CN115813972A - Zhuang medicine compound medicine for treating ischemic stroke in acute stage and preparation method thereof - Google Patents
Zhuang medicine compound medicine for treating ischemic stroke in acute stage and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Zhuang medicine compound medicine for treating ischemic stroke in an acute stage, which comprises the following raw materials in parts by weight: 30 to 40 portions of earthworm, 30 to 40 portions of suberect spatholobus stem and 30 to 40 portions of Szechuan lovage rhizome. The invention also discloses a preparation method of the Zhuang nationality compound medicine for treating the acute stage of ischemic stroke, which comprises the following steps: (1) soaking the raw materials in water; and (2) after soaking, decocting in a thick liquid to obtain the liquid medicine. The invention improves the symptoms of patients with ischemic stroke by dredging the pathogenic factors and stasis of the dragon road and the fire road, has simple prescription and good curative effect, overcomes the defects of great side effect and easy generation of drug resistance of western medicines, and develops the advantages of small side effect of traditional Chinese medicines and difficult generation of drug resistance.
Description
Technical Field
The invention belongs to the technical field of traditional Chinese medicine formulas, and particularly relates to a Zhuang medicine compound medicine for treating ischemic stroke in an acute stage and a preparation method thereof.
Background
Acute Ischemic Stroke (AIS) accounts for 43% -65% of all cerebrovascular diseases, and is one of common cerebrovascular diseases. The AIS has the characteristics of high disability rate and high recurrence rate, and the main mechanism is that the main artery supplying cerebral blood is blocked, so that the blood perfusion of cerebral tissues is reduced, and nerve vessels of the cerebral tissues in an ischemic area are damaged. AIS can be induced by hypertension, diabetes, arteriosclerosis and other factors, and cerebrovascular thrombosis can be promoted, so that ischemia reperfusion injury is caused, and formation of brain tissue edema is accelerated.
Acute ischemic stroke is a major lethal, disabling disease worldwide, reaching millions of people each year. Although the treatment of cerebral infarction has been greatly advanced in recent years, intravenous tissue plasminogen activator (tPA) and intravascular thrombus removal (endovasculus thrombetmv) remain the standard treatments for acute ischemic stroke. Although the use of intravenous tPA and intravascular thrombectomy have greatly improved the rate of recanalization of occluded vessels, more than half of patients have failed to achieve effective tissue reperfusion and improved clinical prognosis. The mechanism is very complex and cannot be completely clarified at present. There is increasing evidence that thrombus formation in the microvasculature downstream of the occluded cerebral vessels is involved in mediating the formation of this ineffective recanalization (with or without recanalization). Furthermore, inflammatory cells also influence the formation of these thrombi, and the two processes of inflammatory reaction and thrombosis are interwoven together to jointly mediate the formation of micro-thrombi after AIS.
Although experts and scholars make a great deal of research on the pathogenesis of ischemic stroke, the pathogenesis of ischemic stroke is still not clear and is on a perfect way. Due to the complexity of the etiology and pathogenesis of ischemic stroke, the origin cause of clinical patients cannot be determined, and in the aspect of western medicine treatment, the treatment measures are difficult to be carried out according to the etiology and only can be carried out according to the symptoms.
In the aspect of traditional Chinese medicine treatment:
chinese patent CN110613758A discloses a Chinese medicinal composition for treating ischemic stroke, which is prepared from radix astragali, radix Acanthopanacis Senticosi, caulis Spatholobi, rhizoma Ligustici Chuanxiong, herba Lycopodii, fructus crataegi, eupolyphaga Seu Steleophaga, zaocys, fructus Chaenomelis, scolopendra, lumbricus and Hirudo. In the formula, the astragalus root is a monarch drug, which can greatly tonify the spleen and stomach qi to nourish the source, and the acanthopanax root tonifies the spleen and lung qi; the raw hawthorn can eliminate food retention, dissipate blood stasis, harmonize the stomach and invigorate the spleen, and help the astragalus root to benefit true qi, and is used as a ministerial drug. Rhizoma ligustici wallichii is assisted, the caulis spatholobi is used for promoting blood circulation and removing blood stasis, and earthworm, centipede, ground beeltle, leech and zaocys dhumnade are further assisted, and the earthworm is used for calming endogenous wind and relieving spasm; the fastest centipede moving force; the ground beetles enter blood to soften hardness and dispel stasis; leeches like eating human blood, enter slowly, black-tail snakes move and flee well, dredge collaterals and stop convulsion, and the leeches and the astragalus root are used together to strengthen the force of tonifying qi and dredging collaterals. Chuan pawpaw is also specialized in liver, benefiting tendons and removing blood; lycopodium clavatum is used as a guiding drug when it is combined with others to relax tendons and activate collaterals. The combination of the raw materials can promote the circulation of qi and blood, eliminate stasis, activate collaterals, nourish tendons and muscles, and recover from flaccidity and disability.
