Patti Francesco, Chisari Clara Grazia, Solaro Claudio, Benedetti Maria Donata, Berra Eliana, Bianco Assunta, Bruno Bossio Roberto, Buttari Fabio, Castelli Letizia, Cavalla Paola, Cerqua Raffaella, Costantino Gianfranco, Gasperini Claudio, Guareschi Angelica, Ippolito Domenico, Lanzillo Roberta, Maniscalco Giorgia Teresa, Matta Manuela, Paolicelli Damiano, Petrucci Loredana, Pontecorvo Simona, Righini Isabella, Russo Margherita, Saccà Francesco, Salamone Giovanna, Signoriello Elisabetta, Spinicci Gabriella, Spitaleri Daniele, Tavazzi Eleonora, Trotta Maria, Zaffaroni Mauro, Zappia Mario
Department "G.F. Ingrassia", section of Neurosciences, University of Catania, Catania, Italy.
Department of Neurology, ASL3 Genovese, and Department of Rehabilitation, ML Novarese Hospital Moncrivello, Genoa, Italy.
Neurol Sci. 2020 Oct;41(10):2905-2913. doi: 10.1007/s10072-020-04413-6. Epub 2020 Apr 25.
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.
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.
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.
Our study confirmed that the therapeutic benefit of cannabinoids may extend beyond spasticity, improving spasticity-related symptoms even in non-NRS responder patients.
9-δ-四氢大麻酚（THC）+大麻二酚（CBD）口腔黏膜喷雾剂（Sativex®）在意大利获批作为附加药物用于治疗多发性硬化症（MS）中的中度至重度痉挛，这为患有耐药性痉挛的MS患者提供了新的机会。我们旨在调查在日常临床实践中，一大群中度至重度痉挛患者的MS痉挛相关症状的改善情况。
从30个意大利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治疗条件：年龄≥18岁，至少为中度痉挛（MS痉挛数字评定量表[NRS]评分≥4）且对常用抗痉挛药物无反应。患者在基线（T0）和治疗4周后（T1）用痉挛NRS量表进行评估，并被询问6种关键痉挛相关症状是否有有意义的改善。
在1615名登记患者中，1432名患者完成了第一个月的试验期（T1）。其中，1010名患者（70.5%）与基线相比NRS评分降低≥20%（初始反应者；IR）。我们发现627名患者（1432名中的43.8%%）至少一种痉挛相关症状有所改善（SRSr组），其中543名（86.6%）属于IR组，84名（13.4%）属于痉挛NRS无反应者组。
我们的研究证实，大麻素的治疗益处可能不仅限于痉挛，即使在NRS无反应者中也能改善痉挛相关症状。
