A Chinese medicine composition for treating atherosclerosis and its application

Abstract

The present invention provides a Chinese medicine composition, which comprises the following raw materials in parts by weight: 5 to 15 parts of cassia twig, 5 to 15 parts of seaweed, and 20 to 45 parts of iris pubescens. The present invention also provides a medicine for treating atherosclerosis, which comprises the above-mentioned Chinese medicine composition. The Chinese medicine composition is safe to take, has no toxic side effects, can effectively improve the blood stasis syndrome score, carotid artery IMT, carotid artery maximum plaque area, maximum plaque length, maximum plaque thickness, and significantly improves the clinical symptoms of patients caused by atherosclerosis.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and specifically relates to a traditional Chinese medicine composition for treating atherosclerosis and application thereof. Background Art

[0002] Modern medicine believes that the "injury response theory" is the main mechanism of atherosclerosis. The main process of the pathogenesis of atherosclerosis is first endothelial damage, due to changes in hemodynamics, or smoking, hypercholesterolemia, increased blood pressure, diabetes, etc., which lead to chronic damage to the vascular endothelium; secondly, lipid accumulation, this process depends on the participation of low-density lipoprotein (LDL), while high-density lipoprotein (HDL) can counteract this pathological process; finally, fibrous atherosclerotic plaques are formed. Traditional Chinese medicine does not have the name of "atherosclerosis", but it is often discussed in clinical practice as pulse bi. "Pulse bi" is the TCM disease name for atherosclerosis. Traditional Chinese medicine does not have the name of "atherosclerosis", but it is often discussed in clinical practice as pulse bi. Atherosclerosis is a common and important type of vascular disease called arteriosclerosis. The lipids accumulated in the intima of the artery appear yellow porridge-like. Lipid metabolism disorder is the basis of atherosclerotic lesions. Its characteristic is that the lesions of the affected arteries start from the intima, generally with lipid and complex carbohydrate accumulation, bleeding and thrombosis, followed by fibrosis and calcification, and gradual degeneration and calcification of the middle layer of the artery, leading to thickening and hardening of the arterial wall and narrowing of the blood vessel lumen. The lesions often involve large and medium muscular arteries. Once they develop to the point of blocking the arterial lumen, the tissues or organs supplied by the artery will be ischemic or necrotic.

[0003] At present, Western medicine treatment drugs for atherosclerosis include lipid-regulating drugs (mainly statins), antiplatelet drugs (such as aspirin, clopidogrel, ticagrelor), anticoagulants (heparin, low molecular weight heparin, dabigatran, rivaroxaban), thrombolytic drugs (such as urokinase, streptokinase, recombinant tissue plasminogen activator), vasodilator drugs (nitrate preparations), antioxidant drugs (vitamin C, vitamin E, probucol), anti-inflammatory drugs (statins, aspirin, angiotensin converting enzyme inhibitors), etc. There are many types of drugs for the treatment of atherosclerosis in Western medicine, but all of them have obvious adverse reactions. The adverse reactions of long-term medication are difficult to avoid causing harm to patients. The adverse reactions of lipid-regulating drugs include rhabdomyolysis, increased levels of blood transaminases and creatine kinase, gastrointestinal symptoms, etc., among which rhabdomyolysis is the most dangerous adverse reaction. The adverse reactions of antiplatelet drugs are mainly gastrointestinal symptoms and bleeding. Anticoagulants are mainly bleeding risks and need to be tested regularly. The effectiveness and safety of antioxidant drugs need further study.

[0004] Although there are Chinese patent medicines for treating atherosclerosis, they have defects such as complex prescription components, insufficient efficacy or toxic side effects. Summary of the invention

[0005] Based on this, the object of the present invention is to provide a traditional Chinese medicine composition, which has simple components, clear efficacy, safety and no side effects, and has a good therapeutic effect on atherosclerosis.

[0006] To achieve the above object, the present invention adopts the following technical solution.

[0007] A traditional Chinese medicine composition comprises the following raw materials in parts by weight: 5-15 parts of cassia twig, 5-15 parts of seaweed, and 20-45 parts of ilex pubescens.

[0008] In some embodiments, the Chinese medicine composition comprises the following raw materials in parts by weight: 10-15 parts of cassia twig, 10-15 parts of seaweed, and 30-45 parts of ilex pubescens.

[0009] In a preferred embodiment, the Chinese medicine composition comprises the following raw materials in parts by weight: 10 parts of cassia twig, 10 parts of seaweed, and 30 parts of ilex pubescens.

