11】报告题目：中医四诊评估的耳穴疗法联合药食同源食材干预顽固性失眠的临床研究

                                                         第二届食药物质健康中国国际高峰论坛

                                              暨"菩惠宁"癌瘤非药物干预产品功效认证新闻发布会

                                             中欧一带一路药食同源健康产业研究院研究员 曹磐毅

摘    要：中医四诊辨证 穴压豆疗法联合药食同源复方食材调理

关键词：顽固性失眠 辩证 穴压疗法 药食同源

论   述：探讨基于中医四诊辨证评估前提下，运用耳穴压豆疗法联合药食同源复方食材调理，对顽固性失眠

患者的临床治疗效果、睡眠质量、情志状态及中医证候积分的改善作用，为顽固性失眠无创疾病非药物干

预提供临床参考

方   法：选取本院收治顽固性失眠患者 96 例，随机分为观察组、对照组各 48 例。对照组单纯给予常规健康睡眠指导+基础情志调理；观察组采用中医望闻问切四诊辨证分型，个体化配伍耳穴穴位按压，联合药食同源食疗复方长期干预，连续干预 8 周。对比两组干预前后 PSQI 睡眠质量评分、中医失眠证候积分、入睡潜伏期、夜间觉醒次数、总睡眠时间及临床总有效率。结果：干预后两组各项睡眠指标、中医积分均较治疗前明显改善，观察组改善幅度显著优于对照组；观察组入睡更快、夜醒次数减少、深度睡眠延长，整体临床有效率更高，差异具有统计学意义（P＜0.05）。

结   论：依托中医四诊精准辨证，实施个体化耳穴疗法搭配药食同源食材综合干预，能够疏肝养心、健脾安

神、调和阴阳，有效改善顽固性失眠人群入睡困难、多梦易醒、早醒焦虑等问题，绿色安全无副作用，适

合长期反复失眠人群推广应用，临床运用价值广阔。

1、资料与方法

1.1 一般资料

选取 2025 年 1 月—2025 年 12 月就诊顽固性失眠患者 96 例，病程均大于 6 个月，长期存在入睡障碍、睡眠浅、频繁夜醒、晨起疲惫，属于慢性顽固性失眠。排除重度精神疾病、器质性脑病、肝肾疾病、长期服用 安眠药物依赖人群。

随机均分两组各 48 例。对照组男 22 例，女 26 例，年龄 35～68 岁；观察组男 21 例，女 27 例，年龄 34～69 岁。两组年龄、病程、失眠程度、基础身体资料对比无差异，可对照研究。

