扎来普隆胶囊与艾司唑仑片对比治疗失眠症的临床疗效观察

The efficacy of Zaleplon on insomnia compared with Estazolam

目的观察新型镇静催眠药扎来普隆治疗失眠症的疗效。方法58例失眠症患者随机接受扎来普隆胶囊5～10mg和艾司唑仑1～2mg治疗,其中扎来普隆组30例,艾司唑仑组28例。两组患者均治疗7天,停药后随访7天。结果治疗7天后,扎来普隆组总有效率76.67%,艾司唑仑组总有效率71.43%,P>0.05,说明扎来普隆和艾司唑仑对失眠均有效。扎来普隆组早段失眠程度和频度评分差值均显著大于艾司唑仑组(P<0.05),显示扎来普隆对早段失眠的改善优于艾司唑仑。两组常见不良反应为口干、食欲下降、头晕及嗜睡,发生率无统计学差异。停药后反弹性失眠发生率艾司唑仑组(14.29%)高于扎来普隆(3.33%),但亦无统计学差异。结论扎来普隆与艾司唑仑均有改善睡眠的作用。扎来普隆对早段失眠的改善更为明显,且停药后反跳率较低,治疗睡眠障碍安全有效。

Objective For investigating the efficacy of Zaleplon,a novel hypnotic agent, on insomnia. Methods 58 patients were treated randomly with Zaleplon capsule 5-10mg or Estazolam 1-2mg,in which, 30 patients were assigned to Zaleplon group, whileas 28 patients in Estazolam group.Both groups were treated for 7 days and followed up for 7 days after the treatment. Results The total response rate after 7 days treatment was 76.67% in Zaleplon group and 71.43% in Estazolam group respectively,P〉0.05,suggesting both Zaleplon and Estazolam were effective on insomnia.For early phase insomnia degree and frequence,the sore differences in Zalepton group were significatcly larger than Estazolam group （P〈0.05）,showing Zaleplon bad a better effect on early phase insomnia than Estazolam.The most common adverse effects were dry mouth, loss of appetite, dizziness,and sleepiness.The incidences had no significant difference. The rebound insomnia incidence in Estazolam （14.29%） was higher than Zaleplon （3.33%）,but without significant difference. Conclusion Both Zaleplon and Estazolam were effective on insomnia.Zaleplon was more effective on early phase insomnia,with a lower rebound rate after withdraw.It is a effective and safe agent for insomnia treatment.