Hansen Julie Schjødtz, Hansen Rikke Middelhede, Petersen Thor, Gustavsen Stefan, Oturai Annette Bang, Sellebjerg Finn, Sædder Eva Aggerholm, Kasch Helge, Rasmussen Peter Vestergaard, Finnerup Nanna Brix, Svendsen Kristina Bacher
Department of Neurology, Aarhus University Hospital, DK-8200 Aarhus N, Denmark.
Department of Clinical Medicine, Aarhus University, DK-8200 Aarhus N, Denmark.
Brain Sci. 2021 Sep 14;11(9):1212. doi: 10.3390/brainsci11091212.
Disease or acquired damage to the central nervous system frequently causes disabling spasticity and central neuropathic pain (NP), both of which are frequent in multiple sclerosis (MS) and spinal cord injury (SCI). Patients with MS and SCI often request treatment with cannabis-based medicine (CBM). However, knowledge about effects, side effects, choice of active cannabinoids (Δ9-tetrahydrocannabinol (THC), cannabidiol (CBD) alone or in combination), and doses of CBM remains limited. Using a double-blind, parallel design in a national multicenter cohort, this study examines the effect of CBM on spasticity and NP. Patients are randomized to treatment with capsules containing either THC, CBD, THC and CBD, or placebo. Primary endpoints are patient-reported pain and spasticity on a numerical rating scale. Other endpoints include quality of life and sleep, depression and anxiety, and relief of pain and spasticity. Side-effects of CBM are described. In a sub-study, the pharmacodynamics (PD) and pharmacokinetics (PK) of oral capsule CBM are examined. We expect that the study will contribute to the literature by providing information on the effects and side-effects of CBD, THC, and the combination of the two for central neuropathic pain and spasticity. Furthermore, we will describe the PD/PK of THC and CBD in a patient population.
中枢神经系统疾病或后天损伤常导致致残性痉挛和中枢神经性疼痛（NP），这两种情况在多发性硬化症（MS）和脊髓损伤（SCI）中都很常见。MS和SCI患者常要求使用大麻素类药物（CBM）进行治疗。然而，关于CBM的疗效、副作用、活性大麻素（Δ9-四氢大麻酚（THC）、大麻二酚（CBD）单独或联合使用）的选择以及剂量的知识仍然有限。本研究在一项全国多中心队列研究中采用双盲、平行设计，考察CBM对痉挛和NP的影响。患者被随机分配接受含有THC、CBD、THC和CBD或安慰剂的胶囊治疗。主要终点是患者在数字评分量表上报告的疼痛和痉挛情况。其他终点包括生活质量和睡眠、抑郁和焦虑以及疼痛和痉挛的缓解情况。描述了CBM的副作用。在一项子研究中，考察了口服胶囊CBM的药效学（PD）和药代动力学（PK）。我们预计该研究将通过提供关于CBD、THC以及两者联合用于中枢神经性疼痛和痉挛的疗效和副作用的信息，为相关文献做出贡献。此外，我们将描述THC和CBD在患者群体中的PD/PK情况。
