Trazodone Improves Sleep Parameters in Alzheimer Disease Patients: A Randomized, Double-Blind, and Placebo-Controlled Study
Trazodone Improves Sleep Parameters in Alzheimer Disease Patients: A Randomized, Double-Blind, and Placebo-Controlled Study
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DOI：
10.1016/j.jagp.2013.12.174
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发表时间：
2014-12-01
影响因子：
7.2
通讯作者：
Nobrega, Otavio T.
中科院分区：
文献类型：
--
作者：
Camargos, Einstein F.;Louzada, Luciana L.;Nobrega, Otavio T.
目的：尚无关于曲唑酮治疗阿尔茨海默病（AD）患者睡眠障碍（SD）疗效的随机临床试验。我们测试了曲唑酮治疗AD患者SD的有效性和安全性。设计：我们进行了一项双盲、随机和对照试验，在基线7-9天和2周的治疗期间。单位：大学综合医院老年医学中心。参与者：可能患有AD和SD的个体。完整分析包括30例分配至活性药物治疗组（N = 15）或安慰剂组（N = 15）的患者。干预措施：患者在晚上10：00接受曲唑酮50 mg，每日一次。或安慰剂以1：1的比例给药2周。测量：患者在干预前后使用体动记录仪和结构化量表进行评估。结果如下：与安慰剂组相比，曲唑酮使用者每晚多睡42.5分钟，根据治疗后的活动记录数据，夜间睡眠百分比增加8.5个百分点。曲唑酮和安慰剂均未引起明显的日间嗜睡或小睡。曲唑酮或安慰剂治疗对认知（简易精神状态检查、向前/向后数字跨度任务、字母-数字排序、算术、数字符号编码和符号搜索）或功能（Katz指数）均无任何影响。两组之间不良事件的频率或严重程度等级无差异。结论：本研究显示曲唑酮50 mg对社区AD伴SD患者有显著的治疗作用。
Objectives: There are no randomized clinical trials regarding efficacy of trazodone in the treatment of sleep disturbances (SD) in patients with Alzheimer disease (AD). We tested the efficacy and safety of trazodone to treat SD in patients with AD. Design: We conducted a double-blind, randomized and controlled trial during periods of 7-9 days at baseline and 2 weeks of treatment. Setting: Geriatric medical center of the university's general hospital. Participants: Individuals with probable AD and SD. The complete analysis comprised 30 patients assigned to either the active treatment group (N = 15) or the placebo group (N = 15). Intervention: Patients received 50 mg of trazodone once daily at 10: 00 P. M. or placebo in a 1: 1 ratio for 2 weeks. Measurements: Patients were evaluated using actigraphy and structured scales before and after intervention. Results: Compared with the placebo group, trazodone users slept 42.5 more minutes per night and had their nighttime percent sleep increased 8.5 percentage points according to actigraphic data post-treatment. Neither trazodone nor placebo induced significant daytime sleepiness or naps. The treatments with trazodone or placebo did not show any effects either on cognition (Mini-Mental State Examination, forward/backward digit span task, letter-number sequencing, arithmetic, digit symbol-coding, and symbol search) or functionality (Katz index). There were no differences in frequency or severity rating of adverse events between the groups. Conclusions: This study shows significant therapeutic effects of trazodone 50 mg in community-dwelling AD patients with SD.