Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. MRC Vitamin Study Research Group.
Prevention of neural tube defects: results of the Medical Research Council Vitamin Study. MRC Vitamin Study Research Group.
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DOI：
10.1016/0140-6736(91)90133-a
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发表时间：
1991-07-20
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在7个国家的33个中心进行了一项析因设计的随机双盲预防试验，以确定在怀孕期间补充叶酸（B组维生素之一）或其他7种维生素（A、D、B1、B2、B6、C和烟酰胺）的混合物是否可以预防神经管缺陷（无脑畸形、脊柱裂、脑膨出）。总共有1817名妇女在高风险的怀孕与神经管缺陷，因为以前受影响的怀孕，被随机分配到四组之一-即叶酸，其他维生素，两者兼而有之，或都没有。1195例已完成妊娠，已知胎儿或婴儿有或没有神经管缺陷;其中27例已知有神经管缺陷，其中6例在叶酸组，21例在其他两组，保护效果为72%（相对风险0.28，95%置信区间0.12-0.71）。其他维生素没有显示出显著的保护作用（相对危险度0.80，95%CI 0.32-1.72）。叶酸补充剂没有明显的危害，尽管该研究检测罕见或轻微不良反应的能力有限。现在可以坚定地建议所有受影响怀孕的妇女在怀孕前开始补充叶酸，并应采取公共卫生措施，确保所有可能生育的妇女的饮食中含有足够的叶酸。
A randomised double-blind prevention trial with a factorial design was conducted at 33 centres in seven countries to determine whether supplementation with folic acid (one of the vitamins in the B group) or a mixture of seven other vitamins (A,D,B1,B2,B6,C and nicotinamide) around the time of conception can prevent neural tube defects (anencephaly, spina bifida, encephalocele). A total of 1817 women at high risk of having a pregnancy with a neural tube defect, because of a previous affected pregnancy, were allocated at random to one of four groups--namely, folic acid, other vitamins, both, or neither. 1195 had a completed pregnancy in which the fetus or infant was known to have or not have a neural tube defect; 27 of these had a known neural tube defect, 6 in the folic acid groups and 21 in the two other groups, a 72% protective effect (relative risk 0.28, 95% confidence interval 0.12-0.71). The other vitamins showed no significant protective effect (relative risk 0.80, 95% Cl 0.32-1.72). There was no demonstrable harm from the folic acid supplementation, though the ability of the study to detect rare or slight adverse effects was limited. Folic acid supplementation starting before pregnancy can now be firmly recommended for all women who have had an affected pregnancy, and public health measures should be taken to ensure that the diet of all women who may bear children contains an adequate amount of folic acid.