CN116211940A

CN116211940A - Traditional Chinese medicine composition for treating paroxysmal atrial fibrillation and preparation method thereof

Info

Publication number: CN116211940A
Application number: CN202310165593.6A
Authority: CN
Inventors: 冯玲
Original assignee: Individual
Current assignee: Individual
Priority date: 2023-02-27
Filing date: 2023-02-27
Publication date: 2023-06-06

Abstract

The invention discloses a traditional Chinese medicine composition for treating paroxysmal atrial fibrillation, which comprises 9-15 parts of rosewood heart wood, 1-5 parts of agilawood, 10-15 parts of radix salviae miltiorrhizae, 5-10 parts of earthworm, 3-10 parts of platycladi seed, 10-25 parts of mother-of-pearl, 9-15 parts of Chinese pine knots, 9-30 parts of astragalus mongholicus and 3-6 parts of cortex lycii radicis. The invention has the advantages that: based on two physiological functions of ' heart governing blood vessels ', ' heart governing mind ', the ' adverse blood vessels ', the mind is put away as a core pathogenesis of paroxysmal atrial fibrillation ', and the ' pulse spirit synchronization ' theory formula is adopted for medication. The medicine Jian Lihong has the effects of tonifying qi, activating blood, calming endogenous wind, stopping palpitation, nourishing yin, calming heart, and relieving the nerves, can effectively reduce the frequency and duration of atrial fibrillation attacks of patients, reduce the ventricular rate, the atrial fibrillation symptom classification, the atrial fibrillation load, improve the quality of life, improve the sleeping condition, has the effects of resisting coagulation and enhancing myocardial contraction, and can effectively avoid complications such as heart failure caused by cerebral apoplexy and heart load aggravation due to atrial fibrillation thrombosis. The traditional Chinese medicine composition is used for treating paroxysmal atrial fibrillation with qi stagnation and blood stasis and restlessness of heart spirit as main pathogenesis, and has good curative effect.

Description

Traditional Chinese medicine composition for treating paroxysmal atrial fibrillation and preparation method thereof

Technical Field

The invention relates to a pharmaceutical composition for treating paroxysmal atrial fibrillation, in particular to a pharmaceutical composition for treating paroxysmal atrial fibrillation and a preparation method thereof.

Background

Paroxysmal atrial fibrillation (Paroxysmal atrial fibrillation, POAF) is a clinically common arrhythmia, which is an supraventricular tachyarrhythmia accompanied by uncoordinated atrial electrical activity, thus causing ineffective atrial contraction, and is characterized by atrial fibrillation with automatic termination or intervention termination within 7 days, usually with onset time of less than or equal to 48 hours, and has the characteristics of sudden and abrupt stop and irregular onset, and the onset is mainly characterized by palpitation, hypodynamia, dizziness, dyspnea and the like.

The first large-scale epidemiological investigation result of atrial fibrillation in 2004 shows that the total prevalence of atrial fibrillation in China is 0.77%, and the prevalence of atrial fibrillation in paroxysmal is 0.26%. The risk factors of paroxysmal atrial fibrillation are numerous, and the aging is an important risk factor of atrial fibrillation, but other co-diseases including hypertension, diabetes, heart failure, coronary heart disease, chronic kidney disease, hyperthyroidism, first-class attenuation, obesity, obstructive sleep apnea and the like play an important role in the occurrence and progress of atrial fibrillation. A significant proportion of patients cannot find clear causes and can only be defined as idiopathic paroxysmal atrial fibrillation. Clinical onset of paroxysmal atrial fibrillation is hidden, is not easily found in early stage, often causes repeated attacks due to various causes, serious patients can cause hemodynamic changes, form wall-attached thrombus, cause cerebral apoplexy and even cause fatal heart embolism. Atrial fibrillation can also cause atrial electrical and structural remodeling, leading to enlargement of the left atrium, fibrosis of the atrium, and thus myocardial involvement, reduced cardiac function, and heart failure. In addition, atrial fibrillation can cause the decline of cognitive functions, anxiety and depression, the decline of life quality, the increase of hospitalization rate and even death of patients, and the prevention and treatment of inappropriateness can progress to continuous atrial fibrillation, thus bringing great burden to global patients and medical systems. All the problems need to be solved, so that the search of a novel treatment method for preventing and treating paroxysmal atrial fibrillation has important clinical significance from the theory of traditional Chinese medicine.

At present, modern medicine has no specific medicine for treating paroxysmal atrial fibrillation, and the 2020 ESC/EACTS atrial fibrillation diagnosis and management guidelines indicate that the latest comprehensive management strategies of atrial fibrillation are respectively cerebral apoplexy prevention/anticoagulation treatment; control rhythm, stabilize ventricular rate, improve patient symptoms; management of treatment complications/cardiovascular risk factors. Wherein the anticoagulants mainly comprise warfarin, rivaroxaban, dabigatran etexilate, and the like; the antiarrhythmic drugs include amiodarone, dronedarone, sotalol, propafenone hydrochloride, etc., and beta-blockers commonly used for stabilizing ventricular rate. However, various side effects caused by oral administration, such as bleeding risk caused by anticoagulant, arrhythmia caused by antiarrhythmic drugs, extra-cardiac toxicity, etc., are unavoidable, and beta blockers cause atrioventricular block and blood pressure decrease. Even if patients with atrial fibrillation are optimally treated with drugs, some patients have clinical symptoms that are not well controlled. When the oral medicine has poor treatment effect, usually, surgical treatment such as pulmonary vein isolation, catheter radio frequency ablation and cryoablation is considered, a non-drug treatment mode is high in price and high in postoperative recurrence rate, and is limited in China usually because of factors such as economy, acceptance intention and technical problems of patients, clinical researches show that the recurrence rate of patients suffering from atrial fibrillation is 11% -29% after single ablation for 1-5 years, the recurrence rate after repeated ablation is 7% -24%, the power of an atrial fibrillation ablation assembly in China is 77.1%, the recurrence rate is about 22.9%, and the complication occurrence rate is 5.3%. Therefore, in recent years, the medicine for treating paroxysmal atrial fibrillation with good curative effect and few side effects is sought to be the key point of traditional Chinese medicine research.

