A traditional Chinese medicine compound for treating adult community-acquired pneumonia with phlegm-heat obstructing lung syndrome, a preparation method and application thereof

Abstract

This invention discloses a traditional Chinese medicine compound for treating community-acquired pneumonia (CAP) with phlegm-heat obstructing the lungs, its preparation method, and its application, belonging to the field of traditional Chinese medicine technology. The compound is made from the following raw materials in parts by weight: 15-45 parts gypsum, 15-30 parts reed stem, 3-6 parts processed ephedra, 6-9 parts trichosanthes peel, 6-9 parts scutellaria, 6-12 parts fritillaria thunbergii, 15-30 parts houttuynia cordata, 6-9 parts bitter almond, 6-9 parts platycodon, 3-9 parts processed pinellia, and 3-6 parts raw licorice. Clinical trials have demonstrated that the "Weishi Qingjin Fang" (Reed and Gypsum Clearing the Lungs Formula) is significantly effective in improving cough symptoms and shows significant efficacy in improving clinical symptoms and reducing lung inflammation imaging in certain populations. It can effectively reduce hospitalization costs, herbal medicine costs, and antibiotic costs for CAP patients, and promote clinical recovery for CAP patients with phlegm-heat obstructing the lungs.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a traditional Chinese medicine compound for treating phlegm-heat obstructing the lungs syndrome in adults with community-acquired pneumonia, its preparation method, and its application. Background Technology

[0002] Community-acquired pneumonia (CAP) refers to infectious inflammation of the lung parenchyma (including alveolar walls, i.e., the lung interstitium in a broad sense) outside of a hospital setting. This includes pneumonia caused by pathogens with a defined incubation period that develops during the incubation period after hospitalization. Clinical manifestations include fever, cough, sputum production, shortness of breath, chest tightness, or chest pain. In recent years, due to various factors, the incidence and mortality rates of CAP have been rising continuously, making it the sixth leading cause of death worldwide. CAP imposes a heavy disease burden on adults, especially elderly patients over 65 years of age. It is characterized by atypical respiratory symptoms, inconspicuous infection symptoms, and extrapulmonary manifestations as the initial symptoms, making it prone to serious complications and resulting in a poor prognosis.

[0003] In recent years, with the increasing prevalence of high-throughput sequencing and virus detection technologies, novel pathogens causing community-acquired pneumonia (CAP) have been continuously discovered, and the rate of CAP caused by viral infection has been rising, indicating that the pathogens causing CAP are becoming increasingly diverse and complex. Studies show that the virus detection rate in adult CAP patients in my country is as high as 15.0% to 34.9%, with influenza virus being the most prevalent. CAP caused by viral infection is becoming more common, and viruses have become one of the main pathogens of CAP. However, Western medicine still heavily relies on antibiotics for the treatment of CAP. Due to the lack of etiological evidence in the early stages of CAP, empirical treatment is mainly used. Clinicians often use broad-spectrum antibiotics or combination therapy empirically to cover most pathogens. However, the overuse of broad-spectrum antibiotics can cause dysbiosis, leading to increased drug resistance in pathogens. Studies have found that the most common pathogens of CAP are Streptococcus pneumoniae and Mycoplasma pneumoniae. Currently, the resistance rate of Streptococcus pneumoniae to macrolides has reached over 75%, and the insensitivity rates of Mycoplasma pneumoniae to azithromycin and erythromycin are 70% and 60%, respectively. With the increasing rate of community-acquired pneumonia (CAP) caused by viral infections, coupled with the rising resistance rate of pathogens to antibiotics, the clinical efficacy of antimicrobial drugs in CAP is becoming increasingly limited, thus posing a significant challenge to the treatment of CAP.

