DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL OF FOLATE TREATMENT BEFORE CONCEPTION TO PREVENT RECURRENCE OF NEURAL-TUBE DEFECTS

DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL OF FOLATE TREATMENT BEFORE CONCEPTION TO PREVENT RECURRENCE OF NEURAL-TUBE DEFECTS
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DOI:
10.1136/bmj.282.6275.1509
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发表时间:
1981-01-01
影响因子:
105.7
通讯作者:
CAMPBELL, H
CAMPBELL, H
中科院分区:
医学1区
文献类型:
--
作者:
LAURENCE, KM;JAMES, N;CAMPBELL, H

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在南威尔士[英国]进行了一项随机对照双盲试验,以防止有1个神经管缺陷儿童的妇女神经管缺陷复发。60名妇女在怀孕前被分配在怀孕前和怀孕早期每天服用4毫克叶酸,44名妇女遵守了这些指示。51名妇女被分配到安慰剂治疗。在顺从的母亲中没有复发,但在不顺从的母亲中发现了2例,在安慰剂组的妇女中发现了4例。因此,在接受补充剂的患者中没有复发,在未接受补充剂的患者中有6例复发;这一差异具有显著性(P = 0.04)。补充叶酸可能是一种廉价,安全和有效的一级预防神经管缺陷的方法,但这必须在一个大的,多中心的试验中得到证实。
A randomized controlled double-blind trial was undertaken in south Wales [UK] to prevent the recurrence of neural tube defects in women who had had 1 child with a neural tube defect. Sixty women were allocated before conception to take 4 mg of folic acid a day before and during early pregnancy and 44 complied with these instructions. Fifty-one women were allocated to placebo treatment. There were no recurrences among the compliant mothers, but 2 were found among the non-compliers and 4 among the women in the placebo group. Thus, there were no recurrences among those who received supplementation and 6 among those who did not; this difference is significant (P = 0.04). Folic acid supplementation might be a cheap, safe and effective method of primary prevention of neural tube defects, but this must be confirmed in a large, multicenter trial.