Oxford Centre for Enablement, Windmill Road, Oxford, OX3 7LD, UK.
Mult Scler. 2010 Jun;16(6):707-14. doi: 10.1177/1352458510367462.
To determine the efficacy of Sativex (USAN: nabiximols) in the alleviation of spasticity in people with multiple sclerosis.
The results from three randomized, placebo-controlled, double-blind parallel group studies were combined for analysis.
666 patients with multiple sclerosis and spasticity.
A 0-100 mm Visual Analogue Scale (VAS, transformed to a 0-10 scale) or a 0-10 Numerical Rating Scale (0-10 NRS) was used to measure spasticity. Patients achieving a > or =30% improvement from baseline in their spasticity score were defined as 'responders'. Global impression of change (GIC) at the end of treatment was also recorded.
The patient populations were similar. The adjusted mean change of the numerical rating scale from baseline in the treated group was -1.30 compared with -0.97 for placebo. Using a linear model, the treatment difference was -0.32 (95% CI -0.61, -0.04, p = 0.026). A statistically significant greater proportion of treated patients were responders (odds ratio (OR) = 1.62, 95% CI 1.15, 2.28; p = 0.0073) and treated patients also reported greater improvement: odds ratio 1.67 (95% CI 1.05, 2.65; p = 0.030). High numbers of subjects experienced at least one adverse event, but most were mild to moderate in severity and all drug-related serious adverse events resolved.
The meta-analysis demonstrates that nabiximols is well tolerated and reduces spasticity.
评估 Sativex（通用名：纳比昔醇）在缓解多发性硬化症患者痉挛中的疗效。
对三项随机、安慰剂对照、双盲平行组研究的结果进行合并分析。
666 例多发性硬化症伴痉挛患者。
使用 0-100mm 视觉模拟量表（VAS，转换为 0-10 分制）或 0-10 数字评分量表（0-10 NRS）测量痉挛程度。将痉挛评分较基线改善≥30%的患者定义为“应答者”。还记录治疗结束时的总体印象变化（GIC）。
患者人群相似。治疗组数字评分量表的平均基线变化较安慰剂组为-1.30，而安慰剂组为-0.97。采用线性模型，治疗差异为-0.32（95%CI-0.61，-0.04，p=0.026）。治疗组有更多的患者应答（比值比（OR）=1.62，95%CI 1.15，2.28；p=0.0073），且治疗组报告的改善程度更大：比值比 1.67（95%CI 1.05，2.65；p=0.030）。大量受试者至少经历了一次不良事件，但大多数不良事件为轻度至中度，所有与药物相关的严重不良事件均已解决。
荟萃分析表明，纳比昔醇具有良好的耐受性并能减轻痉挛。
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