右旋与消旋佐匹克隆治疗睡眠障碍的随机双盲双模拟临床试验

Randomized controlled clinical trial on(+) zopiclone versus zopiclone in the treatment of insomnia

目的以消旋佐匹克隆为阳性对照药评价右旋佐匹克隆治疗睡眠障碍的疗效及安全性。方法用双盲双模拟随机对照临床试验方法,每晚睡前,分别口服(试验与对照药)右旋和消旋佐匹克隆口服3,7.5mg,疗程为14天。结果右旋佐匹克隆(试验组)为68例,痊愈率为20.59%;消旋佐匹克隆(对照组)为57例,痊愈率为14.04%。药物不良反应发生率分别为36.76%,49.12%。2组临床疗效及药物不良反应发生率比较具有统计学差异。结论右旋佐匹克隆治疗睡眠障碍,安全、有效。

Objective To evaluate the efficacy and safety of （ ＋ ） zopiclone and zopictone in treatment of insomnia . Methods A randomized controlled double - blind, double - simulation clinical study was conducted for treatment of patients with insomnia. The dosages were of （ ＋ ） zopiclone （trial） amd zopiclone （control） 3mg and 7.5mg, respectively , and all patients have nightly drugs intake , close to bedtime. The duration of treatment was 14 days in both groups. Results Sixty eight insomnia patients were enrolled in trial group, while 57 patients recruited in controt group. The results showed that the cure for （ ＋ ） zopiclonepian and zopiclone based on sleep quality and sleep latency were 20. 59% and 14.04% （ P 〈0.05 ） , respectively. While occurrence rate of side effect were 36.76% and 49.12% （ P 〈 0.05 ）, individually. Conclusion Compared with zopiclone, （ ＋ ） zopiclonepian is a high efficacy and safety drug for insomnia.