健康成年人中的大麻和肝酶水平升高:一项随机临床试验
Jeffry Florian1, Pablo Salcedo1, Keith Burkhart1
1Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.
JAMA internal medicine
|July 7, 2025
概括
这项研究发现,一些健康的成年人服用较低剂量的大麻 (CBD) 经历了肝酶的升高,表明潜在的肝损伤. 需要进一步研究广泛使用的CBD产品的安全性.
科学领域:
- 药理学 药理学是指药理学的学科.
- 肝病学 肝病学是一种肝病学.
- 内分泌学 在内分泌学.
背景情况:
- 不受监管的大麻 (CBD) 产品被广泛使用,这引发了安全问题.
- 对于消费者通常使用的较低剂量的CBD,安全性数据有限.
- 大多数研究都集中在临床环境中使用的更高剂量上.
研究的目的:
- 为了研究4周,每天两次,低剂量CBD使用对健康成年人的肝功能和内分泌激素的影响.
- 评估与消费者水平CBD产品使用相关的安全参数.
主要方法:
- 随机,双盲,安慰剂对照试验涉及201名健康成年人.
- 参与者接受了CBD (5mg/kg/d) 或安慰剂28天.
- 每周的实验室评估监测肝酶和内分泌激素水平.
主要成果:
- 在CBD组的8名参与者 (5.6%) 显示肝酶升高 (ALT或AST>3xULN),与安慰剂组的0名参与者相比.
- 在CBD组中,有7名参与者满足了潜在的药物诱导肝损伤的戒断标准.
- 两组之间内分泌激素水平 (,B抑制素,甲状腺激素) 没有显著差异.
结论:
- 在使用较低剂量的CBD的健康成年人中,肝酶升高的发生率突出了潜在的安全问题.
- 这些发现强调需要进一步研究消费者级别CBD剂量的长期影响和安全性.
- 与肝酶升高结合的埃索诺菲利亚需要进一步的研究.
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