CN114767801B - Traditional Chinese medicine composition for preventing and treating atherosclerosis cerebral infarction - Google Patents
Traditional Chinese medicine composition for preventing and treating atherosclerosis cerebral infarction Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for preventing and treating atherosclerosis cerebral infarction, and relates to the technical field of traditional Chinese medicines. The Chinese medicinal composition comprises radix astragali, bran-parched Coicis semen, alismatis rhizoma, notoginseng radix, lumbricus and vinegar processed carapax Trionycis. The traditional Chinese medicine composition has a good treatment effect on qi-deficiency phlegm-stasis type atherosclerosis cerebral infarction, can obviously improve the traditional Chinese medicine symptoms of sICAS patients, and improves the relative cerebral blood flow (rCBF) of the patients. In the aspect of curative effect mechanism, the traditional Chinese medicine composition can inhibit local inflammatory reaction and generation of new vessels in plaques by reducing the levels of serum IL-6, hs-CRP, MMP-9 and Icam-1, thereby playing the roles of slowing the progression of atherosclerosis and stabilizing plaques. Meanwhile, the traditional Chinese medicine composition provided by the invention is used for treating qi-deficiency phlegm-stasis type atherosclerosis cerebral infarction, and has no obvious toxic or side effect and adverse reaction.
Description
Technical Field
The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for preventing and treating atherosclerosis cerebral infarction.
Background
Stroke is a disease with high mortality and disability rate, and about 80% of the stroke types are ischemic stroke, and vascular stenosis due to atherosclerosis is one of the important causes of ischemic stroke. Atherosclerotic Cerebral Infarction (ACI) is a disease in which cerebral atherosclerosis and thrombosis narrow or occlude the lumen of cerebral blood vessels, resulting in acute cerebral insufficiency and ischemic necrosis of local cerebral tissues. The patients may have symptoms of focal cerebral injury such as hemiplegia and aphasia. From 33% to 50% of stroke and more than 50% of transient ischemic attacks (TLA) present symptomatic manifestation of atherosclerotic intracranial stenoses (sICAS). ACI also has a high risk of clinical relapse. The disease brings pain to patients and economic pressure to society, and is a cerebrovascular epidemic disease which seriously harms the health of people at present.
CAS has become a high-risk pathological stage for the development of stroke, and there are 4 hypotheses for the mechanism of causing ischemic stroke: cerebral hypoperfusion due to vascular stenosis; (2) plaque rupture causes thrombosis at the stenosis; (3) distal embolism caused by embolus shedding at the plaque; (4) Occlusion is caused by plaque involvement of the small perforator artery at the site. Cerebral hypoperfusion can cause aggravation of atherosclerotic intracranial arterial stenosis and increase of ischemic stroke incidence risk to a certain extent, and good collateral circulation compensation can obviously reduce the risk of stroke recurrence of arterial stenosis. Plaque ulceration, rupture and shear forces in severely stenosed vessels caused by atherosclerosis can form emboli by the aggregation of platelet fibrinogen, leading to embolization of the artery distal to the stenosed site. In order to ensure the blood supply of a deep structure of brain tissue, a plurality of deep-crossing branch arteries are emitted from a middle cerebral artery and a basilar artery and penetrate into the brain tissue, and if a blood vessel at the opening of the deep-crossing branch artery is narrowed, the deep-crossing branch arteries are often involved, so that occlusion is caused.
The current method for treating ACI in Western medicine mainly comprises the following steps: (1) Control of risk factors (hypertension, hyperglycemia, hyperlipidemia, etc.); (2) anti-platelet aggregation therapy; (3) statins; (4) Surgical treatment (for preventing sICAS patients from recurrent stroke, intracranial-external artery bypass surgery is the most commonly used in a plurality of surgical treatment means, however, compared with simple medical treatment, the risk of recurrent stroke is not different, and more complications exist); (5) Endovascular therapies, including angioplasty and stent therapy, however, most suffer from a risk of stroke or restenosis and a higher incidence of complications than drug therapy. At present, most patients still mainly adopt drug treatment and conservative treatment for improving life style, but even if the best drug treatment scheme of the existing guidelines is adopted, the annual stroke recurrence rate is still as high as 10% -24%.
With the vigorous development of the traditional Chinese medicine industry, the traditional Chinese medicine shows excellent advantages in the treatment of many diseases, such as small side effect, lasting drug effect, higher patient compliance, capability of playing a role from a plurality of ion channels and a plurality of target points, and the like, and the clinical symptoms and prognosis of patients are obviously improved. At present, the research on the treatment of the atherosclerotic cerebral infarction by the traditional Chinese medicine is relatively lacked, so that the traditional Chinese medicine composition capable of effectively preventing and treating the atherosclerosis cerebral infarction is provided, and has important significance on the clinical treatment of the atherosclerosis cerebral infarction.
