Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Efficacy, Safety, and Tolerability of THC:CBD Extract and THC Extract in Patients with Intractable Cancer-Related Pain
Multicenter, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study of the Efficacy, Safety, and Tolerability of THC:CBD Extract and THC Extract in Patients with Intractable Cancer-Related Pain
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DOI：
10.1016/j.jpainsymman.2009.06.008
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发表时间：
2010-02-01
影响因子：
4.7
通讯作者：
Fallon, Marie T.
中科院分区：
文献类型：
--
作者：
Johnson, Jeremy R.;Burnell-Nugent, Mary;Fallon, Marie T.
这项研究比较了四氢大麻酚-大麻二醇(THC：CBD)提取物，一种非阿片类止痛内源性大麻系统调节剂，以及THC提取物与安慰剂在缓解晚期癌症患者疼痛方面的效果。总共有177名癌症疼痛患者参加了为期两周的多中心、双盲、随机、安慰剂对照、平行组试验，这些患者尽管长期服用阿片类药物，但镇痛效果不佳。患者被随机分成三组：CBD提取物(n=60)、THC提取物(n=58)或安慰剂(n=59)。对平均疼痛数值等级(NRS)评分较基线的变化的初步分析在统计学上显著有利于THC：与安慰剂相比，CBD：CBD(改善-1.37比-0.69)，而THC组显示出不显著的变化(-1.01比-0.69)。服用THC的患者是对照组的两倍：与安慰剂相比，CBD显示基线疼痛NRS评分降低了30%以上(23[43%]比12[21%])。相关的优势比有统计学意义，而THC组应答者的数量与安慰剂相似(12[23%]对12[21%])，没有达到统计学意义。在治疗组中，阿片类药物背景药物的中位剂量或突破性药物的平均剂量与基线没有变化。在MRS睡眠质量或恶心评分或疼痛控制评估方面，两组之间没有发现显著差异。然而，来自欧洲癌症研究和治疗组织癌症质量调查问卷的结果显示，与安慰剂相比，服用THC：CBD的患者恶心和呕吐情况更严重(P=0.02)，而THC没有差异(P=1.0)。大多数与药物相关的不良事件严重程度为轻/中度。这项研究表明，THC：CBD提取物对强阿片类药物未能完全缓解的晚期癌症疼痛患者具有有效的止痛作用。J疼痛症状管理2010；39：167-179。(C)2010年美国癌症疼痛缓解委员会。爱思唯尔公司出版，版权所有。
This study compared the efficacy of a tetrahydrocannabinol:cannabidiol (THC:CBD) extract, a nonopioid analgesic endocannabinoid system modulator, and a THC extract, with placebo, in relieving pain in patients with advanced cancer. In, total, 177 patients with cancer pain, who experienced inadequate analgesia despite chronic opioid dosing, entered a two-week, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial. Patients were randomized to THC:CBD extract (n = 60), THC extract (n = 58), or placebo (n = 59). The primary analysis of change from baseline in mean pain Numerical Rating Scale (NRS) score was statistically significantly in favor of THC:CBD compared with placebo (improvement of -1.37 vs. -0.69), whereas the THC group showed a nonsignificant change (-1.01 vs. -0.69). Twice as many patients taking THC:CBD showed a reduction of more than 30% from baseline pain NRS score when compared with placebo (23 [43 %] vs. 12 [21%]). The associated odds ratio was statistically significant, whereas the number of THC group responders was similar to placebo (12 [23%] vs. 12 [21%]) and did not reach statistical significance. There was no change from baseline in median dose of opioid background medication or mean number of doses of breakthrough medication across treatment groups. No significant group differences were found in the MRS sleep quality or nausea scores or the pain control assessment. However; the results from the European Organisation for Research and Treatment of Cancer Quality of Life Cancer Questionnaire showed a worsening in nausea and vomiting with THC:CBD compared with placebo (P = 0.02), whereas THC had no difference (P = 1.0). Most drug-related adverse events were mild/moderate in severity. This study shows that THC:CBD extract is efficacious for relief of pain in patients with advanced cancer pain not fully relieved by strong opioids. J Pain Symptom Manage 2010;39:167-179. (C) 2010 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.