Traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease

Abstract

The present invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, aiming to provide an effective, stable and less side-effect treatment plan. A traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease is composed of the following raw materials in parts by mass: 4-8 parts of fried ephedra, 4-8 parts of blanched bitter apricot kernels, 4-8 parts of scutellaria baicalensis, 12-18 parts of sea clam shell, 12-18 parts of mulberry bark, 12-18 parts of cortex lycii radicis, 12-18 parts of houttuynia cordata, 4-8 parts of blanched peach kernels, 4-8 parts of earthworm, 25-35 parts of dioscorea nipponica, 25-35 parts of elaeagnus root, and 4-8 parts of raw licorice. The whole formula of the traditional Chinese medicine composition of the present invention combines cold and warm herbs to restore the smoothness of lung qi and clear away the heat in the lung; combines clearing and resolving to remove the excess heat in the lung and resolve phlegm, eliminate the mutual binding of phlegm and heat; treat both qi and blood, regulate the ascending and descending of lung qi and improve blood circulation in the lungs. Treating heat-phlegm clearing, promoting blood circulation and relieving asthma not only targets the surface symptoms, but also starts from the pathogenesis of "heat-phlegm stasis" to fundamentally eliminate the cause.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine compositions, and particularly relates to a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, aiming to provide an effective, stable and less side-effect treatment plan. Background Art

[0002] Chronic respiratory diseases, cardiovascular and cerebrovascular diseases, diabetes, and malignant tumors are collectively called the four major chronic diseases. Chronic obstructive pulmonary disease (COPD) is a common chronic respiratory disease, which is mainly characterized by airway inflammation and is mainly caused by multiple factors such as smoking, air pollution, and genetics. In recent years, the infected population has shown a higher risk than healthy people, making the disease risk of COPD continue to increase. Western medicine mainly relieves symptoms such as anti-inflammation and bronchodilation to treat COPD, but its potential risks are that the bacterial resistance rate increases year by year, the mortality rate does not decrease but increases, and there are many adverse reactions, such as poor patient compliance, some patients cannot tolerate mechanical ventilation treatment, lung function shows progressive decline, and the long-term prognosis is poor. COPD mainly belongs to the categories of "dyspnea syndrome" and "pulmonary distension". Traditional Chinese medicine treatment of COPD often starts from the whole, emphasizes the unity of man and nature, seeks the root cause of the disease, and runs the syndrome differentiation and treatment throughout. It can mainly achieve the purpose of treating the disease through the overall regulatory effects such as dispersing the lung qi to relieve asthma, descending qi to resolve phlegm, tonifying the lung, kidney and spleen, and there are few adverse reactions.

[0003] According to the current domestic and foreign relevant diagnosis and treatment guidelines, COPD is divided into a stable period and an acute exacerbation period according to the urgency and severity of symptoms. In clinical practice, the "acute exacerbation period" is a stage with obvious clinical characteristics of this disease and has an important impact on the development of the disease, which is also the key staging of the disease. This staging is mostly seen as a mixture of deficiency and excess in traditional Chinese medicine clinical practice, and is often diagnosed as the syndrome of phlegm-heat congesting the lung, with the main accompanying symptoms such as aggravated cough due to pulmonary infection, wheezing and shortness of breath, excessive phlegm that is yellow or white and sticky, difficult expectoration, fever, dry stool, and decreased activity tolerance.

[0004] Chinese Patent CN104043037A discloses a pharmaceutical preparation for treating acute exacerbation of chronic obstructive pulmonary disease. The raw materials include Salvia miltiorrhiza, Agrimonia pilosa, Polygonatum sibiricum, Curcuma zedoaria, Cinnamomum cassia, Fritillaria thunbergii, Morus alba, Euryale ferox, Psychotria serpens, Gleditsia sinensis, Geranium wilfordii, Panax vietnamensis, Silene conoidea, Conyza canadensis, Asparagus cochinchinensis, Vernonia cinerea, Eriobotrya japonica, Anemarrhena asphodeloides, Glehnia littoralis, Ephedra sinica, Trichosanthes kirilowii, Morinda officinalis, Olibanum, Eclipta prostrata, Hippohgae rhamnoides, Polygonum cuspidatum, Changium smyrnioides, Phyllostachys nigra, Acorus tatarinowii, and Lycium chinense. The raw materials of this preparation contain more than thirty kinds of components, and the formula is complex. This prescription intervenes through multiple channels such as tonifying, clearing heat, and resolving phlegm, but there are defects such as weak anti-asthmatic effect and qi stagnation caused by tonifying drugs. The medicinal properties of the whole prescription are relatively warm and have strong astringency, which may aggravate phlegm-heat congesting the lungs and airway obstruction, and is not conducive to the treatment of the acute stage of COPD.

[0005] Chinese Patent CN104815171A discloses a traditional Chinese medicine preparation for treating phlegm-heat syndrome in the acute exacerbation stage of chronic obstructive pulmonary disease. The traditional Chinese medicine preparation is made from the following Chinese medicines in parts by weight: Habenaria lancea 15 - 25 parts, Pseudostellaria palibinensis 10 - 20 parts, Parabarium chinense 10 - 20 parts, Arundina graminifolia 15 - 25 parts, Myriactis wallichii 20 - 30 parts, Ficus hirta var. palmatiloba 30 - 40 parts, Bletilla formosana 8 - 12 parts, Bergenia ciliata 15 - 25 parts, Dendrobium aphyllum 10 - 20 parts, Phyllanthus urinaria 6 - 10 parts, Dracocephalum integrifolium 9 - 15 parts. This prescription intervenes through multiple channels such as clearing heat, resolving phlegm, promoting blood circulation, and tonifying, but there are problems such as insufficient anti-asthmatic effect, contradiction between cold and heat medicinal properties, qi stagnation caused by tonifying drugs, and complexity and dispersion of the formula, which may reduce the pertinence to the core pathogenesis of phlegm-heat congesting the lungs and airway spasm in the acute exacerbation stage of COPD, and even aggravate qi deficiency, yin injury, or the burden on the spleen and stomach. Medicinal materials such as Habenaria lancea, Pseudostellaria palibinensis, and Parabarium chinense in this formula are relatively rare, costly, and difficult to obtain.

[0006] Chinese Patent CN107569655A discloses a traditional Chinese medicine composition for the acute exacerbation stage of chronic obstructive pulmonary disease, which is made from the following Chinese medicines in parts by weight: Arisaema cum Bile 16 - 20 parts, Pinellia ternata 16 - 20 parts, Trichosanthes kirilowii 13 - 17 parts, Aurantii Fructus Immaturus 10 - 14 parts, Platycodon grandiflorum 10 - 14 parts, Scutellaria baicalensis 10 - 14 parts, Coptis chinensis 10 - 14 parts, Gardenia jasminoides 10 - 14 parts, Prunus davidiana 10 - 14 parts, Morus alba 10 - 14 parts, Houttuynia cordata 10 - 14 parts, Atractylodes macrocephala 8 - 10 parts, Citrus medica var. sarcodactylis 8 - 10 parts, Curcuma aromatica 8 - 10 parts, Poria cocos 8 - 10 parts, Atractylodes lancea 8 - 10 parts, Magnolia officinalis 5 - 7 parts, Gypsum Fibrosum 5 - 7 parts, and Glycyrrhiza uralensis 2 - 4 parts. This prescription uses a relatively large amount of bitter-cold medicines, such as Coptis chinensis, Gardenia jasminoides, and Gypsum Fibrosum. Although these have strong heat-clearing power, they may damage the spleen and stomach. Especially for COPD patients who may have weak spleen and stomach themselves, long-term or excessive use of bitter-cold medicines may cause damage to the stomach qi, affect digestion and absorption, and even cause side effects such as diarrhea. And this prescription lacks a powerful anti-asthmatic medicine such as Ephedra sinica. In the acute exacerbation stage of COPD, the anti-asthmatic effect of this prescription needs to be strengthened.

[0007] In view of the deficiencies in the existing technology, after fully considering the pathological mechanism and clinical manifestations of COPD, it is necessary to finely adjust the composition to ensure that the synergistic effect among various medicinal materials is maximally exerted, aiming to improve the therapeutic effect and the quality of life of patients. The present invention will contribute to promoting the in-depth research on the treatment of COPD with traditional Chinese medicine and providing more treatment options for COPD patients. Summary of the Invention

[0008] The purpose of the present invention is to provide a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease.

[0009] The technical solution of the present invention is as follows:

[0010] A traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, which is composed of the following raw medicinal materials in parts by mass: 4 - 8 parts of honey-fried ephedra, 4 - 8 parts of blanched bitter apricot seeds, 4 - 8 parts of scutellaria baicalensis, 12 - 18 parts of sea clam shell, 12 - 18 parts of mulberry bark, 12 - 18 parts of cortex lycii radicis, 12 - 18 parts of houttuynia cordata, 4 - 8 parts of blanched peach kernels, 4 - 8 parts of pheretima aspergillum, 25 - 35 parts of dioscorea nipponica, 25 - 35 parts of elaeagnus root, and 4 - 8 parts of raw licorice root.

