CN112717021A

CN112717021A - Traditional Chinese medicine composition for treating middle and later congestive heart failure and preparation method and application thereof

Info

Publication number: CN112717021A
Application number: CN202110210425.5A
Authority: CN
Inventors: 何建成; 李小茜
Original assignee: Shanghai University of Traditional Chinese Medicine
Current assignee: Shanghai University of Traditional Chinese Medicine
Priority date: 2021-02-25
Filing date: 2021-02-25
Publication date: 2021-04-30
Anticipated expiration: 2041-02-25
Also published as: CN112717021B

Abstract

The invention discloses a traditional Chinese medicine composition for treating middle and later congestive heart failure and a preparation method and application thereof, and the traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 10-20 parts of prepared aconite slice, 15-30 parts of herba epimedii, 20-30 parts of semen lepidii, 10-20 parts of ligusticum wallichii, 10-20 parts of prepared rhizome of rehmannia, 10-20 parts of schisandra chinensis, 10-30 parts of motherwort and 10-30 parts of grifola. The invention can effectively aim at the pathogenesis of the CHF in the middle and later stages, has satisfactory clinical curative effect, no side effect, lower cost, strong pertinence of clinical application and definite long-term curative effect, and is worthy of popularization and application.

Description

Traditional Chinese medicine composition for treating middle and later congestive heart failure and preparation method and application thereof

Technical Field

The invention relates to a traditional Chinese medicine composition (a formula of Fu xian cardiotonic) for treating middle and later stages of congestive heart failure, and a preparation method and application thereof, belonging to the technical field of traditional Chinese medicines.

Background

Congestive Heart Failure (CHF) refers to a cardiac contractile dysfunction caused by different etiologies under normal venous return conditions, with insufficient cardiac output to maintain tissue metabolic needs while the circulating blood volume and vasomotor function are normal, resulting in hemodynamic abnormalities in the body and activation of the neurohormonal system. Clinically, it is characterized by pathophysiological syndromes characterized by insufficient cardiac output, reduced tissue blood flow, pulmonary circulation and/or venous congestion of the systemic circulation. CHF is common in the terminal stages of various heart diseases, and the clinical morbidity and mortality rate rise year by year, thus seriously threatening the health of human beings. The 'golden triangle' scheme optimized by western medicine has unsatisfactory clinical curative effect, long-term curative effect needs to be further verified, and the side effect of the medicine limits the wide clinical application. More and more evidences show that the traditional Chinese medicine for treating CHF not only can obviously improve the clinical symptoms of patients and relieve the side effects of western medicines, but also has the advantages of improving the cardiac function, improving the life quality of the patients and the like.

Syndrome differentiation and treatment are the main features of traditional Chinese medicine, and the combination of symptoms and signs is the guiding principle of the traditional Chinese medicine syndrome research. The prescription principle of the traditional Chinese medicine is based on the characteristics of syndrome differentiation and treatment in traditional Chinese medicine, and has the characteristics of specificity and individuation. The inventor summarizes the comprehensive research results of the early-stage literature mining, case review, clinical regulation, expert study and the like to obtain that the syndrome types of the traditional Chinese medicine are not invariable in the occurrence and development process of the CHF, but show different syndrome types in the early stage, the middle stage and the later stage and show a dynamic evolution trend, wherein the early-stage syndrome is often a qi-deficiency blood-stasis syndrome and a qi-yin deficiency syndrome, and the middle-and-later stage is gradually transformed into a yang-deficiency water-flooding syndrome and the like. The syndrome of yang deficiency with water flood is one of the common diseases of the disease, is mostly seen in the delayed development stage of congestive heart failure, has high clinical incidence and great treatment difficulty, and lacks effective treatment medicines so far. Based on the above, the inventor inherits the experience of the famous old traditional Chinese medicine and combines the long-term clinical experience of the inventor to summarize a traditional Chinese medicine composition, namely a formula of fu xian cardiotonic, which can effectively treat the middle and late stage yang-deficiency and water-flooding syndrome of congestive heart failure.