Disclosure of Invention
Based on the above, the traditional Chinese medicine composition for preventing and treating the atherosclerosis cerebral infarction provided by the invention has a good effect on treating the atherosclerosis cerebral infarction caused by qi deficiency of phlegm and blood stasis, and has small side effects.
In order to achieve the purpose, the invention provides the following scheme:
according to one technical scheme, the traditional Chinese medicine composition for preventing and treating the atherosclerosis cerebral infarction comprises, by mass, 30-60 parts of astragalus membranaceus, 15-20 parts of bran-fried coix seeds, 15-25 parts of rhizoma alismatis, 5-15 parts of pseudo-ginseng, 5-15 parts of earthworms and 10-20 parts of vinegar turtle shells.
Furthermore, the traditional Chinese medicine composition comprises, by mass, 30-60 parts of astragalus membranaceus, 15-20 parts of bran-fried coix seeds, 15-25 parts of rhizoma alismatis, 5-15 parts of pseudo-ginseng, 5-15 parts of earthworms and 10-20 parts of vinegar turtle shells.
According to the second technical scheme, the traditional Chinese medicine composition is applied to preparation of medicines for preventing and treating atherosclerosis cerebral infarction.
According to the third technical scheme, the granular preparation for preventing and treating the atherosclerosis cerebral infarction is prepared by taking the traditional Chinese medicine composition as a raw material.
The preparation method of the granular preparation for preventing and treating the atherosclerosis cerebral infarction comprises the following steps:
weighing radix astragali, bran-fried semen Coicis, rhizoma Alismatis, pheretima, and vinegar-processed carapax Trionycis, decocting in water twice, filtering, mixing the filtrates, concentrating to obtain fluid extract, adding adjuvant, mixing, drying, granulating, and making into radix astragali, bran-fried semen Coicis, rhizoma Alismatis, pheretima, and vinegar-processed carapax Trionycis granule;
drying Notoginseng radix, pulverizing, adding adjuvant, mixing, and granulating to obtain Notoginseng radix granule;
subpackaging the granules to obtain the granular preparation for preventing and treating the atherosclerosis cerebral infarction.
The decoction for preventing and treating the atherosclerosis cerebral infarction is prepared from the traditional Chinese medicine composition serving as a raw material.
The sixth technical scheme of the invention is that the preparation method of the decoction for preventing and treating atherosclerosis cerebral infarction comprises the following steps:
decocting turtle shells with vinegar for 30 minutes by strong fire, adding astragalus, bran-fried coix seeds, rhizoma alismatis, pseudo-ginseng and earthworms, adding water to soak for 30-40 minutes, decocting for 60-70 minutes by strong fire, and filtering to obtain first liquid medicine and filter residues; adding water into the filter residue, decocting the filter residue for 40 to 50 minutes by slow fire, and filtering the mixture to obtain a second liquid medicine; and (3) mixing the first liquid medicine and the second liquid medicine, filtering and concentrating to 1/4-1/2 of the original volume to obtain the decoction for preventing and treating the atherosclerosis cerebral infarction.
Further, the vinegar-soaked turtle shell also comprises a soaking step before decoction.
The technical idea of the invention is as follows:
according to the traditional Chinese medicine, stroke (apoplexy) is mainly caused by deficiency of vital qi due to improper diet, impairment of work and rest and emotional internal injury, pathological products such as wind, fire, phlegm, stasis, deficiency and the like are generated in the body, yin and yang are further disordered, qi and blood are disordered to cause the stroke, and phlegm, stasis and deficiency are main pathogenesis.
The theoretical basis of the traditional Chinese medicine composition is as follows: the brain is the house of spirit, the stroke is located in the brain, and the deficiency qi refers to the deficiency of primordial qi of the old or the exuberant qi deficiency of the obese people, according to the pathogenesis of deficiency qi retention. The brain collaterals are marked by qi deficiency, qi stagnation, blood stasis, or phlegm-dampness, which are retained for a long time, i.e., brain collaterals retention. Qi and blood circulate in brain collaterals to achieve the effects of warming, irrigation and nourishing brain marrow, if qi and blood phlegm stasis stagnates in brain collaterals, the brain marrow is not nourished, the function of brain spirit is impaired, and stroke occurs, so the treatment is based on qi-tonifying and stagnation-eliminating, the medication is based on qi-tonifying, and the treatment is based on blood circulation-promoting and meridian-dredging. With the essence of replenishing qi, it is intended to consolidate the constitution of "deficiency qi", so that the healthy qi can be recovered to promote qi movement and transportation, and smooth distribution of qi, blood and body fluids; meanwhile, the medicine takes the aim of dredging the stagnation, and is applied to promoting blood circulation to remove meridian obstruction, reducing phlegm and removing dampness, softening hardness and dissipating stagnation, and eliminating the pathogenic factors of the stagnation so as to dredge the channels.
