Bencaiova Gabriela, von Mandach Ursula, Zimmermann Roland
Department of Obstetrics and Gynaecology, Institute of Obstetric Research, Zurich University Hospital, Switzerland.
Eur J Obstet Gynecol Reprod Biol. 2009 Jun;144(2):135-9. doi: 10.1016/j.ejogrb.2009.03.006. Epub 2009 Apr 29.
To assess and compare the efficacy and safety of two and three doses of intravenous iron sucrose with daily oral ferrous sulphate in the prophylaxis of iron deficiency anaemia in pregnant women.
260 women with singleton pregnancy who met inclusion criteria and who gave informed consent were randomised between the 21st and 24th week into either the intravenous iron group or the oral iron group. Of 130 women in the intravenous iron group, 75 women received two doses of 200mg iron sucrose and 55 three doses of 200mg iron sucrose. The first dose was administered between the 21st and 24th gestational weeks, the second between the 28th and 32nd and the third between the 35th and 37th. The women of the oral group were given oral tablets of 80 mg ferrous sulphate daily, beginning on the day of study enrolment and stopping on the day of delivery.
There was a non-significant trend to a higher frequency of responders (haemoglobin> or =11 g/dl) in the intravenous iron group (75 vs. 80%). There was a significant difference of repleted iron stores before delivery (ferritin>50 microg/l) in the group with three intravenous iron doses in comparison to the oral iron group (49 vs. 14%; p<0.001). No differences were observed in regard to maternal and perinatal outcomes.
There was no clinically significant difference in the haematological, maternal and foetal outcomes in the parenteral route of iron prophylaxis in pregnant women.
评估并比较两剂和三剂静脉注射蔗糖铁与每日口服硫酸亚铁预防孕妇缺铁性贫血的疗效和安全性。
260名单胎妊娠且符合纳入标准并签署知情同意书的女性在第21至24周被随机分为静脉铁剂组或口服铁剂组。静脉铁剂组的130名女性中,75名接受两剂200mg蔗糖铁,55名接受三剂200mg蔗糖铁。第一剂在妊娠第21至24周给药,第二剂在第28至32周,第三剂在第35至37周。口服组女性从研究入组日开始至分娩日每日口服80mg硫酸亚铁片。
静脉铁剂组中反应者(血红蛋白≥11g/dl)频率有升高趋势但无统计学意义(75%对80%)。与口服铁剂组相比,静脉注射三剂铁剂组在分娩前铁储备充足(铁蛋白>50μg/l)方面有显著差异(49%对14%;p<0.001)。在母体和围产期结局方面未观察到差异。
孕妇铁预防的肠外途径在血液学、母体和胎儿结局方面无临床显著差异。