睡眠障碍的药物治疗随机双盲对照研究

Comparison between Imported and Homebred Zopitan

目的 :比较国产和进口酒石酸唑吡坦在治疗失眠症上的疗效和副作用。方法 :采用多中心双盲随机对照研究方法 ,共纳入 10 3位失眠症患者 (CCMD -2 -R标准 ) ,其中 95例完成 3天清洗期和为期 2周的治疗 ,国产组 49例 ,进口组 46例。在治疗前后用睡眠障碍评定量表 (SDRS)和汉密尔顿焦虑量表及临床总体印象量表评定疗效 ,用TESS量表评定副作用。结果 :经过治疗 ,两组的上述疗效评分均下降 ,与治疗前比有统计学意义 ,其中 ,进口组睡眠障碍评分由 2 3± 7下降到 13± 7,国产组由 2 3± 6降到 13± 8。但各种测评的两组间差异没有统计学意义 ,包括副作用评价。结论 :国产酒石酸吡唑坦与进口产品对失眠症有同等疗效 ,副作用相似。

Objective:To compare the therapeutic effect and side effects of imported and homebred Zopitan Methods:A multiple center double blind random control study was made in 105 patients diagnosed as insomnia according to diagnostic criteria of ICD-10 Ninety-five patients completed the study, with 46 in imported group, 49 in homebred group Sleep Dysfunction Rating Scale (SDRS), HAMA and CGI were used to assess the effect before and after 2 weeks treatment TESS was used to assess the side effects Result:After treatment, both groups decreased in the above assessment of clinical effects, with SDRS score decreased from 23±7 to 13±7 in imported group and 23±6 to 13±8 in homebred group There was no significant difference between the results of the two groups in all above assessments including that of the side effects assessment Conclusion:Homebred Zopitan had same effect as the imported one and with similar side effects