TTi Health Research & Economics, 1231 Tech Ct, Suite 201, Westminster, MD 21157, USA.
TTi Health Research & Economics, 1231 Tech Ct, Suite 201, Westminster, MD 21157, USA.
Reprod Toxicol. 2019 Jan;83:14-20. doi: 10.1016/j.reprotox.2018.10.010. Epub 2018 Oct 29.
This study investigates risk of specific structural birth defects associated with ondansetron exposure during the first trimester in a large US commercially-insured population. Medical claims data were obtained from Truven Health Analytics for 864,083 mother-infant pairs from 2000 to 2014. Logistic regression was used to measure the association between first trimester exposure to ondansetron and risk of cardiac defects, orofacial clefts and other specific structural defects in offspring. First trimester exposure to ondansetron was associated with increased risk of cardiac (OR: 1.52 95% CI: 1.35-1.70) and orofacial cleft defects (OR: 1.32 95% CI: 0.76-2.28) in offspring compared to women with no antiemetic exposure during pregnancy. This analysis addresses limitations of prior studies including limited power, exposure misclassification, and generalizability to the US population. In a large, US population we found a statistically significant association between early pregnancy ondansetron exposure and specific structural birth defects in offspring.
本研究调查了在一个大型美国商业保险人群中，昂丹司琼在妊娠早期暴露与特定结构出生缺陷风险之间的关系。从 2000 年到 2014 年，研究人员从 Truven Health Analytics 获得了 864083 对母婴对的医疗索赔数据。使用逻辑回归来衡量妊娠早期暴露于昂丹司琼与后代中心脏缺陷、口腔面部裂和其他特定结构缺陷风险之间的关联。与妊娠期间没有抗恶心药物暴露的女性相比，妊娠早期暴露于昂丹司琼与后代中心脏（OR：1.52 95%CI：1.35-1.70）和口腔面部裂缺陷（OR：1.32 95%CI：0.76-2.28）的风险增加相关。与以往研究相比，该分析解决了研究的局限性，包括研究能力有限、暴露错误分类以及对美国人群的普遍性。在一个大型的美国人群中，我们发现妊娠早期昂丹司琼暴露与后代特定结构出生缺陷之间存在统计学显著关联。
