CN117122644B - Traditional Chinese medicine composition for treating coronary heart disease angina and carotid plaque and application thereof - Google Patents

Traditional Chinese medicine composition for treating coronary heart disease angina and carotid plaque and application thereof Download PDF

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CN117122644B
CN117122644B CN202311272693.5A CN202311272693A CN117122644B CN 117122644 B CN117122644 B CN 117122644B CN 202311272693 A CN202311272693 A CN 202311272693A CN 117122644 B CN117122644 B CN 117122644B
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朱红俊
陆佳
陆曙
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Wuxi Hospital of Traditional Chinese Medicine
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Abstract

The invention relates to a traditional Chinese medicine composition for treating coronary heart disease angina and carotid plaque and application thereof; the traditional Chinese medicine composition comprises, by weight, 20-60 parts of astragalus membranaceus, 5-30 parts of salvia miltiorrhiza, 5-20 parts of ginger processed pinellia, 5-15 parts of snakegourd fruit, 1-10 parts of coptis chinensis, 5-15 parts of thunberg fritillary bulb, 5-30 parts of cortex albiziae, 5-30 parts of hawkthorn, 5-15 parts of seaweed, 5-30 parts of endothelium corneum gigeriae galli, 5-15 parts of oyster, 5-15 parts of vinegar tortoise shell, 5-15 parts of ground beetle, 1-5 parts of scalding leech, 5-20 parts of climbing fern spore, 5-15 parts of lysimachia christinae and 10-30 parts of pumice. The traditional Chinese medicine composition has good effect of treating coronary heart disease and angina, and particularly has good treatment effect on carotid plaque.

Description

Traditional Chinese medicine composition for treating coronary heart disease angina and carotid plaque and application thereof
Technical Field
The invention relates to a traditional Chinese medicine preparation, in particular to a traditional Chinese medicine composition for treating coronary heart disease angina and carotid plaque and application thereof.
The invention is supported by the fifth group of national Chinese medicine clinical excellent talent research and repair project of the national Chinese medicine administration, the teaching function of the national Chinese medicine (2022) No. 1 and the medical health sharp talent project of the two hundred middle-aged and young people in the tin-free city.
Background
Coronary atherosclerotic heart disease, often referred to as "coronary heart disease" (CoronaryHeart Disease, CHD), is one of the leading causes of cardiovascular death. Investigation showed that approximately 1790 ten thousand people die annually from cardiovascular disease, 740 ten thousand of them die from CHD. In recent years, along with changes of life style, increasing of social aging and the like, the morbidity of the disease is in a trend of rising year by year, social economic burden is increased, and the disease progression is delayed by reducing symptom onset times, death risk is reduced, so that the medical pressure of public health systems in China can be relieved. Modern medical research has found that atherosclerosis is the pathological basis for the occurrence and development of coronary heart disease, and is mainly caused by coronary arterial plaque formation and accumulation, so that coronary arterial lumen is narrowed and is plugged, and myocardial hypoxia and ischemia are caused. Atherosclerotic thrombosis is a progressive systemic disease. When the vascular endothelium of the artery is not fully functional, the intima is thickened to form fibrous plaques, the fibrous plaques are deposited on the large artery and the medium artery, such as the coronary artery, the carotid artery and the like, the vascular wall is hardened, the lumen is thinned and the elasticity of the vascular wall is weakened, atherosclerosis is gradually formed, unstable plaques are further generated, and when the unstable plaques are ruptured, the unstable plaques often leak into the vascular lumen to cause acute thrombus and induce acute cardiovascular and cerebrovascular diseases.
The current Western medicine treatment mode of coronary heart disease mainly comprises medicine treatment, interventional treatment and coronary artery bypass grafting. Most patients' symptoms can be relieved to a certain extent after the treatment, but the defects such as intolerance of drugs, restenosis after operation, thrombosis and the like are also present. And although western medicines have better curative effects on coronary heart disease, the injury to human bodies is not small after long-term administration.
In traditional Chinese medicine, coronary heart disease is characterized by abnormal water course, with qi deficiency and water retention as the principal, phlegm stasis and stagnation and vein stasis as the principal. Specifically, the basic pathogenesis of coronary heart disease is considered to be chest stuffiness and pain due to obstruction of heart vessels by qi deficiency as the principal and phlegm stasis as the principal. In clinical practice, the frequent blood deficiency is water, water retention is often accompanied, or heat is transformed from depression to heat, which leads to excessive heat, blood stasis, qi deficiency and yang, and heart-yang deficiency. Because the traditional Chinese medicine is usually prepared from natural traditional Chinese medicines, the price is low, the effects of improving the efficacy and not generating toxic or side effects in a relatively long time can be achieved through reasonable compatibility and selection of the medicines, and the traditional Chinese medicine has good treatment prospect. Therefore, the traditional Chinese medicine composition for effectively treating coronary heart disease and angina pectoris, relieving carotid stenosis caused by carotid plaque, and further causing chest stuffiness and pain, heart blood stasis and symptoms, reducing operation risk and reducing toxic and side effects of western medicines has important significance.
