固本育阴膏联合右佐匹克隆片对阴虚火旺型亚健康失眠的疗效观察

Effects Observation of Guben Yuyin Ointment Combined with Eszopiclone Tablets on Sub-health Insomnia of Yin-deficiency and Fire Excess Type

目的:评价固本育阴膏联合右佐匹克隆片干预阴虚火旺型亚健康失眠的临床疗效、安全性和依从性。方法:,研究对象为80例阴虚火旺型亚健康失眠受试者,随机分为对照组和固本育阴膏观察组,每组40例,治疗8周。比较两组有效率及相关量表评分比较、多导睡眠图(PSG)检测指标、两组阴虚体质积分转化指标。结果:两组有效率比较,观察组(95%)高于对照组(75%),差异有统计学意义(P<0.05);对照组和观察组治疗前PSQI(匹兹堡睡眠质量指数表)评分分别为(16.20±2.33)分、(16.27±2.34)分,治疗后PSQI评分分别为(8.92±1.87)分、 (6.97±1.79)分,对照组和观察组治疗前的PSQI评分无明显差别 (P=0.886),但两组治疗后PSQI评分比较差异有统计学意义(P=0.000)。两组治疗后CGI(临床医生总体印象)评分、WHOQOL-BREF(WHO生活质量测定量表简明版)评分也有改善(P<0.05)。观察组治疗后与对照组治疗后相比,觉醒次数、觉醒时间及睡眠潜伏期、RL、睡眠效率均改善得更加明显(P<0.05)。睡眠结构变化来说,观察组治疗后与对照组治疗后相比,NREM (S1、S2、S3+S4)、REM均改善得更加明显(P<0.05)。结论:固本育阴膏联合右佐匹克隆片与单纯右佐匹克隆片比较,固本育阴膏联合右佐匹克隆片对阴虚火旺型亚健康失眠的干预更有显著效果,疗效更好。

Objective:To evaluate the clinical efficacy,safety and compliance of Guben Yuyin Ointment combined with Ezopiclone Tablets in the intervention of sub-healthy insomnia due to Yin deficiency and fire.Methods:The research object was 80 sub-healthy insomnia subjects with yin deficiency and fire vigour type,randomly divided into control group and Guben Yuyin ointment observation group,40 cases in each group,treatment for 8 weeks.Comparison of the effective rate and related scale scores of the two groups,polysomnography (PSG) detection indicators,and yin deficiency constitution score conversion indicators of the two groups.Results:The effective rate of the two groups was compared.The observation group (95%) was higher than the control group (75%),and the difference was statistically significant (P<0.05);PSQI (Pittsburgh Sleep Quality Index) scores before treatment between the control group and the observation group They were (16.20±2.33) points and (16.27±2.34) points.The PSQI scores after treatment were (8.92±1.87) points and (6.97±1.79) points,respectively.There was no significant difference between the control group and the observation group before treatment (P=0.886),but the difference in PSQI scores between the two groups after treatment was statistically significant (P=0.000).The CGI (clinician’s overall impression) score and WHOQOL-BREF (WHO quality of life measurement scale concise version) scores also improved after treatment in the two groups (P<0.05).In the observation group,compared with the control group,the number of awakenings,awakening time,sleep latency,RL,and sleep efficiency were all improved more significantly after treatment (P<0.05).In terms of sleep structure changes,NREM (S1,S2,S3+S4) and REM improved significantly in the observation group compared with the control group after treatment (P<0.05).Conclusion:Guben Yuyin ointment combined with dexzopiclone tablets is more effective than dexzopiclone tablets alone.Gubenyuyin ointment combined with dexzopiclone tablets has a more significant effect on the intervention of sub-healthy insomnia due to Yin deficiency and fire.