一个Ib期,双盲,随机研究大麻油治疗帕金森病患者疼痛
Daniel G Di Luca1, Gabriela S Gilmour1, Conor Fearon1
1Edmond J. Safra Program in Parkinson's Disease, Movement Disorders Clinic Krembil Brain Institute, Toronto Western Hospital Toronto Ontario Canada.
Movement disorders clinical practice
|July 21, 2023
概括
这项研究发现,delta-9-tetrahydrocannabinol (THC) 和cannabidiol (CBD) 的混合配方对于帕金森氏症是安全的.
科学领域:
- 神经科学是一个神经科学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 疼痛是帕金森病 (PD) 的常见和使人衰弱的症状.
- 目前PD疼痛的治疗选择有限.
- 研究PD疼痛的新疗法至关重要.
研究的目的:
- 评估不同型号的delta-9-tetrahydrocannabinol (THC) 和cannabidiol (CBD) 的安全性和最大耐受剂量 (MTD).
- 评估这些大麻素配方在患有帕金森病和疼痛的患者中的耐受性.
主要方法:
- 阶段1b,双盲,随机,单中心研究设计.
- 参与者接受了三种THC/CBD配方中的一种 (比例为18:0,10:10,1:20).
- 对每种配方的MTD,不良事件 (AE) 和耐受性的评估.
主要成果:
- 招募了8名参与者;MTD在不同组 (0.8-0.9毫升/天) 中一致.
- 没有报告严重不良事件 (AE) 或研究中断.
- 嗜睡和头是最常见的副作用;较高的CBD配方 (1:20) 与增加的嗜睡相关.
结论:
- 混合THC/CBD配方在患有疼痛的PD患者中表现出良好的耐受性和安全性.
- 没有观察到严重的不良事件,支持进一步调查.
- 未来的II期研究是有必要的,以探索疗效.
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