[0010] The present invention also provides application of the above-mentioned Chinese medicine composition in preparing medicine for treating atherosclerosis.

[0011] The present invention also provides a medicine for treating atherosclerosis, comprising the above-mentioned Chinese medicine composition and pharmaceutically acceptable auxiliary materials.

[0012] In some embodiments, the drug is in the form of tablets, capsules, granules, or oral liquid.

[0013] In a preferred embodiment, the dosage form of the drug is a tablet.

[0014] In some embodiments, the excipients include mannitol, magnesium stearate and starch.

[0015] The present invention also provides a method for preparing a drug for treating atherosclerosis, comprising the following steps: (1) taking the above-mentioned traditional Chinese medicine composition, adding water in a volume of 8 to 10 times the total weight of the traditional Chinese medicine composition, decocting and extracting for 1 to 2 times, collecting the filtrate, concentrating under reduced pressure to obtain an extract, drying, and crushing to obtain a dry paste; and (2) adding auxiliary materials to the dry paste to prepare the drug.

[0016] In some embodiments, the conditions for reduced pressure concentration are: temperature 60 to 80° C., vacuum degree -0.08 to -0.10 MPa.

[0017] According to the treatment principle of "using the drug to clear the meridians", the present invention provides a Chinese medicine composition for treating atherosclerosis. The Chinese medicine composition comprises three raw materials: cinnamon twig, seaweed and hollyhock. In the prescription, cinnamon twig is the main drug, which warms the meridians and dredges the blood vessels, and assists yang and transforms qi; seaweed is the auxiliary drug, which activates blood circulation, dissipates blood stasis, eliminates masses and dredges the meridians; hollyhock is the adjuvant, which activates blood circulation, dredges the blood vessels, and clears away stasis and toxins. The three drugs are used together with cold and warm properties to achieve the functions of activating blood circulation, dispersing stagnation and dredging collaterals. The Chinese medicine composition is safe to take, has no toxic side effects, can effectively improve the blood stasis syndrome symptom score, carotid artery IMT, carotid artery maximum plaque area, maximum plaque length, and maximum plaque thickness, and significantly improves the clinical symptoms of patients caused by atherosclerosis. DETAILED DESCRIPTION

[0018] The experimental methods in the following examples of the present invention, where no specific conditions are specified, are usually carried out under conventional conditions or under conditions recommended by the manufacturers. The various commonly used chemical reagents used in the examples are all commercially available products.

[0019] Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0020] The terms "including" and "having" and any variations thereof of the present invention are intended to cover non-exclusive inclusions. For example, a process, method, device, product or equipment comprising a series of steps is not limited to the listed steps or modules, but may optionally include steps not listed, or may optionally include other steps inherent to these processes, methods, products or equipment.

[0021] In the present invention, the term "multiple" refers to two or more than two. "And / or" describes the association relationship of associated objects, indicating that three relationships may exist. For example, A and / or B can represent the following three situations: A exists alone, A and B exist at the same time, and B exists alone. The character " / " generally indicates that the associated objects are in an "or" relationship.

[0022] The following describes the invention in conjunction with specific embodiments.

[0023] Example 1

[0024] The present embodiment provides a traditional Chinese medicine composition, which comprises the following raw materials in parts by weight: 10 parts of cassia twig, 10 parts of seaweed, and 30 parts of ilex pubescens.

[0025] Example 2

[0026] The present embodiment provides a traditional Chinese medicine composition, which comprises the following raw materials in parts by weight: 15 parts of cassia twig, 15 parts of seaweed, and 45 parts of ilex pubescens.

[0027] Example 3

[0028] The present embodiment provides a traditional Chinese medicine composition, which comprises the following raw materials in parts by weight: 12 parts of cassia twig, 12 parts of seaweed, and 36 parts of ilex pubescens.

[0029] Example 4

[0030] The present embodiment provides a drug for treating atherosclerosis, which is a tablet and contains the following raw materials in parts by weight: 833 parts of cassia twig, 833 parts of seaweed, 2499 parts of ilex pubescens, 80 parts of mannitol, 1.65 parts of magnesium stearate, and 7.26 parts of starch.

