扎来普隆胶囊治疗失眠症的多中心临床研究  

Double blind and multi center clinical trial of Zaleplon capsule on insomnia

作　　者：李静[1] 王雪[1] 李进[1] 黄明生[1] 陈远光[2] 马崔[3] 黄淑珍[4] 

机构地区：[1]四川大学华西医院,四川成都610041 [2]湖南医科大学精神卫生研究所,湖南长沙410011 [3]广州市精神病医院,广东广州510370 [4]北京安定医院,北京100088

出　　处：《华西药学杂志》2005年第2期172-174,共3页West China Journal of Pharmaceutical Sciences

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。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%?

关 键 词：扎来普隆胶囊 佐匹克隆片 失眠症 临床疗效 安全性 治疗 

分 类 号：R749.7[医药卫生—神经病学与精神病学] R971.3[医药卫生—临床医学]