解郁丸与艾司唑仑治疗失眠症对照研究

目的 探讨解郁丸与艾司唑仑治疗失眠症的临床疗效和安全性.方法 将60例失眠症患者随机分成两组,每组30例,研究组口服解郁丸治疗,对照组口服艾司唑仑治疗,观察4周.于治疗前及治疗2周、4周末采用匹兹堡睡眠质量指数、睡眠障碍评定量表评定临床疗效,在治疗过程中,随时记录药物不良反应.结果 治疗后两组匹兹堡睡眠质量指数、睡眠障碍评定量表评分均较治疗前有显著下降(P＜0.01),治疗4周末研究组较对照组下降更显著(P＜0.01),且总有效率显著高于对照组(P＜0.05).研究组未见明显不良反应,对照组不良反应发生率为30.0%,显著高于研究组(χ2=13.47,P＜0.01).结论 纯中药制剂解郁丸治疗失眠疗效显著,安全性高,依从性好,显著优于艾司唑仑治疗.

A control study of Jieyu pill vs estazolam in the treatment of insomnia

Objective To explore the efficacy and safety of Jieyu pill vs estazolam in the treatment of in- somnia. Methods Sixty insomnia patients were randomly divided into two groups of 30 ones each, research group took orally Jieyu pill and controI group did estazolam for 4 weeks. Efficacies were assessed with the Pittsburgh Sleep Quality Index （PSQI） and Sleep Disorders Rating Scale （SDRA） before treat- ment and at the end of the 2nd and 4th week, adverse reactions recorded at any time during treatment. Re- sults The PSQI and SDRS scores of both groups lowered more significantly after treatment compared with pretreatment （P〈0.01）, so did those （P〈0.01） and total effective rate was significantly higher （P〈0.05） in research than in control group at the end of the 4th week. Research group had no obvious adverse reactions, the incidence of control group （30.0%） was significantly higher than that of research group （χ^2 = 13.47, P〈0.05）. Conclusion Jieyu pill, a pure Chinese medicine preparation （CMP）, has an evi- dent effect, higher safety and better compliance, and an advantage over estazolam in the treatment of in- somnia.