Abstract：
Psychotherapies assisted by psychedelic substances have shown promising results in the treatment of psychiatric disorders. The aim of this systematic review and meta-analysis was to evaluate safety data in human subjects. We carried out a search on MEDLINE, Embase and PsycINFO databases between 2000 and 2022. Standardized mean differences between different dose ranges and between acute and subacute phases were calculated for cardiovascular data after psychedelic administration. Risk differences were calculated for serious adverse events and common side effects. Thirty studies were included in this meta-analysis. There were only nine serious adverse events for over 1000 administrations of psychedelic substances (one during the acute phase and 8 during the post-acute phase). There were no suicide attempts during the acute phase and 3 participants engaged in self-harm during the post-acute phase. There was an increased risk for elevated heart rate, systolic and diastolic blood pressure for all dose range categories, as well as an increased risk of nausea during the acute phase. Other common side effects included headaches, anxiety, and decreased concentration or appetite. This meta-analysis demonstrates that psychedelics are well-tolerated, with a low risk of emerging serious adverse events in a controlled setting with appropriate inclusion criteria.
摘要：
由迷幻物质辅助的心理治疗在精神疾病的治疗中显示出有希望的结果。本系统评价和荟萃分析的目的是评估人类受试者的安全性数据。我们在MEDLINE上进行了搜索,2000年至2022年之间的Embase和PsycINFO数据库。迷幻药给药后，计算了不同剂量范围之间以及急性期和亚急性期之间的标准化平均差异，以获取心血管数据。计算严重不良事件和常见副作用的风险差异。这项荟萃分析包括30项研究。超过1000次迷幻药给药只有9次严重不良事件（急性期1次，急性期8次）。在急性期没有自杀未遂，3名参与者在急性期后进行了自我伤害。心率升高的风险增加，所有剂量范围类别的收缩压和舒张压，以及在急性期恶心的风险增加。其他常见的副作用包括头痛，焦虑,注意力或食欲下降。这项荟萃分析表明，迷幻药耐受性良好，在具有适当纳入标准的受控环境中，出现严重不良事件的风险较低。
