扎来普隆胶囊治疗失眠症的多中心随机双盲对照试验  

Efficacy and safety of zaleplon in the treatment of insomnia

作　　者：陈晋东[1] 赵靖平[1] 国效峰[1] 罗琼[1] 薛志敏[1] 李乐华[1] 马崔[2] 许秀峰[3] 高成阁[4] 陈远光[1] 

机构地区：[1]中南大学湘雅二医院精神卫生研究所,长沙410011 [2]广州市精神病医院,广州510370 [3]昆明医学院第一附属医院,昆明650032 [4]西安交通大学第一医院,西安710061

出　　处：《中国新药杂志》2005年第1期96-98,共3页Chinese Journal of New Drugs

摘　　要：目的:评价国产Ⅱ类新药扎来普隆胶囊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、阳性药平行对照、剂量可调整研究。入选229例失眠症患者,随机分为试验组108例和对照组111例,分别口服扎来普隆胶囊5～10mg·d^(-1)或佐匹克隆片7.5～15mg·d^(-1),两组疗程均为14d。结果:睡眠障碍量表(SDRS)评分在治疗结束时两组较基线均显著减少(P<0.01);试验组的有效率为82.41%,对照组的有效率为82.88%,两组比较差异无显著性(P>0.05)。不良反应分析显示两药较常见的不良反应为口干、头昏、口苦、恶心、头痛,均未出现严重的不良反应。结论:扎来普隆胶囊治疗睡眠障碍安全、有效。Objective:To evaluate the efficacy and safety of a new agent zaleplon in treatment of insomnia. Methods:A multicenter, randomized, double-blind and parallel-controlled clinical trial recruited 229 patients with insomnia. The patients were randomized to orally receive either zaleplon 5～10mg daily (n=108) or zopicolone 7.5～15mg daily (n=111) for 14 days. Results:Both groups showed significant improvement in the sleeping dysfunction rating scale compared to the baseline data (P<0.01). In the clinical trial with zaleplon, there was no significant difference from zopicolone with respect to insomnia treatment (82.41% vs. 82.88% , P>0.05). No notable difference was observed in the overall incidence of adverse events, including dry month, dizziness, bitter taste, nausea and headache,between zaleplon and zopicolone through 14 days. Conclusion: Zaleplon offers an alternative to treat insomnia.

关 键 词：扎来普隆 失眠症 佐匹克隆 

分 类 号：R973.3[医药卫生—药品] R969.4[医药卫生—药学]