1.2 诊断标准

1.2.1 西医诊断：符合顽固性慢性失眠诊断，每周失眠≥4 次，持续 6 个月以上，睡眠结构紊乱，日间精神萎靡、头晕乏力。

1.2.2 中医辨证标准：通过四诊合参望、闻、问、切综合评估，划分证型：心脾两虚型、肝郁火旺型、阴虚

火旺型、痰热扰神型、心肾不交型五大常见证型。

1.3 干预方法

1.3.1 对照组

开展常规睡眠健康宣教，规律作息指导，情绪疏导，睡前禁忌浓茶、电子产品，单纯基础护理干预，不采

用耳穴及食疗配方，干预周期 8 周。

1.3.2 观察组

2、观察指标

2.1 匹兹堡睡眠质量指数 PSQI 评分：总分越高，失眠症状越严重；

2.2 中医证候积分：多梦、心慌、烦躁、头晕、盗汗、健忘各项分值；

2.3 睡眠客观指标：入睡时间、夜间觉醒次数、深度睡眠时间；

2.4 临床疗效：痊愈：入睡正常，睡眠完整，无多梦早醒；显效：失眠明显好转，夜醒减少；有效：睡眠轻度改善；无效：症状无变化。

3、研究结果

3.1 两组 PSQI 睡眠评分对比干预前两组睡眠评分相近（P＞0.05）；干预 8 周后，两组 PSQI 评分均下降，

观察组下降程度更加突出，睡眠质量提升更明显（P＜0.05）。

3.2 中医四诊证候积分对比干预后观察组舌质脉象、情志烦躁、心神不宁等中医症候改善优于对照组，阴

阳失衡状态得到调和，体质本源得以调理。

3.3 临床总有效率对照组总有效率 72.91%，观察组总有效率 91.67%，观察组综合干预疗效显著优于普通常

规干预。

3.4 安全性观察全程所有受试者未出现皮肤过敏、胃肠不适、头晕不良反应，耳穴外用+药食内服内外同治，

安全性极高。

4、讨论

4.1 顽固性失眠发病中医机理祖国医学认为顽固性失眠核心病机为阴阳失交、心神失养。现代人长期压力

过大、思虑过度、作息紊乱，日久肝气郁结、脾胃亏虚、精血不足，进而心神无所依附，夜晚阳不入阴，

造成长期顽固失眠。单纯镇静安眠治标不治本，极易反复，无法根治慢性失眠。

4.2 中医四诊评估的临床意义四诊合参是中医辨证施治核心，单一症状无法判定根本病机。通过望闻问切

全方位收集体质、脉象、舌苔、情志、脏腑虚实，精准区分失眠不同证型，避免统一方案盲目治疗，实现

个体化精准调理，大幅提升治疗有效率。

4.3 耳穴疗法作用机理耳为宗脉之所聚，耳廓经络连通全身五脏六腑。刺激对应耳穴，可以疏通经络、镇

静安神、调节植物神经功能，舒缓交感神经兴奋，平复焦虑紧绷神经，快速缩短入睡时间，减少夜间惊醒，

外用调理无药物依赖性。

4.4 药食同源食材协同作用药食同源草本食材药性温和，归脾、肝、心、肾诸经，能够固本培元，健脾养

血、疏肝清心、补益肾精。以内服食补调和脏腑本源，耳穴外治疏通经络，外调经络、内养脏腑，内外双

向联合。

总结：综上所述，针对临床顽固性失眠患者，采用中医四诊辨证评估为基础，个体化耳穴压豆外用治疗，

配合分型药食同源食材膳食干预，内外同治、标本兼顾。既能即时改善睡眠障碍，又可以调理脏腑气血、

平衡机体阴阳，杜绝失眠反复发作。整体操作简单、绿色无创、安全性高，符合当下大健康、中医药食康

养发展理念，适宜临床康养机构、中医健康行业广泛推广运用。

11】Report topic:Clinical research on the intervention of stubborn insomnia with ear acupuncture therapy combined

with medicinal food and homologous ingredients evaluated by the four diagnoses of traditional Chinese medicine

The 2nd China International Summit Forum on Food and Drug Quality Health

Press conference on efficacy certification of "Puhuining" cancer tumour non-drug intervention products

Researcher of China-Europe Belt and Road Research Institute of Medicine and Food Co-Source Health Industry

Panyi Cao

Abstract：Diagnosis and identification of four traditional Chinese medicine Acupoint pressure bean therapy

combined with medicinal food homologous compound ingredient conditioning

Keyword：Intractable insomnia Investigate and verify Acupressure therapy The same origin of medicine and food

Expound：Based on the premise of the four-diagnosis discrimination and evaluation of traditional Chinese medicine,

the use of ear acupuncture bean pressure therapy combined with medicinal food homology compound food

conditioning to improve the clinical treatment effect, sleep quality, emotional state and traditional Chinese medicine

syndrome score of patients with stubborn insomnia, and provide clinical reference for non-drug intervention of

intractable insomnia non-invasive diseases.

Way：96 patients with intractable insomnia were selected and randomly divided into 48 patients in the observation

group and the control group. The control group was simply given regular healthy sleep guidance + basic emotional

conditioning; the observation group adopted the four-diagnosis discrimination and division of traditional Chinese

medicine, individualised with ear acupoint pressure, combined with medicinal food homogenic diet therapy compound

for long-term intervention, and continuous intervention for 8 weeks. Compare the PSQI sleep quality score, traditional

Chinese medicine insomnia syndrome score, sleep incubation period, number of night awakenings, total sleep time and

total clinical efficiency before and after the intervention of the two groups. Results: After the intervention, the sleep

indicators and traditional Chinese medicine scores of the two groups were significantly improved compared with

before treatment, and the improvement of the observation group was significantly better than that of the control group;

the observation group fell asleep faster, woke up at night was reduced, deep sleep was prolonged, and the overall

clinical efficiency was higher. The difference was statistically significant (P<0.05).

Conclusion：Relying on the accurate identification of the four diagnoses of traditional Chinese medicine, the

implementation of individualised ear acupuncture therapy with the comprehensive intervention of medicinal food and

food ingredients can drain the liver and nourish the heart, strengthen the spleen and calm the mind, harmonise yin and

yang, and effectively improve the problems of difficult sleep, frequent dreams, early awakening anxiety and other

problems of people with stubborn insomnia. It is green, safe and has no side effects. It is suitable for the promotion

and application of long-term repeated insomnia, and has a wide clinical application value.

1、Information and methods

1.1General information

From January 2025 to December 2025, 96 patients with intractable insomnia were selected. The course of the disease

was more than 6 months. There were long-term sleep disorders, light sleep, frequent night awakening, and morning

fatigue, which belonged to chronic stubborn insomnia. Exclude people who are dependent on severe mental illness,

organic encephalopathy, liver and kidney disease, and long-term sleeping pills.

48 cases were randomly divided into two groups. There were 22 male and 26 female cases in the control group, aged

35 to 68; there were 21 male and 27 female cases in the observation group, aged 34 to 69. There is no difference in the

age, course, degree of insomnia and basic physical data of the two groups, which can be studied in comparison.

1.2Diagnostic criteria

1.2.1Western medical diagnosis: consistent with the diagnosis of stubborn chronic insomnia, insomnia ≥4 times a

week, lasting more than 6 months, sleep structure disorder, daytime mental depression, dizziness and weakness.

