在临床计划中,母亲或父亲暴露于托法西提尼布后,怀孕结果
Uma Mahadevan1, María Chaparro2, Michelle Segovia3
1Colitis and Crohn's Disease Center, University of California San Francisco, San Francisco, California, USA.
The American journal of gastroenterology
|September 26, 2025
概括
在免疫媒介疾病患者中对托法西提尼布暴露后的怀孕结果进行了评估. 与一般人群相比,怀孕期间接触托法西替尼的不良结果没有增加.
科学领域:
- 类风湿病学 类风湿病学
- 药物监督 药物监督 药物监督
- 生殖健康 生殖健康
背景情况:
- 这项分析报告了在被诊断患有免疫媒介疾病的患者中暴露于托法西提尼布后更新的妊娠结果.
- 托法西提尼布是一种简氏激酶 (JAK) 抑制剂,用于治疗各种自身免疫性疾病.
研究的目的:
- 评估暴露于托法西提尼布的患者怀孕和新生儿后果.
- 评估托法西提尼布在怀孕期间对母亲和父亲暴露的安全性.
主要方法:
- 从干预性研究中确定了涉及托法西替尼暴露的怀孕和伴侣怀孕病例.
- 从瑞安全数据库收集到2023年3月的数据.
主要成果:
- 报告共有184例怀孕,包括85例母亲和99例父亲暴露事件.
- 母亲暴露导致46名健康新生儿,12名医疗终止,1胎儿死亡,1先天性形,1个自发性流产和11个未决结果.
- 父亲暴露导致67名健康新生儿,1名胎儿死亡,9名自发流产和22名待定结果.
结论:
- 在母亲或父亲暴露于托法西提尼布后,怀孕结果与一般人群中观察到的结果相似.
- 托法西替尼在怀孕期间应谨慎使用,并且只有在明确指示时使用.
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