“益神颗粒”对于心脾两虚型失眠患者的疗效观察与安全性评价

Observation of Curative Effect and Safety Evaluation of “Yi Shen Particle”for Patients with Heart and Spleen Deficiency Type of Insomnia

为观察院内自制制剂益神颗粒治疗心脾两虚型失眠患者临床疗效并进行安全性评价,本研究选取了188例心脾两虚型失眠患者,分为治疗组及对照组,观察治疗组（益神颗粒组）及对照组（安慰剂组）在治疗前、治疗2周后、治疗4周后及治疗完成后随访1周的睡眠SPIEGEL量表、中医症候量表、汉密尔顿抑郁量表、汉密尔顿焦虑量表变化及血常规、肝肾功能、心电图的改变。研究发现治疗2周、4周后益神颗粒组的睡眠SPIEGEL量表、中医症候量表、汉密尔顿抑郁量表、汉密尔顿焦虑量表评分均明显低于安慰剂组,差异有统计学意义（p〈0.05）;血液指标皆在正常范围内,异常心电图表现发生率在治疗前后无统计学差异（p〉0.05）。研究结果表明益神颗粒对于心脾两虚型失眠患者具有良好的临床疗效且无明显不良反应,具有进一步推广应用的临床价值。

In order to observe the clinical effect and evaluate safety of the hospitalmade preparation（Yi Shen particle） for patients with heart and spleen deficiency type of insomnia, this research chose 188 patients and divided them into treatment group and control group. We observed the changes of sleep SPIEGEL scale, TCM symptom scale, Hamilton depression scale, Hamilton anxiety scale, routine blood count, liver and kidney functions,electrocardiogram in the treatment group（Yi Shen particle group） and the control group（placebo group） in different stages including before treatment, 2 weeks after treatment, and 4 weeks after treatment, 1 week follow-up after the treatment. The results showed that 2 weeks and 4 weeks after the treatment, the sleep SPIEGEL scale, TCM syndrome Scale, Hamilton depression scale, and the Hamilton Anxiety Scale scores were significantly lower than those in the placebo group, the differences between two groups had statistical significance（p〈0.05）. The blood indexes were all in normal range, the incidence of abnormal ECG showed no significant difference in comparison between groups（p〉0.05）. It could indicate that the Yi Shen particle might have good clinical effect to the patients with heart and spleen deficiency type of insomnia and no obvious adverse reaction, which might have further clinical application value.