养阴安神胶囊治疗失眠的临床研究

Clinical Observation on Yangyin Anshen Capsule for Treatment of Insomnia

目的观察养阴安神胶囊治疗失眠的临床疗效,探讨养阴安神胶囊对睡眠质量影响的作用机制。方法选择符合失眠诊断标准病人165例,按2∶1的比例随机分为治疗组(110例)和对照组(55例),治疗组给予中药养阴安神胶囊,每次6粒,早晚温水送服。对照组每晚睡前30min口服阿普唑仑0.4mg～0.8mg。各组依据不同病情和副反应调整用药剂量,就诊前就服用镇静催眠药者,1周内逐渐停用。疗程为4周。结果治疗4周后,临床疗效评估:治疗组愈显率为72.7%,总有效率80.9%,对照组愈显率为45.5%,总有效率54.5%,两组比较差异有统计学意义(P<0.05)。匹兹堡睡眠质量指数(PSQI)主要睡眠指标:治疗组入睡时间平均缩短68min,睡眠时间平均延长3.6h,睡眠效率提高43%,与对照组治疗后比较,治疗组各项指标差异有统计学意义(P<0.05或P<0.01)。结论养阴安神胶囊能够对失眠病人睡眠质量各项指标的改善有较好的疗效,能够针对失眠病人的病因发挥中医整体治疗的作用,是多组分、多环节、多靶点的整体调节、综合治疗。

Objective To investigate the clinical curative effect of Yangyin Anshen capsule（YAC） for treatment of insomnia. Methods One hundred and sixty-five patients with insomnia were randomly divided （based on 2：1） into treatment group （n-110） treated with YAC and control group （n 55） administrated orally alprazolam. Each group adjusted dosage according to the illness and side effects, and the sedative and hypnotic taken before treatment were gradually discontinued within one week. The course of treat ment was four weeks. Results After four weeks of treatment, the cure rate in treatment group was 72.7%, and the total effective rate was 80.9 %, That in control group was 45.5 % and 54.6 %, respectively （P〈0.05）. Pittsburgh Sleep Quality Index （PSQI） indi ces and average sleep latency time were shortened 68 min, average sleep time was extended 3.6 h,sleeping efficiency was increased by 43%. These index was significant differences compared with that in control group （P%0.05 or P%0.01）. Conclusion YAC had the better efficacy to improve sleep quality indicators in patients with insomnia.