Division of Pediatric Medicine and the Pediatric Outcomes Research Team (PORT), Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, Canada, M5G 1X8.
Public Health Nutr. 2013 Aug;16(8):1497-506. doi: 10.1017/S1368980012003709. Epub 2012 Aug 16.
To systematically review the efficacy and safety of oral Fe therapy in pre-school children (1–5 years) with non-anaemic Fe deficiency, determined by children’s developmental and haematological status and the incidence of reported side-effects.
A random-effects model was used to show mean differences with 95% confidence intervals of developmental and haematological scores between Fe-treated and non-treated groups.
MEDLINE, EMBASE, Cochrane library and bibliographies of identified articles were searched up to September 2011. Randomized and observational studies were assessed by two reviewers independently. Quality of the trials was assessed on the basis of concealment of allocation, method of randomization, masking of outcome assessment and completeness of follow-up.
From the titles of 743 articles, full text review was completed on forty-six and two randomized trials of acceptable quality met the inclusion criteria. The two trials included a total of sixty-nine children.
One study showed a statistically significant difference in the post-treatment Mental Developmental Index score among children who received oral Fe therapy v. no therapy (mean difference56?3, 95% CI 1?5, 11?0, P value not provided). Both studies showed significant improvement in serum ferritin level (mg/l: mean difference551? 1, 95% CI 33?6, 68?6, P,0?01 and mean difference517?1, 95% CI 7?5, 26?6, P value not provided, respectively) in children who received Fe therapy.
Evidence is insufficient to recommend oral Fe therapy to children with non-anaemic Fe deficiency. There is urgent need of conducting adequately powered, randomized trials examining the efficacy of oral Fe therapy in pre-school children with non-anaemic Fe deficiency.
系统评价口服铁剂治疗学龄前儿童(1-5 岁)非贫血性缺铁症的疗效和安全性,该疗效和安全性通过儿童的发育和血液状况以及不良反应报告发生率来确定。
采用随机效应模型显示铁剂治疗组和未治疗组之间发育和血液评分的均数差值及其 95%置信区间。
检索 MEDLINE、EMBASE、Cochrane 图书馆和已确定文章的参考文献,检索截至 2011 年 9 月。两名评审员独立评估随机和观察性研究。试验质量根据分配隐匿、随机化方法、结局评估的盲法和随访的完整性进行评估。
从 743 篇文章的标题中,对 46 篇和 2 篇质量可接受的随机试验进行了全文审查,符合纳入标准。这两项试验共纳入 69 名儿童。
有一项研究显示,接受口服铁剂治疗的儿童与未接受治疗的儿童相比,治疗后智力发育指数评分有统计学意义的差异(平均差值 56?3,95%可信区间 1?5,11?0,未提供 P 值)。两项研究均显示血清铁蛋白水平显著改善(mg/L:平均差值 551?1,95%可信区间 33?6,68?6,P 值,0?01 和平均差值 517?1,95%可信区间 7?5,26?6,未提供 P 值)在接受铁剂治疗的儿童中。
目前尚无足够证据推荐口服铁剂治疗非贫血性缺铁症的儿童。急需开展充分有力的、随机试验,以检验口服铁剂治疗学龄前非贫血性缺铁症儿童的疗效。