Chinese patent CN102648961B discloses a medicine for treating ischemic stroke sequelae, which is prepared from radix Salviae Miltiorrhizae, radix Angelicae sinensis, rhizoma Chuanxiong, stigma croci, ramulus Cinnamomi, herba speranskiae tuberculatae, radix Stephaniae Tetrandrae, semen Strychni, cortex Eucommiae, radix Gentianae Macrophyllae, caulis Spatholobi, radix Angelicae Pubescentis, radix Saposhnikoviae, daphne giraldii Nitsche, radix Anisodi, radix Aconiti Kusnezoffii, radix Angelicae Dahuricae, fructus Chaenomelis, herba Lycopodii, sanguis Draxonis, moschus, borneolum Syntheticum, radix Cyathulae, pheretima, squama Manis, hirudo, radix Platycodonis, radix Glycyrrhizae, sanguis Draxonis, arisaema cum bile, and radix astragali by soaking and heating to obtain decoction, fumigation medicine and plaster.
Chinese patent CN101310737B discloses a medicine for treating ischemic stroke, which is mainly prepared from radix salviae miltiorrhizae, radix astragali, caulis spatholobi, angelica, safflower, rhizoma ligustici wallichii, radix paeoniae rubra, leech, eupolyphaga, earthworm, zaocys dhumnade and radix notoginseng according to a certain weight ratio. The medicine has effects of removing blood stasis, dredging collaterals, invigorating qi and promoting blood circulation.
Chinese patent CN1272039C discloses a Chinese patent medicine for treating apoplexy and its preparation method, which is prepared into required dosage forms mainly from astragalus root, spatholobus stem, angelica, ligusticum wallichii, earthworm, leech, batryticated silkworm, scorpion, uncaria and other medicinal materials; the Chinese medicinal preparation has effects of benefiting qi, nourishing blood, dispelling pathogenic wind, eliminating phlegm, promoting blood circulation and dredging collaterals, and is mainly suitable for patients with qi deficiency and blood stasis syndrome, wind phlegm and blood stasis obstruction of collaterals syndrome seen in channels and collaterals of (ischemic) apoplexy, especially convalescent patients.
The medicament formulas of the above 4 patents all contain a plurality of medicament components, are relatively complex, and have complex declaration of new medicaments and higher cost.
Chinese patent CN113713010A discloses a formula for treating acute ischemic stroke by yang-strengthening method, which is prepared from a raw material drug of yang-strengthening drug and compatible drugs. The compatible medicinal materials comprise cassia twig-ligusticum wallichii, cassia twig-angelica, cassia twig-earthworm, cassia twig-astragalus mongholicus, cassia twig-angelica sinensis, cassia twig-red paeony root, cassia twig-peach kernel, cassia twig-safflower and cassia twig-salvia miltiorrhiza. The prescription has simple components, and is mainly used for treating acute ischemic stroke by a yang-strengthening method.
Long Lu and fire road are names of two very important internal closed paths which are used by Zhuang medicine to maintain human vitality and reflect disease dynamics, although the internal closed paths are not directly communicated with nature in human body. Zhuang nationality traditionally considers dragon as water production, and dragon road is a blood channel in human body (so some Zhuang medicine is also called blood vessel and dragon vessel), and the function of dragon road is mainly to transport nutrition to internal organs, bones and muscles. The dragon road has a main line and a network, is distributed all over the body and circulates, and the center of the dragon road is in the heart. The fire is the trigger, which is rapid in nature (called "fire speed") and feels hot. Zhuang nationality doctors think that the fire path is the sensing path in the human body, and can also be called as the "information channel" in modern languages. Its center is in the skilful dock. The fire path is the same as the dragon path, has a main line and a network, and is distributed all over the body, so that normal people can feel various external information and stimulation in a very short time, and can quickly respond through the processing of the central nervous system 'skilful dock', thereby adapting to various external changes and realizing the physiological balance of 'three qi synchronization'. If the fire path is blocked, the human body loses the reaction and adaptability to external information, resulting in diseases and even death.
