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甘氨酸亚铁与硫酸甘氨酸亚铁治疗妊娠期缺铁性贫血的疗效:一项随机双盲临床试验。

Efficacy of ferrous -glycinate versus ferrous glycine sulfate in the treatment of iron deficiency anemia with pregnancy: a randomized double-blind clinical trial.

作者信息

Abbas Ahmed M, Abdelbadee Safaa A, Alanwar Ahmed, Mostafa Sayed

机构信息

Department of Obstetrics & Gynecology, Faculty of Medicine, Assiut University, Egypt.

Department of Obstetrics & Gynecology, Faculty of Medicine, Ain Shams University, Egypt.

出版信息

J Matern Fetal Neonatal Med. 2019 Dec;32(24):4139-4145. doi: 10.1080/14767058.2018.1482871. Epub 2018 Jun 20.

Abstract

The aim of this study is to compare the efficacy and tolerability of oral ferrous -glycinate versus ferrous glycine sulfate in the treatment of iron deficiency anemia (IDA) with pregnancy. A randomized double-blind clinical trial (NCT02590224) conducted at a tertiary University Hospital in the period between 1 January 2016 and 31 July 2017 included pregnant women at 14-18 weeks of gestation with mild to moderate IDA. Patients were randomized into two groups: (Group I) received oral ferrous -glycinate tablets once daily for eight consecutive weeks and (Group II) received oral ferrous glycine sulfate capsules in the same dose and duration. The primary outcome of the study was the rate of increase of hemoglobin (HB) level after 8 weeks of iron treatment. The study included 187 women in the final analysis. The mean increase in HB level after 8 weeks of treatment in ferrous -glycinate group was 2.48 ± 0.12 g/dL versus 1.32 ± 0.18 g/dL in ferrous glycine sulfate group ( ≤ .0001). The percentage of women with HB level more than 11 g/dL after 8 weeks of treatment was 89.2% in ferrous -glycinate group versus 71.3% in ferrous glycine sulfate group ( < .0001). The rate of adverse effects was significantly higher in ferrous glycine sulfate group ( = .001). Pregnant women with second trimester IDA could be supplied with ferrous -glycinate which is more efficient in increasing HB level. Moreover, it has tolerable adverse effects and high compliance than ferrous glycine sulfate.

摘要

本研究旨在比较甘氨酸亚铁与硫酸甘氨酸亚铁治疗妊娠期缺铁性贫血(IDA)的疗效和耐受性。2016年1月1日至2017年7月31日期间,在一所三级大学医院进行了一项随机双盲临床试验(NCT02590224),纳入妊娠14 - 18周的轻度至中度IDA孕妇。患者被随机分为两组:(I组)连续8周每日口服一次甘氨酸亚铁片,(II组)接受相同剂量和疗程的硫酸甘氨酸亚铁胶囊。本研究的主要结局是铁治疗8周后血红蛋白(HB)水平的升高率。最终分析纳入了187名女性。甘氨酸亚铁组治疗8周后HB水平的平均升高值为2.48±0.12 g/dL,而硫酸甘氨酸亚铁组为1.32±0.18 g/dL(P≤0.0001)。治疗8周后HB水平超过11 g/dL的女性百分比,甘氨酸亚铁组为89.2%,硫酸甘氨酸亚铁组为71.3%(P<0.0001)。硫酸甘氨酸亚铁组的不良反应发生率显著更高(P = 0.001)。孕中期IDA孕妇可补充甘氨酸亚铁,其在提高HB水平方面更有效。此外,与硫酸甘氨酸亚铁相比,其不良反应可耐受且依从性高。

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