基于“营卫–神志–脏腑”轴探讨中医不寐病核心病机及调卫安神法干预机制研究

Core Pathogenesis of Insomnia in TCM Based on the “Ying-Wei, Spirit, and Zang-Fu” Axis and the Intervention Mechanism of the Regulating-Defense-and-Calming-Spirit Method

摘要: 背景：慢性不寐发病率高、病程缠绵、易复发且常伴多系统共病，长期睡眠结构紊乱显著增加情志、代谢、免疫及心脑血管疾病风险，已成为重要的公共卫生问题。现代镇静催眠干预仅短期改善睡眠表象，难以修复昼夜节律稳态，且存在药物耐受、依赖及停药高复发等弊端。中医药基于营卫昼夜节律、五脏藏神等多维层面辨治不寐，注重标本同治与节律修复，但当前研究多局限于单方疗效观察，病机碎片化，缺乏原创病机模型。其病理特征表现为入睡困难、睡眠维持障碍、早醒及醒后不解乏等多维睡眠紊乱，并与情绪障碍、代谢紊乱形成相互加重的恶性环路，单一镇静催眠难以打破这一环路。目的：立足《黄帝内经》营卫昼夜节律理论，融合后世五脏藏神及气血阴阳学说，突破单一脏腑病机局限，原创构建“营卫失和–神志失司–脏腑失衡”三维递进式慢性不寐病机新体系，验证调卫安神法的临床疗效与安全性，揭示其节律修复与安神定志的现代科学内涵。方法：采用“理论溯源–文献研判–数据挖掘–临床实证–机制阐释”一体化体系。梳理《内经》《伤寒论》《金匮要略》及明清医家学术思想；检索2015~2024年CNKI、万方、维普、PubMed文献并进行CiteSpace分析；对慢性不寐病例行频数、关联规则及复杂系统熵聚类分析；将120例患者随机分为观察组(调卫安神方加减)与对照组(常规安神中成药)，干预8周随访3个月，以PSQI、ISI、中医证候积分、昼夜节律评分、SAS/SDS及安全性指标评价疗效；结合昼夜节律、HPA轴及中枢神经递质理论耦合阐释机制。结果：理论明确不寐以营卫昼夜失序为始发、神志失司为持续核心、五脏气血失衡为迁延基础。文献计量证实当前重疗效观察、轻理论创新与节律机制。数据挖掘示病机本虚标实、虚实夹杂，遵循“气机郁滞→营卫失和→神志不宁→脏腑亏虚→虚实夹杂”演变规律。观察组PSQI、ISI、证候积分、昼夜节律及情志评分均显著优于对照组(P < 0.05)，远期复发率更低且无不良反应。机制研究证实本法可修复节律、调控神志、平衡脏腑并改善神经内分泌紊乱。结论：慢性不寐并非单一脏腑失常，而是营卫节律紊乱启动、神志失司持续、脏腑气血失衡迁延的三维递进病理过程。基于该体系创立的调卫安神法多层级靶向干预，可显著改善睡眠质量、修复昼夜节律、缓解情志与躯体症状，近期疗效确切、远期复发率低且安全性良好，为中医不寐理论创新与规范化诊疗提供学术支撑与循证依据。

Abstract: Background: Chronic insomnia has a high incidence, a lingering course, a tendency to relapse, and frequent multi-system comorbidities. Long-term disruption of sleep architecture significantly increases the risk of emotional, metabolic, immune, and cardiovascular and cerebrovascular diseases, constituting a major public health concern. Modern sedative-hypnotic interventions only improve sleep manifestations in the short term and fail to restore circadian rhythm homeostasis; they are also associated with drug tolerance, dependence, and a high relapse rate upon discontinuation. TCM treats insomnia from multiple dimensions, including the ying-wei circadian rhythm and the storage of spirit by the five zang organs, emphasizing simultaneous treatment of both the root and the manifestation as well as rhythm restoration. However, current studies are mostly limited to observations of single-formula efficacy, with fragmented pathogenesis research and a lack of original pathogenesis models. Pathologically, chronic insomnia manifests as multi-dimensional sleep disturbances—difficulty falling asleep, sleep maintenance impairment, early morning awakening, and non-restorative sleep—which form a vicious cycle with emotional disorders and metabolic disturbances that a single sedative-hypnotic approach cannot break. Objective: Grounded in the Huangdi Neijing theory of the ying-wei circadian rhythm, and integrating later doctrines of the five zang organs storing spirit and of qi, blood, yin, and yang, this study breaks through the limitation of single-organ pathogenesis to construct an original three-dimensional progressive pathogenesis system of chronic insomnia—“disharmony of ying-wei → dysfunction of spirit → imbalance of zang-fu organs.” It further verifies the clinical efficacy and safety of the method of regulating defense and calming spirit, and reveals its modern scientific connotations in rhythm restoration and spirit stabilization. Methods: An integrated framework of “theoretical tracing → literature analysis → data mining → clinical empirical study → mechanism elucidation” was adopted. Classical texts including the Neijing, Shanghan Lun, and Jinkui Yaolüe, together with academic thoughts of physicians from the Ming and Qing dynasties, were systematically reviewed. Literature published from 2015 to 2024 in CNKI, Wanfang, VIP, and PubMed was retrieved and analyzed using CiteSpace. Frequency analysis, association rule mining, and complex system entropy clustering were performed on chronic insomnia cases. A total of 120 patients were randomized into an observation group (modified Regulating-Defense-and-Calming-Spirit formula) and a control group (conventional sedative Chinese patent medicine), with an 8-week intervention and a 3-month follow-up. Efficacy was evaluated using the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), TCM syndrome score, circadian rhythm score, Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and safety indicators. The mechanism was elucidated by coupling circadian rhythm, the hypothalamic-pituitary-adrenal (HPA) axis, and central neurotransmitter theories. Results: Theoretical analysis established that insomnia initiates with circadian disorder of ying-wei, is sustained by dysfunction of the spirit, and is protracted by imbalance of the five zang organs and qi-blood. Bibliometric analysis confirmed that current research emphasizes efficacy observation while neglecting theoretical innovation and rhythm-related mechanisms. Data mining revealed a pathogenesis of deficiency at the root and excess in manifestation, with intermingled deficiency and excess following an evolutionary pattern of “qi movement stagnation → ying-wei disharmony → spirit unrest → zang-fu deficiency → intermingled deficiency and excess.” The observation group showed significantly greater improvements than the control group in PSQI, ISI, syndrome scores, circadian rhythm scores, and emotional scores (P < 0.05), with a lower long-term relapse rate and no adverse reactions. Mechanistic studies demonstrated that this method restores circadian rhythm, regulates the spirit, balances zang-fu organs, and ameliorates neuroendocrine disturbances. Conclusions: Chronic insomnia is not a disorder of a single zang or fu organ, but a three-dimensional progressive pathological process initiated by ying-wei rhythm disturbance, sustained by spirit dysfunction, and protracted by zang-fu and qi-blood imbalance. The multi-level targeted intervention derived from this system—the method of regulating defense and calming spirit—can significantly improve sleep quality, restore circadian rhythm, and relieve emotional and somatic symptoms, with definite short-term efficacy, a low long-term relapse rate, and good safety. It provides academic support and evidence-based grounds for theoretical innovation and standardized diagnosis and treatment of insomnia in TCM.