中国全科医学 ›› 2026, Vol. 29 ›› Issue (13): 1666-1672.DOI: 10.12114/j.issn.1007-9572.2025.0271

• 论著 • 上一篇    下一篇

柴胡加龙骨牡蛎汤联合失眠认知行为疗法治疗肝郁化火型急性失眠的临床疗效研究

余学芳1, 朱敏2, 马清林2, 谭神朗2, 吴子幸3,*(), 江伟3,*()   

  1. 1.230031 安徽省合肥市,中国人民解放军联勤保障部队第九〇一医院中医科
    2.241003 安徽省芜湖市,皖南医学院研究生学院
    3.230031 安徽省合肥市,中国人民解放军联勤保障部队第九〇一医院全科医学科
  • 收稿日期:2025-04-10 修回日期:2025-11-20 出版日期:2026-05-05 发布日期:2026-04-14
  • 通讯作者: 吴子幸, 江伟

  • 作者贡献:

    余学芳主要负责研究框架的构建、论文撰写;朱敏、马清林共同承担实验数据的采集与整理;谭神朗负责研究数据的统计处理与分析;吴子幸、江伟负责研究方向的确定、实验方案设计,并对论文终稿进行审阅与修改。

  • 基金资助:
    安徽省重点研究与开发计划项目(202104j07020002); 安徽医科大学校科学基金项目(2022xkj251,2023xkj125); 中国人民解放军联勤保障部队第九〇一医院院级项目(2023YGYB02)

Clinical Efficacy of Chaihu Longgu Muli Decoction Combined with Cognitive Behavioral Therapy in the Treatment of Acute Insomnia of Liver Qi Stagnation with Fire Transformation Type

YU Xuefang1, ZHU Min2, MA Qinglin2, TAN Shenlang2, WU Zixing3,*(), JIANG Wei3,*()   

  1. 1. Department of Traditional Chinese Medicine, the 901th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army, Hefei 230031, China
    2. Graduate School, Wannan Medical College, Wuhu 241003, China
    3. Department of General Practice, the 901th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army, Hefei 230031, China
  • Received:2025-04-10 Revised:2025-11-20 Published:2026-05-05 Online:2026-04-14
  • Contact: WU Zixing, JIANG Wei

摘要: 背景 肝郁化火型急性失眠源于情志失调,致扰心失眠,治疗以疏肝解郁、清热泻火、安神为主,柴胡加龙骨牡蛎汤具有镇静安神之功效,失眠认知行为疗法(CBT-I)被推荐为非药物治疗失眠的首选方案。目前有关柴胡加龙骨牡蛎汤联合CBT-I治疗肝郁化火型急性失眠的研究尚少。 目的 本研究旨在评估柴胡加龙骨牡蛎汤联合CBT-I治疗肝郁化火型急性失眠患者的临床疗效。 方法 选取2023年3月—2024年9月在中国人民解放军联勤保障部队第九〇一医院就诊的90例符合肝郁化火型急性失眠诊断标准的患者为研究对象。根据随机数字表法将患者分为对照组(45例)和观察组(45例)。对照组接受CBT-I干预,观察组则在CBT-I基础上联合应用柴胡加龙骨牡蛎汤治疗,两组均接受4周干预。研究评估指标包括:(1)临床症状改善情况(中医证候积分);(2)睡眠质量参数[匹兹堡睡眠质量指数(PSQI)评分、光电容积脉搏波描记法(PPG)监测指标];(3)情绪状态指标[汉密尔顿焦虑量表(HAMA)评分、汉密尔顿抑郁量表(HAMD)评分];(4)血清生物标志物水平[肿瘤坏死因子α(TNF-α)、白介素1β(IL-1β)、5-羟色胺(5-HT)];(5)临床疗效及安全性。 结果 观察组临床总有效率[88.89%(40/45)]优于对照组[66.67%(30/45)](χ2=14.284,P<0.05)。组内比较显示,与治疗前比较,两组治疗后总睡眠时间、睡眠效率和5-HT水平提升(P<0.05),而睡眠潜伏期、觉醒次数、PSQI评分、HAMA评分、HAMD评分、中医证候积分及炎症因子(TNF-α、IL-1β)水平降低(P<0.05)。治疗后组间比较表明,观察组上述指标均优于对照组(P<0.05)。对照组和观察组不良事件发生率比较,差异无统计学意义(χ2=0.511,P>0.05)。 结论 柴胡加龙骨牡蛎汤联合CBT-I治疗肝郁化火型急性失眠安全可行,能有效改善患者的睡眠质量、缓解情绪障碍、降低中医症候评分、调节神经递质水平和抑制炎症反应,治疗效果优于单独使用CBT-I。

