经典迷幻药研究中的不良事件:系统性审查和元分析
Jared T Hinkle1, Marianna Graziosi1,2, Sandeep M Nayak1
1Center for Psychedelic and Consciousness Research, Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.
像LSD和psilocybin这样的经典迷幻药在临床环境中通常耐受良好,严重不良事件 (SAE) 很少发生. 持续的药物监测对于了解这些物质的风险益处概况至关重要.
科学领域:
- 心理药理学 心理药理学
- 临床神经科学 临床神经科学
- 医学研究 医学研究
背景情况:
- 迷幻药辅助疗法正在扩展到新的群体和适应症.
- 必须全面了解与经典迷幻药物相关的风险.
- 评估不良事件 (AE) 对患者安全至关重要.
研究的目的:
- 在临床和研究环境中系统地审查和元分析与经典迷幻药物 (LSD,psilocybin,DMT,5-MeO-DMT) 相关的不良事件 (AE),包括严重的AE (SAE) 和非严重的AE (NSAE).
- 量化常见的AE和特别感兴趣的AE的频率.
- 评估发表的研究中AE报告的质量.
主要方法:
- 在Scopus,MEDLINE,PsycINFO和Web of Science数据库中进行系统的文献搜索.
- 包括涉及在临床或研究环境中使用经典迷幻药的研究.
- 对AE频率和异质性的随机效应元分析,采用混合方法来捕获所有报告的AE.
主要成果:
- 在214项研究中,有114项 (53.3%) 报告了3504名参与者的可分析AE数据.
- 大约4%的参与者有先前存在的神经精神疾病,但在健康参与者中没有发生SAE.
- 在当代研究环境中,没有报告自杀,持续性精神障碍或幻觉持续性知觉障碍的死亡.
- 观察到AE监测和报告质量的显著异质性.
结论:
- 经典的迷幻药在临床/研究环境中通常被很好地容忍,可怕事件很少发生.
- 在目前的试验参与者中没有报告在非临床环境中观察到的灾难性事件.
- 加强和系统的药物监测是必要的,以充分阐明风险-益处概况,并为公众传播提供信息.
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