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英国医用大麻注册处姑息治疗患者队列:初步经验与结果

UK Medical Cannabis Registry palliative care patients cohort: initial experience and outcomes.

作者信息

Nimalan Devaki, Kawka Michal, Erridge Simon, Ergisi Mehmet, Harris Michael, Salazar Oliver, Ali Rayyan, Loupasaki Katerina, Holvey Carl, Coomber Ross, Platt Michael, Rucker James J, Khan Shaheen, Sodergren Mikael H

机构信息

Department of Surgery and Cancer, St Mary's Hospital, Imperial College Medical Cannabis Research Group, Imperial College London, Academic Surgical Unit, 10th Floor QEQM, South Wharf Road, London, W2 1NY, UK.

Sapphire Medical Clinics, London, UK.

出版信息

J Cannabis Res. 2022 Jan 4;4(1):3. doi: 10.1186/s42238-021-00114-9.

Abstract

INTRODUCTION

Palliative care aims to improve quality of life through optimal symptom control and pain management. Cannabis-based medicinal products (CBMPs) have a proven role in the treatment of chemotherapy-induced nausea and vomiting. However, there is a paucity of high-quality evidence with regards to the optimal therapeutic regimen, safety, and effectiveness of CBMPs in palliative care, as existing clinical trials are limited by methodological heterogeneity. The aim of this study is to summarise the outcomes of the initial subgroup of patients from the UK Medical Cannabis Registry who were prescribed CBMPs for a primary indication of palliative care, cancer pain and chemotherapy-induced nausea and vomiting, including effects on health-related quality of life and clinical safety.

METHODS

A case series from the UK Medical Cannabis Registry of patients, who were receiving CBMPs for the indication of palliative care was undertaken. The primary outcome consisted of changes in patient-reported outcome measures including EQ-5D-5L, General Anxiety Disorder-7 (GAD-7), Single-Item Sleep Quality Scale (SQS), Pain Visual Analog Scale (VAS) and the Australia-Modified Karnofsky Performance Scale at 1 and 3 months compared to baseline. Secondary outcomes included the incidence and characteristics of adverse events. Statistical significance was defined by p-value< 0.050.

RESULTS

Sixteen patients were included in the analysis, with a mean age of 63.25 years. Patients were predominantly prescribed CBMPs for cancer-related palliative care (n = 15, 94%). The median initial CBD and THC daily doses were 32.0 mg (Range: 20.0-384.0 mg) and 1.3 mg (Range: 1.0-16.0 mg) respectively. Improvements in patient reported health outcomes were observed according to SQS, EQ-5D-5L mobility, pain and discomfort, and anxiety and depression subdomains, EQ-5D-5L index, EQ-VAS and Pain VAS validated scales at both 1-month and 3-months, however, the changes were not statistically significant. Three adverse events (18.75%) were reported, all of which were either mild or moderate in severity.

CONCLUSION

This small study provides an exploratory analysis of the role of CBMPs in palliative care in the first cohort of patients since CBMPs legalisation in the UK. CBMPs were tolerated with few adverse events, all of which were mild or moderate and resolved spontaneously. Further long-term safety and efficacy studies involving larger cohorts are needed to establish CBMPs role in palliative care, including comparisons with standard treatments.

摘要

引言

姑息治疗旨在通过优化症状控制和疼痛管理来提高生活质量。基于大麻的药用产品(CBMPs)在治疗化疗引起的恶心和呕吐方面已被证明有作用。然而,关于CBMPs在姑息治疗中的最佳治疗方案、安全性和有效性,高质量证据匮乏,因为现有的临床试验受到方法学异质性的限制。本研究的目的是总结英国医用大麻登记处最初一组患者的结果,这些患者因姑息治疗、癌症疼痛和化疗引起的恶心和呕吐等主要适应症而被开具CBMPs,包括对健康相关生活质量和临床安全性的影响。

方法

对英国医用大麻登记处接受CBMPs用于姑息治疗适应症的患者进行了病例系列研究。主要结局包括与基线相比,1个月和3个月时患者报告的结局指标的变化,包括EQ-5D-5L、广泛性焦虑障碍-7(GAD-7)、单项睡眠质量量表(SQS)、疼痛视觉模拟量表(VAS)和澳大利亚改良卡诺夫斯基功能状态量表。次要结局包括不良事件的发生率和特征。统计学显著性定义为p值<0.050。

结果

16名患者纳入分析,平均年龄63.25岁。患者主要因癌症相关的姑息治疗而被开具CBMPs(n = 15,94%)。CBD和THC的初始每日中位剂量分别为32.0毫克(范围:20.0 - 384.0毫克)和1.3毫克(范围:1.0 - 16.0毫克)。在1个月和3个月时,根据SQS、EQ-5D-5L的活动能力、疼痛和不适、焦虑和抑郁子领域、EQ-5D-5L指数、EQ-VAS和疼痛VAS验证量表,观察到患者报告的健康结局有所改善,但变化无统计学显著性。报告了3例不良事件(18.75%),所有事件的严重程度均为轻度或中度。

结论

这项小型研究对自英国CBMPs合法化以来首批患者队列中CBMPs在姑息治疗中的作用进行了探索性分析。CBMPs耐受性良好,不良事件较少,所有不良事件均为轻度或中度且自行缓解。需要进一步开展涉及更大队列的长期安全性和有效性研究,以确定CBMPs在姑息治疗中的作用,包括与标准治疗方法的比较。

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