抗氧化剂补充与胎膜早破：一项计划中的二次分析。
Antioxidant supplementation and premature rupture of the membranes: a planned secondary analysis.
作者信息
Spinnato Joseph A, Freire Salvio, Pinto e Silva Joao Luiz, Rudge Marilza Vieira Cunha, Martins-Costa Sérgio, Koch Matthew A, Goco Norman, Santos Cleide de Barros, Cecatti Jose Guilherme, Costa Roberto, Ramos José Geraldo, Moss Nancy, Sibai Baha M
机构信息
University of Cincinnati College of Medicine, Cincinnati, OH, USA.
出版信息
Am J Obstet Gynecol. 2008 Oct;199(4):433.e1-8. doi: 10.1016/j.ajog.2008.07.011.
OBJECTIVE
The purpose of this study was to determine if antioxidant supplementation during pregnancy reduces the incidence of premature rupture of the membranes (PROM).
STUDY DESIGN
A placebo-controlled, double-blind trial was conducted. PROM and preterm PROM (PPROM) were planned secondary outcomes of the trial. Women between 12(0/7) and 19(6/7) weeks of gestation and diagnosed to have chronic hypertension or a prior history of preeclampsia were randomized to daily treatment with both vitamin C (1000 mg) and E (400 IU) or placebo.
RESULTS
Outcome data for PROM were available for 697 of 739 patients. The rates of PROM (37/349 [10.6%] vs 19/348 [5.5%]; adjusted risk ratio [RR] 1.89 [95.42% CI, 1.11-3.23]; P = .015), and PPROM (16/349 [4.6%] vs 6/348 [1.7%]; RR 2.68 [1.07-6.71]; P = .025) were increased in the antioxidant group.
CONCLUSION
Contrary to expectations, vitamins C and E supplementation in this dose combination may be associated with an increased risk of PROM and PPROM.
目的
本研究旨在确定孕期补充抗氧化剂是否能降低胎膜早破（PROM）的发生率。
研究设计
进行了一项安慰剂对照的双盲试验。胎膜早破和早产胎膜早破（PPROM）是该试验计划的次要结局。孕周在12（0/7）至19（6/7）周之间且被诊断为慢性高血压或有先兆子痫病史的女性被随机分为每日服用维生素C（1000毫克）和维生素E（400国际单位）或安慰剂。
结果
739例患者中有697例获得了胎膜早破的结局数据。抗氧化剂组的胎膜早破发生率（37/349 [10.6%] 对比19/348 [5.5%]；调整风险比 [RR] 1.89 [95.42% CI，1.11 - 3.23]；P = 0.015）以及早产胎膜早破发生率（16/349 [4.6%] 对比6/348 [1.7%]；RR 2.68 [1.07 - 6.71]；P = 0.025）均有所增加。
结论
与预期相反，这种剂量组合的维生素C和维生素E补充可能与胎膜早破和早产胎膜早破风险增加有关。
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