Medical Cannabis and Cannabinoids最新文献

英文中文

Medicinal Cannabis for the Treatment of Chronic Refractory Pain: An Investigation of the Adverse Event Profile and Health-Related Quality of Life Impact of an Oral Formulation. 药用大麻治疗慢性难治性疼痛:一种口服制剂的不良事件概况和健康相关生活质量影响的调查。

Q1 Medicine

Medical Cannabis and Cannabinoids

Pub Date : 2022-02-09 eCollection Date: 2022-01-01 DOI: 10.1159/000521492

Sarah Abelev, Leon N Warne, Melissa Benson, Mark Hardy, Sunny Nayee, John Barlow

Introduction: Medicinal cannabis is prescribed in Australia for patients with chronic refractory pain conditions. However, measures of safety and effectiveness of different cannabinoids are lacking. We designed an observational study to capture effectiveness, adverse events (AEs), and health-related quality of life (HRQoL) measures in patients prescribed an oral medicinal cannabis formulation at Cannabis Access Clinics through the Cannabis Access Clinics Observational study (CACOS).

Objectives: We aimed to evaluate effectiveness, reported AEs, and change in patient-reported outcomes in individuals prescribed a cannabinoid oil formulation for management of chronic pain.

Methods: A cross-sectional analysis was conducted on patients prescribed an oil formulation of Δ9-tetrahydrocannabinol and cannabidiol for pain symptoms of at least 3-month duration. Clinician-reported AEs were organized by system, organ, class, and frequency. Analysis of patient-reported responses to a questionnaire was conducted using published minimal clinically important differences to determine meaningful change in HRQoL over time.

Results: More than half (n = 91/151, 60.3%) of the participants experienced at least one AE during the observation period (mean 133 ± 116 days). No serious AEs were reported. Patient-reported pain impact scores were significantly reduced across the cohort (p = 0.034), and pain intensity scores verged on significance (p = 0.053). The majority of patients saw meaningful improvements in sleep (49.3%) and fatigue (35.6%).

Conclusion: This analysis presents real-world data collected as part of standard of care. More than one-third of patients benefited from oral medicinal cannabis, which is impactful given the refractory nature of their pain. Amelioration of the impact of pain confirms continued prescribing of this formulation and validates our observational methodology as a tool to determine the therapeutic potency of medicinal cannabinoids.

简介:药用大麻在澳大利亚是为慢性难治性疼痛患者开的处方。然而，缺乏对不同大麻素的安全性和有效性的测量。我们设计了一项观察性研究，通过大麻准入诊所观察性研究(CACOS)，捕捉在大麻准入诊所处方口服药用大麻制剂的患者的有效性、不良事件(ae)和与健康相关的生活质量(HRQoL)指标。目的:我们旨在评估使用大麻素油制剂治疗慢性疼痛的有效性、报告的ae和患者报告结果的变化。方法:对服用Δ9-tetrahydrocannabinol和大麻二酚油制剂治疗疼痛症状持续至少3个月的患者进行横断面分析。临床报告的ae按系统、器官、类别和频率进行组织。利用已公布的最小临床重要差异对患者报告的问卷反应进行分析，以确定HRQoL随时间的有意义变化。结果:超过一半(n = 91/151, 60.3%)的参与者在观察期间(平均133±116天)至少经历了一次AE。没有严重的ae报告。患者报告的疼痛影响评分在整个队列中显著降低(p = 0.034)，疼痛强度评分接近显著(p = 0.053)。大多数患者在睡眠(49.3%)和疲劳(35.6%)方面有明显改善。结论:该分析提供了作为标准护理的一部分收集的真实世界数据。超过三分之一的患者受益于口服药用大麻，鉴于其疼痛的难治性，这是有效的。疼痛影响的改善证实了该配方的持续处方，并验证了我们的观察方法作为确定药用大麻素治疗效力的工具。

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引用次数: 10

A Phase I Trial to Determine the Pharmacokinetics, Psychotropic Effects, and Safety Profile of a Novel Nanoparticle-Based Cannabinoid Spray for Oromucosal Delivery 一项确定新型基于纳米颗粒的大麻素口服喷雾剂药代动力学、精神作用和安全性的I期试验

