CN116570680A - Traditional Chinese medicine composition for treating cardiac neurosis and preparation method and application thereof - Google Patents
Traditional Chinese medicine composition for treating cardiac neurosis and preparation method and application thereof Download PDFInfo
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- CN116570680A CN116570680A CN202310504911.7A CN202310504911A CN116570680A CN 116570680 A CN116570680 A CN 116570680A CN 202310504911 A CN202310504911 A CN 202310504911A CN 116570680 A CN116570680 A CN 116570680A
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Abstract
The application discloses a traditional Chinese medicine composition for treating cardiac neurosis and a preparation method and application thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 30 parts of wild jujube seed, 10 parts of platycladi seed, 10 parts of dwarf lilyturf tuber, 10 parts of fried white peony root, 10 parts of Chinese angelica, 12 parts of Chinese magnoliavine fruit, 30 parts of poria cocos, and 15 parts of honey-fried licorice root. Years of clinical researches show that the traditional Chinese medicine composition can obtain obvious clinical curative effect on treating cardiac neurosis, the prescription can obviously improve clinical symptoms, is high in safety and tolerance, and can improve or restore social functions. The traditional Chinese medicine composition has the characteristics of easily available medicinal materials, low cost, reasonable formula, good curative effect, short treatment course, no side effect and the like, and can be used for effectively treating heart and liver yin deficiency type cardiac neurosis.
Description
Technical Field
The application relates to a traditional Chinese medicine composition for treating cardiac neurosis, a preparation method and application thereof, in particular to a traditional Chinese medicine composition prepared by taking Chinese herbal medicines as raw materials, and belongs to the field of traditional Chinese medicines.
Background
Cardiac Neurosis (cardioneurosis), also known as Cardiac Neurosis, belongs to the category of symptoms which are difficult to explain by somatic symptom disorder or medicine, and is a Neurosis which takes cardiovascular symptoms as main clinical manifestations and is accompanied or not accompanied by anxiety, depression and fear, wherein the cardiovascular symptoms mainly comprise palpitation, chest distress, precordial pain and the like. Although cardiac neurosis is defined as a functional disease without an organic lesion, it does not mean that the patient is "disease-free" or "sham disease", and the quality of life and mental health of the patient are greatly affected.
The earliest of cardiac neurosis was proposed in 1867 by the vienna clinician Oppenholzer, and foreign studies have shown that the incidence of cardiac neurosis is 20-30%, about one third of cardiac diseases are associated with psychological disorders. Symptoms of cardiac neurosis are divided into two aspects, one is cardiovascular system symptoms including palpitation, precordial pain, chest distress, shortness of breath, and the like, and the other is nervous system symptoms including anxiety, depression, fear, obsessive compulsive, insomnia, hyperhidrosis, and the like. The world health organization classifies the psychological disorder as the fourth disease of the world, and the numerous diseases are seen to be closely related to the psychological disorder. Diamondoids et al (adamant, etc.2013) investigated 180 patients with cardiac neurosis and found that nearly half of them had significant symptoms of depression anxiety. Because of the unclear understanding of the current medicine for cardiac neurosis, the current treatment regimen is based on beta blockers, anxiolytic depression drugs, and psychotherapy. Patients with cardiac neurosis have more symptoms and fewer positive signs; the inspection is more, and the abnormal result is less; the number of misdiagnosis is large, and the missed diagnosis is small; the clinical characteristics of different duration and few serious consequences, and the factors such as repeated examination and incapability of diagnosis result in serious waste of definite treatment schemes and medical resources.
Disclosure of Invention
In view of the above, the application aims to provide a traditional Chinese medicine composition for treating cardiac neurosis, a preparation method and application thereof, and the traditional Chinese medicine composition for treating cardiac neurosis has the advantages of definite curative effect, wide targets, small toxic and side effects, capability of being integrally regulated and the like.
The application provides a traditional Chinese medicine composition which is prepared from the following raw materials in parts by mass:
30 parts of wild jujube seed, 10 parts of platycladi seed, 10 parts of dwarf lilyturf tuber, 10 parts of fried white peony root, 10 parts of Chinese angelica, 12 parts of Chinese magnoliavine fruit, 30 parts of poria cocos, and 15 parts of honey-fried licorice root.
In the application, the dosage form of the traditional Chinese medicine composition can be any dosage form acceptable by traditional Chinese medicine preparation, such as decoction.
The application further provides a preparation method of the traditional Chinese medicine composition, which comprises the following steps:
1) Mixing the raw materials of the traditional Chinese medicine composition, adding water for the first time, soaking, decocting, and taking medicine liquid;
2) Adding water into the liquid medicine obtained in the step 1) for the second time, decocting, and taking the liquid medicine;
3) Mixing the liquid medicine obtained in the step 1) and the liquid medicine obtained in the step 2) to obtain the traditional Chinese medicine composition.
In the above preparation method, the ratio of the first water addition to the second water addition is as follows: adding 600mL of water into each raw material with the mass of 30g of spina date seed, 10g of platycladi seed, 10g of dwarf lilyturf tuber, 10g of fried white paeony root, 10g of Chinese angelica, 12g of Chinese magnoliavine fruit, 30g of Indian buead and 15g of honey-fried licorice root, and adding 500mL of water into the obtained liquid medicine;
in the step 1), the soaking time is 30-60 minutes;
in the step 1), the decoction is slow decoction with small fire, and the decoction is carried out for 40 minutes after boiling;
in the step 2), the decoction is slow decoction with small fire, and the decoction is carried out for 20 minutes after boiling.
The application also provides application of the traditional Chinese medicine composition in any one of the following:
a1 Preparing a medicament for treating cardiac neurosis;
a2 The use of a pharmaceutical composition for the treatment of cardiac neurosis, in combination with or in synergy with a behavioral cognitive therapy of an individual;
a3 For the preparation of a medicament for treating cardiac neurosis in a patient undergoing behavioral cognition therapy in an individual.
Preferably, the cardiac neurosis is a deficiency of heart-liver yin. The symptoms are vexation, insomnia, dreaminess, easy convulsion, dizziness, dry eyes, dry mouth, dry throat, emaciation, red tongue, little tongue fur, thin pulse or rapid disease, low fever or baking fever, night sweat, feverish palms and soles, red cheeks, low menstrual flow, dark red color and the like.
