Poston L, Briley A L, Seed P T, Kelly F J, Shennan A H
Maternal and Fetal Research Unit, Division of Reproductive Health, Endocrinology and Development, King's College London, St Thomas' Hospital, London SE1 7EH, UK.
Lancet. 2006 Apr 8;367(9517):1145-54. doi: 10.1016/S0140-6736(06)68433-X.
Oxidative stress could play a part in pre-eclampsia, and there is some evidence to suggest that vitamin C and vitamin E supplements could reduce the risk of the disorder. Our aim was to investigate the potential benefit of these antioxidants in a cohort of women with a range of clinical risk factors.
We did a randomised, placebo-controlled trial to which we enrolled 2410 women identified as at increased risk of pre-eclampsia from 25 hospitals. We assigned the women 1000 mg vitamin C and 400 IU vitamin E (RRR alpha tocopherol; n=1199) or matched placebo (n=1205) daily from the second trimester of pregnancy until delivery. Our primary endpoint was pre-eclampsia, and our main secondary endpoints were low birthweight (<2.5 kg) and small size for gestational age (<5th customised birthweight centile). Analyses were by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN 62368611 .
Of 2404 patients treated, we analysed 2395 (99.6%). The incidence of pre-eclampsia was similar in treatment placebo groups (15% [n=181] vs 16% [n=187], RR 0.97 [95% CI 0.80-1.17]). More low birthweight babies were born to women who took antioxidants than to controls (28% [n=387] vs 24% [n=335], 1.15 [1.02-1.30]), but small size for gestational age did not differ between groups (21% [n=294] vs 19% [n=259], 1.12 [0.96-1.31]).
Concomitant supplementation with vitamin C and vitamin E does not prevent pre-eclampsia in women at risk, but does increase the rate of babies born with a low birthweight. As such, use of these high-dose antioxidants is not justified in pregnancy.
氧化应激可能在子痫前期中起作用，并且有一些证据表明补充维生素C和维生素E可降低该病的风险。我们的目的是在一群具有一系列临床风险因素的女性中研究这些抗氧化剂的潜在益处。
我们进行了一项随机、安慰剂对照试验，从25家医院招募了2410名被确定为子痫前期风险增加的女性。我们给这些女性从妊娠中期至分娩每天服用1000毫克维生素C和400国际单位维生素E（RRRα生育酚；n = 1199）或匹配的安慰剂（n = 1205）。我们的主要终点是子痫前期，主要次要终点是低出生体重（<2.5千克）和小于胎龄儿（<第5定制出生体重百分位数）。分析采用意向性分析。本研究已注册为国际标准随机对照试验，编号ISRCTN 62368611。
在2404例接受治疗的患者中，我们分析了2395例（99.6%）。治疗组和安慰剂组子痫前期的发生率相似（15% [n = 181] 对16% [n = 187]，RR 0.97 [95% CI 0.80 - 1.17]）。服用抗氧化剂的女性所生低出生体重儿比对照组多（28% [n = 387] 对24% [n = 335]，1.15 [1.02 - 1.30]），但小于胎龄儿在两组间无差异（21% [n = 294] 对19% [n = 259]，1.12 [0.96 - 1.31]）。
同时补充维生素C和维生素E不能预防有风险女性患子痫前期，但会增加低出生体重儿的出生率。因此，孕期使用这些高剂量抗氧化剂是不合理的。
