迪苏尔菲拉姆的安全性评估:基于FAERS数据库的现实世界不良事件分析
Jing Luo1,2, Yaqi Zeng1,2, Zhe Chen3
1Department of Psychiatry, The School of Clinical Medicine, Hunan University of Chinese Medicine, Changsha, Hunan, China.
Frontiers in psychiatry
|December 4, 2024
概括
用于治疗酒精使用障碍的迪苏尔菲拉姆在瘤学和传染病方面表现出潜力,但存在风险. 监测肝脏,精神病和神经系统不良事件对于安全的重定向使用至关重要.
科学领域:
- 药物监督 药物监督 药物监督
- 药物重用 药物重用
- 临床安全 临床安全
背景情况:
- 迪苏尔菲拉姆是FDA批准的治疗酒精使用障碍 (AUD) 的药物.
- 新兴的研究突出显示了dissulfiram在瘤学和传染病中的潜力.
- 了解其安全概况对于新型应用至关重要.
研究的目的:
- 分析与disulfiram相关的不良事件 (AEs).
- 评估二硫在传统用途和重新用途中的安全性.
- 从现实数据中识别潜在的新安全信号.
主要方法:
- 从FAERS数据库 (2002年第四季度 - 2023年第三季度) 提取了disulfiram的AE报告.
- 在AE分析中采用多种信号检测方法 (ROR,PRR,BCPNN,MGPS).
- 根据首选术语 (PT) 和系统器官类别 (SOC) 分类识别的AE.
主要成果:
- 分析了508份涉嫌使用disufiram的AE报告,在25个SOC中确定了104个PT.
- 最重要的AE类别包括非标签使用,精神症状,肝移植和多神经病.
- 确定了潜在的新AE:低躁狂,妄想,声带,心电图ST段抑郁和Jarisch-Herxheimer反应.
结论:
- 迪苏尔菲拉姆带来了各种不良反应的风险,以及作为重新定位的药物的承诺.
- 临床使用需要对肝胆道,精神病和神经系统疾病进行警监测.
- 对dissulfiram的安全性进行进一步的研究是有必要的,因为它正在扩大治疗作用.
相关概念视频
01:19Pharmacovigilance
773
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...
773
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