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每日补铁与隔日补铁治疗缺铁性贫血孕妇的随机对照试验

Daily versus Alternate-Day Iron Supplementation for Pregnant Women with Iron Deficiency Anemia: A Randomized Controlled Trial.

作者信息

Lam Melissa Chu, Khandakar Binny, Heon Isaak, Hussain Farrah, Feldman Kristina, Kaplowitz Elianna, Overbey Jessica R, Brustman Lois, Rosenn Barak

机构信息

Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Northshore University Hospital, Manhasset, New York.

Department of Pathology, Mount Sinai West, New York, New York.

出版信息

Am J Perinatol. 2025 Apr;42(6):699-707. doi: 10.1055/a-2405-1381. Epub 2024 Aug 29.

Abstract

This study aimed to evaluate the most effective regimen to raise hemoglobin (Hb) by comparing alternate-day dosing of iron to daily dosing in pregnant women with iron deficiency anemia. Women with Hb < 11.0 g/dL and ferritin ≤ 25 µg/L between 12 and 34 weeks' gestation were recruited. A total of 88 patients were randomized using block randomization with 1:1 allocation to receive either 1 tablet of 325 mg ferrous sulfate on consecutive days or 2 tablets every other day. The primary outcome, the change in Hb after 6 weeks of treatment was assessed using an analysis of covariance to adjust for baseline level. Secondary outcomes included change in ferritin, hepcidin, side effects, and compliance. Patients completed a questionnaire to assess for adverse symptoms and adherence was monitored by installing a pill reminder app on smartphones of patients. A total of 88 patients were consented. The daily iron group had a greater proportion of nulliparous women (40 vs. 7%). Most patients (98%) had mild anemia (Hb: 9-10.9 g/dL) at recruitment, with a median gestational age of 28.1 weeks (interquartile range [IQR]: 25.6, 30.9) and median duration of treatment of 42 days (IQR: 35, 45). At 6 weeks, the daily iron group had a mean increase in Hb of 0.8 ± 0.9 g/dL, whereas the alternate-day iron group had a mean increase of 0.5 ± 1.0 g/dL (baseline adjusted difference of means: -0.3 [95% confidence interval: -0.7, 0.1],  = 0.15). Frequency of adverse effects attributable to iron were similar between groups. Patient self-reported compliance to treatment was also similar between groups. Among those that used the app, compliance was higher among the daily group compared with the alternate daily group (median: 95.5% [IQR: 75, 100] vs. 85% [IQR: 40, 92]), although this difference was not statistically significant ( = 0.07). This trial suggests that there are no significant differences between alternate-day iron supplementation and daily iron supplementation for treating iron deficiency anemia. · Intermittent iron provides no additional benefit compared to daily iron in the treatment of anemia.. · Patient compliance to treatment was similar between the groups.. · The frequency of side effects was not significantly different between the groups..

摘要

本研究旨在通过比较缺铁性贫血孕妇隔日补铁与每日补铁方案,评估提高血红蛋白(Hb)水平的最有效方案。招募妊娠12至34周、Hb<11.0 g/dL且铁蛋白≤25 μg/L的女性。共88例患者采用区组随机化按1:1分配,随机接受连续每日服用1片325 mg硫酸亚铁或隔日服用2片。主要结局为治疗6周后Hb的变化,采用协方差分析对基线水平进行校正后评估。次要结局包括铁蛋白、铁调素的变化、副作用及依从性。患者完成一份问卷以评估不良症状,并通过在患者智能手机上安装服药提醒应用程序来监测依从性。共有88例患者签署知情同意书。每日补铁组初产妇比例更高(40% vs. 7%)。大多数患者(98%)入组时为轻度贫血(Hb:9 - 10.9 g/dL),中位孕周为28.1周(四分位间距[IQR]:25.6,30.9),中位治疗时间为42天(IQR:35,45)。6周时,每日补铁组Hb平均升高0.8±0.9 g/dL,而隔日补铁组平均升高0.5±1.0 g/dL(基线校正后均值差异:-0.3[95%置信区间:-0.7,0.1],P = 0.15)。两组间铁所致不良反应的发生率相似。两组患者自我报告的治疗依从性也相似。在使用该应用程序的患者中,每日补铁组的依从性高于隔日补铁组(中位数:95.5%[IQR:75,100] vs. 85%[IQR:40,92]),尽管这一差异无统计学意义(P = 0.07)。该试验表明,隔日补铁与每日补铁治疗缺铁性贫血无显著差异。· 与每日补铁相比,间歇性补铁在治疗贫血方面无额外益处。· 两组患者的治疗依从性相似。· 两组间副作用的发生率无显著差异。

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