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Iberet 叶酸与锌铁复合物治疗妊娠期缺铁性贫血的比较。

Comparison between Iberet Folic and Zincofer in treatment of iron deficiency anaemia in pregnancy.

机构信息

Department of Obstetrics and Gynaecology, UKM Medical Centre, Kuala Lumpur, Malaysia.

出版信息

Horm Mol Biol Clin Investig. 2020 Dec 14;42(1):49-56. doi: 10.1515/hmbci-2020-0034.

Abstract

OBJECTIVES

To compare the effect of Iberet Folic and Zincofer on haemoglobin (Hb) and serum ferritin level; and its adverse effect.

METHODS

This randomised controlled trial conducted from January 2018 until December 2018. Pregnant women below 34 weeks of gestation, with Hb concentration less than 11 g/dL and serum ferritin level less than 12 ug/L were randomised to receive either one tablet Zincofer or one tablet Iberet Folate daily for four weeks. Both groups were compared in terms of effect on Hb level, serum ferritin level, and other haematological indices adverse effect related to treatment, and treatment cost.

RESULTS

Hundred and thirty patients were recruited in this study with 68 patients in Iberet Folic group and 62 patients in Zincofer group. The change in the Hb and serum ferritin level from baseline to day 30 did not differ significantly between treatment groups. The mean (±SD) change from baseline to day 30 was 2.15 (±0.59) g/dL in the Iberet Folic group, and 1.98 (±0.49) in the Zincofer (p value = 0.08). Mean serum ferritin at day 30 was 17.2 (±3.68) ug/L and 16.7 (±4.28) ug/L with 8.44 (±3.41) and 8.55 (±3.50) difference, respectively (p = 0.86). Adverse events were comparable in between groups, with p value >0.05. GI intolerance and constipation were among the common side effects, occurred in 34.6 and 29.2% cases, respectively.

CONCLUSIONS

Zincofer offers equivalent efficacy and side effect profile in comparison with Iberet Folic for the treatment of iron deficiency anaemia (IDA) during pregnancy, but with lower cost.

摘要

目的

比较 Iberet Folic 和 Zincofer 对血红蛋白(Hb)和血清铁蛋白水平的影响及其不良反应。

方法

这是一项随机对照试验,于 2018 年 1 月至 2018 年 12 月进行。将妊娠 34 周以下、Hb 浓度低于 11g/dL 且血清铁蛋白水平低于 12μg/L 的孕妇随机分为每日服用 1 片 Zincofer 或 1 片 Iberet Folate 组,每组 68 例和 62 例。比较两组 Hb 水平、血清铁蛋白水平及其他血液学指标的变化,以及治疗相关的不良反应和治疗费用。

结果

本研究共纳入 130 例患者,其中 Iberet Folic 组 68 例,Zincofer 组 62 例。治疗组间从基线到第 30 天的 Hb 和血清铁蛋白水平的变化无显著差异。Iberet Folic 组从基线到第 30 天的平均(±SD)变化为 2.15(±0.59)g/dL,Zincofer 组为 1.98(±0.49)g/dL(p 值=0.08)。第 30 天的平均血清铁蛋白水平分别为 17.2(±3.68)μg/L 和 16.7(±4.28)μg/L,差异分别为 8.44(±3.41)μg/L 和 8.55(±3.50)μg/L(p=0.86)。两组不良反应相似,p 值均>0.05。胃肠道不耐受和便秘是常见的副作用,分别发生在 34.6%和 29.2%的病例中。

结论

Zincofer 在治疗妊娠期缺铁性贫血(IDA)方面与 Iberet Folic 具有等效的疗效和安全性,但成本更低。

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