Disclosure of Invention
Aiming at the defects existing in the prior art, the inventor discovers and searches out a traditional Chinese medicine composition formula suitable for treating the phlegm stagnation type unstable angina through long-term patient contact and clinical observation, and continuously researches, perfects and optimizes by taking the qi-tonifying, blood-activating, phlegm-resolving, hardness-softening and water-passing channels as a treatment principle. Therefore, the traditional Chinese medicine composition for treating coronary heart disease and angina provided by the invention has the advantages of definite curative effect, reasonable prescription compatibility and less medicine taste, is more suitable for processing preparations and is convenient for patients to take.
The invention aims at realizing the following technical scheme:
The invention provides a traditional Chinese medicine composition for treating coronary heart disease angina and carotid plaque, which comprises astragalus mongholicus, radix salviae miltiorrhizae, ginger processed pinellia, snakegourd fruit, coptis chinensis, thunberg fritillary bulb, cortex albiziae, hawthorns, seaweed, endothelium corneum gigeriae galli, oyster, vinegar tortoise shell, ground beetle, scalding leech, climbing fern spore, lysimachia christinae and pumice. The medicinal materials or decoction pieces used by the composition of the invention meet the first requirement of the 2020 edition of Chinese pharmacopoeia.
The invention provides a traditional Chinese medicine composition for treating coronary heart disease angina and carotid plaque, which is prepared from the following components in parts by weight: 20-60 parts of astragalus membranaceus, 5-30 parts of root of red-rooted salvia, 5-20 parts of ginger processed pinellia, 5-15 parts of snakegourd fruit, 1-10 parts of coptis chinensis, 5-15 parts of thunberg fritillary bulb, 5-30 parts of cortex albiziae, 5-30 parts of hawthorn, 5-15 parts of seaweed, 5-30 parts of chicken's gizzard-membrane, 5-15 parts of oyster, 5-15 parts of vinegar tortoise shell, 5-15 parts of ground beetle, 1-5 parts of scalding leech, 5-20 parts of climbing fern spore, 5-15 parts of lysimachia christinae and 10-30 parts of pumice.
Preferably, the traditional Chinese medicine composition is prepared from the following components in parts by weight: 25-35 parts of astragalus membranaceus, 8-12 parts of root of red-rooted salvia, 8-12 parts of ginger processed pinellia, 8-12 parts of snakegourd fruit, 2-4 parts of coptis chinensis, 8-12 parts of thunberg fritillary bulb, 8-12 parts of cortex albiziae, 8-12 parts of hawthorn, 8-12 parts of seaweed, 8-12 parts of chicken's gizzard-membrane, 8-12 parts of oyster, 8-12 parts of vinegar tortoise shell, 8-12 parts of ground beetle, 2-4 parts of scalding leech, 8-12 parts of climbing fern spore, 8-12 parts of lysimachia christinae and 15-25 parts of pumice.
Preferably, the traditional Chinese medicine composition is prepared from the following components in parts by weight: 30 parts of astragalus membranaceus, 10 parts of red-rooted salvia root, 10 parts of ginger processed pinellia tuber, 10 parts of snakegourd fruit, 3 parts of coptis chinensis, 10 parts of fritillaria thunbergii, 10 parts of cortex albiziae, 10 parts of hawthorn, 10 parts of seaweed, 10 parts of chicken's gizzard-membrane, 10 parts of oyster, 10 parts of vinegar tortoise shell, 10 parts of ground beeltle, 3 parts of scalding leech, 10 parts of climbing fern spore, 10 parts of lysimachia christinae hance and 20 parts of pumice.
In another aspect, the invention provides a traditional Chinese medicine preparation comprising the traditional Chinese medicine composition, which is characterized in that the traditional Chinese medicine preparation is selected from one or more of decoction, powder, ointment or pill.
The invention also provides a traditional Chinese medicine preparation, which comprises the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials, wherein the traditional Chinese medicine preparation is one or more selected from granules, capsules, tablets, powder or liquid preparations.
Preferably, the pharmaceutically acceptable auxiliary materials are selected from at least one of dextrin, lactose or soluble starch, and the traditional Chinese medicine preparation is a capsule.
In still another aspect, the present invention provides a method for preparing the above-mentioned Chinese medicinal preparation, comprising the following steps: (1) Decocting radix astragali, saviae Miltiorrhizae radix, rhizoma Pinelliae preparata, fructus Trichosanthis, coptidis rhizoma, bulbus Fritillariae Thunbergii, cortex Albiziae, fructus crataegi, sargassum, endothelium corneum Gigeriae Galli, concha Ostreae, carapax et Plastrum Testudinis, eupolyphaga Seu Steleophaga, scalding Hirudo, spora Lygodii, herba Lysimachiae, and Pumex with water, filtering to obtain filtrate, and concentrating; (2) Adding pharmaceutically acceptable adjuvants, mixing, and drying.
Preferably, the number of times of decoction in the step (1) is 1-3, and the drying in the step (2) is spray drying.
In a further aspect, the invention provides application of the traditional Chinese medicine composition in preparing medicines for treating coronary heart disease and angina pectoris.
