CONTEXT:Chronic pain in patients with advanced cancer poses a serious clinical challenge. The Δ9-tetrahydrocannabinol (THC)/cannabidiol (CBD) oromucosal spray (U.S. Adopted Name, nabiximols; Sativex(®)) is a novel cannabinoid formulation currently undergoing investigation as an adjuvant therapy for this treatment group. OBJECTIVES:This follow-up study investigated the long-term safety and tolerability of THC/CBD spray and THC spray in relieving pain in patients with advanced cancer. METHODS:In total, 43 patients with cancer-related pain experiencing inadequate analgesia despite chronic opioid dosing, who had participated in a previous three-arm (THC/CBD spray, THC spray, or placebo), two-week parent randomized controlled trial, entered this open-label, multicenter, follow-up study. Patients self-titrated THC/CBD spray (n=39) or THC spray (n=4) to symptom relief or maximum dose and were regularly reviewed for safety, tolerability, and evidence of clinical benefit. RESULTS:The efficacy end point of change from baseline in mean Brief Pain Inventory-Short Form scores for "pain severity" and "worst pain" domains showed a decrease (i.e., improvement) at each visit in the THC/CBD spray patients. Similarly, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 scores showed a decrease (i.e., improvement) from baseline in the domains of insomnia, pain, and fatigue. No new safety concerns associated with the extended use of THC/CBD spray arose from this study. CONCLUSION:This study showed that the long-term use of THC/CBD spray was generally well tolerated, with no evidence of a loss of effect for the relief of cancer-related pain with long-term use. Furthermore, patients who kept using the study medication did not seek to increase their dose of this or other pain-relieving medication over time, suggesting that the adjuvant use of cannabinoids in cancer-related pain could provide useful benefit.

译文

背景:晚期癌症患者的慢性疼痛提出了严峻的临床挑战。 Δ9-四氢大麻酚(THC)/大麻二酚(CBD)口腔粘膜喷雾剂(美国采用名称,nabiximols;Sativex®)是一种新型大麻素制剂,目前正在接受治疗,作为该治疗组的辅助疗法。
目的:这项随访研究调查了THC / CBD喷雾剂和THC喷雾剂在缓解晚期癌症患者的疼痛方面的长期安全性和耐受性。
方法:共有43例癌症相关疼痛患者尽管使用了阿片类药物长期服用,但仍没有足够的镇痛作用,他们参加了先前的三组试验(THC / CBD喷雾剂,THC喷雾剂或安慰剂),为期两周的父母随机对照试验,参加了这项开放性,多中心的后续研究。患者自行滴定THC / CBD喷雾剂(n = 39)或THC喷雾剂(n = 4)以缓解症状或最大剂量,并定期检查其安全性,耐受性和临床获益证据。
结果:THC / CBD喷剂患者每次就诊时,“疼痛严重程度”和“最严重疼痛”域的平均简短疼痛清单-简表得分的基线变化的功效终点显示出降低(即改善)。同样,欧洲癌症生活质量研究和治疗组织问卷-C30的得分显示,失眠,疼痛和疲劳程度较基线水平有所降低(即有所改善)。这项研究没有引起与THC / CBD喷雾剂的广泛使用相关的新安全隐患。
结论:这项研究表明,长期使用THC / CBD喷雾剂通常具有良好的耐受性,没有证据表明长期使用THC / CBD喷雾剂可减轻癌症相关疼痛。此外,继续使用研究药物的患者并未寻求随时间增加这种药物或其他缓解疼痛药物的剂量,这表明在与癌症相关的疼痛中辅助使用大麻素可提供有益的益处。

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