MS Center Sant'Andrea Hospital, Sapienza University of Rome, Rome, Italy.
Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.
PLoS One. 2019 Jul 30;14(7):e0219670. doi: 10.1371/journal.pone.0219670. eCollection 2019.
Nabiximols (THC/CBD Oromucosal Spray, Sativex) is used as an add-on therapy to treat moderate to severe spasticity of Multiple Sclerosis (MS).
To examine the impact of physiotherapy (PT) programs on effectiveness and persistence of nabiximols treatment in people with MS-related spasticity.
This is an observational multicenter study with a follow-up period of 12 weeks, conducted in routine care settings in Italy. Patients with moderate to severe MS-related spasticity who started nabiximols were included. Spasticity was evaluated by the patient-rated 0-10 numerical rating scale (NRS). Clinical data were collected at baseline (T0), 4 weeks (T1) and 12 weeks (T2) months after enrollment.
A total of 297 MS patients were selected, 290 completed the 3 months follow-up period. Mean NRS scores were 7.6 ± 1.1 at T0, 5.8 ± 1.4 at T1 and 5.5 ± 1.5 at T2. At T1, 77% of patients reached ≥20% improvement (initial response, IR); 22% reached ≥30% improvement (clinically relevant response, CRR). At T1, patients undergoing PT had a higher probability to reach CRR (Odds Ratio = 2.6 95% CI 1.3-5.6, p = 0.01). Nabiximols was discontinued in 30/290 (10.3%) patients at T1 (early discontinuers) and in 71/290 (24.5%) patients at T2 (late discontinuers). The probability of being late discontinuers was reduced in patients undergoing PT (Hazard Ratio = 0.41; 95% CI 0.23-0.69, p = 0.001).
Our real-life study confirms nabiximols' effectiveness in MS-related spasticity and suggests that the association of a PT program may improve overall response and persistence to nabiximols treatment.
纳比西莫司（THC/CBD 口腔喷雾剂，Sativex）被用作治疗多发性硬化症（MS）中度至重度痉挛的附加疗法。
研究物理治疗（PT）方案对纳比西莫司治疗 MS 相关痉挛患者的疗效和持久性的影响。
这是一项在意大利常规护理环境中进行的观察性多中心研究，随访期为 12 周。纳入了开始接受纳比西莫司治疗的中重度 MS 相关痉挛患者。患者的痉挛程度通过患者自评的 0-10 数字评分量表（NRS）进行评估。临床数据在入组时（T0）、4 周（T1）和 12 周（T2）后收集。
共纳入 297 例 MS 患者，290 例完成了 3 个月的随访期。T0 时 NRS 评分均值为 7.6 ± 1.1，T1 时为 5.8 ± 1.4，T2 时为 5.5 ± 1.5。T1 时，77%的患者达到了≥20%的改善（初始反应，IR）；22%的患者达到了≥30%的改善（临床相关反应，CRR）。T1 时，接受 PT 的患者更有可能达到 CRR（优势比=2.6，95%置信区间 1.3-5.6，p=0.01）。纳比西莫司在 T1 时被 30/290（10.3%）例患者停用（早期停药者），在 T2 时被 71/290（24.5%）例患者停用（晚期停药者）。接受 PT 的患者晚期停药的概率降低（风险比=0.41；95%置信区间 0.23-0.69，p=0.001）。
我们的真实世界研究证实了纳比西莫司在 MS 相关痉挛中的疗效，并表明与 PT 方案联合应用可能会提高纳比西莫司治疗的总体反应和持久性。
