CN110693929A

CN110693929A - Application of compound medicine components in treating cerebral infarction recovery period

Info

Publication number: CN110693929A
Application number: CN201910848234.4A
Authority: CN
Inventors: 韩辉; 吴丽敏; 宋书婷
Original assignee: Anhui University of Traditional Chinese Medicine AHUTCM
Current assignee: Anhui University of Traditional Chinese Medicine AHUTCM
Priority date: 2019-09-09
Filing date: 2019-09-09
Publication date: 2020-01-17

Abstract

The invention discloses an application of compound medicine components in the recovery period of cerebral infarction, which is characterized in that: the compound medicine components comprise traditional Chinese medicine components and western medicine components: the traditional Chinese medicine components comprise ginseng and ligusticum wallichii; the western medicine components comprise aspirin enteric-coated tablets and atorvastatin calcium tablets. It has obvious curative effect.

Description

Application of compound medicine components in treating cerebral infarction recovery period

Technical Field

The invention relates to an application of a compound medicine component in the recovery period of cerebral infarction.

Background

In recent years, the incidence of cerebrovascular diseases has been rapidly increasing nationwide due to the ubiquitous presence of many risk factors such as heart disease, obesity, and hypertension. Among them, ischemic stroke, which is characterized by "high blood pressure, high blood sugar level" (high incidence, high disability rate, high mortality), is actively treated in the acute stage, and then sequela such as language dysfunction and hemiplegia are often left, which seriously affects the mood and daily life of patients, and causes considerable psychological and physiological burden to patients and their families, thus enhancing the therapeutic significance of the recovery stage of ischemic stroke. The western medicine has single target, no effective medicine which is clinically evaluated and can comprehensively improve the clinical symptoms of patients exists, and the application of the traditional Chinese medicine with the characteristics of multiple ways, multiple targets and the like in the cerebral infarction recovery period shows more remarkable advantages. However, at present, no effective drugs including traditional Chinese medicines capable of comprehensively improving clinical symptoms of patients are reported.

Disclosure of Invention

The invention aims to solve the technical problem of providing the application of the compound medicine components in the treatment of the cerebral infarction in the recovery period, and the application and treatment effects are obvious.

In order to achieve the purpose, the invention adopts the following technical scheme:

the invention provides an application of a compound medicine component in the recovery period of cerebral infarction, which comprises the following components in part by weight: the compound medicine components comprise traditional Chinese medicine components and western medicine components:

the traditional Chinese medicine components comprise ginseng and ligusticum wallichii;

the western medicine components comprise aspirin enteric-coated tablets and atorvastatin calcium tablets.

As a further improvement of the invention: the aspirin enteric-coated tablet comprises the following components: 100 mg/time.

As a further improvement of the invention: the preparation formulation prepared from the compound medicine components is granular.

As a further improvement of the invention: the atorvastatin calcium tablet comprises: 10 mg/time.

As a further improvement of the invention: the ratio of the ginseng to the ligusticum wallichii is 1:1 by weight.

As a further improvement of the invention: the etiology type of the cerebral infarction is ischemic stroke.

As a further improvement of the invention: according to the weight ratio, the ratio of the aspirin enteric-coated tablet to the atorvastatin calcium tablet is 10: 1.

As a further improvement of the invention: the atorvastatin calcium tablet is replaced by one of rosuvastatin, fluvastatin, simvastatin, pravastatin and lovastatin.

Similar anti-platelet aggregation and anticoagulation medicines such as clopidogrel are clinically used for the long-term secondary prevention of stroke in the dual anti-platelet therapy, and the treatment does not increase the benefit compared with the single anti-platelet therapy, but obviously increases the bleeding risk. The single aspirin has obvious curative effect in the long-term secondary prevention of the stroke, and the latest guidelines for the secondary prevention of the stroke still use the single aspirin as a first-line medicine for the long-term secondary prevention of the stroke. The medicine has similar lipid regulating and plaque stabilizing effects, such as rosuvastatin, fluvastatin, simvastatin, pravastatin and lovastatin, but the lipid reducing effect of atorvastatin calcium is better than that of other lipid reducing medicines.

The granules have the advantages that: the traditional Chinese medicine granule is a new formulation developed on the basis of traditional Chinese medicine decoction, syrup and other formulations, and has more obvious advantages compared with other formulations, the development prospect is very good, and the specific advantages are as follows:

1. compared with the traditional Chinese medicine tablet

A large amount of excipient, disintegrant and lubricant are added into the traditional Chinese medicine tablets for granulation and tabletting, and auxiliary materials such as gelatin, talcum powder, syrup pigment and the like are added when the traditional Chinese medicine tablets are coated with sugar, and generally, the coating part accounts for more than 6O percent of the weight of the whole tablet. Not only has large amount of auxiliary materials and long flow, but also the tablet is not easy to disintegrate and dissolve, and the phenomena of mottling, cracking and the like are easy to generate during the storage period. The granules are quick to dissolve and release and good to absorb and utilize, and the problems of loose tablets, split tablets, sticking, lamination, color-changing spots and the like in the production of the traditional Chinese medicine tablets are avoided. If the granules are coated differently and prepared into gastric-soluble or enteric-coated granules, the application range of the medicine is wider, and the traditional Chinese medicine granules not only keep the characteristics of quick absorption and quick action of decoction. But also overcomes the defects of inconvenient decoction, large dosage, easy deterioration and the like when the decoction is used, and the preparation process is suitable for industrial production and has small dosage. Convenient administration, carrying, storage and transportation, and good development prospect.

2. Compared with the Chinese medicinal oral liquid

The decoction prepared from the traditional Chinese medicine decoction pieces is suitable for the principle and flexibility of treatment based on syndrome differentiation and addition and subtraction according to symptoms in traditional Chinese medicine, has the characteristics of quick absorption and quick action, and has wider clinical application. However, with the development of society and the progress of science and technology, the traditional Chinese medicine decoction can not meet the medical needs more and more, and a plurality of defects and incompatible problems are exposed: firstly, traditional chinese medicine decoction is bulky, easily goes bad, and it is all inconvenient to take, carry, store: secondly, the addition and preparation method is not easy to be completely mastered by non-professional personnel due to the limitation of the solvent, and the method is time-consuming and labor-consuming. The preparation quality is difficult to control, and the like, so that a large amount of medicinal material resources are wasted; the quality of decoction pieces is also greatly influenced, and the decoction pieces with the same name have different qualities and different clinical effects due to different producing areas, processing methods, storage conditions and the like. These seriously hinder the development of traditional Chinese medicine and influence the practical clinical application of traditional Chinese medicine decoction. Some precious medicinal materials are not suitable for being prepared into oral liquid due to complex components and poor solubility in water. However, these valuable medicinal materials. Can be made into fine powder, and can be mixed with human extract or extract powder to make into granule, and the granule is allowed to be suspended when being taken, so that the appearance and internal quality of the granule are not affected. This is the situation that the preparation form of the traditional Chinese medicine oral liquid cannot be compared with the preparation form of the traditional Chinese medicine oral liquid in the aspects of process stability and quality stability.