Disclosure of Invention

In order to solve the problems, the invention provides a traditional Chinese medicine composition and a preparation method thereof, wherein the traditional Chinese medicine composition is used for treating paroxysmal atrial fibrillation.

A traditional Chinese medicine composition for treating paroxysmal atrial fibrillation comprises the following components in parts by weight: 9-15 parts of rosewood, 1-5 parts of agilawood, 10-15 parts of radix salviae miltiorrhizae, 5-10 parts of earthworm, 3-10 parts of platycladi seed, 10-25 parts of mother-of-pearl, 9-15 parts of Chinese pine knots, 9-30 parts of astragalus mongholicus and 3-6 parts of cortex caryophylli.

As a preferred embodiment, the Chinese medicinal composition preferably comprises, based on parts by weight: 10 parts of rosewood heart wood, 3 parts of agilawood, 15 parts of radix salviae miltiorrhizae, 10 parts of earthworm, 10 parts of platycladi seed, 25 parts of mother-of-pearl, 10 parts of oil pine knots, 30 parts of raw astragalus mongholicus and 6 parts of cortex lycii radicis.

The following are the actions and effects of the components.

And (3) rosewood heart wood: pungent and warm. It enters heart and liver meridians. Has effects of promoting blood circulation, dispelling blood stasis, stopping bleeding, relieving pain, eliminating turbid pathogen, and relieving vomit. Is suitable for chest and hypochondrium pain caused by qi stagnation and blood stasis, traumatic injury, traumatic hemorrhage, internal obstruction of turbid urine, emesis and abdominal pain, etc. Modern pharmacological researches show that rosewood heart wood has the effects of resisting oxidization and myocardial ischemia, and the myocardial stiffness is reduced by reducing the proportion of I/III collagen in a myocardial non-infarcted area, so that ventricular remodeling is improved. In addition, rosewood heart wood has the functions of anti-thrombus and anti-platelet, the activity of the anti-platelet increases with the increase of the concentration, but the activity of the anti-thrombus is poor.

Agilawood: pungent and bitter, warm. It enters spleen, stomach and kidney meridians. Has effects of activating qi-flowing, relieving pain, lowering adverse qi, regulating middle warmer, warming kidney, and invigorating qi. It is indicated for cold congealing and qi stagnation, chest and abdomen distention and pain, stomach cold vomiting, hiccup, deficiency cold of lower energizer, deficiency asthma of kidney without receiving qi, cough and asthma due to phlegm-fluid, excessive upper and lower deficiency. Modern pharmacological research shows that the agilawood volatile oil can play an anxiolytic and antidepressant role by inhibiting excessive activities of Corticotropin Releasing Factor (CRF) and hypothalamus-pituitary-adrenal (HPA) axes, and in addition, the agilawood volatile oil also has the functions of resisting oxidization, myocardial ischemia, bacteriostasis and reducing blood sugar.

Root of red-rooted salvia: bitter and slightly cold. It enters heart, pericardium and liver meridian. Has effects of promoting blood circulation, removing blood stasis, cooling blood, resolving carbuncle, clearing heart fire, and relieving restlessness. Is suitable for palpitation, insomnia and other symptoms caused by blood stasis and heat generation. Modern pharmacological researches have shown that the root of red-rooted salvia has the functions of dilating coronary artery, increasing coronary blood flow, improving microcirculation, resisting thrombosis, promoting tissue repair and regeneration, reducing blood fat and the like.

Earthworm: salty and cold. Enter liver, spleen and bladder meridians. Has effects of clearing heat, calming endogenous wind, relieving asthma, dredging collaterals, and promoting urination. It is indicated for severe fever, convulsion, wheezing and wheezing, red, swelling and pain of joints, difficulty in flexing and extending, heat accumulation in bladder, difficulty in urination, or obstruction of urination. Modern pharmacological research shows that the earthworm water extract can obviously prolong the formation time of platelet thrombus and fibrin thrombus in a body, reduce the length and dry weight of thrombus, has stronger functions of anticoagulation and thrombolysis, and is a thrombolytic medicament with very good effect.

Semen Platycladi: sweet in flavor and neutral in nature. It enters heart, kidney and large intestine meridians. Has effects of nourishing heart, tranquilizing mind, loosening bowel to relieve constipation, and relieving sweat. Is suitable for treating deficiency of yin and blood, dysphoria and insomnia, palpitation, constipation due to intestinal dryness, night sweat due to yin deficiency, etc. Modern pharmacological research shows that the semen Platycladi volatile oil has effects of suppressing central nerve, tranquilizing and hypnotizing.

