诺普拉桑相关的微观结肠炎和发病后的持续使用:使用日本药监数据库的研究
Kota Nakanishi1, Yuichi Uwai2, Tomohiro Nabekura1
1School of Pharmacy, Aichi Gakuin University, Nagoya, Japan.
In vivo (Athens, Greece)
|June 27, 2025
概括
这项研究发现诺普拉桑与微观结肠炎之间存在潜在联系,这种副作用在标签上没有列出. 患者可以在出现大肠炎症状后继续服用vonoprazan.
科学领域:
- 胃肠病学 胃肠病学
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
背景情况:
- 微观性结肠炎是已知的质子抑制剂的副作用之一.
- 沃诺普拉桑 (vonoprazan) 是一种与竞争的酸阻断剂,与微观大肠炎之间的关联尚未得到充分证实.
- 调查潜在的药物诱导的胃肠道不良事件对于患者的安全至关重要.
研究的目的:
- 为了调查诺普拉桑使用与微观结肠炎之间的关联.
- 评估微观结肠炎发作后继续使用诺普拉桑的情况.
- 为了比较vonoprazan与lansoprazole在微观结肠炎方面的安全性.
主要方法:
- 2004年至2024年日本药物不良事件报告 (JADER) 数据库的分析.
- 报告几率比率 (ROR) 和协会后勤回归的计算.
- 药物持续率和持续时间的比较,使用费舍尔精确测试和Steel-Dwass测试.
主要成果:
- 确定了与诺普拉桑相关的微观结肠炎的安全信号 (ROR=33.5).
- 调整后的几率比率表明诺普拉桑与微观结肠炎之间存在显著的关联 (aOR=2.87).
- 诺普拉赞诱导的微观结肠炎的发病时间中位数为31天,诊断后继续使用观察到.
结论:
- 诺普拉赞与微观结肠炎的风险有关,这一发现目前没有在其包装说明书中.
- 在显微性结肠炎发作后继续给予vonoprazan被注意到.
- 需要进一步的研究来证实这些发现,尽管依赖于自发报告.
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