[0011] Preferably, the traditional Chinese medicine composition is composed of the following raw medicinal materials in parts by mass: 6 parts of honey-fried ephedra, 6 parts of blanched bitter apricot seeds, 6 parts of scutellaria baicalensis, 15 parts of sea clam shell, 15 parts of mulberry bark, 15 parts of cortex lycii radicis, 12 parts of houttuynia cordata, 6 parts of blanched peach kernels, 6 parts of pheretima aspergillum, 30 parts of dioscorea nipponica, 25 parts of elaeagnus root, and 6 parts of raw licorice root; or

[0012] 4 parts of honey-fried ephedra, 4 parts of blanched bitter apricot seeds, 4 parts of scutellaria baicalensis, 12 parts of sea clam shell, 12 parts of mulberry bark, 18 parts of cortex lycii radicis, 18 parts of houttuynia cordata, 4 parts of blanched peach kernels, 4 parts of pheretima aspergillum, 25 parts of dioscorea nipponica, 35 parts of elaeagnus root, and 4 parts of raw licorice root; or

[0013] 8 parts of honey-fried ephedra, 8 parts of blanched bitter apricot seeds, 8 parts of scutellaria baicalensis, 18 parts of sea clam shell, 18 parts of mulberry bark, 18 parts of cortex lycii radicis, 18 parts of houttuynia cordata, 8 parts of blanched peach kernels, 8 parts of pheretima aspergillum, 35 parts of dioscorea nipponica, 35 parts of elaeagnus root, and 8 parts of raw licorice root; or

[0014] 7 parts of honey-fried ephedra, 7 parts of blanched bitter apricot seeds, 7 parts of scutellaria baicalensis, 16 parts of sea clam shell, 16 parts of mulberry bark, 12 parts of cortex lycii radicis, 16 parts of houttuynia cordata, 7 parts of blanched peach kernels, 7 parts of pheretima aspergillum, 28 parts of dioscorea nipponica, 32 parts of elaeagnus root, and 7 parts of raw licorice root; or

[0015] 6 parts of honey-fried ephedra, 6 parts of blanched bitter apricot seeds, 6 parts of scutellaria baicalensis, 12 parts of sea clam shell, 15 parts of mulberry bark, 15 parts of cortex lycii radicis, 15 parts of houttuynia cordata, 5 parts of blanched peach kernels, 7 parts of pheretima aspergillum, 28 parts of dioscorea nipponica, 30 parts of elaeagnus root, and 6 parts of raw licorice root.

[0016] The traditional Chinese medicine composition is prepared into oral preparations, including but not limited to decoctions and powders.

[0017] The preparation method of the decoction is as follows: Weigh various raw medicinal materials according to the parts by mass of the traditional Chinese medicine composition. After cleaning and chopping or cutting, first put the sea clam shell into water and decoct for 30 - 50 minutes, then put the other raw medicinal materials into water, decoct for 15 - 20 minutes for the first time, pour out 1 / 2 of the medicinal liquid, add warm water for the second decoction for 15 - 20 minutes, pour out all the medicinal liquid, and mix the two portions of medicinal liquid evenly to obtain the decoction.

[0018] The preparation method of the powder is as follows: Weigh various raw medicinal materials according to the above parts by weight. After cleaning and chopping or cutting, first put the sea clam shell into water and decoct for 30 - 50 minutes, then put the other raw medicinal materials into water and decoct for 30 - 50 minutes, pour out all the medicinal liquid, filter to obtain the filtrate, continue to decoct and concentrate the filtrate to a paste state, then granulate, dry, and sterilize to obtain the traditional Chinese medicine powder.

[0019] The preparation method of the blanched bitter apricot seeds is as follows: Take bitter apricot seeds, boil them in water with a weight multiple of 10 times, keep warm for 5 minutes, pick them up when the seed coat is slightly swollen, soak them in cold water, take them out and rub open the seed coat and the kernel, dry and sieve out the seed coat, and crush the kernel to obtain the blanched bitter apricot seeds.

[0020] The preparation method of the blanched peach kernels is as follows: Take peach kernels, boil them in water with a weight multiple of 10 times, keep warm for 5 minutes, pick them up when the seed coat is slightly swollen, soak them in cold water, take them out and rub open the seed coat and the kernel, dry and sieve out the seed coat, and crush the kernel to obtain the blanched peach kernels.

[0021] For the pretreatment methods of various medicinal materials in the present invention, refer to the Pharmacopoeia of the People's Republic of China (2020 Edition). The medicinal materials after standardized treatment can be used as the raw medicinal materials of the traditional Chinese medicine composition in this case.

[0022] The formula analysis of a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease in the present invention is as follows:

[0023] King drugs: stir - fried ephedra, blanched bitter apricot seeds;

[0024] Stir - fried ephedra is pungent, warm, and can disperse the lung qi and relieve asthma. Blanched bitter apricot seeds are slightly warm in nature, can lower the lung qi, resolve phlegm, relieve cough and asthma. The combination of stir - fried ephedra and blanched bitter apricot seeds, one dispersing and one descending, enhances the effect of relieving depression and asthma, enables the normal ascending and descending movement of the lung qi, and at the same time can prevent excessive dispersion of the lung qi from damaging body fluids. Based on the theory of "the lung and the large intestine are interior - exteriorly related", the effect of promoting defecation of bitter apricot seeds also helps to expel heat pathogens and phlegm in the lung, promote the smooth flow of the large intestine, and indirectly remove the pathogenic factors in the lung. Bitter apricot seeds are processed by blanching to obtain blanched bitter apricot seeds, removing the seed coat, preserving amygdalin, and reducing toxicity.

[0025] Minister drugs: scutellaria baicalensis, sea clam shell, mulberry bark, cortex lycii radicis, houttuynia cordata;

[0026] Scutellaria baicalensis Georgi is bitter in taste and cold in nature, and is good at entering the lung meridian, capable of clearing heat and drying dampness, purging fire and detoxifying. The nature and flavor of Meretrix meretrix Linnaeus are bitter, salty, and cold. Bitter can purge stasis, and salty can soften hardness and resolve phlegm, clear lung heat, transform heat phlegm, regulate qi movement, and the fire is removed and phlegm is eliminated. "Shennong Ben Cao Jing" states that it "maintains cough with upward adverse qi, wheezing, vexation and fullness, chest pain, fever and chills". "Compendium of Materia Medica" also records the efficacy of "clearing heat and promoting diuresis, resolving phlegm-fluid retention". The compatibility of Meretrix meretrix Linnaeus and Scutellaria baicalensis Georgi can enhance its efficacy of relieving cough and asthma. Houttuynia cordata Thunb. is bitter and cold, with the power of clearing heat and detoxifying, specifically targeting the source of lung heat, and can clear heat phlegm in the lungs. The combination of Scutellaria baicalensis Georgi, Meretrix meretrix Linnaeus, and Houttuynia cordata Thunb. enhances the power of clearing heat and purging fire, and can effectively clear lung heat to achieve the effects of resolving phlegm, relieving cough, and asthma. Both Morus alba L. root bark and Lycii radicis cortex have the dual effects of clearing and purging lung heat and relieving cough and asthma. Morus alba L. root bark clears heat and relieves asthma, resolves phlegm and stops cough, enters the qi aspect of the lung meridian, and focuses on purging lung heat to relieve asthma. Lycii radicis cortex is cold in nature, clears the lung and purges fire, relieves cough and asthma, is good at entering the blood aspect, and has the effect of purging the latent fire in the lung. The combination of the two clears both qi and blood, clears lung heat without damaging yin, protects yin fluid without retaining pathogenic factors, enhances the power of clearing and purging lung heat and relieving cough and asthma, and can effectively relieve the symptoms of cough and asthma due to phlegm-heat.

[0027] Assistant herbs: semen persicae, pheretima, dioscorea nipponica makino, elaeagnus root;