Mother of pearl: salty and cold taste. Enter liver and heart meridians. Has effects of suppressing hyperactive liver, subsiding yang, improving eyesight, removing nebula, tranquilizing mind, and arresting convulsion. Is suitable for treating headache, liver heat, conjunctival congestion, dizziness, palpitation, tinnitus, insomnia, mania, female metrorrhagia, etc. caused by liver yin deficiency and liver yang hyperactivity. Modern pharmacological researches show that the mother-of-pearl is rich in microelements such as calcium, iron, sodium, potassium and the like, and the microelements can inhibit nerve and skeletal muscle excitation, and the mother-of-pearl has the effects of calming and hypnotizing experimental mice.

Oil pine knots: bitter and warm. Enter liver meridian. Has effects of dispelling pathogenic wind, removing dampness, and relieving pain. It is suitable for treating rheumatalgia, traumatic injury pain, etc. Modern pharmacological researches show that the pine knots have the effects of resisting inflammation and easing pain.

Radix astragali: sweet and slightly warm. Enter spleen and lung meridians. Has effects in invigorating qi, supporting yang, consolidating superficial resistance, relieving sweating, inducing diuresis, relieving edema, promoting salivation, nourishing blood, removing stagnation, relieving arthralgia, removing toxic materials, expelling pus, healing sore, and promoting granulation. It is indicated for spleen qi deficiency and depression, lung qi deficiency and exterior deficiency spontaneous perspiration, qi deficiency edema, blood deficiency and sallow complexion, diabetes, hemiplegia, arthralgia and numbness. Modern pharmacological research shows that astragalus total saponins contained in astragalus can effectively improve heart function of heart failure rats and reverse ventricular remodeling.

Cortex Periplocae Radicis: pungent, bitter and warm; is toxic. It enters liver, kidney and heart meridians. Has effects of inducing diuresis to alleviate edema, dispelling pathogenic wind and removing dampness, and strengthening tendons and bones. Is suitable for treating edema, dysuria, arthralgia due to wind-cold-dampness, soreness of waist and knees, etc. Modern pharmacological research shows that the cortex Periplocae Radicis contains cardiac glycoside compounds, has similar effect to digoxin, and can increase cardiac ejection fraction.

The traditional Chinese medicine composition can be prepared into a conventional pharmaceutical preparation by adding pharmaceutically acceptable excipients, wherein the excipients comprise a disintegrating agent, a lubricant, a binding agent and the like, and the conventional pharmaceutical preparation preferably comprises an oral preparation; wherein the oral preparation comprises decoction, pill, powder, ointment, capsule or tablet.

The invention also provides two methods for preparing the traditional Chinese medicine composition for treating paroxysmal atrial fibrillation, and decoction preparation comprises the following steps:

(1) Weighing the traditional Chinese medicine components according to the weight ratio;

(2) Mixing the traditional Chinese medicine components, placing the mixture in a container, adding water, soaking the mixture for 20 to 30 minutes after the water is soaked on the medicine surface;

(3) Decocting for 20-30 minutes after boiling, and decocting for three times;

(4) Mixing the three decoctions, and filtering to obtain decoction.

The preparation method of the granule comprises the following steps:

(1) Taking all the traditional Chinese medicine components according to the weight parts;

(2) Decocting the traditional Chinese medicine components in a closed container, adding water for 6-10 times, and preserving heat for 25-45 minutes at 80-95 ℃ after boiling to obtain decoction;

(3) Adding water 4-8 times, boiling, and maintaining the temperature at 80-95 ℃ for 15-25 minutes to obtain a second decoction;

(4) Mixing the two decoctions, filtering, and concentrating under reduced pressure to obtain paste;

(5) Adding conventional adjuvants, and making into granule.

The invention has the advantages that:

1. based on the theory of "heart governing blood vessels", "heart governing mind" and "internal channels" blood vessels and benefiting, spirit and residing ", it is proposed that the core pathogenesis of paroxysmal atrial fibrillation is the disfunction of blood vessels, the insanity is better, and the paroxysmal atrial fibrillation is treated by" pulse-spirit coherent "theory. The heart stores spirit and spirit is the heart, and patients suffering from paroxysmal atrial fibrillation usually have the symptoms of stress, anxiety, alcohol consumption and the like, and the spirit activities belong to the category of heart spirit and are all symptoms of no spirit and no spirit. The pulse is one of the carriers of vital activities and is a tangible substance, and patients suffering from atrial fibrillation have symptoms of irregular pulse and short pulse, and are caused by qi stagnation and blood stasis obstruction and blockage of the pulse, and the pulse is lost in circulation. The pulse-regulating therapy of paroxysmal atrial fibrillation mainly adopts the method of regulating qi and activating blood circulation, which can remove the physical and excessive evil and smooth pulse and full blood. The patients suffering from paroxysmal atrial fibrillation are treated from the viewpoint of regulating spirit, and mainly tranquilization is achieved.

2. A real-world study based on a pulse-nerve synchronization treatment method discovers that the clinical total effective rate of the particle prescription for treating paroxysmal atrial fibrillation reaches 90.67%, the atrial fibrillation frequency and duration of patients can be obviously reduced, the ventricular rate is reduced, the atrial fibrillation symptom classification and the atrial fibrillation load are reduced, the life quality is improved, the sleep condition is improved, and the difference has statistical significance (P is less than 0.01); the total clinical effective rate of the prescription of the defibrillation granule combined with western medicines for treating paroxysmal atrial fibrillation is 83.72%, the frequency and duration of atrial fibrillation attacks (P < 0.05) of patients can be reduced, and the ventricular rate is reduced without statistical difference (P > 0.05).

