基于西斯的组合与相关血管病变 - - 对现实世界药监数据的不成比例分析
Krutarth K Pandya1, Chitsimran Mann2, Wei Fang3
1Department of Cardiology, Cleveland, Ohio, 44195, USA.
Current drug safety
|August 13, 2025
概括
西斯普拉丁化学疗法组合与血管事件的增加有关,特别是在gemcitabine. 医疗保健提供者应在治疗期间监测患者是否有血栓事件.
科学领域:
- 在瘤学瘤学.
- 药物监督 药物监督 药物监督
- 心血管医学 心血管医学
背景情况:
- 西斯是一种广泛用于固体瘤和血液恶性瘤的化疗剂.
- 虽然有效,西斯丁与脏,胃肠道和肝毒性等毒性有关.
- 有限的数据存在于西斯普拉丁与血管不良事件的关联.
研究的目的:
- 调查与四种基于西斯的组合疗法相关的与药物相关的血管不良事件的风险.
- 使用FDA不良事件报告系统 (FAERS) 进行分析.
主要方法:
- 使用报告几率比率 (ROR) 对2016-2020年FAERS数据进行案例/非案例不成比例分析.
- 包括外周,脑血管,冠状动脉,静脉血栓和动脉事件.
- 分析了四个西斯普拉丁组合组:西斯普拉丁/埃托普西德,西斯普拉丁/吉姆西塔,西斯普拉丁/帕克利塔克塞尔和西斯普拉丁/多克塔克塞尔.
主要成果:
- 所有四个基于西斯的组合组均显示出统计学上显著的血管病变.
- 西斯普拉丁和格姆奇塔宾组合显示了相关血管病变 (ROR和IC) 的最高信号.
- 西斯普拉丁和帕克利塔克塞尔/多塞塔克塞尔呈现出趋势,但对于血管病变没有达到统计学意义.
结论:
- 与西斯普拉丁组合相关的血管病变增加可能源于前血栓状况.
- 强调需要谨慎和监测在接受基于西斯的化疗的患者中发生的血栓事件.
- 强调在治疗决策和管理血管风险时考虑患者特定因素.
相关概念视频
Pharmacovigilance
993
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...
993
Analysis of Population Pharmacokinetic Data
383
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
383
Combination Therapies and Personalized Medicine
5.1K
Combining two or more treatment methods increases the life span of cancer patients while reducing damage to vital organs or tissue from the overuse of a single treatment. Combination therapy also targets different cancer-inducing pathways, thus reducing the chances of developing resistance to treatment.
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
The combination of the drug acetazolamide and sulforaphane is a good example of combination therapy to treat cancer. The cells in the interior of a large tumor often die due to the hypoxic and...
5.1K
Antiplatelet Drugs: Prostaglandin Synthesis, P2Y12 and Glycoprotein IIb/IIIa Inhibitors
645
Antiplatelet drugs emerge as frontline defenders against the insidious threat of thromboembolic diseases, where abnormal clots obstruct vital blood vessels. These drugs stand as bulwarks, inhibiting platelet aggregation and clot formation, thereby mitigating the risk of life-threatening conditions like myocardial infarction, coronary artery disease, and thrombotic strokes.
Prostaglandin synthesis inhibitors, exemplified by the widely known aspirin, wield their power by irreversibly acetylating...
Prostaglandin synthesis inhibitors, exemplified by the widely known aspirin, wield their power by irreversibly acetylating...
645
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
174
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
174
Chemotherapy-Induced Nausea and Vomiting: Neurokinin-1 Receptor Antagonists
259
Neurokinin 1 (NK1) receptors are distributed across the GI tract, vagal afferents, and key CNS regions including the central vomiting center and chemoreceptor trigger zone (CTZ) Chemotherapy agents stimulate enterochromaffin cells in the gastrointestinal (GI) tract to release large amounts of substance P (SP). SP is a neuropeptide released by specific sensory nerves in response to many different stressors, including those in the GI mucosa affected by chemotherapy. SP binds and activates...
259