Q1 Medicine

Medical Cannabis and Cannabinoids

Pub Date : 2022-01-18 DOI: 10.1159/000521352

S. Lorenzl, Franz Gottwald, Angelika Nistler, Laura Brehm, Renate Grötsch, Georg Haber, Christian Bremm, Christiane Weck, Carina Trummer, Werner Brand

Introduction: A phase I, open-label clinical trial in healthy male subjects was conducted to assess the pharmacokinetic and safety profile of an oromucosal cannabinoid spray (AP701) containing a lipid-based nanoparticular drug formulation standardized to ∆-9-tetrahydrocannabinol (THC). Methods: Twelve healthy male subjects received a single dose of AP701 (12 sprays) containing 3.96 mg THC. Plasma samples were drawn 10 min–30 h post dose for analysis of THC and the active metabolite 11-hydroxy-∆-9-THC (11-OH-THC). Results: The single dose of the applied oromucosal cannabinoid spray AP701 (12 sprays, 3.96 mg THC) resulted in a mean maximum plasma concentration (Cmax) of 2.23 ng/mL (90% CI 1.22–3.24) and a mean overall exposure (area under the concentration-time curve from time 0 to last measurable concentration [AUC0–t]) of 7.74 h × ng/mL (90% CI 5.03–10.45) for THC. For the active metabolite 11-OH-THC, a Cmax of 2.09 mg/mL (90% CI 1.50–2.68) and AUC0–t of 10.4 h × ng/mL (90% CI 7.03–13.77) was found. The oromucosal cannabinoid spray AP701 caused only minor psychotropic effects despite the relatively high dosage applied by healthy subjects. No serious adverse effects occurred. Overall, the oromucosal cannabinoid spray AP701 was well tolerated. Conclusion: Compared to currently available drugs on the market, higher AUC values could be detected for the oromucosal cannabinoid spray AP701 despite administration of a lower dose. These comparatively higher blood levels caused only minor psychotropic adverse effects. The oromucosal cannabinoid spray AP701 was well tolerated at a single dose of 3.96 mg THC. The oromucosal administration may provide an easily applicable and titratable drug formulation with a high safety and tolerability profile.

前言:在健康男性受试者中进行了一项I期开放标签临床试验，以评估口服大麻素喷雾剂(AP701)的药代动力学和安全性，该喷雾剂含有标准化为∆-9-四氢大麻酚(THC)的脂基纳米颗粒药物配方。方法:12名健康男性受试者接受含3.96 mg四氢大麻酚的AP701单次(12支)喷雾剂。给药后10 min-30 h抽取血浆样本，分析四氢大麻酚及其活性代谢物11-羟基-∆-9-THC (11-OH-THC)。结果:单剂量应用口腔黏膜大麻素喷雾剂AP701(12次喷雾剂，3.96 mg THC)导致THC的平均最大血浆浓度(Cmax)为2.23 ng/mL (90% CI 1.22-3.24)，平均总暴露(从时间0到最后可测量浓度[AUC0-t]的浓度-时间曲线下面积)为7.74 h × ng/mL (90% CI 5.03-10.45)。活性代谢物11-OH-THC的Cmax为2.09 mg/mL (90% CI 1.50 ~ 2.68)， AUC0-t为10.4 h × ng/mL (90% CI 7.03 ~ 13.77)。口腔黏膜大麻素喷雾剂AP701仅引起轻微的精神作用，尽管健康受试者使用的剂量相对较高。未发生严重不良反应。总体而言，口腔黏膜大麻素喷雾剂AP701耐受性良好。结论:与目前市场上可用的药物相比，口服大麻素喷雾剂AP701的AUC值更高，尽管给药剂量较低。这些相对较高的血药浓度只会引起轻微的精神不良反应。口服大麻素喷雾剂AP701在单剂量3.96 mg THC时耐受性良好。口服给药可以提供一种易于应用和可滴定的药物制剂，具有高安全性和耐受性。

