Traditional Chinese medicine composition for treating cough after infection caused by wind pathogen invading lung and application of traditional Chinese medicine composition
A Chinese medicine composition of roasted ephedra, bitter almond, and others applied via acupoints effectively treats cough caused by wind evil in the lungs, reducing symptoms and serum CRP levels, addressing the inefficacies of existing treatments.
Patent Information
- Application Number
- CN202411318979.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2024-09-21
- Publication Date
- 2024-12-20
AI Technical Summary
Existing traditional Chinese medicine compositions for treating cough caused by wind evil lurking in the lungs are ineffective, difficult to obtain, expensive, and have unclear efficacy, lacking a safe and effective treatment option for long-term cough.
A traditional Chinese medicine composition comprising roasted ephedra, bitter almond, aster, platycodon, camellia sinensis, oroxylum, siler, schizonepeta, and roasted licorice, applied via acupoint application to acupoints like Feishu, Tiantu, and Dazhui, to disperse wind, resolve phlegm, and relieve cough.
The composition effectively reduces cough symptoms and serum CRP levels, demonstrating an 88.57% effective rate after 10 days, superior to control groups, with no adverse reactions.
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Abstract
Description
Technical Field
[0001] The invention relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition for treating cough after wind evil lurking in the lungs infection and application thereof. Background Art
[0002] Post-infection cough is a disease in which the cough persists and is difficult to cure as the early symptoms after respiratory infection subside. Long-term and repeated cough seriously interferes with the patient's normal life and work. Post-infection cough is mainly manifested as paroxysmal dry cough or only a small amount of white sticky sputum. The cough is more severe, even spasmodic, and irregular. It is often caused by throat itching and is difficult to control. It is induced or aggravated by cold or hot air, irritating odors, or by talking, emotional excitement, etc., and is often manifested by irritating dry cough and coughing a small amount of white sticky sputum. Inhalation of cold air, dust, and irritating gases can induce this disease. The pathogenesis of this disease is mostly believed to be related to airway inflammation, airway mucosal loss, airway hyperresponsiveness, etc. In terms of treatment, symptomatic treatment is mainly used. Western medicine currently mainly uses antihistamines, antitussives, hormones and other methods for treatment, which can relieve cough symptoms, but it is easy to recur, the course of the disease is long, and there is a lack of high-efficiency, low-side effect and low recurrence rate drugs.
[0003] There is no such disease name as "post-infectious cough" in traditional Chinese medicine. According to its main clinical symptoms, it can be classified into the categories of "cough", "stubborn cough" and "long-term cough" in traditional Chinese medicine. Wind is the root of all diseases, and wind evil is an important pathogenic factor of this disease. Traditional Chinese medicine believes that the pathogenesis of this disease is that wind evil invades the lungs, the lungs fail to descend, and the qi rises up, causing cough, or although the symptoms of the cold are relieved, the wind evil still exists, the wind evil hides in the lungs, and the lung qi fails to descend, resulting in repeated coughing. The clinical manifestations of cold and heat are not prominent, but there are main manifestations such as sudden onset and cessation, paroxysmal cough, and itchy throat. The treatment should focus on dispersing wind and lung, relieving cough and reducing phlegm. Traditional Chinese medicine has a definite effect on treating post-infectious cough, and has certain advantages in alleviating symptoms, shortening the course of the disease, regulating the whole body, and improving physical fitness.
[0004] Acupoint application is a transdermal external therapy in traditional Chinese medicine. It is a therapy that integrates drugs, acupoints, and meridians. Meridians are channels for the circulation of qi and blood in the human body. They connect the upper and lower parts, the inside and outside of each other, and connect the internal organs and the body surface to form a whole, so that the body functions maintain a relatively balanced and coordinated state. Acupoint application therapy applies the formulated drugs to specific acupoints, which can exert multiple effects through meridian effects, stimulation of effective ingredients, and absorption through the skin. This method of administration bypasses the first-pass effect of the liver, kidney metabolism and excretion, protects the liver and kidneys, and reduces toxic damage.
