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低剂量阿司匹林对预防子痫前期及妊娠结局的影响:来自中国上海的一项随机对照试验。

Effects of low-dose aspirin on the prevention of preeclampsia and pregnancy outcomes: A randomized controlled trial from Shanghai, China.

机构信息

The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China; Shanghai Municipal Key Clinical Specialty, Shanghai, China.

The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China; Shanghai Key Laboratory of Embryo Original Diseases, Shanghai, China; Shanghai Municipal Key Clinical Specialty, Shanghai, China.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2020 May;248:156-163. doi: 10.1016/j.ejogrb.2020.03.038. Epub 2020 Mar 19.

DOI:10.1016/j.ejogrb.2020.03.038
PMID:32217429
Abstract

OBJECTIVES

To evaluate the preventive effects of low-dose aspirin on the incidence of preeclampsia and pregnancy outcomes of women at high-risk for preeclampsia.

STUDY DESIGN

This prospective randomized clinical trial was conducted at the Obstetrics Department of The International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, China. It analyzed data from 1105 high-risk women who were divided into the control group (placebo group) and the aspirin group (including three subgroups: 25 mg, 50 mg and 75 mg). The aspirin group in this study was instructed to take aspirin daily before bedtime beginning in the 12th week of pregnancy.

MAIN OUTCOME MEASURES

The primary outcome is the occurrence of preeclampsia. The secondary outcomes included maternal and neonatal outcomes (such as premature delivery, FGR etc.), maternal serum biomarkers (including d-dimers, platelet aggregation rates, etc.) and uterine arterial blood flow resistance. The onset of preeclampsia and pregnancy outcomes were recorded after all participants delivered.

RESULTS

Low-dose aspirin significantly reduced the incidence of preeclampsia and early-onset preeclampsia. Aspirin also showed significant dose dependence in preeclampsia prevention. The results of Mantel-Haenszel trend test showed that there was a linear relationship between the dosage and the incidence of preeclampsia and early preeclampsia (P < 0.05). Pearson's results showed that the incidence of preeclampsia and early preeclampsia was negatively correlated with aspirin dosage. There was also a linear relationship between the dosage and the rates of postpartum hemorrhage, fetal growth restriction, premature births and cesarean section (P < 0.05). There was no evidence to suggest differences in the incidence of fetal distress, miscarriage and placental abruption among the four groups. The blood resistance S/D value of uterine artery in early pregnancy was the only independent factor affecting the efficacy of aspirin (OR = 1.405; 95 %CI,1.058-1.867; P = 0.019).

CONCLUSION

Low-dose aspirin can prevent preeclampsia and early-preeclampsia. Its efficacy is dose-dependent. It can reduce the rates of postpartum hemorrhage, fetal growth restriction, premature births and cesarean section. The prophylactic effect of aspirin on preeclampsia seemed to be greater in patients with higher blood resistance S/D value of uterine artery during early pregnancy.

摘要

目的

评估小剂量阿司匹林对子痫前期高危妇女子痫前期发生率及妊娠结局的预防作用。

研究设计

本前瞻性随机临床试验在中国上海交通大学医学院附属国际和平妇幼保健院妇产科进行。分析了 1105 名高危妇女的数据,将其分为对照组(安慰剂组)和阿司匹林组(包括 25mg、50mg 和 75mg 三个亚组)。该研究中的阿司匹林组被指示从妊娠第 12 周开始每天睡前服用阿司匹林。

主要观察指标

主要结局是子痫前期的发生。次要结局包括母婴结局(如早产、胎儿生长受限等)、母体血清生物标志物(如 D-二聚体、血小板聚集率等)和子宫动脉血流阻力。所有参与者分娩后记录子痫前期和妊娠结局的发病情况。

结果

小剂量阿司匹林可显著降低子痫前期和早发型子痫前期的发生率。阿司匹林在子痫前期预防中也表现出显著的剂量依赖性。Mantel-Haenszel 趋势检验结果显示,剂量与子痫前期和早发型子痫前期的发生率之间存在线性关系(P<0.05)。Pearson 结果显示,子痫前期和早发型子痫前期的发生率与阿司匹林剂量呈负相关。剂量与产后出血、胎儿生长受限、早产和剖宫产率之间也存在线性关系(P<0.05)。四组间胎儿窘迫、流产和胎盘早剥的发生率无差异证据。早期妊娠子宫动脉 S/D 值是影响阿司匹林疗效的唯一独立因素(OR=1.405;95%CI,1.058-1.867;P=0.019)。

结论

小剂量阿司匹林可预防子痫前期和早发型子痫前期。其疗效呈剂量依赖性。可降低产后出血、胎儿生长受限、早产和剖宫产率。阿司匹林对子痫前期的预防作用在早期妊娠子宫动脉 S/D 值较高的患者中似乎更大。

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