Leen Nadia A, Kowal Mikael A, Batalla Albert, Bossong Matthijs G
Bedrocan International BV, Clinical Research Unit, Utrecht, Netherlands.
Department of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, Utrecht, Netherlands.
Front Pharmacol. 2024 Oct 17;15:1411631. doi: 10.3389/fphar.2024.1411631. eCollection 2024.
There is growing recognition of the potential of cannabis to treat various medical conditions and symptoms, such as chronic pain, spasticity, and epilepsy. However, one of the biggest challenges is the assurance of a standardized cannabis product that contains a consistent amount of its main psychoactive substances delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), and which is compliant with predetermined specifications for these compounds. This is crucial not only to ensure consistent cannabis quality and dosage for patients but also to effectively translate research findings into clinical practice.
This systematic literature review provides an overview of the effects of standardized cannabis products from Bedrocan, a leading Dutch producer of pharmaceutical-quality standardized medicinal cannabis.
Cannabis administration to healthy volunteers induces dose-dependent acute effects, such as rapidly rising THC and CBD blood concentrations, the subjective experience of high and anxiety, slower reaction time and impaired attention, learning and working memory. Patient studies suggest that treatment with medicinal cannabis reduces pain intensity across a broad range of chronic pain-related medical conditions. Medicinal cannabis showed a mild safety profile, with minor and transient side effects, such as feeling high, coughing and mental confusion. The strength of acute effects, the experience of side effects and the drop-out rate in patient studies may depend on cannabis dose, cannabis composition (CBD:THC ratio), and cannabis use history of participants.
Safety and efficacy of standardized medicinal cannabis products should be further investigated in randomized clinical trials with sufficient sample size, with particular focus on cannabis dose and composition, age and differences between males and females.
大麻治疗各种医疗状况和症状(如慢性疼痛、痉挛和癫痫)的潜力日益得到认可。然而,最大的挑战之一是确保标准化的大麻产品,其主要精神活性物质Δ⁹-四氢大麻酚(THC)和大麻二酚(CBD)的含量一致,并且符合这些化合物的预定规格。这不仅对于确保患者使用大麻的质量和剂量一致至关重要,而且对于有效地将研究结果转化为临床实践也至关重要。
本系统文献综述概述了荷兰领先的药用级标准化大麻生产商Bedrocan生产的标准化大麻产品的效果。
对健康志愿者使用大麻会产生剂量依赖性的急性效应,如THC和CBD血药浓度迅速上升、兴奋和焦虑的主观体验、反应时间减慢以及注意力、学习和工作记忆受损。患者研究表明,药用大麻治疗可减轻多种慢性疼痛相关医疗状况下的疼痛强度。药用大麻的安全性良好,副作用轻微且短暂,如兴奋感、咳嗽和精神错乱。急性效应的强度、副作用体验以及患者研究中的脱落率可能取决于大麻剂量、大麻成分(CBD:THC比例)以及参与者的大麻使用史。
应在足够样本量的随机临床试验中进一步研究标准化药用大麻产品的安全性和有效性,尤其要关注大麻剂量和成分、年龄以及男女之间的差异。