The application also protects the application of the traditional Chinese medicine composition in any one of the following:
b1 Preparing a medicament for improving the traditional Chinese medicine symptoms of the cardiac neurosis;
b2 Preparing a medicament for improving the traditional Chinese medicine symptoms of the cardiac neurosis by synergizing the individual behavior cognitive treatment;
b3 The use of a pharmaceutical composition for improving symptoms of traditional Chinese medicine in cardiac neurosis in a patient undergoing behavioral cognitive therapy in the individual;
b4 Preparing a medicament for treating or relieving or improving or inhibiting anxiety;
b5 Preparing a medicament for treating or relieving or improving or inhibiting anxiety in coordination with the behavioral cognitive treatment of the individual;
b6 Use of a medicament for the preparation of a medicament for the treatment or alleviation or amelioration or inhibition of anxiety in a patient undergoing behavioral cognitive therapy in an individual;
b7 Preparing a medicament for treating or relieving or improving or inhibiting depression;
b8 Preparing a medicament for treating or relieving or improving or inhibiting depression in coordination with the behavioral cognitive treatment of the individual;
b9 Preparing a medicament for treating or alleviating or ameliorating or inhibiting depression in a patient undergoing behavioral cognitive therapy in the individual;
b10 Preparing a medicament for improving cardiac autonomic nerve function;
b11 Preparing a medicament for improving cardiac autonomic nerve function in cooperation with the behavioral cognitive treatment of the individual;
b12 Preparing a medicament for improving cardiac autonomic nerve function in a patient undergoing behavioral cognitive therapy in the individual;
b13 Preparing a medicament for regulating and controlling the whole brain neurotransmitter or treating the whole brain neurotransmitter disorder;
b14 Preparing a medicament for regulating whole brain neurotransmitter or treating whole brain neurotransmitter disorder in coordination with the behavioral cognitive therapy of the individual;
b15 Preparing a medicament for modulating a whole brain neurotransmitter or treating a whole brain neurotransmitter disorder in a patient undergoing behavioral cognitive therapy in the individual;
b16 Preparing the medicine for improving palpitation, palpitation and/or insomnia.
Specifically, the symptoms of the traditional Chinese medicine for treating the cardiac neurosis are at least one of palpitation, shortness of breath, chest pain, chest distress, eye astringency, dry mouth, insomnia and dreaminess.
In particular, the improvement of cardiac autonomic functions is embodied in improving at least one of the heart rate variability indicators SDNN, SDANN, rMSSD.
Specifically, the whole brain neurotransmitter includes at least one of whole brain 5-HT, DA and EXC.
A product for treating cardiac neurosis comprising the traditional Chinese medicine composition of any one of the above claims and an individual cognitive behavioral therapy apparatus, which is also within the scope of the present application.
The application of the traditional Chinese medicine composition and the individual cognitive behavior therapeutic apparatus in preparing products for treating cardiac neurosis is also within the protection scope of the application.
The application of the traditional Chinese medicine composition and the individual cognitive behavior therapeutic instrument in any one of the following is also within the protection scope of the application;
c1 Preparing a product for improving the traditional Chinese medicine symptoms of the cardiac neurosis;
c2 Preparing a product for treating or alleviating or ameliorating or inhibiting anxiety;
c3 Preparing a product for treating or relieving or improving or inhibiting depression;
c4 Preparing a product for improving cardiac autonomic nerve function;
c5 Preparing a product for regulating the whole brain neurotransmitter or treating the whole brain neurotransmitter disorder.
Specifically, the individual cognitive behavior therapeutic apparatus is a product capable of realizing the following therapeutic steps:
step 1: question assessment, namely finding out the pathogenic factors of a patient, and understanding the psychological mode of symptom question formation of the patient; the symptoms of the patients, the limited degree and the current coping mode are evaluated in detail on the beliefs of the etiology; meanwhile, understand the interaction modes of physiological, cognitive, emotional and behavioral aspects formed by the symptoms of the patient;
step 2: correcting patient distortion and mishaps with cognitive skills including subjective speculation, misinterpretation and negative understanding;
step 3: factors that address maintenance issues; identifying and treating lifestyle and personality factors that maintain symptoms with means to solve the problem; identifying and challenging those unassisted hypotheses for the patient using cognitive methods;
step 4: the method guides the patient to correctly treat the contradiction between society and families, explores the intrinsic craving of the patient for substance spirit, helps the patient to recover the self-intense living attitude, and actively participates in the outdoor group exercise;
step 5: and at the end of the visit period, setting a cognitive behavioral treatment key point for the patient according to the social and psychological reasons of the patient, thereby reducing the recurrence rate.
In the application, the subject is a patient with cardiac neurosis, and the dosage is as follows: the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 30g of wild jujube seed, 10g of platycladi seed, 30g of poria cocos, 10g of dwarf lilyturf tuber, 10g of white paeony root, 10g of Chinese angelica, 12g of Chinese magnoliavine fruit and 15g of honey-fried licorice root; one dose per day, twice a day.
The application has the following beneficial effects:
the inventor of the application continuously researches the symptoms and rules of the cardiac neurosis and effective medicaments, and discovers that the heart-liver yin deficiency is the core symptoms of the disease. Aiming at the symptoms, the inventor refines the liver-moistening and heart-nourishing prescription for the treatment of the symptoms according to the early research results and the clinical experience summary of the traditional Chinese medicine, namely the traditional Chinese medicine composition, which can play roles in moistening liver, astringing yin, nourishing heart and soothing the nerves. Years of clinical researches show that the traditional Chinese medicine composition can obtain obvious clinical curative effect on treating cardiac neurosis, the prescription can obviously improve clinical symptoms, is high in safety and tolerance, and can improve or restore social functions. The traditional Chinese medicine composition has the characteristics of easily available medicinal materials, low cost, reasonable formula, good curative effect, short treatment course, no side effect and the like, and can be used for effectively treating heart and liver yin deficiency type cardiac neurosis.
