Wang Bo, Zhan Siyan, Gong Ting, Lee Liming
Health Science Popularization Research Center, Chinese Academy of Medical Sciences, Beijing, China.
Cochrane Database Syst Rev. 2013 Jun 6;2013(6):CD001444. doi: 10.1002/14651858.CD001444.pub2.
Iron deficiency and iron deficiency anaemia (IDA) are common in young children. It has been suggested that the lack of iron may have deleterious effects on children's psychomotor development and cognitive function. To evaluate the benefits of iron therapy on psychomotor development and cognitive function in children with IDA, a Cochrane review was carried out in 2001. This is an update of that review.
To determine the effects of iron therapy on psychomotor development and cognitive function in iron deficient anaemic children less than three years of age.
We searched the following databases in April 2013: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, CINAHL, PsycINFO, LILACS, ClinicalTrials.gov and World Health Organization International Clinical Trials Registry Platform (ICTRP). We also searched the reference lists of review articles and reports, and ran citation searches in the Science Citation Index for relevant studies identified by the primary search. We also contacted key authors.
Studies were included if children less than three years of age with evidence of IDA were randomly allocated to iron or iron plus vitamin C versus a placebo or vitamin C alone, and assessment of developmental status or cognitive function was carried out using standardised tests by observers blind to treatment allocation.
Two review authors independently screened titles and abstracts retrieved from the searches and assessed full-text copies of all potentially relevant studies against the inclusion criteria. The same review authors independently extracted data and assessed the risk of bias of the eligible studies. Data were analysed separately depending on whether assessments were performed within one month of beginning iron therapy or after one month.
We identified one eligible study in the update search that had not been included in the original review. In total, we included eight trials.Six trials, including 225 children with IDA, examined the effects of iron therapy on measures of psychomotor development and cognitive function within 30 days of commencement of therapy. We could pool data from five trials. The pooled difference in pre- to post-treatment change in Bayley Scale Psychomotor Development Index (PDI) between iron and placebo groups was -1.25 (95% confidence interval (CI) -4.56 to 2.06, P value = 0.65; I(2) = 33% for heterogeneity, random-effects meta-analysis; low quality evidence) and in Bayley Scale Mental Development Index (MDI) was 1.04 (95% CI -1.30 to 3.39, P value = 0.79; I(2) = 31% for heterogeneity, random-effects meta-analysis; low quality evidence).Two studies, including 160 randomised children with IDA, examined the effects of iron therapy on measures of psychomotor development and cognitive function more than 30 days after commencement of therapy. One of the studies reported the mean number of skills gained after two months of iron therapy using the Denver Developmental Screening Test. The intervention group gained 0.8 (95% CI -0.18 to 1.78, P value = 0.11, moderate quality of evidence) more skills on average than the control group. The other study reported that the difference in pre- to post-treatment change in Bayley Scale PDI between iron-treated and placebo groups after four months was 18.40 (95% CI 10.16 to 26.64, P value < 0.0001; moderate quality evidence) and in Bayley Scale MDI was 18.80 (95% CI 10.17 to 27.43, P value < 0.0001; moderate quality evidence).
AUTHORS' CONCLUSIONS: There is no convincing evidence that iron treatment of young children with IDA has an effect on psychomotor development or cognitive function within 30 days after commencement of therapy. The effect of longer-term treatment remains unclear. There is an urgent need for further large randomised controlled trials with long-term follow-up.
缺铁和缺铁性贫血(IDA)在幼儿中很常见。有人认为缺铁可能对儿童的精神运动发育和认知功能产生有害影响。为评估铁剂治疗对IDA患儿精神运动发育和认知功能的益处,2001年进行了一项Cochrane系统评价。这是该评价的更新版。
确定铁剂治疗对3岁以下缺铁性贫血儿童精神运动发育和认知功能的影响。
我们于2013年4月检索了以下数据库:Cochrane对照试验中心注册库(CENTRAL)、医学索引数据库(MEDLINE)、荷兰医学文摘数据库(EMBASE)、护理学与健康领域数据库(CINAHL)、心理学文摘数据库(PsycINFO)、拉丁美洲和加勒比卫生科学数据库(LILACS)、临床试验注册库(ClinicalTrials.gov)以及世界卫生组织国际临床试验注册平台(ICTRP)。我们还检索了综述文章和报告的参考文献列表,并在科学引文索引中对初步检索确定的相关研究进行了引文检索。我们还联系了主要作者。
纳入的研究需为3岁以下有IDA证据的儿童,随机分配至铁剂或铁剂加维生素C组,与安慰剂或仅维生素C组进行对比,且由对治疗分配不知情的观察者使用标准化测试对发育状况或认知功能进行评估。
两位综述作者独立筛选检索到的标题和摘要,并根据纳入标准评估所有潜在相关研究的全文。同样是这两位综述作者独立提取数据并评估合格研究的偏倚风险。根据评估是在开始铁剂治疗后1个月内还是1个月后进行,对数据进行了分别分析。
在更新检索中我们确定了一项符合条件的研究,该研究未被纳入原综述。我们总共纳入了8项试验。6项试验,包括225名IDA患儿,在治疗开始后30天内研究了铁剂治疗对精神运动发育和认知功能指标的影响。我们可以汇总5项试验的数据。铁剂组与安慰剂组在贝利婴幼儿发育量表精神运动发育指数(PDI)治疗前后变化的合并差异为-1.25(95%置信区间(CI)-4.56至2.06,P值 = 0.65;异质性I(2)=33%,随机效应荟萃分析;低质量证据),在贝利婴幼儿发育量表智力发育指数(MDI)方面为1.04(95%CI -1.30至3.39,P值 = 0.79;异质性I(2)=31%,随机效应荟萃分析;低质量证据)。两项研究,包括160名随机分组的IDA患儿,在治疗开始后30天以上研究了铁剂治疗对精神运动发育和认知功能指标的影响。其中一项研究报告了使用丹佛发育筛查测验在铁剂治疗两个月后获得的技能平均数量。干预组平均比对照组多获得0.8项技能(95%CI -0.18至1.78,P值 = 0.11,中等质量证据)。另一项研究报告,四个月后铁剂治疗组与安慰剂组在贝利婴幼儿发育量表PDI治疗前后变化的差异为18.40(95%CI 10.16至26.64,P值<0.0001;中等质量证据),在贝利婴幼儿发育量表MDI方面为18.80(95%CI 10.17至27.43,P值<0.0001;中等质量证据)。
没有令人信服的证据表明对IDA幼儿进行铁剂治疗在治疗开始后30天内对精神运动发育或认知功能有影响。长期治疗的效果仍不清楚。迫切需要进一步开展有长期随访的大型随机对照试验。