3. In the aspect of cell experiments, the alcohol extract of the defibrillation particles is adopted to administer HEK293 or CHO cell lines which are stably expressed, and the membrane technology is used for recording the change of ion channels, so that the anti-arrhythmic particles have the tendency of inhibiting IKr channels, the inhibition rate is 66.51% +/-3.07%, and the enhancement rate on IKs channels is 199.28% +/-4.15%, which indicates that the defibrillation particles can play an anti-arrhythmic role by inhibiting hERG channels, and the side effect of prolonging QT intervals by other anti-arrhythmics is avoided.

Detailed Description

The advantages and features of the present invention will become more apparent from the following detailed description of the invention in conjunction with the accompanying examples. These examples are merely exemplary and do not limit the scope of the invention in any way. It will be understood by those skilled in the art that various changes and substitutions of details and forms of the technical solution of the present invention may be made without departing from the spirit and scope of the present invention, but these changes and substitutions fall within the scope of the present invention.

Example 1

10g of rosewood, 3g of agilawood, 15g of radix salviae miltiorrhizae, 10g of earthworm, 10g of platycladi seed, 25g of mother-of-pearl, 10g of Chinese pine knot, 30g of raw astragalus root and 6g of cortex lycii radicis.

Mixing the above raw materials together, placing into a marmite, adding water, soaking for 20-30 min, decocting with slow fire, boiling, decocting for 30 min again, decocting for three times, mixing decoctions, and filtering to obtain decoction. Instruction of use: decoction is decocted with water for one dose per day, and is taken once in the morning and evening, and 28 days is a treatment course; the raw material medicaments are mixed and put into a closed container for boiling and extracting twice, wherein the first time is added with 6-10 times of water, the temperature is kept at 80-95 ℃ for 25-45 minutes after boiling, the decoction is obtained, the second time is added with 4-8 times of water, the temperature is kept at 80-95 ℃ for 15-25 minutes after boiling, the second decoction is obtained, the two decoctions are combined, filtered and concentrated into paste under reduced pressure, and conventional auxiliary materials are added to prepare the granule. Instruction of use: the granule is taken after one dose of water and one dose of water every day, and is taken once in the morning and evening, and 28 days is a treatment course;

example 2

9 g of rosewood, 2g of agilawood, 15g of radix salviae miltiorrhizae, 10g of earthworm, 9 g of platycladi seed, 25g of mother-of-pearl, 10g of Chinese pine knot, 30g of raw astragalus root and 6g of cortex lycii radicis.

The preparation and administration method are as in example 1.

Example 3

9 g of rosewood, 2g of agilawood, 10g of red sage root, 10g of earthworm, 9 g of platycladi seed, 20 g of mother-of-pearl, 10g of Chinese pine node, 25g of raw astragalus root and 6g of cortex acanthopanacis.

The preparation and administration method are as in example 1.

Example 4

10g of rosewood, 1 g of agilawood, 15g of radix salviae miltiorrhizae, 6g of earthworm, 10g of platycladi seed, 25g of mother-of-pearl, 10g of Chinese pine knot, 25g of raw astragalus root and 6g of cortex lycii radicis.

The preparation and administration method are as in example 1.

Example 5

The preparation and administration method are as in example 1.

Example 6

10g of rosewood, 3g of agilawood, 10g of radix salviae miltiorrhizae, 6g of earthworm, 10g of platycladi seed, 20 g of mother-of-pearl, 9 g of Chinese pine knot, 20 g of raw astragalus root and 3g of cortex lycii radicis.

The preparation and administration method are as in example 1.

Example 7

6g of rosewood, 5g of agilawood, 10g of radix salviae miltiorrhizae, 10g of earthworm, 10g of platycladi seed, 25g of mother-of-pearl, 10g of Chinese pine knot, 30g of raw astragalus root and 6g of cortex lycii radicis.

The preparation and administration method are as in example 1.

Example 8

9 g of rosewood, 1 g of agilawood, 15g of radix salviae miltiorrhizae, 6g of earthworm, 3g of platycladi seed, 15g of mother-of-pearl, 15g of Chinese pine knot, 15g of raw astragalus root and 3g of cortex lycii radicis.

The preparation and administration method are as in example 1.

Example 9

15g of rosewood, 5g of agilawood, 15g of radix salviae miltiorrhizae, 10g of earthworm, 10g of platycladi seed, 25g of mother-of-pearl, 15g of Chinese pine knot, 30g of raw astragalus root and 3g of cortex lycii radicis.

The preparation and administration method are as in example 1.

Example 10

15g of rosewood, 3g of agilawood, 10g of red sage root, 6g of earthworm, 10g of platycladi seed, 20 g of mother-of-pearl, 15g of Chinese pine knot, 20 g of raw astragalus root and 6g of cortex acanthopanacis.

The powder comprises the following steps:

(1) Mixing the above raw materials together;

(2) Drying the traditional Chinese medicine components, and grinding into powder, wherein the powder is preferably 60-100 meshes;

(3) And subpackaging the medicine powder to obtain the powder.

Example 11

15g of rosewood, 5g of agilawood, 15g of radix salviae miltiorrhizae, 5g of earthworm, 9 g of platycladi seed, 15g of mother-of-pearl, 12 g of Chinese pine knot, 12 g of raw astragalus root and 3g of cortex lycii radicis.

