Hirasawa Yumiko, Tagashira Hisashi, Ueno Anna, Tasaka Yuki, Goto Mikako, Murashima Atsuko, Yamamoto Hiroshi
Department of Pharmacy, NHO Shikoku Medical Center for Children and Adults, Zentuuji-shi, Kagawa, Japan.
Department of Pharmacy, NHO Okayama Medical Center, Okayama, Japan.
Dig Dis Sci. 2025 Jul 9. doi: 10.1007/s10620-025-09197-3.
Data on mosapride citrate hydrate (mosapride) safety during pregnancy are limited. This study aimed to evaluate the effects of maternal mosapride exposure on pregnancy and infant outcomes.
We conducted a prospective cohort study using data from two teratology information centers in Japan. Pregnant women who consulted these centers between April 1988 and December 2017 were included. The incidence of major congenital anomalies was compared between women exposed to mosapride during the first trimester and a control group. Multivariate logistic regression analysis was performed to assess potential risks.
Major congenital anomalies were observed in 2 of 104 infants (1.92%) in the mosapride group and 32 of 1693 infants (1.89%) in the control group. The relative risk was 1.02 (95% confidence interval [CI] 0.24-4.26), indicating no statistically significant difference. Other pregnancy outcomes, including stillbirth, spontaneous abortion, preterm birth, and low birth weight, also showed no significant differences between groups.
Although our study may not exclude small increases in risk due to sample size limitations, the findings suggest that mosapride exposure during early pregnancy is not associated with a substantial increase in the risk of major congenital anomalies. These findings may help alleviate concerns related to mosapride use during pregnancy.
关于枸橼酸莫沙必利水合物（莫沙必利）在孕期安全性的数据有限。本研究旨在评估孕期母亲接触莫沙必利对妊娠及婴儿结局的影响。
我们利用日本两个致畸学信息中心的数据进行了一项前瞻性队列研究。纳入了1988年4月至2017年12月期间向这些中心咨询的孕妇。比较了孕早期接触莫沙必利的女性与对照组中重大先天性畸形的发生率。进行多因素逻辑回归分析以评估潜在风险。
莫沙必利组104例婴儿中有2例（1.92%）出现重大先天性畸形，对照组1693例婴儿中有32例（1.89%）出现重大先天性畸形。相对风险为1.02（95%置信区间[CI] 0.24 - 4.26），表明无统计学显著差异。其他妊娠结局，包括死产、自然流产、早产和低出生体重，两组之间也无显著差异。
尽管我们的研究可能因样本量限制无法排除风险有小幅度增加的情况，但研究结果表明孕早期接触莫沙必利与重大先天性畸形风险的大幅增加无关。这些发现可能有助于减轻对孕期使用莫沙必利的担忧。
