Department of Pharmacology and Pharmacotherapy, Faculty of Medicine, UMF Carol Davila, Bucharest, Romania.
Department of Fundamental Disciplines and Clinical Prevention, Faculty of Medicine, Transilvania University of Brasov, Romania; and.
Am J Ther. 2020 May/Jun;27(3):e249-e269. doi: 10.1097/MJT.0000000000001120.
The systematic reviews and meta-analyses performed until now did not provide the adequate picture of actual knowledge in the field of neuropsychiatric symptoms treatment using psychotropic cannabinoids in patients with Alzheimer disease (AD).
Which is the level of evidence, from quantitative and qualitative point of view, concerning the efficacy and safety of the treatment with psychotropic cannabinoids of neuropsychiatric symptoms in AD?
PubMed, EMBASE, Cochrane Database of Systematic Reviews, Google Scholar Data, and Clinicaltrials.gov were searched for randomized clinical trials with cannabinoids in Alzheimer dementia agitation and aggression.
The rationale, the objectives, and the methods used for searching the trials have been established according to PRISMA Criteria 2009.
The total number of patients in the 9 publications evaluated in this study, which included data from 6 clinical trials, was 422 patients-treatments, where treatment was a psychoactive cannabinoid or placebo, some of them obtained by multiplying selected patients with the number of cannabinoid treatments in the crossover studies. There are multiple sources of bias in the analyzed studies; 2 elements have prevented conclusive results. One element was polypragmazia, a major role being played by the use of psychotropic drugs other than cannabinoids, in an effort to reduce agitation and aggressive behavior. The second one was the large number of concomitant symptoms, for example, pain (commonly causing anxiety and agitation).
No clear conclusion can be drawn on the effectiveness of psychoactive cannabinoids in the treatment of psychiatric manifestations, in particular agitation and aggression, in AD. In the future, large randomized controlled trial with adequate designs, without crossover and for longer duration, adapted to cannabinoid pharmacokinetics, is required to establish the real efficacy and safety of these drugs in aggressive and/or agitated patients with AD.
到目前为止，已进行的系统评价和荟萃分析并未提供关于使用精神活性大麻素治疗阿尔茨海默病（AD）患者神经精神症状的实际知识的充分情况。
从定量和定性的角度来看，关于使用精神活性大麻素治疗 AD 患者的神经精神症状的疗效和安全性的证据水平如何？
在 PubMed、EMBASE、Cochrane 系统评价数据库、Google Scholar Data 和 Clinicaltrials.gov 中搜索了关于大麻素治疗阿尔茨海默病激越和攻击的随机临床试验。
根据 PRISMA 2009 标准确定了试验搜索的理由、目标和方法。
在这项研究中评估的 9 篇出版物中，总共包括 6 项临床试验的数据，共有 422 名患者接受治疗，其中治疗方法是使用精神活性大麻素或安慰剂，其中一些是通过将交叉研究中选定的患者人数乘以大麻素治疗数来获得的。分析研究中存在多种偏倚来源；有两个因素阻止了得出明确的结论。一个因素是多药治疗，除了大麻素之外，还使用了其他精神药物，以努力减轻激越和攻击行为。另一个因素是大量并存症状，例如疼痛（常引起焦虑和激越）。
不能得出关于精神活性大麻素在治疗 AD 患者的精神症状，特别是激越和攻击方面的有效性的明确结论。未来需要进行更大规模的、设计合理的、无交叉的、持续时间更长的随机对照试验，适应大麻素药代动力学，以确定这些药物在具有攻击性和/或激越的 AD 患者中的真正疗效和安全性。