[0031] The preparation method of the medicine is as follows: cinnamon twig, seaweed and holly are taken, and water is added and decocted twice, 10 times of water is added for the first time, and 8 times of water is added for the second time, and each time is decocted for 1 hour; the filtrate is collected, passed through a 200-mesh sieve, and concentrated under reduced pressure at 70°C to a thick paste with a relative density of about 1.30 (about 60°C); the drying plate loading amount is about 0.56g thick paste / cm 2 , dry under reduced pressure below 70℃, control the vacuum degree to 0.08MPa~0.09Mpa, pass through 80 mesh sieve; add appropriate amount of mannitol, wet granulate with 12% starch slurry; drying plate loading: about 0.34g granules / cm 2 , 60℃ blast drying, granule moisture is about 5-7%; 16 mesh granules; add magnesium stearate and mix evenly; 11mm shallow arc punching tablets, tablet weight 0.55g, tablet weight difference ±4%, hardness about 5-8kgf. Film coating, coating liquid concentration 18%, film coating tablet weight 0.57g, tablet weight difference ±4%.

[0032] Usage: Oral, 4 tablets at a time, 3 times a day.

[0033] Example 5

[0034] Taking the Chinese medicine composition described in Example 1 as an example, the efficacy of the Chinese medicine composition of the present invention on atherosclerosis was studied.

[0035] 1. Clinical Data

[0036] 1. Source of cases

[0037] All cases were from wards or outpatients of the First Affiliated Hospital of Guangzhou University of Chinese Medicine from June 2017 to February 2019. 60 patients with carotid artery sclerosis who met the inclusion criteria were randomly divided into two groups at a 1:1 ratio using a random number table method. A total of 30 cases were included in the control group, which was treated with conventional Western medicine. A total of 30 cases were included in the treatment group, which was given the Chinese medicine composition described in Example 1 on the basis of conventional Western medicine treatment.

[0038] 2. Diagnostic criteria

[0039] 2.1 Western medicine diagnostic criteria

[0040] (1) Refer to "Ultrasound in Medicine (Sixth Edition)" edited by Guo Wanxue and published in 2011: Diagnostic criteria for carotid artery sclerosis: thickening of the intima-media thickness (IMT), IMT ≥ 1.0 mm (≥ 1.2 mm at the bifurcation) is considered thickening; when the local IMT thickness range is ≥ 1.5 mm, it can be defined as plaque formation. Repeatedly scan the plaques appearing in various parts, record the location of the largest plaque, and measure its maximum length and thickness.

[0041] (2) Determination of the degree of carotid artery stenosis: According to the North American Symptomatic Endarterectomy Trial (NASCET) method, the vascular stenosis rate can be determined: stenosis rate = (Dd) / D×100%. Where D is the original lumen diameter, and d is the remaining lumen diameter at the stenosis. The NASCET grading color Doppler ultrasound measurement stenosis standard is divided into:

[0042] 1) Normal (no stenosis);

[0043] 2) <50% stenosis;

[0044] 3) 50%-69% stenosis;

[0045] 4) ≥70% defined as stenosis to near occlusion;

[0046] 5) Near occlusion;

[0047] 6) Complete occlusion.

[0048] 2.2 Standards of TCM Syndrome Differentiation

[0049] According to the 2016 "Practical Diagnostic Criteria for Blood Stasis Syndrome", the Blood Activating and Stasis Removing Professional Committee of the Chinese Association of Integrated Traditional Chinese and Western Medicine formulated the following standards:

[0050] Main criteria:

[0051] (1) The tongue is dark purple or has ecchymoses or petechiae;

[0052] (2) Dark or purple spots on the face, gums, lips, eye area, and fingertips;

[0053] (3) abnormal dilatation or varicose veins of capillaries in different parts of the body;

[0054] (4) Blood that escapes from the meridians (refers to blood stasis or accumulation in organs, tissues, subcutaneous tissues, or serous cavities caused by bleeding);

[0055] (5) abdominal tenderness and resistance;

[0056] (6) intermittent claudication;

[0057] (7) Amenorrhea or dark menstrual bleeding;

[0058] (8) Imaging studies suggest vascular occlusion or moderate to severe stenosis (≥50%), thrombosis, embolism or infarction, or objective evidence of organ ischemia.

[0059] Minor criteria:

[0060] (1) Fixed pain, or stabbing pain, cramping pain, or pain that is worse at night;

[0061] (2) Limb numbness or hemiplegia;

[0062] (3) Dysmenorrhea;

[0063] (4) Skin and nail disorders (increased scaling, hypertrophy, and rough skin);

[0064] (5) Forgetfulness or mental mania;

[0065] (6) Pulse is sluggish or intermittent, or absent;

[0066] (7) Organomegaly, neoplasms, inflammatory or non-inflammatory masses, and tissue hyperplasia;

[0067] (8) Imaging examinations showed vascular stenosis (<50%);

[0068] (9) Abnormal physical and chemical tests such as blood rheology, coagulation, fibrinolysis, and microcirculation, indicating blood circulation stasis;

[0069] (10) Trauma, surgery or artificial abortion in the past month.

