卡佩西塔相关的胃肠道,出血和阻塞:基于FAERS的药监测分析
Yuwei Wang1, Long Meng2, Xiao Liu3
1Department of Radiation Oncology, The Cancer Hospital of Chongqing University, Chongqing, China.
Frontiers in pharmacology
|July 1, 2024
概括
这项研究发现,capecitabine与胃肠道 (GI) 问题的增加有关,如,出血和阻塞,有些病例是致命的. 医疗保健提供者应监测这些严重的胃肠道药物不良反应,包括阻塞,在服用capecitabine的患者.
科学领域:
- 药物监督和药物安全研究.
- 瘤学和乳腺癌治疗.
- 胃肠道药物不良反应.
背景情况:
- 卡佩奇他与严重的胃肠道 (GI) 药物不良反应有关,包括,出血和阻塞.
- 这些关联的统计证据,特别是胃肠道阻塞,缺乏,并且药物标签上没有列出阻塞.
研究的目的:
- 研究使用capecitabine与乳腺癌患者胃肠道,出血或阻塞的发生之间的关联.
- 分析美国食品和药物管理局不良事件报告系统 (FAERS) 的这些药物不良反应的数据.
主要方法:
- 使用报告几率比率 (ROR) 和信息组件 (IC) 的不成比例分析,具有95%的置信区间 (CI).
- 对2004年1月1日至2020年12月31日的FAERS数据的检查.
主要成果:
- 总共有279例与capecitabine相关的胃肠道,出血或阻塞病例被确定.
- 卡佩奇他的使用显示出不成比例的高报告率的胃肠道 (ROR 1.94),出血 (ROR 2.27),和阻塞 (ROR 2.19).
- 大约四分之一的报告病例导致患者死亡.
结论:
- 药监数据表明,在capecitabine使用者中,胃肠道,出血和阻塞的风险增加,可能导致严重或致命的结果.
- 除了已知的不良反应外,密切监测肠道阻塞至关重要,以防止治疗中止和危及生命的事件.
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