The method comprises the following steps:
monarch drug: semen Ziziphi Spinosae and semen Platycladi
The wild jujube seed has sweet and neutral taste, enters heart, liver and gall meridians, and mainly nourishes yin and liver, calms heart and calms mind; platycladi seed, semen Platycladi, with a sweet nature, enters heart, kidney and large intestine meridians, and has effects of nourishing heart, tranquilizing mind, nourishing blood, relieving constipation, and arresting sweating. The two medicines of the wild jujube seed and the platycladi seed are sweet and neutral in nature, enter heart meridian and are all monarch medicines together to play roles of nourishing yin and softening liver, nourishing heart and tranquillizing, and the heart-liver yin and blood are sufficient to assist tranquillizing and stabilizing.
Ministerial drugs: radix Paeoniae alba, radix Angelicae sinensis, radix Ophiopogonis, fructus Schisandrae, poria, and radix Glycyrrhizae Preparata
White peony root, radix Paeoniae alba, with sour and bitter taste and slightly cold nature, enters liver meridian and spleen meridian, plays a role in nourishing yin and softening liver in the whole prescription, tonifying heart and regulating heart and liver. Dang Gui is sweet and warm in nature, enters heart, liver and spleen meridians, and is good at replenishing blood and activating blood, and relaxing bowel. Dang Gui is compatible with Bai Shao, and nourishes yin and blood, and has good effect on macroscopical power, sufficient yin and blood and calm heart. Mai Dong is sweet and cold in nature, enters heart, stomach and lung meridians, and has the actions of nourishing yin and promoting fluid production, clearing heart fire and moistening lung. The schisandra chinensis has the effects of promoting the production of body fluid, tonifying qi, tonifying kidney, calming heart, astringing and inducing astringency, and has the effects of aligning the heart and the kidney, relieving both water and fire and stabilizing heart spirit in the prescription. Poria is sweet and neutral in taste, enters heart, spleen, lung and kidney meridians, has the effects of strengthening spleen and promoting diuresis, and calming heart and tranquillizing, and honey-fried licorice is sweet and neutral in taste, mainly enters spleen and stomach meridians, and has the main effects of regulating middle energizer and relieving urgency and regulating medicines, and honey-fried licorice is the formula for regulating and moistening liver and nourishing heart medicines, so that each traditional Chinese medicine plays roles, is special for each part and supplements each other.
The medicines for nourishing liver and heart Fang Quanfang are used together for 'nourishing' and 'nourishing', and the spine date seed and the platycladi seed are used for nourishing heart and spirit, relaxing bowel, the white paeony root and the Chinese angelica are used for nourishing blood and liver, the dwarf lilyturf tuber and the Chinese magnoliavine fruit are used for nourishing yin and promoting the production of body fluid, and the poria cocos and the honey-fried licorice root are used for nourishing spleen and stomach to assist qi and blood for biochemical treatment. The wood is the mother of fire, white paeony root and angelica are used for nourishing liver, enriching the mother viscera and nourishing the son viscera; fire is the mother of earth, poria cocos is used for promoting diuresis and strengthening spleen, honey-fried licorice root is used for harmonizing spleen and stomach, spleen and earth are protected, son and son viscera are full, and mother and son viscera are carefree; the shizandra berry is used for inducing astringency and nourishing essence, and heart and kidney are coordinated, so that water and fire are both relieved.
Drawings
FIG. 1 is a flow chart of the experiment in example 2 of the present application.
Detailed Description
For further understanding of the present application, the following examples are given for illustration only and are not intended to limit the scope of the present application. The examples provided below are intended as guidelines for further modifications by one of ordinary skill in the art and are not to be construed as limiting the application in any way.
The experimental methods used in the following examples are all conventional methods unless otherwise specified; the materials, reagents and the like used, unless otherwise specified, are all commercially available.
The raw materials of the wild jujube seed, the platycladi seed, the dwarf lilyturf tuber, the fried white peony root, the Chinese angelica, the shizandra berry, the poria cocos and the honey-fried licorice root in the following embodiments are all medicinal materials collected in Chinese pharmacopoeia or Chinese medicinal preparation standards, and all indexes meet the regulations through identification.
Example 1 preparation of a Chinese medicinal composition for treating cardiac neurosis
1. Formulation of
30g of wild jujube seed, 10g of platycladi seed, 30g of poria cocos, 10g of dwarf lilyturf tuber, 10g of white paeony root, 10g of Chinese angelica, 12g of Chinese magnoliavine fruit and 15g of honey-fried licorice root.
2. Preparation method
The preparation method of the water decoction comprises the following steps: according to the formula, the raw materials with corresponding mass are taken, all the raw materials in the traditional Chinese medicine composition are put into a marmite, 600ml of tap water is added, the raw materials are soaked for 45 minutes, the raw materials are decocted slowly with small fire, and the decoction is taken after boiling for 40 minutes. Adding 500ml of water for the second time, decocting slowly with slow fire, boiling, decocting for 20 min, and collecting the medicinal liquid. The two medicinal liquids are mixed (one dose) and divided into two parts.
3. Dosage of usage
Warm taking, one dose a day, twice a day.
Example 2 clinical trials
2.1 diagnostic criteria
2.1.1 Western diagnostic criteria: according to Utility science (fifteenth edition) and ICD-10, the following diagnostic criteria are formulated with reference to the gist of autonomic dysfunction in somatic form: (1) persistent autonomic nervous system symptoms: anxiety and suspicion are the main symptoms, and depression, fear, forcing and the like can be caused, and insomnia, tension, dizziness, sweating, hypodynamia, tremble and the like can be caused at different degrees; (2) Symptoms of persistent cardiovascular system dysfunction: such as palpitations, precordial pain, shortness of breath, excessive ventilation, and the like; (3) Through comprehensive systematic cardiovascular examinations (such as electrocardiogram, dynamic electrocardiogram, echocardiogram, coronary artery CT or coronary angiography, etc.), no organic basis or organic basis exists for diagnosis of heart disease which cannot explain the current clinical symptoms or which often does not give satisfactory therapeutic effects after treatment with heart disease.
2.1.2 dialectical typing criteria in TCM: the heart neurosis is classified according to the syndrome differentiation and typing of the traditional Chinese medicine clinical diagnosis and treatment term syndrome part and the related clinical study of the earlier subject group. Deficiency of heart-yin and liver-yin: the symptoms are vexation, insomnia, dreaminess, easy convulsion, dizziness, dry eyes, dry mouth, dry throat, emaciation, red tongue, little tongue fur, thin pulse or rapid disease, low fever or baking fever, night sweat, feverish palms and soles, red cheeks, low menstrual flow, dark red color and the like.