Preferably, the invention also provides application of the traditional Chinese medicine composition in preparation of a medicine for treating carotid plaque.
The invention has the following basic principle and beneficial effects:
(1) In the prescription, astragalus root supplements the air passage, and also leads to yang and water retention; leech, red sage root and ground beetle can promote blood circulation to remove blood stasis and the veins can protect kidney; coptis root, rhizoma Coptidis has the effects of clearing heat and tonifying qi, and rhizoma Pinelliae and fructus Trichosanthis are combined to clear upper jiao; hawthorn fruit and chicken's gizzard-membrane can strengthen spleen, promote digestion and channel cereal to promote middle energizer; cortex Albiziae, pinellia ternate and fritillary bulb resolve phlegm Li Gudao and smooth middle energizer; seaweed is used for resolving phlegm and softening hardness; oyster and tortoise shell nourish yin and suppress yang; spora Lygodii, herba Lysimachiae Christinae has effects of clearing heat and promoting diuresis, and promoting blood circulation for removing blood stasis, dredging channels and descending the lower jiao.
(2) The invention provides a theoretical basis for treating coronary heart disease, angina, carotid plaque and other diseases. Through effect verification, the upper Jiao Chong has remarkable effects of clearing heat and resolving masses, resolving phlegm and promoting digestion and reducing blood circulation and promoting diuresis, and has remarkable effects of improving symptoms of chest distress, palpitation, hypodynamia and lassitude, reducing blood fat and the like of patients with coronary heart disease.
(3) According to the invention, the astragalus root is matched with the root of red-rooted salvia, the ginger processed pinellia, the snakegourd fruit, the climbing fern spore, the lysimachia christinae hance and the like to promote blood circulation to remove blood stasis, clear heat and resolve phlegm, and experiments prove that the synergistic effect is remarkable when treating coronary heart disease angina and carotid plaque.
Detailed Description
The invention will be further illustrated with reference to specific examples.
Example 1: curative effect for treating phlegm stagnation type unstable angina pectoris and influence on serum matrix metalloproteinase 9 level
1 Data and method
1.1 Screening out 2021 month 10 to 2023 month 06, taking out from cardiovascular department clinic and ward clinic of Nanjing university of Chinese medicine, and 88 cases of unstable angina pectoris (Unstable angina, UA) patients with phlegm and blood stasis syndrome meeting the case diagnosis standard. The treatment group and the control group were divided into 44 cases by using a random number table method. The study was reviewed by the ethical committee of the tin-free attached institute of traditional Chinese medicine university of Nanjing, and the panelists signed informed consent. The two groups of gender, age, angina CCS grade and disease course were compared, and the differences were not statistically significant, as shown in Table 1 below.
Table 1 comparison of general data for two groups of unstable angina patients
1.2 Diagnostic criteria
1.2.1 Western medicine diagnosis Standard the latest management guidelines diagnosis issued by the European heart disease Association of non-ST elevation type acute coronary syndrome diagnosis and treatment guidelines and 2015, which are established by the cardiovascular disease Association of the China medical society of 2016.
Clinical manifestation ① resting angina pectoris last more than 20 minutes; ② New onset angina or exertional angina reaches grade CCSII or III; ③ The existing stable angina pectoris aggravates within 1 month, reaching CCSIII grade or more (worsening angina pectoris).
Electrocardiogram: typical features are ST-segment downshifting, transitional ST-segment elevation, or T-wave change.
Cardiac troponin I (cTnI) results were not abnormal.
Can meet any clinical manifestation with or without electrocardiogram change, and can be used for diagnosing unstable angina pectoris. Angina pectoris severity is ranked with reference to CCS angina pectoris.
1.2.2 Diagnostic criteria for Chinese medicine in reference to "Chinese medicine science" (Zhang Bali, wu Mianhua. "Chinese medicine science". Beijing: chinese medical Press, 2017) and "guide for clinical research on New Chinese medicine" (Chinese medical science and technology Press, 2002, zhengyu) for diagnosis of chest stuffiness and pain, phlegm and blood stasis syndrome.
Main symptoms are as follows: ① chest pain: chest tightness, distending pain, stinging or colic, even pain to the shoulder back or the inner side of the left arm; ② chest distress: chest and hypochondrium distension and fullness, even chest oppression like asphyxia;
secondary symptoms: ① Palpitation, shortness of breath, tiredness, and weakness; ② Purple and dark lips and faces; ③ Excessive phlegm manifests: spitting out phlegm and saliva, subjective feeling of foreign body in the pharynx, obesity, limb heaviness and constipation; tongue appearance: dark or purple tongue, or ecchymosis, white greasy or slippery coating, tortuosity of sublingual veins, and dark purple; pulse condition: the pulse is wiry, slippery or fine.
The chest pain and chest distress with at least 2 symptoms can be diagnosed by adding tongue pulse condition to the patient with chest pain and chest distress with symptoms of chest pain and chest pain (phlegm and blood stasis syndrome).
1.3 Inclusion criteria ① are met for the above-described diagnostic criteria for traditional Chinese and western medicine; ② The subject informed and agrees, and voluntarily signs an informed consent; ③ The age is between 18 and 82 years old; ④ The physical state is good, and the vital signs are stable.
