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[大学生论坛]:孕妇补碘对儿童神经发育的作用

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fee. 发表于 2017-12-31 10:57:09 | 显示全部楼层 |阅读模式
本帖最后由 fee. 于 2017-12-31 10:57 编辑


Effect of iodine supplementation in pregnant women on child neurodevelopment: a randomised, double-blind, placebo-controlled trial.
孕妇补碘对儿童神经发育的作用:一项随机,双盲,安慰剂对照试验




Abstract摘要

BACKGROUND:背景

Iodine deficiency during pregnancy might be associated with reduced intelligence quotient (IQ) score in offspring. We assessed the effect of iodine supplementation in mildly iodine-deficient pregnant women on neurodevelopment of their offspring in areas where schoolchildren were iodine sufficient.
怀孕期间缺碘可能与后代智商(IQ)降低有关。研究人员在学龄儿童碘充足的地区评估了碘补充对轻度缺碘孕妇的子女的神经发育的影响。


METHODS:方法

In this randomised, placebo-controlled trial, pregnant women in Bangalore, India, and Bangkok, Thailand, were randomly assigned (1:1) to receive 200 μg iodine orally once a day or placebo until delivery.
在该项随机的安慰剂对照试验中,印度班加罗尔和泰国曼谷的孕妇按照1:1的比例随机分配并接受每天一次,每次200μg的口服碘补充或是安慰剂直到分娩。


Randomisation was done with a computer-generated sequence and stratified by site. Co-primary outcomes were verbal and performance IQ scores on the Wechsler Preschool and Primary Scale of Intelligence Third Edition (WPPSI-III) and the global executive composite score from the Behaviour Rating Inventory of Executive Function-Preschool Version (BRIEF-P) in the children at age 5-6 years. The trial was double-blinded; some unmasking took place at age 2 years for an interim analysis, but participants and nearly all investigators remained masked to group assignment until age 5-6 years. Analysis was by intention to treat using mixed-effects models. This trial is registered with ClinicalTrials.gov, number NCT00791466.
通过计算机生成的序列完成了随机分配,并根据地区进行了分层。共同的主要结果是在韦氏学前教育和智力第三版(WPPSI-III)上的语言和表现的智商(IQ)得分以及5至6岁儿童在执行功能幼儿版(BRIEF-P)的行为评估量表中的全球执行综合评分。这个试验采取双盲的方式,一些两岁儿童在一次期中分析时知道了真相,但是参与者和几乎所有的调查人员在到5-6岁前任然毫不知情。此分析使用混合效应模型进行治疗。该试验已在ClinicalTrials.gov上注册,编号为NCT00791466


FINDINGS:结果

Between Nov 18, 2008, and March 12, 2011, 832 women entered the trial at a mean gestational age of 10·7 weeks (SD 2·7); median urinary iodine concentration was 131 μg/L (IQR 81-213).
在2008年11月18日至2011年3月12日期间,共有832名妇女参加试验,她们的平均胎龄为10.7周(标准差2·7);尿碘中位数为131微克/升(IQR 81-213)。


Mean compliance with supplementation was 87%, assessed by monthly tablet counts. 313 children (iodine group, n=159; placebo group, n=154) were analysed for verbal and performance IQ with WPPSI-III and 315 (iodine group, n=159; placebo group, n=156) for overall executive function with BRIEF-P.
按每月片剂计数评估,平均符合补充率为87%。这个实验使用WPPSI-Ⅲ对313名儿童(碘组,n = 159;安慰剂组,n = 154)进行口头和表现智商分析,并且用BRIEF-P对315名儿童(碘组,159例;安慰剂组,156例)进行总体执行能力分析。


Mean WPPSI-III scores for verbal IQ were 89·5 (SD 9·8) in the iodine group and 90·2 (9·8) in the placebo group (difference -0·7, 95% CI -2·9 to 1·5; p=0·77), and for performance IQ were 97·5 (12·5) in the iodine group and 99·1 (13·4) in the placebo group (difference -1·6, -4·5 to 1·3; p=0·44).
碘组在言语智商的WPPSI-III平均得分在为89.5(SD 9·8),安慰剂组为90·2(9·8)(差异-0.7,95%CI -2·9〜 1·5; P = 0.77),碘组在表现智商的WPPSI-III平均得分组为97·5(12·5),安慰剂组为99·1(13·4)(差异为-1·6,-4 ·5至1·3; p = 0·44)


The mean BRIEF-P global executive composite score was 90·6 (26·2) in the iodine group and 91·5 (27·0) in the placebo group (difference -0·9, -6·8 to 5·0; p=0·74).
碘组的BRIEF-P全球执行综合评分平均为90·6(26·2),安慰剂组为91·5(27·0)(差异为-0·9,-6·8〜5·0 ; p = 0.74)。


The frequency of adverse events did not differ between groups during gestation or at delivery: 24 women in the iodine group and 28 in the placebo group reported adverse events (iodine group: abortion, n=20; blighted ovum, and n=2; intrauterine death, n=2; placebo group: abortion, n=22; blighted ovum, n=1; intrauterine death, n=2; early neonatal death, n=1; and neonatal death, n=2).
不良事件的发生频率在妊娠期间或分娩时没有差异:碘组有24名妇女发生不良事件,在安慰剂组有28名妇女不良事件(碘组:流产20例;败血症,n = 2;宫内死亡2例;安慰剂组:流产22例;败血症n = 1;宫内死亡2例;早产儿 死亡,n = 1;新生儿死亡,n = 2)。


INTERPRETATION:结论

Daily iodine supplementation in mildly iodine-deficient pregnant women had no effect on child neurodevelopment at age 5-6 years.
轻度缺碘的孕妇每日补碘对5-6岁儿童的神经发育没有影响。







Source:
Lancet Diabetes Endocrinol. 2017 Nov;5(11):853-863. doi: 10.1016/S2213-8587(17)30332-7. Epub 2017 Oct 10.




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