2.2 case selection
2.2.1 case Source
The study is carried out by taking the patients with the cardiac neurosis, which are in compliance with the inclusion standard, out of the department of the cardiac medicine in Guangan-Ann hospitals of Chinese medical college, as study subjects, taking 30 cases of the patients with the cardiac neurosis, which are in compliance with the inclusion standard and out of the exclusion standard, as study subjects, and taking 30 cases of the patients with the cardiac neurosis, which are in compliance with the inclusion standard, out of the clinical department of the cardiac neurosis, as study subjects, in the year of 10, which are taken as study subjects.
2.2.2 case inclusion criteria
The study inclusion cases according to the "Utility Endoconcha" (fifteenth edition) and ICD-10, reference to the gist of autonomic dysfunction in somatic form, the inclusion criteria for this subject were defined as follows:
(1) Meets the diagnosis standard of cardiac neurosis, and has 18-60 years of age and unlimited sex.
(2) Meets the diagnosis standard of syndrome differentiation and classification of the traditional Chinese medicine for heart-liver yin deficiency.
(3) Patients were not taking anxiolytic, antidepressant or psychotropic drugs within 2 weeks prior to group entry.
(4) The patient signed an informed consent form.
2.2.3 case exclusion criteria
One of the following cases was not included in this study.
(1) Combined with coronary heart disease, myocarditis, mitral valve prolapse, etc., electrocardiogram, 24H dynamic electrocardiogram, echocardiogram, coronary artery CT, and PCI examination prompt for clear heart disease;
(2) Combining endocrine and metabolic diseases such as hyperthyroidism, diabetes mellitus, etc.;
(3) Combining ST-T segment changes caused by other causes and uncorrectable, such as hypokalemia, digitalis or other drug responses, and "juvenile T-wave" changes;
(4) Chronic infection, drug affliction; other serious somatic diseases such as kidney and brain; epilepsy, etc.;
(5) Patients with severe mental illness or family history of mental illness;
(6) Pregnant women or women with a desire for pregnancy;
(7) Another clinical trial of study drug was taken one month prior to inclusion in the study.
2.2.4 termination criteria
(1) Those who find out to be out of compliance with the test scheme after entering the group;
(2) Patients who continue to participate in the trial study are refused;
(3) Losing access;
(4) After the group is put into the group, the test person is interrupted due to the fact that non-drug sources such as serious somatic diseases are combined;
(5) Not following the administration guidelines;
(6) And the combination of disabling drugs or other therapeutic methods.
2.2.5 termination test criteria
(1) In the clinical test process, the secret is leaked from all blind bottoms;
(2) The emergency letter disassembling rate exceeds 20%;
(3) The ethics committee has rights to terminate or pause;
(4) The side effect of the clinical medicine is great.
2.2.6 drop criteria
One of the following cases is considered to be falling off.
(1) Poor compliance with subject treatment, persons not prescribed;
(2) The patients who naturally fall off and lose visit in observation include the patients who are effective in treatment but do not complete the whole treatment course, so that the data is incomplete, and the curative effect and the safety are affected;
(3) Adverse reactions or serious adverse events occur during the observation period, and the observation cannot be continued and the observation is terminated.
2.3 methods of treatment
Patients were divided into treatment groups and control groups using a randomized double-blind method, with treatment groups being 18 and control groups being 12. The study was a double blind trial, and the patient took the drug consistently in form packaging.
2.3.1 treatment protocol for test group: decoction of example 1 + cognitive behavioral therapy.
The treatment method comprises the following steps: nourish liver yin, nourish heart and tranquilize mind
Specification and usage: the preparation method of the decoction is the same as that of example 1: according to the formula of the embodiment 1, the raw materials with corresponding mass are taken, all the raw materials in the traditional Chinese medicine composition are put into a marmite, 600ml of tap water is added, the raw materials are soaked for 45 minutes, the raw materials are decocted slowly with small fire, and the decoction is taken after boiling for 40 minutes. Adding 500ml of water for the second time, decocting slowly with slow fire, boiling, decocting for 20 min, and collecting the medicinal liquid. The two medicinal liquids are mixed (one dose) and divided into two parts. Is taken orally for 8 weeks after breakfast and supper.
Frequency of treatment of cognitive behaviors in individuals: the treatment steps were as follows:
step 1: question assessment, finding out the pathogenic factors of patients, and understanding the psychological mode of patient symptom question formation. At this stage, the patient's symptoms, to a limited extent, are treated in the current manner, with a detailed assessment of the etiology beliefs. At the same time, the pattern of interactions in terms of physiology, cognition, emotion, behavior, etc. of the patient's symptoms are understood.
Step 2: the use of cognitive skills to correct patient distortion and mistakes includes subjective speculation, misinterpretation and negative understanding.
Step 3: factors that address maintenance issues. Lifestyle and personality factors that maintain symptoms are identified and treated with means to solve the problem, such as: high pressure lifestyle. Cognition was used to identify and challenge those unassisted hypotheses in the patient.
Step 4: the method guides the patient to correctly treat the contradiction between society and families, explores the intrinsic craving of the patient for substance spirit, helps the patient to recover the self-strength life attitude, and actively participates in outdoor group exercises such as mountain climbing, running and the like.
Step 5: at the end of the visit period, we formulate cognitive behavioral therapy points for the patient according to the social and psychological cause of the patient's morbidity, thereby reducing the recurrence rate.
2.3.2 control treatment protocol: placebo of traditional Chinese medicine + treatment of cognitive behavior.
The traditional Chinese medicine decoction placebo is used for treatment, and the appearance of the medicine is the same as that of a test group. The components are as follows: 1/20 of the original dose and a water decoction placebo made with edible bitter principle. Is taken orally for 8 weeks after breakfast and supper.
The treatment steps of the cognitive behaviors of the individual are the same as before.
