扎来普隆胶囊治疗失眠症的临床研究

A Double Blind Clinical Trial of Novel Hypnotic Zaleplon in Treatment of Insomnia

目的 :评价扎来普隆胶囊治疗失眠症的疗效及安全性。方法 :采用多中心随机双盲双模拟平行对照的方法 ,共观察 2 14例 ,治疗组 10 6例 ,对照组 10 8例 ,疗程 10天。治疗期间采用睡眠状况评定表对睡眠情况进行评定。结果 :两组治疗 10天后均可明显改善睡眠 ,与治疗前相比 ,有显著性差异 (P <0 0 0 1) ;治疗组有效率 75 4 7% ,对照组有效率 72 2 2 % ,临床疗效两组无显著性差异 (P >0 0 5 ) ;两组均明显缩短入睡时间 ,延长睡眠时间 ,减少夜间醒的次数 ,减轻梦的程度 ,减轻白天困倦 ,提高睡眠质量。以上各项指标与治疗前相比均有显著性差异 (P <0 0 0 1) ,但两组间比较无统计学意义 (P >0 0 5 )。两组不良反应发生率为治疗组17 5 9% ,对照组 19 2 7% ,两组间无显著差异 (P >0 0 5 )。扎来普隆胶囊不良反应主要为头晕、乏力、头痛。结论

OBJECTIVE: To evaluate the efficacy and safety of domestic made novel hypnotic z aleplon. METHODS:Total sample 214 cases were observed with randommiyed double bl ind and double dummy method, including 106 cases of treatment group zaleplon and 108 cases of zolpedem as control group. Both group followed a 10 day treatment course. RESULTS:Both group revealed cimilian obvious clinical efficacy at the en d of treatment, i. e. (1) marked improvement of sleeplessness as compared with b efore and after treatment( P <0.001); (2)effectiveness of treatment group was 75 .49% whereas control group 72.22%( P >0.05); (3)sleep induction time and inte rmittent awakening both shortened, while total sleeping time markedly prolonged; (4)no more nightmare as well as hungover were reported. As for adverse reaction , only mild symptoms such as headache, digginess or fatigue were observed in mi nority cases. CONCLUSION:Zaleplon is an effective drug for insomnia which may re lieve the trouble of sleeplessness.