在现实世界中对维诺雷尔宾的安全性分析:基于FAERS数据库的药监测研究
Yuhui Li1, Zheng Shi2, Xiaoshuang Fu3,4
1Department of Pharmacy, College of Pharmaceutical Science, Zhejiang University of Technology, Hangzhou, China.
Journal of chemotherapy (Florence, Italy)
|January 23, 2026
概括
癌症药物维诺雷尔宾的真实安全数据显示,经常出现不良事件,如中性衰竭和恶心. 老年患者面临严重肺部问题的更高风险,需要密切监测.
科学领域:
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
- 临床药理学 临床药理学
背景情况:
- 维诺雷尔宾是治疗非小细胞肺癌,乳腺癌和其他固体瘤的关键化疗剂.
- 对于维诺雷尔宾,现实世界的安全数据有限,这阻碍了全面的风险评估.
- 了解不良事件概况对于优化患者护理和治疗方案至关重要.
研究的目的:
- 分析和描述与维诺雷尔宾治疗相关的现实世界不良事件.
- 识别特定的安全信号和风险因素,包括患者人口统计和事件严重程度.
- 在临床实践中为维诺雷尔宾监测提供基于证据的建议.
主要方法:
- 从2004年第一季度到2025年第一季度使用了FDA不良事件报告系统 (FAERS) 数据库.
- 检索和删除与维诺雷尔宾相关的报告,分析了2,321份报告和8,956起不良事件.
- 进行了不成比例性分析 (ROR,PRR,BCPNN,EBGM),并根据年龄,性别和严重程度进行了子组分析.
主要成果:
- 最常见的不良事件包括中性质减退,发烧,恶心,吐,呼吸不良,发烧性中性质减退和腹.
- 老年患者表现出间歇性肺病和呼吸系统衰竭的风险增加.
- 女性患者的中性质减弱发病率较高,中位数发病时间为20天,主要是在第一个月内.
结论:
- 确定了维诺雷尔宾的重要安全信号,强调需要对患者进行警监测.
- 强调老年患者和女性的特定风险,需要量身定制的安全方法.
- 建议密切监测,特别是在治疗的早期和老年人群,以减轻不良事件.
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