[0028] Earthworm enters the lung meridian and has the effects of clearing heat and resolving phlegm, dredging collaterals and relieving asthma. Dioscorea nipponica is bitter and warm, entering the lung meridian can clear the lung and resolve phlegm, perform the functions of relieving cough and asthma, promoting blood circulation and dredging obstruction, and can both defend and move, both tonify and dredge; at the same time, modern pharmacology has found that Dioscorea nipponica has an anti-inflammatory effect and can inhibit the expression of inflammatory factors. For example, the diosgenin component in Dioscorea nipponica can inhibit the secretion of inflammatory factors such as tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β) and interleukin-6 (IL-6) and the expression of HSP70 protein. The combination of Dioscorea nipponica and Scutellaria baicalensis purges the lung fire, and the effect of relieving cough, resolving phlegm and relieving asthma is multiplied. Dioscorea nipponica also has the effect of strengthening healthy qi. The combination of the whole formula can achieve the effect of dispelling pathogenic factors without damaging healthy qi. Therefore, Dioscorea nipponica is used heavily in this formula to enhance its anti-asthmatic effect. Prepared semen persicae descends and purges the lung qi, relieves cough and asthma; prepared bitter apricot kernel has the property of bitter descent, is good at descending the rebellious lung qi, and also disperses the stagnant lung qi. It is mainly for descending, and disperses while descending. The combination of prepared semen persicae and prepared bitter apricot kernel can enhance the effect of relieving cough and asthma. The simultaneous use of prepared semen persicae, earthworm and Dioscorea nipponica combines the effects of clearing heat and relieving asthma with promoting blood circulation and dredging collaterals, achieving two effects simultaneously: one is to dredge the qi and blood circulation in the lungs, and the other is to remove phlegm stasis in the lungs. In this way, the qi and blood in the lungs flow smoothly, the metabolism of body fluids returns to normal, and all symptoms will be eliminated. Elaeagnus root is neutral in nature and good at astringing, astringing the lung qi, relieving cough and asthma, expelling wind, promoting diuresis, removing food stagnation, and benefiting the throat. Its effect of relieving cough and resolving phlegm nodules is relatively strong. It is recorded in classical medical books such as "Zhejiang Folk Herbs" and "Jiangsu Medical College Handbook of Chinese Herbal Medicines" that Elaeagnus root can relieve cough and asthma. Therefore, using Elaeagnus root can enhance its effect of relieving cough and asthma. At the same time, Elaeagnus root has an antibacterial effect, including the inhibitory effect on respiratory tract infection bacteria (Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Klebsiella pneumoniae) and Gram-positive representative bacteria (Bacillus subtilis). The simultaneous use of Concha Meretricis Seu Cyclinae and Elaeagnus root can harmonize the five flavors and eliminate the cough and asthma of long-term diseases and disperse phlegm coagulation. The lung is the chief of the five zang-organs and is vulnerable to external pathogenic factors. However, the climate in the south is mostly humid, and external pathogenic factors often carry dampness when causing diseases. Moreover, patients with chronic respiratory diseases such as COPD who do not recover often have damp pathogenic factors remaining and cannot leave. When they are invaded by external pathogenic factors again, the pathogenic factors of wind-dampness and damp-heat cannot be transformed for a long time. Over time, it is easy to generate phlegm and heat, aggravating cough and asthma. "Treatise on Febrile and Miscellaneous Diseases" records: "For patients with damp pathogen diseases, there are body aches, fever, sallow complexion and asthma." For cough and asthma caused by damp pathogen, antirheumatic drugs are often used in combination with drugs for clearing heat and resolving phlegm. At the same time, there have long been records in ancient books about the use of antirheumatic drugs in the treatment of lung diseases. Therefore, when treating, antirheumatic drugs such as Dioscorea nipponica and Elaeagnus root can be used concurrently to treat wind and damp, and combined with the treatment principles of clearing heat and resolving phlegm, relieving cough and asthma, etc., which can achieve twice the result with half the effort.

[0029] Guiding drug: raw licorice;

[0030] Raw licorice can not only clear heat and relieve cough, but also harmonize all the drugs, and to a certain extent play a role in protecting healthy qi, achieving the effect of dispelling pathogenic factors without damaging healthy qi.

[0031] The beneficial effects of the present invention are as follows:

[0032] The traditional Chinese medicine composition of the present invention combines cold-natured and warm-natured herbs to restore the smooth dispersion of lung qi and clear away the heat in the lungs; it combines clearing and resolving to remove the excessive heat in the lungs and to resolve phlegm and eliminate the binding of phlegm-heat; it treats both qi and blood disorders, regulating the ascending and descending of the qi movement in the lungs and improving the blood circulation in the lungs. Treating heat-phlegm and promoting blood circulation to relieve asthma simultaneously not only targets the surface symptoms, but more importantly, starts from the pathogenesis of "heat-phlegm stasis" to fundamentally eliminate the causes.

[0033] 1. Comprehensive treatment with multiple targets, treating both the symptoms and the root cause;

[0034] Through the combination of multiple herbs, it achieves multi-target treatment such as dispersing lung qi to relieve asthma, clearing heat and detoxifying, promoting blood circulation to remove blood stasis, tonifying the kidney and benefiting the lungs, etc., taking into account various complex diseases.

[0035] 2. Appropriate ascending and descending, with ascending containing descending and descending containing ascending;

[0036] In the monarch herbs, stir-fried bitter apricot seeds and honey-fried ephedra are combined. While lifting yang qi, it is necessary to prevent the qi movement from being overly hyperactive and chaotic, and while descending turbidity, it is necessary to prevent the qi movement from descending too much and collapsing. One dispersing and one descending enhance the effect of relieving depression and asthma.

[0037] 3. Mutual assistance between cold and heat, regulating yin and yang;

[0038] Cold-natured and warm-natured herbs are combined with each other, which can not only clear heat but also warm yang, avoiding the excessive preponderance or decline caused by single herb use. It achieves the purpose of regulating yin and yang and balancing cold and heat.

[0039] 4. Combining attacking and tonifying, taking into account deficiency and excess;

[0040] The herbs for attacking pathogens and the herbs for tonifying are complementary to each other. They not only dispel pathogenic factors but also strengthen the healthy qi and consolidate the foundation. While tonifying deficiency, they do not forget to dispel pathogens, so as to achieve the purpose of not leaving pathogens when strengthening the healthy qi and not damaging the healthy qi when dispelling pathogens, and it is applicable to the diseases with long duration and the mixture of deficiency and excess.

[0041] 5. Treating stasis and heat simultaneously;

[0042] For this disease with a long duration and being difficult to cure, blood stasis blocks the collaterals, heat pathogen is internally accumulated, blood stasis and heat pathogen depend on each other, like oil mixing into flour and being difficult to separate. The disease lingers without healing. In this formula, the herbs for promoting blood circulation to remove blood stasis and the herbs for clearing heat and detoxifying are combined. Promoting blood circulation enhances the effect of promoting qi movement. When qi movement is smooth, coughing and asthma stop. It is applicable to both blood stasis blockage and heat toxin internal accumulation, fitting the symptoms of the disease.

[0043] 6. Treating the lungs and the kidneys simultaneously, generating metal with the nourishment of water;

[0044] The herbs for dispersing lung qi to relieve asthma and the herbs for tonifying the kidney and benefiting the lungs are combined, enabling the descending of the purifying qi of the lung metal and the abundance of the kidney water. Water moistens metal and metal generates water, maintaining the clarity and tranquility of the lungs, embodying the theory of "generating metal with the nourishment of water" in traditional Chinese medicine.

[0045] 7. Harmonizing the properties of herbs, harmony is precious;

[0046] Earthworm can clear the lung and relieve asthma, and is also good at dredging the meridians, which can make the promoting effect of various drugs on guiding them to their respective meridians smoother. Then Glycyrrhiza uralensis Fisch. is added to harmonize various drugs and balance the drug properties, making the whole prescription more coordinated. Looking at the whole prescription, when various drugs are combined, the five flavors are harmonized, the compatibility is appropriate, the ascending and descending of the drug flavors are in order, the generation and transformation have sources, the cold and heat, attacking and tonifying are considered, both deficiency and excess are taken into account, hitting the key mechanism of chronic obstructive pulmonary disease and conforming to its long-term illness state, so as to achieve the balance of yin and yang and treat both the symptoms and the root causes. It emphasizes harmony, balance and coordination, reflecting the treatment principle of "harmony is precious" in traditional Chinese medicine.

[0047] In the formulation concept of this prescription, the attacking and tonifying are combined, the cold and heat are harmonized, the yin and yang are harmonized, the five flavors are harmonized, and the qi movement is harmonized. It pays attention to the overall treatment based on harmony, balance and coordination. Emphasizing "harmony is precious", it avoids the deficiencies of the traditional prescription with perverse drug properties and single prescription efficacy, conforms to the pathogenesis and characteristics of COPD, pays more attention to the overall and gentle aspects, pursues the dynamic balance of the yin and yang, qi and blood, and zang-fu organs functions of the human body, and finally achieves the healthy state of "yin being peaceful and yang being secret", which is the embodiment of the pursuit of overall harmony and dynamic balance in traditional Chinese medicine. Specific implementation manners

[0048] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0049] Unless otherwise specified, the medicinal materials and reagents involved in the embodiments of the present invention are all commercially available products and can be obtained through commercial channels.

[0050] According to the principles of "syndrome differentiation and treatment" and "dosage adjustment according to symptoms", considering factors such as the properties of the traditional Chinese medicine composition and raw materials, compatibility relationship, dosage form, and applicable patients, the present invention provides a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease. Its basic formula consists of the following raw materials in parts by mass: roasted Ephedra 4 - 8 parts, blanched Bitter Apricot Seed 4 - 8 parts, Scutellaria baicalensis Georgi 4 - 8 parts, Clam Shell 12 - 18 parts, Mulberry Bark 12 - 18 parts, Cortex Lycii Radicis 12 - 18 parts, Houttuynia cordata Thunb. 12 - 18 parts, blanched Peach Kernel 4 - 8 parts, Earthworm 4 - 8 parts, Dioscorea nipponica Makino 25 - 35 parts, Elaeagnus root 25 - 35 parts, and raw Glycyrrhiza uralensis Fisch. 4 - 8 parts.

[0051] All the raw material medicinal materials used in the basic formula meet the requirements of "Pharmacopoeia of the People's Republic of China (2020 Edition)".