According to the theoretical research result and symptom expression, the traditional Chinese medicine composition for preventing and treating qi-deficiency phlegm-stasis type arteriolar porridge-like sclerosing cerebral infarction is researched and developed. The traditional Chinese medicine composition is prepared according to the principle of monarch, minister, assistant and guide, and consists of 30-60 parts of astragalus, 15-20 parts of bran-fried coix seeds, 15-25 parts of rhizoma alismatis, 5-15 parts of pseudo-ginseng, 5-15 parts of lumbricus and 10-20 parts of vinegar turtle shells. In the formula, the monarch drug astragalus is sweet in taste and slightly warm in nature, and enters spleen and lung channels, 45 parts of the monarch drug is used for tonifying qi of spleen and lung so as to strengthen spleen qi and promote lung qi to be transported, phlegm, water and dampness are dissolved, and blood circulation is promoted; the ministerial drug, namely the pseudo-ginseng, is sweet, slightly bitter and warm in taste, enters liver and stomach meridians, and is used for nourishing blood and activating blood; the ministerial medicine semen coicis is sweet and light in taste and cool in nature, and has the effects of invigorating qi and strengthening spleen, promoting diuresis and excreting dampness, strengthening spleen and eliminating dampness after stir-frying with bran, and removing toxicity and dissipating stagnation, and clearing away toxic and pathogenic factors and tangible plaques; the vinegar turtle shell, being salty and cold in flavor and entering liver and kidney meridians, is combined with coix seed to achieve the effects of softening hardness and dissipating stagnation, further strengthening the capability of digesting plaques, nourishing yin and suppressing yang, and controlling the hyperactivity of wind-yang with earthworm; the adjuvant drug alisma rhizome, sweet and light in taste and cold in nature, enters kidney and bladder channels, is used for clearing heat, excreting dampness, resolving turbidity, reducing fat and mainly treating 'retention' of clear phlegm, turbid phlegm and watery fluid; the earthworm is salty in taste and cold in property, enters liver, spleen and bladder channels, has stronger effect of dredging collaterals by worm medicines, can directly reach the focus of disease, can dredge brain collaterals and limb collaterals, can clear heat, relieve convulsion and stop convulsion, and can treat stroke caused by wind-yang disturbance.
The invention discloses the following technical effects:
the traditional Chinese medicine composition has good curative effect on qi-deficiency phlegm-stasis type atherosclerosis cerebral infarction, can obviously improve the traditional Chinese medicine symptoms of sICAS patients, and improves the relative cerebral blood flow (rCBF) of the patients. In the aspect of curative effect mechanism, the traditional Chinese medicine composition can inhibit local inflammatory reaction and generation of new vessels in plaques by reducing the levels of IL-6, hs-CRP, MMP-9 and Icam-1 in serum, thereby playing the roles of slowing the progression of atherosclerosis and stabilizing plaques. Meanwhile, the traditional Chinese medicine composition disclosed by the invention is used for treating qi-deficiency phlegm-stasis type atherosclerosis cerebral infarction, and has no obvious toxic or side effect and adverse reaction.
The traditional Chinese medicine composition is used for treating the qi-deficiency phlegm-stasis type atherosclerosis cerebral infarction, and compared with non-medicine treatment means such as angioplasty and stent treatment, the economic burden of patients and the national medical cost are reduced. In terms of action mechanism, the traditional Chinese medicine composition disclosed by the invention can effectively improve the traditional Chinese medicine symptoms of patients, solves the clinical problems, widens the possibility of treating the atherosclerosis cerebral infarction at present, further promotes the vigorous development of traditional Chinese medicines in the treatment of apoplexy, and has a great social value.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to these drawings without creative efforts.
FIG. 1 is a LC-MS/MS peak diagram of Neg (negative ion) sample granular preparation of Chinese medicinal composition;
FIG. 2 is a LC-MS/MS peak plot of a Pos (positive ion) sample granular preparation of a Chinese medicinal composition;
FIG. 3 is the score comparison result of the TCM syndrome diagnostic scale of the experimental group and the control group; wherein, a represents phlegm deficiency, b represents qi deficiency, c represents blood stasis, and d represents total score;
FIG. 4 is a statistical chart of the serum mechanism before and after treatment in the experimental group and the control group of the present invention; wherein, a represents IL-6, b represents Hs-CRP, c represents Icam-I, and d represents MMP-9;
FIG. 5 is a statistical plot of the relative cerebral blood flow rCBF before and after treatment in the experimental and control groups of the present invention.
Detailed Description
Reference will now be made in detail to various exemplary embodiments of the present invention, which should not be construed as limiting the invention but rather as providing a more detailed description of certain aspects, features and embodiments of the invention.
It is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. In addition, for numerical ranges in the present disclosure, it is understood that each intervening value, to the upper and lower limit of that range, is also specifically disclosed. Every smaller range between any stated value or intervening value in a stated range and any other stated or intervening value in a stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included or excluded in the range.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although only preferred methods and materials are described herein, any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention. All documents mentioned in this specification are incorporated by reference herein for the purpose of disclosing and describing the methods and/or materials associated with the documents. In case of conflict with any incorporated document, the present specification will control.