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引用次数: 4

Cannabinoids as Cocrystals 大麻类共晶

Q1 Medicine

Medical Cannabis and Cannabinoids

Pub Date : 2022-01-13 DOI: 10.1159/000521137

C. N. Filer

Dear Editor, The fascinating portfolio of Cannabis cannabinoids (phytocannabinoids) [1] continues to grow with new members continually added [2]. Interest in these intriguing natural products has accelerated in recent years, fueled by their potential as medicinal agents [3]. However, along with the promising pharmaceutical opportunity for cannabinoids come some challenging chemistry issues. The first concern is a common property shared by most cannabinoids, namely, their physical state as lipophilic, low melting point semisolids. This physical nature has profound implications. Since crystalline substances are usually more stable than amorphous solids, many cannabinoids have stability limitations. Acidic cannabinoids (functionalized with an aromatic carboxyl [CO2H] group) are especially prone to decarboxylation, but even neutral cannabinoids (lacking a carboxyl group) can be unstable to heat or light. With an estimated 70% of pharmaceuticals given as tablets [4], the low melting point-semisolid state of most cannabinoids has certainly complicated this convenient administration route for them. Another consequence of the cannabinoid lipophilic nature is their lack of water solubility. In fact, limited water solubility with accompanying delay of drug absorption and bioavailability has been a major problem for many candidate pharmaceuticals like the cannabinoids [5]. Finally, the large number (but smaller individual amounts) of “minor cannabinoids” as a complex mixture in the Cannabis trichomes has confounded their purification and hindered their pharmaceutical development. The purpose of this note is to highlight a recent and exciting alternative approach to these various technical challenges. Ongoing efforts by cannabinoid chemists to address these daunting obstacles have usually focused on each of them individually. However, the recent return to the 19th century chemistry of “cocrystallization” may well be able to solve some of them simultaneously. This transformative technique is significantly different from traditional crystallization. Cocrystallization involves the intermolecular noncovalent bonding of a molecule of interest (like a cannabinoid) with a companion neutral partner molecule (often termed a “coformer”), crystallizing as a stoichiometric pair in a well-defined and repeating 3-dimensional cocrystal lattice. The discovery of cocrystals is widely attributed to noted German chemist Friedrich Wohler [6] in 1844 and his preparation of quinhydrone, a cocrystal redox couple of quinone and hydroquinone. Wohler was likely unaware of his discovery’s significance and the full characterization of quinhydrone as a cocrystal (by X-ray crystal analysis) took more than a century to accomplish. Cocrystal technology with its many synthetic methods has now been eagerly embraced by the pharmaceutical sector to improve drug stability and bioavailability [7]. Interestingly, early indications that cannabinoids might

亲爱的编辑，大麻大麻素（植物大麻素）[1]的迷人组合随着新成员的不断增加而不断增长[2]。近年来，由于其作为药物的潜力，人们对这些有趣的天然产品的兴趣加速了[3]。然而，随着大麻素有望成为药物，随之而来的是一些具有挑战性的化学问题。第一个问题是大多数大麻素的共同特性，即它们的物理状态为亲脂性、低熔点半固体。这种物理性质具有深刻的含义。由于结晶物质通常比无定形固体更稳定，许多大麻素具有稳定性限制。酸性大麻素（用芳香羧基[CO2H]官能化）特别容易脱羧，但即使是中性大麻素也可能对热和光不稳定。据估计，70%的药物是以片剂的形式给药[4]，大多数大麻素的低熔点半固态无疑使它们的这一方便给药途径变得复杂。大麻素亲脂性的另一个后果是它们缺乏水溶性。事实上，水溶性有限，伴随着药物吸收和生物利用度的延迟，一直是许多候选药物（如大麻素）的主要问题[5]。最后，大麻毛状体中大量（但个体数量较小）的“小大麻素”作为一种复杂的混合物，混淆了它们的纯化，阻碍了它们的药物开发。本说明的目的是强调一种最近令人兴奋的替代方法来应对这些各种技术挑战。大麻素化学家为解决这些令人生畏的障碍所做的持续努力通常集中在每一个方面。然而，最近回到19世纪的“共结晶”化学很可能能够同时解决其中的一些问题。这种转化技术与传统的结晶技术有很大不同。共结晶涉及感兴趣的分子（如大麻素）与伴随的中性伴侣分子（通常称为“共形成物”）的分子间非共价键，在定义明确且重复的三维共晶格中以化学计量对的形式结晶。共晶的发现被广泛归因于著名的德国化学家弗里德里希·沃勒[6]在1844年和他制备的醌氢醌，一种醌和对苯二酚的共晶氧化还原偶。Wohler可能没有意识到这一发现的重要性，并且（通过X射线晶体分析）将醌氢醌完全表征为共晶花了一个多世纪的时间才完成。共晶技术及其许多合成方法现在已被制药部门热切地接受，以提高药物的稳定性和生物利用度[7]。有趣的是，大麻素可能