3. Chinese medicinal granule and Chinese medicinal injection

Compared with the injection prepared from traditional Chinese medicinal materials, the injection has the advantages of long process, complex operation, repeated alcohol precipitation, refrigeration and filtration by high-concentration ethanol, and serious loss of effective components, so that the medicine contains components such as polysaccharides, peptides, proteins and the like with curative effect. Suffer from different losses and reduce the curative effect. Some Chinese medicine extracting solutions are alcohol precipitated and repeatedly filtered, and the loss of partial effective components can reach more than 50%. After the stable injection is prepared, the effective components are almost remained. Some Chinese medicine injection. Can be clarified only after high-speed centrifugation and ultrafiltration, and has higher cost. In addition, in recent years, the traditional Chinese medicine injection has complex in-vivo components, the number of medicine impurities and insoluble particles is increased, and the risk of adverse reaction is increased.

Because aspirin has a bleeding risk, the dosage for clinically inhibiting platelet aggregation and preventing cardiovascular diseases and cerebral apoplexy is below 150mg/d, and the dosage for clinically taking aspirin is 100mg/d at most. The safe range of the atorvastatin calcium is 10-80mg/d, and the test uses aspirin, atorvastatin calcium and traditional Chinese medicines at the same time, so the test is started from a small dose for safety.

The modern pharmacological actions of ginseng for improving the nerve function of patients with ischemic stroke are as follows:

① scavenging free radicals and resisting lipid peroxidation

The brain tissue needs more oxygen during ischemia reperfusion, but the increase of the oxygen supply can lead to excessive generation of Reactive Oxygen Species (ROS) which can directly act with macromolecular substances such as lipid, protein, nucleic acid and the like in the ischemic brain tissue to aggravate brain damage, and during the cerebral ischemia reperfusion, a large amount of NO can be generated to accelerate the generation of free radicals and induce apoptosis. The ginsenoside can inhibit NO release after cerebral tissue ischemia reperfusion, reduce free radical generation during cerebral ischemia, improve organism ability of scavenging oxygen free radical, significantly increase expression of superoxide dismutase (SOD), enhance activity of glutathione peroxidase, reduce content of Malondialdehyde (MDA), and relieve pathological damage of brain tissue cells. Ginsenoside Rg1 has effects in improving SOD activity, inhibiting lipid peroxidation of biological membrane, reducing MDA content, protecting lysosome membrane, scavenging free radicals, and inhibiting lipid peroxidation reaction to protect brain.

② inhibiting the expression of inflammatory factors

After cerebral ischemia, the macrophage around blood vessel will produce proinflammatory cell factors IL-1 beta, IL-12, IL-23, chemotactic factor, active oxygen and TNF-alpha 3 to promote the infiltration of inflammatory cell and relevant inflammatory reaction. IL-1, cell adhesion molecule, TNF-alpha and the like are main inflammatory factors involved in cerebral ischemia, and can form a complex cascade reaction under the interaction with vascular endothelial cells, neurons, glial cells and peripheral immunocompetent cells, so that the inflammatory reaction caused after cerebral ischemia is in a state of vicious circle, further damages brain tissues, and has direct influence on treatment and rehabilitation after cerebral stroke, and therefore one of important measures for protecting the brain is to inhibit the inflammatory reaction. The ginsenoside can reduce signal transmission by inhibiting expression of TNF-alpha and IL-1 beta, reduce content of IL-8 and cell adhesion molecule-1, reduce infiltration of macrophage and neutrophil in brain tissue, and promote recovery of nerve function.

③ inhibit apoptosis of nerve cells and promote regeneration of peripheral nerve cells

The death of neurons around infarct foci in early stages of cerebral ischemia is closely related to apoptosis. EAA release, calcium overload and oxidative stress caused by cerebral ischemia reperfusion can cause apoptosis. Apoptosis is associated with a variety of proteins, such as the family of cysteine protease (Caspase) proteins with multiple apoptotic pathway junctions.

④ inhibit Glu excitotoxicity and calcium ion influx

Glu has the function of nourishing nervous tissues in the early development stage, has obvious toxic effect on the later development stage, and is the amino acid with the widest distribution and the largest content in excitatory neurotransmitters of the central nervous system. During cerebral ischemia, adenosine triphosphate synthesis is insufficient, which causes reuptake of Glu to generate obstacle, a large amount of Glu is gathered at focal part, Glu related receptors are stimulated, calcium ion inflow is caused, excitable neurotoxicity is caused, ischemic brain tissue is damaged, therefore, Glu is inhibited from being excessively released, excitable toxicity is inhibited, reuptake is promoted, receptor activity is inhibited, and cerebral ischemia injury can be prevented and treated.

⑤ intervention in thrombosis

Damage to the vascular endothelium and changes in the blood flow state and blood composition can lead to the development of a thrombus. The whole blood viscosity is one of the basic indexes reflecting the blood flow resistance and the blood rheology characteristics. The whole blood viscosity is increased, so that the blood flow rate is reduced, the microcirculation perfusion is insufficient, the tissue is anoxic, and then the thrombus is easier to form.

The modern pharmacological action of the ligusticum wallichii for improving the nerve function of patients with ischemic stroke is as follows:

① antagonize calcium ions

Ligustrazine is a calcium ion antagonist which can directly act on a calcium ion channel. The research shows that the ligustrazine can not only increase the activity of calcium ion-adenosine triphosphatase in brain tissues, increase the outflow of calcium ions in cells, but also reduce the inflow of calcium, thereby slowing down the calcium overload in the cells and promoting the erythrocyte function to be normal. Ligustrazine can regulate calcium ion/calmodulin kinase II to inhibit calcium ion inflow and promote the release of intracellular calcium ion, so that it has the effect of relaxing blood vessel.

② scavenging free radicals

During the cascade of cerebral ischemia and reperfusion, a large number of free radicals are generated, causing lipid peroxidation and further aggravating brain damage. A large number of researches find that the ligustrazine can not only increase the activity of free radical scavenging enzyme, protect the activity of glutathione peroxidase and glutathione reductase and reduce the damage caused by free radicals, but also can down regulate the content of malonic acid in cerebral ischemia damaged cortical tissues and the content/activity of NO in neutrophils, clear free radicals and resist lipid peroxidation.

③ anti-inflammatory effect

After the rat cerebral ischemia reperfusion, the expressions of mononuclear/macrophage surface specificity mark antigens ED-1, IL-1 beta and TNF-alpha on the surfaces of infiltrated white cells and activated microglia are increased, and the ligustrazine can obviously reduce the expression of the ligustrazine in cerebral ischemia tissues, inhibit the inflammatory reaction of an ischemic area and protect the cerebral tissues.

④ resistance to apoptosis

Although apoptosis is initiated by various exogenous and exogenous signals, the apoptosis is finally completed through the expression of apoptosis gene regulatory protein, Bcl-2 family plays an important role in the apoptosis process, and ligustrazine can obviously inhibit apoptosis after cerebral tissue ischemia injury.

