Serpell M, Ratcliffe S, Hovorka J, Schofield M, Taylor L, Lauder H, Ehler E
Pain Clinic Office, Gartnavel General Hospital, University of Glasgow, UK.
Eur J Pain. 2014 Aug;18(7):999-1012. doi: 10.1002/j.1532-2149.2013.00445.x. Epub 2014 Jan 13.
Peripheral neuropathic pain (PNP) associated with allodynia poses a significant clinical challenge. The efficacy of Δ(9) -tetrahydrocannabinol/cannabidiol (THC/CBD) oromucosal spray, a novel cannabinoid formulation, was investigated in this 15-week randomized, double-blind, placebo-controlled parallel group study.
In total, 303 patients with PNP associated with allodynia were screened; 128 were randomized to THC/CBD spray and 118 to placebo, in addition to their current analgesic therapy. The co-primary efficacy endpoints were the 30% responder rate in PNP 0-10 numerical rating scale (NRS) score and the mean change from baseline to the end of treatment in this score. Various key secondary measures of pain and functioning were also investigated.
At the 30% responder level, there were statistically significant treatment differences in favour of THC/CBD spray in the full analysis (intention-to-treat) dataset [p = 0.034; 95% confidence interval (CI): 1.05-3.70]. There was also a reduction in mean PNP 0-10 NRS scores in both treatment groups that was numerically higher in the THC/CBD spray group, but which failed to reach statistical significance. Secondary measures of sleep quality 0-10 NRS score (p = 0.0072) and Subject Global Impression of Change (SGIC) (p = 0.023) also demonstrated statistically significant treatment differences in favour of THC/CBD spray treatment.
These findings demonstrate that, in a meaningful proportion of otherwise treatment-resistant patients, clinically important improvements in pain, sleep quality and SGIC of the severity of their condition are obtained with THC/CBD spray. THC/CBD spray was well tolerated and no new safety concerns were identified.
伴有痛觉过敏的外周神经性疼痛（PNP）带来了重大的临床挑战。在这项为期15周的随机、双盲、安慰剂对照平行组研究中，对一种新型大麻素制剂Δ(9) -四氢大麻酚/大麻二酚（THC/CBD）口腔黏膜喷雾剂的疗效进行了研究。
总共筛选了303例伴有痛觉过敏的PNP患者；除了当前的镇痛治疗外，128例患者被随机分配接受THC/CBD喷雾剂治疗，118例患者接受安慰剂治疗。共同主要疗效终点为PNP 0 - 10数字评分量表（NRS）评分的30%缓解率以及该评分从基线到治疗结束的平均变化。还研究了疼痛和功能的各种关键次要指标。
在30%缓解水平上，在全分析（意向性分析）数据集中，有利于THC/CBD喷雾剂的治疗差异具有统计学意义[p = 0.034；95%置信区间（CI）：1.05 - 3.70]。两个治疗组的PNP 0 - 10 NRS平均评分均有所降低，THC/CBD喷雾剂组在数值上更高，但未达到统计学意义。睡眠质量0 - 10 NRS评分（p = 0.0072）和患者整体变化印象（SGIC）（p = 0.023）的次要指标也显示出有利于THC/CBD喷雾剂治疗的统计学显著差异。
这些发现表明，在相当一部分原本对治疗耐药的患者中，THC/CBD喷雾剂可使疼痛、睡眠质量以及病情严重程度的SGIC得到临床上重要的改善。THC/CBD喷雾剂耐受性良好，未发现新的安全问题。
