自拟“神安Ⅲ号胶囊”与舒乐安定治疗失眠症的双盲对照研究  

Double blind control study of insomnia treatment by selfmade Shen An3 Capsule and Estozolam

作　　者：周金林[1] 汪厚根[1] 布蕾蕾[1] 董峰[2] 

机构地区：[1]湖北省鄂州市优抚医院,436000 [2]湖北省中医药研究院,430074

出　　处：《中国民政医学杂志》2002年第6期336-338,共3页Medical Journal of Chinese Civil Administration

摘　　要：目的 :探讨自拟中药制剂“神安Ⅲ号胶囊”与舒乐安定治疗失眠症的疗效和不良反应。方法 :对 12 0例失眠症患者随机分为研究组和对照组 ,分别用自拟“神安Ⅲ号胶囊”与舒乐安定 ,采用睡眠障碍量表 (SDRS) ,汉密尔顿焦虑量表 (HAMA) ,临床总体印象量表 (CGI)和付反应量表 (TESS)评定疗效和不良反应。结果 :SDRS评定研究组减分率为 4 9 3% ,对照组减分率为 4 9 5 % ,二者比较 ,结果相近 ,但研究组治疗期间无不良反应 ,停药 7天后无戒断症状 ,对照组治疗期间有部分病人出现头痛、嗜睡、记忆损害等不良反应 ,停药 7天后出现明显戒断症状 ,组间比较 ,停药 7天后SDRS :P <0 0 0 1,CGI :P <0 0 5 ,TESS :P <0 0 5。结论 :自拟“神安Ⅲ号胶囊”与舒乐安定治疗失眠症疗效相当 ,但停药7天后 ,前者疗效较稳定 ,且无不良反应 ,病人服药的依从性好。Objective: To investigate by self-made Shen An3 Capsule and Estozolam. method: 120 Cases with insomnia were divided randomly into two groups(n=62);Estozolam group (n=58).The Curative effect and harmful reaction is evaluated by sleep dysfunction rating scale(SDRS) hamiltion anxiety scale(HAMA),the clinical global impression scale(CGI),and the treatment emergent symptom scale(TESS). Results: The respetive reducing rates of self-made Shen An3 Capsule group and Estozolam group by SDRS is 49.3%,49.5%.The two results are near.But there were not harmful reactions in the former during the treatment and not withdrawal symptom after the time when the treatment had been ended for seven days.while there were harmful reactions such as dizziness,somnolence and damage of memory in the latter during the treatment and obvions withdiawal symptom after the time when the treatment had been ended for seven days which has stronger relationships as compared with the former.SDRS P <0.05 CGI P <0.05 TESS P <0.05) Conclusion: The selfmade Shen An3 and Estozolam are wellmatched in Curative effect in insomnia treatment and the former with which the patients has good dependency has more stabile effect

关 键 词：神安Ⅲ号胶囊 舒乐安定 治疗 失眠症 双盲对照研究 

分 类 号：R749.71[医药卫生—神经病学与精神病学]