Moreno-Sanz Guillermo, Madiedo Alvaro, Lynskey Michael, Brown Matthew R D
Khiron Life Sciences Spain, 28001 Madrid, Spain.
Khiron Life Sciences, Bogotá 110221, Colombia.
Biomedicines. 2022 Oct 14;10(10):2576. doi: 10.3390/biomedicines10102576.
In November 2018, the UK’s Home Office established a legal route for eligible patients to be prescribed cannabis-based products for medicinal use in humans (CBPMs) as unlicensed medicines. These include liquid cannabis extracts for oral administration (“oils”) and dried flowers for inhalation (“flos”). Smoking of CBPMs is expressly prohibited. To date, THC-predominant cannabis flowers remain the most prescribed CBPMs in project Twenty21 (T21), the first multi-center, prospective, observational UK cannabis patient registry. This observational, prospective data review analyzes patient-reported outcome measures (PROMS) collected by T21 associated with the inhalation of KHIRON 20/1, the most prescribed CBPM in the project. PROMS collected at baseline and at subsequent 3-month follow-up included health-related quality of life (HRQoL), general mood, and sleep. Condition-specific measures of illness severity were performed with the Brief Pain Inventory Short Form (BPI-SF) and the Generalized Anxiety Disorder 7-Item Scale (GAD-7). Participants (N = 344) were mostly males (77.6%, average age = 38.3) diagnosed mainly with chronic pain (50.9%) and anxiety-related disorders (25.3%). Inhalation of KHIRON 20/1 was associated with a marked increase in self-reported HRQoL, general mood, and sleep (N = 344; p < 0.001). Condition-specific assessments showed significant improvements in pain severity (T = 6.67; p < 0.001) and interference (T = 7.19; p < 0.001) in patients using KHIRON 20/1 for chronic pain (N = 174). Similar results were found for patients diagnosed with anxiety-related disorders (N = 107; T = 12.9; p < 0.001). Our results indicate that controlled inhalation of pharmaceutical grade, THC-predominant cannabis flos is associated with a significant improvement in patient-reported pain scores, mood, anxiety, sleep disturbances and overall HRQoL in a treatment-resistant clinical population.
2018年11月，英国内政部为符合条件的患者开辟了一条合法途径，可将大麻类产品作为未获许可的药品用于人类医疗用途（基于大麻的药用产品，CBPMs）。这些产品包括口服液体大麻提取物（“油剂”）和吸入用干花（“花类”）。明确禁止吸食CBPMs。迄今为止，在英国首个多中心、前瞻性、观察性大麻患者登记项目“2021计划”（T21）中，以四氢大麻酚（THC）为主的大麻花仍然是开具处方最多的CBPMs。这项观察性、前瞻性数据回顾分析了T21收集的与吸入该项目中开具处方最多的CBPM——KHIRON 20/1相关的患者报告结局指标（PROMS）。在基线期及随后3个月随访时收集的PROMS包括健康相关生活质量（HRQoL）、总体情绪和睡眠情况。使用简明疼痛问卷简表（BPI-SF）和广泛性焦虑障碍7项量表（GAD-7）对特定疾病的严重程度进行评估。参与者（N = 344）大多为男性（77.6%，平均年龄 = 38.3岁），主要诊断为慢性疼痛（50.9%）和焦虑相关障碍（25.3%）。吸入KHIRON 20/1与自我报告的HRQoL、总体情绪和睡眠显著改善相关（N = 344；p < 0.001）。特定疾病评估显示，使用KHIRON 20/1治疗慢性疼痛的患者，疼痛严重程度（T = 6.67；p < 0.001）和干扰程度（T = 7.19；p < 0.001）有显著改善（N = 174）。诊断为焦虑相关障碍的患者也有类似结果（N = 107；T = 12.9；p < 0.
