Department of Obstetrics and Gynecology, University Hospital Insel and University of Bern, Bern, Switzerland.
J Perinat Med. 2012 May 13;40(5):469-74. doi: 10.1515/jpm-2011-0231.
Oral iron substitution has shown to be insufficient for treatment of severe iron deficiency anemia in pregnancy. Ferric carboxymaltose is a new intravenous (i.v.) iron formulation promising to be more effective and as safe as iron sucrose. We aimed to assess side effects and tolerance of ferric carboxymaltose compared to i.v. iron sucrose in pregnant women.
We performed a retrospective analysis of 206 pregnant women who were treated either with ferric carboxymaltose or iron sucrose for iron-deficiency anemia with intolerability to oral iron substitution, or insufficient hemoglobin increase after oral iron treatment, or need for rapid hemoglobin reconstitution. Primary endpoint was to evaluate the maternal safety and tolerability. Secondary endpoint was to assess efficacy of the treatment and exclude safety concerns for the fetus.
The incidence of drug-related adverse events was low and mostly mild in both groups. Mild adverse events occurred in 7.8% for ferric carboxymaltose and in 10.7% for iron sucrose. The mean rise of hemoglobin value was 15.4 g/L for ferric carboxymaltose and 11.7 g/L for iron sucrose.
Ferric carboxymaltose administration in pregnant women is well tolerated and is not associated with any relevant clinical safety concerns. Ferric carboxymaltose has a comparable safety profile to iron sucrose but offers the advantage of a much higher iron dosage at a time reducing the need for repeated applications and increasing patients' comfort. Ferric carboxymaltose is the drug of choice, if i.v. iron treatment becomes necessary in the second or third trimester of pregnancy.
口服铁剂治疗妊娠重度缺铁性贫血效果不佳。羧基麦芽糖铁是一种新型的静脉(i.v.)补铁药物,有望比蔗糖铁更有效且安全。本研究旨在评估羧基麦芽糖铁与蔗糖铁治疗妊娠缺铁性贫血的副作用和耐受性。
我们对 206 例因口服铁剂不耐受、口服铁剂治疗后血红蛋白增加不足或需要快速纠正血红蛋白而接受羧基麦芽糖铁或蔗糖铁治疗的妊娠缺铁性贫血患者进行了回顾性分析。主要终点是评估母体安全性和耐受性。次要终点是评估治疗效果,并排除对胎儿的安全性担忧。
两组药物相关不良事件的发生率均较低,且大多为轻度。羧基麦芽糖铁组轻度不良事件发生率为 7.8%,蔗糖铁组为 10.7%。羧基麦芽糖铁组血红蛋白值平均升高 15.4 g/L,蔗糖铁组为 11.7 g/L。
羧基麦芽糖铁在孕妇中的应用具有良好的耐受性,且与任何相关的临床安全性问题无关。羧基麦芽糖铁的安全性与蔗糖铁相当,但具有更高的单次铁剂量优势,减少了重复应用的需要,增加了患者的舒适度。如果在妊娠第二或第三孕期需要静脉补铁,羧基麦芽糖铁是首选药物。