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Δ9-四氢大麻酚/大麻二酚口腔喷雾剂(Sativex):用于多发性硬化相关痉挛的综述。

Delta-9-Tetrahydrocannabinol/Cannabidiol Oromucosal Spray (Sativex): A Review in Multiple Sclerosis-Related Spasticity.

机构信息

Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand.

出版信息

Drugs. 2017 Apr;77(5):563-574. doi: 10.1007/s40265-017-0720-6.

Abstract

Delta-9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (THC/CBD, Sativex, nabiximols) is available in numerous countries worldwide for the treatment of multiple sclerosis (MS)-related moderate to severe spasticity in patients who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity-related symptoms during an initial trial of therapy. Twelve weeks' therapy with THC/CBD improved MS-related spasticity in patients with an inadequate response to other anti-spasticity agents who had undergone a successful initial trial of THC/CBD therapy, according to the results of a pivotal phase 3 trial. Improvements in spasticity were maintained in the longer term with THC/CBD with no evidence of dose tolerance, and results of real-world studies confirm the effectiveness of THC/CBD in everyday clinical practice. Improvements in health-related quality of life and activities of daily living were also seen with THC/CBD. THC/CBD is generally well tolerated; adverse effects such as dizziness may occur whilst the THC/CBD dosage is being optimized. THC/CBD has low abuse potential and a low risk of psychoactive effects. In conclusion, THC/CBD oromucosal spray is a useful option for the treatment of MS-related spasticity not completely relieved with current anti-spasticity medication.

摘要

Delta-9-四氢大麻酚(THC)/大麻二酚(CBD)口腔黏膜喷雾剂(THC/CBD,Sativex,那比西醇)在全球许多国家都可用于治疗多发性硬化症(MS)相关的中度至重度痉挛,适用于对其他抗痉挛药物反应不足且在初始治疗试验中痉挛相关症状有临床显著改善的患者。一项关键的 3 期试验结果显示,对于对其他抗痉挛药物反应不足且成功进行初始 THC/CBD 治疗试验的患者,12 周的 THC/CBD 治疗可改善 MS 相关痉挛。随着 THC/CBD 的使用,痉挛的改善在长期内得以维持,且无剂量耐受的证据,真实世界研究的结果证实了 THC/CBD 在日常临床实践中的有效性。THC/CBD 还可改善与健康相关的生活质量和日常生活活动能力。THC/CBD 通常具有良好的耐受性;在优化 THC/CBD 剂量时可能会出现头晕等不良反应。THC/CBD 滥用潜力低,且产生精神活性作用的风险低。总之,THC/CBD 口腔黏膜喷雾剂是治疗目前抗痉挛药物未能完全缓解的 MS 相关痉挛的一种有效选择。

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