孕期外用激素的安全性

孕期外用激素的安全性。过去认为或者至少在孕期外用激素软膏都是很谨慎,至少仅用大多数的外用激素软膏都在说明书上明确表明孕妇慎用。最新发表于JAMA Dermatol的研究表明,孕期外用激素是与先天性畸形及早产和死产无明显相关性,但是可能与患作体重过低有关。

本研究调查了2658名孕期外用激素的孕妇和7246名孕期未外用激素的孕妇。最后发现孕期接触外用激素与先天性唇腭裂、早产、死产、爱普格新生儿评分(Apgar score)低以及分娩方式之间无明显联系。但是综合本研究及其现有的研究结果,低体重儿可能与外用激素的量有关。

ABSTRACT

Importance  Topical corticosteroids are indicated for pregnant women with skin conditions, but their safety in pregnancy is not fully understood.

Objective  To investigate whether maternal exposure to topical corticosteroids results in adverse pregnancy outcomes.

Design  Retrospective cohort study.

Setting  United Kingdom National Health Service.

Participants  A total of 2658 pregnant women exposed to topical corticosteroid and 7246 unexposed pregnant women.

Exposure  Topical corticosteroids dispensed during pregnancy.

Main Outcomes and Measures  Orofacial cleft, low birth weight, preterm delivery, fetal death, low Apgar score, and mode of delivery.

Results  No associations of maternal topical corticosteroid exposure with orofacial cleft, low birth weight, preterm delivery, fetal death, low Apgar score, and mode of delivery were found in the primary analysis (adjusted risk ratio [RR], 1.85 [95% CI, 0.22-15.20] [P = .57]; 0.97 [95% CI, 0.78-1.19] [P = .75]; 1.20 [95% CI, 0.73-1.96] [P = .48]; 1.07 [95% CI, 0.56-2.05] [P = .84]; 0.84 [95% CI, 0.54-1.31] [P = .45]; and P = .76, respectively). Stratified analyses based on potency did not reveal any significant associations in most of these categories either, but an exploratory analysis showed a significantly increased risk of low birth weight when the dispensed amount of potent or very potent topical corticosteroids exceeded 300 g during the entire pregnancy (adjusted RR, 7.74 [95% CI, 1.49-40.11]; P = .02).

Conclusions and Relevance  This study reassuringly showed no associations of maternal topical corticosteroid exposure with orofacial cleft, preterm delivery, fetal death, low Apgar score, and mode of delivery. With this study and all available evidence taken together, the risk of low birth weight seems to correlate with the quantity of topical corticosteroid exposure.

Topical corticosteroids are the most frequently used drugs for treating skin conditions and are prescribed to more than 6% of pregnant women,1(p130) but their safety in pregnancy is not fully understood. Topical corticosteroids are teratogenic and result in fetal growth restriction in animals.2- 3 However, pharmacology references do not offer explicit instructions on prescribing topical corticosteroids in pregnancy.4 The prescribing information of topical corticosteroids states that they should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The US Food and Drug Administration (FDA) labels topical corticosteroids as pregnancy risk category C, meaning that animal studies have shown adverse fetal effects, but there are no adequate and well-controlled studies in pregnant women.5(ppxxiii-xxiv)

The current available evidence on the safety of topical corticosteroid use in human pregnancy is limited.6- 7 Many of the previous studies only investigated the relation between topical corticosteroid use in early pregnancy and orofacial cleft.8- 12 The results were inconsistent: 1 small case-control study showed a link between maternal first-trimester use of topical corticosteroids and orofacial cleft,11 but other studies found no such association.9- 10,12- 14 A recent Cochrane review6- 7 has highlighted potential problems with low birth weight (LBW). A hospital-based cohort study showed significant associations of use of very potent topical corticosteroids with lower plasma cortisol levels, decreased placental weight, and LBW infants.15 Our previous population-based cohort study also found a significant association between maternal exposure to potent or very potent topical corticosteroids and fetal growth restriction.14 However, no similar associations were found in an earlier study.16 Therefore, the available data on the effects of topical corticosteroid use on pregnancy outcomes are inconclusive. The objective of this study was to investigate whether maternal exposure to topical corticosteroids has adverse effects on pregnancy by examining a comprehensive set of outcomes.

参考文献:Ching-Chi Chi et al. Pregnancy Outcomes After Maternal Exposure to Topical Corticosteroids: A UK Population-Based Cohort Study. JAMA Dermatol. Published online September 04, 2013. doi:10.1001/jamadermatol.2013.5768

 

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