Disclosure of Invention
The invention aims to provide a Zhuang medicine compound medicine for treating ischemic stroke in the acute stage, which improves symptoms of ischemic stroke patients by dredging toxic and stasis of Longlu and fire paths, has simple prescription and good curative effect, overcomes the defects of great side effect and easy generation of drug resistance of western medicines, and develops the advantages of small side effect of traditional Chinese medicines and difficult generation of drug resistance.
The Zhuang medicine compound medicine for treating the acute stage of ischemic stroke comprises the following raw materials in parts by weight: 30 to 40 portions of earthworm, 30 to 40 portions of suberect spatholobus stem and 30 to 40 portions of Szechuan lovage rhizome.
Further, the Zhuang medicine compound medicine for treating the acute stage of ischemic stroke comprises the following raw materials in parts by weight: earthworm 30 parts, spatholobus stem 40 parts and hemlock parsley 30 parts.
Further, the preparation method of the Zhuang medicine compound medicine for treating the acute stage of ischemic stroke comprises the following steps:
(1) Soaking the raw materials in water;
(2) After soaking, decocting to obtain medicinal liquid.
Further, the using method comprises the following steps: 150mL of the raw materials are taken after being prepared into liquid medicine and are taken warmly after 2 meals in the morning and evening.
Further, 8 weeks is a treatment course.
Further, in the step (1), the ratio of the material to the liquid is 1:6.
Further, in the step (1), the soaking time is 30-60 min.
Further, in the step (2), the decoction time is 30-40 min.
Furthermore, in the step (2), the volume of the obtained liquid medicine is 150-170 mL.
The raw materials of the invention have the following sources and efficacies:
earthworm: it is named as Pheretima, bombyx Batryticatus, radix Angelicae sinensis, fructus fici Pumilae, herba asari, fructus Chebulae, and Eupolyphaga Seu Steleophaga. Cold in nature, salty in flavor, it enters liver, stomach, lung and bladder meridians. The functions are as follows: clearing heat, suppressing hyperactive liver, relieving asthma, and dredging collaterals. Headache due to wind-heat, conjunctival congestion, hemiplegia, etc. The main treatment is as follows: hemoptysis, hematemesis, epistaxis, hematochezia, metrorrhagia, traumatic hemorrhage, thoracico-abdominal pain, traumatic swelling and pain, and can be used for treating hyperpyrexia, mania, coma, convulsion, arthralgia, cough and asthma due to lung heat, oliguria, edema, and hypertension.
Caulis spatholobi: is dried rattan of Leguminosae plant Spatholobus subelectus Dunn. Bitter and sweet in nature and warm in taste; it enters liver and kidney meridians. The efficacy is as follows: promoting blood circulation, tonifying blood, regulating menstruation, relieving pain, relaxing muscles and tendons, and activating collateral flow. The main treatment is as follows: can be used for treating menoxenia, dysmenorrhea, amenorrhea, rheumatalgia, numbness, paralysis, and sallow complexion due to blood deficiency.
Ligusticum wallichii: the academic name Ligusticum chuanxiong Hort. Alias mountain Ju, ligusticum wallichii, fragrant fruit, pepper are planted and are prevented and plant, sparrow brain ligusticum wallichii, jingXiong, rhizoma ligustici wallichii, sheng chuan jun. Pungent and warm in flavor. It enters gallbladder and liver meridian. The efficacy is as follows: move qi and relieve depression, dispel wind-dryness and dampness, activate blood and alleviate pain. The main indications are as follows: menoxenia, amenorrhea, dysmenorrhea, abdominal pain, pricking pain in chest and hypochondrium, traumatic injury, headache, and rheumatalgia.
