Traditional Chinese medicine composition for treating vascular dementia and use method thereof

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly discloses a traditional Chinese medicine composition for treating vascular dementia and a using method thereof, and the traditional Chinese medicine composition comprises cassia twig, poria with hostwood, moutan bark, peach kernel, Chinese herbaceous peony, acorus calamus, polygala tenuifolia and ginseng. According to the traditional Chinese medicine composition for treating the vascular dementia and the use method thereof, the cognitive function and daily life ability of a patient with the vascular dementia can be obviously improved, the levels of serum cognitive related transmitters CGRP and 5-HT can be improved, and the levels of neuron apoptosis related factors such as BCL-2, Bax and Caspase-3 can be reduced. Results show that the blood stasis removing and resuscitation inducing prescription can improve the cognitive function and related factor level of the vascular dementia patient, and the advantage that the traditional Chinese medicine takes effect in multiple ways and multiple targets is exerted.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for treating vascular dementia and a use method thereof. Background Art

[0002] Vascular dementia (VD) is a type of dementia caused by brain damage due to cerebrovascular disease. It is a type of central nervous system degenerative disease characterized by memory loss, cognitive function and executive ability disorders. It is the second most common type of dementia after Alzheimer's disease.

[0003] At present, the treatment of vascular dementia mainly includes calcium antagonists, excitatory amino acid receptor antagonists, cholinesterase inhibitors, neurotrophic factors, drugs that improve brain metabolism, etc., but it is often difficult to achieve the expected effect through single-target drug treatment. Recent studies have found that the occurrence and development of vascular dementia are closely related to cognitive function-related transmitters, which are endogenous active neuropeptides and monoamine neurotransmitters. Endogenous active neuropeptides can dilate blood vessels, open collateral circulation, increase cerebral perfusion blood flow, and reduce brain tissue ischemia and hypoxia. The serum level of endogenous active neuropeptides is closely related to the prognosis of cognitive dysfunction in cerebral infarction. Monoamine neurotransmitters are involved in the formation and maintenance of memory function and can affect the patient's mental state and higher brain function. Animal experimental studies have also found that the occurrence and development of vascular dementia is related to neuronal apoptosis-related factors such as anti-apoptotic protein (BCL-2), crude apoptotic protein (Bax), and executive cysteine ​​protease (Caspase-3). Bcl-2 can inhibit pathologically related target cell apoptosis, and Bax can activate Caspase-3 and promote cell apoptosis.

[0004] Vascular dementia belongs to the category of "dementia", "epilepsy", "forgetfulness" and "forgetfulness" in traditional Chinese medicine. The disease is located in the brain, and dementia is the loss of function of the spirit. Traditional Chinese medicine believes that vascular dementia after cerebral infarction belongs to the category of "dementia" and "dementia". The main pathogenesis is blood stasis and obstruction, and the loss of function of the spirit. The brain is the home of the primordial spirit, the source of the spirit, and the body is independent. Due to the old age of the patients, the blood circulation is slow, the blood vessels are stagnant, and the brain vessels are blocked, resulting in loss of function of the spirit; or because of the imbalance of yin and yang, the disorder of qi and blood, and the direct attack on the brain in stroke patients, the brain vessels are blocked or blood overflows outside the vessels, blood stasis and obstruction, and the loss of function of the spirit. The treatment should be based on promoting blood circulation and removing blood stasis, awakening the brain and opening the orifices.

[0005] Studies have found that the pathogenesis of VD is related to calcium overload after cerebral ischemia, brain tissue acidosis, inflammatory response and activation of related apoptosis pathways. The clinical efficacy of Western medicine in treating vascular dementia is poor, while traditional Chinese medicine has achieved good results in treating vascular dementia. Traditional Chinese medicine has multiple targets and its advantages are constantly reflected in clinical applications. Summary of the invention

[0006] The purpose of the present invention is to provide a Chinese medicine composition for treating vascular dementia and a method of using the same. The Chinese medicine composition is used to prepare a drug for treating vascular dementia. The Chinese medicine composition can also be used to improve the cognitive function and daily living ability of patients with vascular dementia, and can significantly improve the cognitive function and daily living ability of patients with vascular dementia, and can increase the levels of serum cognitive-related transmitters CGRP and 5-HT, and reduce the levels of neuronal apoptosis-related factors such as BCL-2, Bax and Caspase-3. The Chinese medicine composition can improve the cognitive function and the levels of related factors of vascular dementia patients, and give play to the advantages of multi-pathway and multi-target effects of traditional Chinese medicine.

