舒眠胶囊联合右佐匹克隆治疗失眠症的临床研究

目的探讨舒眠胶囊联合右佐匹克隆片治疗失眠症的临床疗效。方法选择2016年1月—2017年2月陕西省人民医院收治的失眠症患者112例作为研究对象,将所有患者随机分为对照组和治疗组,每组各56例。对照组口服右佐匹克隆片,3 mg/次,1次/d。治疗组在对照组基础上于晚饭后临睡前口服舒眠胶囊,1.2 g/次,2次/d。两组患者均治疗4周。观察两组的临床疗效,比较两组的匹兹堡睡眠质量指数(PSQI)评分、促甲状腺激素(TSH)、三碘甲状腺氨酸(T3)和甲状腺素(T4)水平。结果治疗后,对照组和治疗组的总有效率分别为82.14%、94.64%,两组比较差异有统计学意义(P0.05)。治疗后,两组睡眠时间、主观质量、入睡时间、睡眠障碍、睡眠效率、日间功能、药物应用和PSQI评分均明显降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗组这些观察指标明显低于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组TSH、T3和T4水平均明显降低,同组治疗前后比较差异有统计学意义(P0.05);且治疗组这些观察指标明显低于对照组,两组比较差异具有统计学意义(P0.05)。结论舒眠胶囊联合右佐匹克隆片治疗失眠症具有较好的临床疗效,能改善临床症状,调节甲状腺激素水平,安全性较好,具有一定的临床推广应用价值。

Clinical study on Shumian Capsules combined with eszopiclone in treatment of insomnia

Objective To investigate the clinical efficacy of Shumian Capsules combined with Eszopiclone Tablets in treatment of insomnia. Methods Patients (112 cases) with insomnia in Shaanxi Provincial People''s Hospital from January 2016 to February 2017 were randomly divided into control and treatment groups, and each group had 56 cases. Patients in the control group were po administered with Eszopiclone Tablets, 3 mg/time, once daily. Patients in the treatment group were po administered with Shumian Capsules after dinner and before sleep on the basis of the control group, 1.2 g/time, once daily. Patients in two groups were treated for 4 weeks. After treatment, the clinical efficacies were evaluated, and PSQI scores and the levels of TSH, T3, and T4 in two groups were compared. Results After treatment, the clinical efficacies in the control and treatment groups were 82.14% and 94.64%, respectively, and there was difference between two groups (P<0.05). After treatment, the scores of sleep time, subjective quality, fall asleep time, sleep disorders, sleep efficiency, daytime function, drug use, and PSQI in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). After treatment, the levels of TSH, T3 and T4 in two groups were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And the observational indexes in the treatment group were significantly lower than those in the control group, with significant difference between two groups (P<0.05). Conclusion Shumian Capsules combined with Eszopiclone Tablets has clinical curative effect in treatment of insomnia, can improve clinical symptoms and regulate thyroid hormone level, with less adverse reaction, which has a certain clinical application value.