Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India.
Department of Hematology, All India Institute of Medical Sciences, New Delhi, India.
BMC Pregnancy Childbirth. 2019 Feb 4;19(1):54. doi: 10.1186/s12884-019-2200-3.
To evaluate the efficacy and safety of intravenous Ferric Carboxymaltose. (FCM) in comparison with intravenous Iron sucrose complex (ISC) for treatment of iron deficiency anemia in pregnancy.
A randomized clinical trial was conducted from (January 2016-August 2017). at a tertiary hospital. Pregnant women diagnosed with moderate to severe iron deficiency anaemia were screened for the study. One hundred patients were randomized to receive either intravenous FCM or ISC. Primary outcome was rise in hemoglobin (Hb) from baseline after 12 weeks. Secondary outcomes were change in RBC indices, serum iron studies, improvement in fatigue scores, number of visits and perinatal outcome.
Mean rise in Hb at 12 weeks was significantly higher in FCM group (29 g/L vs 22 g/L; p value < 0.01). FCM was associated with greater improvement in fatigue scores. Number of visits were significantly less in FCM group. No serious adverse events were noted in either group.
Treatment with FCM resulted in rapid replenishment of iron stores in pregnant women with significantly higher Hb rise over a 12 week period. The convenient dosing with lesser number of total doses to complete the treatment will lead to better compliance in community setting. CLINICAL TRIAL REGISTRATION ( WWW.CTRI.NIC.IN ): CTRI/2015/09/006224. Registered on 21/07/2017 (Trial registered retrospectively).
评估静脉注射羧基麦芽糖铁（FCM）与静脉注射蔗糖铁复合物（ISC）治疗妊娠缺铁性贫血的疗效和安全性。
一项随机临床试验于（2016 年 1 月至 2017 年 8 月）在一家三级医院进行。对诊断为中重度缺铁性贫血的孕妇进行了研究筛选。100 名患者被随机分为静脉注射 FCM 或 ISC 组。主要结局是 12 周后血红蛋白（Hb）从基线升高。次要结局是 RBC 指数、血清铁研究、疲劳评分改善、就诊次数和围产期结局的变化。
FCM 组 12 周时 Hb 升高的平均值明显高于 ISC 组（29g/L 比 22g/L；p 值<0.01）。FCM 组的疲劳评分改善更明显。FCM 组的就诊次数明显减少。两组均未出现严重不良事件。
FCM 治疗可迅速补充孕妇铁储备，在 12 周内 Hb 升高明显更高。方便的给药方式，较少的总剂量完成治疗，将导致社区治疗的更好依从性。临床试验注册（www.ctri.nic.in）：CTRI/2015/09/006224. 于 2017 年 7 月 21 日注册（回顾性注册）。