It will be apparent to those skilled in the art that various modifications and variations can be made in the specific embodiments of the present disclosure without departing from the scope or spirit of the disclosure. Other embodiments will be apparent to those skilled in the art from consideration of the specification. It is intended that the specification and examples be considered as exemplary only.
As used herein, the terms "comprising," "including," "having," "containing," and the like are open-ended terms, i.e., meaning including, but not limited to.
The "parts" in the present invention are all parts by mass unless otherwise specified.
EXAMPLE 1 preparation of granular formulation
The raw materials consist of the following components:
45 parts of astragalus root, 20 parts of bran-fried coix seed, 15 parts of oriental waterplantain rhizome, 10 parts of pseudo-ginseng, 10 parts of earthworm and 15 parts of vinegar turtle shell.
The preparation method comprises the following steps:
decocting radix astragali decoction pieces with water twice, each time adding three times of water, decocting for 30min, filtering, mixing the filtrates, concentrating into fluid extract, adding adjuvant (dextrin, mass ratio of fluid extract to dextrin is 1;
decocting bran-parched Coicis semen decoction pieces in water twice, filtering, concentrating the filtrate into fluid extract, adding appropriate amount of adjuvant, drying, granulating, and packaging.
Decocting rhizoma Alismatis decoction pieces in water twice, mixing decoctions, filtering, mixing filtrates, concentrating to obtain fluid extract, drying, adding adjuvants (dextrin, the mass ratio of fluid extract to dextrin is 1.
Decocting carapax Trionycis decoction pieces in water twice, filtering, mixing the filtrates, concentrating into fluid extract, adding adjuvants (dextrin, mass ratio of fluid extract to dextrin is 1.
Decocting Lumbricus decoction pieces in water twice, filtering, mixing the two filtrates, concentrating into fluid extract, adding adjuvants (dextrin, mass ratio of fluid extract to dextrin is 1.
Taking pseudo-ginseng decoction pieces, drying, crushing into fine powder (1200 meshes), adding auxiliary materials (the auxiliary materials are dextrin, and the mass ratio of the clear paste to the dextrin is 1.
Subpackaging granules (45 g of astragalus mongholicus, 20g of bran-fried coix seeds, 15g of rhizoma alismatis, 10g of pseudo-ginseng, 10g of earthworm and 15g of vinegar turtle shells) according to the gram weight ratio of decoction pieces to obtain the traditional Chinese medicine composition granular preparation for preventing and treating qi-deficiency phlegm-stasis type atherosclerosis cerebral infarction.
The ingredients of the granular preparation of the traditional Chinese medicine composition prepared in this example were identified as follows:
1. experimental procedure
Mainly adopts liquid chromatography-mass spectrometry (LC-MS) technology to carry out non-targeted metabolome research on a sample, and the experimental process comprises the following steps: sample collection, metabolite extraction, mass spectrometry detection and data analysis.
2. Data analysis flow
In order to accurately identify the metabolites, the results of this experiment were analyzed as follows based on SCIEX OS analysis software. Identification of metabolites using SCIEX OS software is based primarily on a comprehensive consideration of Mass Error, retention Time, isotope Match, MS/MS Library Score, scaled Molecular Formula. The library searching setting parameter is that Mass Error is less than 10ppm; an isocyanate Ratio Difference < 20; library Score > 50.
3. Reagent
Water (CAS: 7732-18-5)
Acetonitrile (CAS: 75-05-8)
Methanol (CAS: 67-56-1)
4. Instrument
High performance liquid phase (ExionLC) AB SCIEX
High resolution Mass Spectrometry (SCIEX Triple TOF 5600 +) AB SCIEX
Chromatography column (ACQUITY UPLC HST 31.8 μm (2.1x100mm) column) Waters
Centrifuge (Legend Micro 17R) Thermo
5. Experimental methods
5.1 extraction of metabolites
1. Grinding the pulverized sample (Chinese medicinal composition granule preparation);
2. 10mg of sample are weighed into an EP tube, and 500uL of lysis buffer (MeOH: H) are added 2 O＝7：3)；
