双合枣仁颗粒对原发性失眠患者睡眠脑电图的影响

目的:观察双合枣仁颗粒对原发性失眠患者的睡眠脑电图主要参数的影响及临床疗效,并探讨其机制。方法:将120例原发性失眠患者按随机方法分为观察组和对照组,各60例。观察组口服双合枣仁颗粒,每次1袋,tid。对照组予以艾司唑仑1 mg,临睡前口服,每晚1次;两组均以2周为1个疗程。观察两组治疗前后睡眠潜伏期(SL),睡眠总时间(TSA),觉醒次数(AT),觉醒时间(ASA),觉醒睡眠比(A/TSA),S1期,S2期,S3期,S4期,异相睡眠期(REM期),睡眠效率(SE)等主要睡眠脑电图参数变化,匹兹堡睡眠质量量表(PSQI)评分,中医证候积分及临床疗效。结果:观察组总有效率(90%)高于对照组总有效率(73%)(P0.05)。两组治疗后睡眠脑电图参数均改善,入睡时间缩短,觉醒次数和觉醒时间减少,深睡期显著延长,浅睡期和异相睡眠(REM期)减少,睡眠效率增加(P0.01),观察组各项参数改善优于对照组(P0.05,P0.01)。观察组和对照组治疗前PSQI评分分别为16,17分,治疗后两组PSQI评分显著下降,各为5,8分(P0.01);观察组PSQI评分减少较对照组更显著(P0.01)。两组治疗后中医证候积分较治疗前显著下降(P0.01),观察组中医证候积分下降幅度是对照组的3倍(P0.01)。结论:双合枣仁颗粒能缩短入睡时间,减少觉醒次数和觉醒时间,延长深睡眠期,改善睡眠结构和睡眠质量,尤其对阴虚火旺型、心脾两虚型患者疗效更佳,是治疗原发性失眠安全、有效的药物。

Effect of Shuanghe Zaoren Granule on Sleep Electroencephalogram in Patients with Primary Insomnia

Objective: To observe the effects of Shuanghe Zaoren granule on sleep electroencephalogram (EEG) and its clinical curative effects on patients with primary insomnia. Method: Totally 120 patients with primary insomnia were randomly divided into observation group and control group. The observation group (60 cases) was treated with Shuanghe Zaoren granule, 1 pack/time, tid. The control group (60 cases) was treated with Estazolam tablets, 1 mg, bedtime, qd. The therapeutic course was 2 weeks for both groups. The Pittsburgh Sleep Quality Index (PSQI), traditional Chinese medicine (TCM) symptom score and clinical efficacy, and key parameters of sleep EEG, such as sleep latency (SL), total sleep duration (TSA), awakening frequency (AT), awakening duration (ASA), awakening sleep ratio (A/TSA), S1, S2, S3, S4, paradoxical sleep (REM) and sleep efficiency (SE) were observed and evaluated for both groups. The clinical curative effects of the two groups were recorded. Result: The total effective rate in the observation group was 90%, which was much higher than 73%in the control group (P<0.05). Compared with before treatment, a shortened sleep latency, awakening frequency and awakening duration, prolonged deep sleep, increased sleep efficiency, shortened light sleep and paradoxical sleep (REM) were observed in the sleep EEG parameters in two groups (P<0.01). However, the sleep electroencephalogram parameters in the observation group were better than control group (P<0.05, P<0.01). The scores of PSQI in observation group and control group were 16 points and 17 points, respectively before treatment, after treatment, the PSQI score was significantly decreased to 5 points and 8 points in two groups (P<0.01). The PSQI score of observation group was significantly lower than the control group (P<0.01). Score of TCM clinical symptoms after treatment were significantly lower than that before treatment in each group (P<0.01). In the observation group, TCM clinical symptom score reduced by 3 times of the control group (P<0.01). Conclusion: Shuanghe Zaoren granule could shorten the time for falling asleep, decrease awakening frequency and awakening duration, prolong the deep sleep, improve the structure and quality of sleep, with an especially better clinical curative effect for patients with fire excess from yin deficiency and heart-spleen deficiency. Therefore, it is a safe and effective drug to treat primary insomnia.