扎来普隆与唑吡坦治疗失眠症的多中心随机双盲对照比较

目的 :评价国产Ⅱ类新药扎来普隆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、阳性药平行对照研究。唑吡坦组 12 0例 ,扎来普隆组 118例分别口服扎来普隆片 10mg·d- 1或唑吡坦片 10mg·d- 1。 14d为一个疗程。结果 :意向性 (ITT)分析样本病人有 2 38例。疗效评价的睡眠障碍量表 (SDRS)评分在治疗结束时较基线显著减少 (F检验 ,P <0 .0 1)。唑吡坦组的有效率77.5 % ,扎来普隆组的有效率 73.7% ,差异无显著意义 (P >0 .0 5 )。不良反应分析显示 2组较常见的不良反应为思睡、口干、便秘、头晕和头痛。结论 :国产扎来普隆与唑吡坦具有类似的疗效 ,不良反应相当。为治疗睡眠障碍的安全而有效的新药。

Zaleplon vs zolpidem in treatment of insomnia: a multicenter, randomized,double-blind controlled clinical trial

AIM: To evaluate the efficacy and safety of domestic new agent zaleplon in treatment of insomnia. METHODS: A multicenter, randomized and double blind controlled clinical trial was conducted for treating insomnia. The zaleplon group ( n =118) was treated with zaleplon 10 mg·d -1 and the zolpidem group ( n =120) was treated with zolpidem 10 mg·d -1 for 14 d. RESULTS: Two hundred thirty eight patients with insomnia were enrolled by intention to treat analysis. The scores of sleep dysfunction rating scale in endpoint were significantly reduced by comparison with baseline in both groups ( P <0.01). The efficacy rates of zaleplon group and zolpidem group were 73.7 % and 77.5 %, respectively. There was no significant difference between two groups( P >0.05). The common adverse reactions of both groups were drowsiness, dry mouth, constipation, dizziness and headache. The adverse reactions had no significant difference between two groups ( P >0.05). CONCLUSION: Zaleplon has similar efficacy and adverse reactions compared with zolpidem. It is an effective and safe new agent for treatment insomnia.