[0007] To achieve the above object, the present invention provides a traditional Chinese medicine composition for treating vascular dementia, comprising cinnamon twig, poria, moutan bark, peach kernel, peony root, calamus, polygala tenuifolia and ginseng.

[0008] Preferably, the amount of each component used by mass is 12-18g of cinnamon twig, 12-18g of poria, 12-18g of moutan bark, 12-18g of peach kernel, 7-13g of peony root, 7-13g of calamus, 7-15g of polygala, and 12-18g of ginseng.

[0009] Preferably, the amount of each component by mass is 15g of cinnamon twig, 15g of poria, 15g of peony bark, 15g of peach kernel, 10g of peony root, 10g of calamus, 10g of polygala, and 15g of ginseng.

[0010] The present invention also provides a pharmaceutical composition for treating vascular dementia, comprising a traditional Chinese medicine composition and donepezil hydrochloride tablets.

[0011] A method for using a pharmaceutical composition for treating vascular dementia, comprising the following steps:

[0012] (1) After weighing each component of the Chinese medicine composition, decoct it with water, remove the residue and juice, and take 200 ml each time, decoct twice, and take it warm once in the morning and once in the evening;

[0013] (2) After taking the Chinese medicine composition in the morning after meals, take 5 mg of donepezil hydrochloride tablets once a day.

[0014] The advantages and beneficial effects of the Chinese medicine composition for treating vascular dementia and the method of using the same are as follows:

[0015] 1. The present invention can significantly improve the cognitive function and daily living ability of patients with vascular dementia, and can increase the levels of serum cognitive-related transmitters CGRP and 5-HT, and reduce the levels of neuronal apoptosis-related factors such as BCL-2, Bax and Caspase-3.

[0016] 2. The present invention can improve the cognitive function and related factor levels of patients with vascular dementia, and give full play to the advantages of traditional Chinese medicine in terms of multi-pathway and multi-target effects.

[0017] The technical solution of the present invention is further described in detail below through embodiments. DETAILED DESCRIPTION

[0018] The technical solution of the present invention is further illustrated by the following examples.

[0019] Unless otherwise defined, technical or scientific terms used in the present invention shall have the common meanings understood by one having ordinary skills in the field to which the present invention belongs.

[0020] Unless otherwise defined, the reagents, drugs, equipment and other materials used in the present invention are all commercially available.

[0021] Example 1

[0022] 1. Data and methods

[0023] A multicenter randomized controlled trial design was adopted, and 90 patients with vascular dementia admitted to Zhumadian Hospital of Traditional Chinese Medicine and Henan Hospital of Traditional Chinese Medicine from February 2019 to February 2022 were selected as the research subjects. The patients were divided into two groups according to the random number table method, with 45 cases in the observation group and 45 cases in the control group.

[0024] 1.1 Medical records.

[0025] There were 22 male patients and 23 female patients in the observation group, aged 50 to 72 years old, with an average age of (64.77±7.16) years old; education level: 21 cases with junior high school or above, 13 cases with junior high school, and 11 cases with primary school; the average course of disease was (5.01±0.66) months. There were 22 male patients and 23 female patients in the control group, aged 52 to 72 years old, with an average age of (64.89±7.82) years old; education level: 23 cases with junior high school or above, 12 cases with junior high school, and 10 cases with primary school; the average course of disease was (4.98±0.61) months. There was no significant difference in the basic case data between the two groups (P>0.05).

[0026] 1.2 Diagnostic criteria

[0027] Western medicine diagnostic criteria: Refer to the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) and the VD-related diagnostic criteria in the 2018 Chinese Dementia and Cognitive Disorders Diagnosis and Treatment Guidelines: Dementia and Its Classification Diagnostic Criteria: (1) The following multiple cognitive deficits exist: ① Memory impairment. ②a Aphasia; b Apraxia; c Agnosia; d Reduced executive management ability, at least one of the above. (2) Any cognitive deficit in ① and ② leads to a decline in the patient's social ability or occupation. (3) There is etiological evidence that may lead to cognitive impairment: such as symptoms or signs of focal neurological deficits, or imaging evidence suggesting cerebrovascular disease.

