Alwan Sura, Reefhuis Jennita, Rasmussen Sonja A, Olney Richard S, Friedman Jan M
Department of Medical Genetics, University of British Columbia, Vancouver, BC, Canada.
N Engl J Med. 2007 Jun 28;356(26):2684-92. doi: 10.1056/NEJMoa066584.
Information regarding the safety of selective serotonin-reuptake inhibitors (SSRIs) in human pregnancy is sparse. Concern has been raised about the risk of congenital heart defects associated with the use of SSRIs in pregnancy.
We obtained data on 9622 case infants with major birth defects and 4092 control infants born from 1997 through 2002 from the National Birth Defects Prevention Study. Case infants were ascertained through birth-defects surveillance systems in eight U.S. states; controls were selected randomly from the same geographic areas. Mothers completed a standardized telephone interview regarding exposure to potential risk factors, including medications, before and during pregnancy. Exposure to SSRIs was defined as treatment with any SSRI from 1 month before to 3 months after conception. Birth defects were assigned to 26 categories and subcategories.
There were no significant associations between maternal use of SSRIs overall during early pregnancy and congenital heart defects or most other categories or subcategories of birth defects. Maternal SSRI use was associated with anencephaly (214 infants, 9 exposed; adjusted odds ratio, 2.4; 95% confidence interval [CI], 1.1 to 5.1), craniosynostosis (432 infants, 24 exposed; adjusted odds ratio, 2.5; 95% CI, 1.5 to 4.0), and omphalocele (181 infants, 11 exposed; adjusted odds ratio, 2.8; 95% CI, 1.3 to 5.7).
Maternal use of SSRIs during early pregnancy was not associated with significantly increased risks of congenital heart defects or of most other categories of birth defects. Associations were observed between SSRI use and three types of birth defects, but the absolute risks were small, and these observations require confirmation by other studies.
关于选择性5-羟色胺再摄取抑制剂（SSRI）在人类孕期安全性的信息匮乏。人们对孕期使用SSRI与先天性心脏缺陷风险之间的关联表示担忧。
我们从国家出生缺陷预防研究中获取了1997年至2002年出生的9622例患有主要出生缺陷的病例婴儿和4092例对照婴儿的数据。病例婴儿通过美国八个州的出生缺陷监测系统确定；对照婴儿从相同地理区域随机选取。母亲们完成了一项关于孕期及孕前接触潜在风险因素（包括药物）的标准化电话访谈。SSRI暴露定义为受孕前1个月至受孕后3个月使用任何一种SSRI进行治疗。出生缺陷被分为26个类别和子类别。
孕期早期母亲总体使用SSRI与先天性心脏缺陷或大多数其他类别及子类别的出生缺陷之间无显著关联。母亲使用SSRI与无脑儿（214例婴儿，9例暴露；校正比值比，2.4；95%置信区间[CI]，1.1至5.1）、颅缝早闭（432例婴儿，24例暴露；校正比值比，2.5；95%CI，1.5至4.0）和脐膨出（181例婴儿，11例暴露；校正比值比，2.8；95%CI，1.3至5.7）有关。
孕期早期母亲使用SSRI与先天性心脏缺陷或大多数其他类别出生缺陷的风险显著增加无关。观察到SSRI使用与三种类型的出生缺陷之间存在关联，但绝对风险较小，这些观察结果需要其他研究加以证实。