关键词: 入睡和睡眠障碍, 急性失眠, 肝郁化火型, 柴胡加龙骨牡蛎汤, 失眠认知行为疗法

Abstract:

Background

Acute insomnia with liver qi stagnation and fire transformation type originates from emotional imbalance, which disturbs the heart and causes sleeplessness. The treatment focuses on soothing the liver, relieving depression, clearing heat, purging fire, and calming the mind. Chaihu Longgu Muli Decoction has the effect of calming and soothing the mind, and Cognitive Behavioral Therapy for Insomnia (CBT-I) is recommended as the first choice for non-drug treatment of insomnia. At present, there are few studies on Chaihu Longgu Muli Decoction combined with CBT-I in the treatment of acute insomnia with liver qi stagnation and fire transformation type.

Objective

The purpose of this study is to systematically evaluate the clinical effect of Chaihu Longgu Muli Decoction combined with CBT-I on acute insomnia patients with liver qi stagnation and fire transformation type.

Methods

From March 2023 to September 2024, 90 patients who met the diagnostic criteria of acute insomnia with liver qi stagnation and fire transformation type at the 901th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army were selected as the research objects. According to the table of random numbers method, patients were divided into control group (45 cases) and observation group (45 cases). The control group received CBT-I intervention, while the observation group was treated with Chaihu Longgu Muli Decoction on the basis of CBT-I. Both groups received intervention for 4 weeks. Research evaluation indicators include: (1) Clinical symptom improvement [traditional Chinese medicine (TCM) syndrome score]; (2) Sleep quality parameters [Pittsburgh Sleep Quality Index (PSQI) score, photoplethysmography (PPG) monitoring indicators]; (3) Mood state indicators [Hamilton Anxiety Scale (HAMA) score, Hamilton Depression Scale (HAMD) score]; (4) Serum biomarker levels [Tumor Necrosis Factor-alpha (TNF-α), Interleukin-1beta (IL-1β), 5-Hydroxytryptamine (5-HT) ]; (5) Clinical efficacy and safety.

Results

The clinical total effective rate of the observation group [88.89% (40/45) ] was significantly better than that of the control group [66.67% (30/45), χ2=14.284, P<0.05]. Intra-group comparison showed that compared with before treatment, the total sleep time, sleep efficiency and 5-HT level in the two groups were significantly increased (P<0.05), while the sleep latency, awakening times, PSQI score, HAMA score, HAMD score, TCM syndrome score and inflammatory factors (TNF-α, IL-1β) levels were significantly decreased (P<0.05). The comparison between groups showed that the above indexes in the observation group were significantly better than those in the control group (P<0.05). There was no significant difference in the incidence of adverse events between the two groups (χ2=0.511, P>0.05) .

Conclusion

The combination of Chaihu Longgu Muli Decoction with CBT-I is safe and feasible for treating acute insomnia with liver qi stagnation and fire transformation type. It effectively improves patients' sleep quality, alleviates emotional disturbances, reduces TCM symptom scores, regulates neurotransmitter levels, and suppresses inflammatory responses. The therapeutic efficacy surpasses that of CBT-I alone.

Key words: Sleep initiation and maintenance disorders, Acute insomnia, Liver qi stagnation with fire transformation, Chaihu longgu muli decoction, Cognitive behavioral therapy

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