Pasricha Sant-Rayn, Moya Ernest, Ataíde Ricardo, Mzembe Glory, Harding Rebecca, Mwangi Martin N, Zinenani Truwah, Prang Khic-Houy, Kaunda Justina, Mtambo Owen P L, Vokhiwa Maclean, Mhango Gomezgani, Mamani-Mategula Elisabeth, Fielding Katherine, Demir Ayşe, Von Dinklage Naomi, Verhoef Hans, McLean Alistair Rd, Manda-Taylor Lucinda, Braat Sabine, Phiri Kamija S
Walter and Eliza Hall Institute of Medical Research, Parkville, Victoria, Australia.
Diagnostic Haematology, The Royal Melbourne Hospital, Parkville, Victoria, Australia.
Nat Med. 2025 Jan;31(1):197-206. doi: 10.1038/s41591-024-03385-w. Epub 2025 Jan 6.
Over 46% of African pregnant women are anemic. Oral iron is recommended but often suboptimal, particularly late in pregnancy. Intravenous ferric carboxymaltose (FCM) could treat anemia in women in the third trimester in sub-Saharan Africa. In an open-label, individually randomized trial in antenatal clinics in southern Malawi, we randomized 590 women at 27-35 weeks of gestation with capillary hemoglobin <10.0 g dl to FCM (20 mg kg up to 1,000 mg, once at enrollment) or standard of care (60 mg elemental iron, twice daily for 90 days). Participants and their infants were followed to 4 weeks postpartum. Primary outcomes were maternal anemia at 36 weeks' gestation or delivery (whichever occurred first) and neonatal birthweight. At the primary timepoint, 126 of 270 (46.7%) of women in the FCM group were anemic, compared to 170 of 271 (67.3%) women in the standard-of-care group (PR, 0.74 (95% CI 0.64, 0.87); P = 0.0002). There was no difference between groups in birthweight (mean difference 10.9 g (-65.7, 87.5 g); P = 0.78). No serious infusion-related reactions occurred, and there were no differences in adverse events between groups. In Malawian women in late pregnancy, FCM effectively and safely reduced anemia before childbirth. Australia New Zealand Clinical Trial registration: ANZCTR12621001239853.
超过46%的非洲孕妇患有贫血。推荐口服铁剂，但效果往往不理想，尤其是在妊娠晚期。静脉注射羧麦芽糖铁（FCM）可治疗撒哈拉以南非洲地区孕晚期妇女的贫血。在马拉维南部产前诊所进行的一项开放标签、个体随机试验中，我们将590名妊娠27 - 35周、毛细血管血红蛋白<10.0 g/dl的妇女随机分为FCM组（20 mg/kg，最大剂量1000 mg，入组时注射一次）或标准治疗组（60 mg元素铁，每日两次，共90天）。对参与者及其婴儿进行随访至产后4周。主要结局指标为妊娠36周或分娩时（以先发生者为准）的产妇贫血情况和新生儿出生体重。在主要时间点，FCM组270名妇女中有126名（46.7%）贫血，而标准治疗组271名妇女中有170名（67.3%）贫血（相对危险度，0.74（95%置信区间0.64, 0.87）；P = 0.0002）。两组出生体重无差异（平均差异10.9 g（-65.7, 87.5 g）；P = 0.78）。未发生严重的输液相关反应，两组不良事件无差异。对于马拉维晚期妊娠妇女，FCM在分娩前有效且安全地减轻了贫血。澳大利亚新西兰临床试验注册编号：ANZCTR12621001239853。
