First-Trimester Use of Paroxetine and Congenital Heart Defects: A Population-Based Case-Control Study
First-Trimester Use of Paroxetine and Congenital Heart Defects: A Population-Based Case-Control Study
复制标题
DOI：
10.1002/bdra.20641
复制
发表时间：
2010-02-01
影响因子：
--
通讯作者：
de Jong-van den Berg, Lolkje T. W.
中科院分区：
文献类型：
--
作者：
Bakker, Marian K.;Kerstjens-Frederikse, Wilhelmina S.;de Jong-van den Berg, Lolkje T. W.
背景：需要对帕罗西汀对特定心脏缺陷发生的影响进行病例对照研究。方法：我们利用荷兰人口出生缺陷登记处的数据进行了一项病例对照研究。所有1997年至2006年出生的孩子都被选中。病例被定义为患有孤立性心脏缺陷的胎儿和儿童，对照组是患有遗传性疾病但无心脏缺陷的胎儿和儿童。我们排除了没有母亲用药信息的儿童以及未进行尸检的已故儿童和胎儿。通过计算调整后的比值比 (AOR)，比较病例和对照的妊娠早期帕罗西汀暴露情况。结果：我们纳入了 678 名患有孤立性心脏缺陷的病例和 615 名对照者。妊娠早期的病例暴露率为 1.5%，对照组为 1.0%。在排除妊娠早期以外使用帕罗西汀或使用另一种 SSRI 的母亲后，我们发现总体心脏缺陷的风险没有显着增加（10 例暴露病例；AOR，1.5；95% 置信区间 [CI]，0.5-4.0），但我们确实发现房间隔缺损的风险显着增加（3 例暴露病例；AOR，5.7；95% CI，1.4-23.7）。结论：我们的结果表明，妊娠早期使用帕罗西汀与房间隔缺损风险增加相关。结果强调了研究药物可能的致畸作用的重要性，特别是针对明确的畸形。出生缺陷研究（A 部分）88:94-100，2010。(C) 2009 Wiley-Liss, Inc.
BACKGROUND: There is a need for case-control studies of the effect of paroxetine on the occurrence of specific heart defects. METHODS: We performed a case-control study with data from a population-based birth defects registry in the Netherlands. All the children born between 1997 and 2006 were selected. Cases were defined as fetuses and children with isolated heart defects, and the controls were fetuses and children with a genetic disorder with no heart defect. We excluded children for whom there was no information on maternal medication use and deceased children and fetuses who were not examined postmortem. First-trimester exposure to paroxetine was compared between cases and controls by calculating adjusted odds ratios (AOR). RESULTS: We included 678 cases with isolated heart defects and 615 controls. The first trimester exposure rate was 1.5%, for cases and 1.0% for controls. After excluding mothers who used paroxetine outside the first trimester, or who had used another SSRI, we found no significantly increased risk for heart defects overall (10 exposed cases; AOR, 1.5; 95% confidence interval [CI], 0.5-4.0), but we did find a significantly increased risk for atrium septum defects (three exposed cases; AOR, 5.7; 95% CI, 1.4-23.7). CONCLUSIONS: Our results suggest that the use of paroxetine in early pregnancy is associated with an increased risk of atrium septum defects. The results stress the importance of studying possible teratogenic effects of a drug, preferably in regard to well-specified malformations. Birth Defects Research (Part A) 88:94-100, 2010. (C) 2009 Wiley-Liss, Inc.