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评估妊娠期外用皮质类固醇的使用与新生儿小于胎龄和低出生体重的风险。

Evaluation of Topical Corticosteroid Use in Pregnancy and Risk of Newborns Being Small for Gestational Age and Having Low Birth Weight.

机构信息

Department of Epidemiology Research, Statens Serum Institut, Copenhagen, Denmark.

Department of Clinical Pharmacology, Copenhagen University Hospital Bispebjerg and Frederiksberg, Copenhagen, Denmark.

出版信息

JAMA Dermatol. 2021 Jul 1;157(7):788-795. doi: 10.1001/jamadermatol.2021.1090.

Abstract

IMPORTANCE

Topical corticosteroids are frequently used during pregnancy. Limited data have raised concerns about an increased risk of the newborn being small for gestational age (SGA) and having low birth weight, in particular with use of potent to very potent agents during pregnancy.

OBJECTIVE

To evaluate whether topical corticosteroid use in pregnancy is associated with increased risks of SGA and low birth weight.

DESIGN, SETTING, AND PARTICIPANTS: From a source cohort of 1.1 million pregnancies with individual-level informed data from various registries, this nationwide cohort study identified topical corticosteroid-exposed pregnancies in Denmark from January 1, 1997, to December 31, 2016, for a total of 60 497, that were matched with 241 986 unexposed pregnancies on the basis of propensity scores, including a wide set of baseline characteristics. Data analysis was performed from September 8, 2020, to February 23, 2021.

EXPOSURES

Filled prescriptions for topical corticosteroids during pregnancy.

MAIN OUTCOMES AND MEASURES

Primary outcomes were SGA and low birth weight. Association between outcomes and exposure was assessed by relative risk ratios (RRs) and absolute risk differences (ARDs).

RESULTS

Among the 60 497 matched pregnancies exposed to topical corticosteroids, 5678 (9.4%) of the delivered infants were born SGA compared with 22 634 infants (9.4%) among the matched unexposed pregnancies (RR, 1.00; 95% CI, 0.98-1.03 and ARD, 0.3; 95% CI, -2.3 to 2.9 per 1000 pregnancies). Low birth weight occurred in 2006 (3.3%) of the exposed pregnancies compared with 8675 (3.6%) of the unexposed pregnancies (RR, 0.92; 95% CI, 0.88-0.97 and ARD, -2.7; 95% CI, -4.3 to -1.1 per 1000 pregnancies). Exposure to potent to very potent topical corticosteroids at any amount was not associated with an increased risk of SGA (RR, 1.03; 95% CI, 0.99-1.07) or low birth weight (RR, 0.94; 95% CI, 0.88-1.00). Post hoc analyses did not find a significant increased risk among those receiving large amounts of potent to very potent topical corticosteroids (ie, >200 g throughout pregnancy) compared with unexposed pregnancies (RR, 1.17; 95% CI, 0.95-1.46 for SGA and RR 1.14; 95% CI, 0.81-1.60 for low birth weight).

CONCLUSIONS AND RELEVANCE

This large cohort study found no association between topical corticosteroid use in pregnancy and an increased risk of SGA or low birth weight. These results suggest that a moderate to large increase in the risk is unlikely, even when large amounts of potent to very potent topical corticosteroids are used in pregnancy.

摘要

背景

局部皮质类固醇在怀孕期间经常使用。有限的数据引起了人们的关注,即怀孕期间使用强效至极强效制剂会增加新生儿小于胎龄儿(SGA)和低出生体重的风险。

目的

评估怀孕期间使用局部皮质类固醇是否会增加 SGA 和低出生体重的风险。

设计、地点和参与者:本全国性队列研究从一个 110 万例妊娠的源队列中,通过来自各种登记处的个体水平知情数据,确定了 1997 年 1 月 1 日至 2016 年 12 月 31 日期间丹麦的局部皮质类固醇暴露妊娠,共有 60497 例,根据倾向评分与 241986 例未暴露妊娠进行了匹配,包括广泛的基线特征。数据分析于 2020 年 9 月 8 日至 2021 年 2 月 23 日进行。

暴露

怀孕期间局部皮质类固醇的处方。

主要结果和测量

主要结局为 SGA 和低出生体重。通过相对风险比(RR)和绝对风险差异(ARD)评估结局与暴露之间的关联。

结果

在 60497 例匹配的局部皮质类固醇暴露妊娠中,与未暴露妊娠(22634 例,9.4%)相比,5678 例(9.4%)的新生儿出生时为 SGA(RR,1.00;95%CI,0.98-1.03;ARD,0.3;95%CI,-2.3 至 2.9/每 1000 例妊娠)。暴露妊娠中低出生体重为 2006 例(3.3%),未暴露妊娠中为 8675 例(3.6%)(RR,0.92;95%CI,0.88-0.97;ARD,-2.7;95%CI,-4.3 至-1.1/每 1000 例妊娠)。任何剂量使用强效至极强效局部皮质类固醇均与 SGA(RR,1.03;95%CI,0.99-1.07)或低出生体重(RR,0.94;95%CI,0.88-1.00)风险增加无关。事后分析未发现与未暴露妊娠相比,接受大量强效至极强效局部皮质类固醇(即整个怀孕期间>200g)的人群风险显著增加(RR,1.17;95%CI,0.95-1.46 为 SGA,RR 1.14;95%CI,0.81-1.60 为低出生体重)。

结论和相关性

这项大型队列研究未发现怀孕期间使用局部皮质类固醇与 SGA 或低出生体重风险增加之间存在关联。这些结果表明,即使在怀孕期间使用大量强效至极强效的局部皮质类固醇,也不太可能出现风险适度至大幅增加。

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本文引用的文献

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Safety of Topical Corticosteroids in Pregnancy.妊娠期外用皮质类固醇的安全性。
JAMA Dermatol. 2016 Aug 1;152(8):934-5. doi: 10.1001/jamadermatol.2016.1009.
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Safety of topical corticosteroids in pregnancy.孕期外用糖皮质激素的安全性。
Cochrane Database Syst Rev. 2015 Oct 26;2015(10):CD007346. doi: 10.1002/14651858.CD007346.pub3.
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A comparison of 12 algorithms for matching on the propensity score.匹配倾向评分的 12 种算法比较。
Stat Med. 2014 Mar 15;33(6):1057-69. doi: 10.1002/sim.6004. Epub 2013 Oct 7.
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Scand J Public Health. 2011 Jul;39(7 Suppl):38-41. doi: 10.1177/1403494810394717.
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The Danish National Patient Register.丹麦国家患者登记处。
Scand J Public Health. 2011 Jul;39(7 Suppl):30-3. doi: 10.1177/1403494811401482.
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The Danish Civil Registration System.丹麦民事登记系统。
Scand J Public Health. 2011 Jul;39(7 Suppl):22-5. doi: 10.1177/1403494810387965.

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