羧基麦芽糖铁治疗炎症性肠病并发缺铁性贫血的临床安全性及有效性研究

Clinical efficacy and safety of ferric carboxymaltose in the treatment of inflammatory bowel disease complicated with iron deficiency anemia

[目的]探讨静脉注射羧基麦芽糖铁治疗炎症性肠病患者的安全性和有效性。[方法]选取2015-11-2017-11期间因口服铁剂治疗失败,在本院接受羧基麦芽糖铁(总补铁剂量≤1 500 mg)静脉注射治疗缺铁性贫血的炎症性肠病患者72例,观察其治疗前及治疗4、8、12周后临床疗效及不良反应。[结果]72例静脉注射羧基麦芽糖铁治疗12周后,血红蛋白(Hb)水平平均升高21.96 g/L,红细胞平均体积(MCV)水平平均升高6.27 fl,血清铁蛋白平均升高24.46μg/L,与治疗前相比均差异有统计学意义(P<0.05)。静脉补铁的剂量与IBD的类型是Hb升高的影响因素,静脉补铁>1 000 mg的患者比≤1 000 mg的患者的Hb更易上升20 g/L(OR:4.28;95%CI:2.34~9.82,P<0.001)。72例中6例(8.33%)在静脉补铁过程中出现了不良反应,与口服铁剂的不良反应发生率(20.83%)比较差异有统计学意义(P=0.034)。[结论]羧基麦芽糖铁静脉制剂可显著提高炎症性肠病患者Hb和MCV水平,耐受性好,是治疗炎症性肠病患者缺铁性贫血的有效和安全的方法。

[Objective]To analyze the clinical efficacy and safety of intravenous ferric carboxymaltose in the treatment of inflammatory bowel disease(IBD)complicated with iron deficiency anemia.[Methods]Clinical data and laboratory results of 72 IBD patients with failed oral iron treatment who were treated with ferric carboxymaltose(total iron dose≤1 500 mg)from November 2015 to November 2017 were collected and analyzed in this study.[Results]After 12 weeks treatment,the mean increase of hemoglobin levels,mean corpuscular volume and serum ferritin in the 72 patients were 21.96 g/L,6.27 fl and 24.46μg/L respectively.The dosage of ferric carboxymaltose and the type of IBD were the influencing factors of hemoglobin level f and the hemoglobin levels more than 1 000 mg were more likely to increase by 20 g/L than those with less than 1 000 mg(OR:4.28,95%CI:2.34-9.82,P<0.001)after ferric carboxymaltose intravenous injection.Six of the 72 patients(6.25%)reported side-effects during the iron infusion,which was significantly lower than that treated with oral ferric supplement(P=0.034).[Conclusion]Ferric carboxymaltose could increase the hemoglobin level and the mean corpuscular volume(MCV),and was found to be an effective and well tolerated treatment for IBD patients complicated with iron deficiency anemia.