来自FAERS数据库的crizotinib在现实世界中的不良事件概况:为期12年的药监测研究
Huan Zhang1, Yunrui Song1, Fantong Xia1
1College of Medicine, Chongqing University, No. 131 Yubei Road, Shapingba District, Chongqing, China.
BMC pharmacology & toxicology
|March 15, 2025
概括
这项研究分析了crizotinib的现实世界不良事件 (AE),这是用于非小细胞肺癌的ALK-TKI. 结果证实了已知的副作用,并揭示了意想不到的严重风险,有助于未来的监测和安全评估.
科学领域:
- 药监和药物安全 药监和药物安全
- 瘤学和癌症治疗学 癌症治疗学
- 数据挖掘和健康信息学
背景情况:
- 克里佐替尼 (Crizotinib) 是一种被批准用于治疗ALK阳性非小细胞肺癌 (NSCLC) 的形淋巴瘤激酶氨酸激酶抑制剂 (ALK-TKI).
- 现实世界的数据分析对于了解临床试验之外的药物安全至关重要.
- 美国食品和药物管理局的不良事件报告系统 (FAERS) 是药物监测的关键资源.
研究的目的:
- 为了评估与crizotinib治疗相关的现实世界的不良事件 (AE).
- 在FAERS数据库上使用数据挖掘技术进行全面的AE评估.
- 确定已知和以前未被识别的crizotinib安全信号.
主要方法:
- 从FAERS数据库 (2011-2023) 中提取与crizotinib相关的AE报告.
- 不成比例分析的应用,包括报告几率比率 (ROR),比例报告比率 (PRR),贝叶斯信任传播神经网络 (BCPNN) 和多项目马鱼缩小器 (MGPS).
- 在多个分析算法中识别统计显著的不良事件.
主要成果:
- 总共分析了10226份与crizotinib相关的AE报告.
- 147个首选术语 (PT) 在所有四个算法中都显示出显著的不成比例.
- 常见的副作用包括转氨酶的升高,心肌梗塞,QT延长,恶心,吐,腹,便秘,视力障碍和间歇性肺部疾病. 发现的意想不到的严重副作用包括深静脉血栓,肺炎,胃肠粉症和肝昏迷.
结论:
- 克里佐替尼 (crizotinib) 证明了治疗效果,但存在各种不良事件的风险.
- 这项研究证实了之前报告的副作用,并突出了新的严重不良事件.
- 这些发现为加强对crizotinib剂量和相关风险的监测提供了基础.
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