[0005] Chinese patent document CN111569024A discloses a Chinese medicine composition for treating cough, a Chinese medicine preparation and a preparation method thereof, comprising the following components in parts by weight: 20-50 parts of Platycodon grandiflorum, 5-15 parts of Licorice, 5-15 parts of Aster, 5-15 parts of Nepeta, 5-20 parts of Tangerine peel, 5-20 parts of Stemona, 10-30 parts of roasted loquat leaves, 5-15 parts of Cicadae Periostracum, 10-30 parts of Belamcanda, 5-15 parts of Ephedra, 5-15 parts of Apricot, 10-20 parts of Trichosanthes peel, 10-20 parts of Pinellia and 5-15 parts of Adenophora australis. The Chinese medicine preparation includes pills, granules, tablets and capsules. The Chinese medicine composition can effectively solve the problems of existing drugs that are extremely bitter and cold, which damage the stomach and yang, extremely spicy and hot, which damage yin, and nourishing and greasy, which restrain evil.
[0006] Chinese patent document CN102988735A discloses a Chinese medicine composition for treating cough, which is composed of the following Chinese medicine raw materials in parts by weight: 5-15 parts of ephedra, 5-15 parts of apricot kernel, 10-20 parts of liquorice, 10-20 parts of poria, 10-20 parts of cinnamon twig, 10-20 parts of white peony root, 10-30 parts of yam, 10-30 parts of lily, 10-20 parts of ophiopogon, 10-20 parts of adenophora, 10-20 parts of tangerine peel, 6-18 parts of magnolia bark, 10-20 parts of aster, 10-20 parts of coltsfoot, 6-18 parts of pinellia, 10-20 parts of anemarrhena, 10-20 parts of pseudostellaria, 10-20 parts of radix polygoni multiflori, 10-20 parts of belamcanda, and 10-30 parts of cicada shell. The Chinese medicine composition of the invention has the effects of clearing away heat and detoxifying, moistening the lungs and relieving qi, nourishing yin and promoting the production of body fluid, resolving phlegm and relieving cough, and invigorating the spleen and replenishing qi. It has a significant therapeutic effect on cough and a reliable effect. Its components have a wide source of medicines, are simple to prepare, and have no toxic side effects.
[0007] There are many traditional Chinese medicine compositions for treating cough, but they all have more or less disadvantages, such as too many medicinal flavors, difficult to obtain materials, expensive prices, unclear efficacy, poor therapeutic effect, etc. Therefore, there is an urgent need for a traditional Chinese medicine acupoint application for cough that has obvious effect on treating wind-evil-hidden lung infection, few medicinal flavors, is practical, highly compliant, safe and effective. Summary of the invention
[0008] The purpose of the present invention is to provide a Chinese medicine composition for treating cough after wind evil lurking in the lungs infection and its application in view of the technical difficulties in the prior art that long-term cough is difficult to cure and cannot be cured by taking western medicine antibiotics.
[0009] In the first aspect, the present invention provides a traditional Chinese medicine composition for external use for treating cough after wind-evil-lurking lung type infection, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 4-8 parts of roasted ephedra, 13-17 parts of bitter almond, 7-11 parts of aster, 7-11 parts of radix platycodonis, 7-11 parts of platycodon, 10-14 parts of camellia sinensis, 7-11 parts of oroxylum bungeana, 13-17 parts of siler, 10-14 parts of schizonepeta, and 1-5 parts of roasted licorice, and the traditional Chinese medicine composition is in the form of acupoint application.
[0010] As a preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 5-7 parts of roasted ephedra, 14-16 parts of bitter almond, 8-10 parts of aster, 8-10 parts of scutellaria, 8-10 parts of platycodon, 11-13 parts of dwarf camellia, 8-10 parts of oroxylum, 14-16 parts of siler, 11-13 parts of schizonepeta, and 2-4 parts of roasted licorice.
[0011] As another preferred example, the Chinese medicine composition is made of the following raw materials in parts by weight: 6 parts of roasted ephedra, 15 parts of bitter almond, 9 parts of aster, 9 parts of scutellaria, 9 parts of platycodon, 12 parts of dwarf camellia, 9 parts of oroxylum, 15 parts of siler, 12 parts of schizonepeta, and 3 parts of roasted licorice.