1.4 Cases exclusion criteria ① do not coincide with inclusion criteria; ② Acute and severe diseases such as arrhythmia, other heart diseases (myocarditis, myocardial infarction, etc.), cerebral infarction, pulmonary insufficiency, etc.; ③ Patients with serious primary diseases such as liver, kidney and hematopoietic system; ④ Women in pregnancy, pregnancy and lactation who are allergic to known components of the studied drugs; ⑤ Malignant disease or patients unsuitable for participation in the trial; ⑥ Patients with heavy mental disease; ⑦ Other clinical trial participants have participated in or are participating in the last three months.
1.5 Eliminating, removing cases and stopping test standard ①; ② During the research process, special physiological changes and other complications appear, which are not suitable for continuously receiving researchers; ③ Poor compliance or refusal to continue the therapist; ④ For various reasons, withdrawal from study or aborters is required; ⑤ The patients were not interviewed without adherence to the medication.
1.6 Methods of treatment
Basic treatment: both groups in the study were treated according to the coronary heart disease angina pectoris treatment protocol specification in the coronary heart disease guideline, including anti-myocardial ischemia, anti-platelet therapy, vasodilation, and lipid metabolism regulating drugs. Patients with basic diseases such as hyperlipidemia, hypertension, diabetes and the like can simultaneously take corresponding medicaments for reducing blood sugar, blood lipid, blood pressure and the like. The treatment group uses the traditional Chinese medicine composition of the invention on the basis of basic treatment: 30g of astragalus membranaceus, 10g of salvia miltiorrhiza, 10g of ginger processed pinellia tuber, 10g of snakegourd fruit, 3g of coptis chinensis, 10g of fritillaria thunbergii, 10g of cortex albiziae, 10g of hawthorn, 10g of seaweed, 10g of chicken's gizzard-membrane, 10g of oyster, 10g of vinegar tortoise shell, 10g of ground beetle, 3g of scalding leech, 10g of climbing fern spore and 10g of lysimachia christinae. Decocting with water to obtain 200mL decoction, and taking 100mL each time 2 times in the morning and evening. Both treatment cycles were 4 weeks.
1.7 Observation index and efficacy evaluation criteria
1.7.1 Observations index
Observability index: angina pectoris symptoms, short-acting anti-angina pectoris drug withdrawal, chinese medicine symptom score, blood stasis symptom score, seattle angina pectoris scale [ (SEATTLEANGINA QUESTIONNAIRE, SAQ), including limited body movement (PL), angina pectoris plateau (AS), angina pectoris occurrence (AF), medical satisfaction (TS) and cognitive ability (DP) ], serum MMP-9 levels, blood lipid levels [ total cholesterol (Total Cholesterol, TC), triglyceride (TRIGLYCERIDE MATRIX, TG), high density Lipoprotein (Low Density Lipoprotein, LDL), high density Lipoprotein (HIGH DENSITY Lipoprotein, HDL). Safety index: adverse event occurrence rate and safety index (liver function, kidney function, electrolyte, blood routine).
1.7.2MMP-9 level detection
The detection was performed by enzyme-linked immunosorbent assay (ELISA) and the method of operation was described with reference to the kit protocol, which was purchased from Wohan Iretto biosciences Co., ltd.
1.7.3 Standard of efficacy
1) The curative effect of angina pectoris is formulated by referring to (trial) 8 of the guidelines of clinical study of new Chinese medicine. The curative effect evaluation of the traditional Chinese medicine symptoms and the blood stasis symptoms is evaluated according to the integral change condition before and after treatment: efficacy index (%) = (pre-treatment integral-post-treatment integral)/pre-treatment integral x 100%. The effect is shown: >70%; the method is effective: 30% -70%; invalidation: <30%.
2) Comparing the blood lipid level and MMP-9 level according to the assay values before and after intervention, wherein P is less than 0.05, the result has statistical significance, and the treatment is effective; otherwise, if P > 0.05, the result is not statistically significant, i.e., invalid. The blood lipid level reduction amplitude in a short period is smaller, and the difference value before and after treatment can be adopted for comparison, so that the analysis of the result is the same as that of the previous step.
The above index was tested and evaluated for two groups of patients before treatment and after a treatment period of 4 weeks, respectively.
1.7.4 Follow-up
After 4 weeks of treatment, follow-up was continued for 12 months, and the efficacy of the Qijendan for a long term was evaluated with coronary angiography or coronary CTA outcome scores as criteria.
Coronary results were assessed using Gensini scoring system: total integral = coronary stenosis degree score sum of lesion coefficients.
1.8 Statistical methods
Counting all study data by using an EXCEL table, carrying out data analysis by using spss 25.0.0, and expressing the data by using standard deviation (X+/-S) when the data accords with normal distribution, wherein paired sample t-test is adopted between the same groups, and independent sample t-test or correction t-test is adopted between the two groups; the bias distribution is represented by P50 (P25, P75), independent sample rank combination test is adopted between two groups, and paired sample rank combination test is adopted between the same groups; count data and classification data can be represented by the number of cases and percent (%), and rank data is tested by chi-square test or rank sum test, assuming that P < 0.05 has a statistical difference.