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引用次数: 1

Cannabis for the Treatment of Attention Deficit Hyperactivity Disorder: A Report of 3 Cases. 大麻治疗注意缺陷多动障碍3例报告

Q1 Medicine

Medical Cannabis and Cannabinoids

Pub Date : 2022-01-01 DOI: 10.1159/000521370

Holly Mansell, Declan Quinn, Lauren E Kelly, Jane Alcorn

Attention deficit hyperactivity disorder (ADHD) is a chronic neurobehavioral disorder that is highly prevalent in children and adults. An increasing number of patients with ADHD are self-medicating with cannabis, despite a lack of evidence on efficacy and safety. This case report describes 3 males (ages 18, 22, and 23) who have integrated cannabis into their treatment regimen with positive results. Semistructured interviews conducted with the patients describe subjective improvements in symptoms and on quality of life. Improvements on validated rating scales conducted post-cannabis initiation, compared to pre-cannabis initiation obtained from the medical chart, corroborated their personal accounts. Scores on the PHQ-9 (measuring depression) improved by 8-22 points (30-81%), and the SCARED (measuring anxiety) ranged from 0 to 27 points (up to 33%). Improvements on the CEER-9 scale (measuring regulation) ranged from 2 to 7 points (22-78%), and the 9-item SNAP scale (measuring inattention) showed improvements of 2-8 points (7-30%). Mild adverse events including short-term memory problems, dry mouth, and sleepiness were reported. Blood samples were also collected from the patients to determine the plasma concentrations of the cannabinoids and relevant metabolites before and after a cannabis administration. After cannabis use, the plasma levels for CBD and THC ranged from 0 to 15.29 ng/mL and 1.32 to 13.76 ng/mL, respectively. Cannabinoids, however, were not detected prior to dosing, suggesting that cannabis played a complimentary role in the therapeutic regimen of these 3 patients. Clinical trials are recommended to confirm the efficacy of cannabis in the treatment of ADHD.

注意缺陷多动障碍(ADHD)是一种慢性神经行为障碍，在儿童和成人中非常普遍。尽管缺乏有效性和安全性的证据，但越来越多的ADHD患者使用大麻进行自我治疗。本病例报告描述了3名男性(18岁、22岁和23岁)将大麻纳入其治疗方案并取得积极结果。与患者进行的半结构化访谈描述了症状和生活质量的主观改善。与从医疗图表中获得的大麻开始使用前相比，在大麻开始使用后进行的有效评分量表的改进证实了他们的个人说法。PHQ-9(测量抑郁)的得分提高了8-22分(30% -81%)，而SCARED(测量焦虑)的得分从0到27分(高达33%)不等。CEER-9量表(测量调节)改善2-7分(22-78%)，9项SNAP量表(测量注意力不集中)改善2-8分(7-30%)。轻度不良事件包括短期记忆问题、口干和嗜睡。还收集了患者的血液样本，以确定大麻给药前后大麻素和相关代谢物的血浆浓度。使用大麻后，血浆中CBD和THC的水平分别为0至15.29 ng/mL和1.32至13.76 ng/mL。然而，在给药前未检测到大麻素，这表明大麻在这3名患者的治疗方案中发挥了补充作用。建议进行临床试验以证实大麻治疗ADHD的有效性。

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引用次数: 7

Erratum. 勘误表。

Q1 Medicine

Medical Cannabis and Cannabinoids

Pub Date : 2022-01-01 DOI: 10.1159/000527071

[This corrects the article DOI: 10.1159/000521370.].

