帕罗西汀联合小剂量阿米替林治疗抑郁性睡眠障碍的临床疗效和安全性观察

目的:比较单用帕罗西汀及联合小剂量阿米替林治疗抑郁性睡眠障碍(DSD)的疗效和安全性。方法:60例患者随机分为A、B2组,A组晨服帕罗西汀20mg/d;B组晨服帕罗西汀20mg/d,睡前1～2h另服阿米替林6.25～25mg。疗程均6周。分别于治疗前以及治疗后2、4、6周末采用汉密尔顿抑郁量表(HAMD)评分,观察记录不良反应;同时由患者逐日填写“睡眠障碍记录表”。结果:治疗6周后,2组睡眠感均有所改善,但B组比A组起效迅速,作用持久(均P<0.01)。2组的其他临床疗效无统计学差异(P>0.05);A组主要不良反应为在治疗初期焦虑、失眠,B组为口干、便秘及性功能减退等。结论:帕罗西汀与小剂量阿米替林联用比帕罗西汀单用能更有效安全地治疗抑郁性睡眠障碍。

Observations on efficacy and safety of paroxetine plus low-dose amitriptyline in treating patients with depressive sleep disorder

Objective: To compare the efficacy and safety of paroxetine plus low-dose amitriptyline with paroxetine use alone in treating patients with depressive sleep disorder. Methods:Sixty patients were randomly divided into two groups: group A and group B. The patients in the group A were given paroxetine 20 mg/day in the morning. The patients in the group B were given paroxitine 20 mg/day in the morning and amitriptyline 6.25~25 mg at 1~2 h before bedtime at night. The duration of therapy was six weeks. HAMD was scored before the therapy and in the end of 2nd, 4th, and 6th week after the therapy. The adverse reactions of patients in the two groups were observed and recorded, while the"Sleep Difficulty Form"was filled by the patients every day. Results:After six weeks of treatment, the patients in the two groups were improved in their feeling of sleep. Compared with the group A, the group B had more rapid and sustained action to facilitate sleep (P<0.01). There were no statistically differences in other clinical effects between the two groups (P>0.05). The common adverse reactions in the group A were anxiety and insomnia at the initiation of therapy, and in the group B were dry mouth, constipation, and decreased sexual function. Conclusion:Compared with paroxetine use alone, paroxetine plus low-dose amitriptyline is more effective and safer in treating the depressive sleep disorder.