CDT Analytics, Adelaide, South Australia, Australia.
Department of Epidemiology, University of North Carolina, Chapel Hill, North Carolina, USA.
Birth Defects Res. 2020 Oct;112(16):1234-1252. doi: 10.1002/bdr2.1749. Epub 2020 Jul 13.
It is estimated that approximately 10-15% of pregnant women report antihistamine use during pregnancy. Although antihistamines are generally considered safe during pregnancy, results from published studies are inconsistent.
Using a case-control study design we analyzed 41,148 pregnancies (30,091 cases and 11,057 controls) from the National Birth Defects Prevention Study (1997-2011). Logistic regression models were used to estimate odds ratios (OR) and 95% confidence intervals for 64 birth defect groupings in relation to early pregnancy exposure to 14 distinct antihistamines. Models were adjusted for maternal age, race, parity, education level, prenatal care, folic acid use, smoking and alcohol use, and study site.
Approximately 13% of cases and controls were exposed to an antihistamine during early pregnancy. Analyses were restricted to those defects where more than five cases were exposed to the antihistamine of interest, generating 340 analyses which yielded 20 (5.9%) significant positive associations (adjusted ORs ranging from 1.21 to 4.34).
Only a few of our findings were consistent with previous studies. There is a lack of strong evidence to conclude that birth defects are associated with exposure to antihistamines during early pregnancy.
据估计，约有 10-15%的孕妇在怀孕期间报告使用抗组胺药。虽然抗组胺药在怀孕期间通常被认为是安全的，但已发表的研究结果并不一致。
我们使用病例对照研究设计，分析了来自国家出生缺陷预防研究（1997-2011 年）的 41148 例妊娠（30091 例病例和 11057 例对照）。逻辑回归模型用于估计 64 种出生缺陷分组与 14 种不同抗组胺药在早期妊娠暴露时的比值比（OR）和 95%置信区间。模型调整了母亲的年龄、种族、产次、教育水平、产前保健、叶酸使用、吸烟和饮酒以及研究地点。
约 13%的病例和对照在早期妊娠时暴露于抗组胺药。分析仅限于那些有超过 5 例暴露于感兴趣的抗组胺药的缺陷，产生了 340 项分析，其中有 20 项（5.9%）具有显著阳性关联（调整后的 OR 范围从 1.21 到 4.34）。
我们的发现只有少数与以前的研究一致。没有强有力的证据可以得出结论，认为出生缺陷与早期妊娠暴露于抗组胺药有关。