3. Vortex and mix for 1min;
4. ultrasonic treatment for 30 minutes
5. Centrifuging for 20min,12000rpm, bottling and packaging.
5.2 Instrument parameters
5.2.1 liquid phase conditions
Column temperature (. Degree. C.): 40; sample temperature (. Degree. C.): 4; liquid phase flow rate: 0.3mL/min;
phase A water +0.1% FA
Phase B acetonitrile +0.1% FA
5.2.2 Mass Spectrometry conditions
Under the anion acquisition mode, adopt IDA high sensitivity scanning mode, dynamic background is deducted, and the ion source parameter sets up to: sheath gas flow rate 35, gas1 flow rate 55, gas2 flow rate 55, temperature 550, spray voltage-4500. The scanning time is 20min; the primary scanning range is 100-1200m/z, each primary scanning is followed by 12 secondary scanning, the secondary scanning range is 50-1200m/z, the secondary accumulation time is 0.05s, the collision energy is-40, and the collision energy range is the theoretical frequency +/-20. Under the positive ion collection mode, an IDA high-sensitivity scanning mode is adopted, dynamic background subtraction is carried out, and ion source parameters are set as follows: sheath gas flow rate 35, gas1 flow rate 55, gas2 flow rate 55, temperature 550, spray voltage 5500. The scanning time is 20min; the primary scanning range is 100-1200m/z, each primary scanning is followed by 12 secondary scanning, the secondary scanning range is 50-1200m/z, the secondary accumulation time is 0.05s, the collision energy is 40, and the collision energy range is the theoretical frequency +/-20.
6. Experimental results (pharmaceutical composition test chart)
The results are shown in FIG. 1: LC-MS/MS peak profile of Neg (negative ion) sample chinese medicinal composition granule preparation, fig. 2: the LC-MS/MS peak pattern of the Pos (positive ion) sample Chinese medicinal composition granule preparation is shown.
The results of searching the storehouse show that the components of the granular preparation prepared in example 1 are all the effective components of astragalus root, bran-fried coix seed, alisma orientale, notoginseng, earthworm and vinegar turtle shell. The preparation method of the granular preparation of the traditional Chinese medicine composition can achieve the aim of ensuring the product quality, and the process is stable.
EXAMPLE 2 preparation of decoction
The raw materials consist of the following components:
30-60g of astragalus membranaceus, 15-20g of bran-fried coix seeds, 15-25g of rhizoma alismatis, 5-15g of pseudo-ginseng, 5-15g of earthworms and 10-20g of vinegar turtle shell.
The preparation method comprises the following steps:
according to the disease condition of a patient, after the prescription dosage is adjusted (the adjustment mode follows that the maximum astragalus can be 60g for patients with serious qi deficiency, the maximum astragalus can be blood stasis, the earthworm and the pseudo-ginseng can be increased to 15g, the phlegm dampness is serious, and the coix seed can be 20 g), the raw materials are weighed according to the parts by weight, vinegar turtle shell is soaked in water which is 3 times of the weight of the vinegar turtle shell for 20 minutes in advance, the vinegar turtle shell is decocted for 30 minutes by strong fire, then the astragalus, the bran-fried coix seed, the rhizoma alismatis, the pseudo-ginseng and the earthworm are added, the water which is 15 times of the weight of all the traditional Chinese medicine components is soaked for 30 to 40 minutes, the mixture is decocted for 60 to 70 minutes by strong fire, and the medicine residue and the first liquid medicine are obtained by filtration; adding 10 times of water by weight into the dregs of a decoction, decocting for 40-50 minutes by using a slow fire, and filtering to obtain a second liquid medicine; and (3) combining the liquid medicines obtained in the 2 times, filtering by gauze, concentrating in a water bath at 100 ℃ to one third of the original volume to obtain the traditional Chinese medicine composition decoction for preventing and treating the qi-deficiency phlegm-stasis type atherosclerosis cerebral infarction.
The clinical effect of the decoction of the traditional Chinese medicine composition prepared in this example was verified:
1. research and design:
the study is designed by a single-center and random method.
1.1 participants
54 patients of sICAS admitted to beijing university of traditional Chinese medicine eastern hospital from 2 months in 2019 to 11 months in 2021 were selected as subjects. All participants were outpatient and hospitalized patients.
1.2 nano-rank standard
1.2.1 inclusion criteria:
(1) The method meets the western medicine diagnosis standard of symptomatic atherosclerotic intracranial arterial stenosis in the management standard of symptomatic intracranial and extracranial arterial atherosclerotic stenosis issued by the scientific statement expert group of the Chinese stroke society in 2017;
(2) Accords with the Chinese traditional medicine society's release of the diagnosis standard of apoplexy, which is part of the traditional Chinese medicine medical science medical guideline for diagnosis and treatment of common diseases in the internal medicine of traditional Chinese medicine';
(3) Meets the standard of 'ischemic stroke syndrome element diagnosis scale': qi deficiency is more than or equal to 10 minutes, blood stasis is more than or equal to 10 minutes, and phlegm dampness is more than or equal to 10 minutes;
(4) Intracranial artery stenosis is detected by nuclear magnetic assay;
(5) The doctor who is the attending physician judges that ischemic stroke and TIA are related to intracranial arterial stenosis;
(6) The first disease or the prior history of ischemic stroke without leaving serious sequelae;
(7) The age is more than or equal to 40 and less than or equal to 80 years old;
(8) Can sign itself or sign an informed consent through the consent family members.
