3,4-甲基二氧化甲胺使用者的肝损伤和肝衰竭不良事件向FDA不良事件报告系统报告
Tigran Makunts1, Ruben Abagyan1
1Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, La Jolla, CA, United States.
Frontiers in psychiatry
|July 3, 2024
概括
在对FDA不良事件报告的审查中,3,4-甲基二氧化甲胺 (MDMA) 与药物诱导的肝损伤 (DILI) 没有显著的关联. 大多数报告的肝脏事件涉及其他可疑药物,而不是MDMA.
科学领域:
- 药理学和毒理学 药理学和毒理学
- 精神病学是一个精神病学.
- 肝病学 肝病学是一种肝病学.
背景情况:
- 3,4-甲基二氧化甲胺 (MDMA) 正在为创伤后应激障碍治疗进行调查.
- MDMA经历了广泛的肝脏代谢,引发了人们对潜在的药物诱导性肝损伤 (DILI) 的担忧.
- 非同步性DILI很少见,在临床试验中经常无法检测到.
研究的目的:
- 调查MDMA使用与药物诱导性肝损伤 (DILI) 之间的关联.
- 分析潜在的MDMA相关肝损伤的不良事件报告.
主要方法:
- 调查了来自FDA不良事件报告系统 (FAERS) 的1500多份报告.
- 确定了23个肝损伤或肝功能衰竭的病例,其中MDMA与其他物质同时使用.
- 将可疑药物与FDA的DILIrank数据集进行交叉引用.
主要成果:
- 在23例肝损伤病例中,22例涉及与已知DILI相关的药物联合使用.
- 只有在一个报告中,MDMA被列为主要嫌疑人.
- 鉴于每年使用量广泛,单独的报告不足以确定MDMA与DILI有重大关联.
结论:
- 目前的证据不确定MDMA和药物诱导的肝损伤之间存在显著的关联.
- 同时使用其他具有已知的DILI潜力的药物复杂化了因果关系的评估.
- 可能需要进一步的研究,但初步发现表明,MDMA不是报告肝病事件的主要驱动因素.
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