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使用FAERS数据库对与PI3K/AKT/mTOR途径抑制剂相关的口服毒性进行不成比例分析

Monica Marni¹, Djamilla Simoens¹, Nicholas Romero¹

¹Program in Pharmacovigilance, Stritch School of Medicine, Loyola University Chicago, 2160 S. First Ave., Maywood, IL 60153, USA.

Pharmaceuticals (Basel, Switzerland)

|October 29, 2025

概括

口炎是针对性癌症治疗的常见副作用. 这项研究发现,与其他药物相比,everolimus,alpelisib和palbociclib的口炎报告几率更高.

科学领域:

药物监督药物监督药物监督
在瘤学瘤学.
药品安全药品安全

背景情况:

口炎是激素受体阳性,HER2阴性乳腺癌患者接受向治疗,特别是PI3K/AKT/mTOR抑制剂的常见不良事件.
虽然已知与mTOR抑制剂相关的口腔炎,但其他激酶抑制剂的真实数据有限.

研究的目的:

为了评估使用FDA不良事件报告系统 (FAERS) 数据对alpelisib,capivasertib,everolimus和palbociclib的口腔炎报告.
为了比较这些激酶抑制剂的口腔炎报告不成比例.

主要方法:

对FAERS数据的药监不成比例性分析.
使用四个术语集 (口腔炎,OTT,CTT,SAMT) 进行事件识别.
计算报告概率比率 (ROR),比例报告比率 (PRR) 和信息组件 (IC) 使用95%的置信区间.

主要成果:

与其他药物相比,所有分析的药物 (everolimus,alpelisib,palbociclib,capivasertib) 显示牙炎的几率和报告比例增加.
埃弗罗利莫斯的相关性最强 (ROR: 30.72),其次是阿尔佩利西布 (ROR: 13.11) 和帕尔博西基布 (ROR: 11.73).
卡皮瓦塞尔蒂布显示出报告率最低的几率 (ROR:3.14),仅限于报告数量较少.

结论:

牙炎相关主要术语 (SAMT) 术语集是一种有效的牙炎查工具.
优化口腔炎检测和监测对于PI3K和mTOR抑制剂在临床试验和营销后监测中至关重要.

关键词:

在CDK4/6中使用.公平的人是公平的.在HER2−的基础上,HER2−人力资源+人力资源+人力资源在PI3K/AKT/mTOR中使用.在阿尔佩里斯比利斯,它是可靠的.乳腺癌乳腺癌乳腺癌这是一个有趣的 capivasertib.这是Everolimus.这是不可抗拒的,不可抗拒的.这是palbocicliblib.药物监督和药物监督牙炎是一种口腔炎.

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