唑吡坦治疗老年原发性失眠的开放性前瞻性多中心自身对照研究

Efficacy and safety of zolpidem in treatment of primary insomnia in Chinese elderly： an open, selfcontrolled, multicenter study

目的评价唑吡坦5mg每日1次治疗老年原发性失眠的疗效和安全性。方法采用开放性、前瞻眭、固定剂量、多中心、自身对照的研究方法。115例符合美国精神障碍诊断和统计手册第4版原发性失眠诊断标准的老年门诊患者每日1次服用固定剂量唑吡坦5mg，疗程3周。以治疗第1周末匹兹堡睡眠质量指数评分（PSQI）相对于基线的差值作为研究的主要疗效评价指标，次要疗效指标包括：治疗第3周末PSQI评分相对于基线的差值，治疗第1周末和第3周末主观睡眠有效参数评分（睡眠潜伏期、总的睡眠时间、睡眠质量）相对于基线的差值，治疗第3周末17项汉密尔顿抑郁量表（HAMD-17）评分和汉密尔顿焦虑量表（HAMA）评分相对于基线的差值。结果治疗第1周末，PSQI量表总分较基线下降2．8分，差异有统计学意义（P〈0．01）；治疗第3周末，PSQI评分较基线下降3．2分，差异有统计学意义（P〈0．01）；治疗第1周末和第3周末主观睡眠有效参数均有明显改善：睡眠潜伏期缩短（P〈0．01），睡眠时间延长（P〈0．01），日间功能提高（P〈0．01）；治疗第3周末，患者的HAMD-17和HAMA评分较基线均有降低（P〈0．01）；不良事件的发生率为19．1％，主要为头晕、头痛、困倦、恶心、乏力等，程度为轻、中度。结论每日1次服用固定剂量唑吡坦5mg治疗老年原发性失眠安全有效。

Objective To evaluate the clinical efficacy and safety of zolpidem in treatment of primary insomnia in elderly patients. Methods An open, perspective, fixed-dose, muhieentre and selfcontrolled clinical trial was conducted. Total of 115 elderly patients who met with the Diagnostic and Statistical Manual of Mental Disorders, 4^th edition criteria for primary insomnia were administered 3 week nightly treatment with zolpidem 5 mg. The primary efficacy measurement was the change of Pittsburg Sleep Quality Index（PSQI） score after 1 week treatment in comparison with the baseline. The secondary efficacy measurement included the changes from baseline in total score of the PSQI, Hamilton Depression Scale （HAMD-17） and Hamilton Anxiety Scale （HAMA） and self-reported sleeping parameters （latency of falling asleep, total sleeping time and sleeping quality） after 3 week treatment. Results The mean reduction score 17 items of PSQI were 2. 8 after 1 week treatment and 3.2 at the end of 3 week （ P 〈 0. 01 ）. The selfreported sleeping parameters were much improved from the baseline （P 〈 0. 01 ）. The total scores of HAMD and HAMA were reduced significantly （ P 〈 0. 01 ） after 3 week treatment. The overall incidence of adverse events was 19. 1%, with the frequent adverse events of dizziness, headache, sleepiness, nausea and fatigue, and the severity was mild or moderate. Conclusion It is effective and safe of zolpidem 5 mg nightly in treatment of elderly insomnia patients.