益气安神膏对心脾两虚型失眠患者睡眠质量及中医证候疗效的影响

Effect of Yiqi Anshen Ointment on Sleep Quality and TCM Syndrome Efficacy in Patients with Insomnia Due to Heart and Spleen Deficiency

目的:观察益气安神膏对心脾两虚型失眠患者睡眠质量及中医症候疗效的影响,为膏方应用于失眠调理提供理论依据。方法:选取2016年10月至2017年10月来广州中医药大学第一附属医院就诊的70例心脾两虚型失眠患者作为研究对象,按照就诊顺序,由电脑产生随机数字,根据数字奇偶性分为对照组(35例)和试验组(35例)。在认知行为治疗(CBT-I)干预基础上,试验组予口服益气安神膏1匙(约15g)/次,每日2次,对照组予口服归脾丸10丸/次,每日3次,4周为1疗程,两组均连续服用8周2疗程。采用匹兹堡睡眠质量指数量表(PSQI)、中医证候评分量表评分评估睡眠质量及中医证候疗效。结果:试验组总有效率为94.3%(治愈2例,有效31例),高于对照组的77.1%(治愈1例,有效26例),差异有统计学意义(P<0.05)。治疗前,两组PSQI评分差异无统计学意义(P>0.05);治疗后,试验组得分(8.1±2.8)分,对照组得分(10.4±3.8)分,前者明显低于后者,差异具有统计学意义(P<0.05)。中医证候疗效方面,相较于对照组,试验组疗效更佳,差异有统计学意义(P<0.05)。结论:益气安神膏在改善睡眠质量及中医证候疗效方面均优于归脾丸,其临床疗效明显,服用方便,可适用于临床慢性失眠患者的调理。

Objective: To observe the effect of Yiqi Anshen Ointment on the quality of sleep and the efficacy of TCM syndrome in patients with insomnia, and provide a theoretical basis for the application of ointment to insomnia conditioning. Methods: 70 patients with insomnia due to heart and spleen deficiency were selected from the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine from October 2016 to October 2017. According to the order of treatment, random numbers were generated by computer and divided into the experimental group(35 cases) and the control group(35 cases) according to the number parity. On the basis of Cognitive Behavioral Therapy for Insomnia(CBT-I) intervention, the experimental group was given 1 spoon(about 15 g)/time of oral Yiqi Anshen, 2 times/d, and the control group was given guipi pill, 10 pills per time, 3 times/d, 4 weeks for a course of treatment, the two groups were consecutively taking 8 weeks of 2 courses. The Pittsburgh Sleep Quality Index(PSQI) and TCM Syndrome Rating Scale were used to assess sleep quality and TCM syndrome efficacy. Results: The total effective rate of the experimental group was 94.3%(2 cases were cured and 31 cases were effective), higher than77.1% of the control group(1 case cured, 26 cases effective), the difference was statistically significant(P<0.05). There was no significant difference in PSQI score between the two groups before treatment(P>0.05). After treatment, the experimental group scored(8.1±2.8), and the control group scored(10.4±3.8). The former was significantly lower than the latter, the difference was statistically significant(P<0.05). Compared with the control group, the TCM syndrome efficacy of the experimental group was better, and the difference was statistically significant(P<0.05). Conclusion: Yiqi Anshen Ointment is superior to Guipi Pill in improving sleep quality and TCM syndrome efficacy. Its clinical curative effect is obvious, it is convenient to take, and it can be applied to the conditioning of patients with clinical chronic insomnia.