⑤ Regulation plasticity

Synaptophysin (SYP) increases in expression after cerebral ischemia reperfusion, forming new synapses, and new synaptic connections begin to appear.

⑥ antiplatelet aggregation

Sodium ferulate in rhizoma Ligustici Chuanxiong can inhibit platelet aggregation, inhibit 5-hydroxytryptamine released by platelet, inhibit thromboxane synthetase, generate antagonism with thromboxane, prevent abnormal contraction of intracranial and extracranial blood vessels, block vicious circle of abnormal vasoconstriction, inhibit phospholipase A2 to prevent arachidonic acid from dissociating, selectively inhibit TXA2 synthetase activity, inhibit TXA 2-like substance release, block generation of TXA2, increase adenosine monophosphate content in platelet, inhibit platelet aggregation, inhibit calcium ion inflow of vascular smooth muscle cells, open potassium ion-adenosine triphosphate channel, and reduce thrombin generation and activity in blood coagulation process.

Drawings

FIG. 1 shows the comparison of the treatment results (%) between the treatment groups (left) and the control groups (right).

Figure 2 comparison of total clinical efficacy of two groups of patients after treatment in the treatment group (left) and the control group (right).

FIG. 3 is a comparison of the Chinese medical syndrome integrals of two groups of patients in the treatment group (left) and the control group (right).

Figure 4 treatment (left) versus control (right) two groups of patients were compared on NIHSS scores.

Figure 5 treatment group (left) and control group (right) two groups of patients were compared on the modified Rankin scale score.

Figure 6 Barthel index score for the treatment group (left) compared to the control group (right) for both groups of patients.

Figure 7 treatment group (left) versus control group (right) two groups of patients total score for SSQOL.

Detailed Description

The application of the compound medicine component in the recovery period of cerebral infarction provided by the invention is further explained in more detail through the specific embodiment as follows:

Chinese-English comparison table of common abbreviations

First experiment, clinical research

1 study object

1.1 sources of cases

60 patients who visit an outpatient department or a residential department of the department of encephalopathy of the first subsidiary hospital of the university of traditional Chinese medicine in Anhui between 2018, 1 month and 1 day to 2018, 10 months and 31 days and have the age of 35 to 75 years old at the recovery stage of cerebral infarction (meridian-qi deficiency and blood stasis syndrome in stroke) are collected.

1.2 grouping method:

60 patients (36 men and 24 women) meeting the diagnosis, inclusion and exclusion criteria are sequentially numbered as No. 1-60, a first row and a first column of a random number table are randomly assigned, 60 two-digit random numbers are read from top to bottom or from left to right, the random numbers are discarded when the random numbers are the same, the random numbers are read downwards continuously and are sequentially marked below the serial numbers of the tested subjects, and then the random numbers are sorted according to the ascending order to obtain the random number serial numbers. The serial numbers 1-30 are divided into a control group, and the serial numbers 31-60 are divided into a treatment group. The random distribution card (including number, random number, group and treatment method) is compiled, sealed by envelope, and numbered, and orderly arranged (the envelope number is identical to the random distribution card number in the envelope), and then the envelope is handed to the personnel irrelevant to the study for storage, when the qualified subject is met, the envelope with the same sequence number as the test is opened, and the treatment is given according to the specified group and medical advice of the card.

1.3 diagnostic criteria

1.3.1 Western diagnostic standards

(1) Cerebral infarction diagnosis standard

Refer to the Chinese guideline for diagnosis and treatment of acute ischemic stroke (2010).

① acute onset;

② symptoms and signs last more than 24 h;

③ the imaging examination (craniocerebral CT or craniocerebral MRI) has definite ischemic focus, and can eliminate hemorrhagic diseases and other pathological changes.

④ excluding non-vascular brain lesions;

⑤ are primarily focal neurological deficits, with only a few likely being global neurological deficits.

(2) Typing diagnosis

Because the collateral circulation compensation ability, infarct position, infarct area, secondary encephaledema and other differences exist, the clinical pathological types of cerebral infarction are different, so that the treatment schemes are also greatly different, and the accurate typing is particularly important for the treatment of cerebral infarction.

1) Clinical typing

Oxfordshire community stroke study (OCSP) typing can be divided into four categories, namely, Total Anterior Circulation Infarction (TACI), Partial Anterior Circulation Infarction (PACI), postcirculatory infarction (POCI), lacunar infarction (LACI), ocp is simple and easy to implement, can be rapidly typed only according to clinical manifestations, and has important significance for diagnosis, treatment, prognosis and evaluation of diseases. The standard is as follows:

2) structural image (CT) typing

Structural image (CT) is classified into four types, namely large (focus) infarction, medium (focus) infarction, small (focus) infarction and lacunar infarction, and the specific standards are as follows:

1.3.2 Chinese medicine diagnostic Standard

(1) Diagnostic criteria for stroke

Refer to "diagnosis of apoplexy and evaluation of therapeutic efficacy" (trial implementation).

The main symptoms are: hemiplegia, coma, facial distortion, aphasia or speech difficulty, and abnormal feeling.

The secondary symptoms are as follows: dizziness, headache, choking of drinking water, mydriatic changes, impaired vision and ataxia.

The onset age is usually 40 years or older. The acute onset of the disease is caused by various causes and premonitory symptoms before the onset of the disease.

The diagnosis of stroke disease requires more than 2 major symptoms or 1 major symptom and more than 2 minor symptoms or clear imaging examination results, depending on the age, cause and precursor symptoms of the patient.

(2) Staging criteria

In the acute stage: the course of disease does not exceed 2 weeks (except for the middle zang organs, which is up to 1 month).

A recovery period: the course of the disease is over 2 weeks, but not over 6 months.

In the sequela stage: the course of the disease exceeds 6 months.

(3) Diagnostic standard of meridian

Meridian collateral dredging: without mental confusion.

The middle zang-fu organs: there is a coma of mind.

(4) Diagnostic standard for qi deficiency and blood stasis syndrome

Quantitative scores of the degree of qi deficiency and blood stasis of apoplexy patients refer to "diagnosis criteria for syndrome differentiation of apoplexy" (trial).

1) Quantitative standard for qi deficiency syndrome of apoplexy

① the tongue proper is marked by pale tongue (score 3), swollen tongue (score 4) and flaccidity or swollen tongue with multiple teeth marks (score 5).

② the posture sounds of qi deficiency, no desire to speak, lassitude (1 point), cough, weakness, low voice (2 points), lassitude, sleepiness (3 points), and snore and rest (4 points).

③ sweat when it is slightly dynamic (2 points), when it is quiet (3 points), and when it is not cool (4 points).

④ loose stool or loose stool after first hard (1 point), loose urine (2 points) and loose stool (4 points).

⑤ swelling of limbs (score 2), paralysis and weakness of limbs (score 3), and cold limbs (score 4).