Chinese patent document CN1241632C discloses a Chinese patent medicine (granule, capsule, tablet) for treating heart failure, which is prepared from 100 portions of ginseng, 150 portions of aconitum fischeri peichb, 200 portions of cassia twig, 1200 portions of salvia miltiorrhiza, 250 portions of red paeony root, 500 portions of motherwort, 250 portions of alisma, 600 portions of polyporus umbellatus, 600 portions of plantain seed, 200 portions of Chinese date, 600 portions of semen lepidii, 400 portions of amomum villosum, and 600 portions of areca peel. Chinese patent document CN102423347B discloses a traditional Chinese medicine composition for treating heart failure and application thereof: 10-15 parts of radix aconiti lateralis preparata, 20-40 parts of raw astragalus root, 15-20 parts of antler slice, 20-30 parts of semen lepidii and 10-15 parts of raw white paeony root. Chinese patent document CN102652779A discloses a traditional Chinese medicine granule for treating intractable heart failure, which is prepared from the following components: 300g of astragalus, 200g of ginseng, 100g of prepared aconite root, 200g of cassia twig, 250g of red paeony root, 300g of salvia miltiorrhiza, 150g of ligusticum wallichii, 150g of bighead atractylodes rhizome, 150g of poria cocos, 300g of rhizoma alismatis, 150g of polyporus umbellatus, 300g of semen lepidii and 150g of plantain seed. At present, the pharmaceutical composition and the Chinese patent medicine for clinically treating heart failure have certain curative effect, but the problems are few, such as too wide diagnosis range of heart failure diseases, lack of guidance of disease and syndrome combination principle, weak pertinence of clinical application and the like, and finally result in complex prescription, unstable curative effect and the like.

Disclosure of Invention

In order to overcome the defects of the prior art, the invention provides a traditional Chinese medicine composition for treating the middle and later stage yang deficiency and water flood syndrome of congestive heart failure and a preparation method and application thereof.

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

a traditional Chinese medicine composition (Fuxian cardiotonic formula) for treating middle and later stages of congestive heart failure is prepared from the following raw materials in parts by mass: 10-20 parts of prepared aconite slice, 15-30 parts of herba epimedii, 20-30 parts of semen lepidii, 10-20 parts of ligusticum wallichii, 10-20 parts of prepared rhizome of rehmannia, 10-20 parts of schisandra chinensis, 10-30 parts of motherwort and 10-30 parts of grifola.

Preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 10 parts of prepared aconite root, 20 parts of herba epimedii, 20 parts of semen lepidii, 10 parts of ligusticum wallichii, 15 parts of prepared rhizome of rehmannia, 15 parts of schisandra chinensis, 15 parts of motherwort and 10 parts of polyporus umbellatus.

The preparation method of the traditional Chinese medicine composition for treating the middle and later stages of congestive heart failure comprises the following steps: soaking all the medicinal materials in clear water for 1 hr, decocting radix Aconiti lateralis Preparata for 1 hr, decocting the rest materials with water over strong fire until boiling, decocting with slow fire for half an hour, removing residues, collecting decoction, and mixing the decoctions.

The application of the formula of Fu xian cardiotonic is used for preparing a medicinal preparation for treating congestive heart failure yang-deficiency water flooding.

The pharmaceutical formulation may be in the form of any pharmaceutically acceptable oral dosage form including: tablet, sugar-coated tablet, film-coated tablet, enteric-coated tablet, capsule, hard capsule, soft capsule, oral liquid, buccal agent, granule, pill, powder, etc.

The traditional Chinese medicine holds that the pathogenesis of the disease is mainly of deficiency and excess of origin, the basic pathogenesis is of qi deficiency, yang deficiency and yin deficiency, blood stasis, water retention and phlegm turbidity are the targets, and the syndrome of yang deficiency and water flooding is one of the main traditional Chinese medicine syndromes in the clinic of the disease. The traditional Chinese medicine formula of the invention, namely the aconite, has the effects of strengthening heart and warming yang, and can quickly restore yang and rescue collapse. Book materia medica summary of the invention Zeng Yun: the main drugs of Mingmen, named Fu Zi, enter the cave to extinguish the floating fire when the fire returns to the original, . It has the special effect of killing the disease caused by yang deficiency and cathode deficiency with pyretic lung and kidney. "Xianling spleen, Ben Cao gang mu" records: it is good for those with warm nature, no cold, and essence and qi tonifying, and yang deficiency. So it has the effects of warming kidney and supporting yang, and has long-lasting effect; ting Li Zi has the actions of purging lung and promoting diuresis, inducing diuresis to alleviate edema, and mentioned in Bai Cao Jing Zhong Lu recorded in the book, "Ting Li is smooth and fragrant and is used for purging lung qi, and lung qi is water source, so it can purge lung qi and water. It is mainly indicated for cold and heat accumulation coming from water. Chuan Xiong can activate blood and move qi; prepared rehmannia root, radix rehmanniae Praeparata nourishes yin and blood of liver and kidney, and also controls dryness-heat of prepared aconite root; the schisandra chinensis has the effects of tonifying qi, promoting the production of body fluid, tonifying the kidney and calming the heart, and has the function of astringing heart qi; motherwort herb has the effects of activating blood and inducing diuresis; polyporus umbellatus has effects of promoting diuresis and eliminating dampness without damaging yang qi. The medicines are combined to play the effects of warming yang, promoting diuresis, tonifying kidney and calming heart.