The water pill comprises the following steps:

(1) Mixing the above raw materials together;

(3) Adding a proper amount of water to the drug powder;

(4) And (5) after mixing, shaping by hand or by a machine to obtain the watered pill.

Example 12

15g of rosewood, 1 g of agilawood, 15g of radix salviae miltiorrhizae, 6g of earthworm, 10g of platycladi seed, 15g of mother-of-pearl, 10g of Chinese pine knot, 25g of raw astragalus root and 6g of cortex lycii radicis.

The paste pill comprises the following steps:

(1) Mixing the above raw materials together;

(3) Adding a proper amount of starch paste or rice paste into the medicine powder;

(4) And (5) after mixing, manually or mechanically molding to obtain the paste pill.

Example 13

9 g of rosewood, 5g of agilawood, 12 g of radix salviae miltiorrhizae, 6g of earthworm, 6g of platycladi seed, 25g of mother-of-pearl, 12 g of Chinese pine knot, 20 g of raw astragalus root and 3g of cortex lycii radicis.

The capsule comprises the following steps:

(1) Mixing the above raw materials together;

(2) Drying the traditional Chinese medicine components, and grinding into powder, wherein the powder is preferably 80-100 meshes;

(3) Granulating the medicinal powder, and drying;

(4) And (5) filling the medicinal granules into capsules by a machine to obtain capsules.

Example 14

9 g of rosewood, 2g of agilawood, 12 g of radix salviae miltiorrhizae, 8 g of earthworm, 8 g of platycladi seed, 20 g of mother-of-pearl, 15g of Chinese pine knot, 30g of raw astragalus root and 3g of cortex lycii radicis.

The honeyed pill comprises the following steps:

(1) Mixing the above raw materials together;

(3) Weighing honey according to the weight ratio of the medicinal powder of 1:1-1.5, and cooking the honey to medium honey;

(4) Mixing the medicinal powder with Chinese honey, and shaping by hand or machine to obtain honeyed pill.

Example 15

9 g of rosewood, 5g of agilawood, 10g of radix salviae miltiorrhizae, 6g of earthworm, 5g of platycladi seed, 20 g of mother-of-pearl, 15g of Chinese pine knot, 25g of raw astragalus root and 3g of cortex lycii radicis.

The paste comprises the following steps:

(1) Mixing the above materials, cutting into suitable pieces, segments or grinding into coarse powder;

(2) Mixing the traditional Chinese medicine components, placing the mixture into a decoction device, adding water to wet for 1-2 hours, adding water to decoct for 2-5 hours, taking out decoction, and filtering the decoction by a proper filter to obtain filtrate;

(3) Adding water into the residue to continue decoction until the smell of the decoction is thin, and taking out the decoction for later use;

(4) Squeezing residues, mixing squeezed liquid with all decoction, standing for 1-2 hours, and filtering by a proper filter;

(5) Placing the filtrate in a suitable evaporating pot, concentrating to obtain soft extract;

(6) Adding honey with the same weight or multiple weight as the clear paste into the clear paste to obtain a paste formula;

(7) Packaging into sterile container, and sealing.

Clinical efficacy test

In order to prove the curative effect of the traditional Chinese medicine composition, the traditional Chinese medicine composition is added on the basis of western medicines by a traditional Chinese medicine loading treatment method, and the curative effect of the traditional Chinese medicine composition on patients suffering from paroxysmal atrial fibrillation is studied in aspects of atrial fibrillation attack frequency, duration, ventricular rate, symptom classification, atrial fibrillation load and the like. The research result shows that the total effective rate of the clinical curative effect of the traditional Chinese medicine composition for treating paroxysmal atrial fibrillation is 90.67%, the ventricular rate (P is less than 0.01), atrial fibrillation symptom classification and atrial fibrillation load (P is less than 0.01) can be obviously reduced, the life quality (P is less than 0.01) is improved, the sleep quality (P is less than 0.01) is improved, and the traditional Chinese medicine composition has good clinical safety.

1. Case selection: and 75 patients suffering from paroxysmal atrial fibrillation who take long-term diagnosis in cardiovascular department outpatient service in Guangan-Men's hospital of China from 2021, 6 months and 2022, 3 months are included.

2. Diagnostic criteria:

diagnosis standard of Western medicine: reference is made to the relevant criteria for paroxysmal atrial fibrillation in the "2020 ESC/EACTS atrial fibrillation diagnosis and management guidelines".

Diagnostic criteria for traditional Chinese medicine: the method is formulated by referring to the traditional Chinese medicine diagnostic curative effect standard issued by the national administration of Chinese medicine in 1994 and the new traditional Chinese medicine clinical research guidelines issued in 1995.

3. Inclusion criteria: (1) male and female are not limited, and the ages of 25-90 years old; (2) Meets the diagnosis standard of paroxysmal atrial fibrillation in the traditional Chinese medicine and the western medicine; (3) Those who did not receive or have discontinued traditional Chinese medicine treatment for more than 1 month prior to study initiation; (4) atrial fibrillation symptom grading score (EHRA) < 4 points: (5) continuously re-diagnosing the patient in the clinic for more than or equal to 2 months; (6) agree and sign informed consent.

