扎莱普隆治疗失眠症的随机双盲对照临床试验

目的评价新药扎莱普隆治疗失眠症的有效性和安全性。方法采用随机双盲双模拟、阳性药平行对照 ,剂量可调整的研究。受试者分别口服扎莱普隆 5～ 10mg/d或佐匹克隆片 7.5～ 15mg/d。疗程 2周。结果共收集符合入组条件的失眠病人 2 0 0例 ,其中扎莱普隆组 10 0例 ,佐匹克隆组 10 0例。主要疗效指标睡眠障碍量表 (SDRS)评分在治疗结束时较基线显著减少 (P <0 .0 1)。有效率扎莱普隆组为 76%,佐匹克隆为 78%,无显著性差异。两组常见不良反应有头晕、口干、食欲减退、恶心、嗜睡、便秘 ,两组间无显著性差异。结论试验药扎莱普隆与对照药佐匹克隆具有类似的疗效与不良反应。为治疗失眠症的安全而有效的新药。

A randomized and double-blind controlled clinical trial of zaleplon for treatment of insomnia

Objective To evaluate the efficacy and safety of new agent zaleplon in treatment of insomnia. MethodsA randomized and double-blind controlled clinical trial was conducted for treating insomnia, the test group was given with zaleplon 5mg-10mg/day and the control group given with zopicolone 7.5 mg-15mg/day during two weeks treatment period.Results200 cases qualified with entrance criterion were enrolled among which 100 cases were in the test group and 100 cases in the control group. The primarily efficacy index, scores of sleep dysfunction rating scale in endpoint were significantly reduced in comparison with baseline in both groups( P <0.01). The efficacy rates of test and control group were 76%and 78% respectively, there was no significant difference between two groups( P >0.05). The common adverse reactions of both groups were giddy, dry mouth, loss of appetite, nausea, drowsiness and astriction with no significant difference between two groups. ConclusionZaleplon has similar efficacy and side effects compared with zopiclone, it is an effective and safe new agent for treating insomnia.