The compound prescription compatibility embodies four bright spots:

(1) the concept of yin-yang balance. The balance of yin and yang is an important criterion for Chinese medicine to recognize human body, identify diseases and judge prognosis, and is the main basis of treatment principle and Chinese medicine compatibility. The traditional Chinese medicine holds that the person who is good at tonifying yang must ask for yang from yin, so yang can help yin and become infinite in biochemistry. In the recipe, radix aconiti lateralis preparata and herba epimedii have the effects of tonifying heart, warming kidney and supporting yang, and radix rehmanniae preparata and schisandra chinensis have the effect of nourishing yin, thereby reflecting the important theoretical support of yin-yang balance.

(2) And (3) embodying the holistic concept. The holistic concept is one of the important features of traditional Chinese medicine. The characteristic is also shown in the formula principle of the invention. Through extensive data mining and long-term clinical practice, the pathogenesis of CHF is closely related to other organs although the pathogenesis of CHF is in the heart. "want to tonify heart yin and differentiate kidney yin", the Chinese magnoliavine fruit in the recipe is combined with prepared rhizome of rehmannia to nourish heart and kidney yin, so as to play the role of tonifying kidney and calming heart together, and is the characteristic embodiment of the overall appearance.

(3) Coordination of ascending and descending factors. The classic traditional Chinese medicine of Su Wen, six micro theory of the human body, is that the rising is descending, and the descending is day; descending and ascending are ground. The weather is declined, and the air flows to the ground; the rising of earth qi in the sky causes the higher and lower phases to be called and the rising and falling of earth qi become . The relationship between the ascending and descending is not only the coordination among the zang-fu organs, meridians and tissues of the human body, but also the important feature of the compatibility of the Chinese medicinal herbs. In the compound prescription, the prepared aconite accessory slice can tonify fire and strengthen yang, and the pepperweed seed can descend qi and promote diuresis, thereby fully embodying the application advantages of the ascending and descending factors in the treatment of CHF.

(4) The synergy of hardness and softness. The prepared radix aconiti lateralis has the advantages of pungent and strong heat, thick and thin smell, endless nature, rigid and dry property, and quick exertion of the effects of strengthening heart and warming yang; xianlingpi is pungent and warm in nature, good in tonifying qi and strengthening will, warm and moist in property, and has lasting effect of warming kidney and tonifying yang, and can restrict the warmth and dryness of the aconite. The combination of the two is called as the combination of stiffness and softness, has the effects of strengthening heart, warming kidney and tonifying yang, and has quick response and lasting effect. Particularly, the special effect between the prepared aconite accessory tuber and the active ingredients of the epimedium herb is that the synergistic effect is irreplaceable for the same type of medicaments, which is verified in clinical observation.

In conclusion, the invention can effectively aim at the pathogenesis of the CHF in the middle and later stages, has satisfactory clinical curative effect, no side effect, lower cost, strong pertinence of clinical application and definite long-term curative effect, and is worthy of popularization and application.

Detailed Description

The present invention will be described in detail and fully with reference to the following clinical examples and clinical experimental observations and therapeutic effects.

The raw materials of prepared aconite, herba epimedii, semen lepidii, rhizoma ligustici wallichii, prepared rhizome of rehmannia, schisandra chinensis, motherwort and grifola which are used in the following embodiments all meet the relevant regulations under the medicinal material items in the text of the first part of Chinese pharmacopoeia 2005 edition. The medicinal materials are cleaned, cut, processed, crushed and the like, and before the materials are put into the medicine, the material objects of the medicinal materials are identified, the names of the material objects are consistent, and the quality of the material objects accords with the standard of national pharmacopeia (the identification method of the specific medicinal materials is executed by referring to the standard of the pharmacopeia).

Example 1

Weighing 10 parts by mass of prepared monkshood, 20 parts by mass of herba epimedii, 20 parts by mass of semen lepidii, 10 parts by mass of ligusticum wallichii, 15 parts by mass of prepared rehmannia root, 15 parts by mass of schisandra chinensis, 15 parts by mass of leonurus and 10 parts by mass of polyporus umbellatus. Soaking all the medicinal materials in clear water for 1 hr, decocting radix Aconiti lateralis Preparata for 1 hr, decocting the rest materials with water over strong fire until boiling, decocting with slow fire for half an hour, removing residues, collecting decoction, and mixing the decoctions.

Example 2

Weighing 15 parts by mass of prepared monkshood, 15 parts by mass of herba epimedii, 25 parts by mass of semen lepidii, 15 parts by mass of ligusticum wallichii, 10 parts by mass of prepared rehmannia root, 10 parts by mass of schisandra chinensis, 20 parts by mass of leonurus and 15 parts by mass of polyporus umbellatus. Soaking all the medicinal materials in clear water for 1 hr, decocting radix Aconiti lateralis Preparata for 1 hr, decocting the rest materials with water over strong fire until boiling, decocting with slow fire for half an hour, removing residues, collecting decoction, and mixing the decoctions.