1.2.2 exclusion criteria:
(1) Cerebral embolism and intracranial hemorrhage or hemorrhagic cerebral infarction within 6 weeks;
(2) Complicated with intracranial aneurysm, vascular malformation, or brain tumor;
(3) Obviously treating the patients with heart, liver, kidney and other important organ failure and mental diseases;
(4) Patients with liver and kidney dysfunction (glutamic-pyruvic transaminase exceeds the upper limit of the normal value by 50% or more and/or serum creatinine exceeds the upper limit of the normal value by 10% or more);
(5) Patients with stroke due to non-atherosclerotic angiostenosis, including cardiogenic stroke, vasculitis, vasospasm, smog, etc.;
(6) Hemoglobin is less than 100g/L, and platelet count is less than 100 × 10 9 (ii)/L or an International Normalized Ratio (INR) greater than 1.5 (irreversible), uncorrectable bleeding factor;
(7) Patients with severe brain hypofunction.
1.3 grouping and treatment methods
The samples were randomly divided into 27 control groups and 27 experimental groups according to the random number table method. Both groups of patients refer to 'guide 2016 for preventing and treating cerebrovascular diseases in China', and are subjected to intervention treatment aiming at risk factors such as hypertension, diabetes, dyslipidemia, coronary heart disease, smoking and the like.
The experimental group is added with the traditional Chinese medicine decoction on the basis of the conventional treatment of western medicine; the control group is treated by conventional western medicine (1) controlling risk factors, referring to 'Chinese cerebrovascular disease prevention and treatment guideline 2016', intervening treatment is carried out on risk factors such as hypertension, diabetes, dyslipidemia, coronary heart disease, smoking, etc., (2) aspirin is given in an amount of 100mg, and QD.po and clopidogrel hydrogen sulfate tablets in an amount of 75 mg). The treatment period is 3 months.
1.4 Observation index
General information such as sex, height, weight, age, medical history of the subject on the day of enrollment was collected. When patients in each group are treated for 3 months, clinical efficacy indexes (NIHSS scale, SS-QOL scale, apoplexy traditional Chinese medicine clinical efficacy evaluation scale and traditional Chinese medicine symptom scale) and safety indexes (TESS, four items of blood coagulation, blood routine, liver function and kidney function) are respectively carried out, and the incidence rate of adverse reactions is calculated.
1.5 statistical analysis
Establishing a database and data by using an SPSS 20.0 statistical software package for analysis, and aiming at the collected data, if the measured data accords with normal distribution, expressing the measured data by mean plus standard deviation, comparing the placebo group and the test group by using pairing t test, comparing the groups by using independent sample t test, expressing the measured data by mean plus standard deviation, and if the measured data does not accord with normal distribution, adopting rank sum test; the counting data are compared by adopting rank sum test to evaluate whether the change of curative effect symptoms and the safety between groups and two groups have difference. Differences were considered statistically significant with P <0.05.
1.6 results
1.6.1 general data results
54 individuals of sICAS patients admitted to beijing university of traditional Chinese medicine eastern hospital from 2 months in 2019 to 11 months in 2021 were selected as subjects, and were randomly divided into experimental groups and control groups in a ratio of 1. The control group was included in 27 cases and the experimental group was included in 27 cases. In the control group, 18 men and 9 women were aged at the mean age (65.33 ± 10.01); in the experimental group, 17 men and 10 women were aged (66.11. + -. 7.38). Comparison of pre-treatment gender, age, BMI, and number of patients with concomitant disease in the two groups showed no significant difference between the two groups. The two general data were compared, and the difference was not statistically significant (P > 0.05), and was comparable, as shown in Table 1. The two groups of patients had no statistical difference in baseline conditions such as sex, age, course of disease, and the like, and were comparable, as shown in table 3.
TABLE 1
1.6.2nihss score
The comparison of NIHSS before and after treatment in the experimental and control groups is shown in table 2. The difference in NIHSS scores before treatment was not statistically significant (P > 0.05). After 3 months of treatment, the treatment of the experimental group and the control group are obviously improved compared with the NIHSS before treatment, and the comparison in the groups has statistical significance (P is less than 0.0001). The median NIHSS scores of the experimental and control groups after treatment were 0 (0, 2) and 1 (1, 3.5), with significant differences between groups (P less than 0.05).
TABLE 2
| Group of | Before treatment | After treatment | Z | P value |
| Experimental group (n = 27) | 3(2,4) | 0(0,2) *△ | -4.418 | ＜0.001 |
| Control group (n = 27) | 3(2,4.5) | 1(1,3.5) * | -4.216 | ＜0.001 |
Note: pre-and post-treatment comparisons within the same group, # compared to pre-treatment P <0.05, # compared to pre-treatment P <0.01; compared before and after the internal treatment of the two groups, the comparison P of the delta two groups is less than 0.05, \ 9632while the comparison P of the two groups is less than 0.01.
