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目的 :评价国产二类新药扎来普隆 (zaleplon)治疗失眠的疗效和安全性 ,以及停用后的反跳性失眠 .方法 :对 4 8例失眠患者进行扎来普隆和唑吡坦的多中心随机双盲双模拟对照、剂量可调整的研究 .其中扎来普隆组 2 4例 (5～ 10mg/d) ,唑吡坦组 2 4例 (10mg/d) ,共治疗 2周 .采用睡眠障碍量表 (SDRS)、临床总体评定量表 (CGI)评定临床疗效 ,以不良反应量表 (TESS)评定不良反应 .结果 :扎来普隆组的治疗总有效率为 77 2 7% ,显效率为 36 36 % .唑吡坦组分别为 79 17%和 2 5 0 0 % .两组相比差异无显著性 (P >0 0 5 ) .睡眠障碍量表 (SDRS)评分在治疗结束时均较基线显著减少 (F检验 ,P <0 0 1) .不良反应分析 ,两组药物不良反应的发生率无显著性差异 (P >0 0 5 ) .较常见的不良反应为头昏、口干、头痛、嗜睡及厌食等 .停药后 ,反弹性失眠少 .结论 :扎来普隆与唑吡坦治疗失眠安全有效 ,不良反应少而轻
Objective: To evaluate the efficacy and safety of domestic second-class zaleplon in the treatment of insomnia and rebound insomnia after discontinuation.Methods: Forty-eight insomniacs were treated with zaleplon and zolpidem A multicenter, randomized, double-blind, double-dummy, dose-adjusted study was performed in which 24 (5-10 mg / d) of zaliplon and 24 (10 mg / d) of zolpidem were given for 2 weeks. The clinical curative effect was assessed by SDRS and CGI, and the adverse reaction was assessed by TESS.Results The total effective rate of treatment with Zaleplon was 77 2 7% , Markedly effective rate was 36 36%. Zolpidem group was 79 17% and 25 0 0% respectively, there was no significant difference between the two groups (P 0 05) .The sleep disorder scale (SDRS) score in the treatment (F test, P <0.01) .Analysis of adverse reactions, the incidence of adverse drug reactions in the two groups showed no significant difference (P> 0.05) .The more common adverse reactions were dizziness , Dry mouth, headache, drowsiness and anorexia, etc. After withdrawal, rebound insomnia less.Conclusion: Zaleplon and zolpidem are safe and effective in the treatment of insomnia, poor The light should be less