扎来普隆、佐匹克隆和艾司唑仑治疗失眠症的对照研究

A comparison study of zaleplon, zopiclone and estazolam in the treatment of insomnia

目的评价扎来普隆片、佐匹克隆片和艾司唑仑片治疗失眠症的疗效和不良反应。方法将156例符合ICD-10非器质性失眠症标准的患者随机分为扎来普隆组(n=50)、佐匹克隆组(n=53)和艾司唑仑组(n=53),治疗期2周。疗效观察指标采用睡眠障碍量表(SDRS)和药物副作用量表(TESS)评价安全性。结果扎来普隆组、佐匹克隆组和艾司唑仑组的有效率分别为96.00%、94.34%、96.23%,三组SDRS评分均呈显著降低(P<0.05);扎来普隆组、佐匹克隆组早段失眠程度和频度评分差值显著大于艾司唑仑组(P<0.05),扎来普隆组和佐匹克隆组比较差异无统计学意义(P>0.05),显示扎来普隆、佐匹克隆对早段失眠的改善相当,均优于艾司唑仑。不良反应发生率扎来普隆组和佐匹克隆组比较差异无统计学意义(P>0.05)。但二者显著低于艾司唑仑组(P<0.05)。结论扎来普隆、佐匹克隆和艾司唑仑对入睡困难具有相似的疗效。扎来普隆对早段失眠的改善更为明显,不良反应均少于艾司唑仑。

Objective To study the efficacy and safeness of zaleplon compared with zopiclone and estazolam in the treatment of insomnia. Method 156 cases with insomnia were enrolled,the zaleplon group （n=50）,the zopiclone group （n= 53） and the estazolam group （n = 53） were treated for 14 days.The therapentic effects and adverse reactions were assessed with the Sleep Dysfunction Rating Scale（SDRS） and Treatment Emergent Sympion Scale （TESS）. Results The effective ratio of zaleplon, zopiclone and estazolam group were 96.00%, 94.34%, 96.23%, three groups of SDRS scores were significantly lower （P〈 0.05）; For early phase insomnia degree and frequence, zaleplon has similar efficacy to zopiclone（P 〉 0.05）,but zaleplon and zopiclone had better effect than estazolam（P 〈 0.05）. There was no statistical significance Incidence of adverse reaction between zaleplon and zopiclone group（P 〉 0.05）. But they were both significantly lower than that of estazolam group （P 〈 0.05）.Conclusion Zaleplon, zopiclone and estazolam similar curative effect. Zaleplon and zopiclone were more effective on early phase insomnia. They had less side effect in safety compared with estazolam.