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孕期低剂量阿司匹林与儿童早期发育:孕期低剂量阿司匹林协作研究的随访。CLASP协作组

Low dose aspirin in pregnancy and early childhood development: follow up of the collaborative low dose aspirin study in pregnancy. CLASP collaborative group.

出版信息

Br J Obstet Gynaecol. 1995 Nov;102(11):861-8. doi: 10.1111/j.1471-0528.1995.tb10872.x.

DOI:10.1111/j.1471-0528.1995.tb10872.x
PMID:8534620
Abstract

OBJECTIVE

To determine any benefits or risks, expressed in early childhood, of low dose aspirin treatment in pregnancies at high risk of complications due to pre-eclampsia or intrauterine growth retardation.

DESIGN

A questionnaire-based follow-up at 12 and 18 months of age of cohorts of surviving children whose mothers participated in a large randomised, double-blind placebo-controlled trial of 60 mg aspirin.

SETTING

United Kingdom and Ottawa, Canada.

SUBJECTS

4168 children assessed at 12 months through information provided by general practitioners, and 4365 assessed at 18 months through a questionnaire to parents.

MAIN OUTCOME MEASURES

Hospital visits in the first 18 months for congenital malformations, motor deficit, developmental delay, respiratory problems or bleeding problems; height or weight below the third centile; and delayed acquisition of certain developmental skills.

RESULTS

There were no clear differences in any of the main outcome measures, although some confidence intervals were wide.

CONCLUSIONS

Although an adverse effect can not be ruled out, these findings are reassuring about the safety of low dose aspirin started after the first trimester, at least in respect of congenital malformations, major motor deficit, and severe neuromotor or developmental delay identifiable in early childhood. They provide no clear evidence of benefit. Taking into account evidence from large randomised controlled trials, the place of low-dose aspirin in pregnancy appears to be limited, although it may be beneficial for women at high risk of early onset pre-eclampsia; for them, evidence suggesting that it is not harmful is important.

摘要

目的

确定对于因先兆子痫或胎儿宫内生长受限而有并发症高风险的妊娠,在幼儿期低剂量阿司匹林治疗的任何益处或风险。

设计

对母亲参与一项60毫克阿司匹林大型随机、双盲、安慰剂对照试验的存活儿童队列,在12个月和18个月时进行基于问卷的随访。

地点

英国和加拿大渥太华。

研究对象

通过全科医生提供的信息在12个月时评估了4168名儿童,通过向家长发放问卷在18个月时评估了4365名儿童。

主要观察指标

在出生后的前18个月内因先天性畸形、运动缺陷、发育迟缓、呼吸问题或出血问题的住院就诊情况;身高或体重低于第三百分位数;以及某些发育技能获得延迟。

结果

尽管一些置信区间较宽,但在任何主要观察指标上均无明显差异。

结论

虽然不能排除不良反应,但这些结果至少在先天性畸形、主要运动缺陷以及幼儿期可识别的严重神经运动或发育迟缓方面,对于孕中期后开始使用低剂量阿司匹林的安全性令人安心。它们没有提供明显的益处证据。考虑到大型随机对照试验的证据,低剂量阿司匹林在妊娠中的应用似乎有限,尽管它可能对早发型先兆子痫高风险的女性有益;对于她们而言,表明其无害的证据很重要。

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