[0028] TCM diagnostic criteria: refer to the "Guidelines for Clinical Research of New Chinese Medicines (Trial)" and the TCM Syndrome Differentiation Scale for Vascular Dementia (SDSVD) developed by Tian Jinzhou et al. in 1997, which defines dementia - qi deficiency and blood stasis and phlegm and blood stasis blocking the orifices.

[0029] 1.3 Inclusion criteria.

[0030] (1) Meet the diagnostic criteria of vascular dementia in Western medicine and the diagnostic criteria of dementia in traditional Chinese medicine - qi deficiency and blood stasis and phlegm and blood stasis blocking the meridians. (2) Refer to the clinical dementia rating scale (CDR) for classification diagnosis of mild (CDR = 1.0) and moderate dementia (CDR = 2.0). (3) Montreal Cognitive Assessment (MoCA) score < 26 points (1 point added for education years < 12 years). (4) TCM syndrome score ≥ 7 points; (5) Gender is not limited, age range is between 50 and 79 years old, and the course of disease ranges from 3 to 12 months. (6) Patients with onset within 6 months after stroke and their condition is basically stable. (7) The study complies with the Declaration of Helsinki and the "Ethical Review Methods for Biomedical Research Involving Humans (Trial)", and is reviewed and approved by the hospital ethics committee, and the patient signs the informed consent.

[0031] 1.4 Exclusion criteria

[0032] (1) Dementia of the non-vascular cognitive impairment type; (2) Patients with a history of mental illness; (3) Patients with a history of cognitive impairment caused by other brain diseases; (4) Patients who cannot receive Chinese medicine treatment for various reasons.

[0033] 1.5 Instructions for use.

[0034] Control group: Donepezil hydrochloride tablets (Aricept, national medicine standard number H20050978), 5 mg / time, once a day (taken after breakfast), for a total of 12 weeks.

[0035] Observation group: treated with donepezil hydrochloride tablets combined with Chinese medicine composition, the use of donepezil hydrochloride tablets is the same as the control group. Chinese medicine composition formula: 15g cinnamon twig, 15g poria, 15g peony bark, 15g peach kernel, 10g peony root, 10g calamus, 10g polygala, 15g ginseng. Decoction with water, remove the residue and take the juice, decoct 200ml each time, decoct twice, take warm once in the morning and evening, and treat for a total of 12 weeks.

[0036] Cinnamon twig has the effects of sweating and relieving muscles, warming and unblocking meridians, assisting yang and transforming qi, and balancing and descending qi. It is often used for colds, cold pain in the abdomen, amenorrhea due to cold blood, joint pain, phlegm and fluid, edema, palpitations, etc.

[0037] Poria, nature and flavor: sweet, mild and flat. It has the functions of dispelling dampness, strengthening the spleen and calming the mind. It is used for phlegm, edema, urinary incontinence, diarrhea, palpitations and dizziness.

[0038] Peony bark, clearing heat and cooling blood: used for bleeding and rashes caused by blood heat. Activating blood circulation and removing blood stasis: used for dysmenorrhea and trauma caused by blood stasis. Clearing the liver and reducing fever: used for headache and red eyes caused by liver fire.

[0039] Peach kernel, taste: bitter, sweet, neutral. Meridians: heart, liver, large intestine. Activating blood circulation and removing blood stasis: used for dysmenorrhea, amenorrhea, traumatic injury, etc. caused by blood stasis. Moistening the intestines and relieving constipation: used for dry intestines and constipation. Relieving cough and relieving asthma: used for cough with sputum and asthma.

[0040] Peony, nature and flavor: bitter, sour, slightly cold. Meridians: liver and spleen. Nourishes blood and softens the liver: used for dizziness and pale complexion caused by blood deficiency. Relieves pain: used for abdominal pain and flank pain caused by liver-stomach disharmony. Calms liver yang: used for headaches and dizziness caused by hyperactivity of liver yang.

[0041] Acorus calamus, nature and flavor: pungent, bitter, warm. Meridians: heart, liver, spleen. Refreshing: used for coma, memory loss, etc. Eliminates dampness and harmonizes the stomach: used for abdominal distension, nausea and vomiting caused by dampness blocking the middle jiao. Calms the mind: used for palpitations, insomnia, anxiety, etc.