[0012] In a second aspect, the present invention provides a pharmaceutical composition for treating cough caused by wind evil lurking in the lungs, the pharmaceutical composition comprising an external Chinese medicine composition for treating cough caused by wind evil lurking in the lungs and compound methoxyphenamine.
[0013] In a third aspect, the present invention provides the use of a Chinese medicine composition for external use in the preparation of a medicine for treating cough after wind-evil-infiltrating lung infection.
[0014] In a fourth aspect, the present invention provides use of the pharmaceutical composition in preparing a medicine for treating cough after wind-evil-infiltrating lung infection.
[0015] The invention has the advantages that: the six exogenous pathogens can all become the pathogenic factors of the disease, among which the most important pathogenic factor is wind evil. Cough after infection belongs to the category of "long-term cough and stubborn cough" in traditional Chinese medicine. Although the external symptoms have been resolved, the wind evil has not been eliminated and remains in the lungs, causing the lung's function of ascending and descending to be disordered, so the cough is prolonged and unhealed. The Chinese medicine composition of the invention comprises a total of ten Chinese medicines.
[0016] Roasted ephedra is pungent, slightly bitter and warm, and mainly enters the lung meridian; it is good at dispersing lung and relieving cough, and dispersing wind evil that lingers in the lung. Ephedra contains a variety of alkaloids, including ephedrine and pseudoephedrine, which can relax bronchial smooth muscle, and have anti-inflammatory, anti-allergic and immune function regulating effects; bitter almond is bitter, slightly warm, and enters the lung and large intestine meridians; it descends qi, relieves cough and relieves asthma, and it is mainly descending, descending and dispersing, and is an important medicine for treating cough and asthma. Modern research shows that amygdalin has antitussive and antiasthmatic effects, and has a high degree of lung tissue distribution specificity. The concentration of amygdalin is positively correlated with the inhibitory effect on bronchial smooth muscle cells; ephedra and almond are both suitable for ascending and descending, regulating lung qi and expelling evil. Both are monarch drugs.
[0017] Platycodon grandiflorum is bitter, pungent and neutral in nature, and belongs to the lung meridian. It is "a medicine that opens up the lung qi" and "can be used as a boat for various medicines to float upward". It has the effects of clearing the lungs and removing phlegm, relieving throat and discharging pus. Modern research has found that Platycodon grandiflorum can stimulate the secretion of mucus in the airway lumen, induce cough reflex, thereby promoting the discharge of phlegm and achieving the effect of suppressing cough and removing phlegm. Baiqian is pungent and sweet, neutral in nature, and enters the lung meridian; it is good at descending qi and resolving phlegm, and the two work together, one promoting and the other descending, to restore the descending and promoting of lung qi, and enhance the power of the main medicine to promote lung and relieve cough; Aster is a pungent, pungent and warm product, and enters the lung meridian; it has the effects of resolving phlegm and relieving cough, and moistening the lungs, and is an important medicine for relieving cough, relieving asthma, and moistening the lungs. Modern studies have shown that asterone, epicoryols and other substances in Aster have expectorant effects. At the same time, studies have shown that Aster can inhibit the contraction of histamine on the guinea pig trachea and inhibit tracheal spasm, achieving the effect of relieving asthma; Aidicha is neutral in nature, pungent and slightly bitter in taste, and enters the lung meridian and liver meridian; it has the functions of resolving phlegm and relieving cough, promoting blood circulation and removing blood stasis, and clearing away dampness and heat. The effective cough suppressant in dwarf tea is bergenin, and the expectorant component may be flavonoid glycosides (quercetin, kaempferol, etc.); dwarf tea can reduce the proliferation of goblet cells in experimental bronchitis and reduce sputum; Oroxylum indica is bitter, sweet, and cool in nature, and belongs to the lung, liver, and stomach meridians; it has the effects of moistening the lungs, soothing the liver, harmonizing the stomach, and promoting muscle growth. Its outstanding effects are antitussive and expectorant. Modern pharmacological studies have shown that this drug has anti-inflammatory, antibacterial, antioxidant, and antiviral and tumor growth inhibition. The above drugs are combined, and they can be used to ascend and descend, and cold and heat, to help the monarch drug to clear the lungs and resolve phlegm, descend the adverse and stop coughing, and they are all minister drugs.