1.6.3 Chinese medicine syndrome integral quantitative table results
The scores of the traditional Chinese medicine syndrome diagnostic scale before and after treatment of the experimental group and the control group are compared and shown in the table 3 and the figure 3. The difference of the scores of the pre-treatment Chinese syndrome diagnostic scale in the two groups has no statistical significance (P > 0.05). After 3 months of treatment, the traditional Chinese medicine syndrome diagnostic scale of the experimental group is decreased in qi deficiency, phlegm dampness and blood stasis subscales and total fractions compared with the traditional Chinese medicine syndrome diagnostic scale before treatment, and the intra-group difference is obvious (P is less than 0.01). The phlegm-dampness score of the control group is reduced, the intra-group difference has statistical significance (P < 0.05), the blood stasis score of the control group is reduced, the intra-group difference is significant (P < 0.01), and the qi deficiency score has no statistical significance (P > 0.05) compared with the pre-treatment score. The scores of the traditional Chinese medicine syndrome diagnostic scale of the experimental group and the control group after treatment are respectively 28.41 +/-17.00 and 50.44 +/-15.13, the difference between the groups is obvious (P is less than 0.01), and the scores of the qi deficiency syndrome diagnostic scale, the phlegm dampness diagnostic scale and the blood stasis scale of the experimental group and the control group are obvious.
TABLE 3
Note: compared before and after the treatment in the same group, # compared with before treatment P<0.05， * Compared with before treatment P<0.01; the comparison between the before and after the treatment in the two groups, △ two phase comparisons P<0.05， ■ Two groups of phase comparisons P<0.01。
1.6.4 serological mechanism index results
1.6.4.1 serological mechanism index
Because some patients do not complete two blood drawing examinations before and after treatment, 24 patients in total of 14 patients in the experimental group and 10 patients in the control group are subjected to serological mechanism index detection before and after treatment, and the results are as follows:
in statistical analysis before and after treatment in the same group, after treatment of two groups of Hs-CRP, vcam-1 and Icam-1 are obviously reduced compared with before treatment, and the statistical significance is achieved; after the IL-6 and MMP-9 in the experimental group are treated, the treatment is also obviously reduced compared with the treatment before, and the difference has statistical significance.
In the statistical analysis before and after treatment between two groups (experimental group and control group), the indexes of the two groups before treatment have no statistical difference except the index of Icam-1; the levels of Hs-CRP, MMP-9, IL-6 and Delta Icam-I in the treated experimental group are lower than those in the control group, the difference has statistical significance, and the index unit is shown in the table 4 and the figure 4 and is shown in the appendix 1. The improvement of the traditional Chinese medicine composition decoction on serum Hs-CRP, MMP-9, IL-6 and Icam-1 levels of sICAS patients by combining conventional western medicine treatment is better than that of the simple western medicine treatment.
TABLE 4
Note 1: pre-and post-treatment comparisons within the same group, # P <0.05 compared to pre-treatment, # P <0.01 compared to pre-treatment: compared before and after treatment, delta comparison between the two groups is less than 0.05, 96320, and P is less than 0.01
Note 2: because the two groups of before-treatment Icam-1 have statistical difference, the difference value delta Icam-1 of the two groups of before-treatment Icam-1 and the two groups of after-treatment Icam-1 is compared, and the result P is less than 0.05
1.6.5 imaging index results
1.6.5.1 brain perfusion results
Because some patients do not complete all ASL examination, according to the condition that the patients have hypoperfusion, the brain ASL detection before and after treatment is carried out on 12 cases in the experimental group and 10 cases in the control group, and the results are as follows:
in the statistical analysis before and after treatment in the same group, the CBF value and rCBF value on the affected side after treatment in the experimental group are both increased more than before, and the difference has statistical significance; the control group had no significant difference in the affected CBF value, healthy CBF value and rCBF value after treatment.
In the statistical analysis before and after treatment between two groups (experimental group and control group), the CBF value and rCBF value of the affected side and the healthy side before treatment have no statistical difference between the two groups; after treatment, the experimental group had higher rCBF values than the control group, and the differences were statistically significant. Therefore, the traditional Chinese medicine formula can improve the relative cerebral blood flow rCBF of sICAS patients by combining with the conventional western medicine treatment, and the table 5 and the figure 5 are shown. The index units are shown in appendix 1.
TABLE 5
Note: before and after treatment in the same group, # P <0.05 compared to before treatment, # P <0.01 compared to before treatment: compared before and after treatment, the comparison between delta two groups is less than 0.05 and 9632P, and the comparison between the two groups is less than 0.01
1.6.5.2 intracranial vascular plaque results
HRMRI examination was performed on 18 patients in the experimental group and 15 patients in the control group before and after treatment, and the results are shown in Table 6.
TABLE 6
1.6.5.2.1 plaque distribution
The two groups of plaques were not differentially distributed.
1.6.5.2.2 plaque characteristics
Table 7 shows the plaque characteristics before and after treatment, and it can be seen from table 7 that the degree of stenosis in the experimental group is significantly improved compared to that before treatment, and the difference has statistical significance. The control group had a decreased vascular remodeling index and the differences were statistically significant.