[这更正了文章DOI: 10.1159/000521370]。

引用次数: 0

Clinical Considerations for Cannabis Use and Cardiovascular Health. 大麻使用和心血管健康的临床考虑。

Q1 Medicine

Medical Cannabis and Cannabinoids

Pub Date : 2022-01-01 DOI: 10.1159/000526731

Ruba Sajdeya, Sebastian Jugl, Robert Cook, Joshua D Brown, Amie Goodin

aConsortium for Medical Marijuana Clinical Outcomes Research, University of Florida, Gainesville, FL, USA; bDepartment of Epidemiology, University of Florida, Gainesville, FL, USA; cCenter for Drug Evaluation and Safety (CoDES), Department of Pharmaceutical Outcomes & Policy, University of Florida, Gainesville, FL, USA Received: June 14, 2022 Accepted: August 13, 2022 Published online: September 28, 2022

引用次数: 1

Effects of Cannabis on Cardiovascular System: The Good, the Bad, and the Many Unknowns 大麻对心血管系统的影响:好，坏，和许多未知

Q1 Medicine

Medical Cannabis and Cannabinoids

Pub Date : 2021-11-12 DOI: 10.1159/000519775

A. E. Dabiri, G. Kassab

Cannabis is currently the most consumed illicit substance in the world, and gradual legalization in the USA makes it important to understand the health consequences of the use of this substance. With growing body of evidence that some cannabis ingredients may be beneficial in various aspects of hemostasis, additional research is clearly needed in various clinical areas. In addition to understanding the efficacy, research efforts should also include studies that address any harmful effects of the compounds or administration methods that may result in adverse effects. This review is focused on the cardiometabolic effects of cannabis use. Cardiometabolic diseases are among the leading causes of death in the USA and around the world. The purpose of this review was to provide an overview of the known medicinal benefits of selected cannabis cannabinoids and the known side effects or contraindications. More importantly, we have proposed new questions and signposts in cannabis research to uncover additional medicinal benefits and identify the health hazards with focus on cardiovascular disease.

大麻是目前世界上消费量最大的非法物质，在美国逐渐合法化使得了解使用这种物质对健康的影响变得重要。随着越来越多的证据表明，一些大麻成分可能对止血的各个方面有益，显然需要在各个临床领域进行更多的研究。除了了解疗效外，研究工作还应包括解决化合物的任何有害影响或可能导致不良影响的给药方法的研究。这篇综述的重点是大麻使用对心脏代谢的影响。心脏代谢性疾病是美国和世界各地死亡的主要原因之一。本综述的目的是概述所选大麻大麻素的已知药用益处以及已知的副作用或禁忌症。更重要的是，我们在大麻研究中提出了新的问题和路标，以揭示额外的药用益处，并确定健康危害，重点关注心血管疾病。

引用次数: 7

Abstracts of the 2021 Cannabis Clinical Outcomes Research Conference 2021年大麻临床结果研究会议摘要

Q1 Medicine

Medical Cannabis and Cannabinoids

Pub Date : 2021-09-21 DOI: 10.1159/000519038

引用次数: 0

Proceedings of the 2021 Cannabis Clinical Outcomes Research Conference 2021年大麻临床结果研究会议论文集

Q1 Medicine

Medical Cannabis and Cannabinoids

Pub Date : 2021-09-10 DOI: 10.1159/000519037

A. Goodin, Debbie L. Wilson, Robert L. Cook, Yan Wang, Joshua D. Brown, A. Winterstein

The Cannabis Clinical Outcomes Research Conference (CCORC) 2021 was held virtually on April 8 and 9, 2021. The conference was hosted by the Consortium for Medical Marijuana Clinical Outcomes Research, a research organization instituted by the state legislature of Florida in the United States. The inaugural annual CCORC 2021 was organized as a scientific meeting to foster and disseminate research on medical marijuana (MM) clinical outcomes, while promoting engagement among MM researchers, patients, clinicians, policymakers, and industry partners. Key conference themes included: (a) the disconnect between policy, practice, and evidence and steps towards reconciliation, (b) approaches to overcome common barriers to MM research, and (c) the use of focused translational approaches utilizing both mechanistic and clinical research methodology to tackle the complexities of MM outcomes. CCORC 2022 is planned for spring 2022 in Orlando, Florida, United States.

