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英国基于大麻舌下油治疗慢性疼痛患者的首个队列的临床结局数据:来自英国医用大麻登记处的分析。

Clinical Outcome Data of First Cohort of Chronic Pain Patients Treated With Cannabis-Based Sublingual Oils in the United Kingdom: Analysis From the UK Medical Cannabis Registry.

机构信息

Imperial College Medical Cannabis Research Group, Imperial College London, London, UK.

Sapphire Medical Clinics, London, UK.

出版信息

J Clin Pharmacol. 2021 Dec;61(12):1545-1554. doi: 10.1002/jcph.1961. Epub 2021 Oct 5.

Abstract

Cannabis-based medicinal products (CBMPs) are an emerging therapeutic option in the management of primary chronic pain, using the role of the endocannabinoid system in modulating central and peripheral pain processes. Despite promising preclinical data, there is a paucity of high-quality evidence to support the use of CBMPs for chronic pain. This study aimed to investigate the health-related quality-of-life outcomes of patients with chronic pain who were prescribed CBMP oil preparations (Adven, Curaleaf International, Guernsey, UK). This study is a case series of patients from the UK Medical Cannabis Registry, who were treated with CBMP oils for an indication of chronic pain. The primary outcomes were the changes in Brief Pain Inventory short form, Short-Form McGill Pain Questionnaire-2, Visual Analog Scale Pain, General Anxiety Disorder-7, Sleep Quality Scale, and EQ-5D-5L, at 1, 3, and 6 months. One hundred ten patients were included. Significant improvements in Sleep Quality Scale, EQ-5D-5L pain and discomfort subscale, and Brief Pain Inventory Interference Subscale (P < .05) at 1, 3, and 6 months were demonstrated. There were no notable differences between cannabis-naïve and previous cannabis users in quality-of-life outcomes. The adverse event incidence was 30.0%, with most (n = 58; 92.1%) adverse events being mild or moderate in intensity. Treatment of chronic pain with Adven CBMP oils was associated with an improvement in pain-specific outcomes, health-related quality of life, and self-reported sleep quality. Relative safety was demonstrated over medium-term prescribed use. While these findings must be treated with caution considering the limitations of study design, they can inform future clinical trials.

摘要

基于大麻的药用产品(CBMP)是治疗原发性慢性疼痛的新兴治疗选择,利用内源性大麻素系统调节中枢和外周疼痛过程。尽管有有前景的临床前数据,但支持 CBMP 用于慢性疼痛的高质量证据有限。本研究旨在调查接受 CBMP 油制剂(Adven、Curaleaf International、Guernsey、UK)治疗的慢性疼痛患者的健康相关生活质量结果。本研究是英国医疗大麻登记处的患者病例系列研究,他们因慢性疼痛的适应症接受 CBMP 油治疗。主要结局是在 1、3 和 6 个月时 Brief Pain Inventory 简短形式、Short-Form McGill Pain Questionnaire-2、视觉模拟量表疼痛、一般焦虑症-7、睡眠质量量表和 EQ-5D-5L 的变化。共纳入 110 例患者。在 1、3 和 6 个月时,睡眠质量量表、EQ-5D-5L 疼痛和不适子量表以及 Brief Pain Inventory 干扰子量表(P <.05)均有显著改善。在生活质量结果方面,无用药和既往使用大麻的患者之间无显著差异。不良事件发生率为 30.0%,大多数(n = 58;92.1%)不良事件为轻度或中度。使用 Adven CBMP 油治疗慢性疼痛与疼痛特定结局、健康相关生活质量和自我报告的睡眠质量改善相关。在中期规定使用期间显示出相对安全性。尽管考虑到研究设计的局限性,这些发现必须谨慎对待,但它们可以为未来的临床试验提供信息。

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