醒脾解郁方治疗抑郁症相关性失眠的临床研究

Clinical study of Xingpi Jieyu Formula in treating depression-related insomnia

摘要

目的 探究醒脾解郁方对抑郁症相关性失眠（depression-related insomnia，DRI）的临床疗效及血清褪黑素（melatonin，MT）、谷氨酸（glutamate，Glu）、γ氨基丁酸（γ-aminobutyric acid，GABA）的影响。方法 采用随机双盲双模拟平行阳性对照研究。将90例DRI患者随机分成西药组45例和中药组45例，西药组予草酸艾司西酞普兰片加醒脾解郁方颗粒模拟剂治疗，中药组予醒脾解郁方颗粒加草酸艾司西酞普兰模拟片口服治疗。2组均治疗8周。观察2组患者治疗前后汉密尔顿抑郁量表（HAMD）评分、匹兹堡睡眠指数量表（PSQI）评分、中医证候评分及血清MT、GABA、Glu水平变化，计算Glu/GABA。结果 治疗后，中药组总有效率为84.44%，西药组总有效率为71.11%，2组间差异无统计学意义（P＞0.05）。2组治疗后HAMD、PSQI及中医证候量表评分均较治疗前显著降低（P＜0.05），2组间比较，差异均无统计学意义（P＞0.05）。2组治疗后睡眠质量、入睡时间、日间功能障碍均较治疗前显著改善（P＜0.05），睡眠障碍、催眠药物使用亦有改善（P＜0.05），而睡眠时间、睡眠效率改善不明显（P＞0.05）；治疗后，2组间PSQI各因子分比较，差异均无统计学意义（P＞0.05）。血清指标方面，治疗后，中药组血清MT水平较治疗前显著升高（P＜0.05），Glu/GABA较治疗前显著降低（P＜0.05）；西药组仅Glu/GABA比值较治疗前显著降低（P＜0.05）；2组治疗后血清Glu、GABA水平较治疗前均无明显变化（P＞0.05）；治疗后2组间MT、Glu、GABA及Glu/GABA比较，差异均无统计学意义（P＞0.05）。结论 醒脾解郁方可提高血清MT水平及降低Glu/GABA比值，有效改善DRI患者睡眠质量及抑郁情绪。

Abstract

Objective To investigate the clinical efficacy of Xingpi Jieyu Formula (Spleen-Awakening and Constraint-Relieving Formula) in the treatment of depression-related insomnia (DRI) and its effects on serum melatonin (MT), glutamate (Glu), and γ-aminobutyric acid (GABA) levels. Methods Randomized double-blind double-dummy parallel positive-controlled study. 90 DRI patients were randomly divided into the Western medicine group (n=45) and the TCM group (n=45). The patients in the Western medicine group were given esiciprom oxalate tablets and Xingpi Jieyu Formula Granule placebo, and those in the TCM group were given Xingpi Jieyu Formula Granules and escitalopram oxalate tablet placebo. Both groups were treated for 8 weeks. The changes of Hamilton Depression (HAMD) score, Pittsburgh Sleep Index (PSQI) score, TCM pattern score, and serum MT, Glu, GABA levels were recorded before and after treatment of the two groups, and the Glu/GABA ratio was calculated. Results After treatment, the total effective rate was 84.44% in the TCM group and 71.11% in the Western medicine group. The differences between the groups were not statistically significant (P＞0.05). After treatment, the scores of HAMD, PSQI and TCM pattern scale were significantly lower than before treatment (P＜0.05), but there was no statistical difference between the groups (P＞0.05). After treatment, the sleep quality, sleep time and daytime dysfunction of the two groups were significantly improved (P＜0.05), sleep disorders and the use of hypnotic drugs were also improved (P＜0.05), while the improvement in sleep time and sleep efficiency was not obvious (P＞0.05); the factors of sleep between the groups were compared and there is no difference (P＞0.05). In terms of serum indicators, the serum MT level increased significantly after treatment in the TCM group (P＜0.05), and the Glu/GABA ratio decreased significantly (P＜0.05); only the Glu/GABA ratio in the Western medicine group decreased significantly (P＜0.05); There was no significant change in the average serum Glu and GABA after treatment of the two groups (P＞0.05); there was no statistical difference between the comparison of MT, Glu, GABA and Glu/GABA groups after treatment (P＞0.05). Conclusion Xingpi Jieyu Formula demonstrates efficacy equivalent to Escitalopram Oxalate Tablets in treating DRI. It significantly improves sleep quality and alleviates depressive mood in DRI patients. The therapeutic mechanism involves elevating serum MT levels and reducing the Glu/GABA ratio, thereby restoring excitation/inhibition balance in the central nervous system.

关键词

醒脾解郁方 / 抑郁相关性失眠 / 褪黑素 / 谷氨酸 / γ-氨基丁酸

Key words

Xingpi Jieyu Formula / depression-related insomnia / melatonin / glutamic acid / γ-aminobutyric acid

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基金资助

国家重点研发计划课题(2021YFC2501405)

北京市科技计划课题(Z191100006619074)

北京中医药大学基本科研业务费项目(2023-JYB-JBQN-032)

北京中医药大学东方医院高水平能力建设人才项目(DFRCZY-2024ARX-005)