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创伤后应激障碍患者临床结局评估:来自英国医用大麻登记处的分析

Assessment of clinical outcomes in patients with post-traumatic stress disorder: analysis from the UK Medical Cannabis Registry.

作者信息

Pillai Manaswini, Erridge Simon, Bapir Lara, Nicholas Martha, Dalavaye Nishaanth, Holvey Carl, Coomber Ross, Barros Daniela, Bhoskar Urmila, Mwimba Gracia, Praveen Kavita, Symeon Chris, Sachdeva-Mohan Simmi, Rucker James J, Sodergren Mikael H

机构信息

Imperial College Medical Cannabis Research Group, Department of Surgery and Cancer, Imperial College London, London, UK.

Department of Medicine, Sapphire Medical Clinics, London, UK.

出版信息

Expert Rev Neurother. 2022 Nov-Dec;22(11-12):1009-1018. doi: 10.1080/14737175.2022.2155139. Epub 2022 Dec 12.

Abstract

BACKGROUND

The current paucity of clinical evidence limits the use of cannabis-based medicinal products (CBMPs) in post-traumatic stress disorder (PTSD). This study investigates health-related quality of life (HRQoL) changes and adverse events in patients prescribed CBMPs for PTSD.

METHODS

A case-series of patients from the UK Medical Cannabis Registry was analyzed. HRQoL was assessed at 1-, 3-, and 6-months using validated patient reported outcome measures (PROMs). Adverse events were analyzed according to the Common Terminology Criteria for Adverse Events version 4.0. Statistical significance was defined as p < 0.050.

RESULTS

Of 162 included patients, 88.89% (n = 144) were current/previous cannabis users. Median daily CBMP dosages were 5.00 (IQR: 0.00-70.00) mg of cannabidiol and 145.00 (IQR: 100.00-200.00) mg of Δ9-tetrahydrocannabinol. Significant improvements were observed in PTSD symptoms, sleep, and anxiety across all follow-up periods (p < 0.050). There were 220 (135.8%) adverse events reported by 33 patients (20.37%), with the majority graded mild or moderate in severity (n = 190, 117.28%). Insomnia and fatigue had the greatest incidence (n = 20, 12.35%).

CONCLUSIONS

Associated improvements in HRQoL were observed in patients who initiated CBMP therapy. Adverse events analysis suggests acceptability and safety up to 6 months. This study may inform randomized placebo-controlled trials, required to confirm causality and determine optimal dosing.

摘要

背景

目前临床证据匮乏,限制了基于大麻的药用产品(CBMPs)在创伤后应激障碍(PTSD)中的应用。本研究调查了因PTSD而服用CBMPs的患者的健康相关生活质量(HRQoL)变化及不良事件。

方法

对来自英国医用大麻注册库的一系列病例进行分析。使用经过验证的患者报告结局指标(PROMs)在1个月、3个月和6个月时评估HRQoL。根据不良事件通用术语标准第4.0版分析不良事件。统计学显著性定义为p < 0.050。

结果

在纳入的162例患者中,88.89%(n = 144)为当前/既往大麻使用者。CBMPs的每日中位剂量为5.00(四分位间距:0.00 - 70.00)mg大麻二酚和145.00(四分位间距:100.00 - 200.00)mg Δ9 - 四氢大麻酚。在所有随访期间,PTSD症状、睡眠和焦虑均有显著改善(p < 0.050)。33例患者(20.37%)报告了220起(135.8%)不良事件,大多数严重程度为轻度或中度(n = 190,117.28%)。失眠和疲劳的发生率最高(n = 20,12.35%)。

结论

开始CBMP治疗的患者的HRQoL有相关改善。不良事件分析表明在6个月内具有可接受性和安全性。本研究可为随机安慰剂对照试验提供参考,以确认因果关系并确定最佳剂量。

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