1.2.2Identification standards of traditional Chinese medicine: Through the comprehensive evaluation of the four

diagnoses, listening, smelling, asking and cutting, the syndrome types are divided into five common witnessing types:

heart and spleen deficiency type, liver depression and fire prosperity type, yin deficiency and fire prosperity type,

phlegm and heat disturbance type, and heart and kidney non-compation type.

1.3Intervention method

1.3.1Control group

Carry out routine sleep health education, regular routine guidance, emotional guidance, taboo strong tea and electronic

products before bedtime, simple basic nursing intervention, do not use ear acupuncture points and diet formulas, and

the intervention cycle is 8 weeks.

1.3.2Observation group

2、Observe the indicators

2.1Pittsburgh Sleep Quality Index PSQI score: the higher the total score, the more serious the insomnia symptoms;

2.2Traditional Chinese medicine syndrome points: multiple dreams, panic, irritability, dizziness, night sweats,

forgetfulness scores;

2.3Objective indicators of sleep: time to fall asleep, number of wake-ups at night, deep sleep time;

2.4Clinical effect: healing: normal sleep, complete sleep, no frequent dreams and early awakening; effect: insomnia is

significantly improved, and nocturnal awakening is reduced; effective: sleep is mildly improved; ineffective: no change

in symptoms.

3、Research results

303.1Compared with the previous two groups of PSQI sleep scores, the two groups of sleep scores were similar (P>0.05);

after 8 weeks of intervention, the PSQI scores of both groups decreased. The decrease in the observation group was

more prominent, and the sleep quality was improved more obvious (P<0.05).

3.2After the comparative intervention of the four-diagnosis syndromes of traditional Chinese medicine, the

improvement of traditional Chinese medicine symptoms such as lingual pulse image, emotional irritability, and mental

restlessness was better than that of the control group. The imbalance of yin and yang was harmonised, and the origin

of the constitution was adjusted.

3.3The total clinical efficiency of the control group was 72.91%, and the total efficiency of the observation group was

91.67%. The comprehensive intervention effect of the observation group was significantly better than that of ordinary

routine intervention.

3.4In the whole process of safety observation, all subjects did not have skin allergies, gastrointestinal discomfort,

dizziness adverse reactions, and the external use of ear acupuncture points + internal medicine was treated internally

and externally, and the safety was extremely high.

4、Discuss

4.1The mechanism of intractable insomnia in traditional Chinese medicine The motherland believes that the core

pathogenesis of intractable insomnia is the loss of yin and yang and mental loss. Modern people are under too much

pressure for a long time, overthinking, and have a disordered routine. Over time, the liver qi is depressed, the spleen

and stomach are deficicient, and the sperm and blood are insufficient, so that the mind and mind have no attachment

to it, and the yang does not enter the yin at night, resulting in long-term stubborn insomnia. Simple sedation and sleep

can treat the symptoms but not the root cause. It is very easy to recur and cannot cure chronic insomnia.

4.2The clinical significance of the evaluation of the four diagnoses of traditional Chinese medicine. The combination

of four diagnoses is the core of the diagnosis and treatment of traditional Chinese medicine. A single symptom cannot

determine the fundamental pathology. Collect the constitution, pulse image, tongue moss, emotion, internal organs and

reality in an all-round way, accurately distinguish the different syndrome types of insomnia, avoid blind treatment with

a unified plan, realise individualised and accurate conditioning, and greatly improve the efficiency of treatment.

4.3The mechanism of action of ear acupuncture therapy is that the ear is the gathering of the vein, and the auricle

meridians connect the five organs and six organs of the whole body. Stimulation corresponds to the ear acupoint,

which can dredge the meridians, calm down, regulate vegetative nerve function, soothe sympathetic excitement, calm

anxiety and tense nerves, quickly shorten sleep time, reduce night awakening, and external conditioning without drug

dependence.

4.4The synergistic effect of medicinal food is the same origin of ingredients. The medicinal food is mild in medicinal

properties, which belongs to the spleen, liver, heart and kidney meridians. It can solidify the original culture, strengthen

the spleen and nourish the blood, drain the liver and clear the heart, and benefit the kidney essence. Internal food tonic

and the origin of the internal organs, external treatment of the ear acupoint to dredge the meridians, externally adjust

the meridians, nourish the internal organs, and combine the inside and outside in both directions.

Conclusion：In summary, for patients with clinical intractable insomnia, based on the discrimination and evaluation of

the four diagnoses of traditional Chinese medicine, individualised ear acupuncture and bean pressure for external

treatment, combined with dietary intervention of the same origin of medicinal food, internal and external treatment,

and the specimen and the specimen are taken into account. It can not only immediately improve sleep disorders, but

also condition internal organs, qi and blood, balance the yin and yang of the body, and eliminate repeated insomnia.

The overall operation is simple, green and non-invasive, and the safety is high, which is in line with the current

development concept of health and traditional Chinese medicine food and health care, and is suitable for the extensive

promotion and application of clinical health institutions and traditional Chinese medicine health industry.

编辑：食药物质国际交流栏目组  愚晏

翻译：国际食药物质与健康产业联盟 执行秘书长 孙丽

校对：国际疾病非药物干预科学应用联盟（中国代表处）执行秘书长 吴玲