[0052] The following is an explanation in combination with the preferred embodiments and technical effects of the present invention. The decoctions or powders prepared in each embodiment and comparative example are all one dose.

[0053] Example 1:

[0054] This embodiment provides a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, which is composed of the following raw materials in parts by mass: stir-fried Ephedra 6g, blanched Bitter Apricot Kernel 6g, Scutellaria baicalensis 6g, Clam Shell 15g, Mulberry Bark 15g, Cortex Lycii Radicis 15g, Houttuynia cordata 12g, blanched Peach Kernel 6g, Earthworm 6g, Dioscorea nipponica 30g, Elaeagnus root 25g, and raw Licorice Root 6g.

[0055] Decoction preparation: Weigh various raw materials according to the above parts by weight. After cleaning and chopping or cutting, first put the Clam Shell into water and decoct for 40 minutes, then put the other raw materials into water. Decoct for 15 minutes for the first time, pour out 1 / 2 of the medicinal liquid, add warm water to the original liquid level and decoct for 20 minutes for the second time. Pour out all the medicinal liquid, and combine and mix the two decoctions to obtain the decoction.

[0056] Example two:

[0057] This embodiment provides a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, which is composed of the following raw materials in parts by mass: stir-fried Ephedra 4g, blanched Bitter Apricot Kernel 4g, Scutellaria baicalensis 4g, Clam Shell 12g, Mulberry Bark 12g, Cortex Lycii Radicis 18g, Houttuynia cordata 18g, blanched Peach Kernel 4g, Earthworm 4g, Dioscorea nipponica 25g, Elaeagnus root 35g, and raw Licorice Root 4g.

[0058] Decoction preparation: Weigh various raw materials according to the above parts by weight. After cleaning and chopping or cutting, first put the Clam Shell into water and decoct for 30 minutes, then put the other raw materials into water. Decoct for 15 minutes for the first time, pour out 1 / 2 of the medicinal liquid, add warm water to the original liquid level and decoct for 15 minutes for the second time. Pour out all the medicinal liquid, and combine and mix the two decoctions to obtain the decoction.

[0059] Example three:

[0060] This embodiment provides a traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, which is composed of the following raw materials in parts by mass: stir-fried Ephedra 8g, blanched Bitter Apricot Kernel 8g, Scutellaria baicalensis 8g, Clam Shell 18g, Mulberry Bark 18g, Cortex Lycii Radicis 18g, Houttuynia cordata 18g, blanched Peach Kernel 8g, Earthworm 8g, Dioscorea nipponica 35g, Elaeagnus root 35g, and raw Licorice Root 8g.

[0061] Weigh various raw materials according to the above parts by weight. After cleaning and chopping or cutting, first put the Clam Shell into water and decoct for 50 minutes, then put the other raw materials into water and decoct for 50 minutes. Pour out all the medicinal liquid, filter to obtain the filtrate, continue to decoct and concentrate the filtrate to a paste state, then granulate, dry, and sterilize to obtain the traditional Chinese medicine powder.

[0062] Example four:

[0063] Ephedra praeparata cum honey 7g, Armeniaca vulgaris var. ansu semen praeparata 7g, Scutellaria baicalensis Georgi 7g, Concha Meretricis seu Cyclinae 16g, Cortex Mori 16g, Cortex Lycii Radicis 12g, Houttuynia cordata Thunb. 16g, Persica semen praeparata 7g, Pheretima 7g, Dioscorea nipponica Makino 28g, Elaeagnus pungens Thunb. root 32g, Glycyrrhiza uralensis Fisch. 7g.

[0064] Weigh various raw medicinal materials according to the above weight portions. After cleaning and chopping or cutting, first put Concha Meretricis seu Cyclinae into water and decoct for 40 minutes, then put other raw medicinal materials into water and decoct for 40 minutes. Pour out all the medicinal liquid, filter to obtain the filtrate, continue to decoct and concentrate the filtrate to a paste state, and then carry out granulation, drying, and sterilization to obtain the traditional Chinese medicine powder.

[0065] Example Five:

[0066] Ephedra praeparata cum honey 6g, Armeniaca vulgaris var. ansu semen praeparata 6g, Scutellaria baicalensis Georgi 6g, Concha Meretricis seu Cyclinae 12g, Cortex Mori 15g, Cortex Lycii Radicis 15g, Houttuynia cordata Thunb. 15g, Persica semen praeparata 5g, Pheretima 7g, Dioscorea nipponica Makino 28g, Elaeagnus pungens Thunb. root 30g, Glycyrrhiza uralensis Fisch. 6g.

[0067] Weigh various raw medicinal materials according to the above weight portions. After cleaning and chopping or cutting, first put Concha Meretricis seu Cyclinae into water and decoct for 30 minutes, then put other raw medicinal materials into water and decoct for 30 minutes. Pour out all the medicinal liquid, filter to obtain the filtrate, continue to decoct and concentrate the filtrate to a paste state, and then carry out granulation, drying, and sterilization to obtain the traditional Chinese medicine powder.

[0068] Control Group:

[0069] In this control group, a traditional Chinese medicine decoction was prepared. The preparation method refers to Example One, but the composition of the ministerial drugs and adjuvant drugs was adjusted. Specifically, Concha Meretricis seu Cyclinae was removed from the ministerial drugs in this control group; Elaeagnus pungens Thunb. root was removed from the adjuvant drugs. A traditional Chinese medicine decoction was prepared in the same way as in Example One.

[0070] Clinical Trial Part:

[0071] I. General Information and Case Sources

[0072] A total of 123 patients with acute exacerbation of chronic obstructive pulmonary disease in the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from January 1, 2021, to December 31, 2023, were collected as the research objects.

[0073] II. Diagnostic Criteria:

[0074] 1. Western Medicine Diagnostic Criteria:

[0075] Refer to the diagnostic criteria for chronic obstructive pulmonary disease in the "Diagnosis and Treatment Guidelines for Chronic Obstructive Pulmonary Disease" (2021 Revised Edition):

[0076] ① Having a smoking history, exposure to risk factors such as biomass fuel exposure, air pollution, or host factors;

[0077] ②History of recurrent lower respiratory tract infections;

[0078] ③The main symptoms are dyspnea, chronic cough or expectoration;

[0079] ④Pulmonary function measurement: After using a bronchodilator, FEV1 / FVC < 0.7. FEV1 is the forced expiratory volume in one second, which refers to the volume of gas that the subject can exhale in the first second after inhaling as deeply as possible and then exhaling as forcefully as possible. FVC is the forced vital capacity, which refers to the total volume of gas that the subject exhales as quickly and as much as possible starting from the maximum inhalation position. FEV1 / FVC is the ratio of FEV1 to FVC, usually expressed as a percentage, abbreviated as the one-second rate, and is the main indicator for judging airflow obstruction. When the FEV1 / FVC ratio is lower than 0.7, airway obstruction is usually considered to exist;

[0080] ⑤After excluding other diseases, it can be diagnosed as COPD according to ①②③④.

[0081] The acute exacerbation of chronic obstructive pulmonary disease refers to the aggravation of cough, expectoration, and dyspnea compared with the daily level, or an increase in sputum volume, or expectoration of sputum, and requires a change in the medication regimen.

[0082] 2. Traditional Chinese medicine diagnostic criteria: Refer to the diagnostic criteria for the syndrome of phlegm-heat obstructing the lung in the acute exacerbation period in the "2022 Edition of the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment Guidelines for Chronic Obstructive Pulmonary Disease":

[0083] ①Cough or wheezing and shortness of breath;

[0084] ②Excessive phlegm, yellow or white and sticky, difficult to expectorate;

[0085] ③Fever or thirst, preference for cold drinks;

[0086] ④Dry stools;

[0087] ⑤Red tongue, yellow or yellow-greasy tongue coating, or rapid or slippery-rapid pulse.

[0088] Meeting items ① and ②, plus any two of ③, ④, and ⑤, then it meets the traditional Chinese medicine diagnostic criteria.

[0089] III. Inclusion criteria:

[0090] 1. Patients with acute exacerbation of chronic obstructive pulmonary disease who meet the western medicine diagnostic criteria;

[0091] 2. Patients who meet the traditional Chinese medicine disease differentiation belonging to the syndrome of phlegm-heat obstructing the lung in the acute exacerbation period of chronic obstructive pulmonary disease;

[0092] 3. Aged between 40 and 85 years old, regardless of gender;

[0093] 4. Those who are tolerant to the drugs and treatment methods designed in this study; voluntarily participate in this clinical study and sign the informed consent form.

[0094] If any of the above items 1 and 2 is met, items 3 and 4 shall be met simultaneously.

[0095] IV. Exclusion Criteria:

[0096] 1. Having other serious primary organic diseases, or having serious complications such as heart, liver, and kidney diseases;

[0097] 2. Suffering from other diseases that cause cough and wheezing, such as pulmonary tuberculosis, lung cancer, bronchiectasis, interstitial pulmonary fibrosis, etc.;

[0098] 3. Having a history of drug allergy to the drugs used in this study;

[0099] 4. Pregnant and lactating women;

[0100] 5. Suffering from diseases such as mental disorders and cognitive impairments;

[0101] 6. Being participants in other trials or research.

