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随机、安慰剂对照、双盲试验评估孕期植物营养素补充预防子痫前期。

Randomized, placebo controlled, double blind trial evaluating early pregnancy phytonutrient supplementation in the prevention of preeclampsia.

机构信息

Departments of Obstetrics and Gynecology and Biostatistics, Winfred L. Wiser Hospital for Women and Infants, University of Mississippi Medical Center, Jackson, MS, USA.

出版信息

J Perinatol. 2013 Aug;33(8):593-9. doi: 10.1038/jp.2013.18. Epub 2013 Feb 28.

DOI:10.1038/jp.2013.18
PMID:23448939
Abstract

OBJECTIVE

Daily provision of pregnant patients with dietary supplements containing antioxidants and phytonutrients, if initiated in the first trimester of pregnancy and continued throughout the gestation, may significantly decrease the incidence of preeclampsia.

STUDY DESIGN

We conducted a single center, randomized, placebo-controlled investigation in which women were randomized by their risk status and assigned to daily ingestion of a supplement consisting primarily of a blended fruit and vegetable juice powder concentrate or placebo.

RESULT

Of the 684 patients randomized to the trial, 267 (39.0%) completed it. The final analysis is based on those participants who completed the study. For the primary outcome of preeclampsia, there was no difference observed between the phytonutrient supplement group and the placebo group: 15.9% vs 16.3%, respectively, (R.R. 0.97 (0.56-1.69)). Non-significant trends toward lower placenta-related obstetrical complications were observed in the supplement group compared with the placebo cohort (8.3% vs 15.5%, respectively, (R.R. 0.57 (0.29-1.14). Those infants born to mothers taking the supplement in the high-risk stratified group demonstrated non-significant trends toward lower rates of respiratory distress syndrome (RDS); 5.3% in the supplement group vs 15.4% in the placebo group: R.R. 0.34 (0.12-1.01).

CONCLUSION

Initiation of antioxidant/phytonutrient supplementation in the first trimester did not decrease rates of preeclampsia. Non-significant trends toward lower incidences of placental derived morbidity in those mothers taking the supplement in addition to decreased rates of RDS in infants born to supplemented mothers considered to be high-risk for preeclampsia, warrant further investigation.

摘要

目的

如果在妊娠早期开始并持续整个孕期向孕妇每日提供含有抗氧化剂和植物营养素的膳食补充剂,可能会显著降低子痫前期的发生率。

研究设计

我们进行了一项单中心、随机、安慰剂对照研究,根据风险状况对女性进行随机分组,并分配每日摄入主要由混合水果和蔬菜汁粉浓缩物组成的补充剂或安慰剂。

结果

在随机分配到试验的 684 名患者中,有 267 名(39.0%)完成了试验。最终分析基于完成研究的参与者。对于子痫前期的主要结局,植物营养素补充剂组与安慰剂组之间没有观察到差异:分别为 15.9%和 16.3%(RR 0.97(0.56-1.69))。与安慰剂队列相比,补充剂组观察到胎盘相关产科并发症的发生率呈下降趋势,但无统计学意义(分别为 8.3%和 15.5%(RR 0.57(0.29-1.14)))。在高危分层组中服用补充剂的母亲所生婴儿的呼吸窘迫综合征(RDS)发生率呈下降趋势,但无统计学意义;补充剂组为 5.3%,安慰剂组为 15.4%:RR 0.34(0.12-1.01)。

结论

在妊娠早期开始使用抗氧化剂/植物营养素补充剂并不能降低子痫前期的发生率。在那些服用补充剂的母亲中,胎盘来源发病率的发生率呈下降趋势,此外,对于被认为子痫前期高危的服用补充剂的母亲所生婴儿的 RDS 发生率降低,这表明需要进一步研究。

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