Example 3

Weighing 20 parts by mass of prepared monkshood, 30 parts by mass of herba epimedii, 30 parts by mass of semen lepidii, 20 parts by mass of ligusticum wallichii, 20 parts by mass of prepared rehmannia root, 20 parts by mass of schisandra chinensis, 30 parts by mass of leonurus and 30 parts by mass of polyporus umbellatus. Soaking all the medicinal materials in clear water for 1 hr, decocting radix Aconiti lateralis Preparata for 1 hr, decocting the rest materials with water over strong fire until boiling, decocting with slow fire for half an hour, removing residues, collecting decoction, and mixing the decoctions.

Example 4

Weighing 18 parts by mass of prepared monkshood, 25 parts by mass of herba epimedii, 25 parts by mass of semen lepidii, 18 parts by mass of ligusticum wallichii, 15 parts by mass of prepared rehmannia rhizome, 15 parts by mass of schisandra chinensis, 25 parts by mass of leonurus and 20 parts by mass of polyporus umbellatus. Soaking all the medicinal materials in clear water for 1 hr, decocting radix Aconiti lateralis Preparata for 1 hr, decocting the rest materials with water over strong fire until boiling, decocting with slow fire for half an hour, removing residues, collecting decoction, and mixing the decoctions.

Example 5

Weighing 12 parts by mass of prepared monkshood, 20 parts by mass of herba epimedii, 25 parts by mass of semen lepidii, 15 parts by mass of ligusticum wallichii, 15 parts by mass of prepared rehmannia root, 20 parts by mass of schisandra chinensis, 25 parts by mass of leonurus and 25 parts by mass of polyporus umbellatus. Soaking all the medicinal materials in clear water for 1 hr, decocting radix Aconiti lateralis Preparata for 1 hr, decocting the rest materials with water over strong fire until boiling, decocting with slow fire for half an hour, removing residues, collecting decoction, and mixing the decoctions.

Example 6

Clinical cases

Some, male, 78 years old

Initial diagnosis in 3 months and 21 days in 2017

The main complaints are: coronary heart disease history is 10 years more, chest distress and chest pain aggravate for 1 week more.

The medical history: patients suffered from chest distress and chest pain symptoms aggravated by cold before 1 week, sometimes had short breath, lumbago, tinnitus, anorexia, defecation for several days, cold limbs, edema of lower limbs, pale tongue with white and greasy fur, and wiry and smooth pulse.

Traditional Chinese medicine diagnosis: thoracic obstruction (yang deficiency syndrome of water flooding)

And (3) Western diagnosis: heart failure

Therapeutic principle: warming yang to promote diuresis and revivifying heart yang

The prescription is as follows: modified Fuxian cardiotonic prescription

10g of prepared aconite (decocted first); herba Epimedii 15g radix astragali Preparata 15g parched Atractylodis rhizoma 10g pericarpium Citri Tangerinae 10g

Fructus Aurantii 10g radix rehmanniae Preparata 15g radix Ophiopogonis 10g fructus Schisandrae 15g Polyporus 20g

15g of trichosanthes bark, 20g of Chinese taxillus twig, 20g of motherwort, 10g of white paeony root and 15g of white paeony root

Ting Li Zi 20g poria 20g Ligusticum wallichii 10g

The use method comprises the following steps: the preparation method comprises decocting radix Aconiti lateralis Preparata for 1 hr, soaking in water for 1 hr, decocting with strong fire until boiling, decocting with slow fire for half an hour, removing residues, collecting decoction, and mixing the decoctions. Taken 3 times a day after meals

Second diagnosis (4 month and 7 days)

The chest pain symptom of the patient is obviously relieved, the patient feels a little stuffy chest and feels comfortable on the four limbs

Adding in the formula of 21 days after 3 months: the salvia miltiorrhiza 20g and the Chinese yam 15g and the fructus cannabis 15g are taken for two months.

Three diagnostic methods (5 months and 22 days) are carried out, and the symptoms of the patient are gradually improved, and the effect is satisfactory.

Observation and curative effect of clinical experiment

1. Diagnostic criteria

(1) Diagnostic criteria for CHF: according to the guidelines for the diagnosis and treatment of chronic heart failure (2007).

Diagnostic criteria for systolic heart failure: history, symptoms and signs of basic heart disease; dyspnea, weakness and fluid retention (edema); left ventricular enlargement, left ventricular end-systolic volume increase and LVEF less than or equal to 40%.

