异麦芽糖酐铁治疗异常子宫出血相关缺铁性贫血的疗效及安全性研究

Efficacy and safety of ferric derisomaltose in the treatment of iron deficiency anemia caused by abnormal uterine bleeding

目的 探讨异麦芽糖酐铁治疗异常子宫出血(AUB)相关缺铁性贫血的疗效及安全性。方法 回顾性分析64例AUB相关缺铁性贫血患者的资料,根据使用抗贫血药物情况将患者分为异麦芽糖酐铁组(n=21)、口服铁剂组(n=20)和蔗糖铁组(n=23)。异麦芽糖酐铁组给予异麦芽糖酐铁注射液治疗,口服铁剂组给予蛋白琥珀酸铁口服溶液或琥珀酸亚铁片治疗,蔗糖铁组给予蔗糖铁注射液进行治疗。观察基线和治疗第3天、第4周、第12周血红蛋白(Hb)及血清铁蛋白(SF)的变化,并比较异麦芽糖酐铁、口服铁剂和蔗糖铁治疗期间过敏反应、胃肠道反应等常见不良反应的发生率。结果 治疗第4、12周时,异麦芽糖酐铁组Hb水平高于口服铁剂组和蔗糖铁组,差异有统计学意义(P<0.05)。相较于口服铁剂组和蔗糖铁组,异麦芽糖酐铁组Hb增幅≥20 g/L的患者占比更高。异麦芽糖酐铁组不良事件发生率最低,口服铁剂组不良事件发生率最高。异麦芽糖酐铁组不良事件主要为输液相关轻度不良反应,无需额外治疗,也并未影响患者治疗依从性。结论 子宫出血相关贫血患者异麦芽糖酐铁治疗后Hb及SF可以获得更大程度的升高,且效果可持续至少12周,不良反应发生率低,耐受性良好。

Objective To evaluate the efficacy and safety of ferric derisomaltose in the treatment of iron deficiency anemia associated with abnormal uterine bleeding(AUB).Methods The data of sixty-four patients with iron deficiency anemia caused by AUB were retrospectively analyzed.According to the use of anti-anemia drugs,the patients were divided into ferric derisomaltose group(n=21),oral iron supplementation group(n=20)and iron sucrose group(n=23).The iron isomaltose group was treated with iron isomaltose injection,the oral iron prescription group was treated with iron protein succinate oral solution or ferrous succinate tablet,and the iron sucrose group was treated with iron sucrose injection.The changes of hemoglobin(Hb)and serum ferritin(SF)were observed at baseline and at the 3rd day,4th and 12th week of treatment.The incidences of common adverse events,such as allergic reactions and gastrointestinal reactions during treated by iron isomaltose,oral iron supplementation and iron sucrose were compared.Results At the 4th and 12th week of treatment,Hb levels in the ferric derisomaltose group was higher than those of the oral iron supplementation group and iron sucrose group(P<0.05).The incidence of adverse events was the lowest in the ferric derisomaltose group and the highest in the oral iron group.The main adverse events in the ferric derisomaltose group were infusion-related adverse reactions,which were mild and did not require additional treatment,and had no effect on compliance.Conclusion For patients with anemia caused by uterine hemorrhage,treatment with ferric derisomaltose could result in increase of Hb and SF,and this beneficial effect can last for at least 12 weeks with low incidence of adverse reaction and good tolerance.