Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.
Department of Clinical Epidemiology, Leibniz Institute for Prevention Research and Epidemiology - BIPS, Bremen, Germany.
Reprod Toxicol. 2021 Jun;102:90-97. doi: 10.1016/j.reprotox.2021.04.005. Epub 2021 May 4.
Little is known about the utilization of St. John's wort (Hypericum perforatum L.) during pregnancy. In Germany, certain preparations of St. John's wort can be reimbursed by statutory health insurances, facilitating to investigate exposure to St. John's wort based on claims data. We therefore aimed to characterize pregnancies exposed to St. John's wort and to explore potential malformations in the babies. Using claims data from the German Pharmacoepidemiological Research Database (GePaRD), pregnancies exposed to St. John's wort during at least one trimester between 2006 and 2016 and the corresponding babies were identified. Exposure was identified via outpatient dispensations. Pregnancies were characterized regarding timing of exposure, use of other antidepressants, pregnancy outcomes and the occurrence of major malformations in the babies (not considering codes for musculoskeletal and other malformations due to low data quality in this regard). Out of 496 pregnancies with a dispensation of St. John's wort during pregnancy, 420 (85 %) had a dispensation during the first trimester. There was a dispensation of other antidepressants before pregnancy in 21 % (during pregnancy: 12 %). Eleven percent of pregnancies ended in non-live births. In 312 babies linked to 305 pregnancies, major malformations were coded in 18 babies (5.8 %), of which 17 were exposed in the first trimester. The crude relative risk of major malformations for babies exposed during the first vs. the second or third trimester only was 3.56 (0.48-26.17). Our results suggest that only in a minority of pregnancies, St. John's wort is used as an alternative to other antidepressants. Even though the relatively high rates of non-live births and major malformations after exposure to St. John's wort during the first trimester need to be interpreted with caution, the findings are striking and generate hypotheses that merit further investigation.
关于孕妇使用贯叶连翘（贯叶金丝桃）的情况知之甚少。在德国，某些贯叶连翘制剂可通过法定健康保险报销，这为基于索赔数据调查贯叶连翘的使用情况提供了便利。因此，我们旨在描述暴露于贯叶连翘的妊娠情况，并探讨婴儿潜在的畸形。我们使用德国药物流行病学研究数据库（GePaRD）的索赔数据，确定了 2006 年至 2016 年期间至少一个孕期暴露于贯叶连翘的妊娠及其相应的婴儿。通过门诊处方识别暴露情况。根据暴露时间、是否使用其他抗抑郁药、妊娠结局以及婴儿是否出现重大畸形（由于在这方面数据质量较低，不考虑肌肉骨骼和其他畸形的代码）来描述妊娠情况。在 496 例妊娠中有贯叶连翘处方的妊娠中，有 420 例（85%）在孕早期有处方。21%（怀孕期间：12%）在怀孕前有抗抑郁药处方。11%的妊娠以非活产结束。在 312 名与 305 例妊娠相关的婴儿中，18 名婴儿（5.8%）编码有重大畸形，其中 17 名在孕早期暴露。与仅在第二或第三孕期暴露相比，在第一孕期暴露的婴儿出现重大畸形的粗相对风险为 3.56（0.48-26.17）。我们的研究结果表明，只有少数妊娠中贯叶连翘被用作其他抗抑郁药的替代品。尽管在孕早期暴露于贯叶连翘后非活产和重大畸形的相对较高发生率需要谨慎解释，但这些发现引人注目，并提出了值得进一步研究的假设。
