■阿尔茨海默病(AD)是一种导致记忆丧失的神经退行性疾病,认知障碍,神经精神症状.第二代抗精神病药(SGAs)通常用于治疗这些神经精神症状,但其在AD患者中的安全性需要进一步研究.
■目的是通过使用美国食品和药物管理局不良事件报告系统(FAERS)数据库分析药物不良反应(ADR)来评估SGA在AD患者中的安全性。
■这项研究对2014年至2023年的FAERS数据进行了全面分析,重点是使用利培酮等SGA治疗的AD患者的ADR,喹硫平,奥氮平,氯氮平,和阿立哌唑.描述性的,不成比例,时间,使用贝叶斯置信度传播神经网络进行剂量分析,威布尔,和基于生理的药代动力学模型。
■在接受SGA治疗的1289例AD患者中,最常见的不良反应涉及神经系统,胃肠系统,和心脏疾病。不成比例分析确定了心脏,肾,和血管系统。喹硫平,利培酮,与氯氮平和阿立哌唑相比,奥氮平显示更多的阳性信号。时间分析显示心血管不良反应随机发生,而肾脏ADR随着长期使用而增加。剂量分析表明,小剂量的SGA并没有增加多心脏的风险,肾,或血管不良反应。
■这项研究强调了监测药品不良反应的重要性,特别是在心脏和肾脏系统中,在AD患者中使用SGAs时。未来的研究纳入更全面的临床数据是必要的,以支持安全和合理的药物利用。
UNASSIGNED: Alzheimer\'s disease (AD) is a neurodegenerative condition leading to memory loss, cognitive impairment, and neuropsychiatric symptoms. Second-generation antipsychotics (SGAs) are commonly used to manage these neuropsychiatric symptoms, but their safety profile in patients with AD requires further investigation.
UNASSIGNED: The objective was to evaluate the safety of SGAs in patients with AD by analyzing adverse drug reactions (ADRs) using the US Food and Drug Administration Adverse Event Reporting System (FAERS) database.
UNASSIGNED: This study conducted a comprehensive analysis of FAERS data from 2014 to 2023, focusing on ADRs in patients with AD treated with SGAs such as risperidone, quetiapine, olanzapine, clozapine, and aripiprazole. Descriptive, disproportionality, time, and dose analysis were performed using the Bayesian confidence propagation neural network, Weibull, and physiologically based pharmacokinetic model.
UNASSIGNED: Out of 1289 patients with AD treated with SGAs, the most common ADRs involved the nervous system, gastrointestinal system, and cardiac disorders. Disproportionality analysis identified significant positive signals in cardiac, renal, and vascular systems. Quetiapine, risperidone, and olanzapine showed more positive signals compared with clozapine and aripiprazole. Time analysis indicated that cardiovascular ADRs occurred randomly, whereas renal ADRs increased with prolonged use. Dose analysis suggested that small doses of SGAs did not elevate the risk of multiple cardiac, renal, or vascular ADRs.
UNASSIGNED: The study underscores the importance of monitoring for ADRs, particularly in the cardiac and renal systems, when using SGAs in patients with AD. Future research incorporating more comprehensive clinical data is warranted to support safe and rational drug utilization.