Department of Pharmacology, Post Graduate Institute of Medical Education & Research, Chandigarh, India.
Department of Obstetrics and Gynaecology, Post Graduate Institute of Medical Education & Research, Chandigarh, India.
J Obstet Gynaecol Res. 2021 Nov;47(11):3828-3841. doi: 10.1111/jog.14999. Epub 2021 Sep 6.
To evaluate the efficacy, tolerability, and cost of four commonly prescribed oral iron preparations: ferrous sulfate (FS), ferrous fumarate (FF), ferrous ascorbate (FA), and carbonyl iron (CI) in the treatment of iron-deficiency anemia (IDA) in pregnant women.
It was a prospective, randomized, open-label, blinded endpoint (PROBE) design with four parallel active control groups: FS, FF, FA, CI. The primary outcome was the proportion of participants becoming non-anemic (Hb ≥ 11 g%) at the end of the study period. The secondary outcomes were the proportion of participants achieving normal red blood corpuscular indices such as mean corpuscular volume, mean corpuscular hemoglobin, and mean corpuscular hemoglobin concentration; the proportion of participants achieving normal iron indices such as serum iron, serum ferritin, total iron-binding capacity, and transferrin saturation; and comparison of incidence of any adverse events between treatment groups and comparison of costs of individual drug therapy between treatment groups.
One hundred and twenty patients were randomized to four different groups (n = 30). The results of the present study show that all the four iron salts at the dose of 200 mg elemental iron per day were equally effective in improving hemoglobin concentration and other hematological parameters. The adverse effects were more common in the FF group (56.7%). The pharmacoeconomic analysis showed that all the drugs are equally cost-effective.
To conclude from the results of the present study, it can be said that FS, FF, FA, and CI are equally effective in treating IDA and they can be prescribed interchangeably.
评估硫酸亚铁（FS）、富马酸亚铁（FF）、抗坏血酸亚铁（FA）和羰基铁（CI）这四种常用口服铁制剂治疗孕妇缺铁性贫血（IDA）的疗效、耐受性和成本。
这是一项前瞻性、随机、开放标签、盲终点（PROBE）设计，有四个平行的活性对照治疗组：FS、FF、FA、CI。主要结局是研究结束时无贫血（Hb≥11g%）的参与者比例。次要结局包括达到正常红细胞指数（如平均红细胞体积、平均红细胞血红蛋白、平均红细胞血红蛋白浓度）的参与者比例，达到正常铁指数（如血清铁、血清铁蛋白、总铁结合能力、转铁蛋白饱和度）的参与者比例，以及各组治疗方案间不良反应发生率的比较和各组药物治疗费用的比较。
120 名患者被随机分为四组（n=30）。本研究结果表明，每天 200mg 元素铁剂量的四种铁盐在改善血红蛋白浓度和其他血液学参数方面同样有效。FF 组不良反应更常见（56.7%）。药物经济学分析表明，所有药物均具有同等的成本效益。
根据本研究结果，可以说 FS、FF、FA 和 CI 在治疗 IDA 方面同样有效，可以相互替代。
