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萨替维克斯:用于治疗多发性硬化症症状和神经性疼痛的临床疗效及耐受性

Sativex: clinical efficacy and tolerability in the treatment of symptoms of multiple sclerosis and neuropathic pain.

作者信息

Barnes Michael Philip

机构信息

Hunters Moor Regional Neurological Rehabilitation Centre, Newcastle upon Tyne, NE2 4NR, UK.

出版信息

Expert Opin Pharmacother. 2006 Apr;7(5):607-15. doi: 10.1517/14656566.7.5.607.

DOI:10.1517/14656566.7.5.607
PMID:16553576
Abstract

Sativex is one of the first cannabis-based medicines to undergo conventional clinical development and to be approved as a prescription medicine. It is an oromucosal spray that allows flexible, individualised dosing. Patients self titrate their overall dose and pattern of dosing according to their response to and tolerance of the medicine. This usually results in the administration of approximately 8-12 sprays/day. Each spray delivers tetrahydrocannabinol 2.7 mg and cannabidiol 2.5 mg, giving an approximate average dose of tetrahydrocannabinol 22-32 mg/day and cannabidiol 20-30 mg/day. Development has concentrated on the treatment of symptoms of multiple sclerosis, notably spasticity and neuropathic pain, as well as the treatment of neuropathic pain of other aetiologies. Positive results in placebo-controlled trials of the use of Sativex as an add-on therapy in these indications demonstrate that Sativex is efficacious and well tolerated in the treatment of these symptoms. Sativex has been approved for use in neuropathic pain due to multiple sclerosis in Canada. If ongoing studies replicate the results already observed, further approvals for the treatment of spasticity in multiple sclerosis and for neuropathic pain are likely.

摘要

萨替维克斯是首批接受传统临床开发并被批准为处方药的大麻类药物之一。它是一种口腔黏膜喷雾剂,可实现灵活的个体化给药。患者根据对药物的反应和耐受性自行调整总体剂量和给药方式。这通常导致每天给药约8 - 12喷。每喷含有2.7毫克四氢大麻酚和2.5毫克大麻二酚,四氢大麻酚的平均日剂量约为22 - 32毫克,大麻二酚的平均日剂量约为20 - 30毫克。其研发主要集中在治疗多发性硬化症的症状,特别是痉挛和神经性疼痛,以及治疗其他病因引起的神经性疼痛。在这些适应症中,将萨替维克斯作为附加疗法使用的安慰剂对照试验取得了积极结果,表明萨替维克斯在治疗这些症状方面有效且耐受性良好。萨替维克斯已在加拿大被批准用于治疗多发性硬化症引起的神经性疼痛。如果正在进行的研究重复已观察到的结果,那么它很可能会进一步获批用于治疗多发性硬化症的痉挛和神经性疼痛。

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