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随机对照试验比较 2 种产前铁补充剂:与母体血红蛋白浓度相关的剂量反应关系?

Randomized controlled trial of 2 prenatal iron supplements: is there a dose-response relation with maternal hemoglobin?

机构信息

Child Health and Nutrition Unit, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium.

出版信息

Am J Clin Nutr. 2011 May;93(5):1012-8. doi: 10.3945/ajcn.110.006239. Epub 2011 Mar 2.

DOI:10.3945/ajcn.110.006239
PMID:21367950
Abstract

BACKGROUND

The most appropriate dose of iron to prevent maternal anemia is still unclear.

OBJECTIVE

We assessed the dose-response relation between maternal hemoglobin and 2 prenatal iron supplements.

DESIGN

An intention-to-treat, double-blind, randomized controlled trial compared 30 mg Fe + folic acid and 13 other micronutrients (UNIMMAP; UNICEF/WHO/UNU multiple micronutrient supplement for pregnant and lactating women) with 60 mg Fe + folic acid (IFA) only in rural Burkina Faso. Home visitors directly observed tablet intake. Mixed-effects models were used for the data analysis.

RESULTS

At inclusion, 43.2% of the 1268 participants were anemic. On average, the hemoglobin concentration decreased over gestation by 0.019 g/dL (95% CI: 0.012, 0.025 g/dL) per week in the IFA and UNIMMAP groups. An increment in hemoglobin concentration per micronutrient tablet [β (±SE) = 0.006 ± 0.001 g/dL; P < 0001] was observed only in women who were anemic at inclusion, whereas a decrease was observed in the other mothers (-0.003 ± 0.001 g/dL; P = 0.002, P for interaction < 0.0001); the finding was similar in both the IFA and UNIMMAP groups. Women with baseline anemia achieved the same hemoglobin concentration (mean ± SD: 11.1 ± 0.64 g/dL) as their counterparts who received ±180 tablets of either UNIMMAP or IFA. Despite this, micronutrient intake did not significantly prevent anemia (51.0% in the third trimester). It was, however, a risk factor for hemoconcentration (odds ratio per tertile of tablet intake: 2.10; 95% CI: 1.12, 3.94), independently of supplement type or initial hemoglobin concentration.

CONCLUSIONS

UNIMMAP triggered the same hemoglobin dose response with half the amount of iron as provided by IFA treatment. The benefit of iron supplements in nonanemic women is unclear. Despite micronutrient supplementation, anemia remained highly prevalent during gestation, partly because of physiologic hemodilution. This trial was registered at clinicaltrials.gov as NCT00642408.

摘要

背景

预防孕产妇贫血的最佳铁剂量仍不清楚。

目的

我们评估了母体血红蛋白与 2 种产前铁补充剂之间的剂量反应关系。

设计

一项意向治疗、双盲、随机对照试验比较了在布基纳法索农村地区使用 30 毫克 Fe + 叶酸和其他 13 种微量营养素(UNIMMAP;UNICEF/WHO/UNU 孕妇和哺乳期妇女多种微量营养素补充剂)与仅使用 60 毫克 Fe + 叶酸(IFA)的剂量反应关系。家访员直接观察片剂摄入量。使用混合效应模型进行数据分析。

结果

在纳入时,1268 名参与者中有 43.2%患有贫血。平均而言,IFA 和 UNIMMAP 组的血红蛋白浓度每周下降 0.019 g/dL(95%CI:0.012,0.025 g/dL)。每片微量营养素片增加的血红蛋白浓度[β(±SE)=0.006±0.001 g/dL;P<0.0001]仅在纳入时患有贫血的妇女中观察到,而在其他母亲中则观察到下降(-0.003±0.001 g/dL;P=0.002,P 交互<0.0001);这一发现在 IFA 和 UNIMMAP 两组中均相似。基线贫血的妇女达到了与接受 UNIMMAP 或 IFA 治疗的妇女相同的血红蛋白浓度(平均±SD:11.1±0.64 g/dL)。尽管如此,微量营养素摄入并没有显著预防贫血(第三孕期 51.0%)。然而,它是血液浓缩的一个危险因素(每三分位摄入片剂的比值比:2.10;95%CI:1.12,3.94),与补充类型或初始血红蛋白浓度无关。

结论

UNIMMAP 触发了与 IFA 治疗相同的血红蛋白剂量反应,而铁的剂量只有 IFA 的一半。非贫血妇女补充铁的益处尚不清楚。尽管进行了微量营养素补充,但妊娠期贫血仍高度流行,部分原因是生理性血液稀释。该试验在 clinicaltrials.gov 上注册为 NCT00642408。

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