右佐匹克隆治疗老年期失眠症的对照研究

Controlled trial of efficacy and safety of eszopiclone in treatment of late-life insomnia

目的评估右佐匹克隆治疗老年期失眠症的疗效和安全性。方法符合失眠症诊断标准,年龄≥65岁患者,共入组80例,研究组40例,对照组40例,分别服右佐匹克隆(3～6 mg)或阿普唑仑(0.4～0.8 mg),共2周。用匹兹堡睡眠质量指数(PSQI)、汉密顿抑郁量表(HAMD)、汉密顿焦虑量表(HAMA)评估失眠严重程度和疗效,不良事件报告评价安全性。结果研究组有效率75.0%,对照组67.5%,两组无统计学意义(P>0.05)。1周和2周末,两组PSQI因子分及总分、HAMD、HAMA、CGI-SI分较治疗前均显著降低(P<0.01),研究组睡眠潜伏期、睡眠效率、白天功能紊乱因子分及PSQI总分显著低于对照组(P<0.05或P<0.01),PSQI平均减分率较对照组高(P<0.05)。对照组不良反应高于研究组(P<0.05)。结论右佐匹克隆治疗老年期失眠症安全、有效,改善主观睡眠质量优于阿普唑仑,不良反应少。

Objective To evaluate the efficacy and safety of eszopiclone in late-life insomnia.Methods 80 elder patients with insommia were randomized assigned to study group（n=40） treated with esczopiclone 3~6 mg/d or control group（n=40） treated with alprazolam 0.4~0.8 mg/d for 2weeks.PSQI,HAMD,HAMA and CGI were employed to evaluate the efficacy and outcomes.Security was evaluated with adverse events reports.Results The response rate of eszopiclone and alprazolam were 75.0% and 67.5%,respectively.At the end of 1,2 week,the score of total and subscales of PSQI,HAMD,HAMA,CGI-SI were significantly decreased in both groups（P0.01）,and score of sleep latency,sleep efficiency,daytime dysfunction and total score of PSQI in eszopiclone group were significantly lower than that of alprazolam group（P0.05 or P0.01）,and reducing rate of PSQI in eszopiclone was significantly higher than that of alprazolam（P0.05）.Conclusion It is effective and safe of eszopiclone for late-life insomnia with advantages of improvement in quality of sleep.