2 Results
2.1 The total effective rate and the curative effect of the two groups of symptoms of the angina pectoris, the traditional Chinese medicine symptoms and the curative effect of the blood stasis and the short-acting anti-angina pectoris drug reduction condition are obviously superior to those of a control group (P < 0.05). The withdrawal rate 84.09% was increased by 61.36% compared to the control group (P < 0.05) for the treatment group, see table 2 below.
Table 2 comparative examples of the cases of the two groups of angina pectoris symptoms, chinese medicine symptoms, blood stasis syndrome curative effects and short-acting anti-angina pectoris drug withdrawal conditions [ examples, (%)
2.2SAQ score analysis no significant difference in scores of SAQ before treatment (P > 0.05) in both groups except PL (P < 0.05); the integral improvement of SAQ was significant (P < 0.001) after both treatment groups compared to treatment groups; the integration was improved (P < 0.001) in both pre-treatment and post-treatment groups SAQ, see Table 3 below.
Table 3 comparison of two sets SAQ of scores
2.3 Analysis of blood lipid levels before treatment, there was a clear difference in the levels of LDL and TC in the two groups (P < 0.05), but there was no clear difference in the differences between the two before and after treatment (P > 0.05). The HDL levels in the treatment group were elevated after treatment, while the differences between the two groups before and after treatment were different, and the HDL levels in the treatment group were elevated (P < 0.05) compared to the control group, as shown in Table 4 below.
Table 4 two sets of blood lipid level analyses
2.4 Serum MMP-9 analysis Each group included 30 cases due to insufficient blood sample in the treatment group. Both groups had reduced MMP-9 levels after treatment, with statistical significance (P < 0.05) for the treated group alone, see Table 5 below.
TABLE 5 analysis of serum MMP-9 (mmol/L) levels
2.5 Coronary Gensini scores are shown in Table 6. Through follow-up, 12 patients in the treatment group are continuously taking Qijingdan treatment (more than or equal to 8 months), and coronary CTA or coronary angiography is rechecked. 11 patients in the control group were reviewed for coronary CTA or coronary angiography. There was no difference in the scores of the coronary Gensini before and after treatment (P > 0.05) for the two groups. The difference between the two groups before and after treatment was compared, the treatment group score was decreased and the control group score was increased (P < 0.05).
TABLE 6 coronary Gensini score analysis
2.6 Safety index the vital signs of two groups of patients are normal and stable within the treatment period of 4 weeks, no obvious discomfort or adverse reaction occurs, no acute or malignant event occurs, and no obvious abnormality is found in blood routine, liver function, kidney function and electrolyte index in the two groups of patients in the research process, so that the safety is good.
Conclusion 3
CHD belongs to the categories of heart pain, chest stuffiness and the like in traditional Chinese medicine, and causes of CHD are mainly caused by invasion of exogenous evil, improper diet, emotional disorder, viscera deficiency and the like, and deficiency is the pathogenesis, and cold coagulation, turbid phlegm, blood stasis and qi stagnation are the pathogenesis. The basic pathogenesis of chest stuffiness and heart pain, namely the deficiency of the principal and secondary aspects and excess and deficiency-excess inclusion, is widely accepted by the calendar doctors. The inventor proposes the treatment principle of angina pectoris of coronary heart disease when the treatment principle is to use qi-tonifying, blood-activating, phlegm-resolving, hard mass-resolving, water-channel-dredging and principal of CHD, the qi-tonifying and blood-nourishing principle is to use qi-tonifying, qi-activating and blood-activating, and the pulse channel-activating is clear, and the promotion, fixation and warming of qi and blood are not separated, so that large dosage of astragalus root is needed for tonifying qi and nourishing blood; CHD is usually caused by blood stasis blocking the pulse, and Dan Shen can be used to promote blood circulation and remove blood stasis; the phlegm stagnation obstructing the upper part Jiao Xinmai but not the upper part of the qi is not passed through, and the qi of the triple energizer is also disadvantageous, so that the machine can be operated to dredge the triple energizer. The decoction (Coptidis rhizoma, fructus Trichosanthis, and rhizoma Pinelliae) is used for clearing heat and eliminating phlegm, dredging channels, and the decoction Xin Kai is especially suitable for heart system diseases with accumulation of phlegm and blood stasis. In addition, the upper jiao is used for dredging the lung, and pinellia tuber, fritillary bulb and hawthorn fruit are used for resolving phlegm and dredging the viscera; CHD is commonly accompanied by food stagnation in middle-jiao, and fructus crataegi and endothelium corneum Gigeriae Galli are used for strengthening spleen and resolving food stagnation; the stagnation of the pulse channel is similar to that of the analog, and the worm medicine leech and ground beetle are used for removing blood stasis; CHD is interwoven and accumulated for a long time to form severe and lingering illness aeipathia, moisten and salty, and seaweed, oyster and turtle shell are used for softening hardness and resolving hard mass; meanwhile, the climbing fern spore and the desmodium herb are used for clearing heat, removing dampness and promoting diuresis to treat coronary heart disease, and the water channel is led. In summary, the inventor considers that the basic pathogenesis of the coronary heart disease is based on qi deficiency, phlegm stasis is the standard, heart obstruction and heart pain are caused by obstruction of heart vessels, and the traditional Chinese medicine composition formula for treating the coronary heart disease is established by combining with the clinical common adverse effects of blood and water, or excessive heat and blood stasis caused by heat transformation caused by depression, qi deficiency, yang and heart yang deficiency and the like.