Compared with the prior art, the invention has the beneficial effects that:
1. the invention starts from dredging the pathogenic toxin stasis of the Longlu and the fire road, is prepared by using Zhuang medicine components with unique curative effect, has the advantages of small side effect and difficult generation of drug resistance, overcomes the defects of great side effect and easy generation of drug resistance of western medicines, and has the characteristics of wide source, low cost, convenient use, obvious curative effect and simple preparation process.
2. The compound of the invention can dredge the toxin and stasis of the dragon road and the fire road. And only 3 medicines are adopted for compatibility, and the medicine is obtained by screening and simplifying the experiments of comparing effects with a plurality of medicines, so that the medicine formula is greatly simplified, the medicine resources are saved, the complexity of reporting new medicines is simplified, the symptoms of patients with ischemic stroke can be improved, and the medicine has the advantages of obvious, exact and stable curative effect and no toxic or side effect.
3. The compound medicine only uses 3 medicines of earthworm, suberect spatholobus stem and Szechuan lovage rhizome, and the earthworm in the formula has the effects of clearing heat, arresting convulsion, reducing blood pressure and activating and relieving fire; caulis Spatholobi has effects of promoting blood circulation, replenishing blood, relaxing muscles and tendons, activating collaterals, and dredging and tonifying fire; the hemlock parsley has the effects of promoting qi circulation and relieving depression, dispelling wind-dryness and dampness, promoting blood circulation and relieving pain, and dredging and relieving dragon road and fire road; the three are combined, on one hand, the dragon road is dredged, so that the blocking condition of main cerebral blood supply arteries of a patient with ischemic stroke is effectively improved, and the blood flow perfusion of cerebral tissues is increased; on the other hand, the medicine can dredge the pathogenic factors of fire path and reduce the influence of inflammatory reaction, thereby protecting the nerve and blood vessels of the brain tissue in the ischemic area from being damaged.
Detailed Description
Before the present embodiments are further described, it is to be understood that the scope of the invention is not to be limited to the specific embodiments described below; it is also to be understood that the terminology used in the examples is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention.
Example 1
The Zhuang medicine compound medicine for treating the acute stage of ischemic stroke comprises the following raw materials in parts by weight: earthworm 30g, spatholobus stem 30g and chuanxiong rhizome 40g.
The preparation method of the Zhuang medicine compound medicine for treating the acute stage of ischemic stroke comprises the following steps:
(1) Cleaning all the raw materials, filtering to remove impurities, and soaking in 600mL water for 30min;
(2) After soaking, the decoction is concentrated and decocted for 30min to obtain 170mL of liquid medicine.
The using method of the Zhuang medicine compound medicine for treating the acute stage of ischemic stroke comprises the following steps: taking 150mL of liquid medicine, and taking the liquid medicine warm after meals 2 times in the morning and at night; a treatment course is 8 weeks.
Example 2
The Zhuang medicine compound medicine for treating the acute stage of ischemic stroke comprises the following raw materials in parts by weight: 40g of earthworm, 30g of suberect spatholobus stem and 30g of Szechuan lovage rhizome.
The preparation method of the Zhuang medicine compound medicine for treating the acute stage of ischemic stroke comprises the following steps:
(1) Cleaning all the raw materials, filtering to remove impurities, and soaking in 600mL water for 50min;
(2) After soaking, decocting for 35min to obtain 160mL of medicinal liquid.
The using method of the Zhuang medicine compound medicine for treating the acute stage of ischemic stroke comprises the following steps: taking 150mL of liquid medicine, and taking the liquid medicine warm after meals 2 times in the morning and at night; a treatment course is 8 weeks.
Example 3
The Zhuang medicine compound medicine for treating the acute stage of ischemic stroke comprises the following raw materials in parts by weight: earthworm 30g, spatholobus stem 40g and chuanxiong rhizome 30g.
The preparation method of the Zhuang medicine compound medicine for treating the acute stage of ischemic stroke comprises the following steps:
(1) Cleaning all the raw materials, filtering to remove impurities, and soaking in 600mL water for 60min;
(2) After soaking, the decoction is concentrated and decocted for 40min to obtain 150mL of liquid medicine.
The using method of the Zhuang medicine compound medicine for treating the acute stage of ischemic stroke comprises the following steps: is taken warmly after meals in the morning and evening for 2 times; a treatment course is 8 weeks.
