缺铁女性隔日与连续口服铁补充剂的比较：一项随机双盲安慰剂对照研究。
Alternate day versus consecutive day oral iron supplementation in iron-depleted women: a randomized double-blind placebo-controlled study.
作者信息
von Siebenthal Hanna K, Gessler Sara, Vallelian Florence, Steinwendner Joachim, Kuenzi Urs-Martin, Moretti Diego, Zimmermann Michael B, Stoffel Nicole U
机构信息
Laboratory of Human Nutrition, Department of Health Sciences and Technology, ETH Zurich, Switzerland.
Division of Internal Medicine, University Hospital and University of Zurich, Zurich, Switzerland.
出版信息
EClinicalMedicine. 2023 Nov 3;65:102286. doi: 10.1016/j.eclinm.2023.102286. eCollection 2023 Nov.
BACKGROUND
Guidelines to treat iron deficiency recommend daily provision of oral iron, but this may decrease fractional iron absorption and increase side effects. Our objective was to compare consecutive-day versus alternate-day iron supplementation.
METHODS
In a double-masked, randomized, placebo-controlled trial, young Swiss women (n = 150; serum ferritin ≤30 μg/L) were assigned to: daily 100 mg iron for 90 d, followed by daily placebo for another 90 d (consecutive-day group) or the same daily dose of iron and placebo on alternate days for 180 d (alternate-day group). The study period was 24/11/2021-10/8/2022. Co-primary outcomes, at equal total iron doses, were serum ferritin and gastrointestinal side effects; secondary outcomes were iron deficiency and serum hepcidin. Compliance and side effects were recorded daily using a mobile application. Data were analysed using mixed models and longitudinal prevalence ratios (LPR). The trial was registered at ClinicalTrials.gov (NCT05105438).
FINDINGS
75 women were assigned to each group and included in the intention-to-treat analysis. Capsule adherence and side effect reporting was >97% in both groups. At equal total iron doses, comparing consecutive-day and alternate-day groups, median serum ferritin was 43.8 μg/L (31.7-58.2) versus 44.8 μg/L (33.8-53.6) (P = 0.98), the LPR for gastrointestinal side effects on days of iron intake was 1.56 (95% CI: 1.38, 1.77; P < 0.0001), and median serum hepcidin was 3.0 nM (IQR 2.0-5.0) versus 1.9 nM (1.4-2.9) (P < 0.0001). Iron deficiency prevalence after 3 months was 5.5% versus 4.3% (P = 0.74) and after 6 months was 11.4% and 3.0% (P = 0.049).
INTERPRETATION
At equal total iron doses, compared to consecutive day dosing of iron, alternate day dosing did not result in higher serum ferritin but reduced iron deficiency at 6 months and triggered fewer gastrointestinal side effects.
FUNDING
Swiss National Science Foundation, Bern, Switzerland.
背景
缺铁性疾病的治疗指南建议每日口服补充铁剂，但这可能会降低铁的吸收分数并增加副作用。我们的目的是比较连续每日补铁与隔日补铁的效果。
方法
在一项双盲、随机、安慰剂对照试验中，年轻的瑞士女性（n = 150；血清铁蛋白≤30 μg/L）被分配到：每日补充100 mg铁剂，持续90天，随后每日服用安慰剂，持续90天（连续每日组），或在180天内隔日服用相同剂量的铁剂和安慰剂（隔日组）。研究时间为2021年11月24日至2022年8月10日。在总铁剂量相同的情况下，共同主要结局指标为血清铁蛋白和胃肠道副作用；次要结局指标为缺铁和血清铁调素。使用移动应用程序每日记录依从性和副作用。数据采用混合模型和纵向患病率比（LPR）进行分析。该试验已在ClinicalTrials.gov注册（NCT05105438）。
结果
每组分配75名女性并纳入意向性分析。两组的胶囊依从性和副作用报告率均>97%。在总铁剂量相同的情况下，比较连续每日组和隔日组，血清铁蛋白中位数分别为43.8 μg/L（31.7 - 58.2）和44.8 μg/L（33.8 - 53.6）（P = 0.98），铁剂摄入日胃肠道副作用的LPR为1.56（95% CI：1.38，1.77；P < 0.0001），血清铁调素中位数分别为3.0 nM（IQR 2.0 - 5.0）和1.9 nM（I.4 - 2.9）（P < 0.0001）。3个月后缺铁患病率分别为5.5%和4.3%（P = 0.74），6个月后分别为11.4%和3.0%（P = 0.049）。
解读
在总铁剂量相同的情况下，与连续每日补铁相比，隔日补铁不会使血清铁蛋白升高，但可在6个月时降低缺铁率，并引发较少的胃肠道副作用。
资助
瑞士国家科学基金会，瑞士伯尔尼。
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