[0102] V. Exclusion, Withdrawal, and Termination Criteria:

[0103] 1. Patients with poor compliance, who do not receive treatment strictly as prescribed and affect the efficacy evaluation;

[0104] 2. Missing, incorrect, or incomplete statistical or evaluation data that affect the efficacy evaluation;

[0105] 3. Developing other diseases during the trial that affect the treatment;

[0106] 4. Developing serious adverse reactions during the trial;

[0107] 5. Developing serious other concurrent diseases or deterioration of the condition during the trial that may lead to dangerous events.

[0108] VI. Trial Methods

[0109] (I) Grouping Method:

[0110] The patients are divided into three groups according to the random number table method, namely the experimental group, the control group, and the comparison group, with 41 cases in each group.

[0111] One case in the control group withdrew voluntarily, and 2 cases had poor compliance, with a total of 3 cases dropping out. Finally, 38 cases completed the trial; 3 cases were lost to follow-up and 1 case had poor compliance in the experimental group, with a total of 4 cases dropping out. Finally, 37 cases completed the trial; 2 cases were lost to follow-up, 1 case withdrew voluntarily, and 1 case had poor compliance in the comparison group, with a total of 4 cases dropping out. Finally, 37 cases completed the trial. A total of 112 patients were included in this study.

[0112] (II) Treatment Method:

[0113] 1. General treatment: Basic treatment is given, including disease-related education, low-salt and low-fat diet, smoking cessation and alcohol restriction, moderate exercise, avoidance of wind and cold, emotional regulation, and careful daily life.

[0114] 2. Drug treatment:

[0115] 1) Control group: Standardized Western medicine treatment refers to the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)", specific dosing regimen:

[0116] ① Low-flow oxygen inhalation: low-flow oxygen inhalation at a flow rate of 2-3L / min through a conventional nasal cannula, monitoring the pulse oxygen saturation (SPO2) to maintain it at 88%-92%, and non-invasive assisted ventilation treatment when necessary;

[0117] ② Nebulized inhalation: budesonide nebulized suspension for inhalation, manufacturer: Changfeng Pharmaceutical Co., Ltd., batch number: 2209159, 2 ml each time; salbutamol sulfate solution for inhalation, manufacturer: Zhejiang Furuixi Pharmaceutical Co., Ltd., batch number: H20160660, 3 ml each time; budesonide nebulized suspension for inhalation and salbutamol sulfate solution for inhalation are combined by nebulization inhalation according to the above standards, twice a day; inhalation time: around 7:00 in the morning and around 19:00 in the evening;

[0118] ③Infection control: Amoxicillin and clavulanate potassium for injection is used empirically according to local common pathogens. Manufacturer: North China Pharmaceutical Co., Ltd., batch number: National Medicine Standard H10910017, specification: 1.2g, intravenous drip, Q8h, antibiotics should be adjusted according to specific circumstances during treatment;

[0119] ④ Expectorant and cough relieving: Ambroxol hydrochloride dispersible tablets, manufacturer: Shanxi Qianyuan Pharmaceutical Group Co., Ltd., batch number: H20060254, oral, 1 tablet each time, three times a day; medication time: around 7:00 in the morning, around 12:00 noon, and around 19:00 in the evening;

[0120] ⑤ Antispasmodic and antiasthmatic: Dihydroxypropylphylline injection (manufacturer: Suicheng Pharmaceutical Co., Ltd., batch number: National Medicine Standard: H20066526) 0.25g, intravenous drip, Bid.

[0121] 2) Experimental group: The control group was given the Chinese medicine decoction of Example 1. Usage: one dose per day, divided into two doses, taken warm in the morning and evening.

[0122] 3) Comparative group: The control group was given the Chinese medicine decoction of comparative example 1 on the basis of the control group. Usage: one dose per day, divided into two doses, taken warm in the morning and evening.

[0123] The three groups were treated for 2 courses in total with 7 days as one course of treatment.

[0124] (III) Observation indicators:

[0125] 1. Safety indicators:

[0126] Examinations such as body temperature, heart rate, blood pressure, pulse, blood routine, liver and kidney function, electrolytes, blood lipids, urine and feces routine (once before and after treatment);

[0127] Observe possible adverse reactions, including local skin reactions and systemic reactions, such as whether general rashes, allergic reactions, and gastrointestinal reactions occur. Pay attention to analyzing the causes of adverse reactions, make accurate judgments in a timely manner, and truthfully record the treatment process and results;

[0128] 2. Efficacy indicators:

[0129] 1) Traditional Chinese medicine (TCM) syndrome scoring criteria: According to the TCM syndrome integral scale: Cough, expectoration, and wheezing are regarded as main symptoms and are assigned different scores according to none, mild, moderate, and severe, from low to high as 0, 2, 4, and 6 points respectively. Four secondary symptoms, namely fever, thirst with preference for drinking, yellowish and scanty urine, and dry stools, are rated as 0, 1, 2, and 3 points according to none, mild, moderate, and severe. The tongue and pulse are recorded as they are and are not included in the scoring items. Inform the patients in detail about the TCM syndrome scoring situation, and the researchers collect the symptom changes of the patients before and after treatment respectively.

[0130] 2) Western medicine efficacy evaluation criteria:

[0131] ① mMRC dyspnea score;

[0132] ② COPD Assessment Test (CAT);

[0133] ③ Laboratory indicators: Inflammatory indicators: white blood cell (WBC), C-reactive protein (CRP); Blood gas analysis: PaO2, PaCO2;

[0134] ④ Pulmonary function index: FEV1 / FVC;

[0135] ⑤ Six-minute walk distance (6MWD), mainly record the activity distance of the patients within six minutes, test the exercise endurance of the patients, record once before and after treatment respectively, and the patients should be informed in detail about the test content and precautions before the test.

[0136] 3) Efficacy judgment criteria:

[0137] Refer to the "Guiding Principles for Clinical Research of New Chinese Medicines" (2002 edition) to determine the efficacy judgment criteria, which are as follows:

[0138] ① Clinical control: Clinical symptoms and signs disappear or basically disappear, and the reduction rate of TCM syndrome integral ≥ 95%;

[0139] ② Marked effect: Clinical symptoms and signs are significantly improved, and the reduction rate of TCM syndrome integral ≥ 70% and < 95%;

[0140] ③ Effective: Both clinical symptoms and signs have improved, and the reduction rate of traditional Chinese medicine syndrome score is ≥ 30% and < 70%;

[0141] ④ Ineffective: Clinical symptoms and signs have not improved significantly or even deteriorated, and the reduction rate of traditional Chinese medicine syndrome score is < 30%;

[0142] The reduction rate of traditional Chinese medicine syndrome score in the above-mentioned curative effect judgment standard adopts the Nimodipine method, and the calculation formula is: Reduction rate of traditional Chinese medicine syndrome score = [ (Total syndrome score before treatment - Total syndrome score after treatment) / Total syndrome score before treatment ] × 100%.

[0143] VII. Statistical analysis:

[0144] The SPSS 26.0 software is used to input and analyze the data. For measurement data, the mean ± standard deviation is used for data description. For data that conforms to normal distribution and homogeneity of variance, paired sample t-test is used for within-group comparison, and one-way ANOVA is used for between-group comparison. If not, the rank sum test is used. For count data, frequency or percentage (%) is used for expression, and chi-square test is used for between-group comparison. For rank data, the rank sum test is used for between-group comparison. When P < 0.05, the difference between the two groups of data is considered to be statistically significant.

[0145] VIII. Research results:

[0146] 1. Comparison of genders among three groups of patients:

[0147] A total of 112 patients were included in this study, including 58 males and 54 females. There were 37 patients in the experimental group, including 19 males, accounting for 51.40%, and 18 females, accounting for 48.60%. There were 37 patients in the control group, including 19 males, accounting for 51.40%, and 18 females, accounting for 48.60%. There were 38 patients in the control group, including 20 males, accounting for 52.60%, and 18 females, accounting for 47.40%. After chi-square test, X 2 =0.016, P = 0.992 > 0.05, indicating that there is no statistically significant difference in the genders among the three groups of patients, suggesting that the gender data of the three groups are comparable. See Table 1.

[0148] Table 1: Comparison of genders among three groups of patients:

[0149] .

[0150] 2. Comparison of ages among three groups of patients:

[0151] The ages of three groups of patients were compared. In the experimental group, the maximum age was 85 years old, the minimum age was 41 years old, and the average age was 67.14 ± 14.43 years; in the comparison group, the maximum age was 85 years old, the minimum age was 40 years old, and the average age was 67.27 ± 14.82 years; in the control group, the maximum age was 85 years old, the minimum age was 40 years old, and the average age was 67.92 ± 12.82 years. After rank sum test, we got H c = 0.086, P = 0.958 > 0.05, indicating that there was no statistically significant difference in the ages among the three groups of patients, suggesting that the two groups of age data were comparable, as shown in Table 2.