2.4 efficacy index and period of observation
2.4.1 major efficacy index
2.4.1.1 Chinese medicine symptom score table the Chinese medicine symptom score table is formulated by the Chinese medicine clinical diagnosis and treatment term made by the national administration of Chinese medicine and medical science. Changes in symptoms such as palpitation, shortness of breath, chest pain, chest distress, insomnia, dyspnea, fatigue and weakness, emotional tension, anxiety and depressed mood were recorded, and each symptom was classified into four classes, including palpitation, shortness of breath, chest pain, chest distress, vexation, astringency of the eye, dry mouth, insomnia and dreaminess, with 0, 2, 4 and 6 minutes in sequence, and the minor symptoms including dyspnea, fatigue and weakness, night sweat, heat, tension and depressed mood, with 0, 1, 2, 3 minutes in sequence, and 0 and 1 minute in sequence. The Chinese medicine symptom score table needs to be filled in before each patient is taken in, 2, 4, 6 and 8 weeks after treatment, and single score and total score are calculated.
Referring to the relevant standard in the "guidelines for clinical study of New Chinese medicine" (2002 edition), it is considered that the total point of all symptoms before and after treatment is evaluated by the score (T): t is more than or equal to 95 percent of cure; t is more than or equal to 70% and less than 95% as obvious effect; t is more than or equal to 30% and less than 70% as effective; t < 30% is ineffective.
2.4.1.2 anxiety depression scale score
Each patient was rated on hamilton anxiety scale (HAMA), hamilton depression scale (HAMD) before treatment, 2, 4, 6, 8 weeks after treatment. The Hamiltonian anxiety scale has a score less than 7 and no anxiety, the score is low in the range of 8-21, the score is medium in the range of 22-28, and the score is more than or equal to 29 and is high. The Hamiltonian depression scale selects 24 scales, the score is less than 8, no depression is generated, the score is 8-19 and is mild, the score is 20-34 and is moderate, and the score is more than or equal to 35 and is severe.
Assessed as HAMA, HAMD decrease rate (T), decrease rate= (score at baseline score-score)/baseline score x 100%: t is more than or equal to 75 percent and is healed; t is more than or equal to 50% and less than 75% as obvious effect; t is more than or equal to 25% and less than 50% as effective; t < 25% is ineffective.
2.4.1.3 heart rate variability index
Data acquisition is carried out before and after the treatment of the subject, and the data acquisition comprises a time domain analysis index and a frequency domain analysis index of a short time course. According to heart rate variability detection suggestions given by the national journal of cardiovascular diseases, committee of heart rate variability countermeasure thematic group, the selected time domain analysis indexes comprise 2 items of normal RR interval Standard Deviation (SDNN) and adjacent RR interval root mean square (RMSSD), and the frequency domain analysis indexes comprise 6 items of Total Power (TP), low Frequency (LF), high Frequency (HF), low frequency normalization (LFNorm), high Frequency Normalization (HFNORM) and low frequency/high frequency (LF/HF).
Heart rate variability analysis evaluation criteria: (1) the effect is shown: the examination result is converted into normal after treatment; (2) the method is effective: the examination result is obviously improved after treatment; (3) invalidation: the examination results were unchanged after treatment.
2.4.1.4 24-hour dynamic electrocardiogram index
Dynamic electrocardiogram (Holter) measurements were performed 24 hours before and after treatment. The 24-hour dynamic electrocardiogram selection indicators include: average heart rate, presence or absence of ventricular premature, presence or absence of atrial premature, and presence or absence of ST-T segment changes.
24 hour dynamic electrocardiogram evaluation criteria: (1) and (3) healing: premature systole and normal heart rate within 24 hours; (2) improvement: the times of the 24-hour pre-contraction and the heart rate are reduced by more than 50% compared with the original times; (3) invalidation: the number of times of 24-hour pre-systole and tachycardia is reduced by less than 50% or increased compared with the original times.
2.4.2 secondary efficacy index
2.4.2.1 brain electrical index
And analyzing the super-diffuse fluctuation of the brain electricity before and after treatment. Electroencephalogram ultra-slow fluctuation analysis (SET) is used for analyzing the activation condition of neurotransmitters in brain by using an electroencephalogram signal through software frequency spectrum, wherein the activation condition comprises 6 neurotransmitters including inhibitory medium (INH), excitatory medium (EXC), 5-hydroxytryptamine (5-HT), acetylcholine (ACh), norepinephrine (NE) and Dopamine (DA).
2.4.2.2 psychological social factor index
The patients are involved in the assessment of psychological and social factors, mainly a social readaptation assessment scale, and statistical analysis is carried out aiming at factors such as pathogenesis inducement, occupation and the like.
2.4.3 evaluation of follow-up efficacy
After the 8-week treatment period is ended, the study is followed by the crowd conforming to the scheme, and the follow-up is carried out once in 8 weeks and 16 weeks, wherein the follow-up can be carried out by telephone, letter or review, and the Chinese medicine symptom integration, HAMA and HAMD evaluation are carried out, wherein the Chinese medicine symptom integration evaluation is equal to 2.4.1.1, and the HAMA and HAMD evaluation is equal to 2.4.1.2.
2.4.4 safety index
Before and after treatment, blood routine, urine routine, feces routine, liver and kidney function, electrocardiogram, etc. are detected for 2 times. If an abnormality occurs during or after the treatment, it is necessary to review at an appropriate time and perform comprehensive analysis of the condition of the subject's onset, treatment, etc., to determine whether it is related to the test drug. Judging the adverse event according to the standard, and filling in an adverse event list: the assessment time is synchronized with the efficacy assessment.
Statistical methods: the measurement data are expressed by mean ± standard deviation or median, quartile range. Comparing the metering data among groups, wherein the groups which do not accord with normal distribution adopt Mann-Wnitney rank sum test; and judging whether the variances have homogeneity according to normal distribution, wherein the group with the homogeneity adopts t-test of independent samples. And comparing the two measurement data sets, wherein the data which do not accord with normal distribution adopts Wilcoxon rank sum test, and the data accord with normal distribution adopts paired sample t test. The counting data is checked by chi-square. SPSS26.0 statistical software is adopted to analyze data, and the difference is statistically significant when P is less than 0.05.
2.5 treatment results and analysis
2.5.1 general data analysis
The study is carried out by taking the study into 2022 for 4 months to 2022 for 10 months, taking 30 cases of cardiac neurosis patients meeting the taking standard in the department of physical and mental medicine outpatient service of Guangan-Ann hospitals of China academy of traditional Chinese medicine as study objects, dividing the patients into a treatment group and a control group by adopting a random double-blind method, wherein 18 cases of the treatment group and 12 cases of the control group have no obvious statistical difference (P > 0.05) in gender, age, chinese medicine symptom integral and depression anxiety degree, and the baseline data are comparable.
