Wood Mollie E, Frazier Jean A, Nordeng Hedvig M E, Lapane Kate L
Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.
Department of Psychiatry, University of Massachusetts Medical School, Worcester, MA, USA.
Pharmacoepidemiol Drug Saf. 2016 May;25(5):493-502. doi: 10.1002/pds.3902. Epub 2015 Nov 11.
Triptan medications are serotonin agonists used to treat migraine, a chronic pain condition highly prevalent in women of reproductive age. Data on the safety of triptans during pregnancy are scant. We sought to quantify the association of prenatal triptan exposure on neurodevelopment in 3-year-old children.
Using data from the Norwegian Mother and Child Cohort Study, we used propensity score matching to examine associations between prenatal triptan exposure and psychomotor function, communication, and temperament. We used an external validation study to perform propensity calibration to adjust effect estimates for confounders unmeasured in the main study (migraine severity, type, and maternal attitudes towards medication use).
We identified 4204 women who reported migraine headache at baseline, of which 375 (8.9%) reported using a triptan greater than or equal to once during pregnancy. Children with prenatal triptan exposure had 1.37-fold greater unadjusted odds of fine motor problems (95% confidence interval (CI): 1.06-1.77), which decreased after propensity score matching (odds ratio (OR): 1.29, 95%CI 0.97-1.73) and was further attenuated after calibration (OR: 1.25, 95%CI 0.89-1.74). We observed no increased risk for gross motor or communication problems, and no differences in temperament. Adjustment for migraine severity using propensity score calibration had a moderate impact on effect estimates, with percent changes ranging from 2.4% to 50%.
Prenatal triptan exposure was not associated with psychomotor function, communication problems, or temperament in 3-year-old children. Adjustment for migraine severity reduced effect estimates and should be considered in future studies of the safety of triptans during pregnancy. Copyright © 2015 John Wiley & Sons, Ltd.
曲坦类药物是血清素激动剂,用于治疗偏头痛,这是一种在育龄女性中高度流行的慢性疼痛病症。关于曲坦类药物在孕期安全性的数据很少。我们试图量化孕期接触曲坦类药物与3岁儿童神经发育之间的关联。
利用挪威母婴队列研究的数据,我们采用倾向得分匹配法来研究孕期接触曲坦类药物与心理运动功能、沟通能力和气质之间的关联。我们使用一项外部验证研究进行倾向校准,以调整主要研究中未测量的混杂因素(偏头痛严重程度、类型以及母亲对用药的态度)对效应估计值的影响。
我们确定了4204名在基线时报告有偏头痛头痛的女性,其中375名(8.9%)报告在孕期使用过曲坦类药物至少一次。孕期接触曲坦类药物的儿童出现精细运动问题的未调整优势比高1.37倍(95%置信区间(CI):1.06 - 1.77),在倾向得分匹配后有所降低(优势比(OR):1.29,95%CI 0.97 - 1.73),在校准后进一步减弱(OR:1.25,95%CI 0.89 -