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.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2005年第1期96-98,共3页
Chinese Journal of New Drugs
