Objective: 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. Methods: 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. Results: 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. Conclusion: 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
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机译:目的:口服铁替代品已不足以治疗妊娠期严重缺铁性贫血。羧基麦芽糖铁是一种新的静脉内(i.v.)铁制剂,有望比蔗糖铁更有效,更安全。我们的目的是评估与i.v.相比,羧甲基麦芽糖铁的副作用和耐受性。孕妇铁蔗糖。方法:我们对206名接受过铁羧基麦芽糖或蔗糖铁治疗缺铁性贫血的孕妇进行了回顾性分析,这些铁缺乏性贫血无法口服铁替代,或者口服铁治疗后血红蛋白增加不足,或者需要快速重建血红蛋白。主要终点是评估产妇的安全性和耐受性。次要终点是评估治疗效果并排除胎儿的安全隐患。结果:两组药物相关不良事件的发生率均较低,且多数为轻度。轻度不良事件发生在羧基麦芽糖铁中为7.8%,在蔗糖铁中为10.7%。羧基麦芽糖铁的平均血红蛋白值上升为15.4 g / L,蔗糖铁的平均血红蛋白值上升为11.7 g / L。结论:孕妇对羧基麦芽糖铁的耐受性良好,与任何相关的临床安全性无关。羧基麦芽糖铁的安全性可与蔗糖铁媲美,但优点是每次铁剂量更高,从而减少了重复使用的需要并提高了患者的舒适度。羧基麦芽糖铁是选择的药物,如果静脉注射。妊娠中期或中期需要铁剂治疗
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