摘要
目的:评估新研发的右旋佐匹克隆治疗失眠症的疗效和安全性。方法:本研究是随机、双盲双模拟、平行对照设计的多中心临床试验。研究对象是符合《中国精神障碍分类和诊断标准-第3版》(CCMD-3)失眠症诊断标准的门诊或住院患者,共入组225例,试验组113例,对照组112例,分别睡前服用固定剂量的右旋佐匹克隆(3mg)或阳性对照药佐匹克隆(7.5mg),连续治疗2周。用睡眠障碍量表(Sleep Dysfunction Rating Scale,SDRS)评估失眠严重程度,以减分率作为评价疗效的主要指标。根据生命体征、躯体检查、实验室及心电图检查、不良事件报告评价安全性。结果:右旋佐匹克隆组平均SDRS减分率为60.0%,佐匹克隆组为62.5%(P>0.05);不良反应总发生率各为29.41%和26.27%,严重程度为轻至中度,其中以口苦感为最为常见,两组均未见严重不良反应。结论:右旋佐匹克隆短期治疗失眠症有效,安全性良好。
Objective： This randomized, double-blind, zopiclone-controlled, multi-center clinical trial assessed the efficacy and safety of eszopiclone in treating patients with primary insomnia. Methods： A total of 225 outpatients with primary insomnia were randomized to receive either eszopiclone 3 mg（ n = 113 ） or zopiclone 7. 5 nag （ n = 112 ） at bedtime for 2 weeks. The diagnosis of primary insomnia was made according to the Chinese Classification and Diagnostic Criteria for Mental Disorders, the 3rd edition （ CCMD-3 ） criteria. Efficacy was evaluated with score changes of the Sleep Dysfunction Rating Scale （ SDRS ） and Clinical Global Impression （ CGI ）, and safety with physical examination, laboratory tests, electrocardiography and side effects report. Results： Patients treated with eszopiclone had similar reduction rate of SDRS score （ 60. 0% ） to ones with zopiclone （62.5%） . Treatment was well tolerated by patients, and the most common treatment-related adverse event was unpleasant taste. Conclusion： Eszopiclone is effective in treatment of primary insomnia with well toleronce.
出处
《中国心理卫生杂志》
CSSCI
CSCD
北大核心
2009年第8期579-583,594,共6页
Chinese Mental Health Journal
关键词
失眠
入睡和睡眠维持障碍
右旋佐匹克隆
随机对照试验
多中心研究
insomnia
sleep initiation and maintenance disorder
eszopiclone
randomized controlled trial
multicenter study
