摘要
目的:评价右旋佐匹克隆治疗失眠症患者的疗效和安全性。方法:257例失眠症患者随机分为研究组(131例)和对照组(126例)。研究组给予右旋佐匹克隆和佐匹克隆模拟剂,对照组给予佐匹克隆及右旋佐匹克隆模拟剂,治疗2周。采用睡眠障碍量表(SDRS)评定疗效。基线和终点时进行血生化、血常规、尿常规以及心电图检查,以评价安全性。结果:两组的SDRS评分在治疗2周末较基线均明显下降(P<0.01),而两组间比较差异无统计学意义(P>0.05)。治疗2周,研究组和对照组在有效率(71.0%,69.8%)方面相当(P>0.05),1周后随访,两组的症状反跳率(2.0%,3.1%)无显著差异。研究中未出现严重不良事件,两组间不良事件的总发生率差异无统计学意义(P>0.05)。结论:右旋佐匹克隆治疗失眠安全有效。
Objective：To evaluate the efficacy and safety of eszopiclone in the treatment of patients with insomnia. Method： 257 patients were randomly divided into eszopiclone group （n = 131 ） and zopiclone group （n = 126 ）. Eszopiclone group were orally given eszopiclone and zopiclone mimesis tablet, zopiclone group with zopiclone and eszopiclone mimesis tablet in the same administration for 2 weeks. Efficacy was assessed with sleep dysfunction rating scale （SDRS）. The changes of biochemical index, blood tests, urine tests and electrocardiogram were determined before and at the end of treatments to assess the safety. Results：After 2-week treatment,the scores of SDRS were decreased significantly in two groups （P 〈 0.01 ）, but no significant difference was detected between two groups （P 〉 0.05 ）. After 2-week treatment of eszopiclone and zopiclone, the respond rate （71.0% ,69.8% ） were similar （P 〉 0.05 ） ,and the rebound rates were 2.0% and 3.1% respectively after one week follow-up. No serious adverse event occurred, and rates of the adverse effects occurred same in two groups （ P 〉 0. 05 ）. Conclusion： Eszopiclone is effective and safe in the treatment of insomnia.
出处
《临床精神医学杂志》
2010年第1期26-28,共3页
Journal of Clinical Psychiatry
