INTRODUCTION The approval of 9-δ-tetrahydocannabinol (THC)+cannabidiol (CBD) oromucosal spray (Sativex®) in Italy as an add-on medication for the management of moderate to severe spasticity in multiple sclerosis (MS) has provided a new opportunity for MS patients with drug-resistant spasticity. We aimed to investigate the improvement of MS spasticity-related symptoms in a large cohort of patients with moderate to severe spasticity in daily clinical practice. MATERIALS AND METHODS MS patients with drug-resistant spasticity were recruited from 30 Italian MS centers. All patients were eligible for THC:CBD treatment according to the approved label: ≥ 18 years of age, at least moderate spasticity (MS spasticity numerical rating scale [NRS] score ≥ 4) and not responding to the common antispastic drugs. Patients were evaluated at baseline (T0) and after 4 weeks of treatment (T1) with the spasticity NRS scale and were also asked about meaningful improvements in 6 key spasticity-related symptoms. RESULTS Out of 1615 enrolled patients, 1432 reached the end of the first month trial period (T1). Of these, 1010 patients (70.5%) reached a ≥ 20% NRS score reduction compared with baseline (initial responders; IR). We found that 627 (43.8% of 1432) patients showed an improvement in at least one spasticity-related symptom (SRSr group), 543 (86.6%) of them belonging to the IR group and 84 (13.4%) to the spasticity NRS non-responders group. CONCLUSION Our study confirmed that the therapeutic benefit of cannabinoids may extend beyond spasticity, improving spasticity-related symptoms even in non-NRS responder patients.

中文翻译：

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THC / CBD口腔粘膜喷雾剂对多发性硬化症患者痉挛相关症状的影响：一项回顾性多中心研究的结果。

简介在意大利批准9-δ-四氢大麻酚（THC）+卡纳比多醇（CBD）口腔粘膜喷雾剂（Sativex®）作为用于治疗多发性硬化症（MS）中度至严重痉挛的附加药物适用于患有耐药性痉挛的MS患者。我们的目的是在日常临床实践中研究大量中度至严重痉挛患者的MS痉挛相关症状的改善。材料与方法从意大利30个MS中心招募患有耐药性痉挛的MS患者。根据批准的标签，所有患者均符合THC：CBD的治疗条件：年龄≥18岁，至少为中度痉挛（MS痉挛数字等级量表[NRS]得分≥4）且对常用的抗痉挛药物无反应。使用痉挛性NRS量表在基线（T0）和治疗4周（T1）后对患者进行评估，并询问患者在6种主要痉挛相关症状方面的有意义的改善。结果在1615名患者中，有1432名患者在第一个月试验期（T1）结束。其中，有1010名患者（70.5％）的NRS得分较基线水平降低了20％以上（初始应答者； IR）。我们发现627名患者（1432名中的43.8％）显示出至少一种痉挛相关症状（SRSr组）有所改善，其中543名（86.6％）属于IR组，而84名（13.4％）属于非痉挛性NRS。 -响应者组。结论我们的研究证实，即使在非NRS反应患者中，大麻素的治疗益处也可能超出痉挛，改善痉挛相关症状。