate suspension on iron deficiency anemia in children.Methods This was a randomized,active-controlled,parallel group,multi-center,non-inferiority study.A total of 241 children from 9 hospitals,from December 2016 to January 2018,with a diagnosis of iron deficiency anemia were randomly divided into treatment group(134 cases)and control group(107 cases).The treatment group was given an oral solution of iron protein succinylate with 1.5 ml/(kg·d),twice a day before meals.The control group was given a ferric fumarate suspension with 0.9 ml/(kg·d),twice a day before meals.The course of treatment was 4 weeks.At the end of 4-week iron supplementation,therapeutic efficacy and safety were assessed.Results The effective rate was 88.8%in treatment group and 78.5%in control group(P<0.05).The adverse reaction rate was no difference between iron protein succinate oral solution and ferric fumarate suspension(P>0.05).Conclusions Iron protein succinylate is shown to have better curative effect on iron deficiency anemia in children,and has good safety,which is worthy of further popularization in clinical practice.