⑥ palpitations include palpitations (score 1) when there is more activity, palpitations (score 2) when there is slight activity, and palpitations (score 3) when there is no rest.

⑦ the complexion is white (score 1), white and floating (score 3).

⑧ the pulse is thready or slow or deficient (1 point), intermittent (2 points) and thready (3 points).

Note: quantification standard of apoplexy qi deficiency syndrome: the diagnosis can be established only if the score is more than or equal to 7 points, the score is less than or equal to 7 points and less than or equal to 14 points, the score is mild, the score is less than or equal to 15 points and less than or equal to 22 points, the score is moderate, and the score is severe if more than or equal to 23 points.

2) Quantitative standard for apoplexy and blood stasis syndrome

① tongue proper, the sublingual collaterals are dark purple (4 points), dark purple (5 points), petechiae (6 points), petechiae (8 points), and dark purple (9 points).

② headache with no migratory pain (score 5), headache such as needle prick or headache such as burst (score 7).

③ Limb with pain and pain (5 points) and onychomycosis (6 points).

④ dark face (score 2), dark lips (score 3), dark lips and dark complexion (score 5);

⑤ the pulse is deep and wiry (1 point), deep and wiry and slow (2 points), and astringent or knotted (3 points).

Adding the following components: high blood viscosity (5 points).

Note: quantification standard of apoplexy blood stasis syndrome: the diagnosis can be established only if the score is more than or equal to 7 points, the score is less than or equal to 7 points and less than or equal to 14 points, the score is mild, the score is less than or equal to 15 points and less than or equal to 22 points, the score is moderate, and the score is severe if more than or equal to 23 points.

1.4 inclusion criteria

(1) Agreeing and voluntarily taking part in the clinical trial and signing an informed consent form;

(2) age 35 < age < 75 years old;

(3) imaging examination (CT or MRI) confirmed that OCSP was clinically classified as all infarct types;

(4) meeting the cerebral infarction diagnosis standard;

(5) the first clinical attack, 15 days < the recovery period with the disease course less than or equal to 90 days;

(6) the diagnosis standard of the channels and collaterals in the apoplexy of the traditional Chinese medicine is met, and the quantitative score of the qi deficiency and blood stasis syndrome is more than or equal to 7 points;

(7) mild to moderate patients with a modified Rankin scale rating (mRS) of greater than 2 points, a neurological impairment score (NIHSS) of greater than or equal to 7 points, and less than or equal to 22 points.

1.5 exclusion criteria

(1) Acute stage and sequela stage of cerebral infarction;

(2) patients with cerebral arteritis, transient ischemic attack, progressive apoplexy, and cerebral hemorrhage after cerebral infarction;

(3) patients with visceral syndrome in stroke and qi deficiency and blood stasis syndrome quantitative score of less than 7 points;

(4) cerebral embolism caused by heart diseases such as rheumatic heart disease, coronary heart disease, etc. combined with atrial fibrillation, brain tumor, brain trauma, cerebral parasitosis, etc.;

(5) patients treated by acute-stage blood vessel opening and the like (such as ultra-early arterial thrombus extraction, thrombus suction, thrombolysis, stent forming and the like);

(6) patients with hypertension or intractable hypertension, severe diabetes or diabetes with poor control; (7) combined with other diseases such as lameness, osteoarthritis, rheumatoid arthritis, gouty arthritis and the like, which can cause the dysfunction of limb movement;

(8) those with severe hematopoietic/metabolic disorders or hepatic and renal insufficiency;

(9) severe bleeding or bleeding tendency such as peptic ulcer occurred within 3 months;

(10) investigators considered unsuited to participate in the clinical trial or suspected or confirmed to have had a history of drug, alcohol abuse;

(11) the disabled patients who can not independently complete daily activities or have legal requirements for deafness, dumb, blindness, mental disorder, intellectual disorder and the like caused by factors such as physique or diseases seriously affect the evaluation of the curative effect

(12) Those known or suspected to be allergic to the test drug;

(13) patients with dementia, depression and other complications after stroke or cerebral hemorrhage after stroke;

(14) have participated in other drug clinical trials;

(15) those under 35 years of age or over 75 years of age;

(16) pregnant or lactating women.

1.6 criteria for rejection and shedding

(1) Patients were deceased during the study;

(2) cases that were mistakenly entered without meeting inclusion criteria;

(3) patients who withdraw from the treatment course automatically, wherein the treatment course is more than half and the patients who withdraw inefficiently should be recorded with the treatment effect analysis;

(4) in the test process, the patients with serious adverse reactions or adverse events should take the statistics of the adverse reactions into account, and the patients with adverse reactions are stopped to continue the test;

(5) the patients who are not taking the medicine or are not taking the medicine according to the specified dosage and treatment course, and the treatment effect or the safety can not be judged due to the lack of main inspection items and main indexes;

(6) during follow-up, patients were lost due to various reasons.

2 research methods

2.1 methods of treatment

2.1.1 control group

Oral aspirin enteric-coated tablets were unified during the trial: 100 mg/time, early (Shanxi broccoli pharmaceutical industry Co., Ltd., national Standard H14023980); atorvastatin calcium tablets: 10 mg/time, late (manufactured by Beijing Jialin pharmaceutical industry GmbH, national drug Standard H19990258); the course of treatment is as follows: for 12 weeks. The clinic visits 90 days after group entry.

2.1.2 treatment groups

The preparation method comprises adding SHENXIONG granule (specification: 20 g/bag, wherein Ginseng radix and rhizoma Ligustici Chuanxiong are 10g each for 3 times per day, and is produced by Guangdong pharmaceutical Co., Ltd.) to the control group based on western medicines. The course of treatment is as follows: for 12 weeks. The clinic visits 90 days after group entry.

2.2 Observation index

2.2.1 safety index

(1) Possible adverse reactions/events;

(2) vital signs: body temperature, heart rate, respiration, blood pressure;

(3) coagulation conventions (TT, APTT, PT, FIB), blood conventions (WBC, RBC, HGB, PLT, N, L), urine conventions (LEU, BLD, PRO, BIL, urine GLU), liver and kidney functions (ALT, AST, γ -GT, ALP, TBIL, BUN, Cr, urine NAG enzyme, urine microalbumin, eGFR); routine stool, occult blood and electrocardiogram. 1 time was recorded before and after treatment.

And (4) observing possible adverse events/reactions of other indexes before and after treatment.

Main safety evaluation indexes are as follows: adverse reactions/event incidence.

Safety evaluation criteria

Stage I: safety (no abnormity is found in safety index inspection, and no adverse reaction is found in the process of taking the medicine);

and II, stage: the safety is high (no abnormality is found in the safety index inspection, mild adverse reaction occurs in the process of taking the medicine, but the medicine can be continuously taken without treatment);

grade III: has safety problems (slight abnormality is detected by safety index, moderate adverse reaction occurs in the process of taking medicine, and the medicine can be continuously taken after being processed);

IV stage: serious safety problems (obvious abnormity of safety index inspection and test suspension due to serious adverse reaction in the process of taking medicine).

