药物诱导认知障碍的真实世界数据衍生药物监测使用全国自发不良反应报告系统
Yongjun Sunwoo1,2, Sae Hyun Eom3, Ji Seong Yun3
1Department of Regulatory Science, Graduate School, Kyung Hee University, Seoul 02447, Republic of Korea.
Medicina (Kaunas, Lithuania)
|July 27, 2024
概括
药物诱导的认知障碍是一个严重的问题,特别是在抗癌和抗帕金森症药物. 男性性别和癌症诊断增加了因这些药物诱导的认知障碍而导致住院的风险.
科学领域:
- 药物监督 药物监督 药物监督
- 老年医学 老年医学
- 临床药理学 临床药理学
背景情况:
- 认知障碍与衰老是常见的,但药物诱导的认知障碍是研究不足的.
- 关于药物诱导认知障碍的患病率和严重性的证据有限.
- 了解药物诱导的认知障碍对于患者的安全至关重要.
研究的目的:
- 评估药物诱导认知障碍的患病率和严重程度.
- 确定因严重药物诱导认知障碍而导致住院风险的临床预测因素.
主要方法:
- 从韩国不良事件报告系统数据库 (KAERS DB) (2012-2021) 来分析与认知障碍相关的不良药事件 (ADEs).
- 不成比例性分析 (报告几率比率 - ROR) 评估药物类与严重不良事件 (SAE) 之间的关联.
- 多变量物流分析,以确定住院风险的临床预测因素 (赔率 - OR).
主要成果:
- 止痛药和镇静催眠药是药物诱导认知障碍ADEs的最常见原因.
- 抗癌药物 (ROR 57.105) 和抗帕金森病药物 (ROR 4.057) 的严重药物诱导认知障碍报告率显着更高.
- 男性性别 (OR 19.540) 和癌症诊断 (OR 18.115) 是由于严重的药物诱导认知障碍而入院的主要预测因素.
结论:
- 药物诱导的认知障碍,特别是在抗癌药物和癌症患者中,是普遍和严重的.
- 男性性别和癌症诊断是住院治疗的重要风险因素.
- 由于潜在的报告不足和复杂的促成因素,需要进行进一步的大规模研究.
相关概念视频
01:19Pharmacovigilance
805
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...
805
01:30Cognitive Enhancers: Cholinesterase Inhibitors and NMDA Receptor Antagonists
114
Cognitive enhancers, also known as "smart drugs," are substances used to enhance memory, mental alertness, and concentration. These can be natural or synthetic and improve cognition in conditions like Alzheimer's disease (AD) and other neurodegenerative diseases. Some common examples include caffeine, amphetamines, methylphenidate, modafinil, arecoline, donepezil, vortioxetine, and piracetam. These enhancers work on the principle of synaptic plasticity and altered circuit function.
114
01:25Drug Regulation
1.3K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
1.3K
01:12Analysis of Population Pharmacokinetic Data
244
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...
244
01:21Factors Affecting Drug Response: Overview
1.9K
When it comes to infants and young children, they are typically administered smaller doses of medication in comparison to adults. This is primarily because their organ functions still need to fully develop, meaning their bodies are not as efficient at metabolizing or eliminating drugs. Additionally, their blood-brain barrier is more permeable than in adults. As a result, high concentrations of drugs can easily penetrate the central nervous system (CNS), potentially leading to neurological...
1.9K