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基于大麻的药物治疗神经病痛和 - 一个多中心,随机,双盲,安慰剂控制的试验

Julie Schjødtz Hansen^1,2, Stefan Gustavsen³, Homayoun Roshanisefat⁴

¹Department of Neurology, Aarhus University Hospital (AUH), 8200 Aarhus, Denmark.

Pharmaceuticals (Basel, Switzerland)

|August 26, 2023

概括

这项研究发现,在患有多发性硬化或脊髓损伤的患者中,大麻制药 (CBM) 和安慰剂之间的疼痛或性减轻没有显著差异. 需要进一步的研究来探索CBM对神经病痛和的潜在益处.

科学领域:

神经学神经学
药理学药理学是指药理学的学科.
临床试验临床试验

背景情况:

中枢神经病痛 (NP) 和是多发性硬化症 (MS) 和脊髓损伤 (SCI) 中常见的衰弱症状.
基于大麻的药物 (CBM) 已被事建议用于管理这些症状,但强有力的临床证据是有限的.

研究的目的:

研究CBM的疗效,包括单独或组合使用的delta-9-tetrahydrocannabinol (THC) 和cannabidiol (CBD),作为MS和SCI患者NP和的补充治疗.
为了比较THC,CBD,THC&CBD和安慰剂对患者报告的疼痛和性强度的影响.

主要方法:

一项随机,双盲,安慰剂对照试验,涉及134名18岁或以上的中度至重度NP和/或性患者 (119名MS,15名SCI).
参与者每天服用THC (最大22.5毫克),CBD (最大45毫克),THC和CBD (最大22.5/45毫克) 或安慰剂,持续6周.
主要终点包括患者报告的NP变化和在数值评分尺度 (NRS0-10) 上测量的性强度.

主要成果:

在THC,CBD,THC和CBD组和安慰剂组之间的疼痛强度平均减少方面,没有观察到统计学上显著的差异.
同样,与安慰剂相比,在所有治疗手臂中,对性强度的平均减少没有发现显著差异.
二级和三级结局,包括患者对变化和生活质量的总体印象,也没有显示CBM治疗显著改善.

结论:

这项试验表明,与安慰剂相比,CBM (THC,CBD或组合) 在缓解MS或SCI患者的神经病痛或性方面没有显著的影响.
尽管招募挑战影响了计划的样本大小,但结果表明,在测试剂量下,CBM可能不是针对这些特定疾病的有效补充治疗.
对不同CBM配方,剂量或患者群体的进一步调查可能是有必要的,但目前的证据不支持其用于MS/SCI中的NP和性.

关键词:

大麻二醇 (CBD) 的使用.基于大麻的药物 (CBM)德尔塔-9-四化甘醇 (THC) 是一种多化甘醇.神经病痛 (NP) 是一种神经病痛.性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性,性等.

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