Department of Experimental Medicine, School of Medicine, Universidad Nacional, Autonoma de Mexico, Torre de Investigacion, 3er Piso, Ciudad Universitaria, Mexico, DF 04510.
BMJ. 2011 May 19;342:d2901. doi: 10.1136/bmj.d2901.
To test the hypothesis that a relative deficiency in L-arginine, the substrate for synthesis of the vasodilatory gas nitric oxide, may be associated with the development of pre-eclampsia in a population at high risk.
Randomised, blinded, placebo controlled clinical trial.
Tertiary public hospital in Mexico City.
Pregnant women with a history of a previous pregnancy complicated by pre-eclampsia, or pre-eclampsia in a first degree relative, and deemed to be at increased risk of recurrence of the disease were studied from week 14-32 of gestation and followed until delivery.
Supplementation with a medical food-bars containing L-arginine plus antioxidant vitamins, antioxidant vitamins alone, or placebo-during pregnancy.
Development of pre-eclampsia/eclampsia.
222 women were allocated to the placebo group, 228 received L-arginine plus antioxidant vitamins, and 222 received antioxidant vitamins alone. Women had 4-8 prenatal visits while receiving the bars. The incidence of pre-eclampsia was reduced significantly (χ(2) = 19.41; P < 0.001) in women randomised to L-arginine plus antioxidant vitamins compared with placebo (absolute risk reduction 0.17 (95% confidence interval 0.12 to 0.21). Antioxidant vitamins alone showed an observed benefit, but this effect was not statistically significant compared with placebo (χ(2) = 3.76; P = 0.052; absolute risk reduction 0.07, 0.005 to 0.15). L-arginine plus antioxidant vitamins compared with antioxidant vitamins alone resulted in a significant effect (P = 0.004; absolute risk reduction 0.09, 0.05 to 0.14).
Supplementation during pregnancy with a medical food containing L-arginine and antioxidant vitamins reduced the incidence of pre-eclampsia in a population at high risk of the condition. Antioxidant vitamins alone did not have a protective effect for prevention of pre-eclampsia. Supplementation with L-arginine plus antioxidant vitamins needs to be evaluated in a low risk population to determine the generalisability of the protective effect, and the relative contributions of L-arginine and antioxidant vitamins to the observed effects of the combined treatment need to be determined. Trial registration Clinical trials NCT00469846.
检验假设，即合成血管舒张性气体一氧化氮的底物 L-精氨酸相对缺乏可能与高危人群子痫前期的发生有关。
随机、双盲、安慰剂对照临床试验。
墨西哥城的一所三级公立医院。
研究对象为既往妊娠合并子痫前期或一级亲属中有子痫前期病史、且复发风险增加的孕妇，从妊娠 14-32 周开始进行研究，并随访至分娩。
在妊娠期间补充含有 L-精氨酸和抗氧化维生素的医学食品棒、抗氧化维生素单独补充或安慰剂。
子痫前期/子痫的发生。
222 名妇女被分配到安慰剂组，228 名妇女接受 L-精氨酸加抗氧化维生素治疗，222 名妇女单独接受抗氧化维生素治疗。妇女在接受棒状食品期间进行了 4-8 次产前检查。与安慰剂组相比，随机接受 L-精氨酸加抗氧化维生素治疗的妇女子痫前期的发生率显著降低（χ(2) = 19.41；P < 0.001）（绝对风险降低 0.17（95%置信区间 0.12 至 0.21））。单独使用抗氧化维生素观察到有获益，但与安慰剂相比，这种效果无统计学意义（χ(2) = 3.76；P = 0.052；绝对风险降低 0.07，0.005 至 0.15）。L-精氨酸加抗氧化维生素治疗与单独使用抗氧化维生素治疗相比，效果显著（P = 0.004；绝对风险降低 0.09，0.05 至 0.14）。
在高危人群中，妊娠期间补充含有 L-精氨酸和抗氧化维生素的医学食品可降低子痫前期的发生率。单独使用抗氧化维生素对预防子痫前期没有保护作用。需要在低危人群中评估 L-精氨酸加抗氧化维生素的补充治疗，以确定保护作用的普遍性，还需要确定 L-精氨酸和抗氧化维生素对联合治疗观察到的效果的相对贡献。
临床试验 NCT00469846。
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