珍苓解郁胶囊治疗失眠症患者的临床疗效研究

Clinical Efficacy Study of Zhenling Jieyu Capsule in Treating Patients with Insomnia

摘要: 目的：探讨珍苓解郁胶囊联合艾司唑仑治疗失眠症患者的临床疗效。方法 选取2022年3月~2024年2月收治的失眠症患者98例作为研究对象，采用随机数表法进行分组，分为对照组(49例)：给予口服艾司唑仑片，1~2 mg/次，3次/d；观察组(49例)：给予口服珍苓解郁胶囊，一次2粒，一日2次。两组患者均连续治疗2个月。比较两组患者的临床疗效、中医证候积分、匹兹堡睡眠指数(PSQI)评分、睡眠严重程度指数量表(ISI)评分、检测5-羟基色胺(5-Hydroxytryptamine, 5-HT)、γ-氨基丁酸(Gama-Aminobutyric Acid, GABA)、脑源性神经营养因子(Brain-Derived Neurotrophic Factor, BDNF)、多巴胺(Dopamine, DA)水平。并记录两组患者在治疗期间的不良反应发生情况。结果：与对照组总有效率为81.63%相比，观察组总有效率为95.92%明显升高(P < 0.05)。治疗后，与对照组相比，观察组入睡困难、食少纳差、倦怠乏力、多梦、烦躁易怒/抑郁等中医证候积分明显降低(P < 0.05)；观察组PSQI和ISI评分均明显降低(P < 0.05)；观察组5-HT、GABA、BDNF水平明显升高(P < 0.05)；DA水平明显降低(P < 0.05)。与对照组不良反应发生率为10.20%相比，观察组不良反应发生率为4.08%明显降低(P < 0.05)。结论：珍苓解郁胶囊与艾司唑仑联合应用治疗失眠症，能提高临床治疗效果，改善患者的睡眠质量及入睡困难、多梦、抑郁等症状，降低失眠严重程度，并能调控脑内神经递质因子分泌，且具有较好的安全性。

Abstract: Objective: To explore the clinical efficacy of zhenling jieyu capsules combined with eszopiclone in treating insomnia patients. Methods 98 patients with insomnia were treated from March 2022 to February 2024. They were divided into a control group (49 cases) and an observation group (49 cases) using random number table method. The control group was given oral eszopiclone tablets, 1~2 mg per dose, three times a day; the observation group was given oral zhenling jieyu capsules, 2 capsules per dose, twice a day. Both groups were treated continuously for two months. Comparing the clinical efficacy, Traditional Chinese Medicine syndrome scores, Pittsburgh Sleep Quality Index (PSQI) scores, Insomnia Severity Index (ISI) scores, levels of 5-Hydroxytryptamine (5-HT), Gamma-Aminobutyric Acid (GABA), Brain-Derived Neurotrophic Factor (BDNF), and Dopamine (DA) between two groups of patients. Also, the incidence of adverse reactions during treatment for both groups should be recorded. Results Compared to the control group’s overall effective rate of 81.63%, the observation group’s overall effective rate was significantly higher at 95.92% (P < 0.05). After treatment, compared to the control group, the observation group showed a significant reduction in scores for difficulty falling asleep, poor appetite, fatigue, frequent dreams, irritability/depression, and other TCM symptoms (P < 0.05); the observation group also had significantly lower PSQI and ISI scores (P < 0.05); and the levels of 5-HT, GABA, and BDNF were significantly increased (P < 0.05) while DA levels were significantly decreased (P < 0.05). Compared to the control group’s adverse reaction rate of 10.20%, the observation group’s adverse reaction rate was significantly lower at 4.08% (P < 0.05). Conclusion: The combined use of Zhenling Jieyu capsules and eszopiclone in the treatment of insomnia can improve clinical treatment outcomes, enhance patients’ sleep quality, alleviate difficulties in falling asleep, frequent dreaming, and depression, reduce the severity of insomnia, regulate the secretion of neurotransmitter factors in the brain, and has good safety.