4. Exclusion criteria: (1) pregnant and lactating women; (2) left atrial thrombosis; (3) combining the fast and slow syndromes; (4) paroxysmal atrial fibrillation caused by valvular disease; (5) Paroxysmal atrial fibrillation caused by hyperthyroidism or hypofunction; (6) electrolyte disturbance, drug-induced paroxysmal atrial fibrillation; (7) severe heart failure (NYHA class III-IV); (8) Incorporation of severe liver and kidney dysfunction and other organ damage; (9) incomplete medical record.

5. Treatment protocol: CHA score based on age, condition, disease condition, combined disease, constitution, willingness, and anticoagulation of patient ₂ DS ₂ -administration of vacc to a patient for a western medical treatment. The traditional Chinese medicine composition is added on the basis of western medicine treatment, the treatment period is 8 weeks, and the western medicine treatment adopts anticoagulant, beta receptor blocker, non-dihydropyridine calcium channel blocker or digoxin according to the diagnosis and management guidelines of the atrial fibrillation of 2020 ESC/EACTS. During the observation period, if the patient has other diseases, the patient should continue to take relevant western medicines for treatment.

6. The observation indexes and the method are as follows:

the main curative effect index is as follows: atrial fibrillation episode frequency and duration; secondary efficacy index: ventricular rate, atrial fibrillation load, symptom classification, lifestyle scale, sleep scale; a safety index.

6.1 atrial fibrillation episode frequency and duration

The frequency and duration of atrial fibrillation episodes were recorded for treatment once a week for 1 month, once every two weeks for 2 months. The degree of onset is judged according to the central arrhythmia classification of the guidelines of clinical research of new Chinese medicine: (1) sporadically: 1-2 times per month, each time of attack is less than 1 hour, and the medicine can disappear after rest; (2) multiple shot: the attacks are more than 2 times per month, each attack is more than or equal to 1 hour, less than 24 hours, or the medicine is needed to be controlled; (3) frequent: daily attacks, brief, multiple times, or 1 or more per week, 24 hours or more per attack, or need drug control.

6.2 ventricular Rate

The resting ventricular rate of the patient was recorded before and after treatment by a 12-lead electrocardiogram or dynamic electrocardiogram.

6.3 atrial fibrillation burden

The atrial fibrillation load calculating method comprises the following steps: the higher the value the higher the atrial fibrillation load is. The two groups were counted 1 time before and after the treatment.

6.4 grading of atrial fibrillation symptoms

The effect of patient daily activity was graded according to the European rhythm association (EHRA) atrial fibrillation symptom scale, with symptoms commonly associated with atrial fibrillation (palpitations, fatigue, dizziness, dyspnea, chest pain, and anxiety), on a scale of 1 (none): atrial fibrillation does not cause any symptoms; grade 2a (mild): daily activities are not affected by atrial fibrillation symptoms; stage 2b (moderate): daily activities are not affected by symptoms of atrial fibrillation, but patients suffer from symptoms; grade 3 (severe): daily activities are affected by atrial fibrillation symptoms; grade 4 (disability): daily activities have stopped. The two groups were evaluated 1 time before and after each treatment.

6.5 atrial fibrillation specific quality of life assessment scale

The patients are combined with the actual conditions within 1 month, and the atrial fibrillation scale evaluation is carried out according to the influence of atrial fibrillation on the daily activity capacity, and the evaluation is carried out 1 time before and after treatment.

6.6 Pittsburgh sleep quality index Meter

The scale evaluation was performed according to the sleep time and sleep quality of the patient in approximately 1 month, and each evaluation was performed 1 time before and after the treatment.

6.7 safety index

Before and after treatment, the patient observes the blood, urine and stool convention, liver and kidney functions and blood coagulation functions, and records the occurrence of adverse events.

7. Statistical analysis: all test data were collated and statistically processed using SPSS 26.0 software.

8. Results:

8.1 atrial fibrillation seizure frequency and duration

TABLE 1 comparison of the frequency and duration of atrial fibrillation attacks before and after treatment

Note that: through rank sum test, P < 0.01 has significant difference compared with 0 week.

From the frequency and duration of atrial fibrillation episodes: the median of the frequency of atrial fibrillation attacks after treatment is reduced from 7 times/month to 1.5 times/month, and compared with 0 week, P < 0.01 has obvious statistical significance (P < 0.01) after treatment, the median of the duration of atrial fibrillation attacks before and after treatment is 7.25 h/month and 1 h/month respectively through rank and sum test.

8.2 clinical efficacy

After the treatment of the traditional Chinese medicine composition, the total effective rate of clinical curative effect is 90.67%, wherein 17 cases are clinically cured, the cure rate is 22.67%, 18 cases are obvious, the effective rate is 24.00%, 33 cases are effective, the effective rate is 44.00%, 7 cases are ineffective, and the ineffective rate is 9.33%.

TABLE 2 clinical efficacy [ example (%) ]

8.3 ventricular Rate comparison

TABLE 3 ventricular rate comparison before and after treatment

Note that: the P < 0.01 is significantly different from the 0 week comparison by paired t test.

From the resting ventricular rate point of view: the ventricular rate before and after treatment is 74.09+/-11.95 times/min and 68.09+/-6.81 times/min respectively, and P < 0.01 has obvious statistical significance compared with 0 week through paired t test.

8.4 atrial fibrillation burden

TABLE 4 treatment of anterior and posterior atrial fibrillation burden values

Note that: through rank sum test, P is less than 0.01, and the difference is obvious.