TABLE 7
Note: * P <0.05 for the pre-and post-experimental intra-group comparisons.
1.6.5.2.3 plaque burden
The plaque load before and after treatment of the two groups is shown in Table 8, and the plaque load difference before and after treatment of the two groups has no statistical significance.
TABLE 8
1.6.6 safety index results
TESS scale shows: during the experiment, 4 subjects in the treatment group experienced 5 adverse events (incidence of 18.51%), 7 subjects in the control group experienced 7 adverse events (incidence of 25.92%), and statistical differences were not statistically significant (P > 0.05).
The weight of the treatment group is reduced by 1 case, and the weight is reduced by 2.5 kg in 3 months; in 1 case, mild gastrectasia appears, and symptoms disappear without special treatment; 2 cases are dizziness, 1 case is tingling with both hands. The control group had mild edema of both lower limbs 1, and the control group had self-regressed without treatment; frequent urination in 1 case, no untreated symptoms disappeared; 1 rash, 1 nose bleeding and 3 dizziness.
In conclusion, the traditional Chinese medicine composition has a good treatment effect on qi-deficiency phlegm-stasis type atherosclerosis cerebral infarction, can obviously improve the traditional Chinese medicine symptoms of sICAS patients, and improves the relative cerebral blood flow (rCBF) of the patients. In the aspect of curative effect mechanism, the traditional Chinese medicine composition can inhibit local inflammatory reaction and generation of new vessels in plaques by reducing the levels of serum IL-6, hs-CRP, MMP-9 and Icam-1, thereby playing the roles of slowing the progression of atherosclerosis and stabilizing plaques. Meanwhile, the traditional Chinese medicine composition disclosed by the invention is used for treating qi-deficiency phlegm-stasis type atherosclerosis cerebral infarction, and has no obvious toxic or side effect and adverse reaction.
The above-described embodiments are merely illustrative of the preferred embodiments of the present invention, and do not limit the scope of the present invention, and various modifications and improvements of the technical solution of the present invention may be made by those skilled in the art without departing from the spirit of the present invention, which is defined by the claims.
Claims (7)
1. The traditional Chinese medicine composition for preventing and treating the atherosclerosis cerebral infarction is characterized by comprising, by mass, 30-60 parts of astragalus membranaceus, 15-20 parts of bran-fried coix seeds, 15-25 parts of rhizoma alismatis, 5-15 parts of pseudo-ginseng, 5-15 parts of earthworms and 10-20 parts of vinegar turtle shells.
2. The use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for preventing and treating atherosclerotic cerebral infarction.
3. A granular preparation for preventing and treating atherosclerosis cerebral infarction, which is prepared by taking the traditional Chinese medicine composition of claim 1 as a raw material.
4. The method for preparing a granular preparation for preventing and treating atherosclerotic cerebral infarction according to claim 3, characterized by comprising the steps of:
weighing the astragalus, the bran-fried coix seeds, the rhizoma alismatis, the earthworms and the vinegar turtle shells according to the mass parts, respectively adding water to decoct the astragalus, the bran-fried coix seeds, the rhizoma alismatis, the earthworms and the vinegar turtle shells twice, filtering, combining the two filtrates, concentrating the combined filtrates into clear paste, adding auxiliary materials, uniformly mixing, drying and granulating to respectively prepare the astragalus, the bran-fried coix seeds, the rhizoma alismatis, the earthworms and the vinegar turtle shells;
drying Notoginseng radix, pulverizing, adding adjuvant, mixing, and granulating to obtain Notoginseng radix granule;
subpackaging the granules to obtain the granular preparation for preventing and treating the atherosclerosis cerebral infarction.
5. A decoction for preventing and treating atherosclerosis cerebral infarction, which is prepared by taking the traditional Chinese medicine composition of claim 1 as a raw material.
6. The method for preparing a decoction for preventing and treating atherosclerotic cerebral infarction according to claim 5, comprising the steps of:
decocting turtle shells with vinegar for 30 minutes by strong fire, adding astragalus membranaceus, bran-fried coix seeds, rhizoma alismatis, pseudo-ginseng and earthworms, adding water, soaking for 30-40 minutes, decocting for 60-70 minutes by strong fire, and filtering to obtain first liquid medicine and filter residues; adding water into the filter residue, decocting the filter residue for 40 to 50 minutes by slow fire, and filtering the mixture to obtain a second liquid medicine; and combining the first liquid medicine and the second liquid medicine, filtering and concentrating to 1/4-1/2 of the original volume to obtain the decoction for preventing and treating the atherosclerosis cerebral infarction.
7. The method for preparing a decoction for preventing and treating atherosclerotic cerebral infarction according to claim 6, wherein the vinegar-processed carapax trionycis further comprises a step of soaking before decocting.
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