Regional Centre for Endocrinology and Diabetes, Royal Victoria Hospital, Belfast, UK.
Lancet. 2010 Jul 24;376(9737):259-66. doi: 10.1016/S0140-6736(10)60630-7. Epub 2010 Jun 26.
Results of several trials of antioxidant use during pregnancy have not shown a reduction in pre-eclampsia, but the effect in women with diabetes is unknown. We aimed to assess whether supplementation with vitamins C and E reduced incidence of pre-eclampsia in women with type 1 diabetes.
We enrolled women from 25 UK antenatal metabolic clinics in a multicentre randomised placebo-controlled trial. Eligibility criteria were type 1 diabetes preceding pregnancy, presentation between 8 weeks' and 22 weeks' gestation, singleton pregnancy, and age 16 years or older. Women were randomly allocated in a 1:1 ratio to receive 1000 mg vitamin C and 400 IU vitamin E (alpha-tocopherol) or matched placebo daily until delivery. The randomisation sequence was stratified by centre with balanced blocks of eight patients. All trial personnel and participants were masked to treatment allocation. The primary endpoint was pre-eclampsia, which we defined as gestational hypertension with proteinuria. Analysis was by modified intention to treat. This study is registered, ISRCTN27214045.
Between April, 2003, and June, 2008, 762 women were randomly allocated to treatment groups (379 vitamin supplementation, 383 placebo). The primary endpoint was assessed for 375 women allocated to receive vitamins, and 374 allocated to placebo. Rates of pre-eclampsia did not differ between vitamin (15%, n=57) and placebo (19%, 70) groups (risk ratio 0.81, 95% CI 0.59-1.12). No adverse maternal or neonatal outcomes were reported.
Supplementation with vitamins C and E did not reduce risk of pre-eclampsia in women with type 1 diabetes. However, the possibility that vitamin supplementation might be beneficial in women with a low antioxidant status at baseline needs further testing.
The Wellcome Trust.
几项抗氧化剂用于妊娠的试验结果并未显示出减少子痫前期的发生，但糖尿病患者的效果尚不清楚。我们旨在评估维生素 C 和 E 的补充是否能降低 1 型糖尿病妇女子痫前期的发生率。
我们从英国 25 个产前代谢诊所招募了妇女参加一项多中心随机安慰剂对照试验。入选标准为妊娠前患有 1 型糖尿病，在 8 周到 22 周妊娠期间出现，单胎妊娠，年龄在 16 岁或以上。女性按 1:1 的比例随机分配接受 1000 毫克维生素 C 和 400 国际单位维生素 E（α-生育酚）或每日匹配安慰剂，直至分娩。随机序列按中心分层，每个中心有 8 名患者的平衡块。所有试验人员和参与者对治疗分配均不知情。主要终点是子痫前期，我们将其定义为伴有蛋白尿的妊娠期高血压。分析采用修改后的意向治疗。这项研究已注册，ISRCTN27214045。
2003 年 4 月至 2008 年 6 月期间，762 名妇女被随机分配到治疗组（379 名维生素补充剂，383 名安慰剂）。375 名接受维生素治疗的妇女和 374 名接受安慰剂的妇女评估了主要终点。维生素组（15%，n=57）和安慰剂组（19%，70）子痫前期发生率无差异（风险比 0.81，95%CI 0.59-1.12）。未报告不良的母亲或新生儿结局。
维生素 C 和 E 的补充并不能降低 1 型糖尿病妇女子痫前期的风险。然而，补充维生素可能对基线时抗氧化状态较低的妇女有益，这一可能性需要进一步的测试。
惠康信托基金会。