Diastolic heart failure diagnostic criteria: symptoms and signs of typical heart failure; LVEF normal (> 45%) left ventricle size is normal; echocardiography with evidence of left ventricular diastolic dysfunction; echocardiography tests for the absence of valvular heart disease and excludes pericardial disease, hypertrophic cardiomyopathy, restrictive (invasive) cardiomyopathy, and the like.

(2) CHF staging criteria:

and (B) stage A: the early stage of heart failure, including the high risk population of heart failure, does not have structural or functional abnormalities of the heart, nor symptoms and/or signs of heart failure.

And (B) stage: preclinical heart failure stage. Patients have developed structural heart disease, left ventricular hypertrophy, past history of MI, etc. from the symptoms and/or signs of heart failure. This stage corresponds to asymptomatic heart failure, or NYHA class I cardiac function.

And C: clinical heart failure stage. The patient has basic structural heart disease, and has symptoms and/or signs of heart failure at present or before; or, although there are no symptoms and/or signs of heart failure, they have been treated before. This stage includes patients with NYHA class II, III and partial IV cardiac function.

And stage D: refractory terminal heart failure stage. Patients with progressive structural heart disease have symptoms while at rest and require special intervention despite aggressive medical treatment. For example: patients who need to be hospitalized repeatedly and cannot be discharged safely due to heart failure; those who need to take drugs for a long time in the home vein; waiting for the heart transplant; those who use mechanical heart assist devices; partial NYHA grade iv patients are also included.

(3) NYHA classification standard: reference is made to the new york cardiology society of america (NYHA) cardiac function classification standard.

Cardiac function level i: the patient suffers from heart disease, but the activity is not limited, and the general activity does not cause fatigue, palpitation, dyspnea or angina pectoris.

Heart function level ii: the physical activity of the patients with heart disease is slightly limited, and no subjective symptoms exist during rest, but fatigue, palpitation, dyspnea or angina pectoris can appear under normal activities.

Grade III of cardiac function: the physical activity of the patients with heart diseases is obviously limited, and the symptoms are caused by the general activity less than usual.

Grade iv cardiac function: patients with heart disease cannot engage in any physical activity. The symptoms of heart failure also appear at rest, and the physical strength becomes worse after activity.

(4) The traditional Chinese medicine syndrome diagnosis standard is as follows: and (4) referring to the quantitative diagnosis standard of CHF common traditional Chinese medicine syndromes formulated in the early stage.

2. Inclusion and exclusion criteria

(1) Inclusion criteria were: patients who met the CHF diagnostic criteria, were aged 18 years and 85 years or less, and signed an informed consent, and volunteered to participate in the study, in conjunction with staging criteria, stage C.

(2) Exclusion criteria: patients with CHF caused by other heart diseases such as pulmonary heart disease, rheumatic heart disease, and congenital heart disease; patients with acute myocardial infarction, cardiogenic shock, severe arrhythmia accompanied by hemodynamic changes; and those with concurrent infection: heating; ② increase of hemogram and white blood cell count>10×10⁹L, neutrophils>85 percent; thirdly, the chest radiography prompts that sheet-shaped shadows exist; complicated severe hepatic insufficiency (hepatic function index value)>2 times normal), renal insufficiency (Ccr)>20％，Scr>3mg/dl or>265. mu. mol/L), blood system, and other primary diseases and malignant tumors; pregnant or lactating women; psychosis and infectious disease patients.

Diagnosis criteria for syndrome of yang-deficiency and water-flood of CHF

Referring to the technical guidance principle of clinical research on new Chinese medicines for chronic heart failure published by the State food and drug administration in 2017, the diagnosis of yang deficiency and water flood of heart failure can be made by taking the principal symptoms of 2 or 1 plus 1 secondary symptom or 1 plus typical tongue vein as the principal symptom.

The main symptoms are: dyspnea; aversion to cold and cold limbs; scanty urine; edema of the facial limbs.

The secondary symptoms are as follows: palpitations; shortness of breath and lack of strength; spontaneous sweating and night sweat; chest tightness (pain); cough; abdominal distension.

Tongue pulse: a dark tongue with a smooth or white greasy coating and a thready or slippery pulse.

4. Study objects and groups

105 patients with CHF yang-deficiency water-flooding syndrome are selected according to inclusion and exclusion criteria and CHF common traditional Chinese medicine syndrome diagnosis criteria (according to previous scale entries and statistical requirements), and are randomly divided into three groups: the formula comprises a formula group of Fu xian cardiotonic (formula of Fu xian cardiotonic + western medicine), a traditional Chinese medicine control group (similar traditional Chinese medicine composition + western medicine) and a western medicine group, wherein each group comprises 35 cases. Wherein the Buxian cardiotonic formula is aged 54-84 years, 16 men and 19 women have a disease course of 5-8 years, 1 death case and 2 loss cases; the age of the traditional Chinese medicine control group is 56-80 years old, 17 men and 16 women have the course of disease of 4-7 years, 1 case of death and 2 cases of loss; western medicine group, age 57-80 years, 16 men, 19 women, course of disease 5-8 years, 1 death, 3 losses. The age and sex of two groups of cases have no obvious difference (P is more than 0.05), the basic diseases are coronary heart diseases, the degree of severity of symptoms is basically consistent, no obvious difference exists, and the disease is comparable.

