Netherlands Pharmacovigilance Centre Lareb, 5237 MH Hertogenbosch, The Netherlands.
Groningen Research Institute of Pharmacy, PharmacoTherapy-Epidemiology & Economics, University of Groningen, 9713 AV Groningen, The Netherlands.
Int J Environ Res Public Health. 2023 Nov 24;20(23):7107. doi: 10.3390/ijerph20237107.
Paternal medication use around the time of conception is common, but information about its effects on pregnancy outcome and the health of the child is generally limited. The aim of this study is to examine the feasibility of studying paternal exposure in the Dutch Pregnancy Drug Register by using immunosuppressants as a proof of concept. In 113 of 15,959 pregnancies, long-term paternal immunosuppressant use was reported 3 months before conception. In total, 134 immunosuppressants were used. Pregnancy outcome was known for 54 cases and was in accordance with previous findings. Two spontaneous abortions, two premature births, six small for gestational age babies, and two major congenital malformations were reported. Time to pregnancy (TTP) was known for 9548 pregnancies, including 89 with paternal immunosuppressant use. TTP analysis did not show a difference in pregnancies with paternal immunosuppressant use compared to the control group. Moreover, the number of fertility treatments in the paternal immunosuppressant group was similar to the control group. In our opinion, it is feasible to use the Dutch Pregnancy Drug Register to study the effects of paternal exposure on pregnancy outcome. However, to study the potential effects on fertility, more information is needed, particularly since the beginning of pregnancy attempts.
准父亲在受孕前后使用药物的情况较为常见，但关于其对妊娠结局和儿童健康的影响的信息通常有限。本研究旨在以免疫抑制剂为例，检验在荷兰妊娠药物登记处研究准父亲暴露情况的可行性。在 15959 例妊娠中，有 113 例报告称准父亲在受孕前 3 个月长期使用免疫抑制剂。共使用了 134 种免疫抑制剂。54 例妊娠结局已知，与先前的发现相符。报告了两例自然流产、两例早产、六例胎儿生长受限和两例重大先天畸形。对于 9548 例已知妊娠时间（TTP）的妊娠，其中 89 例准父亲使用了免疫抑制剂。TTP 分析并未显示使用准父亲免疫抑制剂的妊娠与对照组之间存在差异。此外，准父亲免疫抑制剂组的生育治疗数量与对照组相似。我们认为，使用荷兰妊娠药物登记处研究准父亲暴露对妊娠结局的影响是可行的。然而，要研究潜在的对生育能力的影响，需要更多的信息，特别是在妊娠开始尝试时。
