小剂量米安色林治疗慢性失眠初期效果评价

目的:评价小剂量米安色林(7.5 mg)治疗慢性失眠初期效果。方法:选择慢性失眠非严重期患者20例,米安色林7.5 mg·d^-1,研究周期为21 d,在第2~3周期间停药2~3 d后安慰剂治疗1 d。用匹兹堡睡眠质量指数量表(PSQI)评分对患者治疗后1周、第3周与治疗前对比评定疗效,副反应量表(TESS)评定药物不良反应。第8~20天多导睡眠监测(PSG)评估药物和安慰剂治疗期睡眠潜伏期(SL)、总睡眠时间(TST)、快速眼动睡眠时间(REM)、慢波睡眠时间(N3)的变化,比较药物与安慰剂疗效差异。结果:治疗3周PSQI评分减少到(3.9±2.2),与治疗前评分(14.3±2.1)对比有显著性差异(P<0.05),PSG结果显示药物较安慰剂治疗增加了TST和N3期时间,2组对比(435.5±45.2/411.2±71.6,16.5±15.6/9.6±10.0),统计学分析有显著性差异(P<0.05),结果证实小剂量米安色林治疗失眠增加睡眠时间和深睡眠时间效果显著。2例出现有轻度头晕和思睡,无需要特殊处理。结论:小剂量米安色林治疗慢性失眠初期有效,增加睡眠时间和深睡眠时间效果显著,有改善睡眠效应。

Evaluated effection of small dose of mianserin treatment on chronic insomnia disorder in preliminary stage

OBJECTIVE To evaluate the initial effect of low-dose mianserin (7.5 mg) in the treatment of chronic insomnia.METHODS Twenty patients with non-severe chronic insomnia were selected and treated with mianserin 7.5 mg·d^-1 with a total duration of 21 days, followed by 1 day of placebo treatment after 2 to 3 days of discontinuation during weeks 2 to 3. PSQI score was used to evaluate the efficacy of the patients at 1 week and 3 weeks after treatment compared with that before treatment, and TESS was used to evaluate adverse drug reactions. PSG was performed on days 8 to 20 to assess changes in SL, TST, REM, and N3 during drug and placebo treatment periods and to compare drug and placebo efficacy differences.RESULTS After 3 weeks of treatment, the PSQI score decreased to (3.9±2.2), which was significantly different from the score before treatment (14.3±2.1) (P<0.05). The PSG results showed that the drug increased the TST and N3 stage time compared with the placebo treatment, which was significantly different between the two groups (435.5±45.2/411.2±71.6, 16.5±15.6/9.6±10.0) (P<0.05). The results confirmed that the low-dose mianserin treatment of insomnia increased the sleep time and deep sleep time significantly.Two patients reported mild dizziness and drowsiness, and no special treatment was required.CONCLUSION Low-dose mianserin is effective in the treatment of chronic insomnia at the early stage, with significant effect of increasing sleep time and deep sleep time, and improving sleep effect.