[0018] Saposhnikovia divaricata, pungent in nature, sweet in taste, slightly warm, enters the bladder, spleen, and liver meridians; it has the effect of dispelling wind and dispersing wind evil, and is used for colds, headaches, rheumatic pain, urticaria, tetanus and other symptoms; Schizonepeta tenuifolia, pungent in nature, slightly warm, enters the lung and liver meridians; it has the effect of light lifting and dispersing, and its main function is to resolve phlegm and relieve cough, so that wind evil can be slightly dissipated. Schizonepeta tenuifolia is suitable for patients with residual evil after dispersing and cough with phlegm. Schizonepeta tenuifolia and Saposhnikovia divaricata are used together as adjuvants, which are the double swords of dispelling wind and dispelling wind, enhancing the body's dispersing ability and helping the monarch and minister drugs to relieve cough.
[0019] Roasted licorice root is sweet and flat in nature, and it enters the heart, lung, spleen, and stomach meridians; it nourishes the spleen and replenishes qi, eliminates phlegm and relieves cough, and harmonizes various medicines, and is a guiding medicine. At the same time, most of the ingredients in the prescription are honey-roasted slices, which can replenish qi and regulate the middle, and enhance the cough-relieving effect. The combination of various medicines has the effect of dispersing wind and lung, resolving phlegm and relieving cough.
[0020] After 10 days of treatment, the efficacy was evaluated according to the cough symptom score. The effective rate of the treatment group was 88.57%, and the effective rate of the control group was 77.14%, which was better than the control group. After 10 days of treatment, the scores of cough, sputum, choking cough, coughing when itchy throat, and cough caused by external factors in patients with cough after wind evil lurking in the lung infection were reduced in the treatment group after intervention, and were better than those in the control group. After 10 days of treatment, the serum CRP levels in the treatment group and the control group decreased after intervention, and the changes before and after intervention in the treatment group were better than those in the control group. In summary, cough acupoint application therapy can safely and effectively improve the clinical symptoms of patients with cough after wind evil lurking in the lung infection and reduce the serum CRP level. DETAILED DESCRIPTION
[0021] The present invention will be further described below in conjunction with specific embodiments. It should be understood that these embodiments are only used to illustrate the present invention and are not intended to limit the scope of the present invention. In addition, it should be understood that after reading the content of the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms fall within the scope limited by the appended claims of the application equally.
[0022] Example 1 Chinese medicine composition for treating cough caused by wind evil invading lung type infection (I)
[0023] 6 parts of roasted ephedra, 15 parts of bitter almonds, 9 parts of aster, 9 parts of white scutellaria, 9 parts of platycodon, 12 parts of dwarf tea, 9 parts of oroxylum, 15 parts of siler, 12 parts of schizonepeta, 3 parts of roasted liquorice.
[0024] Example 2 Chinese medicine composition for treating cough caused by wind evil invading lung type infection (II)
[0025] 6 parts of roasted ephedra, 15 parts of bitter almonds, 7 parts of aster, 11 parts of white purslane, 8 parts of platycodon, 13 parts of dwarf tea, 9 parts of oroxylum, 13 parts of siler, 14 parts of schizonepeta, 2 parts of roasted liquorice.
[0026] Example 3 Chinese medicine composition for treating cough caused by wind evil invading lung type infection (III)
[0027] 4 parts of roasted ephedra, 13 parts of bitter almond, 11 parts of aster, 8 parts of white scutellaria, 10 parts of platycodon, 12 parts of dwarf lily, 7 parts of oroxylum, 17 parts of siler, 11 parts of schizonepeta, 4 parts of roasted liquorice.