Example 1 is aimed at exploring the curative effect of the traditional Chinese medicine composition for treating unstable angina pectoris, and the result shows that the composition has more advantages (P is less than 0.05) in improving clinical symptoms, traditional Chinese medicine symptoms, blood stasis symptoms and SAQ scores. Other research results also show that the traditional Chinese medicine has obvious effects on improving clinical symptoms of patients with coronary heart disease and angina pectoris, improving SAQ scores and the like [12-13]. HDL levels were decreased in the treated control group and increased in the treated group, indicating that the treated group could increase HDL levels. Dyslipidemia is one of the important risk factors for CHD, and studies have shown that LDL-C and HDL-C levels in human blood are highly correlated with the occurrence of coronary heart disease, with positive correlation with HDL-C levels and negative correlation with LDL-C levels. HDL-C has the effect of carrying cholesterol in surrounding tissues and has the effect of resisting atherosclerosis. The process not only can increase the stability of plaque, but also can prevent plaque from cracking, thereby reducing occurrence of cardiovascular events. Research shows that the traditional Chinese medicine composition can prevent and treat coronary heart disease and angina by increasing HDL-C level. In addition, according to the follow-up result, the coronary artery lesion score can be effectively reduced after long-term administration (generally more than or equal to 8 months), and the plaque is stabilized and even resolved.
In addition, the influence of the traditional Chinese medicine composition for treating coronary heart disease and angina pectoris on MMP-9 is also studied in the embodiment 1. Matrix metalloproteinases are the major factor in degrading the extracellular matrix leading to plaque rupture, and most have an inflammatory effect, of which MMP-9 is one. MMP-9 plays a critical role in the development of CHD, is present in atherosclerotic plaques, and is highly expressed in the shoulders of vulnerable plaques. Studies have shown that MMP-9 disrupts the extracellular matrix structure of cells and accelerates the formation of atherosclerotic plaques after massive migration and proliferation of cells. In addition, MMP-9 in human coronary artery AS plaque is over-expressed, extracellular matrix is degraded, vascular wall is reconstructed, fibrous caps are thinned, and plaque stability is reduced and rupture is easy. The reduced levels of MMP-9 in both groups treated in this study indicated that both treatment regimens inhibited MMP-9 expression and the treatment group was more effective (P < 0.05). The traditional Chinese medicine composition provided by the invention can play roles in stabilizing plaque and treating coronary heart disease and angina by inhibiting the expression of MMP-9.
Example 2
Poplar XX, female, 58 years old, clinic number: 080652XXXX, initial diagnosis: 2022-11-04
Complaints: chest distress with onset and palpitation for more than 1 year.
The current medical history: the patients with the symptoms of chest distress caused by middle-night sleep in 2021, chest distress, palpitation, cold sweat, pale complexion, debilitation, nausea, vomiting, stool, and no chest and back pain, throat tightness, and black syncope can be relieved by oneself after half an hour. 2021-06-29 coronary angiography, intraoperative: coronary arteries are right dominant; no abnormality in LM; the stenosis 70% of the LAD mid-section D1; the wall of the LCX middle section tube is irregular; the wall of the middle section of the RCA is irregular. Patients after operation take medicine for 1 month according to the prescription, and then stop the therapy of the anti-platelet aggregation medicine and the statin medicine. Etching: the oral esmolol tablet has the advantages of being easy to take, convenient to adjust, poor in sleep, and capable of helping sleep for a long time. A red tongue with thin and greasy coating, a stagnant tongue bottom, and a weak and deep pulse.
Diagnosis of traditional Chinese medicine: chest stuffiness and pain and phlegm stasis obstruction syndrome
Western diagnosis: coronary atherosclerosis type heart disease
The treatment measures are as follows:
200ml of the decoction is taken after meal twice a day in the morning and evening after 1 dose of water every day, and the decoction is replaced by 7 doses
Two diagnoses: 2023-01-06
The patients have the advantages of relieving symptoms, chest distress, palpitation, sleep improvement, red tongue with thin and greasy coating, blood stasis at the bottom, and slow and weak pulse.
The treatment measures are as follows:
Pulverizing and making pill twice daily, and taking x1 dose after meal
Three diagnoses: the symptoms of the patients are improved, no obvious discomfort is caused, the patients take the medicine in front of the patients, and the liver and kidney functions and blood routine are not obviously abnormal in a plurality of times of repeated inspection in the period. The front is taken continuously.
Coronary angiography was reviewed at 6 of 2023: the stenosis at the mid-LAD D1 was reduced from 70% to 40-50%.