[0042] Polygala, nature and flavor: bitter, pungent, warm. Meridians: heart, kidney, lung. Calming the mind and improving intelligence: used for palpitations, insomnia, forgetfulness and dreaminess. Expectorant and invigorating: used for cough with phlegm and chest tightness. Reduce swelling and relieve pain: used for carbuncle, swelling, bruises, etc.

[0043] Ginseng, nature and flavor: sweet, slightly bitter, warm. Meridians: heart, lung, spleen. Greatly replenishes vital energy: used for qi deficiency, fatigue, pale complexion, low voice, etc. Produces body fluid and quenches thirst: used for thirst due to loss of body fluid, diabetes, etc. Soothes the mind and improves intelligence: used for palpitations, insomnia, forgetfulness and dreaminess, etc. Improves immunity: enhances the body's resistance and resists fatigue.

[0044] 1.6 Observation indicators.

[0045] (1) Cognitive function assessment: The Vascular Dementia Assessment Scale-cog (VADAS-cog) and the Montreal Cognitive Assessment (MoCA) were used to evaluate cognitive function; the modified Barthel Index scoring method was used to evaluate daily living ability.

[0046] (2) Detection of neurotransmitter levels related to cognitive function: Enzyme-linked immunosorbent assay was used to detect the levels of venous procalcitonin gene peptide (CGRP) and serotonin (5-HT).

[0047] (3) Detection of neuronal apoptosis-related factor levels: RT-PCR was used to detect the expression levels of neuronal apoptosis-related factors such as B-cell lymphoma-2 (BCL-2), Bcl-2-associated X protein (Bax), and cysteine ​​protease (Caspase-3) in venous blood.

[0048] 1.7 Clinical efficacy evaluation.

[0049] Refer to the "Diagnosis, Syndrome Differentiation and Efficacy Criteria for Vascular Dementia", use the VADAS-cog scale score as a reference indicator, and use the percentage change to indicate the change in the condition. Efficacy index (%) = (score after treatment - score before treatment) / score before treatment × 100%. Significant effect: efficacy index ≥ 20%; effective: efficacy index ≥ 12% and < 20%; ineffective: efficacy index < 12%. Total effective rate = (significant effect + effective) / total number of cases × 100%.

[0050] 1.8 Statistical analysis.

[0051] SPSS18.0 was used to analyze the data. The chi-square test was used for count data, and the t-test was used for measurement data. The data were expressed as mean ± standard deviation (±s). P < 0.05 was considered statistically significant.

[0052] 2. Results.

[0053] 2.1 Comparison of VADAS-cog, MoCA and Barthel scores between the two groups.

[0054] Before treatment, there were no significant differences in VADAS-cog, MoCA and Barthel scores between the two groups (all P>0.05); after treatment, the VADAS-cog scores of the two groups were significantly lower than those before treatment (all P<0.05), and the VADAS-cog score of the observation group was significantly lower than that of the control group (all P<0.05). After treatment, the MoCA and Barthel scores of the two groups were significantly increased compared with those before treatment (all P<0.05), and the MoCA and Barthel scores of the observation group were significantly higher than those of the control group (all P<0.05). The results are shown in Table 1.

[0055] Table 1 Comparison of VADAS-cog, MoCA and Barthel scores between the two groups ( point)

[0056]

[0057] Note: Compared with before treatment, *P<0.05; after treatment, compared with the control group, ▲P<0.05.

[0058] 2.2 Comparison of CGRP and 5-HT levels between the two groups.

[0059] Before treatment, there was no significant difference in the levels of serum cognitive-related transmitters CGRP and 5-HT between the two groups (all P>0.05). After treatment, the levels of serum cognitive-related transmitters CGRP and 5-HT in the two groups were significantly higher than those before treatment (all P<0.05), and the levels of serum cognitive-related transmitters CGRP and 5-HT in the observation group were significantly higher than those in the control group (all P<0.05). The results are shown in Table 2.

[0060] Table 2 Comparison of CGRP and 5-HT levels between the two groups

[0061]

[0062] Note: Compared with before treatment, *P<0.05; after treatment, compared with the control group, ▲P<0.05.

[0063] 2.3 Comparison of BCL-2, Bax and Caspase-3 levels between the two groups.

