Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, P.O. Box 9101, 6500 HB, Nijmegen, the Netherlands; Radboud REshape Innovation Center, Radboud University Medical Center, P.O. Box 9101, 6500 HB, Nijmegen, the Netherlands.
Department of Pharmacy, Gelre Hospitals, P.O. Box 9014, 7300 DS, Apeldoorn, the Netherlands.
Reprod Toxicol. 2019 Mar;84:93-97. doi: 10.1016/j.reprotox.2019.01.002. Epub 2019 Jan 4.
To compare assessment of early pregnancy medication exposure using three methods of data collection.
Serum samples were obtained from 752 women participating in the PRegnancy and Infant DEvelopment (PRIDE) Study before gestational week 17. For 52 women using medication at the date of blood sampling according to Web-based questionnaires or pharmacy records, we analysed serum samples using untargeted liquid chromatography time-of-flight spectrometry.
Medication was detected in 18 serum samples (35%). Medications taken orally for chronic conditions reported in the questionnaire were detected in serum and vice versa. Pharmacy records did not identify additional exposed women, but missed exposure in 5 women mainly due to unavailability. We observed substantial discordance between the three methods for inhaled medication, dermatological preparations, and medications for short-term use, which went often undetected in serum.
It remains challenging to assess medication use in large-scale studies as no 'gold standard' is currently available.
比较三种数据收集方法评估早期妊娠药物暴露的情况。
妊娠和婴儿发育（PRIDE）研究中，752 名女性在妊娠 17 周前采集血清样本。对于 52 名在采血日根据在线问卷或药房记录使用药物的女性，我们使用非靶向液相色谱飞行时间质谱法分析血清样本。
在 18 份血清样本（35%）中检测到药物。在问卷调查中报告的慢性疾病口服药物在血清中被检测到，反之亦然。药房记录没有发现额外的暴露女性，但由于无法获得，有 5 名女性的暴露情况被遗漏。我们观察到三种方法在吸入药物、皮肤科制剂和短期使用药物方面存在很大的不一致性，这些药物在血清中往往检测不到。
由于目前没有“金标准”，因此在大型研究中评估药物使用仍然具有挑战性。
