Department of Neurological Rehabilitation, Oxford Centre for Enablement, Oxford, England.
Expert Rev Neurother. 2012 Apr;12(4 Suppl):9-14. doi: 10.1586/ern.12.12.
The adoption of new drug therapies involves an assessment of risk:benefit based upon the best clinical evidence, including clinical trials but also everyday clinical practice data collection. However, in the case of Sativex, a cannabinoid medicine containing the two main active ingredients of cannabis, δ-9-tetrahydrocannabinol and cannabidiol, the picture is somewhat clouded by preconceived views regarding the world's most widely used illicit drug, herbal cannabis. In this review, I aim to look beyond these preconceptions and evaluate the body of published data concerning this medicine currently approved in different countries for the management of one of the most frequent and disabling symptoms associated with multiple sclerosis, spasticity. In particular, data relevant to areas of concern such as tolerability, safety, psychoactivity, effects on withdrawal (including possible drug tolerance) and finally the potential for abuse/dependence are evaluated. Balancing these risk factors, the main positive clinical data published over the years by the Oxford Centre for Enablement, following on from the first pilot study in 2004, are presented. Based upon our experience, the benefits that are seen initially with Sativex when treating multiple sclerosis spasticity patients are generally maintained during long-term treatment. Furthermore, following withdrawal of Sativex, symptoms often return, but, beyond this, sudden cessation is generally safe with no evidence of physiological or psychological dependence. Dose escalation has not usually been observed in clinical trials or clinical practice after the first titration weeks. Adverse effects occur relatively frequently, but they are usually mild to moderate in intensity and rarely require drug discontinuation. Overall, Sativex appears to be well-tolerated and a useful addition for patients who have failed treatment with traditional antispastic agents.
基于最佳临床证据，包括临床试验，但也包括日常临床实践数据收集。然而，对于含有大麻两种主要活性成分的大麻素药物 Sativex（含δ-9-四氢大麻酚和大麻二酚），由于对世界上使用最广泛的非法药物大麻的先入为主的看法，情况有些复杂。在这篇综述中，我旨在超越这些先入之见，评估目前在不同国家批准用于治疗多发性硬化症最常见和最致残症状之一痉挛的这种药物的已发表数据。特别是，评估了与可耐受性、安全性、精神活性、戒断影响（包括可能的药物耐受性）以及最终滥用/依赖潜力等相关领域的数据。平衡这些风险因素，呈现了牛津功能增强中心多年来发表的主要积极临床数据，这些数据是在 2004 年的首次试点研究之后进行的。根据我们的经验，在治疗多发性硬化症痉挛患者时，Sativex 最初显示的益处通常在长期治疗中得到维持。此外，停用 Sativex 后，症状通常会恢复，但除此之外，突然停药通常是安全的，没有生理或心理依赖的证据。在首次滴定周后的临床试验或临床实践中，通常不会观察到剂量递增。不良反应相对频繁发生，但通常为轻度至中度，很少需要停药。总体而言，Sativex 耐受性良好，对于那些传统抗痉挛药物治疗失败的患者来说是一种有用的选择。
