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国产扎来普隆治疗失眠症随机对照研究

Randomly controlled study on insomnia treated with domestic zaleplon

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【作者】 林凯张鸿燕李华芳魏竟马崔陈远光舒良

【Author】 LING Kai,ZHANG Hong-yan,LI Hua-fang,WEI Jing,MA Cui,CHEN Yuan -guang,SHU Liang.The 6th Hospital of Beijing University,Beijing 100083,China

【机构】 北京大学第六医院上海市精神卫生中心北京协和医院广州市精神病医院湖南医科大学精神卫生研究所北京大学第六医院 100083100083

【摘要】 目的:评价国产扎来普隆治疗失眠症的有效性和安全性。 方法:采用多中心随机双盲双模拟、阳性药物平行对照的研究方法。 结果:共2 15例,其中扎来普隆组10 6例,佐匹克隆组10 9例。完成试验的2 0 3例,扎来普隆组97例,佐匹克隆组10 6例;扎来普隆组的有效率77 .0 % ,佐匹克隆组的有效率80 . 0 % ;两组不良反应发生率分别为2 9. 3%和36 . 7% ;均无显著差异。较常见的不良反应为口干、头晕及嗜睡。 结论:扎来普隆能改善睡眠,不良反应较少,是一种治疗睡眠障碍安全而有效的新药。

【Abstract】 Objective:To observe the efficacy and safety of domestic zaleplon capsule in the treatment of insomnia. Method:Th e study was a randomized,double blind,double imitation,multi-center control tri al. Results:215 out-patients were received randomly zaleplon( n=106) or zopiclon(n=109).Among all the patients,203 completed the full observation.The response rates of zaleplon and zopiclon were 77.3% and 80.0% re spectively. 29.3% patients with zaleplon and 36.7% patients with zopoclon had ad verse events,some of which,such as dry mouth,drowsiness and drizzling were repor ted among two group patients more frequently. Conclusion:Zalepl on is an effective and safe drug in the treatment of insomnia.

【关键词】 扎来普隆佐匹克隆失眠症
【Key words】 zaleplonzopicloninsomnia
  • 【文献出处】 临床精神医学杂志 ,Journal of Clinical Psychological Medicine , 编辑部邮箱 ,2005年02期
  • 【分类号】R749
  • 【被引频次】3
  • 【下载频次】136
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