2.2.2 evaluation criteria for therapeutic Effect

(1) Evaluation standard of traditional Chinese medicine curative effect

The clinical curative effect is in accordance with the guiding principle of clinical research on treating apoplexy by new Chinese medicine, edited by Zheng Xiao Yu, 2002 edition. If the clinical symptoms and physical signs are not obviously improved or even aggravated, the reduction of the traditional Chinese medicine syndrome integral is less than 30 percent, and the traditional Chinese medicine is judged to be ineffective. The clinical symptoms and physical signs are improved, and the traditional Chinese medicine syndrome integral is reduced by more than or equal to 30 percent and less than 70 percent to judge that the traditional Chinese medicine composition is effective. The clinical symptoms and physical signs are obviously improved, and the traditional Chinese medicine syndrome integral is more than or equal to 70 percent and less than 95 percent, so the traditional Chinese medicine is judged to have obvious effect. Clinical symptoms and physical signs disappear or basically disappear, and the clinical recovery is judged if the reduction of the traditional Chinese medicine syndrome integral is more than or equal to 95 percent. The criterion for judging the single symptom curative effect is expressed by percentage and is equal to the ratio of the integral difference before and after treatment of the single symptom to the integral before treatment.

Note that ① total effective is cured + effective, ② formula (nimodipine method) expressed as percentage is equal to the ratio of the pre-treatment integral difference to the post-treatment integral difference to the pre-treatment integral.

(2) Evaluation standard of curative effect of western medicine

Refer to "clinical neurological deficit scoring Standard for stroke patients" by the fourth national conference on cerebrovascular disease "(1995). The functional impairment score is increased by more than 18 percent and is judged to be worsened; the functional impairment score is reduced or increased by less than 18 percent, and the result is judged to be unchanged; a reduction in functional impairment score of 18% -45% is judged as progression;

the disease disability degree is 1-3 grade, and the functional impairment score is reduced by 46% -90%, so that the disease disability degree is judged to be remarkably improved; the disease disability degree is 0 grade, and the basic recovery is judged if the functional impairment score is reduced by 91% -100%.

Note that ① total effective rate is expressed as a percentage, which is equal to the ratio of the sum of progress, significant progress, substantial recovery to the total number of cases;

② the efficacy index is expressed as a percentage and is equal to the ratio of the pre-and post-treatment integrated difference to the pre-treatment integrated.

2.2.3 comparison of two sets of scores

(1) Traditional Chinese medicine syndrome score

The Chinese medicine qi deficiency syndrome and blood stasis syndrome before and after treatment are quantitatively scored according to 1994 "diagnosis standard for syndrome differentiation of apoplexy" (trial).

(2) Neurological deficit degree (NIHSS) score

The NIHSS score is a scale used to assess the degree of neurological impairment in stroke patients, with higher scores being more severe.

(3) Improved Rankin scale score

The modified Rankin scale is a simplified scale for assessing functional recovery after a stroke in a patient.

(4) BI index score

Self-care in daily life: 100 minutes; basic self-care of life, mild dysfunction: the score is not less than 75 points and not more than 95 points; life needs help, moderate dysfunction: the score is not less than 50 points and not more than 70 points; obvious dependence on life, severe dysfunction: the score is more than 25 points and less than or equal to 45 points; life is totally dependent, very severe dysfunction: the score is not less than 0 point and not more than 20 points.

(5) Total score on stroke specific quality of life scale (SSQOL)

A higher score indicates better quality of life. The assessment of the patient includes language, upper limb function, vision, physical ability, mood, character, exercise, family activity, self-care ability, thinking ability, work ability, social activity, etc.

Note: the neurological impairment degree (NIHSS) score, the modified Rankin scale score, the daily living Activity (ADL) capability scale (BI index) score and the total score of the special stroke quality scale (SSQOL) refer to the neurological division of the Chinese medical society and the disease control division of the Ministry of health, China guidelines for preventing and treating cerebrovascular diseases.

2.3 stability of IMT and carotid atherosclerotic plaques

The method comprises the steps of scanning the near end, the far end and the middle section of the common carotid artery of a patient by using color ultrasound, recording the IMT thickness of the carotid artery of the patient for the patient with the carotid atherosclerotic plaque, and analyzing the size, the part, the echo and the morphological characteristics of the plaque by color ultrasound blood flow imaging. If the plaque is mainly strong echo and cellulose, calcification change mostly occurs, but the intima fiber cap is mostly complete and not easy to break, and belongs to a stable plaque. If the plaque echo is hypoecho or mixed echo, mainly lipid, the intima is easy to rupture and is fragile, and belongs to unstable plaque. The above indexes are observed and recorded at two time points before and 90 days after the group entry.

2.4 statistical treatment

The data statistics in the test are all statistical analysis by using SPSS 21.0, and different statistical methods are selected according to different properties of test data. Wherein the grade data is checked by adopting nonparametric method; checking the counting data by a chi-square method; the measurement data are expressed by mean + -standard deviation (wherein the comparison between the treatment group and the control group adopts t test or nonparametric test of two independent samples, and the comparison between the front and the back of the group adopts t test or nonparametric test of a matched design). P <0.05 suggests that the difference is statistically significant.

3 results

3.1 general data comparison

The sex, age, height, disease course and weight of 30 patients in the control group and 30 patients in the treatment group are statistically analyzed, and the differences are not statistically significant (P >0.05) and are comparable. See table 1 for details.

TABLE 1 general data comparison

3.2 comparison of clinical efficacy between the treated group and the control group

3.2.1 comparison of the efficacy of the treatment groups and the control group in the treatment of the syndrome

The therapeutic effect of the syndrome in the treatment group is compared with that in the control group, and the details are shown in table 2 and figure 1.

TABLE 2 two-group Chinese medicine syndrome curative effect (%) comparison

Note: p <0.05 compared to control.

The total effective rate of the traditional Chinese medicine syndrome curative effect after the treatment of the treatment group is 93.33 percent, the total effective rate of the traditional Chinese medicine syndrome curative effect after the treatment of the contrast group is 73.33 percent, the total effective rate of the treatment group is obviously higher than that of the contrast group, and the difference has statistical significance (P is less than 0.05), which shows that the traditional Chinese medicine syndrome curative effect of the treatment group is better than that of the contrast group.

3.2.2 clinical Total effective rate comparison between the treatment group and the control group

The clinical total effective rates of the two groups are compared and shown in table 3 and figure 2.

Table 3 comparison of total clinical efficacy (%) in two groups

Note: p <0.05 compared to control.

The total clinical effective rate after treatment in the treatment group is 93.33%, the total clinical effective rate after treatment in the control group is 80.00%, the total clinical effective rate after treatment in the treatment group is higher than the total clinical effective rate after treatment in the control group, and the difference has statistical significance (P is less than 0.05), which indicates that the total clinical effective rate in the treatment group is better than that in the control group.

3.3 clinical efficacy score comparison

3.3.1 Chinese medicine syndrome integral comparison

The syndrome integrals of the Chinese medicine in the treatment group and the control group are compared, and the details are shown in the table 4 and the figure 3.