[0070] Note: Blood stasis syndrome can be diagnosed if one of the main criteria or two of the minor criteria are met. Each of the main criteria is 2 points, and each of the minor criteria is 1 point, which can be used as a quantitative diagnostic standard for blood stasis syndrome. Such as sublingual, digestive tract, conjunctiva, oral mucosa, fundus, abdominal wall, lower limbs, etc. Except for those who do not meet this condition after interventional treatment or surgery.

[0071] 3. Inclusion criteria

[0072] Subjects who agree to participate in this clinical trial and sign the written informed consent form; meet the Western medical diagnostic criteria for carotid artery sclerosis and carotid artery stenosis (<50%); meet the diagnostic criteria for blood stasis syndrome in traditional Chinese medicine; and have been clinically diagnosed with blood stasis syndrome by two or more attending Chinese medicine physicians; aged 18 to 80 years old, regardless of gender; have signed the research informed consent form.

[0073] 4. Exclusion criteria

[0074] Patients with ultrasound showing carotid artery stenosis ≥50%; patients with uncontrolled hypertension (blood pressure level controlled at systolic pressure 140mmHg or diastolic pressure 90mmHg or above), uncontrolled type 2 diabetes (glycosylated hemoglobin 11.1mmol / L or above), clinically diagnosed with coronary heart disease, malignant arrhythmia, cerebrovascular accident, chronic heart failure, respiratory failure; patients with severe primary diseases of the liver, kidney and hematopoietic system; known or suspected liver and kidney dysfunction (ALT, AST higher than 2 times the upper limit of normal value, serum creatinine greater than 176umol / L); patients with myopathy of various causes or whose serum creatine phosphokinase is more than 2 times higher than the upper limit of normal value; patients with serious malignant diseases that affect survival, such as tumors or AIDS, and patients with serious organ damage; patients with mental illnesses such as epilepsy and dementia who cannot correctly experience or express conscious discomfort or feelings; patients with familial hypercholesterolemia; women in pregnancy and lactation; patients with poor compliance or who do not receive treatment according to the course of treatment; patients known to be allergic to the ingredients of this drug; patients treated with other Chinese patent medicines or Chinese herbal decoctions; patients who participated in other clinical studies within 3 months before enrollment.

[0075] 5. Shedding criteria

[0076] Severe life-threatening adverse events occur; patients voluntarily give up treatment; women become pregnant during treatment; patients have other serious organic diseases during treatment; patients cannot continue to participate in the treatment process.

[0077] 6. Elimination criteria

[0078] Refers to cases that are included but do not meet the inclusion criteria and should be excluded.

[0079] The subjects experienced serious adverse events, poor compliance, complications and voluntarily withdrew from the study.

[0080] 7. Shedding treatment

[0081] Contact the subjects and keep records by phone, letter, etc.; take appropriate measures for cases of withdrawal from the trial due to allergic reactions or other adverse reactions; relevant trial data of dropout cases will be saved for backup.

[0082] 2. Research Methods

[0083] The researchers introduced the purpose and implementation process of the study to the patients, and the patients were formally included after they understood and signed the informed consent. The researchers carefully filled in the patients' enrollment time, basic information, TCM syndrome scale records, carotid artery ultrasound results, etc., and followed up by phone once after 2 weeks, and notified the patients for face-to-face consultation after 4 weeks.

[0084] 1. Grouping method

[0085] A randomized controlled study was adopted. A total of 60 samples were included in this study, with a ratio of 1:1 between the treatment group and the control group. Cases suitable for this topic were selected according to the diagnostic criteria, inclusion criteria, and exclusion criteria. Eligible subjects were numbered 1-60 in order of their visit time, and 60 numbers were obtained using a random number table. The subjects were randomly divided into a treatment group and a control group with 30 cases each using a simple random method.

[0086] 2. Treatment options

[0087] Treatment group: patients received health education (low-salt and low-fat diet, smoking cessation and alcohol restriction, moderate exercise, etc.), basic treatment (diet control, blood sugar control, blood pressure control, etc.) + the Chinese medicine composition described in Example 1 (provided by the outpatient Chinese medicine pharmacy of the First Affiliated Hospital of Guangzhou University of Chinese Medicine), decocted in water twice and taken in two doses, 1 hour after a meal.

