双合枣仁颗粒治疗中老年阴虚火旺型失眠的临床研究

Clinical study on Shuanghe Zaoren Granule in the treatment of middle-aged and elderly insomnia of syndrome of Yin deficiency and effulgent fire

目的观察双合枣仁颗粒治疗中老年阴虚火旺型失眠患者的临床疗效。方法将年龄40～80岁阴虚火旺型失眠患者60例随机分为2组,观察组30例口服双合枣仁颗粒1袋/次,2次/d,对照组30例每晚睡前口服艾司唑仑1 mg,2组疗程均为2周。观察比较2组治疗前后睡眠脑电图各项指标、匹兹堡睡眠质量量表(PSQI)评分和安全性指标的变化,统计2组临床疗效和不良反应发生情况。结果 2组治疗后睡眠效率(SE)明显高于治疗前(P均<0.05),但2组间比较差异无统计学意义(P>0.05)。2组治疗后睡眠潜伏期、觉醒次数、觉醒时间、觉醒睡眠比、S1期、S2期、异相睡眠期均明显低于治疗前(P均<0.05),且观察组睡眠潜伏期、觉醒次数、觉醒时间、异相睡眠期均明显低于对照组(P均<0.05);2组治疗后S3期、S4期均明显高于治疗前(P均<0.05),且观察组S3期、S4期均明显高于对照组(P均<0.05)。2组治疗后PSQI评分均明显低于治疗前(P均<0.05),且观察组明显低于对照组(P<0.05)。观察组总有效率为67%,对照组总有效率为50%,观察组明显高于对照组(P<0.05)。观察组无不良反应发生,对照组3例有轻度头晕、头昏症状。结论双合枣仁颗粒治疗中老年阴虚火旺型失眠疗效确切,尤其在改善患者主观感觉体验、睡眠结构和提高睡眠效率方面优于艾司唑仑,且安全性好,值得在中老年失眠患者治疗中推广应用。

Objective It is to observe the clinical efficacy of Shuanghe Zaoren Granule in the treatment of middle-aged and elderly patients with insomnia of syndrome of Yin deficiency and effulgent fire. Methods Sixty patients with insomnia of syndrome of Yin deficiency and effulgent fire aged 40-80 years old were randomly divided into two groups. The observation group(n= 30) was given Shuanghe Zaoren granules orally 1 bag/time, 2 times/d, and 30 patients in the control group was given estazolam 1 mg orally before bedtime every night. Both groups were treated for 2 weeks. The changes of sleep EEG indexes, Pittsburgh Sleep Quality Scale(PSQI) scores and safety indexes were observed before and after treatment. The clinical efficacy and adverse reactions of the two groups were statistically analyzed. Results The sleep efficiency(SE) of the two groups was significantly higher than that before treatment(P<0.05), but there was no significant difference between the two groups(P>0.05). The sleep latency, arousal frequency, wakefulness time, wakefulness sleep ratio, S1 phase, S2 phase and surprise appearance Morpheus period of the two groups were significantly lower than those before treatment(P<0.05), and sleep latency, arousal times, and wakefulness time and surprise appearance Morpheus period were significantly lower in the observation group than those of the control group(P<0.05). The S3 and S4 phases of the 2 groups were significantly higher than those before the treatment(P<0.05), and the S3 and S4 phases of the observation group were significantly higher than the control group(P<0.05). The PSQI scores of the two groups were significantly lower than those before treatment(P<0.05), and the scores in the observation group were significantly lower than the control group(P<0.05). The total effective rate of the observation group was 67%, which was higher than that 50% in the control group(P<0.05). No adverse reactions occurred in the observation group, and 3 patients in the control group had mild dizziness and dizziness. Conclusion Shuanghe Zaoren Granule is effective in treating insomnia in middle-aged and elderly insomnia of syndrome of Yin deficiency and effulgent fire, which is superior to estazolam in improving subjective sensory experience, sleep structure and improving sleep efficiency. It is safer and worthy of application in the treatment of elderly patients with insomnia.