[0152] Table 2: Comparison of ages of three groups of patients

[0153] 。

[0154] 3. Comparison of disease courses of three groups of patients:

[0155] The disease courses of three groups of patients were compared. In the experimental group, the longest disease course was 13 years, the shortest disease course was 6 years, and the average disease course was 10.19 ± 2.22 years; in the comparison group, the longest disease course was 14 years, the shortest disease course was 6 years, and the average disease course was 10.32 ± 2.30 years; in the control group, the longest disease course was 14 years, the shortest disease course was 6 years, and the average disease course was 10.34 ± 2.39 years. After rank sum test, we got H c = 0.108, P = 0.948 > 0.05, indicating that there was no statistically significant difference in the disease courses among the three groups of patients, suggesting that the three groups of disease course data were comparable. See Table 3.

[0156] Table 3: Comparison of disease courses of three groups of patients

[0157] 。

[0158] 4. Comparison of TCM syndrome scores of three groups of patients before and after treatment:

[0159] The data within the groups were compared: After treatment, the TCM syndrome scores of all three groups of patients decreased. After t - test, it was found that in the experimental group, t = 21.085, P < 0.001; in the control group, t = 11.841, P < 0.001; after rank sum test, it was found that in the comparison group, Z = -5.312, P < 0.001, indicating that there was a statistically significant difference in the TCM syndrome scores of the three groups of patients before and after treatment, suggesting that all three groups of interventions were effective.

[0160] Comparison of data between groups: Through one-way ANOVA, it was found that for the TCM syndrome scores of the three groups of patients before treatment, F = 0.020, P = 0.980 > 0.05, and the difference was not statistically significant, indicating that the TCM syndrome score data of the three groups before treatment were comparable; through the rank sum test, it was found that for the TCM syndrome scores of the three groups of patients after treatment, H c = 28.862, P < 0.001, and the difference was statistically significant, suggesting that the experimental group had a more obvious effect than the control group and the comparison group in improving TCM symptoms such as wheezing, coughing, expectoration, fever, thirst with preference for drinking, yellowish and scanty urine, and dry stools. See Table 4.

[0161] Table 4: Comparison of TCM syndrome scores of three groups of patients before and after treatment (points):

[0162] 。

[0163] 5. Comparison of mMRC dyspnea scores of three groups of patients before and after treatment:

[0164] Comparison of data within groups: After treatment, the mMRC scores of the three groups of patients all decreased. Through the rank sum test, it was found that for the experimental group, Z = -3.950, P < 0.001; for the control group, Z = -3.400, P = 0.001; for the comparison group, Z = -2.570, P = 0.01 < 0.05, indicating that there was a statistically significant difference in the mMRC scores of the three groups of patients before and after treatment, suggesting that all three interventions were effective.

[0165] Comparison of data between groups: Through the rank sum test, it was found that for the mMRC scores of the three groups of patients before treatment, the difference H c = 0.072, P = 0.964 > 0.05, without statistical significance, indicating that the mMRC score data of the three groups before treatment were comparable; for the mMRC scores of the three groups of patients after treatment, the difference H c = 10.877, P = 0.004 < 0.05, with statistical significance, suggesting that the experimental group had a more obvious effect than the control group and the comparison group in improving the degree of dyspnea of patients. Details are shown in Table 5.

[0166] Table 5: Comparison of mMRC dyspnea scores of three groups of patients before and after treatment (points):

[0167] 。

[0168] 6. Comparison of CAT scores of the Chronic Obstructive Pulmonary Disease Assessment Test in three groups of patients:

[0169] Compare the data within the groups: After treatment, the CAT scores of all three groups increased. Through t-tests, it was obtained that for the experimental group, t = 10.292, P < 0.001; for the control group, t = 7.745, P < 0.001; and for the comparison group, t = 6.239, P < 0.001. This indicates that there are statistically significant differences in the CAT scores of the three groups of patients before and after treatment, suggesting that all three interventions are effective.

[0170] Compare the data between the groups: Through the rank sum test, it was obtained that the difference in the CAT scores of the three groups of patients before treatment, H c = 0.282, P = 0.868 > 0.05, which is not statistically significant, indicating that the CAT score data of the three groups before treatment are comparable; the difference in the CAT scores of the three groups of patients after treatment, H c = 17.035, P < 0.001, which is statistically significant, suggesting that the experimental group has a more obvious effect in improving the quality of life of patients compared with the control group and the comparison group. For details, see Table 6.

[0171] Table 6: Comparison of the CAT scores of the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) for the three groups of patients (points):

[0172] 。

[0173] 7. Comparison of the white blood cell (WBC) levels of the three groups of patients before and after treatment:

[0174] Compare the data within the groups: After treatment, the WBC levels of the three groups of patients decreased. Through the rank sum test, it was obtained that for the experimental group, Z = -5.500, P < 0.001; for the control group, Z = -5.429, P < 0.001; and for the comparison group, Z = -5.548, P = < 0.001. This indicates that there are statistically significant differences in the WBC levels of the three groups of patients before and after treatment, suggesting that all three interventions are effective.

[0175] Compare the data between the groups: Through one-way analysis of variance, it was obtained that for the WBC levels of the three groups of patients before treatment, F = 0.258, P = 0.773 > 0.05, and the difference is not statistically significant, indicating that the WBC data of the three groups before treatment are comparable; through the rank sum test, the difference in the WBC levels of the three groups of patients after treatment, H c = 31.393, P < 0.001, which is statistically significant, suggesting that the experimental group has a more obvious effect in reducing the white blood cell levels of patients compared with the control group and the comparison group. See Table 7.

[0176] Table 7: Comparison of the white blood cell (WBC) levels of the three groups of patients before and after treatment:

[0177] 。

[0178] 8. Comparison of the forced expiratory volume in one second (FEV1) levels of the three groups of patients before and after treatment (%):

[0179] Compare the data within the groups: After treatment, the FEV1 levels of the three groups of patients all increased. After the rank sum test, it was found that in the experimental group, Z = -5.303, P < 0.001; in the control group, Z = -5.373, P < 0.001; in the comparison group, Z = -5.464, P < 0.001. This indicates that there is a statistically significant difference in the FEV1 levels of the three groups of patients before and after treatment, suggesting that all three interventions are effective.

[0180] Compare the data between the groups: After one-way ANOVA, it was found that there was no statistically significant difference in the FEV1 levels of the three groups of patients before treatment (F = 0.279, P = 0.757 > 0.05), indicating that the FEV1 data of the three groups before treatment are comparable; after the rank sum test, it was found that there was a statistically significant difference in the FEV1 levels of the three groups of patients after treatment (H c = 77.623, P < 0.001), suggesting that the experimental group has a more obvious effect than the comparison group and the control group in improving the forced expiratory volume in one second of the patients. The details are shown in Table 8.

[0181] Table 8: Comparison of forced expiratory volume in one second (FEV1) of the three groups of patients before and after treatment (L / S):

[0182] .

[0183] 9. Comparison of the FEV1 / FVC levels of the three groups of patients before and after treatment:

[0184] Compare the data within the groups: After treatment, the FEV1 / FVC levels of the three groups all increased. After the rank sum test, it was found that in the experimental group, Z = -4.745, P < 0.001; in the comparison group, Z = -5.442, P < 0.001; in the control group, Z = -2.777, P < 0.001. This indicates that there is a statistically significant difference in the FEV1 / FVC levels of the three groups of patients before and after treatment, suggesting that all three interventions are effective.

[0185] Compare the data between the groups: After the rank sum test, it was found that the difference in the FEV1 / FVC levels of the three groups of patients before treatment H c = 0.073, P = 0.964 > 0.05, which is not statistically significant, indicating that the FEV1 data of the three groups before treatment are comparable; the difference in the FEV1 / FVC levels of the three groups of patients after treatment H c = 7.448, P = 0.024 < 0.05, which is statistically significant, suggesting that the experimental group has a more obvious effect than the comparison group and the control group in improving the FEV1 / FVC of the patients. The details are shown in Table 9.

[0186] Table 9: Comparison of FEV1 / FVC of the three groups of patients before and after treatment (%):

[0187] 。

[0188] 10. Comparison of C-reactive protein (CRP) levels in three groups of patients before and after treatment:

[0189] Comparing the data within the group: After treatment, the CRP levels in all three groups decreased. After the rank sum test, it was found that in the experimental group, Z = -5.392, P < 0.001; in the control group, Z = -5.424, P < 0.001; in the control group, Z = -5.486, P = <0.001. This indicates that there is a statistically significant difference in the CRP levels of the three groups of patients before and after treatment, suggesting that all three interventions are effective.

[0190] Comparing the data between groups: After one-way ANOVA, it was found that the difference in CRP levels before treatment among the three groups of patients was F = 0.519, P = 0.596 > 0.05, which was not statistically significant, indicating that the CRP data before treatment in the three groups were comparable; after the rank sum test, the difference in CRP levels after treatment among the three groups of patients was H c = 49.979, P < 0.001, which was statistically significant, suggesting that the experimental group was more effective than the control group and the control group in reducing the C-reactive protein level in patients. See Table 10.

