澳大利亚Walter and Eliza Hall医学研究所Sant-Rayn Pasricha团队研究了孟加拉国农村地区婴儿铁干预的益处和风险。2021年9月8日出版的《新英格兰医学杂志》发表了这项成果。

世界卫生组织建议在贫血流行的中低收入国家向幼儿普遍提供铁补充剂（滴剂或糖浆）或多种微量营养素粉并广泛实施。这些干预措施的功能性益处和安全性尚不清楚。

研究组进行了一项三组、双盲、双模拟、单独随机、安慰剂对照试验，以评估孟加拉国农村8个月大婴儿每日补充铁糖浆或含铁多种微量营养素粉3个月与安慰剂相比的近期和中期益处和风险。

主要结局是认知发展，在完成指定的3个月疗程后，立即通过婴幼儿发展贝利量表（第三版）的认知综合评分进行评估；分数从55分到145分不等，分数越高表示认知能力越好。次要结局包括完成指定方案后9个月的认知综合评分；完成后立即和完成后9个月的行为、语言和运动发育，生长和血液学指标；以及安全性。

研究组随机分配3300名婴儿每天服用铁糖浆（1101名婴儿）、多种微量营养素粉（1099名婴儿）或安慰剂（1100名婴儿）。在完成指定的3个月方案后，与安慰剂相比，服用铁糖浆或使用多种微量营养素粉对认知综合评分均无明显影响。

完成指定方案后或完成后9个月，研究组未观察到对任何其他发育或生长结果的明显影响。在完成指定方案的9个月后，所有三个试验组的贫血、缺铁和缺铁性贫血的患病率都有所增加，但服用铁糖浆或多种微量营养素粉的儿童的患病率显著低于服用安慰剂的儿童。三个试验组发生严重不良事件的风险，以及感染症状的发生率均相差不大。

研究结果表明，在这项涉及孟加拉国婴儿的试验中，与安慰剂相比，每日补充铁糖浆或多种微量营养素粉3个月似乎对儿童发育或其他功能结局没有影响。

附：英文原文

Title: Benefits and Risks of Iron Interventions in Infants in Rural Bangladesh

Author: Sant-Rayn Pasricha, M.B., B.S., Ph.D.,, M. Imrul Hasan, M.B., B.S., M.P.H.,, Sabine Braat, M.Sc.,, Leila M. Larson, Ph.D.,, S.M. Mulk-Uddin Tipu, M.B.A.,, Sheikh J. Hossain, M.P.H.,, Shamima Shiraji, M.Sc.,, Andrew Baldi, M.B., B.S.,, Mohammad S.A. Bhuiyan, M.B., B.S.,, Fahmida Tofail, Ph.D.,, Jane Fisher, Ph.D.,, Sally Grantham-McGregor, F.R.C.P.,, Julie A. Simpson, Ph.D.,, Jena D. Hamadani, M.B., B.S., Ph.D.,, and Beverley-Ann Biggs, M.B., B.S., Ph.D.

Issue&Volume: 2021-09-08

Abstract:

Background

Universal provision of iron supplements (drops or syrup) or multiple micronutrient powders to young children in low-to-middle-income countries where anemia is prevalent is recommended by the World Health Organization and widely implemented. The functional benefits and safety of these interventions are unclear.

Methods

We conducted a three-group, double-blind, double-dummy, individually randomized, placebo-controlled trial to assess the immediate and medium-term benefits and risks of 3 months of daily supplementation with iron syrup or iron-containing multiple micronutrient powders, as compared with placebo, in 8-month-old children in rural Bangladesh. The primary outcome was cognitive development, as assessed by the cognitive composite score on the Bayley Scales of Infant and Toddler Development, third edition, immediately after completion of the assigned 3-month regimen; scores range from 55 to 145, with higher scores indicating better cognitive performance. Secondary outcomes included the cognitive composite score at 9 months after completion of the assigned regimen; behavioral, language, and motor development, as well as growth and hematologic markers, immediately after completion and at 9 months after completion; and safety.

Results

We randomly assigned 3300 infants to receive iron syrup (1101 infants), multiple micronutrient powders (1099), or placebo (1100) daily. After completion of the assigned 3-month regimen, no apparent effect on the cognitive composite score was observed with iron syrup as compared with placebo (mean between-group difference in change in score from baseline, 0.30 points; 95% confidence interval [CI], 1.08 to 0.48) or with multiple micronutrient powders as compared with placebo (mean between-group difference in change in score from baseline, 0.23 points; 95% CI, 0.55 to 1.00). No apparent effect on any other developmental or growth outcome was observed immediately after completion of the assigned regimen or at 9 months after completion. At 9 months after completion of the assigned regimen, the prevalences of anemia, iron deficiency, and iron deficiency anemia increased in all three trial groups but remained lower among the children who received iron syrup or multiple micronutrient powders than among those who received placebo. The risk of serious adverse events and incidence of symptoms of infection were similar in the three trial groups.

Conclusions

In this trial involving infants in Bangladesh, 3 months of daily supplementation with iron syrup or multiple micronutrient powders did not appear to have an effect on child development or other functional outcomes as compared with placebo.

DOI: 10.1056/NEJMoa2034187

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2034187