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

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

作者信息

Wani Saleema, Noushad Mariyam, Ashiq Shabana

机构信息

Obstetrics & Gynaecology Department, Corniche Hospital, P.O. Box 3788, Abu Dhabi, UAE.

出版信息

Anemia. 2019 Nov 12;2019:4640635. doi: 10.1155/2019/4640635. eCollection 2019.

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.

摘要

孕期缺铁性贫血(IDA)是由于先前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。口服铁剂,如硫酸亚铁或富马酸亚铁,无论是否添加叶酸,是孕期IDA最常用的治疗方法。静脉注射铁剂在孕期IDA的治疗中具有一定作用,尤其是对于就诊较晚、表现为严重贫血(血红蛋白≤9g/dL)或有危险因素且不耐受/不依从口服铁剂的女性。以前,由于可能发生严重的过敏反应,静脉注射铁剂的使用很少。最近,新型静脉注射铁剂产品已被研发出来,具有更好的依从性、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基麦芽糖铁(FCM)治疗阿联酋孕妇IDA的有效性、安全性和耐受性。回顾性收集了阿联酋阿布扎比滨海医院电子病历中1001名孕妇的数据,这些孕妇在妊娠中期或晚期(研究开始前2年)接受了至少一次FCM(500、1000或1500mg)注射。结果显示,总体上41.4%的女性血红蛋白能够增加≥2g/dL。接受500mg剂量的女性中有27.5%、接受1000mg剂量的女性中有39.2%、接受1500mg剂量静脉注射FCM的女性中有63.9%实现了血红蛋白增加≥2g/dL。这表明静脉注射FCM剂量增加与血红蛋白增加≥2g/dL之间存在正比关系。共有7名(0.7%)女性在研究期间报告了轻度、不严重的不良事件。在这项回顾性研究的范围内,静脉注射FCM疗法在提高IDA孕妇平均血红蛋白水平方面是安全有效的。

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