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隔日与每日口服铁剂治疗缺铁性贫血的随机对照试验。

Alternate day versus daily oral iron for treatment of iron deficiency anemia: a randomized controlled trial.

机构信息

Department of General Medicine, Sri Venkateshwaraa Medical College and Research Centre, Pondicherry, India.

Department of Biostatistics, Pondicherry Institute of Medical Sciences, Pondicherry, India.

出版信息

Sci Rep. 2023 Feb 1;13(1):1818. doi: 10.1038/s41598-023-29034-9.

Abstract

Oral iron is the mainstay of treating iron deficiency anemia. Recent studies indicate better fractional iron absorption with alternate day supplementation. However, the optimal supplementation strategy is unclear. We compared effectiveness of daily versus alternate day supplementation of oral iron for treatment of iron deficiency anemia. This double blind, active control, randomized controlled trial was conducted on two hundred adults having hemoglobin 10 g/dL or less with microcytic hypochromic anemia and/or serum ferritin below 50 ng/mL. They were randomized to receive either two Ferrous sulfate tablets containing 60 mg elemental iron (120 mg total) on alternate days or single tablet of 60 mg elemental iron daily for 8 weeks. Primary outcome was mean change in hemoglobin at week 8 from baseline. Mean hemoglobin was 6.53 (± 1.89) and 6.68 (± 1.89) g/dL in the alternate day and daily arms respectively. Mean change in hemoglobin was + 1.05 ± 1.34 g/dL in alternate day arm and + 1.36 ± 1.51 g/dL in daily arm (p = 0.47) at week 8. There were no statistically significant differences between the arms with respect to any secondary outcome. There is no significant difference between alternate day and daily iron administration in improving hemoglobin. Randomized controlled trials enrolling more participants for longer periods of supplementation and evaluating clinically relevant outcomes like change in hemoglobin may be useful in identifying the ideal dosing strategy.Trial Registration: Clinical Trial Registry of India (CTRI/2019/01/017169).

摘要

口服铁剂是治疗缺铁性贫血的主要方法。最近的研究表明,隔日补充铁剂可以提高铁的分数吸收率。然而,最佳的补充策略尚不清楚。我们比较了每日和隔日补充口服铁剂治疗缺铁性贫血的效果。这是一项双盲、活性对照、随机对照试验,共纳入 200 名血红蛋白<10g/dL 且伴有小细胞低色素性贫血和/或血清铁蛋白<50ng/mL 的成年人。他们被随机分为两组,分别接受隔日服用 2 片硫酸亚铁(含 60mg 元素铁,共 120mg)或每日服用 1 片 60mg 元素铁,持续 8 周。主要终点是第 8 周时血红蛋白相对于基线的平均变化。隔日组和每日组的平均血红蛋白分别为 6.53(±1.89)和 6.68(±1.89)g/dL。隔日组血红蛋白的平均变化为+1.05±1.34g/dL,每日组为+1.36±1.51g/dL(p=0.47)。第 8 周时,两组在任何次要终点上均无统计学差异。在改善血红蛋白方面,隔日和每日铁剂给药没有显著差异。招募更多参与者、延长补充时间并评估临床相关结局(如血红蛋白变化)的随机对照试验可能有助于确定理想的剂量策略。试验注册:印度临床试验注册中心(CTRI/2019/01/017169)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/978a/9892593/caa06f356551/41598_2023_29034_Fig1_HTML.jpg

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