帕罗西汀合并唑吡坦对抑郁症伴失眠患者的治疗效果:多中心合作随机对照研究

目的 比较抑郁症门诊患者在抗抑郁治疗（帕罗西汀）初期合用或不用安眠药（唑吡坦）对患者失眠症状、抑郁症状及其生活质量的影响,探讨抗抑郁治疗初期改善患者失眠症状的必要性与意义。方法 多中心合作、随机对照研究,为期4周;评价工具包括自编调查表、HAMD-17、HAMA、PSQI,以及生活质量调查表（SF-36）;229例抑郁症伴失眠门诊患者随机区组人帕罗西汀＋唑吡坦组或帕罗西汀组,其中221例患者进行意向性分析（ITT）,207例进行完成试验者分析。结果 帕罗西汀＋唑吡坦组治疗1周后PSQI平均减分值达5．7分（睡眠改善）,而帕罗西汀组仅1．6分（P=0．00）;治疗4周后,合用唑吡坦组患者PSQI减分值达9．7分±3．6分,HAMD减分率为68．5％,HAMA减分率为66．2％,SF-36评分改善率为89．0％,而仅用帕罗西汀组患者评分变化则分别为：6．0分±3．5分（PSQI）、56．8％（HAMD）、57．1％（HAMA）、73．0％（SF-36）,组间比较差异有统计学意义。结论抑郁症治疗初期抗抑郁药与安眠药合用,有助于快速改善患者的失眠和提高其生活质量,同时对改善抑郁症状和焦虑症状亦有协同作用。

Effects of paroxetine with or without zolpidem on depression with insomnia: a multi-center randomized comparative study

OBJECTIVE: To compare the effects of paroxethine with or without zolpidem on depression with insomnia. METHODS: 229 consecutive outpatients with the diagnosis of major depression based on the CCMD-3 criteria who visited the departments of mental counseling, psychiatrics, or neurology in 11 general hospitals the country over during a period of 4 weeks, were randomly allocated into 2 groups: paroxetine + zolpidem group (Group A, treated with paroxethine 10 - 20 mg/d and zolpidem 10 mg/d H. d. for 4 weeks) and paroxethine group (Group B, treated with paroxetine only), among which 221 underwent intention-to-treat analysis and 207 underwent completer analysis (CA). Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale-17 (HAMD-17), Pittsburg sleep quality index (PSQI), and 36-item Short Form Health Survey (SF-36) were used to evaluate the outcomes. RESULTS: One week after the beginning of treatment the reduction of PSQI score of Group A was 5.7, showing an improvement of sleep quality, significantly higher than that of Group B (1.6), and 4 weeks later the reduction of PSQI of Group A was 9.7 +/- 3.6, significantly higher than that of Group B (6.0 +/- 3.5, both P = 0.000). Four weeks after the beginning of treatment, the HAMD reduction rate of Group A was 68.5%, significantly higher than that of Group B (56.8%, P < 0.01), and the HAMA reduction rate of Group A was 66.2%, significantly higher than that of Group B (57.1%, P < 0.01), and the SF-36 score of Group A was 66 +/- 19 (last observation carry forward analysis) or 67 +/- 19 (CA), significantly higher than those of Group B (38 +/- 16 or 67 +/- 19 respectively, both P = 0.000). CONCLUSION: selective serotonin reuptake inhibitor antidepressant combined with hypnotic augments the effects of antidepressant on the depressive and anxiety symptoms.