Comparative example 1
Raw materials: 100g of earthworm.
The preparation method comprises the following steps:
(1) Cleaning, filtering to remove impurities, and soaking in 600mL water for 60min;
(2) After soaking, decocting for 40min to obtain 150mL of liquid medicine;
the using method comprises the following steps: warm taking after meals in the morning and evening for 2 times; a treatment course is 8 weeks.
Comparative example 2
Raw materials: caulis Spatholobi (100 g).
The preparation method comprises the following steps:
(1) Cleaning, filtering to remove impurities, and adding 600mL of water to soak for 60min;
(2) After soaking, decocting for 40min to obtain 150mL of liquid medicine;
the using method comprises the following steps: warm taking after meals in the morning and evening for 2 times; a treatment course is 8 weeks.
Comparative example 3
Raw materials: 100g of ligusticum wallichii.
The preparation method comprises the following steps:
(1) Cleaning, filtering to remove impurities, and soaking in 600mL water for 60min;
(2) After soaking, decocting for 40min to obtain 150mL of liquid medicine;
the using method comprises the following steps: warm taking after meals in the morning and evening for 2 times; a treatment course is 8 weeks.
1. Animal experiments
1. Experimental materials
Experimental animals and breeding: healthy male SPF grade SD rats 90, body weight 250 ± 50g, animal certification number 430727211101291332, experimental animal license number: SC XK (Xiang) 2019-0004. All experimental procedures were approved by the ethical committee of the university of traditional Chinese medicine in Guangxi (DW 20200415-53). Feeding conditions are as follows: the room temperature is between 22 and 24 ℃, the humidity is between 4 and 70 percent, the illumination time of alternating light and shade is 12 hours, and the people can drink water freely.
Model preparation of MCAO/R: rat MCAO/R model is prepared by Longa thread-plug method, 10% of 10 mL/kg is injected into abdominal cavity -1 Chloral hydrate anesthetizes the rat, and the skin is incised longitudinally in the center of the neck, the subcutaneous glands and tissues of the neck are bluntly separated, and the right side is separatedThe method comprises the steps of a common carotid artery, threading the common carotid artery at the proximal end of the common carotid artery, separating towards the head, upwards separating an external carotid artery and an internal carotid artery from the bifurcation of the common carotid artery, ligating the proximal end of the common carotid artery and the proximal end of the external carotid artery, preparing a thread below the residual end of the common carotid artery, temporarily clamping the internal carotid artery by a small artery clamp, cutting a small opening at the residual end of the common carotid artery by an ophthalmic scissors, drawing a binding thread at the residual end of the common carotid artery, enabling the residual end of the common carotid artery and the internal carotid artery to be in the same direction, then inserting the ball end of a thread plug into the internal carotid artery, enabling the ball end of the thread plug to enter 2cm, appropriately ligating the prepared thread, suturing the skin of the neck, pulling out the thread plug after 2h to manufacture an MCAO/R model, and adopting TTC dyeing to observe whether a cerebral infarction focus appears to judge whether the model is successful or not.
3. Administration and sampling detection: rats were randomly divided into a control group, a model group, a sham operation group, and 6 liquid medicine groups, 10 of which were each group.
Control group: feeding normally, freely drinking water, and infusing physiological saline with the same volume as the stomach, 1 time each in the morning and afternoon every day;
model group: establishing a rat MCAO/R model, normally raising after molding, freely drinking water, and perfusing stomach with physiological saline with the same volume for 1 time in the morning and afternoon every day;
the sham operation group: the operation steps are the same as those of the model group, no artery ligation is performed, after the operation, the animals are awake, the animals are normally raised, freely drunk and irrigated with physiological saline with the same volume as the stomach, and the operation steps are 1 time respectively in the morning and afternoon every day;
drug group: establishing an MCAO/R model of a rat, and respectively performing intragastric administration on the liquid medicines of the embodiments 1-3 and the comparative examples 1-3 1h after anesthesia and waking, wherein the intragastric administration dosage is 1.4mL/100g of rat every time and is 1 time respectively in the morning and afternoon every day.
Neurological dysfunction scoring: neurological dysfunction scoring was performed 24h after dosing.
