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Iron preparations for women of reproductive age with iron deficiency anaemia in pregnancy (FRIDA): a systematic review and network meta-analysis.
The Lancet Haematology ( IF 24.7 ) Pub Date : 2021-07-01 , DOI: 10.1016/s2352-3026(21)00137-x
Ewelina Rogozińska 1 , Jahnavi Daru 2 , Marios Nicolaides 3 , Carmen Amezcua-Prieto 4 , Susan Robinson 5 , Rui Wang 6 , Peter J Godolphin 1 , Carlos Martín Saborido 7 , Javier Zamora 8 , Khalid S Khan 4 , Shakila Thangaratinam 9
Affiliation  

BACKGROUND Numerous iron preparations are available for the treatment of iron deficiency anaemia in pregnancy. We aimed to provide a summary of the effectiveness and safety of iron preparations used in this setting. METHODS We did a systematic review and network meta-analysis of randomised trials. We searched MEDLINE, Embase, Cochrane Central Register of Controlled Trials, trial registers, and grey literature for trials published in any language from Jan 1, 2011, to Feb 28, 2021. We included trials including pregnant women with iron deficiency anaemia and evaluating iron preparations, irrespective of administration route, with at least 60 mg of elemental iron, in comparison with another iron or non-iron preparation. Three authors independently selected studies, extracted data, and did a risk of bias assessment using the Cochrane tool (version 1.0). The primary outcome was the effectiveness of iron preparations, evaluated by changes in haemoglobin concentration at 4 weeks from baseline. The secondary outcomes were change in serum ferritin concentration at 4 weeks from baseline and treatment-related severe and non-severe adverse events. We did random-effects pairwise and network meta-analyses. Side-effects were reported descriptively for each trial. This study is registered with PROSPERO, CRD42018100822. FINDINGS Among 3037 records screened, 128 full-text articles were further assessed for eligibility. Of the 53 eligible trials (reporting on 9145 women), 30 (15 interventions; 3243 women) contributed data to the network meta-analysis for haemoglobin and 15 (nine interventions; 1396 women) for serum ferritin. The risk of bias varied across the trials contributing to network meta-analysis, with 22 of 30 trials in the network meta-analysis for haemoglobin judged to have a high or medium global risk of bias. Compared with oral ferrous sulfate, intravenous iron sucrose improved both haemoglobin (mean difference 7·17 g/L, 95% CI 2·62-11·73; seven trials) and serum ferritin (mean difference 49·66 μg/L, 13·63-85·69; four trials), and intravenous ferric carboxymaltose improved haemoglobin (mean difference 8·52 g/L, 0·51-16·53; one trial). The evidence for other interventions compared with ferrous sulfate was insufficient. The most common side-effects with oral iron preparations were gastrointestinal effects (nausea, vomiting, and altered bowel movements). Side-effects were less common with parenteral iron preparations, although these included local pain, skin irratation, and, on rare occasions, allergic reactions. INTERPRETATION Iron preparations for treatment of iron deficiency anaemia in pregnancy vary in effectiveness, with good evidence of benefit for intravenous iron sucrose and some evidence for intravenous ferric carboxymaltose. Clinicians and policy makers should consider the effectiveness of individual preparations before administration, to ensure effective treatment. FUNDING None.

中文翻译:

妊娠期缺铁性贫血育龄妇女的铁制剂(FRIDA):系统评价和网络荟萃分析。

背景许多铁制剂可用于治疗妊娠期缺铁性贫血。我们的目的是总结在这种情况下使用的铁制剂的有效性和安全性。方法 我们对随机试验进行了系统评价和网络荟萃分析。我们检索了 MEDLINE、Embase、Cochrane 对照试验中心注册库、试验注册库和灰色文献,以查找 2011 年 1 月 1 日至 2021 年 2 月 28 日期间以任何语言发表的试验。我们纳入了包括缺铁性贫血孕妇和评估铁的试验与其他铁或非铁制剂相比,无论给药途径如何,含有至少 60 mg 元素铁的制剂。三位作者独立选择研究,提取数据,并使用 Cochrane 工具(第 1 版)进行偏倚风险评估。0)。主要结果是铁制剂的有效性,通过基线后 4 周血红蛋白浓度的变化来评估。次要结果是从基线开始 4 周时血清铁蛋白浓度的变化以及与治疗相关的严重和非严重不良事件。我们进行了随机效应成对和网络荟萃分析。描述性地报告了每个试验的副作用。本研究在 PROSPERO 注册,CRD42018100822。结果 在筛选的 3037 条记录中,进一步评估了 128 篇全文文章的资格。在 53 项符合条件的试验(报告 9145 名女性)中,30 项(15 项干预措施;3243 名女性)为血红蛋白的网络荟萃分析提供数据,15 项(9 项干预措施;1396 名女性)为血清铁蛋白提供数据。有助于网络荟萃分析的试验的偏倚风险各不相同,血红蛋白网络荟萃分析的 30 项试验中有 22 项被判定为具有高或中等总体偏倚风险。与口服硫酸亚铁相比,静脉注射蔗糖铁可改善血红蛋白(平均差 7·17 g/L,95% CI 2·62-11·73;7 项试验)和血清铁蛋白(平均差 49·66 μg/L,13 ·63-85·69;四项试验),静脉注射羧基麦芽糖铁可改善血红蛋白(平均差 8·52 g/L,0·51-16·53;一项试验)。与硫酸亚铁相比,其他干预措施的证据不足。口服铁剂最常见的副作用是胃肠道反应(恶心、呕吐和排便改变)。注射铁剂的副作用较少,但包括局部疼痛、皮肤刺激,以及在极少数情况下的过敏反应。解释 用于治疗妊娠期缺铁性贫血的铁制剂的有效性各不相同,有充分证据表明静脉注射蔗糖铁有益,一些证据表明静脉注射羧基麦芽糖铁。临床医生和决策者应在给药前考虑个体制剂的有效性,以确保有效治疗。资金 无。
更新日期:2021-07-01
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