| 扎来普隆胶囊治疗失眠症的多中心临床研究 |
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| 引用本文： | 李静,王雪,李进,黄明生,陈远光,马崔,黄淑珍. 扎来普隆胶囊治疗失眠症的多中心临床研究[J]. 华西药学杂志, 2005, 20(2): 172-174 |
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| 作者姓名： | 李静 王雪 李进 黄明生 陈远光 马崔 黄淑珍 |
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| 作者单位： | 四川大学华西医院,四川,成都,610041;湖南医科大学精神卫生研究所,湖南,长沙,410011;广州市精神病医院,广东,广州,510370;北京安定医院,北京,100088 |
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| 摘 要： | 目的 评价扎来普隆治疗失眠症的疗效和安全性。方法 符合CCMD - 3失眠症(非器质性失眠症)标准患者2 4 0例,采用随机双盲双模拟方法,均分为扎来普隆组(A组)和佐匹克隆组(B组) ,清洗3～7d后分别予扎来普隆10mg·d-1或佐匹克隆7 5mg·d-1,疗程14d。临床观察包括睡眠障碍量表(SDRS)、临床总体印象表(CGI)、治疗药物副作用量表(TESS)、不良事件记录表;实验室检查包括血常规、小便常规、肝肾功能、心电图。结果 两组基线与治疗各阶段SDRS量表总分的变化情况显示,A组有效率为86 .4 4 % ,B组为88.98% ;不良反应率分别为16 .6 7%、35 .0 0 %。结论 两组疗效相当,能有效地改善睡眠障碍,不良反应轻微,无须处理即自行消失。
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| 关 键 词： | 扎来普隆胶囊 佐匹克隆片 失眠症 临床疗效 安全性 |
| 文章编号： | 1006-0103(2005)02-0172-03 |
| 修稿时间： | 2004-11-01 |
Double blind and multi center clinical trial of Zaleplon capsule on insomnia |
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| LI Jing,WANG Xue,LI Jin,HUANG Ming-sheng,CHEN Yuan-guang,MA Cui,HUANG Shu-zhen. Double blind and multi center clinical trial of Zaleplon capsule on insomnia[J]. West China Journal of Pharmaceutical Sciences, 2005, 20(2): 172-174 |
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| Authors: | LI Jing WANG Xue LI Jin HUANG Ming-sheng CHEN Yuan-guang MA Cui HUANG Shu-zhen |
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| Affiliation: | LI Jing1,WANG Xue1,LI Jin1,HUANG Ming-sheng1,CHEN Yuan-guang2,MA Cui3,HUANG Shu-zhen4 |
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| Abstract: | OBJECTIVE To evaluate the therapeutic effect and safety of Zaleplon capsule on insomnia. METHODS 240 cases corresponding with the diagnosis criteria of insomnia of CCMD-3 were randomly treated by Zaleplon or Zopicolong for 14 d. While sleep dysfunction rating scale (SDRS), CGI and TESS were evaluated every week, blood routine test, urine test and ECG were examined before and after treatment. RESULTS The effection ratio of Zaleplon (86.44%) was lower than Zopicolong (88.98%) (P=0.693) with lower side effect ratio(P<0.01). CONCLUSION The therapeutic effect of Zaleplon on insomnia is similar to Zopiclone and the rate of adverse effect is 16.67%? |
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| Keywords: | Zaleplon Zopiclone Insomnia Safety |
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