Determining the cerebral infarction volume: after 3 days of administration, the rat was killed by decapitation, the brain tissue was rapidly removed, and the olfactory bulb, cerebellum and lower brainstem were removed and frozen at-20 ℃ for 10min. 1mm thick coronal sections of brain were cut continuously from the anterior pole (antenorpol e), incubated in 2% aqueous solution of 2,3,5-triphenyltetrazolium chloride (2,3,5-triphenyltetrazolium chloride, TTC, from sigma) in physiological saline for 1mm at 37 ℃ in the dark, and fixed overnight in 10% neutral formaldehyde buffer (pH 7.4). The brain infarction volume was calculated and counted by macro camera shooting and Image pro plus 6.0 Image analysis software, and the results are shown in table 2.
4. Results of the experiment
4.1 neurological dysfunction score: the groups of rats were scored for neuromotor dysfunction according to a five-score scoring standard: score 0, normal, no neurological signs; 1 minute, the left forelimb cannot be fully extended; 2 minutes, the left side rotates when walking; 3 minutes, the left side is inclined when the bicycle is walked; 4. in other words, there is no autonomous walking with a reduced level of consciousness; and 5, death. The results are shown in Table 1.
TABLE 1 rat neurological dysfunction score results
| Group of | Score of |
| Control group | 0 |
| Model set | 4.4 |
| Artificial operation group | 3.8 |
| Example 1 | 2.5 |
| Example 2 | 2.3 |
| Example 3 | 2.2 |
| Comparative example 1 | 3.9 |
| Comparative example 2 | 3.8 |
| Comparative example 3 | 4.1 |
As can be seen from the above table, after the operation, the rats in the model group have significant symptoms of ischemic stroke neurological dysfunction, such as incapability of stretching the injured contralateral left forelimb, turning or toppling over the left side during walking, even incapability of walking autonomously, decreased consciousness level or death. The earthworm, the suberect spatholobus stem and the szechuan lovage rhizome have a protective effect on the nerve function dysfunction caused by the transient cerebral ischemia of rats, and when the earthworm, the suberect spatholobus stem and the szechuan lovage rhizome are mixed, the protective effect is enhanced, wherein the protective effect is strongest in the embodiment 3. The earthworm, the suberect spatholobus stem and the Szechuan lovage rhizome compound medicine has the function of relieving the nerve dysfunction caused by transient cerebral ischemia of rats and has better protection function on ischemic stroke nerve injury.
TABLE 2 rat cerebral infarction volume calculation results
As can be seen from the above table, the earthworm, the suberect spatholobus stem and the Szechuan lovage rhizome all have the effect of reducing the cerebral infarction volume of the rat to a certain degree, and the protection effect is enhanced when the earthworm, the suberect spatholobus stem and the Szechuan lovage rhizome are mixed, wherein the protection effect is strongest in the embodiment 3.
2. Clinical study
1. Medical record data
1.1 number of selected persons
120 patients with ischemic stroke were selected.
1.2 diagnostic criteria
The method is implemented by referring to disease diagnosis standards in apoplexy diagnosis and curative effect evaluation standards formulated by the national medical and pharmaceutical administration department of medical sciences and brain disease emergency coordination group.
Diagnosis standard of stroke:
(1) The main symptoms are: hemiplegia, coma, slurred speech or aphasia, abnormal feeling of partial body, and facial distortion;
(2) The secondary symptoms are as follows: headache, dizziness, mydriasis, choking of drinking water, impaired vision and ataxia;
(3) The onset way is as follows: acute onset, usually has a plurality of inducers before onset, and usually has premonitory symptoms;
(4) Age of onset: mostly over the age of 40.
The diagnosis can be confirmed by combining the onset, the cause, the premonitory symptom and the age with more than 2 main symptoms or 2 secondary symptoms of 1 main symptom and the imaging examination result.
1.3 case inclusion criteria
(1) The Chinese and western medicine diagnosis standard of ischemic stroke is met;
(2) The age is 45-75 years old;
(3) Chinese patent medicine and decoction for treating apoplexy or related western medicine are not used after the disease;
(4) Approved by the hospital ethics committee, each patient enrolled had to sign an informed consent.