Example 3
Thank to XX, female, 73 years old, clinic number: 080342XXXX, initial diagnosis: 2022-01-07
Complaints: chest distress was repeated for more than 3 years.
The current medical history: chest distress occurs in the patient in 2019 and is obvious when chest pain is present in the patient in 3 months, and the patient is relieved after rest when the patient moves more than the patient. Coronary angiography was performed at 9 months 2019, and the results showed that: no abnormality in LM; LAD stenosis 30-40% in the middle; LCX opening is 60% narrow; the middle segment of RCA is 70% narrow. After operation, platelet aggregation is prevented, heart rate is controlled, blood fat is regulated, and plaque is stabilized. Coronary angiography was reviewed 9 months 2020: LM was not stenosed; the wall of the middle section and the far section of the LAD is irregular, and the stenosis is 40-50%; the LCX opening is 80% narrow; RCA did not see stenosis or obstruction. The treatment of platelet aggregation resistance, heart rate control, blood lipid regulation and plaque stabilization is carried out after operation. Etching: chest distress, palpitation, fatigue, appetite, urination and sleep. A red tongue with greasy coating, a stagnant tongue bottom and a thready and rapid pulse.
Diagnosis of traditional Chinese medicine: chest stuffiness and pain and deficiency of both Qi and Yin of the heart
Western diagnosis: coronary atherosclerosis type heart disease
The treatment measures are as follows:
200ml of the decoction is taken after two meals in the morning and evening by 1 dose of water every day, and is decocted for 14 doses instead of for decoction
Two diagnoses: 2022-01-21
Patients have palpitation and chest distress, the tongue pulse is the same as the previous one, and the liver and kidney functions are repeated in the previous period, so that the blood routine is not obviously abnormal. The front is taken continuously.
Coronary angiography at 5 months 2022, results show: LCX opening stenosis is reduced from 80% to 40% -50%.
Example 4
Plum XX, male, 82 years old, clinic number: 080045XXXX.
Complaints: and re-diagnosing the right carotid artery stenosis. The patient had a past history of coronary atherosclerosis type heart disease, 2021-05-07 was shown by the national institute's carotid artery color Doppler ultrasound: 1. the right internal carotid artery was moderately stenosed at the opening (stenosis rate 50-69%). 2. Common carotid plaque formation on both sides. 3. The left internal carotid artery has high circulatory resistance. 4. The circulation resistance of vertebral arteries at two sides is high.
Diagnosis of traditional Chinese medicine: chest stuffiness and pain, heart blood stasis
Western diagnosis: coronary atherosclerosis type heart disease and carotid artery stenosis
The treatment measures are as follows:
The usage method is as follows: powder and pill are taken twice daily after meal for x1 dose
The patient took the pill for more than two years, 2023-05-09 in the second people's hospital in Wuxi city rechecked that carotid color ultrasound was not seen to be stenosed, suggesting bilateral carotid plaque formation. The liver and kidney functions are normal, LDL-C is 2.52mmol/L.
The patient is required to take the traditional Chinese medicine composition pill medicine treatment. A red tongue with purple-light smell, thin coating, stagnation at the bottom, a short pulse, a little astringency and no obvious discomfort.
Example 5
Gold XX, female, 73 years old, date of first visit: 2022, 11, 25
Complaints: chest distress is repeated for more than 5 years, and the weight is increased for 1 month.
The current medical history: the patient has no obvious cause before 5 years, chest distress and discomfort, is in chest region, presents a feeling of oppression, is easy to feel tired, is obvious after activity, lasts for about several minutes, and can relieve symptoms after rest without attention. The patient can feel chest distress after exercise for 1 month, and emits to the back of the shoulder, and the patient is suffocating, dizziness, palpitation and hypodynamia, asthma after movement, and can relieve after half an hour of rest, and the patient has no tearing-like pain, no sweat and paroxysmal sitting and breathing and the like. Coronary artery CTA was examined 11 months 23 days 2022, suggesting: a plaque size at the LCX opening is about: 3.28mm 1.78mm. Etching: chest distress, dizziness, palpitation and hypodynamia, asthma due to movement, insomnia, gastric distention, normal urination, red tongue with thin greasy coating, stagnation of the bottom of the tongue, and deep and wiry pulse.
Diagnosis of traditional Chinese medicine: chest stuffiness and pain and phlegm stasis type obstruction of qi
Western diagnosis: coronary atherosclerotic heart disease
The treatment measures are as follows:
200ml of the decoction is taken after meal twice a day in the morning and evening after 1 dose of water every day, and the decoction is replaced by 7 doses
Two diagnosis times: 2022, 12, 1
Chest distress, dizziness improvement, palpitation, stress relief, stomach-energy, insomnia, restlessness, normal urination, red tongue with thin greasy coating, stagnation at the bottom of the tongue and wiry pulse. The 14 doses are taken in front of the medicine, and the medicine is taken intermittently for several months without obvious discomfort. Coronary CTA was reviewed at 2023, 7, 12, suggesting a plaque size at the LCX opening of approximately: 2.67mm 1.60mm.
