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布基纳法索无生育史妇女每周补充铁和叶酸对疟疾风险的影响:一项围孕期、双盲、随机对照非劣效性试验。

Effects of Weekly Iron and Folic Acid Supplements on Malaria Risk in Nulliparous Women in Burkina Faso: A Periconceptional, Double-Blind, Randomized Controlled Noninferiority Trial.

机构信息

Department of Biomedical Sciences, Prince Leopold Institute of Tropical Medicine, Antwerp, Belgium.

Medical Mission Institute, Würzburg, Germany.

出版信息

J Infect Dis. 2018 Aug 24;218(7):1099-1109. doi: 10.1093/infdis/jiy257.

DOI:10.1093/infdis/jiy257
PMID:29733403
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6107738/
Abstract

BACKGROUND

The safety of iron supplementation for young women is uncertain in malaria-endemic settings.

METHODS

This was a double-blind, randomized controlled noninferiority trial in rural Burkina Faso.

RESULTS

A total of 1959 nulliparae were assigned to weekly supplementation (60 mg iron and 2.8 mg folic acid) (n = 980) or 2.8 mg folic acid (n = 979) until first antenatal visit (ANC1), or 18 months if remaining nonpregnant. Three hundred fifteen women attended ANC1, and 916 remained nonpregnant. There was no difference at ANC1 in parasitemia prevalence (iron, 53.4% [95% confidence interval {CI}, 45.7%-61.0%]; control, 55.3% [95% CI, 47.3%-62.9%]; prevalence ratio, 0.97 [95% CI, .79-1.18]; P = .82), anemia (adjusted effect, 0.96 [95% CI, .83-1.10]; P = .52), iron deficiency (adjusted risk ratio [aRR], 0.84 [95% CI, .46-1.54]; P = .58), or plasma iron biomarkers. Outcomes in nonpregnant women were parasitemia (iron, 42.9% [95% CI, 38.3%-47.5%]; control, 39.2% [95% CI, 34.9%-43.7%]; prevalence ratio, 1.09 [95% CI, .93-1.28]; P = .282); anemia (aRR, 0.90 [95% CI, .78-1.05]; P = .17), and iron deficiency (aRR, 0.99 [95% CI, .77-1.28]; P = .96), with no iron biomarker differences.

CONCLUSIONS

Weekly iron supplementation did not increase malaria risk, improve iron status, or reduce anemia in young, mostly adolescent menstruating women, nor in early pregnancy. World Health Organization Guidelines for universal supplementation for young nulliparous women may need reassessment.

CLINICAL TRIALS REGISTRATION

NCT01210040.

摘要

背景

在疟疾流行地区,为年轻女性补充铁剂的安全性尚不确定。

方法

这是在布基纳法索农村进行的一项双盲、随机对照非劣效性试验。

结果

共有 1959 名未生育的妇女被随机分配到每周补充铁(60 毫克)和叶酸(2.8 毫克)组(n = 980)或仅补充叶酸(2.8 毫克)组(n = 979),直至第一次产前检查(ANC1),如果未怀孕,则持续 18 个月。有 315 名妇女参加了 ANC1,916 名妇女仍未怀孕。在 ANC1 时,两组间寄生虫血症患病率(铁组,53.4%[95%置信区间{CI},45.7%-61.0%];对照组,55.3%[95%CI,47.3%-62.9%];患病率比,0.97[95%CI,0.79-1.18];P =.82)、贫血(调整后效应,0.96[95%CI,0.83-1.10];P =.52)、缺铁(调整后的风险比[aRR],0.84[95%CI,0.46-1.54];P =.58)或血浆铁生物标志物无差异。未怀孕妇女的结局包括寄生虫血症(铁组,42.9%[95%CI,38.3%-47.5%];对照组,39.2%[95%CI,34.9%-43.7%];患病率比,1.09[95%CI,0.93-1.28];P =.282)、贫血(aRR,0.90[95%CI,0.78-1.05];P =.17)和缺铁(aRR,0.99[95%CI,0.77-1.28];P =.96),且铁生物标志物无差异。

结论

每周补充铁剂并未增加年轻、大多处于经期的未生育妇女的疟疾风险,也未改善其铁状况或减少贫血,在早期妊娠时也没有差异。世界卫生组织普遍为年轻未生育妇女补充铁剂的指南可能需要重新评估。

临床试验注册

NCT01210040。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27a1/6107738/11a0ae40029e/jiy25702.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27a1/6107738/a7a3947ad461/jiy25701.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27a1/6107738/11a0ae40029e/jiy25702.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27a1/6107738/a7a3947ad461/jiy25701.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/27a1/6107738/11a0ae40029e/jiy25702.jpg

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