2.5.2 evaluation of efficacy
2.5.2.1 score comparison of the symptoms of the principal symptoms of Chinese traditional medicine after 8 weeks of treatment
Table 1, integral of each symptom of the main symptoms of the Chinese medicine after 8 weeks of treatment
* P is less than 0.05, and the difference has statistical significance.
After treatment, the main symptoms of the two groups of traditional Chinese medicines are compared, the treatment groups have the advantages of palpitation, shortness of breath, chest pain, chest distress, eye astringency, dry mouth, less sleep and dreaminess, and the difference has statistical significance (P < 0.05) compared with the control group.
2.5.2.2 comparison of the curative effects of two groups of Chinese traditional medicine syndromes
The therapeutic effect judgment standard of the clinical Chinese medicine symptoms is formulated by referring to the Chinese medicine new medicine clinical research guidelines, and the main symptoms before and after treatment are compared according to integral. Therapeutic index T (%) = (pre-treatment integral-post-treatment integral)/(pre-treatment integral x 100%).
(1) The original symptoms basically disappear, and the integral of clinical symptoms is reduced by more than or equal to 90 percent; (2) Obvious effect, obvious alleviation of clinical symptoms and signs, and reduction of clinical symptom integration of more than or equal to 70 percent; (3) Effective, improved clinical symptoms and signs, and reduced symptom integral of 30% or more; (4) No significant improvement in clinical symptoms, or even exacerbation, less than 30% decrease in symptom score.
Exterior 2, chinese medical science syndrome curative effect
The difference in the effective rate of the two groups of treatment is statistically significant (P < 0.05), and the effective rate of the two groups of treatment is higher than that of the control group.
2.5.2.3 Hamiltonian depression scale 24 (HAMD-24) score comparison after 8 weeks of treatment
TABLE 3 HAMD-24 integration after 8 weeks of treatmentDividing into two parts
The difference in HAMD-24 score after 8 weeks of treatment was statistically significant (P < 0.01) for both treatment groups, with HAMD-24 score lower than for the control group.
2.5.2.4 Hamiltonian anxiety scale (HAMA) integral comparison after 8 weeks of treatment
TABLE 4 HAMA score (M (QR) after 8 weeks of treatment
The difference in HAMA scores after 8 weeks of treatment was statistically significant (P < 0.01) for both groups, with the HAMA scores for the treatment group being lower than the control group.
2.5.2.5 heart rate variability index SDNN comparison after 8 weeks of two groups of treatment
TABLE 5 SDNN after 8 weeks of treatmentm/s)
The difference of heart rate variability index SDNN after 8 weeks of treatment of the two groups has significant statistical significance (P < 0.01), and the SDNN of the treatment group is higher than that of the control group.
2.5.2.6 comparison of heart rate variability index SDANN after 8 weeks of treatment
TABLE 6 SDANN after 8 weeks of treatmentm/s)
The heart rate variability index SDANN difference after 8 weeks of treatment was not statistically significant (P > 0.05).
2.5.2.6 comparison of heart rate variability index rMSSD after 8 weeks of treatment
TABLE 7 rMSSD (M (QR)) after 8 weeks of treatment
The difference of heart rate variability index rMSSD after 8 weeks of treatment has statistical significance (P < 0.05), and the rMSSD of the treatment group is higher than that of the control group.
After 8 weeks of treatment, the treated group had higher SDNN, rMSSD than the control group (P < 0.05). The traditional Chinese medicine composition disclosed by the application has better curative effects than placebo in improving cardiac autonomic nerve function, reducing sympathetic nerve tension and improving cardiac neurosis prognosis.
Comparison of whole brain neurotransmitters after 8 weeks of treatment in 2.5.2.7 two groups
Table 8, full brain neurotransmitter after 8 weeks of treatment
Note that: * The differences in the group are statistically significant (P < 0.05), and the differences in the group are statistically significant (P < 0.05).
After 8 weeks of treatment, the treatment groups were statistically different from each other (P < 0.05) in whole brain 5-HT, DA, EXC, as indicated by higher levels of whole brain 5-HT than before treatment, lower levels of whole brain DA than before treatment, and lower levels of whole brain EXC than before treatment. The control group was compared with the treatment group, and the two groups had statistical differences (P < 0.05) in total brain DA and EXC after treatment, which was shown to be lower than the control group in the test group after treatment. The traditional Chinese medicine composition disclosed by the application has better curative effects than placebo in improving the level of whole brain 5-HT and balancing the level of DA and EXC, and is beneficial to improving the neurotransmitter of whole brain, so that the traditional Chinese medicine composition plays a role in improving depression and anxiety.
2.5.2.8 two groups of Chinese medicine main symptoms each symptom integral comparison at 16 weeks of visit
Table 9, 16 weeks of visit the integral (M (QR) of each symptom of the principal symptoms of Chinese medicine, score)
* P is less than 0.05, and the difference has statistical significance.
At 16 weeks of visit, the main symptoms of traditional Chinese medicine are compared, and the treatment groups have the advantages of palpitation, shortness of breath, chest pain, chest distress, eye astringency, dry mouth, insomnia and dreaminess which are reduced compared with the control groups, and the difference has statistical significance (P < 0.05).
After 8 weeks of treatment, the integral of symptoms of palpitation, shortness of breath, chest pain, chest distress, dry eyes, hyposomnia and dreaminess in the treatment group is lower than that in the control group (P < 0.05), and the effective rate of the treatment group is higher than that in the control group (P < 0.05). At 16 weeks of follow-up, the treatment group had symptoms of palpitation, shortness of breath, chest pain, chest distress, dryness of the mouth, insomnia, and dreaminess with a score lower than that of the control group, and the difference was statistically significant (P < 0.05). The application shows that the effective rate of the traditional Chinese medicine composition for treating the cardiac neurosis is higher than that of a control group, and the curative effect of relieving the main symptoms of the cardiac neurosis is better than that of a placebo after 8 weeks of treatment and 16 weeks of follow-up.