TABLE 4 comparison of the Chinese medical syndrome integrals of the treatment group and the control group

Note:^#comparison with control group before treatment, P>0.05; comparison of post-treatment and pre-treatment groups, P<0.01；^▲Comparison after treatment with control group, P<0.01。

Table 4 illustrates: the traditional Chinese medicine syndrome integration comparison before treatment of the treatment group and the control group has no significant difference (P is more than 0.05). The difference was statistically significant (P <0.01) in the two groups before and after treatment. The traditional Chinese medicine syndrome integral comparison between the treatment groups and the control groups after treatment has significant difference (P <0.01), which shows that the score improvement condition of the treatment groups is obviously better than that of the control groups.

3.3.2 clinical Neurological Impairment (NIHSS) score comparison

The treatment and control groups were compared for NIHSS scores and are detailed in table 5, figure 4.

TABLE 5 comparison of two groups of clinical neurological deficit scores

Note:^#comparison with control group before treatment, P>0.05; comparison of post-treatment and pre-treatment groups, P<0.01；^▲Comparison after treatment with control group, P<0.05。

Table 5 illustrates: the two groups of pre-treatment neurological deficit scores were compared and showed no significant difference (P > 0.05). After treatment, the treated group and the control group have significant difference (P <0.01) compared with the treatment before treatment. The difference of the treated group and the control group has statistical significance (P is less than 0.05) compared with the neurological deficit score after treatment, which indicates that the improvement condition of the treated group score is obviously better than that of the control group score.

3.3.3 improved comparison of Rankin Scale scores

The modified Rankin scale scores of the treatment group and the control group are compared and are shown in table 6 and fig. 5.

TABLE 6 comparison of modified Rankin Scale scores in treatment and control groups

Table 6 illustrates: compared with the scores of the two groups of pre-treatment modified Rankin scales, no significant difference exists (P > 0.05). The difference between the treatment group and the control group with the improved Rankin scale score after treatment and the pretreatment group with the improved Rankin scale score has statistical significance (P < 0.01). Compared with the improved Rankin scale score after treatment of the treatment group and the control group, the obvious difference (P <0.01) exists, which indicates that the improvement condition of the improved Rankin scale score of the treatment group is obviously better than that of the control group.

3.3.4BI index score comparison

The BI index scores of the treated group and the control group are compared, and are detailed in Table 7 and FIG. 6.

TABLE 7 BI index score comparison of treatment and control groups

Table 7 illustrates: there was no significant difference in pre-treatment BI index scores in the treated and control groups (P > 0.05). The treated group and the control group were compared with the group before treatment, respectively, and had comparability (P < 0.01). Compared with the BI index score of the treated group and the BI index score of the control group, the BI index score has significant difference (P <0.01), which shows that the improvement condition of the score of the treated group is significantly better than that of the control group.

3.3.5 Total score comparison of Stroke specific quality of Life Scale (SSQOL)

The SSQOL scores of the treated and control groups were compared and are detailed in table 8 and fig. 7.

TABLE 8 comparison of SSQOL Total score between treatment and control groups

Table 8 illustrates: compared with the total score of SSQOL before treatment of the treatment group and the control group, the SSQOL has no significant difference (P > 0.05). The differences between the treated group and the control group after treatment were statistically significant (P <0.01) compared to the group before treatment. After treatment, the treated group and the control group are compared, and the significant difference (P <0.01) exists, which shows that the score improvement condition of the treated group is obviously better than that of the control group.

3.4 comparison of carotid intima-media thickness and atherosclerotic plaque stability

1) The carotid intima-media thickness of the treated group and the control group were compared and shown in Table 9.

TABLE 9 comparison of intima-media thickness (mm) in two carotid arteries

Note:^#comparison with control group before treatment, P>0.05; comparison of post-treatment and pre-treatment groups, P>0.05。

Table 9 illustrates: compared with the thickness of the internal tunica media before treatment in the treatment group and the control group, the thickness of the internal tunica media is not significantly different (P > 0.05). Compared with the two groups before and after treatment, the two groups have no significant difference (P > 0.05). The results show that the thickness of the intima-media membrane of the treated group and the control group is not obviously improved after the treatment.

2) The stability of atherosclerotic plaques in the treated and control groups were compared as detailed in Table 10.

TABLE 10 comparison of atherosclerotic plaque stability in two groups

Note:^#comparison with control group before treatment, P>0.05; comparison of post-treatment and pre-treatment, P, in control group>0.05; post-treatment versus pre-treatment, P, in treatment groups<0.05；^▲Comparison after treatment with control group, P<0.05。

The stability of the atherosclerotic plaques before treatment of the two groups is compared, and the difference is not statistically significant (P > 0.05). The differences were not statistically significant (P >0.05) compared to plaque stability after treatment and before treatment in the control group. The differences in plaque stability after treatment compared to pre-treatment in the treatment groups were statistically significant (P < 0.05). The stability of the atherosclerotic plaque of the treatment group is better than that of the control group.

3.5 adverse reactions and adverse events in two groups of patients after treatment

Patients participating in the clinical trial have no pause or rejection in the whole trial period, and have no obvious adverse reaction. The safety indexes before and after treatment of the two groups of patients are statistically compared, and P is more than 0.05. The treatment group and the control group do not affect safety indexes such as liver and kidney functions in a short time, and the treatment group and the control group have safety.

4 analysis of

4.1 theoretical basis for treating ischemic stroke in convalescent period by qi-tonifying and blood-activating method

Apoplexy is a group of cerebrovascular diseases caused by acute cerebral circulation disorders due to various reasons, is a common acute and dangerous disease syndrome in internal medicine, and is often related to wind, fire, stasis, deficiency, phlegm and qi. The pathogenesis of apoplexy can be classified into phlegm-heat fu-organ excess theory, the theory of exogenous wind-induced middle school, apoplexy toxin evil theory, the theory of phlegm-stasis mutual obstruction, the theory of blood stasis, the theory of visceral qi activity disorder, the theory of toxic brain collateral damage, the theory of healthy qi deficiency and accumulation of pathogenic factors, etc., but the pathogenesis is mainly based on healthy qi deficiency and blood stasis. Just as plum donoyuan believes: "apoplexy … … refers to the condition of qi and blood stagnation. "Dongyuan Shi book, tracing tear collection and stroke differentiation" say: for apoplexy, it is not exogenous pathogenic wind, but also the essential qi disease. This is often caused by qi exhaustion or qi impairment due to worry, joy, anger and anger. Deficiency of visceral qi, failure of blood supply, failure of yin essence generation, failure of spirit to maintain consciousness, failure of brain nourishment, vertigo and numbness of limbs in mild cases, and debility of limbs in severe cases. The circulation of blood depends on the smoothing of liver qi, the promotion of heart qi, the consolidation of spleen qi, the warming of lung qi towards all vessels and kidney qi, and qi deficiency of five zang organs can cause the disturbance of qi and blood circulation and stasis in brain. The "records of the Western medicine of the medical science Zhongzhao" (records of the Western medicine of the medical science) states that: for qi and blood deficiency, the meridians and collaterals are stagnant … …. In the recovery period of stroke, the disease course is long, the primordial qi is more exhausted, and the weak movement of the body causes blood stagnation and malnutrition of the tendons and vessels, which is usually withered. Therefore, aiming at the treatment of the recovery stage of the stroke, the theory of tonifying qi, activating blood and dissolving stasis is applied, so that the effect is usually achieved with half the effort, and the symptoms of hemiplegia, slurred speech and the like are easily solved. Just as the Ming and Dai Si Gong come under the influence of the "Nei Jing" (classic of medicine): the therapeutic method is to regulate qi first and then activate blood for a long time.

