药物诱导的瘤疾病:全球药监数据库分析
1Service de pharmacologie médicale et clinique, faculté de médecine, centre hospitalier universitaire, 37, allées Jules-Guesde, 31000 Toulouse, France.
Therapie
|December 2, 2023
概括
拉尼蒂丁,皮奥格利塔和雷戈拉费尼布在药监数据中最常与癌症报告有关. 由于潜在的致癌机制,可能需要对暴露于这些和其他药物的患者进行特殊监测.
科学领域:
- 药物监督 药物监督 药物监督
- 药品安全 药品安全
- 在瘤学瘤学.
背景情况:
- 癌症是一个重大的全球健康负担,每年造成数百万人的死亡.
- 某些常用的药物已被确定为潜在的致癌物.
- 了解与药物相关的癌症风险对于患者安全至关重要.
研究的目的:
- 为了识别和描述与癌症发生有关的最常见的药物.
- 分析药监数据,寻找药物诱导致癌性的信号.
主要方法:
- 在全球药监数据库VigiBase中搜索个人病例安全报告 (ICSR).
- 确定了与"恶性或未指定的瘤"药物不良反应 (ADRs) 相关的50种最常报告的药物.
- 使用不成比例的措施,包括信息组件 (IC) 和报告几率比率 (ROR),以评估安全信号.
主要成果:
- 超过871,000个与恶性瘤相关的ICSR被确定.
- 拉尼蒂丁显示了与癌症相关的副作用的数量最多 (n=106,484).
- 其他具有显著信号的药物包括莱纳利多米德,乙太,皮奥格利塔和雷戈拉费尼布.
结论:
- 已识别的药物表现出潜在的致癌机制,包括N-二甲基胺的形成 (拉尼蒂丁),基因激活 (皮奥格利塔),免疫抑制和不明确的致癌途径 (蛋白质激酶抑制剂).
- 激素对抗剂,如他莫西芬和莱特也与此有关.
- 对于已识别癌症风险的药物,建议对患者进行特殊监测和进一步研究.
相关概念视频
01:19Pharmacovigilance
850
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
850
01:27Tumor Immunotherapy
529
Immunotherapy is a treatment that boosts or manipulates the immune system to fight diseases, including cancer. For instance, by stimulating an immune response through vaccinations against viruses that cause cancers, like hepatitis B virus and human papillomavirus, these diseases can be prevented. Nonetheless, some cancer cells can avoid the immune system due to their rapid mutation and division. The immune response to many cancers involves three phases: elimination, equilibrium, and escape.
529