2.5.2.9 two sets of 16 week interview-time Hamiltonian depression scale 24 (HAMD-24) integral comparisons
TABLE HAMD-24 integral at 16 weeks of visit @Dividing into two parts
At 16 weeks of visit, the difference in HAMD-24 score was statistically significant (P < 0.01) for the treatment group and the HAMD-24 score was lower than for the control group.
8 weeks after treatment, the HAMD-24 score was lower in the treatment group than in the control group (P < 0.05). At 16 weeks of follow-up, the treatment group had a lower HAMD-24 score than the control group (P < 0.05). The traditional Chinese medicine composition has better curative effect than the control group in improving the depressed emotion of the patients with cardiac neurosis after 8 weeks of treatment and 16 weeks of follow-up.
2.5.2.10 two groups of Hamiltonian anxiety scale (HAMA) score comparisons at 16 weeks of visit
TABLE 11 HAMA integral at 16 weeks of visitDividing into two parts
At 16 weeks of visit, the HAMA integral difference was statistically significant (P < 0.01) for the treatment group with HAMA integral lower than the control group.
After 8 weeks of treatment, the HAMA score was lower in the treatment group than in the control group (P < 0.05). At 16 weeks of follow-up, the treatment group had a lower HAMA score than the control group (P < 0.05). The traditional Chinese medicine composition has better curative effect than the control group in improving anxiety and emotion of patients with cardiac neurosis after 8 weeks of treatment and 16 weeks of follow-up.
2.5.3 safety evaluation
Urine, stool convention, liver and kidney functions and electrocardiogram of two groups of patients before treatment and after 8 weeks of treatment are compared, the two groups of patients do not have abnormality, and the incidence rate of adverse reactions of the treatment group is lower than that of the control group.
Table 12, treatment of group urine, stool routine, liver and kidney function, and comparison of Electrocardiogram changes
Table 13, comparison of urine, stool, liver and kidney function and electrocardiogram changes in the control group
TABLE 14 adverse reaction conditions comparison
Urine and stool convention, liver and kidney functions and electrocardiogram of two groups of patients before treatment and after 8 weeks of treatment are compared, the two groups of patients do not have abnormality, and the incidence rate of adverse reactions of the treatment group is lower than that of the control group. The traditional Chinese medicine composition has good safety.
In conclusion, the curative effects of the treatment group on improving the symptoms, depression state, anxiety state, cardiac autonomic nervous function and whole brain neurotransmitter of the traditional Chinese medicine are higher than those of the control group, so that the traditional Chinese medicine composition disclosed by the application can be used for treating cardiac neurosis due to deficiency of heart-yin and liver-yin. In addition, the blood routine, urine routine, faeces routine, liver and kidney function and electrocardiogram of each group of patients before and after treatment are not obviously abnormal, and the patients do not have obvious adverse reactions during the administration period, so that the safety of the traditional Chinese medicine composition is fully demonstrated.
Example 3, typical case:
pattern examination and corner lifting for cardiac neurosis
The patient, female, was 73 years old. The department of mental medicine in Guangdong Hospital was at the clinic for 2023, 3 and 30. Complaints: palpitations are aggravated for 3 months with insomnia for 1 year. The patient has no obvious cause before 1 year, palpitation, difficulty in falling asleep and dreaminess, and is treated by the zopiclone tablet 7.5mg orally taken 1/night in community hospitals, and the sleep is slightly improved. Before 3 months, palpitation and aggravation are caused without obvious causes, dizziness, tight head feel, dysphoria, low emotion, hypomnesis, chest distress and asthma are avoided, heart ultrasound, coronary artery CT and other examinations are not obviously abnormal, but palpitation is still obvious, and the doctor can visit the doctor in the department. Etching: palpitation, no obvious aggravation after exercise, chest distress and breath hold, dizziness, tight head, tension anxiety, dysphoria, throat foreign body sensation, thirst and dry throat, dark urine, dry stool, frequent nocturia, dark red tongue, little coating, and wiry, thin and rapid pulse.
Diagnosis of traditional Chinese medicine: palpitation
Differentiation of syndromes and types: deficiency of Heart-liver Yin
The treatment method comprises the following steps: liver-moistening and heart-nourishing
Modified Xuegang Yinyen Fang (modified Xuexin Fang) is specifically as follows:
30g of wild jujube seed, 10g of platycladi seed, 10g of dwarf lilyturf tuber, 10g of fried white peony root, 10g of Chinese angelica, 12g of Chinese magnoliavine fruit, 30g of poria cocos and 15g of honey-fried licorice root;
7 doses are decocted in water (the decoction method is the same as that of example 1), and one dose is taken in the morning and evening.
The preparation method comprises the following steps: patients should be palpitation and palpitation with insomnia as complaints, and related examinations such as heart ultrasound and coronary artery CT have no obvious abnormality, and can be diagnosed as cardiac neurosis by combining with the accompanying signs. Deficiency of heart-liver yin, deficiency of qi and yin, and malnutrition of heart, palpitation; restlessness of heart-mind, disharmony of yin and yang, insomnia and dreaminess; deficiency of qi and yin, hyperactivity of yin and yang due to prolonged periods of time, dizziness and tightness of the head; dysphoria, reddish urine, foreign body sensation in the throat and constipation are caused by yin deficiency and heat generation. Fever forces the bladder, and body fluids flow downward to cause frequent nocturia. Dark red tongue with little coating and wiry and thready and rapid pulse are also symptoms of deficiency of both qi and yin and yang Kang Xure. The recipe for moistening liver and nourishing heart is proved recipe in the medical science of mind and body. Is prepared from semen Ziziphi Spinosae, semen Platycladi, radix Ophiopogonis, radix Paeoniae alba preparata, radix Angelicae sinensis, fructus Schisandrae chinensis, poria, and radix Glycyrrhizae Preparata, and has effects of nourishing heart, nourishing liver, and tranquilizing mind. "jin Kui Yao Lv Yuan (the key of gold) cloud: "crying the evil causes the soul to be restless and the blood and qi to be less; the people with blood and qi deficiency belong to the people with heart and qi deficiency, and the people are averted, and the people want to sleep, dream, go far and go away, and the spirit is discrete, and the spirit is delusional. Cortex Albiziae is also a common drug taught by Xu Fengquan, cloud of Shennong Bencaojing: albizia, sweet and flat. The five zang organs are kept in charge, and the heart is cleared, so that people are happy and careless. It is desirable to lighten the body and improve the eyesight after long-term administration. The honey-fried licorice root is mixed with a large dose, and the interior channel is treated by treating liver with urgent and rapid eating and slow eating. "reason.