4.2 Shenxiong granule medicine composition

The Shenxiong granule has simple medicinal taste and only contains two medicines of ginseng and chuanxiong rhizome. Not only can exert the efficacy of the injection on ischemic stroke to the utmost extent, but also can effectively avoid adverse reactions brought by the injection. The ginseng is sweet in taste and slightly cold in nature, belongs to the plant of the Araliaceae family, mainly enters spleen and lung channels, has the title of 'Baiyaowang' and has the effects of greatly tonifying primordial qi, restoring pulse, relieving depletion, tonifying spleen and lung, soothing nerves, benefiting intelligence, promoting the production of body fluid and the like, can be used for treating diseases such as heart failure, spleen deficiency, poor appetite, body deficiency, depletion, insomnia, palpitation and the like, is a common treatment medicine for cardiovascular and cerebrovascular diseases, contains various chemical components such as ginsenoside, ginseng polysaccharide, protein, amino acid, polypeptide and the like, but the most important active component determining the medicinal effect of the ginseng is the ginsenoside. Ginseng has effects of enhancing liver detoxification function, promoting metabolism, regulating nerve, stimulating blood vessel, improving bone marrow hemopoiesis function, etc., and has certain effects on human digestive system, central nervous system, cardiovascular system, immune system, etc.

The main pharmacological component of the medicine is ligustrazine, a novel free radical scavenger and calcium ion antagonist which can permeate blood brain barrier, has the functions of reducing vascular resistance, expanding blood vessels, resisting platelet aggregation, resisting coagulation, preventing thrombosis, improving microcirculation, protecting nerves, resisting inflammation, resisting oxidation and the like, has the treatment mechanism of multiple organs and multiple diseases, and is widely applied to the fields of cardiovascular and cerebrovascular diseases, respiration, gynecology, urinary system and the like clinically.

4.3 function of Shenxiong granules in improving traditional Chinese medicine syndromes

The clinical curative effect of the traditional Chinese medicine is to achieve the purpose of improving symptoms or treating diseases by intervening syndromes, and the core and the characteristic of the evaluation are the traditional Chinese medicine syndrome curative effect evaluation, and the higher the score is, the more serious the disease condition is. In the clinical research, the total effective rate of the traditional Chinese medicine syndrome curative effect of the patients with qi deficiency and blood stasis syndrome ischemic stroke convalescent period after the Shenxiong granules are added on the conventional basis is 93.33 percent, which is 73.33 percent higher than that of the patients with qi deficiency and blood stasis syndrome ischemic stroke convalescent period after the Shenxiong granules are added in the control group; the traditional Chinese medicine syndrome score of the control group and the treatment group is reduced compared with that before treatment (P <0.01), and the improvement condition of the treatment group is better than that of the control group (P < 0.05). The Shenxiong granules are added on the basis of conventional treatment, so that the traditional Chinese medicine symptoms of patients can be more effectively improved.

… … deficient blood and qi due to deficiency of spleen and stomach qi, food essence is not nourished for a while, and is invaded by wind pathogen due to deficiency of blood and qi, so hemiplegia is also caused. The core of the attack and damage of apoplexy is qi deficiency and blood stasis, qi is the commander of blood, blood is the mother of qi, and if primordial qi is deficient and blood circulation is weak, blood circulation slowly stays and is stasis. Doctor lin correction, Lung convulsions are not wind "cloud: "original qi is deficient and must not reach the blood vessel, and the blood vessel is not gaseous and must stay to cause stasis. "the cover is numb due to qi deficiency, while the blood is numb due to blood deficiency, while the numbness is … …, which is gradually withered and waste. Qi deficiency fails to promote blood circulation in vessels, resulting in blood stasis, loss of nourishment of muscles and tendons, facial distortion, hemiplegia and speech disorder; secondly, qi and blood are the source of the transformation of the spleen and stomach, and qi and blood stasis, the transformation and the passivity of the spleen and stomach, and the deficiency of the nutrient-defensive qi can cause symptoms such as lassitude, hypodynamia, qi deficiency, disinclination to talk, slobbering at the corners of the mouth, frequent micturition or incomplete enuresis. Ginseng, radix Ginseng, the holy drug for tonifying qi, and the bright seedling of live people, can enter the internal organs of the body, but there is no menstruation, and strong qi can promote blood circulation. The lung is towards all vessels, while the ginseng tonifies lung qi, and the qi is sufficient to keep all vessels moist. Spleen governs blood, ren Shen strengthens spleen qi, and qi is sufficient to control blood and heat. Heart governs blood vessels, ren Shen tonifies heart qi, while sufficient qi makes blood circulate endlessly. Chuan Xiong can not only move upwards to the head and eyes to treat various pains in head and brain, but also move downwards to the blood sea to regulate menstruation and alleviate pain, and has the functions of pungent and dispersing to guide blood upwards, and qi moves upwards without yin coagulation and viscosity. The Shenxiong granules consisting of the ginseng and the Chuan-xiong rhizome have simple medicine, but have the functions of regulating qi and blood and treating both principal and secondary aspects of diseases, thereby improving the symptoms of patients.

4.4 application of SHENXIONG granule in improving neurological function and quality

4.4.1 selection of neurological impairment Scoring Scale and results

In the clinical test, the control group and the treatment group have obvious curative effect (P <0.01) on improving the NIHSS score of the patient, and compared with the NIHSS score after the treatment of the control group and the treatment group, the improvement condition of the treatment group is better than that of the control group (P < 0.05). The Shenxiong granules are added on the basis of conventional treatment to treat ischemic stroke recovery (qi deficiency and blood stasis syndrome), so that the NIHSS score of a patient can be improved more remarkably. Therefore, the Shenxiong granules have obvious effect on improving the recovery condition of the neurological deficit of patients in the recovery period of ischemic stroke (qi deficiency and blood stasis syndrome).

