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多疗程产前皮质类固醇激素治疗(MACS)后的母体副作用:MACS用于早产研究的随机对照试验中女性的三个月随访

Maternal side-effects after multiple courses of antenatal corticosteroids (MACS): the three-month follow-up of women in the randomized controlled trial of MACS for preterm birth study.

作者信息

Murphy Kellie E, Hannah Mary E, Willan Andrew R, Ohlsson Arne, Kelly Edmond N, Matthews Stephen G, Saigal Saroj, Asztalos Elizabeth, Ross Sue, Delisle Marie-France, Tomat Laura, Amankwah Kofi, Guselle Patricia, Gafni Amiram, Lee Shoo K, Armson B Anthony

机构信息

Department of Obstetrics and Gynaecology, Mount Sinai Hospital, University of Toronto, Toronto ON.

出版信息

J Obstet Gynaecol Can. 2011 Sep;33(9):909-21.

PMID:21923988
Abstract

OBJECTIVE

A single course of antenatal corticosteroids (ACS) is associated with a reduction in respiratory distress syndrome and neonatal death. Multiple Courses of Antenatal Corticosteroids Study (MACS), a study involving 1858 women, was a multicentre randomized placebo-controlled trial of multiple courses of ACS, given every 14 days until 33+6 weeks or birth, whichever came first. The primary outcome of the study, a composite of neonatal mortality and morbidity, was similar for the multiple ACS and placebo groups (12.9% vs. 12.5%), but infants exposed to multiple courses of ACS weighed less, were shorter, and had smaller head circumferences. Thus for women who remain at increased risk of preterm birth, multiple courses of ACS (every 14 days) are not recommended. Chronic use of corticosteroids is associated with numerous side effects including weight gain and depression. The aim of this postpartum assessment was to ascertain if multiple courses of ACS were associated with maternal side effects.

METHODS

Three months postpartum, women who participated in MACS were asked to complete a structured questionnaire that asked about maternal side effects of corticosteroid use during MACS and included the Edinburgh Postnatal Depression Scale. Women were also asked to evaluate their study participation.

RESULTS

Of the 1858 women randomized, 1712 (92.1%) completed the postpartum questionnaire. There were no significant differences in the risk of maternal side effects between the two groups. Large numbers of women met the criteria for postpartum depression (14.1% in the ACS vs. 16.0% in the placebo group). Most women (94.1%) responded that they would participate in the trial again.

CONCLUSION

In pregnancy, corticosteroids are given to women for fetal lung maturation and for the treatment of various maternal diseases. In this international multicentre randomized controlled trial, multiple courses of ACS (every 14 days) were not associated with maternal side effects, and the majority of women responded that they would participate in such a study again.

摘要

目的

单疗程产前皮质类固醇(ACS)可降低呼吸窘迫综合征和新生儿死亡的发生率。多疗程产前皮质类固醇研究(MACS)是一项涉及1858名女性的研究,是一项多中心随机安慰剂对照试验,每14天给予多疗程ACS,直至33+6周或分娩,以先到者为准。该研究的主要结局,即新生儿死亡率和发病率的综合指标,在多疗程ACS组和安慰剂组中相似(12.9%对12.5%),但接受多疗程ACS的婴儿体重较轻、身材较矮且头围较小。因此,对于早产风险仍然较高的女性,不建议使用多疗程ACS(每14天一次)。长期使用皮质类固醇会带来许多副作用,包括体重增加和抑郁。这项产后评估的目的是确定多疗程ACS是否与母体副作用有关。

方法

产后三个月,参与MACS的女性被要求完成一份结构化问卷,该问卷询问了MACS期间使用皮质类固醇的母体副作用,并包括爱丁堡产后抑郁量表。还要求女性评估她们对研究的参与情况。

结果

在1858名随机分组的女性中,1712名(92.1%)完成了产后问卷。两组之间母体副作用的风险没有显著差异。大量女性符合产后抑郁的标准(ACS组为14.1%,安慰剂组为16.0%)。大多数女性(94.1%)表示她们会再次参与该试验。

结论

在孕期,会给女性使用皮质类固醇以促进胎儿肺成熟和治疗各种母体疾病。在这项国际多中心随机对照试验中,多疗程ACS(每14天一次)与母体副作用无关,并且大多数女性表示她们会再次参与这样的研究。

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