[0028] Example 4 Chinese medicine composition for treating cough caused by wind evil invading lung type infection (IV)
[0029] 8 parts of roasted ephedra, 17 parts of bitter almonds, 8 parts of aster, 10 parts of white purslane, 9 parts of platycodon, 10 parts of dwarf tea, 11 parts of oroxylum, 14 parts of siler, 13 parts of schizonepeta, 3 parts of roasted liquorice.
[0030] Example 5 Chinese medicinal composition for treating cough caused by wind evil invading lung infection (V)
[0031] 5 parts of roasted ephedra, 14 parts of bitter almond, 10 parts of aster, 9 parts of white scutellaria, 7 parts of platycodon, 14 parts of dwarf tea, 8 parts of oroxylum, 16 parts of siler, 12 parts of schizonepeta, 1 part of roasted liquorice.
[0032] Example 6 Chinese medicine composition for treating cough caused by wind evil invading lung type infection (VI)
[0033] 7 parts of roasted ephedra, 16 parts of bitter almonds, 9 parts of aster, 7 parts of white scutellaria, 11 parts of platycodon, 11 parts of dwarf tea, 10 parts of oroxylum, 15 parts of siler, 10 parts of schizonepeta, 5 parts of roasted liquorice.
[0034] Example 7 Chinese medicine composition for treating cough caused by wind evil invading lung infection (VII)
[0035] 6 parts of roasted ephedra, 13 parts of bitter almonds, 11 parts of aster, 8 parts of white radix, 10 parts of platycodon, 12 parts of dwarf tea, 7 parts of oroxylum, 17 parts of siler, 11 parts of schizonepeta, 4 parts of roasted liquorice.
[0036] Example 8 Chinese medicine composition for treating cough caused by wind evil invading lung infection (VIII)
[0037] 4 parts of roasted ephedra, 17 parts of bitter almond, 8 parts of aster, 10 parts of white scutellaria, 9 parts of platycodon, 10 parts of dwarf tea, 11 parts of oroxylum, 14 parts of siler, 13 parts of schizonepeta, 3 parts of roasted liquorice.
[0038] Example 9 Chinese medicine composition for treating cough caused by wind evil invading lung infection (IX)
[0039] 8 parts of roasted ephedra, 14 parts of bitter almonds, 10 parts of aster, 9 parts of white scutellaria, 7 parts of platycodon, 14 parts of dwarf tea, 8 parts of oroxylum, 16 parts of siler, 12 parts of schizonepeta, 1 part of roasted liquorice.
[0040] Example 10 Chinese medicine composition for treating cough caused by wind evil invading lung infection (ten)
[0041] 5 parts of roasted ephedra, 16 parts of bitter almond, 9 parts of aster, 7 parts of white radix, 11 parts of platycodon, 11 parts of dwarf tea, 10 parts of oroxylum, 15 parts of siler, 10 parts of schizonepeta, 5 parts of roasted liquorice.
[0042] Example 11 Chinese medicinal composition for treating cough caused by wind evil invading lung infection (XI)
[0043] 7 parts of roasted ephedra, 15 parts of bitter almonds, 7 parts of aster, 11 parts of white purslane, 8 parts of platycodon, 13 parts of dwarf tea, 9 parts of oroxylum, 13 parts of siler, 14 parts of schizonepeta, 2 parts of roasted liquorice.
[0044] Example 12: Method of use of a Chinese medicine composition for treating cough caused by wind evil invading the lungs:
[0045] Directions: For external use, clean the application area, and apply to the following acupoints: Feishu, Tiantu, Dazhui. It is recommended to use each patch for 4-6 hours, once a day, and 10 days as a course of treatment. Feishu is a key acupoint for treating cough and asthma, and has the effects of promoting lung function, resolving phlegm, and relieving asthma; Tiantu is the intersection point of Renmai and Yinweimai, and is a key acupoint for treating phlegm and asthma, and has the effects of resolving phlegm and relieving asthma, promoting lung function, and relieving cough; Dazhui is the intersection point of Dumai and the three Yang meridians of the hands and feet, and is the meeting point of all Yang, which can invigorate Yang Qi, and has the functions of dispelling wind, warming Yang and replenishing Qi.
