Ferrè Laura, Nuara Arturo, Pavan Giulia, Radaelli Marta, Moiola Lucia, Rodegher Mariaemma, Colombo Bruno, Keller Sarmiento Ignacio Juan, Martinelli Vittorio, Leocani Letizia, Martinelli Boneschi Filippo, Comi Giancarlo, Esposito Federica
Department of Neurology, San Raffaele Scientific Institute, Via Olgettina 48, 20132, Milan, Italy.
Laboratory of Genetics of Complex Neurological Disorders, Institute of Experimental Neurology (INSPE), Division of Neuroscience, San Raffaele Scientific Institute, Milan, Italy.
Neurol Sci. 2016 Feb;37(2):235-42. doi: 10.1007/s10072-015-2392-x. Epub 2015 Oct 16.
Multiple sclerosis (MS) patients frequently suffer from limb spasticity and pain despite antispastic treatments. To investigate nabiximols efficacy and safety in a real-world monocentric Italian cohort, the following data were collected at baseline, week 4, 14 and 48: Ambulation Index (AI), 10-min walking test (10MWT), combined Modified Ashworth scale (cMAS), scores at numerical rating scale for spasticity (sNRS) and pain (pNRS). Responder status was defined as a ≥20 % reduction in sNRS after 4 weeks of treatment. 144 MS patients (123 progressive and 21 relapsing-remitting) complaining of moderate-to-severe spasticity (mean sNRS: 7.5) were included: 138 (95.8 %) completed the first month of therapy and were classified as follows-23.2 % were non-responders, 5.1 % were responders but discontinued treatment due to side effects, 71.7 % were responders with a mean 32 % reduction in sNRS (p < 0.001). In responders sNRS further decreased between 4 and 14 weeks (p = 0.03). Similarly, pNRS improvement was seen during the first month and between 4 and 14 weeks (p < 0.001 and p = 0.004, respectively). Moreover, at 4 weeks responders showed a significant (p < 0.05) improvement in cMAS, AI and 10MWT, which was maintained at 14 weeks. At 1-year follow-up, a benefit was still evident on spasticity and painful symptoms with a low drop-out rate. Confusion/ideomotor slowing, fatigue and dizziness were the most frequent side effects; no major adverse events were reported. Shorter disease duration at treatment start was associated with better response. This real-world study confirms nabiximols efficacy and safety in the treatment of MS-related spasticity and pain, which is maintained up to 48 weeks.
尽管进行了抗痉挛治疗，但多发性硬化症（MS）患者仍经常遭受肢体痉挛和疼痛。为了调查纳比西莫尔在意大利一个真实世界单中心队列中的疗效和安全性，在基线、第4周、第14周和第48周收集了以下数据：步行指数（AI）、10分钟步行试验（10MWT）、联合改良Ashworth量表（cMAS）、痉挛数字评定量表（sNRS）和疼痛数字评定量表（pNRS）的评分。缓解状态定义为治疗4周后sNRS降低≥20%。纳入了144例抱怨中度至重度痉挛（平均sNRS：7.5）的MS患者（123例进展型和21例复发缓解型）：138例（95.8%）完成了第一个月的治疗，并分类如下：23.2%为无反应者，5.1%为有反应者但因副作用停药，71.7%为有反应者，sNRS平均降低32%（p<0.001）。在有反应者中，sNRS在4至14周之间进一步下降（p = 0.03）。同样，在第一个月以及4至14周期间观察到pNRS改善（分别为p<0.001和p = 0.004）。此外，在第4周时，有反应者在cMAS、AI和10MWT方面有显著（p<0.05）改善，并在第14周时维持。在1年随访时，痉挛和疼痛症状仍有明显益处，脱落率较低。意识模糊/观念运动迟缓、疲劳和头晕是最常见的副作用；未报告重大不良事件。治疗开始时病程较短与反应较好相关。这项真实世界研究证实了纳比西莫尔在治疗MS相关痉挛和疼痛方面的疗效和安全性，这种疗效和安全性可持续至48周。