5. Mode of administration

Fu xian cardiotonic formula: the compound preparation prepared in the embodiment 1 of the invention is taken 2 times a day half an hour after meals, one month is a treatment course, and the compound preparation is continuously used for two treatment courses;

traditional Chinese medicine control group: prepared aconite root 10 parts by mass, morinda officinalis 20 parts by mass, lepidium seed 20 parts by mass, ligusticum wallichii 10 parts by mass, prepared rhizome of rehmannia 15 parts by mass, schisandra chinensis 15 parts by mass, motherwort 15 parts by mass and polyporus umbellatus 10 parts by mass, wherein the preparation is taken 2 times a day half an hour after meals, one month is a treatment course, and the preparation is continuously used for two treatment courses;

western medicine group: the valsartan capsule is orally taken by 80 mg/tablet, 1 tablet/time/day plus 25 mg/tablet of metoprolol tartrate, 1/4-1 tablet/time and 2 times/day.

6. Observation index and curative effect judgment:

6.1 Observation index

6.1.1 safety indices

(1) General data: age, sex, height, weight, occupation, past history, family history, allergy history, medication history, etc.;

(2) and (4) safety observation: blood, urine and stool, blood sugar, blood fat, liver and kidney functions, electrocardiogram and the like;

(3) the above indexes are examined before and after treatment.

6.1.2 therapeutic index

(1) The curative effect of the traditional Chinese medicine syndrome of the patients before and after treatment changes;

(2) the curative effect of the cardiac function of the patients is changed before and after the treatment.

(3) Serum BNP changes in patients before and after treatment;

6.2 therapeutic efficacy criteria

6.2.1 Standard of the treatment Effect of TCM syndrome

The traditional Chinese medicine syndrome integral judgment standard is formulated according to the technical guidance principle of the clinical research on the application of new traditional Chinese medicines to chronic heart failure, which is issued by the State food and drug administration headquarter 2017, and the curative effect evaluation is calculated by adopting a nimodipine method: the efficacy index (n) ═ 100% (pre-treatment integral-post-treatment integral)/pre-treatment integral ].

The effect is shown: the clinical primary and secondary symptoms basically or completely disappear, and the syndrome score is reduced by more than or equal to 70 percent;

the method has the following advantages: the clinical symptoms are obviously improved, and the syndrome score is reduced by 30 percent to 70 percent;

and (4) invalidation: the reduction of the syndrome score after treatment is less than 30 percent;

weighting: the score of the post-treatment syndrome exceeds the score of the pre-treatment syndrome.

All subjects are subjected to detailed inquiry before and after taking the medicine, a traditional Chinese medicine syndrome score table is filled in, each syndrome is divided into none, light, medium and severe according to the severity of the illness, and different scores are given according to the weight of each symptom in the syndrome score: the major symptoms are assigned no 0 point, light 2 points, medium 4 points and heavy 6 points, the minor symptoms are assigned no 0 point, light 1 point, medium 2 points and heavy 3 points, and tongue and pulse conditions are described in detail without quantification.

6.2.2 criteria for determining the curative effects of cardiac function

The judgment standard of the cardiac function curative effect is formulated by referring to the technical guidance principle of new traditional Chinese medicine for chronic heart failure clinical research issued by the State food and drug administration in 2017, which is specifically as follows:

the effect is shown: heart function reaches level I or basic control of heart failure or improvement of heart function is more than 2 levels;

the method has the following advantages: improving heart function by 1-2 levels or relieving heart failure;

and (4) invalidation: the improvement of the cardiac function is less than 1 grade;

weighting: the symptoms of heart failure worsen compared to before.

6.3 criteria for shedding and case culling

Any 1 item meeting the following is regarded as falling off and eliminated:

(1) in clinical observation, the compliance of patients is poor, and the curative effect evaluator is influenced

(2) In the course of treatment, adverse events or adverse reactions occur, and it is not advisable to continue or refuse to treat the patient.

(3) The therapist asks for quit by himself.

(4) Other treatments were accepted during the course of treatment.

(5) Before the treatment course is finished, the patients are quitted from treatment, missed visits or death due to other various factors.