The NIHSS scale is a comprehensive stroke evaluation scale which is generally adopted in the world at present, has strong operability, is more universal and objective, can periodically evaluate the recovery condition of the neural function after treatment and evaluate the defect degree of the neural function, and has better reliability and authenticity. Research shows that in the process of researching the clinical curative effect of the leech-snake vein relaxing capsule on patients with qi deficiency and blood stasis ischemic stroke convalescent period, the reduction of the neurological function defect degree of the patients is found through NIHSS scoring. Research shows that the clinical effect of the injected mouse nerve growth factor combined with yang-tonifying and five-returning decoction on treating the cerebral apoplexy hemiparalysis patient is evaluated through the scale, and the clinical effect of the injected mouse nerve growth factor combined with yang-tonifying and five-returning decoction is greatly improved, so that the nerve function of the patient is obviously recovered. Research finds that western medicines are evaluated based on NIHSS score and combined with the qi-tonifying, blood-circulation-promoting and collateral-dredging decoction to treat the nerve function recovery condition of patients with qi deficiency and blood stasis type in the ischemic stroke recovery stage, and the qi-tonifying, blood-circulation-promoting and collateral-dredging decoction can effectively improve clinical symptoms of the patients and promote recovery of the nerve function of the patients.

4.4.2 selection of quality of Life Scale and results

In the clinical test, the control group and the treatment group have obvious curative effects (P <0.05) on the improvement of the improved Rankin scale score, the BI index score and the total score of the SSQOL scale of the patient, and the improvement condition of the treatment group is better than that of the control group (P <0.05) by comparing the improved Rankin scale score after the treatment of the treatment group and the control group. The Shenxiong granules are added on the basis of conventional treatment to treat ischemic stroke recovery (qi deficiency and blood stasis syndrome), so that the total scores of the modified Rankin scale score, the BI index score and the SSQOL scale of a patient can be improved more remarkably. Therefore, the Shenxiong granules have obvious effect on improving the life quality of patients in the recovery period of ischemic stroke (qi deficiency and blood stasis syndrome).

The improvement of the life quality is not only an ultimate goal of the rehabilitation of the cerebral apoplexy patient, but also an objective basis for evaluating the effect of the clinical treatment scheme of the cerebral apoplexy. The improved Rankin scoring scale can be used for measuring the functional recovery and self-care condition of a patient after stroke. An Activity of Daily Living (ADL) performance scale, which is composed of self-care of physical life and instrumental activities of daily living, is the most widely used and studied in clinical practice, and is mainly used for evaluating the daily living performance of a subject. And SSQOL is a scale for measuring the life quality of the stroke patient, has strong pertinence and has higher practicability. Research shows that when the clinical curative effect of the Naoxintong capsule for adjuvant therapy of cerebral infarction with the effects of tonifying qi, activating blood circulation, removing blood stasis and dredging collaterals is discussed, the improved Rankin scale score of a patient is obviously reduced after the Naoxintong capsule is used for adjuvant therapy, and the daily life capacity of the patient is obviously improved; research finds that the Naoxintong capsule can be used for evaluating the function recovery condition of patients suffering from acute cerebral infarction combined with myocardial ischemia based on the scale, and the Naoxintong capsule can be used for obviously promoting the function recovery of the patients. Researches show that in the nursing process of cerebral infarction, after the traditional Chinese medicine decoction is combined with the five-ingredient decoction for tonifying yang, the BI index score of a patient is obviously increased, and the daily life capacity of the patient is improved; researches show that when the Naoxintong capsule is combined with edaravone to treat acute cerebral infarction, the index score of a patient is obviously improved compared with the index score of the patient, and the living capacity of the patient is obviously improved. Research shows that when the intervention effect of the salvianolic acid on the process of the ischemic stroke disease is discussed, the total integral of the SSQOL scale shows that the salvianolic acid can effectively improve the life quality of patients after stroke; researches show that the life quality of patients with ischemic cerebral apoplexy can be obviously improved by adding the wind-calming and collateral-dredging drink on the conventional basis through the total integral of the scale.

Conclusion

1. The Shenxiong granules can improve the traditional Chinese medicine syndrome score of patients in the cerebral infarction convalescent period (apoplexy involving channels and collaterals-qi deficiency and blood stasis syndrome), and have obvious effect on improving the traditional Chinese medicine syndrome curative effect.

2. The Shenxiong granules can improve the neurological function defect of patients in the recovery period of cerebral infarction (apoplexy involving channels and collaterals-qi deficiency and blood stasis syndrome), promote the recovery of body functions and living ability, and improve the quality of life.

Example 1

The application of the compound medicine components in the treatment of the cerebral infarction in the recovery period comprises the following steps: the compound medicine components comprise traditional Chinese medicine components and western medicine components:

The aspirin enteric-coated tablet comprises the following components: 100 mg/time.

The preparation formulation prepared from the compound medicine components is granular.

The atorvastatin calcium tablet comprises: 10 mg/time.

The ratio of the ginseng to the ligusticum wallichii is 1:1 by weight.

The etiology type of the cerebral infarction is ischemic stroke.

According to the weight ratio, the ratio of the aspirin enteric-coated tablet to the atorvastatin calcium tablet is 10: 1.

The atorvastatin calcium tablet is replaced by one of rosuvastatin, fluvastatin, simvastatin, pravastatin and lovastatin.

It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Further, it should also be understood that various alterations, modifications and/or variations can be made to the present invention by those skilled in the art after reading the technical content of the present invention, and all such equivalents fall within the protective scope defined by the claims of the present application.

It will be appreciated by those skilled in the art that the invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The embodiments disclosed above are therefore to be considered in all respects as illustrative and not restrictive. All changes which come within the scope of or equivalence to the invention are intended to be embraced therein.

Claims

1. The application of the compound medicine components in the recovery period of treating cerebral infarction is characterized in that: the compound medicine components comprise traditional Chinese medicine components and western medicine components:

2. The use of the compound pharmaceutical composition of claim 1 in the treatment of cerebral infarction in the convalescent period, wherein: the aspirin enteric-coated tablet comprises the following components: 100 mg/time.

3. The use of the compound pharmaceutical composition of claim 1 in the treatment of cerebral infarction in the convalescent period, wherein: the preparation formulation prepared from the compound medicine components is granular.

4. The use of the compound pharmaceutical composition of claim 1 in the treatment of cerebral infarction in the convalescent period, wherein: the atorvastatin calcium tablet comprises: 10 mg/time.

5. The use of the compound pharmaceutical composition of claim 1 in the treatment of cerebral infarction in the convalescent period, wherein: the ratio of the ginseng to the ligusticum wallichii is 1:1 by weight.

6. The use of the compound pharmaceutical composition of claim 1 in the treatment of cerebral infarction in the convalescent period, wherein: the etiology type of the cerebral infarction is ischemic stroke.

7. The use of the compound pharmaceutical composition of claim 1 in the treatment of cerebral infarction in the convalescent period, wherein: according to the weight ratio, the ratio of the aspirin enteric-coated tablet to the atorvastatin calcium tablet is 10: 1.

8. The use of the compound pharmaceutical composition of claim 7 in the treatment of the convalescent phase of cerebral infarction, characterized in that: the atorvastatin calcium tablet is replaced by one of rosuvastatin, fluvastatin, simvastatin, pravastatin and lovastatin.