Iskedjian Michael, Bereza Basil, Gordon Allan, Piwko Charles, Einarson Thomas R
PharmIdeas Research & Consulting Inc., Oakville, ON, Canada.
Curr Med Res Opin. 2007 Jan;23(1):17-24. doi: 10.1185/030079906x158066.
Debilitating pain, occurring in 50-70% of multiple sclerosis (MS) patients, is poorly understood and infrequently studied. We summarized efficacy and safety data of cannabinoid-based drugs for neuropathic pain.
Studies were identified from Medline, Embase, and Cochrane databases; Bayer Healthcare provided additional trials.
Accepted were randomized, double-blinded placebo-controlled trials of cannabinoid-based treatments for MS-related/neuropathic pain in adults > or = 18 years of age.
Two reviewers identified studies and extracted data; a third adjudicated disagreements. Data included baseline and endpoint pain scores on visual analog or 11-point ordinal scales.
Of 18 articles and three randomized controlled trial (RCT) reports identified, 12 articles and two reports were rejected (9 = inappropriate disease or outcome, 1 = duplicate, 1 = review, and 1 = abstract); six accepted articles and one RCT-report involved 298 patients (222 treated, 76 placebo); four examined Sativex (a cannabidiol/delta-9-tetrahydrocannabinol (THC) buccal spray) (observations = 196), five cannabidiol (n = 41), and three dronabinol (n = 91). Homogeneity chi(2) values were non-significant, allowing data combination. Analyses focused on baseline-endpoint score differences. The cannabidiol/THC buccal spray decreased pain 1.7 +/- 0.7 points (p = 0.018), cannabidiol 1.5 +/- 0.7 (p = 0.044), dronabinol 1.5 +/- 0.6 (p = 0.013), and all cannabinoids pooled together 1.6 +/- 0.4 (p < 0.001). Placebo baseline-endpoint scores did not differ (0.8 +/- 0.4 points, p = 0.023). At endpoint, cannabinoids were superior to placebo by 0.8 +/- 0.3 points (p = 0.029). Dizziness was the most commonly observed adverse event in the cannabidiol/THC buccal spray arms (39 +/- 16%), across all cannabinoid treatments (32.5 +/- 16%) as well as in the placebo arms (10 +/- 4%).
Cannabinoids including the cannabidiol/THC buccal spray are effective in treating neuropathic pain in MS.
This review was based on a small number of trials and patients. Pain related to MS was assumed to be similar to neuropathic pain.
50%-70%的多发性硬化症（MS）患者会出现使人衰弱的疼痛，对此了解甚少且很少进行研究。我们总结了基于大麻素的药物治疗神经性疼痛的疗效和安全性数据。
从Medline、Embase和Cochrane数据库中检索研究；拜耳医疗保健公司提供了其他试验。
纳入的是针对18岁及以上成年人MS相关/神经性疼痛进行的基于大麻素治疗的随机、双盲、安慰剂对照试验。
两名评审员确定研究并提取数据；第三名评审员裁决分歧。数据包括视觉模拟量表或11点序数量表上的基线和终点疼痛评分。
在确定的18篇文章和3份随机对照试验（RCT）报告中，12篇文章和2份报告被排除（9篇因疾病或结果不适用，1篇为重复研究，1篇为综述，1篇为摘要）；6篇纳入的文章和1份RCT报告涉及298名患者（222名接受治疗，76名接受安慰剂治疗）；4项研究考察了Sativex（一种大麻二酚/δ-9-四氢大麻酚（THC）口腔喷雾剂）（观察对象=196例），5项研究考察了大麻二酚（n=41），3项研究考察了屈大麻酚（n=91）。同质性卡方值无统计学意义，允许合并数据。分析重点为基线-终点评分差异。大麻二酚/THC口腔喷雾剂使疼痛减轻1.7±0.7分（p=0.018），大麻二酚为1.5±0.7分（p=0.044），屈大麻酚为1.5±0.6分（p=0.013），所有大麻素合并使用时为1.6±0.4分（p<0.001）。安慰剂的基线-终点评分无差异（0.8±0.4分，p=0.023）。在终点时，大麻素比安慰剂优0.8±0.3分（p=0.029）。头晕是大麻二酚/THC口腔喷雾剂组最常观察到的不良事件（39±16%），在所有大麻素治疗组中（32.5±16%）以及安慰剂组中（10±4%）均如此。
包括大麻二酚/THC口腔喷雾剂在内的大麻素对治疗MS中的神经性疼痛有效。
本综述基于少量试验和患者。假定与MS相关的疼痛与神经性疼痛相似。
