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一项比较静脉注射蔗糖铁和口服铁剂治疗妊娠期缺铁性贫血的随机对照试验。

A randomised controlled trial to compare intravenous iron sucrose and oral iron in treatment of iron deficiency anemia in pregnancy.

作者信息

Gupta Avantika, Manaktala Usha, Rathore Asmita Muthal

机构信息

Maulana Azad Medical College, New Delhi, India.

出版信息

Indian J Hematol Blood Transfus. 2014 Jun;30(2):120-5. doi: 10.1007/s12288-012-0224-1. Epub 2013 Jan 10.

Abstract

The aim of this study was to compare the efficacy and safety of intravenous iron sucrose with oral iron therapy in pregnant patients with anemia. The primary outcome of the study was increase in haemoglobin on day 7, 14 & 28 and rise of serum ferritin over 28 days. The study population consisted of 100 patients with singleton pregnancy between 24 and 34 weeks, hemoglobin levels between 7.0-9.0 gm/dL and serum ferritin levels less than 15 ng/mL. The participants in the oral group were given daily 180 mg elemental iron in three divided oral doses for 4 weeks. Total calculated dose of iron sucrose with a target hemoglobin of 11 gm %, was given in 200 mg dose on alternate days. Mean haemoglobin rise was 0.58 gm/dL in the IV group as compared to 0.23 gm/dL in the oral group on day 14 and 1.9 gm/dL in the IV group & 1.3 gm/dL in the oral group on day 28, (p <0.05). In the IV group, 76% of the subjects achieved haemoglobin levels of ≥11 gm% at the time of delivery, as compared to only 54% of the subjects in the oral group who achieved these levels. Serum ferritin value was significantly higher in the IV group, 37.45 ± 5.73 ng/mL as compared to 13.96 ± 1.88 ng/mL in the oral group at 4th week (p <0.001). There was no major side effect in the IV group. 36% subjects in the oral group developed gastrointestinal side effects & 10% of the subjects were non compliant. The rate of hemoglobin rise is faster with intravenous iron sucrose therapy as compared to oral iron therapy which can be beneficial in pregnant women presenting with anemia at a later period of gestation. Intravenous iron sucrose is very well tolerated during pregnancy.

摘要

本研究的目的是比较静脉注射蔗糖铁与口服铁剂治疗妊娠合并贫血患者的疗效和安全性。本研究的主要结局指标是第7天、14天和28天血红蛋白的升高以及28天内血清铁蛋白的升高。研究人群包括100名单胎妊娠患者,孕周在24至34周之间,血红蛋白水平在7.0 - 9.0克/分升之间,血清铁蛋白水平低于15纳克/毫升。口服组的参与者每天口服180毫克元素铁,分三次服用,共4周。目标血红蛋白为11克%的蔗糖铁总计算剂量,以200毫克的剂量隔天给药。第14天,静脉注射组平均血红蛋白升高0.58克/分升,口服组为0.23克/分升;第28天,静脉注射组为1.9克/分升,口服组为1.3克/分升,(p<0.05)。在静脉注射组,76%的受试者在分娩时血红蛋白水平达到≥11克%,而口服组只有54%的受试者达到这些水平。第4周时,静脉注射组血清铁蛋白值显著高于口服组,分别为37.45±5.73纳克/毫升和13.96±1.88纳克/毫升(p<0.001)。静脉注射组没有严重副作用。口服组36%的受试者出现胃肠道副作用,10%的受试者不依从。与口服铁剂治疗相比,静脉注射蔗糖铁治疗血红蛋白升高速度更快,这对妊娠后期出现贫血的孕妇可能有益。孕期静脉注射蔗糖铁耐受性良好。

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Treatments for iron-deficiency anaemia in pregnancy.孕期缺铁性贫血的治疗方法。
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