Two diagnoses: the palpitation and the palpitation of the patient are obviously reduced, the tension anxiety is relieved, and the patient is prescribed 28 doses in front of the patient. Later, the phone calls back, sleep is improved, and emotion is improved.
The present application is described in detail above. It will be apparent to those skilled in the art that the present application may be practiced in a wide variety of ways without departing from the spirit and scope of the present application. While the application has been described with respect to specific embodiments, it will be appreciated that the application may be further modified. In general, this application is intended to cover any variations, uses, or adaptations of the application following, in general, the principles of the application and including such departures from the present disclosure as come within known or customary practice within the art to which the application pertains.
Claims (10)
1. A traditional Chinese medicine composition is prepared from the following raw materials in parts by mass:
30 parts of wild jujube seed, 10 parts of platycladi seed, 10 parts of dwarf lilyturf tuber, 10 parts of fried white peony root, 10 parts of Chinese angelica, 12 parts of Chinese magnoliavine fruit, 30 parts of poria cocos, and 15 parts of honey-fried licorice root.
2. The traditional Chinese medicine composition according to claim 1, wherein: the Chinese medicinal composition is a decoction.
3. The method for preparing the traditional Chinese medicine composition according to any one of claims 1-2, comprising the following steps:
1) Mixing the raw materials of the traditional Chinese medicine composition, adding water for the first time, soaking, decocting, and taking medicine liquid;
2) Adding water into the liquid medicine obtained in the step 1) for the second time, decocting, and taking the liquid medicine;
3) Mixing the liquid medicine obtained in the step 1) and the liquid medicine obtained in the step 2) to obtain the traditional Chinese medicine composition.
4. The method for preparing a traditional Chinese medicine composition according to claim 3, wherein: the ratio of the first water addition to the second water addition is as follows: adding 600mL of water into the raw materials of 30g of spina date seed, 10g of platycladi seed, 10g of dwarf lilyturf tuber, 10g of fried white paeony root, 10g of Chinese angelica, 12g of Chinese magnoliavine fruit, 30g of Indian buead and 15g of honey-fried licorice root, and adding 500mL of water into the obtained liquid medicine;
in the step 1), the soaking time is 30-60 minutes;
in the step 1), the decoction is slow decoction with small fire, and the decoction is carried out for 40 minutes after boiling;
in the step 2), the decoction is slow decoction with small fire, and the decoction is carried out for 20 minutes after boiling.
5. Use of the traditional Chinese medicine composition according to any one of claims 1-2 in any one of the following:
a1 Preparing a medicament for treating cardiac neurosis;
a2 The application of the composition in preparing medicines for treating cardiac neurosis in cooperation with individual behavior cognitive therapy;
a3 For the preparation of a medicament for treating cardiac neurosis in a patient undergoing behavioral cognition therapy in an individual.
6. The use according to claim 5, characterized in that: the cardiac neurosis is heart-liver yin deficiency.
7. Use of the traditional Chinese medicine composition according to any one of claims 1-2 in any one of the following:
b1 Preparing a medicament for improving the traditional Chinese medicine symptoms of the cardiac neurosis;
b2 Preparing a medicament for improving the traditional Chinese medicine symptoms of the cardiac neurosis by synergizing the individual behavior cognitive treatment;
b3 The use of a pharmaceutical composition for improving symptoms of traditional Chinese medicine in cardiac neurosis in a patient undergoing behavioral cognitive therapy in the individual;
b4 Preparing a medicament for treating or relieving or improving or inhibiting anxiety;
b5 Preparing a medicament for treating or relieving or improving or inhibiting anxiety in coordination with the behavioral cognitive treatment of the individual;
b6 Use of a medicament for the preparation of a medicament for the treatment or alleviation or amelioration or inhibition of anxiety in a patient undergoing behavioral cognitive therapy in an individual;
b7 Preparing a medicament for treating or relieving or improving or inhibiting depression;
b8 Preparing a medicament for treating or relieving or improving or inhibiting depression in coordination with the behavioral cognitive treatment of the individual;
b9 Preparing a medicament for treating or alleviating or ameliorating or inhibiting depression in a patient undergoing behavioral cognitive therapy in the individual;
b10 Preparing a medicament for improving cardiac autonomic nerve function;
b11 Preparing a medicament for improving cardiac autonomic nerve function in cooperation with the behavioral cognitive treatment of the individual;
b12 Preparing a medicament for improving cardiac autonomic nerve function in a patient undergoing behavioral cognitive therapy in the individual;
b13 Preparing a medicament for regulating and controlling the whole brain neurotransmitter or treating the whole brain neurotransmitter disorder;
b14 Preparing a medicament for regulating whole brain neurotransmitter or treating whole brain neurotransmitter disorder in coordination with the behavioral cognitive therapy of the individual;
b15 Preparing a medicament for modulating a whole brain neurotransmitter or treating a whole brain neurotransmitter disorder in a patient undergoing behavioral cognitive therapy in the individual;
b16 Preparing the medicine for improving palpitation, palpitation and/or insomnia.
8. A product for treating cardiac neurosis comprising the traditional Chinese medicine composition of any one of claims 1-2 and an individual cognitive behavioral therapy apparatus.
9. Use of a traditional Chinese medicine composition according to any one of claims 1-2 and an individual cognitive behavioral therapy apparatus in the manufacture of a product for the treatment of cardiac neurosis.
10. Use of the traditional Chinese medicine composition according to any one of claims 1-2 and an individual cognitive behavioral therapy apparatus in any one of the following:
c1 Preparing a product for improving the traditional Chinese medicine symptoms of the cardiac neurosis;
c2 Preparing a product for treating or alleviating or ameliorating or inhibiting anxiety;
c3 Preparing a product for treating or relieving or improving or inhibiting depression;
c4 Preparing a product for improving cardiac autonomic nerve function;
c5 Preparing a product for regulating the whole brain neurotransmitter or treating the whole brain neurotransmitter disorder.
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