溴替唑仑治疗失眠症患者疗效和安全性的随机双盲对照研究

The efficacy and safety of brotizolam for the treatment of insomnia: a randomly blinded controlled trial

目的:评价溴替唑仑治疗中国人群失眠症的有效性和安全性。方法:采用随机、双盲双模拟、阳性药平行对照、剂量可调整的研究方法,共纳入符合中国精神障碍分类与诊断标准第3版失眠症诊断标准的患者32例,随机分为溴替唑仑组和艾司唑仑组各16例,治疗2周,观察反跳期1周。主要疗效指标采用睡眠障碍评定量表(SDRS),在治疗前、治疗后1、2和3周测评,并对药物不良反应进行安全性评价。结果:治疗2周,两组SDRS评分均较治疗前显著下降(P<0.01),但组间比较差异无统计学意义。治疗1周艾司唑仑组和溴替唑仑组有效率均为62.5%(χ2=0,df=1,P>0.05);治疗2周分别为68.8%和87.5%(χ2=1.65,df=1,P>0.05);治疗3周分别为43.8%和37.5%(χ2=1.13,P>0.05),各时点组间有效率差异均无统计学意义。溴替唑仑组有2例(12.5%)和艾司唑仑组有4例(25.0%)出现不良反应。结论:溴替唑仑治疗失眠症的疗效与艾司唑仑相似,治疗睡眠障碍安全有效。

Objective：To evaluate the efficacy and safety of brotizolam for the treatment of insomnia in China. Method：The study was designed as a random,double blind,double simulated research,controlled with active medicine and treated with flexible dose. Totally 32 patients with insomnia were recruited according to Chinese classification and diagnostic criteria of mental disorders third edition and were evenly divided into two group （ 16 patients in brotizolam group and 16 patients in estazolam group） . The whole treatment course lasted 2 weeks followed with 1 week administration of placebo. The sleep disorder rating scale （ SDRS） was used to evaluate the efficacy at baseline,the end of 1st week,2nd and 3rd week after treatment. The side effect of the drug was evaluated for safety. Results：At the end of 2nd week after treatment,SDRS scores of both groups decreased significantly（ P 0. 01） but there was no statistical difference between groups （ P 0. 05） . At the end of 1st week,both two group showed effective rate of 62. 5% （ χ2 = 0,df = 1,P 0. 05） ; at the end of 2nd week, estazolam group showed effective rate of 68. 8% ,while brotizolam group showed an effective rate of 87. 5% （ χ2 = 1. 65,df = 1,P 0. 05） ; at the end of 3rd week,estazolam group showed effective rate of 43. 8% ,while brotizolam group showed an effective rate of 37. 5% （ χ2 = 1. 13,P 0. 05 ） ,the effective rates were no significant difference between brotizolam group and estazolam group at each point of time. Two patients （ 12. 5% ） in brotizolam group had the adverse effects while four patients （ 25. 0% ） in control group had adverse effects. Conclusion：Brotizolam is an effective and safe drug for the treatment of insomnia,which is similar to estazolam.