As can be seen from the results of the above examples 1-5, compared with the conventional single western medicine treatment, the traditional Chinese medicine composition provided by the invention can remarkably relieve the clinical symptoms of patients with unstable angina pectoris due to phlegm and blood stasis, improve symptoms of angina pectoris, chinese medicine symptoms and blood stasis, improve the withdrawal rate of the short-acting anti-angina pectoris medicine, raise HDL level, reduce MMP-9 level, reduce coronary artery disease score, stabilize and even resolve plaque, improve life quality of patients and strengthen life satisfaction. The traditional Chinese medicine composition for treating coronary heart disease and angina pectoris can stabilize plaque and prevent and treat coronary heart disease by increasing HDL level and reducing MMP-9 level. The invention has good technical effect.
Finally, it should be noted that the above-mentioned embodiments are only for illustrating the technical solution of the present invention, and not for limiting the same, and although the present invention has been described in detail with reference to examples, it should be understood by those skilled in the art that modifications and equivalents may be made to the technical solution of the present invention without departing from the spirit and scope of the technical solution of the present invention, and all such modifications and equivalents are intended to be encompassed in the scope of the claims of the present invention.

Claims (9)

1. A traditional Chinese medicine composition for treating phlegm stagnation type unstable angina pectoris is prepared from the following components in parts by weight: 20-60 parts of astragalus membranaceus, 5-30 parts of root of red-rooted salvia, 5-20 parts of ginger processed pinellia, 5-15 parts of snakegourd fruit, 1-10 parts of coptis chinensis, 5-15 parts of thunberg fritillary bulb, 5-30 parts of cortex albiziae, 5-30 parts of hawthorn, 5-15 parts of seaweed, 5-30 parts of chicken's gizzard-membrane, 5-15 parts of oyster, 5-15 parts of vinegar tortoise shell, 5-15 parts of ground beetle, 1-5 parts of scalding leech, 5-20 parts of climbing fern spore, 5-15 parts of lysimachia christinae and 10-30 parts of pumice.
2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following components in parts by weight: 25-35 parts of astragalus membranaceus, 8-12 parts of root of red-rooted salvia, 8-12 parts of ginger processed pinellia, 8-12 parts of snakegourd fruit, 2-4 parts of coptis chinensis, 8-12 parts of thunberg fritillary bulb, 8-12 parts of cortex albiziae, 8-12 parts of hawthorn, 8-12 parts of seaweed, 8-12 parts of chicken's gizzard-membrane, 8-12 parts of oyster, 8-12 parts of vinegar tortoise shell, 8-12 parts of ground beetle, 2-4 parts of scalding leech, 8-12 parts of climbing fern spore, 8-12 parts of lysimachia christinae and 15-25 parts of pumice.
3. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition is prepared from the following components in parts by weight: 30 parts of astragalus membranaceus, 10 parts of red-rooted salvia root, 10 parts of ginger processed pinellia tuber, 10 parts of snakegourd fruit, 3 parts of coptis chinensis, 10 parts of fritillaria thunbergii, 10 parts of cortex albiziae, 10 parts of hawthorn, 10 parts of seaweed, 10 parts of chicken's gizzard-membrane, 10 parts of oyster, 10 parts of vinegar tortoise shell, 10 parts of ground beeltle, 3 parts of scalding leech, 10 parts of climbing fern spore, 10 parts of lysimachia christinae hance and 20 parts of pumice.
4. A Chinese medicinal preparation comprising the Chinese medicinal composition according to any one of claims 1 to 3, wherein the Chinese medicinal preparation is selected from one or more of decoction, powder, paste or pill.
5. A Chinese medicinal preparation, which is characterized by comprising the Chinese medicinal composition according to any one of claims 1-3 and pharmaceutically acceptable auxiliary materials, wherein the Chinese medicinal preparation is one or more selected from granules, capsules, tablets, powder or liquid preparations.
6. The traditional Chinese medicine preparation according to claim 5, wherein the pharmaceutically acceptable auxiliary materials are selected from at least one of dextrin, lactose and soluble starch, and the traditional Chinese medicine preparation is a capsule.
7. A method for preparing the traditional Chinese medicine preparation according to claim 5 or 6, comprising the following steps: (1) Decocting radix astragali, saviae Miltiorrhizae radix, rhizoma Pinelliae preparata, fructus Trichosanthis, coptidis rhizoma, bulbus Fritillariae Thunbergii, cortex Albiziae, fructus crataegi, sargassum, endothelium corneum Gigeriae Galli, concha Ostreae, carapax et Plastrum Testudinis, eupolyphaga Seu Steleophaga, scalding Hirudo, spora Lygodii, herba Lysimachiae, and Pumex with water, filtering to obtain filtrate, and concentrating; (2) Adding pharmaceutically acceptable adjuvants, mixing, and drying.
8. The method according to claim 7, wherein the number of times of decoction in the step (1) is 1 to 3, and the drying in the step (2) is spray drying.
9. Use of a Chinese medicinal composition according to any one of claims 1-3 in the preparation of a medicament for treating unstable angina pectoris due to phlegm stagnation.
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