[0088] Control group: patients received health education (low-salt and low-fat diet, smoking cessation and alcohol restriction, moderate exercise, etc.) and basic treatment (diet control, blood sugar control, blood pressure control, etc.).

[0089] 3. Observation time

[0090] The treatment and observation period for the patients included in the study was 4 weeks.

[0091] III. Criteria for determining efficacy

[0092] 1. Blood stasis syndrome score

[0093] Refer to the blood stasis syndrome symptom score evaluation method developed by Academician Chen Keji [18-19] The patient's blood stasis symptoms and signs including tongue quality, angina, sublingual veins, lips, pulse, etc. were scored, and the reduction in the blood stasis syndrome score before and after treatment was calculated (reduction in blood stasis syndrome score = blood stasis syndrome score 4 weeks after treatment - blood stasis syndrome score before treatment).

[0094] 2. Carotid artery ultrasound examination

[0095] (1) Carotid intima-media thickness (IMT), carotid peak systolic velocity (PSV)

[0096] The thickness of the carotid intima-media and the total area of ​​carotid plaques were observed before and after the intervention, and the examination was performed by the same professional physician. The patient was placed in the supine position. When the carotid artery was examined, the patient's head was tilted to the opposite side at an angle of about 45 degrees. The IMT of the bilateral carotid arteries 2 cm away from the bifurcation was tested separately. At the end of diastole of the left ventricle, the image of the standard position was locked, and the vertical range between the carotid lumen intima interface and the interface between the media and the adventitia was measured. Repeated measurements were performed for three consecutive cardiac cycles. The IMT on that side was the average of the three measurements, and the average values ​​of the bilateral IMT were statistically analyzed. In addition, the peak systolic velocity (PSV) of the carotid artery was measured and recorded. The ultrasound examination was required to be completed by the same experienced physician with relevant professional knowledge.

[0097] (2) Plaque Crouse score

[0098] Crouse method

[20] The plaque score is calculated by adding up the maximum thickness of each isolated atherosclerotic plaque in the ipsilateral carotid artery without considering the length of each plaque, and obtaining the plaque score of the carotid artery on that side. The sum of the plaque scores of both carotid arteries is the Crouse score of the patient.

[0099] (3) Maximum plaque area

[0100] The plaque area is the maximum area on the longitudinal section of the vessel. The maximum plaque area is the area of ​​the largest plaque in the four vascular segments of the left and right common carotid arteries and sinus.

[21] The total area of ​​atherosclerotic plaques in the bilateral common carotid arteries, the common carotid artery bifurcation, and the extracranial segment of the internal carotid artery was detected. The three diameters of each plaque were measured respectively, and the two diameters with the largest values ​​were selected as the length and width. The plaque area was calculated by multiplying the two, and the total area was the sum of all plaque areas.

[0101] (4) Maximum length and thickness of carotid artery plaque

[0102] Use a two-dimensional color ultrasound probe to repeatedly scan the plaques in various parts, record the location of the largest plaque, and measure its maximum length and thickness

[14] .

[0103] (5) Plaque grade score

[0104] Based on the ultrasonic grading method of carotid artery sclerosis plaque, the range and severity of the plaque were evaluated using a semi-quantitative method to obtain the carotid artery sclerosis plaque score.

[0105] 0 points: no plaque;

[0106] 1 point: unilateral plaque and plaque thickness ≤ 2.0 mm;

[0107] 2 points: bilateral plaques but thickness is less than 2.0 mm, or unilateral plaques but thickness is greater than 2.0 mm;

[0108] 3 points: bilateral plaques, thickness of only one side > 2.0 mm;

[0109] 4 points: bilateral plaques with thickness greater than 2.0 mm.

[0110] 3. Secondary efficacy criteria

[0111] Blood lipid level: Blood lipid test results: Venous blood cholesterol (TC), low-density lipoprotein (LDL-C), and triglycerides (TG) were collected from patients in the morning on an empty stomach before and after treatment.