From the aspect of atrial fibrillation load, the median before and after treatment is 1.01 percent and 0.14 percent respectively, and the significant difference is that P is less than 0.01 through rank sum test.

8.5 atrial fibrillation specific quality of life assessment scale

TABLE 5 quality of life scale integration for treating atrial fibrillation

Note that: the P < 0.01 has significant difference through paired t test.

150 questions of the atrial fibrillation specific quality of life assessment scale questionnaire are issued before and after treatment, 145 questions are recovered, 145 questions are available, 72 people are available, the scores of the atrial fibrillation specific quality of life assessment scale before and after treatment are 62.23 +/-17.10 minutes and 81.26 +/-10.28 minutes respectively, and the difference has obvious statistical significance (P is less than 0.01) through paired t test.

8.6 Pittsburgh sleep quality index Meter

TABLE 6 sleep quality index before and after treatment

Note that: through rank sum test, P < 0.01 has significant statistical difference.

150 parts of Pittsburgh sleep quality scale questionnaires are issued before and after treatment, 140 parts of questionnaires are recovered, 140 parts of effective questionnaires are recovered, 70 people are effectively treated, the integral median of the scale before and after treatment is 8 minutes and 4 minutes respectively, and the significant difference is achieved by the rank and the test that P is less than 0.01.

8.7 Security assessment

After 1 person takes the traditional Chinese medicine, abdominal distention and diarrhea appear, and symptoms are relieved after the dosage of the traditional Chinese medicine is adjusted; 2 people suffer from hypotension and slow heart rate after taking beta-blocker when suffering from atrial fibrillation; thyroid lesions appear after 1 person takes amiodarone for a long period of time. The anticoagulant is taken and the traditional Chinese medicine is added for treatment, meanwhile, bleeding tendency and bleeding performance are not generated, and obvious adverse reactions are not generated.

Clinical experiments prove that the traditional Chinese medicine composition can effectively reduce the frequency and duration of atrial fibrillation attacks of patients, reduce the ventricular rate, the atrial fibrillation symptom classification and the atrial fibrillation load, improve the quality of life, improve the sleep condition, has the functions of resisting coagulation and enhancing myocardial contraction, can effectively avoid complications such as heart failure and the like caused by cerebral apoplexy and heart load aggravation caused by atrial fibrillation thrombosis, and has better safety.

Case of cases

Case 1

Zhang Mou men, 45 years old, had a diagnosis 10 months in 2022, mainly due to "intermittent palpitation for 13 years and aggravated for 1 month". No obvious cause exists before 13 years, palpitation and palpitation are caused, and the patient can see the heart-qi diagram of the local hospital to check "paroxysmal tachycardia" and treat the heart-qi diagram with medicines (in detail, not in detail), and the palpitation symptoms are caused intermittently. The symptoms of palpitation are aggravated in 2020, frequently occur every day, are diagnosed as paroxysmal atrial fibrillation in local hospitals, are treated by sotalol hydrochloride and diltiazem hydrochloride, and are relieved before the symptoms of palpitation are relieved. The patient had no obvious cause of aggravation of palpitation symptoms before 1 month, and was now treated with further traditional Chinese medicine, and was treated in I'm department. The following symptoms are shown in the following formula: the heart palpitation is frequently started, the heart palpitation is 3-4 times per week, each time lasts for 1-2 hours, chest distress, pain and discomfort in precordial areas, dizziness, bad mood, pain and pain in hypochondrium, anorexia, tension, poor sleep, shallow sleep, wakefulness and awkward adjustment. A dark red tongue with thin and white coating and a wiry and astringent pulse. Echocardiography: left Fang Najing (LA) 58mm. Dynamic electrocardiographic representation: atrial fibrillation, heart rate (HRav) 93 beats/minute, heart rate variability (SDNN): 89ms. The traditional Chinese medicine composition comprises the following components: 10g of rosewood heart wood, 3g of agilawood, 15g of radix salviae miltiorrhizae, 10g of earthworm, 10g of platycladi seed, 10g of Chinese pine knots, 30g of mother-of-pearl (decocted first), 30g of astragalus mongholicus, 6g of cortex acanthopanacis and the like. One dose is taken every day, decocted with water, and taken in the morning and evening. After 3 months of taking the medicine, all the symptoms of the patient are reduced, the disease is stable, and no obvious discomfort exists. Auxiliary inspection: LA:32mm, HRav:67 times/min, SDNN:137ms.