[0046] Precautions for acupoint application: (1) Avoid strenuous activities during application to prevent excessive sweating that may cause the drug to move or fall off. (2) During acupoint application, avoid eating spicy food, take a rest, and avoid excessive fatigue. (3) During the application,
[0047] If local burning, severe itching, pain or discomfort occurs, remove the patch immediately.
[0048] Example 13 Clinical Trial
[0049] 1 Clinical Data
[0050] 1.1 General information of the case
[0051] A total of 70 patients with cough after wind evil fu lung infection who were admitted to the outpatient and emergency departments and wards of Shanghai Jing'an District Hospital of Traditional Chinese Medicine from February 2024 to July 2024 were selected and divided into two groups according to the random number table method. Treatment group: 35 cases, average age (41.59±8.34 years old), including 12 males and 23 females, with a course of 32.50±7.91 days; control group: 35 cases, average age (42.78±7.68) years old, including 14 males and 21 females, with a course of 31.04±8.82 days. There was no statistically significant difference in gender, age, and course of disease between the two groups (p>0.05), and they were comparable.
[0052] 1.2 Diagnostic criteria
[0053] 1.2.1 Western medicine diagnostic criteria: These criteria were developed based on the Diagnosis and Treatment Guidelines for Cough (2009 Edition) developed by the Asthma Group of the Chinese Medical Association’s Respiratory Diseases Branch and the American Diagnosis and Management of Cough Executive Summary: ACCP Evidence-Based Clinical Practice Guidelines in 2006.
[0054] ① Cough secondary to previous history of upper respiratory tract infection;
[0055] ② After the acute symptoms of upper respiratory tract infection disappear, the cough persists, manifested as an irritating dry cough or coughing up a small amount of white mucus sputum, which lasts for 3-8 weeks;
[0056] ③ Routine blood test and chest X-ray examination were normal;
[0057] ④ Rule out other causes of cough.
[0058] 1.2.2 TCM diagnostic standards: formulated based on the "Expert Consensus on TCM Diagnosis and Treatment of Cough (2021 Edition)" and the "Guidelines for the Diagnosis and Treatment of Cough (2021 Edition)".
[0059] Clinical manifestations of TCM syndrome differentiation: Main symptom: cough, coughing up a small amount of white sputum, choking cough; Secondary symptom: throat discomfort, irritating dry cough, often induced by inhalation of cold air, dust, irritating odor, laughing, etc., pale red tongue, thin white fur, floating pulse. If the main symptom is met while two or more secondary symptoms are met, combined with the tongue and pulse, it can be identified as wind evil in the lung syndrome.
[0060] 1.3 Inclusion criteria
[0061] ① Meet the diagnostic criteria of Western medicine (diagnostic criteria for cough after infection);
[0062] ② Meet the TCM syndrome differentiation criteria for wind evil in the lungs (the above TCM symptoms and TCM syndrome differentiation);
[0063] ③ Cough symptom score (daytime cough symptom score increased by 3 points and / or nighttime cough symptom score increased by 3 points); ④ Age 18-65 years old;
[0064] ⑤ The course of disease is 3-8 weeks;
[0065] ⑥ Those who signed the informed consent form.
[0066] Those who meet the above conditions at the same time.
[0067] 1.4 Exclusion criteria
[0068] ① Routine blood test: total white blood cell count>10*10 9 / L or neutrophils>80%;
[0069] ② Patients with severe cardiovascular and cerebrovascular diseases, liver and kidney dysfunction, blood system diseases and mental illness;
[0070] ③ Patients with cough or other lung diseases caused by chronic bronchitis, eosinophilic bronchitis, cough variant asthma, gastroesophageal reflux disease, etc.;
[0071] ④ Those with allergic constitution or allergic to the drugs used in this study;
[0072] ⑤ Women who are pregnant, breastfeeding or have unexpected pregnancy;
[0073] ⑥ Those suspected of or confirmed to have a history of tobacco, alcohol, or drug abuse;
[0074] ⑦ Have taken ACEI antihypertensive drugs in the past three months;
[0075] ⑧ Participated in other clinical trials within 1 month;
[0076] ⑨Other reasons that the doctor considers the patient unsuitable for inclusion.
