Damineni Sree Chandana, Thunga Suchitra
Junior Resident, Department of Obstetrics and Gynaecology, KMC , Mangaluru, Karnataka, India .
Professor and Unit Head, Department of Obstetrics and Gynaecology, KMC , Mangaluru, Karnataka, India.
J Clin Diagn Res. 2016 Nov;10(11):QC08-QC10. doi: 10.7860/JCDR/2016/19375.8937. Epub 2016 Nov 1.
Iron deficiency is the most common cause of Post-partum anaemia, reported as 50-60% in India. It is primarily due to inadequate iron intake and due to peripartum blood loss. It has been associated with significant post-partum complications. Therefore, Post-partum iron deficiency warrants greater attention and higher quality care. Oral iron treatment has been considered the standard of care. However, parenteral iron treatment is expected to be advantageous in cases where oral iron therapy is not possible. As a result, there is increased interest in parenteral iron therapy. Recently, a new parenteral iron preparation, Ferric Carboxy Maltose (FCM), was developed to facilitate effective treatment of Iron Deficiency Anaemia (IDA). This study was carried out in women with Post-partum IDA who were expected to benefit from the short treatment period permitted by the larger doses given parenterally.
To evaluate the efficacy, safety and tolerability of intra venous FCM compared to oral iron in treating Post-partum IDA patients.
This was a hospital based prospective comparative study. Women with Haemoglobin (Hb) between 7-10 g/dl and peripheral smear showing microcytic hypochromic anaemia on the first Post-partum day were included in the study. These women were randomised to receive either IV FCM (single dose 1000 mg) or oral ferrous ascorbate (100 mg twice daily for 6 weeks). Statistical analysis was done by student's paired and unpaired t-test and by chi- square test and fischer-exact t-test.
Ninety patients (45 in each group) were followed at one week and six weeks from the start of treatment and their Hb were estimated. Significant rise in Hb was observed in subjects treated with FCM compared to oral iron. FCM treated subjects were more likely to achieve an Hb rise greater than or equal to 3.0 g/dL. FCM was better tolerated with complete adherence to treatment as compared to oral ferrous ascorbate.
FCM showed robust evidence of efficacy, tolerability and safety in comparison to oral iron. Collectively, these data support the clinical utility of FCM in treating Post-partum IDA patients.
缺铁是产后贫血最常见的原因，在印度报告的发生率为50%-60%。这主要是由于铁摄入不足以及围产期失血。它与严重的产后并发症有关。因此，产后缺铁值得更多关注和更高质量的护理。口服铁剂治疗一直被视为护理标准。然而，在无法进行口服铁剂治疗的情况下，胃肠外铁剂治疗预计会更具优势。因此，人们对胃肠外铁剂治疗的兴趣增加。最近，一种新的胃肠外铁剂制剂，羧基麦芽糖铁（FCM），被开发出来以促进缺铁性贫血（IDA）的有效治疗。本研究针对产后IDA女性进行，她们有望从胃肠外给予的较大剂量所允许的短治疗期内获益。
评估静脉注射FCM与口服铁剂相比在治疗产后IDA患者中的疗效、安全性和耐受性。
这是一项基于医院的前瞻性对照研究。研究纳入产后第一天血红蛋白（Hb）在7-10 g/dl且外周血涂片显示小细胞低色素性贫血的女性。这些女性被随机分为接受静脉注射FCM（单次剂量1000 mg）或口服抗坏血酸亚铁（每日两次，每次100 mg，共6周）。采用学生配对和非配对t检验以及卡方检验和费舍尔精确t检验进行统计分析。
从治疗开始起，对90名患者（每组45名）进行了为期一周和六周的随访，并对她们的Hb进行了评估。与口服铁剂相比，接受FCM治疗的受试者Hb有显著升高。接受FCM治疗的受试者更有可能使Hb升高大于或等于3.0 g/dL。与口服抗坏血酸亚铁相比，FCM的耐受性更好，治疗依从性更高。
与口服铁剂相比，FCM显示出有力的疗效、耐受性和安全性证据。总体而言，这些数据支持FCM在治疗产后IDA患者中的临床应用价值。