1.4 case exclusion criteria
Except for one of the following cases:
(1)TIA；
(2) Bleeding after cerebral infarction;
(3) Cerebral embolism caused by brain trauma, intracranial tumors, endoparasitic diseases, atrial fibrillation and the like;
(4) Those with allergic constitution;
(5) The patients with combined primary diseases of liver, kidney, metabolic system, blood system and the like have difficulty in evaluating research safety;
(6) Those who are psychotic cannot express them accurately.
1.5 rejection and shedding Standard
(1) Cases that do not meet inclusion criteria or are mistakenly entered;
(2) The disease condition of the subject does not reach the expected control degree within a period of time;
(3) Those who affect the judgment of curative effect, such as those who do not take the medicine according to the prescription or have insufficient clinical data;
(4) For various reasons, the subject himself requires to quit the test;
(5) Serious other complications occur during the study;
(6) Other drugs that may affect the efficacy assessment are taken during the study.
2. Method of producing a composite material
2.1 methods of treatment
180 patients with ischemic stroke were randomly divided into 6 groups of 30 persons each.
Control group 1: orally taking aspirin enteric-coated tablets (Germany Bayer pharmaceutical company, batch number: chinese medicine standard character J20171021) respectively at 100 mg/time and 1 time/day;
control group 2: the edaravone injection is instilled into the vein (Nanjing Xian Shen Dongyuan pharmaceutical Co., ltd., batch number: national standard character H20031342), 10 mL/time and 1 time/day;
control group 3: oral Butylphthalide soft capsule (Shiyao group Enbipu pharmaceutical Co., ltd., batch number: national Standard H20050299), 0.2 g/time, 3 times/day.
Observation group: the medicine and the method of the embodiment 3 are added on the basis of the control group for treatment;
the treatment course lasts for 8 weeks.
The diet should be light during the treatment period, and spicy food should not be stimulated; all drugs that might interfere with the results of the study were banned.
2.2 Observation indicators and Scoring standards
2.2.1 degree of neurological deficit
The neurological deficit degree scoring standard refers to the standard of stroke scale (NIHSS) score of the national institutes of health.
2.2.2 Activity ability in daily Life
The daily lifestyle competence scoring criteria are referenced to the pap (BI) index rating scale scoring criteria.
2.2.3 evaluation of the degree of disability
The assessment of the degree of disability is made with reference to the criteria of the modified Rankin scale (mRS) score.
2.2.4 quality of Life assessment
The quality of life profile recommended by the world health organization is adopted.
2.2.5 integration of Chinese medicine syndrome
The method is formulated according to the stroke symptom grading quantization table in the clinical research guiding principle of traditional Chinese medicine: the evaluation indexes are 5 symptoms of dizziness, headache, numbness of limbs, urgency of limbs, shortness of breath and hypodynamia. The score 0 is recorded for asymptomatic, the score 2 is recorded for light symptom, the score 4 is recorded for influence on life, and the score 6 is recorded for severe symptom and intolerable symptom.
2.2.6 blood lipids
TC, TG, HDL-C, LDL-C levels were determined.
2.1.7 adverse reactions
The indexes of the patient such as blood, urine, stool routine, blood coagulation function, myocardial enzyme, liver and kidney function, electrocardiogram and the like are observed.
2.3 therapeutic efficacy determination
Referring to the neurological deficit scoring standard of the stroke patient established by the fourth national cerebrovascular academy.
And (3) curing: symptoms and physical signs basically disappear, the life can be self-managed, and the degree of disability is 0 grade;
the effect is shown: symptoms and physical signs are obviously improved, the grade of neurological impairment is reduced by more than or equal to 21 points, and the grade of disability degree is 1-3;
the method has the following advantages: symptoms and physical signs are obviously improved, and the score of neurological impairment is reduced by 8 to 20 points;
and (4) invalidation: symptoms and physical signs are not obviously improved before and after the administration, and the score of the neurological deficit is reduced by less than 8 points.
Effective rate = (number of cure cases + number of significant cases + number of effective cases)/total number of cases × 100%.
2.4 Combined administration
The use of Chinese patent medicine for treating ischemic stroke is avoided. On the premise of not influencing the evaluation of the curative effect of the research medicament, the other complications can be used for symptomatic treatment
2.5 data processing
Statistical analysis was performed using the SPSS17.0 software package. The metering data adopts t test, the counting data adopts chi-square test, and the grade data adopts Ridit test. P is greater than 0.05, no significant difference exists, P is less than 0.05, significant difference exists, and P is less than 0.01, and significant difference exists.
