Hauth J, Sibai B, Caritis S, VanDorsten P, Lindheimer M, Klebanoff M, MacPherson C, Landon M, Paul R, Miodovnik M, Meis P, Dombrowski M, Thurnau G, Walsh S, McNellis D, Roberts J M
University of Alabama at Birmingham, the University of Tennessee, Memphis, TN, USA.
Am J Obstet Gynecol. 1998 Nov;179(5):1193-9. doi: 10.1016/s0002-9378(98)70130-9.
The aim of the study was too determine whether, in a low-dose aspirin trial in high-risk pregnancies, a decrease in maternal serum thromboxane B2 level predicted improved pregnancy outcomes.
This multicenter, randomized, double-blind trial included 2539 women, 1010 of whom had sufficient serum samples at enrollment and at 24 to 28 weeks' gestation, 34 to 38 weeks' gestation, or both to assess longitudinal changes in thromboxane B2 level and their effects on pregnancy outcomes. Women were randomly assigned between 13 and 26 weeks' gestation to receive daily aspirin (60 mg) or placebo.
Overall and in all subgroups women assigned to receive aspirin had markedly lower maternal thromboxane B2 concentration values than did those assigned to receive a placebo (P =.0001). Changes in thromboxane levels were not, however, correlated with adverse pregnancy outcomes. Women with >/=50% reduction in maternal serum thromboxane B2 concentrations from baseline had occurrences of preeclampsia (P =.922), preterm birth (P =.375), small for gestational age neonates (P =.938), and grade III or IV intraventricular hemorrhage (P = 1.000) similar to those of women who had <50% reduction. Similar results were found for women with thromboxane B2 level decreases of <15 versus >15 ng/mL and women with thromboxane B2 level decreases to <10 versus >/=10, <5 versus >/=5, and <1 versus >/=1 ng/mL. Maternal thromboxane B2 concentrations at enrollment were also not predictive of adverse outcomes.
Neither maternal serum thromboxane B2 concentrations at enrollment nor their subsequent reduction were predictive of adverse pregnancy outcomes in a low-dose aspirin trial.
本研究旨在确定在一项针对高危妊娠的低剂量阿司匹林试验中，母体血清血栓素B2水平的降低是否预示着妊娠结局的改善。
这项多中心、随机、双盲试验纳入了2539名女性，其中1010名女性在入组时以及妊娠24至28周、34至38周或这两个时间段均有足够的血清样本，以评估血栓素B2水平的纵向变化及其对妊娠结局的影响。女性在妊娠13至26周之间被随机分配接受每日阿司匹林（60毫克）或安慰剂。
总体而言，在所有亚组中，分配接受阿司匹林的女性母体血栓素B2浓度值明显低于分配接受安慰剂的女性（P = 0.0001）。然而，血栓素水平的变化与不良妊娠结局无关。母体血清血栓素B2浓度较基线降低≥50%的女性发生先兆子痫（P = 0.922）、早产（P = 0.375）、小于胎龄儿（P = 0.938）和III或IV级脑室内出血（P = 1.000）的情况与降低<50%的女性相似。对于血栓素B2水平降低<15 ng/mL与>15 ng/mL的女性，以及血栓素B2水平降低至<10 ng/mL与≥10 ng/mL、<5 ng/mL与≥5 ng/mL、<1 ng/mL与≥1 ng/mL的女性，也发现了类似结果。入组时的母体血栓素B2浓度也不能预测不良结局。
在低剂量阿司匹林试验中，入组时的母体血清血栓素B2浓度及其随后的降低均不能预测不良妊娠结局。