[0112] Statistical Analysis

[0113] All data were processed using SPSS 22.0 statistical software. Percentages and constituent ratios were used to describe count data. Mean ± standard deviation (x ± s) was used to describe measurement data. Independent sample t-test or rank sum test was used for inter-group comparison; paired sample t-test or Wilcoxon signed rank sum test was used for comparison of measurement data before and after treatment; 2 test (or exact probability method) was used to compare categorical variables between the two groups, and rank sum test was used to compare graded data between the two groups. Two-sided tests were used for statistical tests of all data, with P < 0.01 considered statistically significant, and P < 0.05 considered statistically significant.

[0114] V. Research Results

[0115] 1. Research completion status

[0116] A total of 60 cases were included in this clinical trial, 30 in the treatment group and 30 in the control group. During this study, no serious adverse events occurred in the treatment group and the control group. One case in the treatment group dropped out due to poor compliance, and two cases in the control group were lost to follow-up due to refusal to accept follow-up.

[0117] 2. General situation analysis

[0118] (1) Gender comparison between the two groups

[0119] The baseline comparison of the gender of the included patients showed that the difference between the two groups was not statistically significant (P>0.05). During the follow-up, one patient in the treatment group dropped out due to poor compliance, and two patients in the treatment group were lost due to refusal to accept follow-up. After excluding the dropped patients, the baseline comparison was performed. Of the 57 cases included, 29 were in the treatment group, including 14 males and 15 females; and 28 were in the control group, including 17 males and 11 females. The chi-square test showed that there was no statistically significant difference in the male-female ratio between the two groups (P>0.05), and they were comparable, as shown in Table 1-2.

[0120] Table 1 Comparison of gender between the two groups

[0121]

[0122] Table 2 Gender comparison between the two groups (excluding dropout cases)

[0123]

[0124] (2) Age comparison between the two groups

[0125] The baseline comparison of the ages of the included patients showed that there was no statistically significant difference between the two groups (P>0.05). During the follow-up, one patient in the treatment group dropped out due to poor compliance, and two patients in the treatment group were lost due to refusal to accept follow-up. After excluding the dropped patients, a baseline comparison was performed. A total of 57 cases were included, 29 in the treatment group, with an average age of 67.34±10.15 years old; 28 in the control group, with an average age of 72.11±8.30 years old. There was no significant statistical difference in age between the treatment group and the control group (P>0.05), and they were comparable, as shown in Table 3-4.

[0126] Table 3 Comparison of age between the two groups

[0127]

[0128] Table 4 Comparison of age between the two groups (excluding dropout cases)

[0129]

[0130] (3) Comparison of comorbidities between the two groups

[0131] During the follow-up, 1 patient in the treatment group dropped out due to poor compliance, and 2 patients in the treatment group were lost to follow-up due to refusal to accept follow-up. The 3 patients who dropped out had no history of hypertension. Among the 57 cases included, 13 patients in the treatment group had hypertension, 13 patients with type 2 diabetes, 8 patients with hyperlipidemia, 11 patients with a history of smoking, and 10 patients with a history of drinking; 19 patients in the control group had hypertension, 16 patients with type 2 diabetes, 8 patients with hyperlipidemia, 11 patients with a history of smoking, and 9 patients with a history of drinking. The chi-square test showed that there was no significant difference in the comorbidities between the treatment group and the control group (P>0.05), and they were comparable, as shown in Table 5.

[0132] Table 5 Comparison of comorbidities between the two groups

[0133]

[0134] 3. Comparison of baseline before treatment

[0135] (1) Analysis of baseline carotid ultrasound results

[0136] Among the 60 patients included, 23 patients in the treatment group had plaque formation, and 22 patients in the control group had plaque formation. The t-test showed that there were no significant differences in carotid intima-media thickness (IMT), carotid systolic peak velocity (PSV), plaque Crouse score, plaque grade score, maximum plaque area, maximum plaque length, and maximum plaque thickness between the treatment group and the control group before treatment (P>0.05), and the two groups were comparable, as shown in Table 6.

[0137] During the follow-up, one patient in the treatment group dropped out due to poor compliance, and two patients in the control group dropped out due to refusal to accept follow-up. Therefore, 29 patients were included in the treatment group and 28 patients were included in the control group. None of the patients who dropped out had carotid artery plaque formation. Baseline comparison was performed after dropping out, and the t-test showed that there was no statistically significant difference between the two groups (P>0.05). The two groups were comparable. See Table 7.

[0138] Table 6 Carotid artery color Doppler ultrasound results in the two groups before treatment

[0139]

[0140] Table 7 Carotid artery ultrasound baseline in the two groups before treatment (excluding dropout cases)

[0141]

[0142] (2) Analysis of baseline blood lipid results

[0143] According to the t-test, the comparison of blood lipid results between the treatment group and the control group before treatment was P>0.05, indicating that the difference between the two groups was not statistically significant (P>0.05) and was comparable, see Table 8.