2021年大麻临床结果研究会议（CCORC）于2021年4月8日和9日举行。该会议由美国佛罗里达州立法机构成立的研究组织大麻临床结果研究联合会主办。首届年度CCORC 2021是一次科学会议，旨在促进和传播医用大麻（MM）临床结果的研究，同时促进MM研究人员、患者、临床医生、政策制定者和行业合作伙伴的参与。会议的主要主题包括：（a）政策、实践和证据之间的脱节以及和解步骤，（b）克服MM研究常见障碍的方法，以及（c）利用机制和临床研究方法，使用重点转化方法来解决MM结果的复杂性。CCORC2022计划于2022年春季在美国佛罗里达州奥兰多举行。

引用次数: 1

Measuring the Change in Health-Related Quality of Life in Patients Using Marijuana for Pain Relief 测量使用大麻止痛患者健康相关生活质量的变化

Q1 Medicine

Medical Cannabis and Cannabinoids

Pub Date : 2021-08-12 DOI: 10.1159/000517857

A. Peterson, Christine Le, Tyler Dautrich

Introduction: Current evidence suggests that cannabinoids are safe with minimal side effects and are effective in managing chronic pain. Data also show that medical marijuana (MM) may improve quality of life (QoL) among patients. However, there are little data showing the health-related QoL (HRQoL) benefit in MM patients using it for pain. The purpose of this study was to determine if there is a relationship between HRQol and MM use in patients using it to relieve pain. Methods: All pain patients aged 18 years or older enrolled in the Pennsylvania MM program were eligible for inclusion. Recruited subjects completed 4 surveys – at enrollment (baseline) then 2, 4, and 8 weeks post-enrollment. We used the EQ-5D survey tool for measuring HRQoL. The primary outcome measure was the change in the EQ-5D Index Score from survey 2 to survey 4 (6 week difference). Secondary outcomes included self-reported pain and health scores. Data were analyzed using a paired t test and repeated-measures multivariable analysis to control for both gender and length of time between surveys. Results: 1,762 people responded to the screening request, and 1,393 (79%) met screening criteria. Of those, 353 (25.3%) agreed to participate and 51% completed all 4 surveys, for a final sample of 181 with 85 male and 95 female and one nonbinary subject. The average age was 41.21 (SD = 12.9) years, with no difference between genders. The adjusted HRQoL score improved from 0.722 to 0.747 (p = 0.011) from survey 2 to survey 4, as did the self-reported pain and health scores. The EQ-5D subscales revealed no change in mobility or usual activities, significant improvement in anxiety and pain, and a significant worsening in self-care. Conclusion: The results show a significant improvement in HRQoL among patients using MM for pain. The EQ-5D subscales validated the pain improvement and also showed an improvement in anxiety. However, the decline in the self-care subscale may have tempered the overall improvement in HRQoL, and further research into which aspects of self-care are impacted by MM use in this population is warranted. Overall, there is a positive relationship between MM use and HRQoL in patients using it for pain.

目前的证据表明，大麻素是安全的，副作用最小，对治疗慢性疼痛有效。数据还显示，医用大麻(MM)可以改善患者的生活质量(QoL)。然而，很少有数据显示使用它治疗疼痛的MM患者的健康相关生活质量(HRQoL)受益。本研究的目的是确定使用MM缓解疼痛的患者的HRQol与使用MM之间是否存在关系。方法:所有参加宾夕法尼亚MM项目的18岁及以上疼痛患者均符合入选条件。招募的受试者在入组时(基线)、入组后2周、4周和8周完成了4项调查。我们使用EQ-5D测量工具来测量HRQoL。主要结局指标是调查2至调查4期间EQ-5D指数得分的变化(6周差异)。次要结果包括自我报告的疼痛和健康评分。使用配对t检验和重复测量多变量分析对数据进行分析，以控制性别和两次调查之间的时间长度。结果:1762人响应了筛查请求，1393人(79%)符合筛查标准。其中353人(25.3%)同意参与，51%的人完成了所有4项调查，最终样本为181人，其中85名男性，95名女性和1名非二元受试者。平均年龄为41.21岁(SD = 12.9)，性别差异无统计学意义。从调查2到调查4，调整后的HRQoL评分从0.722提高到0.747 (p = 0.011)，自我报告的疼痛和健康评分也是如此。EQ-5D量表显示，在行动能力和日常活动方面没有变化，焦虑和疼痛方面有显著改善，自我照顾方面有显著恶化。结论:使用MM治疗疼痛患者的HRQoL有明显改善。EQ-5D量表证实了疼痛的改善，也显示了焦虑的改善。然而，自我护理量表的下降可能已经缓和了HRQoL的整体改善，并且进一步研究自我护理的哪些方面受到该人群使用MM的影响是有必要的。总体而言，在使用MM治疗疼痛的患者中，MM的使用与HRQoL呈正相关。

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