【摘要】 目的评价扎来普隆治疗失眠的有效性和安全性。方法采用随机、双盲双模拟、阳性药平行对照、多中心、剂量可调整的研究方法。受试者分别服用扎来普隆胶囊5～10mg,qn或唑吡坦片10mg,qn,共2wk。意向性数据集(ITT)样本224例,其中唑吡坦组112例,扎来普隆组112例。符合方案数据集(PP)样本206例,其中唑吡坦组103例,扎来普隆组103例。采用睡眠障碍评定量表(SDRS)评价治疗失眠的疗效,治疗药物副作用量表(TESS)、ECG等评价药物的安全性。结果SDRS评分在治疗结束时均较治疗前显著减少(P<0.01);治疗1wk后,唑吡坦组的有效率为62.5%,扎来普隆组的有效率为58.0%;治疗2wk后,唑吡坦组的有效率为79.5%,扎来普隆组为79.5%,2组相比较,P>0.05;2药较常见的不良反应为轻度头昏、口干、头痛、嗜睡及厌食等,扎来普隆组头昏发生率显著少于唑吡坦组(P<0.05);2组中各有小部分患者出现反跳性失眠。结论扎来普隆治疗失眠的疗效与唑吡坦相似,但不良反应发生率较低。更多还原

【Abstract】 AIM To evaluate the efficacy and safety of zaleplon in the treatment of insomnia.METHODS The study was designed as a randomized,double blind,double dummy,active parallel control,multicenter and with flexible dose.The patients received either zaleplon 5-10 mg,qn or zopidem 10 mg,qn.The whole treatment course was 2 wk.Two hundred and twenty four patients enrolled the study.According to ITT sample,there were 112 patients in zaleplon group and 112 in zopidem group.The sleep disorder rating scale (SDRS) was used to evaluate the efficacy.The safety of the drug was evaluated by treatment emergent side effect scale (TESS),ECG and physical examination. RESULTS The respond rate was 58.0% in zaleplon group and 62.5% in zopidem group after one week treatment.There was no significant difference between the 2 groups.After 2 wk treatment,the respond rates were 79.5% and 79.5% respectively.The common adverse drug reactions were dizziness,dry mouth,headache,drowsiness and disgust.The rate of dizziness in zaleplon group was less than zopidem group.CONCLUSION Zaleplon is a safe hypnotic and its efficacy is comparable to zopidem.更多还原