维生素C和维生素E用于存在先兆子痫风险孕妇的随机安慰剂对照试验(VIP试验)  

Vitamin C and vitamin E in pregnant women at risk for pre-eclampsia (VIP trial):randomised placebo-controlled trial

作　　者：Poston L. Briley A. Seed p 朱磊 

机构地区：[1]Maternal and Fetal Research Unit, Division of Reproductive Health, Endocrinology and Development,Pharmaceutical Sciences Research Division, London,SE1 7EH, United Kingdom Prof. Dr

出　　处：《世界核心医学期刊文摘（妇产科学分册）》2006年第9期1-1,共1页Core Journal in Obstetrics/Gynecology

摘　　要：Background: 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. Methods: 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 α 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 studyis registered as an International Standard Randomised Controlled Trial, number ISRCTN 62368611. Findings:Of 2404 patients treated, we analysed 2395 (99.6% ). The incidence of pre-eclampsia was similar in treatment and 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]). Interpretation: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 antioxidantsis not justified in pregnancy.Background： 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. Methods： 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 α 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 studyis registered as an International Standard Randomised Controlled Trial, number ISRCTN 62368611. Findings： Of 2404 patients treated, we analysed 2395 （99.6%） . The incidence of pre-eclampsia was similar in treatment and placebo groups （15% [n = 181]vs 16% [n = 187], RR0.97195% CI 0. 80 - 1.17]） . More low birthweight babies were born to women who took antioxidants than to controls（28% [n = 387] vs24% [n = 335], 1.15 [1.02-1.30]）, but small size for gestational age did not differ between groups （21% [n = 294] vs19% [n = 259], 1.12 [0.96- 1.31 ] ）. Interpretation： Concomitant supplementation withvitamin 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 antioxidantsis not justified in pregnancy.

关 键 词：随机对照试验 随机安慰剂 先兆子痫 维生素E 维生素C 风险 孕妇 低出生体重儿 

分 类 号：R4[医药卫生—临床医学]