[0191] Table 10: Comparison of C-reactive protein (CRP) in three groups of patients before and after treatment:

[0192] 。

[0193] 11. Comparison of six-minute walking distance (6MWD) levels in three groups of patients before and after treatment:

[0194] Comparing the data within the group: After treatment, the 6MWD levels of all three groups of patients increased. After the rank sum test, it was found that in the experimental group, Z = -5.303, P < 0.001; in the control group, Z = -5.288, P < 0.001; in the control group, Z = -4.938, P = <0.001. This indicates that there is a statistically significant difference in the 6MWD levels of the three groups of patients before and after treatment, suggesting that all three interventions are effective. Comparing the data between groups: After one-way ANOVA, it was found that the difference in 6MWD levels before treatment among the three groups of patients was F = 2.241, P = 0.111 > 0.05, which was not statistically significant, indicating that the 6MWD data before treatment in the three groups were comparable; after the rank sum test, the difference in 6MWD levels after treatment among the three groups of patients was H c = 22.851, P < 0.001, which was statistically significant, suggesting that the experimental group was more effective than the control group and the control group in increasing the six-minute walking distance level of patients. See Table 11.

[0195] Table 11: Comparison of the 6-minute walking distance (6MWD) of the three groups of patients before and after treatment:

[0196] 。

[0197] 12. Comparison of PaO2 of the three groups of patients before and after treatment:

[0198] Comparing the data within the group: After treatment, the PaO2 of the three groups of patients all decreased. After the rank sum test, it was obtained that for the experimental group, Z = -5.569, P < 0.001; for the control group, Z = -5.512, P < 0.001; for the control group, Z = -5.539, P < 0.001. This indicates that there is a statistically significant difference in PaO2 between the three groups of patients before and after treatment, suggesting that the interventions for the three groups are all effective. Comparing the data between groups: After one-way ANOVA, it was obtained that the difference in PaO2 before treatment among the three groups of patients was F = 0.420, P = 0.658 > 0.05, without statistical significance, indicating that the PaO2 data before treatment of the three groups are comparable; the difference in PaO2 after treatment among the three groups of patients was H c = 21.176, P < 0.001, with statistical significance, suggesting that the experimental group has a more obvious effect in improving the PaO2 of patients compared with the control group and the control group. See Table 12.

[0199] Table 12: Comparison of PaO2 of the three groups of patients before and after treatment:

[0200] 。

[0201] 13. Comparison of PaCO2 of the three groups of patients before and after treatment:

[0202] Comparing the data within the group: After treatment, the PaCO2 of the three groups all decreased. After the rank sum test, it was obtained that for the experimental group, Z = -5.485, P < 0.001; for the control group, Z = -5.940, P < 0.001; for the control group, Z = -5.962, P < 0.001. This indicates that there is a statistically significant difference in PaCO2 between the three groups of patients before and after treatment, suggesting that the interventions for the three groups are all effective. Comparing the data between groups: After one-way ANOVA, it was obtained that the difference in PaCO2 before treatment among the three groups of patients was not statistically significant, indicating that the PaCO2 data before treatment of the three groups are comparable; the difference in PaCO2 after treatment among the three groups of patients was statistically significant, suggesting that the experimental group has a more obvious effect in improving the PaCO2 of patients compared with the control group and the control group. For details, see Table 13.

[0203] Table 13: Comparison of PaCO2 of the three groups of patients before and after treatment:

[0204] 。

[0205] 14. Comparison of the curative effects of the three groups of patients after treatment:

[0206] After the completion of the entire treatment course of this study, there were 37 patients in the experimental group. Among them, 6 cases achieved clinical control, 16 cases showed marked improvement, 12 cases were effective, and 3 cases were ineffective. The total effective rate was 91.89%. There were 37 patients in the comparison group. Among them, 3 cases achieved clinical control, 10 cases showed marked improvement, 18 cases were effective, and 6 cases were ineffective. The total effective rate was 83.78%. There were 38 patients in the control group. Among them, 0 cases achieved clinical control, 5 cases showed marked improvement, 23 cases were effective, and 10 cases were ineffective. The total effective rate was 73.68%. The Kruskal-Wallis test was used to analyze the total effective rates of the three groups. After the Kruskal-Wallis test, we obtained H c = 17.524, P < 0.001, indicating that there were statistically significant differences in the total effective rates among the three groups. It was suggested that the total effective rate of the experimental group was higher than that of the comparison group and the control group. The details are shown in Table 14.

[0207] Table 14: Comparison of the therapeutic effects of the three groups of patients after treatment (cases):

[0208] 。

[0209] Note: Total effective rate (%) = (Clinical control + Marked improvement + Effective) / Number of patients × 100%.

[0210] 15. Safety assessment:

[0211] (1) Drug safety assessment:

[0212] During and before and after the treatment of the two groups of patients, routine examinations of vital signs, blood, urine, and feces, as well as liver and kidney functions, electrocardiograms, etc. were carried out to evaluate the drug safety. No results that were normal before treatment but abnormal after treatment were found, indicating that the drug was safe.

[0213] (2) Comparison of adverse reactions among the three groups of patients:

[0214] In terms of adverse reactions, 2 cases, 3 cases, and 2 cases of patients in the experimental group, the comparison group, and the control group respectively had discomfort symptoms such as itching and gastrointestinal reactions during the treatment. After timely symptomatic treatment and intervention, the discomfort symptoms disappeared, and the treatment was not interrupted during this study. The chi-square test was used to analyze the incidence of adverse reactions among the three groups of patients, and we obtained X 2 =0.326, P = 0.849 > 0.05, indicating that there were no statistically significant differences in the incidence of adverse reactions among the three groups of patients. See Table 15.

[0215] Table 15: Comparison of the incidence of adverse reactions among the three groups of patients (cases):

[0216] 。

[0217] Typical treatment cases:

[0218] Case 1: Patient 1, male, 75 years old, married. Chief complaint: "Repeated cough and expectoration for more than 18 years, aggravated for 1 month", so he came to see a doctor.

[0219] History of present illness: The patient has had repeated cough and expectoration for more than 18 years, which is prone to occur during sudden climate changes and in winter and spring seasons.

[0220] Pulmonary function examination showed: Severe obstructive ventilatory dysfunction. One month ago, the cough and expectoration worsened, expectorating yellow sticky sputum, coughing causing pain in the right chest, accompanied by chest tightness, shortness of breath, reduced diet, poor sleep, fever, dry mouth and throat, scanty urine, and dry stools, so he came to see a doctor. The tongue was red, the tongue coating was yellow and greasy, and the pulse was slippery and rapid.

[0221] Past history, personal history, family history, etc.: History of COPD for ten years, treated with long-term low-dose oxygen inhalation and atomization inhalation, specific drugs unknown. Smoking for 30 years, 2 packs / day, has quit smoking for 5 years; the condition often recurs. No history of diabetes, heart disease, or hypertension; denies drug and food allergies; denies family genetic history.

[0222] Auxiliary examinations: Body temperature (T) 37.3°C, heart rate (P) 100 beats / min, respiratory rate (R) 21 times / min, blood pressure (BP) 112 / 89 mmHg. Barrel chest, wheezing sounds were heard in both lungs, and a small amount of moist rales were heard in the right lung. Chest X-ray showed: COPD complicated with infection.

[0223] The patient is an elderly male, presenting with cough, wheezing, and chest tightness. Due to phlegm-heat congesting the lungs and the failure of the lungs to disperse and descend, qi movement is obstructed, and phlegm-heat is internally accumulated. The heat pathogen disturbs upward, so heat manifestations such as fever and dry mouth and throat are seen. Dyspnea and wheezing are obvious due to phlegm-heat blocking the lungs, qi stagnation of the lung qi, and qi movement obstruction. The sputum is large in quantity and viscous, difficult to expectorate, reflecting the internal abundance of phlegm-heat, the failure of the lungs to disperse and descend, and qi movement obstruction. Scanty urine, dry stools, yellow and greasy tongue coating, and slippery and rapid pulse are due to the internal accumulation of phlegm-heat and the disturbance of the heat pathogen upward. Through comprehensive analysis, the syndrome belongs to the syndrome of phlegm-heat congesting the lungs, and the diagnosis is the acute exacerbation stage of chronic obstructive pulmonary disease.

[0224] Intervention measures: Use the traditional Chinese medicine decoction in Example 1. One dose per day, decocted in water and taken warm twice a day, morning and evening, for a total of 14 doses.

[0225] Condition changes and prognosis:

[0226] Second visit: The patient reported that after taking the above prescription, the cough was relieved, still expectorating sputum, light yellow in color, and the shortness of breath after activity was reduced. No fever, improvement in chest tightness and shortness of breath, reduction in pain in the right chest, less fatigue than before, improvement in dry mouth and throat, normal appetite, normal sleep, normal bowel and bladder movements. Traditional Chinese medicine tongue and pulse: The tongue was light red, the tongue coating was yellow, and the pulse was slippery. Continue to take the above prescription one dose per day for a total of 14 doses. Follow-up after half a year showed that the shortness of breath after activity was not obvious, no fever, able to do some housework, the daily living ability was enhanced compared with before, the mental state was good, and the quality of life was improved.

[0227] Case 2: Patient 2, male, 66 years old. Chief complaint: "Repeated cough, expectoration, and shortness of breath after activity for 3 years, aggravated for 1 month", so he came to see a doctor.

