二类新药扎来普隆治疗失眠的II期临床研究

The Second Phase Clinical Trials of the Second Category Novel Hypnotic, Zaleplon for the Treatment of Insomnia

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 。

Objective: To evaluate the efficacy and safety of a zaleplon recently approved nonbenzodiazepine hypnotic in the treatment of primary insomnia, and to observe rebound insomnia upon discontinuation of therapy. Methods: A multicenter, randomized, double-blind, active drug-comparator parallel study with both 5mg and 10mg dose were carried out. 48 patients who met the CCMD-2-R criteria of primary insomnia were entered the study. The 24 cases of total patients were treated with zaleplon (5～10?mg/d) and the others were treated with zolpidem (10mg/d) for 2 weeks. The efficacy was evaluated by clinical judgment, SDRS, CGI,et al. The safety was assessed in terms of TESS. Results: By the end of this study, the scores of sleep dysfunction rating scale (SDRS) were significantly lower through 3 weeks of treatment than datum line (P<0 01), the rate of efficacy and marked improved rate respectively were 79 17% and 25 00% for zolpidem, 77 27% and 36 36% for zaleplon. There was no significant difference in any efficacy measurement between zaleplon group and zolpidem group. The main side-effects of both groups were dizziness, dry mouth, headache, somnolence, anorexia, et al. There was no significant difference in incidence of side effect between zaleplon group and zollidem group. Conclusion: Zaleplon is an effective hypnotics with less side effects and better safety.