咪达唑仑与艾司唑仑治疗失眠症的多中心双盲对照研究  

A multi-center double blind comparative study of midazolum versus estazolum for insomnia

作　　者：姜佐宁[1] 李文标[1] 黄淑贞[1] 秦英绂[1] 

机构地区：[1]首都医科大学附属北京安定医院,100088

出　　处：《中华精神科杂志》2000年第4期229-232,共4页Chinese Journal of Psychiatry

摘　　要：目的　验证咪达唑仑对失眠症的临床疗效和不良反应。方法　将 2 0 5例失眠症患者分为咪达唑仑组 (10 5例 )和艾司唑仑组 (10 0例 ) ,采用的咪达唑仑片 (7 5mg/片 )与艾司唑仑片(1mg/片 )进行多中心随机双盲双模拟对照研究。两药均为每晚睡前口服 1片 ,试验期为 10天。对患者治疗前、治疗第 5天及第 10天的睡眠状况及睡眠障碍改善情况 (入睡时间、睡眠时间、夜间醒的次数、做梦程度、日间困倦感、受试对睡眠的自我评价、医生对药物疗效的总体评价的评分 )进行评定 ,比较药物对两组患者睡眠障碍的疗效及不良反应。结果　咪达唑仑和艾司唑仑均可明显缩短入睡时间、延长睡眠时间、减少睡眠中断次数、提高睡眠质量 ,两组疗效的差异无显著性 (P >0 0 5 )。咪达唑仑在改善患者日间疲乏困倦方面优于艾司唑仑 ,治疗第 5天 (两组间差异有显著性 ,P <0 0 5 )和第 10天艾司唑仑组的减分值分别为 (0 5 1± 0 89)分及 (0 6 2± 0 97)分 ;咪达唑仑组分别为 (0 80± 0 88)分及 (0 89± 0 84)分 ;后者的残留镇静作用较轻。试验期间少数患者出现头晕、疲乏、无力等轻度不良反应 ,两组间差异无显著性 (P >0 0 5 )。结论　咪达唑仑治疗失眠症的疗效与艾司唑仑相当 ,残留镇静作用较轻 ,不良反应轻微 ,安全。Objective The purpose of this study was to investigate the clinical efficacy and side effects of midazolum for insomnia compared with estazolum Methods A multi center, double blind and double dummy comparative study was carried out with 7 5 mg midazolum daily versus 1 mg estazolum daily The sleep status of the patients was assessed before and on the fifth and tenth day of the treatment to compare the therapeutic efficacy and adverse reactions of the two drugs Results No significant difference was found for 7 5 mg/d midazolum and 1 mg/d estazolum in reducing sleep latency, duration and quality (P>0 05), but the patients in midazolum group felt less daytime sedation (P<0 05) A few patients felt dizziness and weakness during the study, and no severe side effect was found Conclusion The therapeutic efficacy of midazolum for insomnia is similar to that of estazolum with less residual sedation

关 键 词：失眠症 咪达唑仑 艾司唑仑 双盲试验 治疗 

分 类 号：R749.710.5[医药卫生—神经病学与精神病学]