Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis
Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis
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DOI：
10.1212/01.wnl.0000176753.45410.8b
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发表时间：
2005-09-27
期刊：
影响因子：
9.9
通讯作者：
Young, CA
中科院分区：
文献类型：
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作者：
Rog, DJ;Nurmikko, TJ;Young, CA
背景：多发性硬化症(MS)的中枢性疼痛是常见的，且往往难以治疗。方法：我们进行了一项单中心、为期5周(1周磨合、4周治疗)、随机、双盲、安慰剂对照、平行组的试验，66例MS患者中枢性疼痛状态(59例感觉障碍，7例疼痛痉挛)患者服用了一种全植物大麻类药物(CBM)，其中含有Delta9-四氢大麻酚：大麻二醇(THC：CBD)，作为辅助止痛治疗。每一次喷雾提供2.7毫克THC和2.5毫克CBD，患者可以在24小时内逐渐自我滴定到最多48次喷雾。结果：64例患者(97%)完成试验，34例接受CBM治疗。在第4周，CBM组(n=32)和安慰剂组(n=31)的平均每日喷雾量分别为9.6次(2~25次，SD=6.0)和19.1次(1~47次，SD=12.9)。每天记录疼痛和睡眠障碍，用11分数字评分表进行评分。CBM在降低平均疼痛强度(CBM平均变化-2.795%CI：-3.4%~-2.0，安慰剂-1.495%CI：-2.0%~-0.8P=0.005)和睡眠障碍(CBM平均变化-2.5%CI：-3.4%~-1.7%安慰剂-0.895%CI：-1.5%~-0.1P=0.003)方面优于安慰剂。CBM总体耐受性良好，尽管服用CBM的患者比服用安慰剂的患者更多地报告头晕、口干和嗜睡。认知副作用仅限于长期记忆存储。结论：大麻类药物能有效减轻多发性硬化症相关中枢神经性疼痛患者的疼痛和睡眠障碍，且耐受性良好。
Background: Central pain in multiple sclerosis (MS) is common and often refractory to treatment. Methods: We conducted a single-center, 5-week (1-week run-in, 4-week treatment), randomized, double-blind, placebo-controlled, parallel-group trial in 66 patients with MS and central pain states (59 dysesthetic, seven painful spasms) of a whole-plant cannabis-based medicine (CBM), containing delta-9-tetrahydrocannabinol:cannabidiol (THC:CBD) delivered via an oromucosal spray, as adjunctive analgesic treatment. Each spray delivered 2.7 mg of THC and 2.5 of CBD, and patients could gradually self-titrate to a maximum of 48 sprays in 24 hours. Results: Sixty-four patients (97%) completed the trial, 34 received CBM. In week 4, the mean number of daily sprays taken of CBM (n = 32) was 9.6 (range 2 to 25, SD = 6.0) and of placebo (n = 31) was 19.1 (range 1 to 47, SD = 12.9). Pain and sleep disturbance were recorded daily on an 11-point numerical rating scale. CBM was superior to placebo in reducing the mean intensity of pain (CBM mean change -2.7, 95% CI: -3.4 to -2.0, placebo -1.4 95% CI: -2.0 to -0.8, comparison between groups, p = 0.005) and sleep disturbance (CBM mean change -2.5, 95% CI: -3.4 to -1.7, placebo -0.8, 95% CI: -1.5 to -0.1, comparison between groups, p = 0.003). CBM was generally well tolerated, although more patients on CBM than placebo reported dizziness, dry mouth, and somnolence. Cognitive side effects were limited to long-term memory storage. Conclusions: Cannabis-based medicine is effective in reducing pain and sleep disturbance in patients with multiple sclerosis related central neuropathic pain and is mostly well tolerated.