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纳曲酮口腔黏膜喷雾剂用于治疗多发性硬化相关痉挛:过去十年临床评估综述

Sativex in the management of multiple sclerosis-related spasticity: An overview of the last decade of clinical evaluation.

作者信息

Giacoppo Sabrina, Bramanti Placido, Mazzon Emanuela

机构信息

IRCCS Centro Neurolesi "Bonino-Pulejo", Via Provinciale Palermo, Contrada Casazza, 98124 Messina, Italy.

出版信息

Mult Scler Relat Disord. 2017 Oct;17:22-31. doi: 10.1016/j.msard.2017.06.015. Epub 2017 Jun 27.

Abstract

BACKGROUND

Spasticity is a common symptom of multiple sclerosis (MS) affecting about 80% of MS patients. Numerous lines of evidence suggest that spasticity due to its complexity is not adequately managed with conventional anti-spastic therapies. Therefore, in order to improve the outcomes for the majority of MS patients, alternative approaches are needed to be discovered. Over the last years, the use of cannabinoid compounds as a potential treatment for MS-related symptoms has aroused great interest, owing to encouraging preclinical and clinical studies. To date, Sativex, an oromucosal spray containing tetrahydrocannabinol and cannabidiol in approximately 1:1 ratio, is the only commercially available formulation containing cannabinoids used as add-on therapy for treatment of spasticity in adult MS patients who are not responding to conventional antispastic therapies.

METHODS

Here, by performing a literature search, we provided an overview of the last decade of clinical evaluations as well as post-marketing studies about effectiveness and safety of Sativex in the management of MS-related spasticity.

RESULTS

Sativex was proven effective in treating spasticity and also in improving the patient's quality of life. In addition, a low incidence of adverse reactions Sativex-related supports the good safety profile and its tolerability.

CONCLUSION

This review by recognizing the clinical effectiveness of Sativex in spasticity management, opened a new opportunity for many patients with spasticity resistant to common antispastic drugs.

摘要

背景

痉挛是多发性硬化症(MS)的常见症状,约80%的MS患者受其影响。大量证据表明,由于痉挛的复杂性,传统的抗痉挛疗法无法对其进行充分治疗。因此,为了改善大多数MS患者的治疗效果,需要探索替代方法。在过去几年中,由于临床前和临床研究结果令人鼓舞,大麻素化合物作为MS相关症状的潜在治疗方法引起了极大关注。迄今为止,Sativex是一种口腔黏膜喷雾剂,含有四氢大麻酚和大麻二酚,比例约为1:1,是唯一一种可商购的含大麻素制剂,用作对传统抗痉挛疗法无反应的成年MS患者痉挛治疗的附加疗法。

方法

在此,通过进行文献检索,我们概述了过去十年中关于Sativex治疗MS相关痉挛的有效性和安全性的临床评估以及上市后研究。

结果

Sativex被证明对治疗痉挛有效,还能改善患者生活质量。此外,与Sativex相关的不良反应发生率较低,这支持了其良好的安全性和耐受性。

结论

本综述认可了Sativex在痉挛管理方面的临床有效性,为许多对常见抗痉挛药物耐药的痉挛患者带来了新的契机。

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