[0064] Before treatment, there was no significant difference in the levels of neuronal apoptosis-related factors such as BCL-2, Bax and Caspase-3 between the two groups (all P>0.05). After treatment, the level of neuronal apoptosis-related factor BCL-2 in the two groups was significantly higher than that before treatment (P<0.05), and the level of BCL-2 in the observation group was significantly higher than that in the control group (P<0.05); after treatment, the levels of Bax and Caspase-3 in the two groups were significantly lower than that before treatment (all P<0.05), and the levels of Bax and Caspase-3 in the observation group were significantly lower than those in the control group (all P<0.05). The results are shown in Table 3.

[0065] Table 3 Comparison of BCL-2, Bax and Caspase-3 levels between the two groups (x±s)

[0066]

[0067] Note: Compared with before treatment, *P<0.05; after treatment, compared with the control group, ▲P<0.05.

[0068] 2.4 Comparison of the total effective rate between the two groups.

[0069] After treatment, the total effective rate of the observation group was 97.77%, which was significantly higher than that of the control group (82.22%) (P<0.05).

[0070] Table 4 Comparison of total effective rate between the two groups (cases / %)

[0071] Group Number of cases Significant effect efficient invalid Total Effectiveness Observation Group 45 41(91.11％) 3(6.00％) 1(2.00％) <![CDATA[44(97.77%) ▲ ]]> Control group 45 28(46.66％) 10(22.22％) 7(15.55％) 37(82.22％)

[0072] Note: Compared with before treatment, *P<0.05; after treatment, compared with the control group, ▲P<0.05.

[0073] Traditional Chinese medicine has a multi-target effect and has unique advantages in the treatment of vascular dementia. The present invention uses a Chinese medicine composition to treat vascular dementia and observes its clinical efficacy. The results show that the Chinese medicine composition can significantly improve the cognitive function and daily living ability of patients with vascular dementia, and can increase the levels of serum cognitive-related transmitters CGRP and 5-HT, and reduce the levels of neuronal apoptosis-related factors such as BCL-2, Bax and Caspase-3. The results show that the Chinese medicine composition can improve the cognitive function and related factor levels of patients with vascular dementia, giving play to the advantages of multi-pathway and multi-target effects of traditional Chinese medicine.

[0074] Therefore, the present invention adopts the above-mentioned Chinese medicine composition for treating vascular dementia and the use method thereof, which can significantly improve the cognitive function and daily living ability of patients with vascular dementia, and can increase the levels of serum cognitive-related transmitters CGRP and 5-HT, and reduce the levels of neuronal apoptosis-related factors such as BCL-2, Bax and Caspase-3. The Chinese medicine composition can improve the cognitive function and the levels of related factors of patients with vascular dementia, and give play to the advantages of multi-pathway and multi-target effect of traditional Chinese medicine.

[0075] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit it. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that they can still modify or replace the technical solution of the present invention with equivalents, and these modifications or equivalent replacements cannot cause the modified technical solution to deviate from the spirit and scope of the technical solution of the present invention.

Claims

1. A Chinese medicine composition for treating vascular dementia, characterized in that: Including cinnamon twig, poria, peony bark, peach kernel, peony, calamus, polygala, and ginseng.

2. A Chinese medicine composition for treating vascular dementia according to claim 1, characterized in that: By mass, the dosage of each component is 12-18g of cinnamon twig, 12-18g of poria, 12-18g of moutan bark, 12-18g of peach kernel, 7-13g of peony root, 7-13g of calamus, 7-15g of polygala, and 12-18g of ginseng.

3. A Chinese medicine composition for treating vascular dementia according to claim 2, characterized in that: By mass, the dosage of each component is 15g of cinnamon twig, 15g of poria, 15g of peony bark, 15g of peach kernel, 10g of peony root, 10g of calamus, 10g of polygala, and 15g of ginseng.

4. A pharmaceutical composition for treating vascular dementia, characterized in that: The invention comprises the traditional Chinese medicine composition according to any one of claims 1 to 3 and donepezil hydrochloride tablets.

5. The method of using the pharmaceutical composition for treating vascular dementia according to claim 4, characterized in that: The steps include: (1) Weigh each component of the Chinese medicine composition, decoct it with water, remove the residue and take the juice, decoct 200 ml each time, decoct twice, and take it warm once in the morning and once in the evening; (2) After taking the Chinese medicine composition in the morning after meals, take 5 mg of donepezil hydrochloride tablets once a day.

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