3. As a result, the
3.1 curative effect on the symptoms of traditional Chinese medicine
After treatment, the quality of life scores and traditional Chinese medicine syndrome scores of 6 groups are obviously improved compared with the former (P is less than 0.05). The observed group improved better than the control group, and the difference had statistical significance (P is less than 0.05).
TABLE 3
As can be seen from Table 3, the compound medicine of the present invention can significantly improve the cure rate and the total effective rate when being taken in combination with the control group.
3. Clinical application
Somesome, male, age 52, in river pool, hemiplegia, facial distortion and choking of drinking water. The clinical diagnosis is cerebral ischemic stroke, and after 1 course of treatment according to the administration of the medicine in the embodiment 1 of the invention, the hemiplegia and the choking of drinking water at the affected part are reduced.
According to the invention, after 1 treatment course, the affected part is difficult to speak and the facial distortion is relieved after the medicine is applied to the patient of one person in the Chinese parasol, 43 years old and Wuzhou city of the invention.
Zhang Yi, NV, 54 years old, nanning City, hemiplegia, slurred speech, and headache. The clinical diagnosis is cerebral arterial thrombosis, and after 1 course of treatment, the affected part has speech difficulty and headache is relieved after the medicine is taken according to the embodiment 3 of the invention.
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.
Claims (9)
1. The Zhuang nationality compound medicine for treating the acute stage of ischemic stroke is characterized by comprising the following raw materials in parts by weight: 30 to 40 portions of earthworm, 30 to 40 portions of suberect spatholobus stem and 30 to 40 portions of Szechuan lovage rhizome.
2. The Zhuang nationality medicine compound for treating ischemic stroke in the acute stage as claimed in claim 1, which is characterized by comprising the following raw materials in parts by weight: earthworm 30 parts, spatholobus stem 40 parts and hemlock parsley 30 parts.
3. The Zhuang nationality medicine compound for treating ischemic stroke in the acute stage according to claim 1 or 2, which is characterized in that: the application method comprises preparing the raw materials into medicinal liquid, and taking 150mL of the medicinal liquid warm after 2 meals in the morning and evening.
4. The Zhuang nationality medicine compound for treating ischemic stroke in the acute stage according to claim 3, which is characterized in that: a treatment course is 8 weeks.
5. The preparation method of Zhuang nationality medicine compound for treating ischemic stroke in acute stage according to claim 1 or 2, which comprises the following steps:
(1) Soaking the raw materials in water;
(2) After the soaking, the decoction is concentrated and decocted to obtain the liquid medicine.
6. The preparation method of Zhuang nationality medicine for treating ischemic stroke in acute stage as claimed in claim 5, wherein the preparation method comprises the following steps: in the step (1), the ratio of the material to the liquid is 1:6.
7. The preparation method of Zhuang nationality medicine for treating ischemic stroke in acute stage as claimed in claim 5, wherein the preparation method comprises the following steps: in the step (1), the soaking time is 30-60 min.
8. The preparation method of Zhuang nationality medicine for treating ischemic stroke in acute stage according to claim 5, which is characterized in that: in the step (2), the decoction time is 30-40 min.
9. The preparation method of Zhuang nationality medicine for treating ischemic stroke in acute stage as claimed in claim 5, wherein the preparation method comprises the following steps: in the step (2), the volume of the obtained liquid medicine is 150-170 mL.
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| CN1857535A (en) * | 2006-03-06 | 2006-11-08 | 赵刚 | Medicine for treating cerebral infraction and its preparing method |
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| CN1857535A (en) * | 2006-03-06 | 2006-11-08 | 赵刚 | Medicine for treating cerebral infraction and its preparing method |
| CN1872180A (en) * | 2006-04-11 | 2006-12-06 | 广西玉林方特药业有限责任公司 | Medication of membranous milk vetch for activating blood and the channels, and preparation method |
| CN101152243A (en) * | 2006-09-26 | 2008-04-02 | 来柏龄 | Traditional Chinese medicine for treating apoplexy and technique of preparing the same |
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