[0144] During the follow-up, one patient in the treatment group dropped out due to poor compliance, and two patients in the control group were lost due to refusal to continue follow-up. Finally, 29 patients were included in the treatment group and 28 patients were included in the control group. The t-test showed that the differences between the two groups were not statistically significant (P>0.05), and they were comparable, as shown in Table 9.

[0145] Table 8 Comparison of blood lipid baseline between the two groups before treatment

[0146]

[0147] Table 9 Comparison of blood lipid baseline between the two groups before treatment (excluding dropout cases)

[0148]

[0149] (3) Baseline analysis of blood stasis syndrome scores

[0150] The t-test showed that the comparison of blood stasis syndrome scores between the treatment group and the control group before treatment showed that there was no statistically significant difference between the two groups (P>0.05), and they were comparable. After excluding 3 cases of dropout, the baseline comparison of blood stasis syndrome scores was performed, which showed that there was no statistically significant difference between the two groups (P>0.05), and they were comparable (see Table 10-11).

[0151] Table 10 Baseline analysis of blood stasis syndrome scores in the two groups before treatment

[0152]

[0153] Table 11 Baseline analysis of blood stasis syndrome scores in the two groups before treatment (excluding dropout cases)

[0154]

[0155] 4. Results before and after treatment

[0156] (1) Carotid artery ultrasound examination results

[0157] 1) Carotid intima-media thickness (IMT)

[0158] According to the t-test, the thickness of the carotid intima-media thickness (IMT) in the treatment group decreased after treatment, and the result was statistically significant (P < 0.05), while the results of the control group before and after treatment were not statistically significant (P > 0.05). The difference in the carotid intima-media thickness (IMT) before and after treatment between the treatment group and the control group was compared, and the result was not statistically significant (P > 0.05), as shown in Table 12-13.

[0159] Table 12 Comparison of IMT between the two groups

[0160]

[0161] Note: *Compared with the group before treatment, P<0.05.

[0162] Table 13 Comparison of IMT difference between the two groups before and after treatment

[0163]

[0164] 2) Carotid artery peak systolic velocity (PSV)

[0165] Comparison of carotid artery systolic peak velocity (PSV) between the two groups before and after treatment. After t-test, the carotid artery PSV of the treatment group decreased (P < 0.05), while the carotid artery systolic peak velocity (PSV) of the control group showed no significant statistical significance. Comparison of the difference between the treatment group and the control group before and after treatment showed that the carotid artery systolic peak velocity (PSV) of the treatment group decreased compared with that of the control group, and the result was statistically significant (P < 0.05). See Table 14-15 for details.

[0166] Table 14 Comparison of PSV between the two groups after treatment

[0167]

[0168] Note: *Compared with the group before treatment, P<0.05.

[0169] Table 15 Comparison of PSV differences between the two groups before and after treatment

[0170]

[0171] 3) Crouse score of plaque

[0172] According to the t-test, after treatment, the Crouse score of the plaques in the treatment group and the control group was not statistically significant (P>0.05). The difference before and after treatment between the treatment group and the control group was compared, and the results showed that it was not statistically significant (P>0.05). See Table 16-17 for details.

[0173] Table 16 Comparison of Crouse scores of plaques

[0174]

[0175] Table 17 Comparison of Crouse score differences between the two groups before and after treatment

[0176]

[0177] 4) Plaque grade score

[0178] According to the t-test, after treatment, the plaque grade scores of the treatment group and the control group were not statistically significant (P>0.05). The difference before and after treatment was compared between the treatment group and the control group, and the results showed that there was no statistical significance (P>0.05), see Table 18 for details.

[0179] Table 18 Comparison of plaque grade scores between the two groups before and after treatment

[0180]

[0181] 5) Maximum carotid artery plaque area

[0182] According to the t-test, after treatment, the maximum plaque area of ​​the carotid artery in the treatment group decreased, and the result was statistically significant (P < 0.05). The maximum plaque area of ​​the control group was not statistically significant (P > 0.05), see Table 19-20 for details.