[0077] Those who meet at least one of the above conditions.
[0078] 1.5 Elimination criteria
[0079] After entering the clinical trial observation, some people are found not to meet the inclusion criteria; some people fail to take the medication on time as required by the trial; some people drop out naturally during the observation, and their efficacy cannot be determined or there is no available data.
[0080] 1.6 Dropout cases Dropout criteria: The subject requests to withdraw from the trial midway; the patient violates the trial protocol and takes other cough suppressants without permission; a serious adverse event occurs during the clinical observation process and the subject is not suitable to continue due to physical condition.
[0081] 2 Research Methods
[0082] 2.1 Grouping method
[0083] Patients with cough after wind-evil-hiding lung infection were randomly divided into two groups: control group (compound methoxyphenamine capsule treatment group) and observation group (compound methoxyphenamine capsule combined with cough acupoint application treatment group). The course of treatment was 10 days. The changes in cough symptom scores before and after treatment and the efficacy of cough symptom scores were compared between the two groups. The data were statistically analyzed to clarify the efficacy of compound methoxyphenamine capsule combined with cough acupoint application on cough after wind-evil-hiding lung infection.
[0084] 2.2 Treatment methods
[0085] Control group: 2 capsules of compound methoxyphenamine capsules, 3 times / day, orally. The course of treatment is 10 days. The manufacturer of compound methoxyphenamine capsules is Shanghai SPH Xinyi Pharmaceutical Factory Co., Ltd., with approval number: National Medicine Standard H10980260.
[0086] Observation group: Compound methoxyphenamine capsule combined with cough acupoint application treatment, 10 days of treatment. Cough acupoint application (Example 1) 1 patch, once a day, external use. Acupoints: Feishu, Tiantu, Dazhui. Each patch is used for 4-6 hours. Compound methoxyphenamine capsule 2 capsules, 3 times / day, oral.
[0087] 2.3 Efficacy evaluation
[0088] 2.3.1 Comparison of the changes in cough symptom scores between the two groups before and after treatment (the cough symptom score table is as follows)
[0089] Points Daytime cough symptom score Nocturnal cough symptom score 0 No cough No cough 1 1-2 short coughs Coughing only in the early morning or before going to bed 2 More than 2 short coughs Waking up once or early due to coughing 3 Frequent coughing that does not interfere with daily activities Frequent awakenings at night due to coughing 4 Frequent coughing that interferes with daily activities Coughing most of the time at night 5 Severe cough that prevents you from carrying out your daily activities Severe cough and unable to sleep Points: □ points Points: □ points
[0090] 2.3.2 Comparison of cough symptom scores between the two groups before and after treatment
[0091] Clinical recovery: cough score after treatment is 0 points;
[0092] Markedly effective: After treatment, the cough score decreased by more than 1 point, but the cough symptom did not disappear;
[0093] Effective: After treatment, the cough score decreased by 1 point, but the cough symptom did not disappear;
[0094] Ineffective: The cough score did not decrease or the cough symptoms worsened after treatment.
[0095] 2.4 Observation indicators
[0096] 2.4.1 The scores of the main and secondary symptoms of TCM cough before and after treatment.
[0097] Formulated based on the "Expert Consensus on TCM Diagnosis and Treatment of Cough (2021 Edition)" and the "Guidelines for Diagnosis and Treatment of Cough (2021 Edition)":
[0098]
[0099] Note: Tongue and pulse are not scored. The patient's tongue and pulse conditions before and after medication must be recorded in detail.
[0100] 2.4.2 Serum CRP index before and after treatment.
[0101] 2.4.3 Safety indicators: routine blood test, liver function (ALT, AST), renal function (Cr, BUN), and electrocardiogram.
