REGAIN STUDY: Retrospective Study to Assess the Effectiveness, Tolerability, and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnant Women

IF 2.2 Q3 HEMATOLOGY

Anemia Pub Date : 2019-11-12 DOI:10.1155/2019/4640635

Saleema Wani, Mariyam Noushad, Shabana Ashiq

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引用次数: 9

Abstract

Iron deficiency anemia (IDA) during pregnancy arises because of preexisting inadequate stores or complex physiological changes and can lead to serious maternal and fetal complications. Oral iron, either as iron sulfate or fumarate, with or without folic acid, is the most commonly used treatment for IDA in pregnancy. Intravenous (IV) iron has a role in the treatment of IDA in pregnancy, particularly in women who present late, display severe anemia (Hb ≤ 9 g/dL), or risk factors, and are intolerant/noncompliant of oral iron. Previously, administration of IV iron was minimal, owing to potentially serious anaphylactic reactions. Recently, new IV iron products have been developed, offering better compliance, tolerability, efficacy, and a good safety profile. Our study aimed to assess the effectiveness, safety, and tolerability of IV ferric carboxymaltose (FCM) in the treatment of IDA in pregnant women in the UAE. Data from 1001 pregnant women who received at least one administration of FCM (500, 1000, or 1500 mg) during their second or third trimester of pregnancy (2 years backward from study initiation) were collected retrospectively from electronic medical records at Corniche Hospital, Abu Dhabi, UAE. Results showed that 41.4% of the women were able to achieve an increase of ≥2 g/dL in blood hemoglobin overall. A change of ≥2 g/dL was achieved by 27.5% of women administered a dose of 500 mg, 39.2% of women administered a dose of 1000 mg, and 63.9% of women administered a dose of 1500 mg of IV FCM. This indicates a directly proportional relationship between increasing IV FCM dose and the increase of ≥2 g/dL in blood hemoglobin. A total of 7 (0.7%) women reported mild, nonserious adverse events during the study. Within the limits of this retrospective study, IV FCM therapy was safe and effective in increasing the mean hemoglobin of pregnant women with IDA.

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REGAIN研究：评估羧麦芽糖铁治疗孕妇缺铁性贫血的有效性、耐受性和安全性的回顾性研究

妊娠期缺铁性贫血（IDA）是由于先前存在的储存不足或复杂的生理变化引起的，可导致严重的母婴并发症。口服铁，如硫酸铁或富马酸铁，加或不加叶酸，是妊娠期IDA最常用的治疗方法。静脉注射（IV）铁在妊娠期IDA的治疗中发挥作用，尤其是在晚期出现严重贫血（Hb ≤ 9 g/dL）或危险因素，并且对口服铁不耐受/不依从。此前，由于潜在的严重过敏反应，静脉注射铁的次数很少。最近，新的静脉注射铁产品被开发出来，提供了更好的依从性、耐受性、疗效和良好的安全性。我们的研究旨在评估静脉注射羧麦芽糖铁（FCM）治疗阿联酋孕妇IDA的有效性、安全性和耐受性。来自1001名至少接受一次FCM给药的孕妇的数据（500、1000或1500 mg）从阿联酋阿布扎比Corniche医院的电子医疗记录中进行回顾性收集。结果显示，41.4%的女性能够实现≥2的增长 g/dL。变化≥2 27.5%的女性服用500 mg，39.2%的女性服用1000 mg，63.9%的女性服用1500 mg的IV FCM。这表明IV FCM剂量的增加与≥2 血红蛋白中的g/dL。研究期间，共有7名（0.7%）女性报告了轻度、非严重的不良事件。在这项回顾性研究的范围内，IV FCM治疗在增加IDA孕妇的平均血红蛋白方面是安全有效的。

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来源期刊

Anemia HEMATOLOGY-

CiteScore

4.80

自引率

3.40%

发文量

审稿时长

18 weeks

期刊介绍： Anemia is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies on all types of anemia. Articles focusing on patient care, health systems, epidemiology, and animal models will be considered, among other relevant topics. Affecting roughly one third of the world’s population, anemia is a major public health concern. The journal aims to facilitate the exchange of research addressing global health and mortality relating to anemia and associated diseases.