Benefits of Ferric Carboxymaltose Administration for Enhanced Hemoglobin Levels in Urban Population of Sindh: BOFERIN® Observational Study

J. Ainuddin, Nasreen Majid, Azram Aslam, R. Sikander, Sarmad Iqbal, Syed Saad Hussain
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Abstract

Abstract: Background: Iron deficiency anemia is a major public health issue in developing countries, especially among women of reproductive age. Anemia is a major public health problem in women of reproductive age in rural Pakistan and a large proportion of women were found to have low levels of serum iron. Materials and Methods: A multicenter observational cohort study was conducted at Karachi & Hyderabad from 8th February 2022 to 30th April 2022. Women with low hemoglobin level and age 18-45 years were included in this study. Patients were grouped according to 1-week assessment and 3-week assessment of hemoglobin concentration. A single dose of a generic substituent ferric carboxymaltose (Boferin®) was administered to the patients over 15 minutes infusion. Baseline hemoglobin levels were compared at 1 week and 3 weeks after administration of Ferric Carboxymaltose. Results: A total of 104 patients were enrolled in this study. The mean hemoglobin levels at baseline were 9.22 ± 0.175 g/dl and 7.55 ± 0.329 g/ dl for 1-week and 3-week, respectively. The mean hemoglobin increases after 1 week and 3 week was reported as 1.4211± 0.169 g/dl (p< 0.001) and 2.321± 0.335 g/dl (p< 0.001) respectively. Only three patients presented with mild to moderate adverse effect which included abdominal discomfort and nausea. Conclusion: This is a first in class study has shown statistically significant increase in hemoglobin at 1-week and 3-week interval with minimal side effects. It is concluded that Boferin® is efficacious in increasing hemoglobin levels in patients with iron deficiency anemia with its safety being documented in pregnant Pakistani population as well.
羧麦芽糖铁对信德省城市人群血红蛋白水平提高的益处:BOFERIN®观察性研究
摘要:背景:缺铁性贫血是发展中国家主要的公共卫生问题,尤其是育龄妇女。贫血是巴基斯坦农村育龄妇女的一个主要公共卫生问题,而且发现很大一部分妇女血清铁含量低。材料和方法:2022年2月8日至2022年4月30日在卡拉奇和海德拉巴进行了一项多中心观察队列研究。研究对象为年龄在18-45岁之间的血红蛋白水平低的女性。根据血红蛋白浓度1周和3周进行分组。单剂量的通用取代基羧基麦芽糖铁(Boferin®)在15分钟内输注给患者。在给药后1周和3周比较基线血红蛋白水平。结果:本研究共纳入104例患者。1周和3周的基线平均血红蛋白水平分别为9.22±0.175 g/dl和7.55±0.329 g/dl。术后1周和3周平均血红蛋白升高分别为1.4211±0.169 g/dl (p< 0.001)和2.321±0.335 g/dl (p< 0.001)。只有3例患者出现轻至中度不良反应,包括腹部不适和恶心。结论:这是一项同类研究中首次显示血红蛋白在1周和3周期间有统计学意义的显著增加,副作用最小。结论是Boferin®在提高缺铁性贫血患者血红蛋白水平方面是有效的,其安全性在巴基斯坦孕妇中也有记录。
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