怀孕期间与素基因相关的抗体:VigiBase®中的不成比例性分析
Roberta Noseda1, Francesca Bedussi1, Claudio Gobbi2,3,4
1Division of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, Switzerland.
The journal of headache and pain
|January 19, 2024
概括
根据全球药物监测数据,这项研究发现,与三类药物相比,在怀孕期间素基因相关抗体 (CGRP-A) 的安全性问题没有增加. 需要进一步的研究来证实这些关于CGRP-A在怀孕中的安全性的发现.
科学领域:
- 药物监督 药物监督 药物监督
- 神经学 神经学
- 生殖健康 生殖健康
背景情况:
- 有限证据表明,素基因相关抗体 (CGRP-A) 在怀孕期间治疗偏头痛的安全性.
- 现有的数据不足以最终评估与CGRP-A在孕妇中使用相关的风险.
研究的目的:
- 通过比较报告频率与三剂来评估CGRP-A在怀孕中的安全性.
- 通过使用全球药物监测数据,识别孕妇CGRP-A的潜在安全信号.
主要方法:
- 在VigiBase®的非重复安全报告上使用了不成比例的分析,直到2023年5月31日.
- 使用报告几率比率 (ROR) 和95%信心区间 (CI) 对与怀孕相关的安全事件和结果进行CGRP-A和三子报告的比较.
- 建立了一个信号检测值,其95%CI下限>1.
主要成果:
- 分析了467份关于CGRP-A在怀孕期间暴露的安全报告,主要来自美国,由女性患者报告.
- 没有发现CGRP-A与三类药物相比,关于整体怀孕安全报告的不成比例报告信号 (ROR 0.91,95% CI 0.78-1.06).
- 具体来说,对于孕产妇/胎儿结局 (ROR 0.54,95% CI 0.45-0.66) 或胎儿/新生儿结局 (ROR 0.53,95% CI 0.41-0.68) 没有发现增加报告信号.
结论:
- 目前的VigiBase®数据表明,与怀孕期间的三类药物相比,CGRP-A的不良事件报告没有增加.
- 这些发现表明,CGRP-A在怀孕期间的安全性概况可能是有利的,需要进一步调查.
- 持续的药物监测对于确认和扩展这些最初的安全性观察是必不可少的.
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