6.4 statistical methods

The analysis was performed using SPSS22.0 statistical software. And (3) performing normality test on the measurement data, wherein data which obeys normal distribution is tested by using t, and data which does not obey normal distribution is tested by adopting rank sum. The data are expressed as mean-squared standard deviation, and P < 0.05 is statistically significant.

7. Results

In the study, 105 cases were collected, and 35 cases were collected, wherein the drug of the formula of the lesser monkshood was cardiotonic, 1 case died, 2 cases missed, and 32 actual cases; the control group of traditional Chinese medicines died 1 case, had 2 cases of death, actually 32 cases; western medicine group, 1 case of death, 3 cases of loss and 31 cases of actual death. The primary diseases of the three groups of cases are coronary heart diseases, and the difference in age and sex has no statistical significance.

7.1 comparison of the therapeutic effects of the traditional Chinese medicine syndromes of the patients before and after treatment

7.1.1 integral changes of Chinese medicine syndrome before and after treatment

TABLE 1 integral changes of Chinese medicine syndrome before and after treatment

Note: compared with the treatment before the treatment,^*p is less than 0.05; compared with the western medicine group,^▲p is less than 0.05; compared with the control group of the traditional Chinese medicine,^#P＜0.05

compared with the traditional Chinese medicine before treatment, the traditional Chinese medicine syndrome integral is obviously reduced after the three groups of patients are treated, which shows that the traditional Chinese medicine syndrome is improved after the three groups of patients are treated; compared with western medicine groups, the traditional Chinese medicine syndrome integrals of the Fuxian cardiotonic formula group and the traditional Chinese medicine control group are reduced after treatment, which shows that the traditional Chinese medicine and western medicine combined medicine is superior to the pure western medicine treatment in improving the traditional Chinese medicine syndrome integrals; compared with the traditional Chinese medicine control group, the traditional Chinese medicine syndrome integral of the patients with the formula of the Fuxian cardiotonic formula is reduced, which indicates that the formula of the Fuxian cardiotonic formula is superior to the traditional Chinese medicine control group in improving the traditional Chinese medicine syndrome integral.

7.1.2 changes in the therapeutic effects of the syndrome of TCM after treatment

TABLE 2 changes in the therapeutic effects of the traditional Chinese medicine syndromes after treatment

Note: compared with the western medicine group,^▲p is less than 0.05; compared with the control group of the traditional Chinese medicine,^#P＜0.05

as can be seen from table 2, the curative effects of the traditional Chinese medicine syndromes after the three groups of treatments are improved, compared with the western medicine group, the effective rates of the fu xian cardiotonic formula group and the traditional Chinese medicine control group after the treatments are improved, and the curative effect of the traditional Chinese medicine and western medicine combined medicine on improving the traditional Chinese medicine syndromes is better than that of the pure western medicine treatment; compared with the traditional Chinese medicine control group, the total effective rate of patients in the Fuxian cardiotonic formula group is improved, which indicates that the curative effect of the Fuxian cardiotonic formula on improving the traditional Chinese medicine symptoms is better than that of the traditional Chinese medicine control group.

7.2 Effect of cardiac function on patients before and after treatment

7.2.1 Graded changes in cardiac function before and after treatment

TABLE 3 Graded variation in cardiac function before and after treatment

As can be seen from Table 3, the number of cases with grade IV cardiac function after the treatment of three groups of patients is obviously reduced compared with the cases before the treatment, and the cases improved to grade II cardiac function sequentially comprise a formula group of the monkshood for strengthening the heart, a traditional Chinese medicine control group and a western medicine group from high to low.

7.2.2 treatment of cardiac functional changes

TABLE 4 treatment of the changes in the effectiveness of the treatment of the posterior cardiac function

as can be seen from table 4, the cardiac function curative effects of the patients after the three groups of treatments are improved, compared with the western medicine group, the effective rates of the aconitum carmichaeli heart strengthening formula group and the traditional Chinese medicine control group after the treatments are improved, and the curative effect of the traditional Chinese medicine and western medicine combined medicine on improving the cardiac function is better than that of the pure western medicine treatment; compared with the traditional Chinese medicine control group, the total effective rate of patients in the formula group of the Fuxian heart strengthening formula is improved, which indicates that the curative effect of the formula of the Fuxian heart strengthening formula on improving the heart function is better than that of the traditional Chinese medicine control group.

7.3 serum BNP changes in patients before and after treatment

TABLE 5 serum BNP changes in patients before and after treatment

Note: compared with the treatment before the treatment,^*p is less than 0.05; compared with the western medicine group,^▲p < 0.05,. P < 0.01; compared with the control group of the traditional Chinese medicine,^#P＜0.05

serum BNP decreased after treatment in all three groups of patients compared to before treatment; compared with western medicine groups, the serum BNP of the Fuxian cardiotonic formula group and the traditional Chinese medicine control group is obviously reduced after treatment; compared with the traditional Chinese medicine control group, the blood serum BNP level of patients in the Fuxian cardiotonic formula group is also reduced.

