疏肝调神针方治疗肝不藏魂型失眠的随机对照临床研究：基于多导睡眠监测与量表评估的疗效分析

Shugan Tiaoshen Acupuncture Formula Intervention for Liver-Failing-to-House-the-Soul Pattern Insomnia: A Randomized Controlled Clinical Study with Efficacy Analysis Based on Polysomnography and Scale Assessment

摘要: 目的：评价疏肝调神针方治疗肝不藏魂型失眠患者的临床疗效，为中医辨证治疗失眠提供客观循证证据。方法：采用随机对照试验设计，纳入乌鲁木齐市第四人民医院就诊的110例肝不藏魂型失眠患者按1:1比例随机分为对照组(55例)和治疗组(55例)。对照组给予右佐匹克隆片1/3 mg~1 mg口服，每晚一次，疗程30天；治疗组给予疏肝调神针方治疗，每2周为1个疗程，连续治疗2个疗程。治疗前后分别进行多导睡眠监测(PSG)及量表评估，观察指标包括总睡眠时间(TST)、睡眠效率(SE)、睡眠潜伏期(SL)、觉醒时间(WT)、觉醒时间占比(WT%)、匹兹堡睡眠质量指数(PSQI)、中医证候积分、汉密尔顿焦虑量表(HAMA)及汉密尔顿抑郁量表(HAMD)。以P < 0.05为差异有统计学意义。结果：两组患者基线资料无统计学意义(P > 0.05)，具有可比性。治疗后，两组各指标均较治疗前显著改善(P < 0.001)。治疗组TST、SE显著高于对照组，SL、WT、WT%、PSQI、中医证候积分、HAMA、HAMD均显著低于对照组(P < 0.001)。治疗组各指标变化量(Delta值)均显著大于对照组(P < 0.001)，效应量(Cohen’s d)为1.739~4.816。治疗组总有效率达100.0%，对照组为69.1%，两组比较差异有统计学意义(chi² = 17.812, P < 0.001)。治疗组未发生不良事件。结论：疏肝调神针方治疗肝不藏魂型失眠疗效确切，可有效改善患者客观睡眠参数及主观睡眠质量，同时缓解焦虑抑郁状态，疗效优于右佐匹克隆常规治疗，且安全性良好，值得临床推广应用。

Abstract: Objective: To evaluate the clinical efficacy of the Shugan Tiaoshen (Liver-Soothing and Spirit-Regulating) acupuncture formula in treating patients with liver-failing-to-house-the-soul (LFTHTS) pattern insomnia, providing objective evidence-based support for TCM syndrome-differentiation treatment of insomnia. Methods: A randomized controlled trial was designed. One hundred and ten patients with LFTHTS pattern insomnia from Urumqi Fourth People’s Hospital were randomly assigned in a 1:1 ratio to a control group (55 cases) and a treatment group (55 cases). The control group received oral eszopiclone (1/3 mg~1 mg) once nightly for 30 days; the treatment group received the Shugan Tiaoshen acupuncture formula, one session daily for 2 weeks per course, for a total of 2 courses. Polysomnography (PSG) and scale assessments were performed before and after treatment. Outcome indicators included total sleep time (TST), sleep efficiency (SE), sleep latency (SL), wake time (WT), wake time percentage (WT%), Pittsburgh Sleep Quality Index (PSQI), TCM syndrome score, Hamilton Anxiety Scale (HAMA), and Hamilton Depression Scale (HAMD). P < 0.05 was considered statistically significant. Results: No statistically significant differences were found in baseline characteristics between the two groups (P > 0.05), indicating comparability. After treatment, all indicators in both groups improved significantly compared with pre-treatment values (P < 0.001). TST and SE in the treatment group were significantly higher than those in the control group, while SL, WT, WT%, PSQI, TCM syndrome score, HAMA, and HAMD were all significantly lower (P < 0.001). The Delta values of all indicators in the treatment group were significantly greater than those in the control group (P < 0.001), with effect sizes (Cohen’s d) ranging from 1.739 to 4.816. The overall effective rate in the treatment group reached 100.0%, compared with 69.1% in the control group, and the difference was statistically significant (χ² = 17.812, P < 0.001). No adverse events occurred in the treatment group. Conclusion: The Shugan Tiaoshen acupuncture formula demonstrates definite efficacy in treating LFTHTS pattern insomnia, effectively improving objective sleep parameters and subjective sleep quality while alleviating anxiety and depression. Its efficacy is superior to conventional eszopiclone therapy, with favorable safety, making it worthy of clinical promotion and application.