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在psilocybin治疗临床试验中的不良事件报告和管理:为指导临床和研究方案开发的系统性审查

Danielle Bukovsky¹, Aron Amaev², Jianmeng Song¹

¹Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health (CAMH), 250 College Street, Toronto, Ontario M5T 1R8, Canada; Institute of Medical Science, University of Toronto, 1 King's College Cir, Toronto, Ontario M5S 3K3, Canada.

Progress in neuro-psychopharmacology & biological psychiatry

|October 25, 2025

概括

псилоцибин在精神疾病中显示出有利的安全性. 头痛和血压升高等不良事件通常是轻微的和短暂的,严重事件在受控环境中很少发生.

科学领域:

精神病学和神经科学精神病学和神经科学
药理学药理学是指药理学的学科.
临床研究临床研究

背景情况:

一种迷幻前药物psilocybin正在为治疗抑郁症和焦虑症等精神疾病进行研究.
人们对 псилоцибин的安全性和不良事件 (AE) 管理存在担忧.
系统性审查对于在临床环境中评估AE概况至关重要.

研究的目的:

系统地审查与松素使用相关的不良事件 (AE) 和严重不良事件 (SAE) 的发生率,性质和严重程度.
综合有关常见,不常见和SAE的数据,包括自杀念头和医疗干预.
提供AE概述和对未来psilocybin研究协议的考虑.

主要方法:

在MEDLINE,Embase和APA PsycInfo的综合文献搜索到2024年6月5日.
包括42项临床研究 (N=1068名参与者) 报告了AE和/或SAE.
综合AE数据,指出由于所有研究中的盲目性问题,存在高偏差风险.

主要成果:

常见的副作用包括头痛,短暂的高血压和恶心,通常会自发消失.
严重不良事件 (SAE) 是罕见的,在2项研究中报告,主要涉及患有潜在抑郁症的参与者.
对AE的医疗干预很少需要.

结论:

在受控的临床条件下使用时,psilocybin表现出良好的安全性.
了解AE的频谱对于安全的西辅助疗法开发至关重要.
未来的研究应该专注于强大的AE监测和管理策略.

关键词:

不良事件是不良事件.这种药物是psilocybin.迷幻药物迷幻药物是一种精神药物.安全的安全的安全的安全的安全.严重的不良事件严重的不良事件

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