8 Security analysis

All patients are subjected to routine safety inspection of blood, urine and excrement, blood sugar, blood fat, liver and kidney functions, electrocardiogram and the like before and after treatment. The above tests show that there is no abnormal change before and after treatment, and no obvious adverse reaction occurs during the treatment process.

Analysis of clinical laboratory results

The invention relates to an effective prescription composition for treating yang deficiency and water flood in the middle and later stages of CHF, which has the common effects of warming yang, promoting diuresis, tonifying kidney and calming heart. The prepared aconite slice has the functions of strengthening heart and warming yang, and the epimedium herb has the functions of warming kidney and tonifying yang, and the compatibility of the prepared aconite slice and the epimedium herb can play a lasting role in strengthening heart and warming kidney, and researches suggest that main active ingredients of aconitine and icariin of the prepared aconite slice and the epimedium herb can effectively protect cardiac muscle cells and inhibit apoptosis; meanwhile, the pepperweed seed purges lung and promotes diuresis, induces diuresis to alleviate edema, and the ligusticum wallichii activates blood and promotes qi; prepared rehmannia root, radix rehmanniae Praeparata nourishes yin and blood of liver and kidney, and also controls dryness-heat of prepared aconite root; fructus Schisandrae chinensis has effects of invigorating qi, promoting fluid production, invigorating kidney, and calming heart; motherwort herb has the effects of activating blood and inducing diuresis; polyporus umbellatus has effects of promoting diuresis and eliminating dampness, and does not damage yang qi. The whole formula embodies the characteristics of yin-yang balance, holistic concept and lifting correlation.

In order to prove the innovativeness and uniqueness of compatibility and medication, other traditional Chinese medicines with similar effects are used for replacing the traditional Chinese medicines used in the invention, and morinda officinalis is used for replacing herba epimedii and is used as a traditional Chinese medicine control group for comparing the clinical effects before and after treatment. As seen from the clinical experimental results, the three groups of patients have improvement in the aspects of traditional Chinese medicine symptoms, cardiac function, BNP and the like after treatment, but the curative effect of the traditional Chinese and western medicine combined treatment is better than that of the simple western medicine. Compared with the replaced traditional Chinese medicine control group, the traditional Chinese medicine composition for treating CHF provided by the invention has significant progress in relieving traditional Chinese medicine symptoms, improving cardiac function and reducing serum BNP level, and the difference has statistical significance. The overall clinical curative effect is satisfactory.

The above is a preferred embodiment of the present invention, and it should be noted that other modifications and additions can be made by those skilled in the art without departing from the method of the present invention, and these modifications and additions should also be considered as a protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating the middle and later stages of congestive heart failure is characterized in that: the material is prepared from the following raw materials in parts by mass: 10-20 parts of prepared aconite slice, 15-30 parts of herba epimedii, 20-30 parts of semen lepidii, 10-20 parts of ligusticum wallichii, 10-20 parts of prepared rhizome of rehmannia, 10-20 parts of schisandra chinensis, 10-30 parts of motherwort and 10-30 parts of grifola.

2. The traditional Chinese medicine composition for treating the middle and later stages of congestive heart failure according to claim 1, wherein the traditional Chinese medicine composition comprises: the traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 10 parts of prepared aconite root, 20 parts of herba epimedii, 20 parts of semen lepidii, 10 parts of ligusticum wallichii, 15 parts of prepared rhizome of rehmannia, 15 parts of schisandra chinensis, 15 parts of motherwort and 10 parts of polyporus umbellatus.

3. The preparation method of the traditional Chinese medicine composition for treating the middle and later stages of congestive heart failure according to claim 1 or 2, which is characterized by comprising the following steps: soaking all the medicinal materials in clear water for 1 hr, decocting radix Aconiti lateralis Preparata for 1 hr, decocting the rest materials with water over strong fire until boiling, decocting with slow fire for half an hour, removing residues, collecting decoction, and mixing the decoctions.

4. The Chinese medicinal composition for treating the middle and later stages of congestive heart failure according to claim 1 or 2, wherein: is applied to preparing the medicinal preparation for treating the syndrome of yang deficiency and water flooding of congestive heart failure.

5. The Chinese medicinal composition for treating the middle and later stages of congestive heart failure according to claim 1 or 2, wherein: the dosage form of the traditional Chinese medicine composition comprises: tablet, sugar-coated tablet, film-coated tablet, enteric-coated tablet, capsule, hard capsule, soft capsule, oral liquid, buccal agent, granule, pill, and powder.