Case 2

Liu Mou men, 73 years old, were diagnosed in month 6 2022, mainly due to "15 years old interrupted palpitation attacks". The patient was in palpitation after tired 15 years ago, had a diagnosis of "paroxysmal atrial fibrillation" at Dan Jingshan hospital, had symptoms relieved after infusion had been reversed, had heart rate controlled 2 times per day with 12.5mg of betaxolol, and had intermittent episodes of palpitation thereafter. In 2020, in 4 months, with palpitation, radio frequency ablation was performed at An Zhen hospitals, 150mg of dabigatran etexilate was administered 2 times per day, and 0.2g of dada dragon was administered 3 times per day, and three months later. The symptoms are relieved after the patient has a panic break, has a rest or takes the heart stabilizing particles/the arrhythmia, and the patient is treated by further traditional Chinese medicine in the clinic of the department of I. The following symptoms are shown in the following formula: intermittent palpitation, 2-3 times per week, each time lasting for 30 minutes to 1 hour, debilitation, shortness of breath, chest distress and dull pain, feeling of fullness and stuffiness under the heart, easy sweating, easy dysphoria, dark complexion, anorexia, insomnia, difficulty in falling asleep, and shivering. A dark tongue with thin and white coating and a wiry and slippery pulse with irregular rhythm. Echocardiography: left Fang Najing (LA) 32mm. Dynamic electrocardiographic representation: heart rate (HRav) 87 times/minute, heart rate variability (SDNN): 78ms. The traditional Chinese medicine composition comprises the following components: 30g of raw astragalus, 15g of red sage root, 10g of rosewood heart wood, 10g of Chinese pine node, 15g of fried spina date seed, 25g of mother-of-pearl (decocted first), 10g of cuttlebone (decocted first), 15g of calcined concha arcae (decocted first), 6g of cortex lycii radicis, 15g of grassleaf sweelflag rhizome and the like. The symptoms of patients are basically relieved and the symptoms are stable after taking the medicine for more than 2 months. Auxiliary inspection: echocardiography: LA:31mm, hrav:68 times/min; SDNN:154ms.

Case 3

Kang Mou men, 68 years old, had a doctor visit in 2022, 8 months, mainly because of "intermittent palpitation for 3 years, exacerbation for 2 weeks". The patient who has generated qi before 3 years is in palpitation and discomfort, and is in the general aerospace hospital, is diagnosed as ventricular tachycardia and paroxysmal atrial fibrillation, and is discharged from the hospital after the symptoms are treated, and the patient is regularly treated by taking medicines (in detail). The patient in month 5 of 2021 is rechecked by radio frequency ablation in An Zhen hospitals in month 5 of 2022, and the electrocardiographic graph of paroxysmal atrial fibrillation is reviewed, so that the patient is now treated by further traditional Chinese medicine treatment, namely, the patient is treated by an outpatient department of I. No obvious cause exists before 2 weeks, the palpitation symptoms are aggravated, chest distress and shortness of breath are accompanied, and the clinic of the department of I is called for further treatment by traditional Chinese medicine. The following symptoms are shown in the following formula: palpitation, 1-2 times/month, each time lasting for 20 minutes to 2 hours, pain and discomfort of precordial region and back, debilitation, spontaneous perspiration, purple-skin, anorexia, difficulty in falling asleep, dreaminess, urination, stool shaping, 1 time/day. Pale purple tongue with blood stasis, white, thick and greasy coating and deep and wiry pulse. Echocardiography: left Fang Najing (LA) 45mm. Dynamic electrocardiographic representation: heart rate (HRav) 73 beats/minute, heart rate variability (SDNN): 67ms. The traditional Chinese medicine composition comprises the following components: 10g of rosewood heart wood, 3g of agilawood, 10g of earthworm, 15g of red sage root, 10g of Chinese pine knots, 10g of platycladi seeds, 30g of mother-of-pearl (first decoction), 6g of cortex caryophylli, 30g of astragalus mongholicus, 10g of grassleaf sweelflag rhizome, 15g of radix curcumae and the like. The medicine is taken for 21 times, the symptoms of patients are obviously relieved, and the symptoms are stable. Auxiliary inspection: echocardiography: LA:38mm. Dynamic electrocardiographic representation: heart rate (HRav) 65 beats/minute, heart rate variability (SDNN): 89.

the foregoing has shown and described the basic principles and main features of the present invention and the advantages of the present invention. It should be noted that it will be apparent to those skilled in the art that several modifications and adaptations can be made without departing from the general principles of the present invention, and such modifications and adaptations are intended to be comprehended within the scope of the present invention.

Claims

1. The traditional Chinese medicine composition for treating paroxysmal atrial fibrillation is characterized by comprising the following components in parts by weight: 9-15 parts of rosewood, 1-5 parts of agilawood, 10-15 parts of radix salviae miltiorrhizae, 5-10 parts of earthworm, 3-10 parts of platycladi seed, 10-25 parts of mother-of-pearl, 9-15 parts of Chinese pine knots, 9-30 parts of astragalus mongholicus and 3-6 parts of cortex caryophylli.

2. The traditional Chinese medicine composition according to claim 1, wherein the traditional Chinese medicine composition comprises 10 parts of rosewood, 3 parts of agilawood, 15 parts of radix salviae miltiorrhizae, 10 parts of earthworm, 10 parts of platycladi seed, 25 parts of mother-of-pearl, 10 parts of pinus koraiensis, 30 parts of astragalus membranaceus and 6 parts of cortex mori radicis.

3. Use of a traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating paroxysmal atrial fibrillation.

4. The traditional Chinese medicine composition according to claim 1 or 2, wherein a pharmaceutically acceptable excipient can be added to prepare a pharmaceutically conventional preparation.

5. A method of preparing a Chinese medicinal composition according to claim 1 or 2, comprising the steps of:

(3) Decocting with slow fire, boiling, and then continuously decocting for 20-30 minutes, wherein the total time of decoction is three times;

(4) Mixing the three decoctions, and filtering to obtain decoction.

6. A method of preparing a Chinese medicinal composition according to claim 1 or 2, comprising the steps of:

(2) Decocting the above Chinese medicinal materials in a closed container, adding 6-10 times of water, boiling, and maintaining the temperature at 80-95 ℃ for 25-45 minutes to obtain decoction;

(5) Adding conventional adjuvants, and making into granule.