[0102] 3 Statistical methods
[0103] SPSS 26.0 statistical software was used for statistical analysis, and the measurement data were expressed as mean ± standard deviation. Description. For comparison between the two groups, if the variance was normal, the independent sample t test was used; if the variance was normal but not normal, the corrected t test (t' test) was used; if the variance was not normal, the median M and quartile Q were used. For comparison before and after treatment within the group, if the variance was normal, the paired t test was used; if the variance was not normal, the median M and quartile Q were used; the rank sum test was used for rank data. All statistical tests were bilateral, P < 0.05 indicated that the difference was statistically significant, and P < 0.01 indicated that the difference was statistically significant.
[0104] 4 Research results
[0105] 4.1 Clinical efficacy
[0106] After 10 days of treatment, the efficacy was evaluated based on the cough symptom score. The effective rate of the treatment group was 88.57%, and the effective rate of the control group was 77.14%. The treatment group was superior to the control group (p < 0.05), as shown in Table 1.
[0107] Table 1 Comparison of clinical efficacy between the two groups of patients (cases)
[0108]
[0109] Note: Compared with the control group, *p<0.05
[0110] 4.2 Changes in the scores of the main and secondary symptoms of TCM cough
[0111] After 10 days of treatment, the scores of cough, expectoration, choking cough, coughing due to throat itching, and coughing caused by external factors in the post-intervention treatment group were lower than those in the control group (p < 0.05). See Table 2.
[0112] Table 2 Comparison of TCM symptom scores of cough between the two groups before and after intervention ( point)
[0113]
[0114]
[0115] Note: Compared with the group before intervention, *p<0.05; compared with the control group after intervention, △p<0.05
[0116] 4.3 Serum CRP level
[0117] After 10 days of treatment, the serum CRP levels of both the treatment group and the control group decreased, and the change before and after the intervention in the treatment group was better than that in the control group (p < 0.05). See Table 3.
[0118] Table 3 Comparison of serum CRP levels between the two groups before and after intervention ( point)
[0119]
[0120] Note: Compared with the group before intervention, *p<0.05; compared with the control group after intervention, △p<0.05
[0121] 4.4 Safety indicators
[0122] No obvious adverse reactions occurred in both groups during the treatment.
[0123] In summary, cough acupoint application therapy can safely and effectively improve the clinical symptoms of patients with cough after wind-evil-infected lung infection and reduce serum CRP levels.
[0124] The above is only a preferred embodiment of the present invention. It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention. These improvements and supplements should also be regarded as the scope of protection of the present invention.
Claims
1. A Chinese medicine composition for external use for treating cough caused by wind evil invading lung type infection, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 4-8 parts of roasted ephedra, 13-17 parts of bitter almond, 7-11 parts of aster, 7-11 parts of radix platycodonis, 7-11 parts of platycodon, 10-14 parts of dwarf camellia, 7-11 parts of oroxylum, 13-17 parts of siler, 10-14 parts of schizonepeta, and 1-5 parts of roasted liquorice. The Chinese medicine composition is used for acupuncture point application.
2. The external Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5-7 parts of roasted ephedra, 14-16 parts of bitter almond, 8-10 parts of aster, 8-10 parts of radix platycodonis, 8-10 parts of platycodon, 11-13 parts of dwarf camellia, 8-10 parts of oroxylum, 14-16 parts of siler, 11-13 parts of schizonepeta, and 2-4 parts of roasted liquorice.
3. The external Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is prepared from the following raw materials in parts by weight: 6 parts of roasted ephedra, 15 parts of bitter almond, 9 parts of aster, 9 parts of radix platycodonis, 9 parts of platycodon, 12 parts of dwarf camellia, 9 parts of oroxylum, 15 parts of siler, 12 parts of schizonepeta, and 3 parts of roasted liquorice.
4. A pharmaceutical composition for treating cough caused by wind evil invading the lungs, characterized in that: The pharmaceutical composition consists of the external Chinese medicine composition according to any one of claims 1 to 3 and compound methoxyphenamine.
5. Use of the external Chinese medicine composition according to any one of claims 1 to 3 in the preparation of a medicine for treating cough caused by wind evil invading the lungs.
6. Use of the pharmaceutical composition according to claim 4 in the preparation of a medicine for treating cough caused by wind evil invading the lungs.