PDF(Pubmed)
Abstract：
The Food and Drug Administration (FDA) granted breakthrough therapy status to 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) in 2017 due to preliminary evidence supporting its efficacy and safety in treating post-traumatic stress disorder (PTSD). A series of six phase-II clinical trials studying MDMA-AT for treatment-resistant PTSD found that 54% of MDMA-AT full-dose participants no longer met the diagnosis of PTSD after two MDMA sessions, compared to 23% in the control group. In the first phase-III clinical trial, 67% no longer met the criteria for PTSD after three sessions. The effects are durable, with 67% no longer diagnosable after one year and 74% at nearly four years. The MDMA-AT is being fast-tracked for potential FDA approval by 2023. In 2021, Hawaii\'s Senate Bill 738 unsuccessfully proposed that psilocybin be removed from the Schedule I controlled substances list due to its clinical efficacy for major depressive disorder. Methylenedioxymethamphetamine is also a Schedule I controlled substance and has proven to be a treatment option that could potentially benefit the people of Hawaii.
摘要：
美国食品和药物管理局（FDA）在2017年授予3,4-甲基烯二氧基甲基苯丙胺辅助治疗（MDMA-AT）突破性治疗地位，因为初步证据支持其治疗创伤后应激障碍（PTSD）的有效性和安全性。一系列研究MDMA-AT用于治疗抗性PTSD的II期临床试验发现，在两次MDMA疗程后，54％的MDMA-AT全剂量参与者不再符合PTSD的诊断，对照组为23%。在第一个III期临床试验中,67%的人在三次疗程后不再符合PTSD的标准。效果持久，67%的人在一年后不再可诊断，74%的人在近四年后不再可诊断。MDMA-AT正在快速追踪，以便在2023年获得潜在的FDA批准。2021年，夏威夷参议院第738号法案未能成功提出，由于其对重度抑郁症的临床疗效，将psilocybin从附表I受控物质清单中删除。甲基二氧基甲基苯丙胺也是附表I控制的物质，已被证明是一种可能使夏威夷人民受益的治疗选择。
