Bhavi Shruti B, Jaju Purushottam B
Gadag institute of medical sciences (GIMS), C/o Dr B R Patil, house No 6679/ B18, Near K.V.S.R College Vidyanagar extension, Gadag, Karnataka, India.
Shri B M Patil Medical college Hospital and Research Center, B.L.D.E University's, Bijapur, 586103, India.
BMC Pregnancy Childbirth. 2017 May 8;17(1):137. doi: 10.1186/s12884-017-1313-9.
The objective of this study was to compare the efficacy, safety and tolerability of intravenous iron sucrose with that of oral ferrous fumarate in iron deficiency anemia during 14 to 34 weeks of pregnancy.
A randomized controlled trial was performed involving 112 patients attending the antenatal clinic at Shri B.M.Patil Medical college Hospital, Bijapur from October 2011 to August 2012,with hemoglobin levels between 70-110 g/L and serum ferritin of < 15 ng/ml. In the intravenous group,200 mg of iron sucrose was administered in 100 ml 0.9% sodium chloride per day. Participants in the oral group were given 200 mg of ferrous fumarate per day. The primary outcome measures for the trial, haemoglobin and serum ferritin levels were measured after 4 weeks. Statistical significance was assessed using Student's t-test.
The change in haemoglobin in women receiving intravenous iron was higher than with oral ferrous fumarate 22 ± 11.5 g/L vs 12 ± 9 g/L (p < 0.0001).Similarly the change of serum ferritin was significantly higher in women receiving intravenous iron compared to oral iron. 55% participants in the intravenous group had an improvement in haemoglobin more than 20 g/L compared to only 11% of the oral therapy group.48% of patients in I.V group showed increase in ferritin level between 51 to 100 ng/ml in comparison to only 3.5% in oral group. Intravenous iron sucrose is an effective in correction of anemia in pregnancy or iron store depletion.
Intravenous iron sucrose is more effective than 200 mg a day ferrous fumarate in increasing maternal iron stores.
The trial registration number is CTRI/2016/12/007552 registered in Clinical Trial Registry India on 8/12/2016. It is a retrospectively registered trial.
本研究的目的是比较妊娠14至34周期间缺铁性贫血患者静脉注射蔗糖铁与口服富马酸亚铁的疗效、安全性和耐受性。
进行了一项随机对照试验,纳入了2011年10月至2012年8月在比贾布尔市什里B.M.帕蒂尔医学院医院产前门诊就诊的112名患者,其血红蛋白水平在70-110g/L之间,血清铁蛋白<15ng/ml。静脉注射组每天将200mg蔗糖铁加入100ml 0.9%氯化钠中给药。口服组参与者每天服用200mg富马酸亚铁。试验的主要结局指标,即血红蛋白和血清铁蛋白水平在4周后进行测量。使用学生t检验评估统计学显著性。
接受静脉注射铁剂的女性血红蛋白变化高于口服富马酸亚铁的女性,分别为22±11.5g/L和12±9g/L(p<0.0001)。同样,接受静脉注射铁剂的女性血清铁蛋白变化显著高于口服铁剂的女性。静脉注射组55%的参与者血红蛋白改善超过20g/L,而口服治疗组仅为11%。静脉注射组48%的患者铁蛋白水平升高至51至100ng/ml,而口服组仅为3.5%。静脉注射蔗糖铁对纠正孕期贫血或铁储备耗竭有效。
静脉注射蔗糖铁在增加母体铁储备方面比每日200mg富马酸亚铁更有效。
试验注册号为CTRI/2016/12/007552,于2016年12月8日在印度临床试验注册中心注册。这是一项回顾性注册试验。