国产佐匹克隆与艾司唑仑治疗失眠症的双盲对照研究

A DOUBLE-BLIND COMPARATIVE STUDY ON ZOPICLONE AND ESTAZOLUM IN PATIENTS WITH INSOMNIA

目的 验证国产佐匹克隆对失眠症的有效性和安全性。方法 将 15 3例失眠症患者分为佐匹克隆组 (77例 )和艾司唑仑组 (76例 ) ,采用国产佐匹克隆 (7.5mg/片 )与艾司唑仑 (1mg/片 ) ,进行随机双盲双模拟对照研究 ,两药均为每晚睡前口服 1片 ,试验期为 2周。对患者治疗前、治疗第 1周、第 2周的睡眠状况及睡眠障碍改善情况 (入睡时间、总睡眠时间、早醒延迟时间、觉醒次数、醒后状况 )进行评定 ,比较药物对 2组患者睡眠障碍的疗效和不良反应。结果 佐匹克隆和艾司唑仑均可明显缩短入睡时间、延长睡眠时间、提高睡眠质量。 2组疗效的差异无显著性。佐匹克隆在改善患者醒后状况方面优于艾司唑仑 ,治疗第 2周 ,2组间差异有显著性 (P <0 .0 1) ,提示佐匹克隆的残留镇静作用较轻。佐匹克隆组患者在用药期间主要的不良反应有口苦、口干、头痛、头晕、食欲减退 ,但程度均较轻。结论 国产佐匹克隆在治疗失眠症方面与艾司唑仑疗效相当、副作用轻、安全性好 ,是一种有效。

Objective To evaluate the clinical curative effects and the side effects of zopiclone on insomnia.Methods Patients who met the CCMD 2 R criteria for insomnia were randomly divided into two groups treated with tablets of 7.5mg zopiclone daily versus 1mg estazolum daily in a double dummy study respectively.Both drugs were taken before sleep each night,two weeks as a course of treatment.The state of sleep and the sleep improvement were assessed before and after the first and second week of treatment to compare the curative effects and adverse reactions of the two drugs.Results Reduced sleep latency,prolonged duration of sleep and improved sleep quality were obtained in both groups.Zopiclone was found superior to estazolum in improving the state of sleep.No severe side effects were found in the study.Zopiclone had less residue sedation and side effects than estazolum.Conclusion The therapeutic efficacy of zopiclone to treat insomnia is similar to that of estazolum.It has proved that zopiclone is an effective drug for the treatment of insomnia with good tolerance and fewer side effects.