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首页> 外文期刊>The American journal of geriatric psychiatry: official journal of the American Association for Geriatric Psychiatry >Tetrahydrocannabinol in Behavioral Disturbances in Dementia: A Crossover Randomized Controlled Trial
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Tetrahydrocannabinol in Behavioral Disturbances in Dementia: A Crossover Randomized Controlled Trial

机译：四氢大麻酚在痴呆的行为障碍中：交叉随机对照试验。

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Objectives: Neuropsychiatric symptoms (NPS) are highly prevalent in dementia, but effective pharmacotherapy without important side effects is lacking. This study aims to assess the efficacy and safety of oral tetrahydrocannabinol (THC) in the treatment of NPS in dementia. Design: Randomized, double-blind, placebo-controlled, repeated crossover trial, consisting of six treatment blocks of 2 weeks each. Setting: Two hospital sites in The Netherlands, September 2011 to December 2013. Participants: Patients with dementia and clinically relevant NPS. Intervention: Within each block THC (0.75 mg twice daily in blocks 1-3 and 1.5 mg twice daily in blocks 4-6) and placebo were administered in random order for 3 consecutive days, followed by a 4-day washout. Measurements: Primary outcome was change in Neuropsychiatric Inventory (NPI) score. Analyses were performed intention-to-treat. Data from all subjects were used without imputation. Sample size required for a power of 80% was 20 patients, because of repeated crossover. Results: 22 patients (15 men, mean age 76.4 [5.3] years) were included, of whom 20 (91%) completed the trial. THC did not reduce NPI compared to placebo (blocks 1-3: 1.8, 97.5% CI: -2.1 to 5.8; blocks 4-6: -2.8, 97.5% CI: -7.4 to 1.8). THC was well tolerated, as assessed by adverse event monitoring, vital signs, and mobility. The incidence of adverse events was similar between treatment groups. Four non-related serious adverse events occurred. Conclusions: This is the largest randomized controlled trial studying the efficacy of THC for NPS, to date. Oral THC did not reduce NPS in dementia, but was well tolerated by these vulnerable patients, supporting future higher dosing studies.
机译：目的：神经精神症状（NPS）在痴呆症中非常普遍，但缺乏有效的药物治疗且没有重要的副作用。这项研究旨在评估口服四氢大麻酚（THC）治疗痴呆症中NPS的疗效和安全性。设计：随机，双盲，安慰剂对照，重复交叉试验，包括六个疗程，每个疗程2周。地点：荷兰的两家医院，2011年9月至2013年12月。研究对象：痴呆症患者和临床相关的NPS。干预：在每个区块中，THC（第1-3区块每天两次，每次0.75 mg，第4-6区块每天两次，两次1.5mg）和安慰剂连续3天随机给药，然后进行4天冲洗。测量：主要结果是神经精神病学量表（NPI）得分的变化。进行意向性治疗分析。来自所有受试者的数据均不加推定。由于反复交叉，需要80％的功效的样本量为20名患者。结果：纳入22名患者（15名男性，平均年龄76.4 [5.3]岁），其中20名（91％）完成了试验。与安慰剂相比，THC并未降低NPI（方框1-3：1.8，97.5％CI：-2.1至5.8;方框4-6：-2.8，97.5％CI：-7.4至1.8）。通过不良事件监测，生命体征和活动能力评估，THC的耐受性良好。治疗组之间不良事件的发生率相似。发生了四个无关的严重不良事件。结论：这是迄今为止研究THC对NPS疗效的最大的随机对照试验。口服THC并不能降低痴呆症中的NPS，但这些弱势患者对它的耐受性很好，支持了未来的更高剂量研究。

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