[0183] Table 19 Comparison of the maximum plaque area between the two groups before and after treatment

[0184]

[0185] Table 20 Comparison of the difference in maximum plaque area between the two groups before and after treatment

[0186]

[0187] 6) Maximum plaque length and maximum plaque thickness

[0188] According to the t test, after treatment, the maximum length and thickness of the carotid plaque in the treatment group decreased, and the results were statistically significant (P < 0.05). After treatment, the P values ​​of the control group were all > 0.05, indicating that there was no significant statistical significance. See Table 21-22 for details.

[0189] Table 21 Comparison of maximum plaque length and maximum plaque thickness before and after treatment between the two groups

[0190]

[0191] Table 22 Comparison of the difference in maximum plaque length and maximum plaque thickness between the two groups before and after treatment

[0192]

[0193] (2) Blood stasis syndrome score

[0194] According to the t test, after treatment, the blood stasis syndrome scores of the treatment group and the control group were improved, and the results were statistically significant (P < 0.05). The difference between the treatment group and the control group before and after treatment was compared, and the results showed that the improvement of blood stasis syndrome in the treatment group was better than that in the control group, and the results were statistically significant (P < 0.05), see Table 23-24 for details.

[0195] Table 23 Comparison of blood stasis syndrome scores between the two groups after treatment

[0196]

[0197] Table 24 Comparison of the difference in blood stasis scores between the two groups before and after treatment

[0198]

[0199] (3) Blood lipid status

[0200] According to the t test, after treatment, the changes of total cholesterol and triglyceride in the treatment group and the control group were not statistically significant (P>0.05). After treatment, the low-density lipoprotein in the treatment group increased, and the result was statistically significant (P<0.05), while the low-density lipoprotein in the control group was not statistically significant (P>0.05). See Table 25 for details.

[0201] Table 25 Comparison of blood lipids between the two groups

[0202]

[0203] Note: Compared with the group before treatment, P < 0.05.

[0204] 5. Adverse Reactions

[0205] During the treatment, both groups of patients had no obvious adverse reactions, indicating that the Chinese medicine composition of the present invention is safe and has no side effects.

[0206] In summary, through clinical randomized controlled trials, the clinical efficacy of the Chinese medicine composition of the present invention in treating patients with carotid artery sclerosis (blood stasis syndrome) was observed from the aspects of TCM syndrome score evaluation and carotid artery ultrasound detection. The results showed that the Chinese medicine composition of the present invention can effectively improve the blood stasis syndrome score, carotid artery IMT, carotid artery maximum plaque area, maximum plaque length, and maximum plaque thickness, and has a good therapeutic effect on carotid artery sclerosis (blood stasis syndrome).

[0207] The technical features of the above-described embodiments may be arbitrarily combined. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0208] The above-mentioned embodiments only express several implementation methods of the present invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the patent of the present invention. It should be pointed out that, for ordinary technicians in this field, several variations and improvements can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention. Therefore, the protection scope of the patent of the present invention shall be subject to the attached claims.

Claims

1. A Chinese medicine composition for treating atherosclerosis, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-15 parts of cassia twig, 5-15 parts of seaweed, and 20-45 parts of iris pubescens.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-15 parts of cassia twig, 10-15 parts of seaweed, and 30-45 parts of iris grandis.

3. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 10 parts of cassia twig, 10 parts of seaweed and 30 parts of iris grandis.

4. Use of the Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicament for treating atherosclerosis.

5. A drug for treating atherosclerosis, characterized in that: The invention comprises the Chinese medicine composition according to any one of claims 1 to 3 and pharmaceutically acceptable auxiliary materials.

6. The drug for treating atherosclerosis according to claim 5, characterized in that: The dosage form of the medicine is tablet, capsule, granule, and oral solution.

7. The drug for treating atherosclerosis according to claim 6, characterized in that: The dosage form of the drug is tablets.

8. The drug for treating atherosclerosis according to claim 5, characterized in that: The auxiliary materials include mannitol, magnesium stearate and starch.

9. The method for preparing the drug for treating atherosclerosis according to claim 5, characterized in that: The following steps are involved: (1) Take the Chinese medicine composition according to any one of claims 1 to 3, add 8 to 10 times the volume of water of the total weight of the Chinese medicine composition, decoct and extract 1 to 2 times, collect the filtrate, concentrate under reduced pressure to obtain an extract, dry, and grind to obtain a dry paste; (2) Add auxiliary materials to the dry paste to prepare the drug.

10. The preparation method according to claim 9, characterized in that: The conditions for the reduced pressure concentration are: temperature 60 to 80° C., vacuum degree -0.08 to -0.10 MPa.

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