[0228] Present history: After getting cold, the patient had a cough, expectorated yellowish-white sticky sputum, which was large in amount and difficult to expectorate. There was chest tightness, fatigue, palpitations, shortness of breath, and the dyspnea was aggravated after activity. There was palpitations below the umbilicus, dense red papules with itching on both lower extremities, poor appetite, yellow urine, and no bowel movement for 3 days. Barrel chest, scattered moist rales and wheezing sounds in both lungs, and the heart sound was enhanced at the xiphoid process. The tongue was red with yellowish-white and thick greasy coating, and there was stasis under the tongue. The pulse was string-like, slippery and rapid, the left guan pulse was string-like, and the right guan pulse was soft.

[0229] Past history, personal history, family history, etc.: He had a history of hypertension for 10 years, denied coronary heart disease and diabetes, and denied infectious diseases such as hepatitis; he had a smoking history of 40 years, 5 cigarettes per day, and did not quit smoking. Denied family genetic history.

[0230] Auxiliary examinations: Pulmonary function examination: FEV1 / FVC: 48.71. Chest CT showed: punctate calcification in the apical segment of the right upper lobe; cord-like shadows in the lingular segment of the left upper lobe and the middle lobe of the right lung, small patchy ground-glass density in the dorsal segment of the right lower lobe, with a cross-sectional size of about 12x6 mm; ground-glass density nodule in the external basal segment of the left lower lobe, about 5 mm in diameter; the trachea and the lumens and shapes of each bronchus were not significantly abnormal.

[0231] Traditional Chinese medicine diagnosis: Phlegm-heat stasis obstruction, qi stagnation of the lung qi, diagnosed as the acute exacerbation stage of chronic obstructive pulmonary disease.

[0232] Intervention measures: The traditional Chinese medicine powder in Example 3 was used. 1 dose per day, decocted in water and taken warm twice a day, morning and evening, for a total of 14 doses.

[0233] Condition changes and prognosis:

[0234] Second diagnosis: The bowel movement was relieved the next day. Now all symptoms have improved, still with dyspnea, no palpitations below the umbilicus, in good spirits, good appetite and sleep, and the red papules have become lighter. Continue to take the above prescription 1 dose per day for a total of 14 doses. Follow-up after half a year showed that the patient's dyspnea was greatly reduced, the red papules disappeared, and there was no obvious discomfort.

[0235] The experimental research and typical cases of the present invention all show that a traditional Chinese medicine composition for treating the acute exacerbation stage of chronic obstructive pulmonary disease of the present invention has certain curative effects and safety for the treatment of this disease. This compound prescription can significantly improve the clinical symptoms of patients, has obvious advantages in improving cough, expectoration, chest tightness, etc., and has significant curative effects in shortening the cough remission time and cure time of patients, improving the quality of life and pulmonary function indexes of patients, and has a high total effective rate.

[0236] Finally, it should be noted that the above are only the preferred embodiments of the present invention and are not used to limit the present invention. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art can still modify the technical solutions described in the foregoing embodiments or perform equivalent replacements for some of the technical features. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease, characterized in that, It is composed of the following raw medicinal materials in parts by weight: Ephedra sinica preparata 4 - 8 parts, Armeniaca vulgaris amarum 4 - 8 parts, Scutellaria baicalensis 4 - 8 parts, Meretrix meretrix Linnaeus 12 - 18 parts, Morus alba L. root-bark 12 - 18 parts, Lycii radicis cortex 12 - 18 parts, Houttuynia cordata Thunb. 12 - 18 parts, Prunus persica (L.) Batsch var. duplex Rehd. 4 - 8 parts, Pheretima aspergillum (E. Perrier) 4 - 8 parts, Dioscorea nipponica Makino 25 - 35 parts, Elaeagnus pungens Thunb. root 25 - 35 parts, Glycyrrhiza uralensis Fisch. 4 - 8 parts.

2. The traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease according to claim 1, wherein, It is composed of the following raw medicinal materials in parts by weight: Ephedra sinica preparata 6 parts, Armeniaca vulgaris amarum 6 parts, Scutellaria baicalensis 6 parts, Meretrix meretrix Linnaeus 15 parts, Morus alba L. root-bark 15 parts, Lycii radicis cortex 15 parts, Houttuynia cordata Thunb. 12 parts, Prunus persica (L.) Batsch var. duplex Rehd. 6 parts, Pheretima aspergillum (E. Perrier) 6 parts, Dioscorea nipponica Makino 30 parts, Elaeagnus pungens Thunb. root 25 parts, Glycyrrhiza uralensis Fisch. 6 parts; or Ephedra sinica preparata 4 parts, Armeniaca vulgaris amarum 4 parts, Scutellaria baicalensis 4 parts, Meretrix meretrix Linnaeus 12 parts, Morus alba L. root-bark 12 parts, Lycii radicis cortex 18 parts, Houttuynia cordata Thunb. 18 parts, Prunus persica (L.) Batsch var. duplex Rehd. 4 parts, Pheretima aspergillum (E. Perrier) 4 parts, Dioscorea nipponica Makino 25 parts, Elaeagnus pungens Thunb. root 35 parts, Glycyrrhiza uralensis Fisch. 4 parts; or Ephedra sinica preparata 8 parts, Armeniaca vulgaris amarum 8 parts, Scutellaria baicalensis 8 parts, Meretrix meretrix Linnaeus 18 parts, Morus alba L. root-bark 18 parts, Lycii radicis cortex 18 parts, Houttuynia cordata Thunb. 18 parts, Prunus persica (L.) Batsch var. duplex Rehd. 8 parts, Pheretima aspergillum (E. Perrier) 8 parts, Dioscorea nipponica Makino 35 parts, Elaeagnus pungens Thunb. root 35 parts, Glycyrrhiza uralensis Fisch. 8 parts; or Ephedra sinica preparata 7 parts, Armeniaca vulgaris amarum 7 parts, Scutellaria baicalensis 7 parts, Meretrix meretrix Linnaeus 16 parts, Morus alba L. root-bark 16 parts, Lycii radicis cortex 12 parts, Houttuynia cordata Thunb. 16 parts, Prunus persica (L.) Batsch var. duplex Rehd. 7 parts, Pheretima aspergillum (E. Perrier) 7 parts, Dioscorea nipponica Makino 28 parts, Elaeagnus pungens Thunb. root 32 parts, Glycyrrhiza uralensis Fisch. 7 parts; or Ephedra sinica preparata 6 parts, Armeniaca vulgaris amarum 6 parts, Scutellaria baicalensis 6 parts, Meretrix meretrix Linnaeus 12 parts, Morus alba L. root-bark 15 parts, Lycii radicis cortex 15 parts, Houttuynia cordata Thunb. 15 parts, Prunus persica (L.) Batsch var. duplex Rehd. 5 parts, Pheretima aspergillum (E. Perrier) 7 parts, Dioscorea nipponica Makino 28 parts, Elaeagnus pungens Thunb. root 30 parts, Glycyrrhiza uralensis Fisch. 6 parts.

3. The traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease according to claim 1, wherein: The traditional Chinese medicine composition is prepared into oral preparations, including but not limited to decoctions and powders.

4. The traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease according to claim 3, wherein The preparation method of the decoction is as follows: Weigh various raw medicinal materials according to the parts by weight of the traditional Chinese medicine composition. After cleaning and chopping or cutting, first put Meretrix meretrix Linnaeus into water and decoct for 30 - 50 minutes, then put the other raw medicinal materials into water. Decoct for the first time for 15 - 20 minutes, pour out 1 / 2 of the medicinal liquid, add warm water and decoct for the second time for 15 - 20 minutes, pour out all the medicinal liquid, and mix the two decoctions evenly to obtain the decoction; The preparation method of the powder is as follows: Weigh various raw medicinal materials according to the above weight parts. After cleaning and chopping or cutting, first put Meretrix meretrix Linnaeus into water and decoct for 30 - 50 minutes, then put the other raw medicinal materials into water and decoct for 30 - 50 minutes, pour out all the medicinal liquid, filter to obtain the filtrate, continue to decoct and concentrate the filtrate to a paste state, then granulate, dry, and sterilize to obtain the traditional Chinese medicine powder.

5. The traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease according to claim 1, wherein The preparation method of Armeniaca vulgaris amarum is as follows: Take Armeniaca vulgaris amarum, place it in water with a weight multiple of 10 times and boil, keep warm for 5 minutes. When the seed coat is slightly swollen, take it out and soak it in cold water. After taking it out, rub open the seed coat and the kernel, dry it, sieve out the seed coat, and crush the kernel to obtain Armeniaca vulgaris amarum.

6. The traditional Chinese medicine composition for treating acute exacerbation of chronic obstructive pulmonary disease according to claim 1, wherein, The preparation method of Prunus persica (L.) Batsch var. duplex Rehd. is as follows: Take Prunus persica (L.) Batsch var. duplex Rehd., place it in water with a weight multiple of 10 times and boil, keep warm for 5 minutes. When the seed coat is slightly swollen, take it out and soak it in cold water. After taking it out, rub open the seed coat and the kernel, dry it, sieve out the seed coat, and crush the kernel to obtain Prunus persica (L.) Batsch var. duplex Rehd.