Gülmezoğlu A M, Hofmeyr G J, Oosthuisen M M
Department of Obstetrics and Gynaecology, Coronation/JG Strijdom Hospitals, Johannesburg, South Africa.
Br J Obstet Gynaecol. 1997 Jun;104(6):689-96. doi: 10.1111/j.1471-0528.1997.tb11979.x.
To determine whether antioxidant therapy alters the disease process in severe early onset pre-eclampsia, in support of the hypothesis that increased lipid peroxides and reactive oxygen species production-play an important role in the pathogenesis of the disease.
Randomised, double-blind, placebo controlled trial.
Two tertiary care, referral hospitals in Johannesburg, South Africa.
Women with severe pre-eclampsia diagnosed between 24 and 32 weeks of gestation.
Combined antioxidant treatment with vitamin E (800 IU/day), vitamin C (1000 mg/day), and allopurinol (200 mg/day).
data on maternal complications, side effects of treatment, infant outcomes and regular assessment of haematologic and renal parameters.
The proportion of women delivered within 14 days in the antioxidant group was 52% (14/27) compared with 76% (22/29) in the placebo group (relative risk 0.68, 95% confidence interval 0.45-1.04). One woman in each group had eclampsia. Eleven women (42%) in the antioxidant and 16 (59%) in the placebo group required two antihypertensives for blood pressure control. Trial medications were well tolerated with few side effects. Lipid peroxide levels were not significantly altered in the antioxidant and placebo groups. Serum uric acid levels decreased and vitamin E levels increased significantly.
The results of this explanatory randomised trial do not encourage the routine use of antioxidants against pre-eclampsia. However, further research with modified strategies such as earlier initiation of therapy or different combinations seem worthwhile.
确定抗氧化治疗是否会改变重度早发型子痫前期的疾病进程，以支持脂质过氧化物和活性氧生成增加在该疾病发病机制中起重要作用这一假说。
随机、双盲、安慰剂对照试验。
南非约翰内斯堡的两家三级护理转诊医院。
妊娠24至32周期间诊断为重度子痫前期的女性。
联合使用维生素E（800国际单位/天）、维生素C（1000毫克/天）和别嘌呤醇（200毫克/天）进行抗氧化治疗。
关于母体并发症、治疗副作用、婴儿结局的数据，以及血液学和肾脏参数的定期评估。
抗氧化剂组在14天内分娩的女性比例为52%（14/27），而安慰剂组为76%（22/29）（相对风险0.68，95%置信区间0.45 - 1.04）。每组各有一名女性发生子痫。抗氧化剂组11名女性（42%）和安慰剂组16名女性（59%）需要两种抗高血压药物来控制血压。试验药物耐受性良好，副作用较少。抗氧化剂组和安慰剂组的脂质过氧化物水平无显著变化。血清尿酸水平降低，维生素E水平显著升高。
这项解释性随机试验的结果不支持常规使用抗氧化剂治疗子痫前期。然而，采用如更早开始治疗或不同组合等改良策略进行进一步研究似乎是值得的。