[0004] CAP (common pulmonary arterial disease) largely falls under the categories of "wind-heat," "wind-heat lung disease," and "cough" in Traditional Chinese Medicine (TCM). Its pathogenesis primarily stems from two aspects: invasion of external pathogens, weakening of the lung and defensive qi, or deficiency of the body's vital energy (Qi) and inability to resist pathogens. The body is exposed to wind-heat pathogens, which invade the lungs through the mouth and nose, or wind-cold pathogens penetrate deeper and transform into heat, turning body fluids into phlegm, leading to phlegm-heat obstruction in the lungs. During the pathological process, it can transform into fire and generate phlegm, damage body fluids and deplete Qi, or the wind-heat pathogen can spread to the pericardium, even leading to a collapse of the body's vital energy due to the weakening of the body's vital energy. In the recovery period, the pathogens gradually dissipate, but the body's vital energy is already weakened, often presenting as a deficiency of vital energy, or a lingering deficiency of vital energy and pathogens, frequently manifesting as deficiency of both Qi and Yin, or deficiency of lung and spleen Qi, accompanied by phlegm-heat or turbid phlegm. Based on these pathological characteristics, TCM treatment focuses on eliminating pathogens and strengthening the body's vital energy. Studies show that the most common excess pattern in wind-heat lung disease is phlegm-heat obstruction in the lungs, accounting for over 50% of cases. Its core pathogenesis can be mainly summarized as the body being exposed to wind-heat pathogens, which invade the lungs through the mouth and nose, or wind-cold pathogens entering the interior and transforming into heat, causing the lungs to lose their ability to disperse and descend, turning body fluids into phlegm, and phlegm and heat obstructing the lungs. The main treatment principle should be to clear heat and resolve phlegm, disperse the lungs and stop coughing. At the same time, attention should be paid to clearing heat and detoxifying, but not to be too cold, so as not to damage the spleen and stomach. Summary of the Invention

[0005] The first technical problem to be solved by this invention is to provide a traditional Chinese medicine compound for treating community-acquired pneumonia in adults with phlegm-heat obstructing the lungs syndrome. This compound is significantly effective in improving cough symptoms and has significant therapeutic effects on clinical symptoms and lung inflammation imaging absorption in certain populations. The second technical problem to be solved by this invention is to provide a simple and convenient method for preparing the traditional Chinese medicine compound for treating community-acquired pneumonia in adults with phlegm-heat obstructing the lungs syndrome. The third technical problem to be solved by this invention is to provide the application of this traditional Chinese medicine compound in the preparation of drugs for treating community-acquired pneumonia in adults with phlegm-heat obstructing the lungs syndrome.

[0006] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is as follows:

[0007] A traditional Chinese medicine compound for treating community-acquired pneumonia in adults with phlegm-heat obstructing the lungs, the compound being made from the following raw materials in parts by weight: 15-45 parts of raw gypsum, 15-30 parts of reed stem, 3-6 parts of processed ephedra, 6-9 parts of trichosanthes peel, 6-9 parts of scutellaria, 6-12 parts of fritillaria thunbergii, 15-30 parts of houttuynia cordata, 6-9 parts of bitter almond, 6-9 parts of platycodon grandiflorus, 3-9 parts of processed pinellia, and 3-6 parts of raw licorice.

[0008] Furthermore, the traditional Chinese medicine compound is made from the following raw materials in parts by weight: 15-45 parts of raw gypsum, 20-30 parts of reed stem, 5-6 parts of processed ephedra, 7-9 parts of trichosanthes peel, 7-9 parts of scutellaria, 9-12 parts of fritillaria thunbergii, 15-30 parts of houttuynia cordata, 7-9 parts of bitter almond, 7-9 parts of platycodon grandiflorus, 6-9 parts of processed pinellia ternata, and 5-6 parts of raw licorice.

[0009] Furthermore, the traditional Chinese medicine compound is made from the following raw materials in parts by weight: 45 parts gypsum, 30 parts reed stem, 6 parts processed ephedra, 9 parts trichosanthes peel, 9 parts scutellaria, 9 parts fritillaria thunbergii, 30 parts houttuynia cordata, 9 parts bitter almond, 9 parts platycodon, 9 parts processed pinellia, and 6 parts raw licorice.

[0010] Furthermore, the preparations of the traditional Chinese medicine compound "Weishi Qingjin Fang" include decoctions, oral liquids, granules, tablets, or capsules.

[0011] Furthermore, the preparation method of the traditional Chinese medicine compound for treating phlegm-heat obstructing the lungs in adults with community-acquired pneumonia includes the following steps:

[0012] 1) Mix the medicinal materials, add 10 times the weight of water and soak for more than 3 hours. Take the gypsum and decoct for 30-35 minutes. Add the remaining medicinal materials and boil for 30-40 minutes. Pour out the liquid.

[0013] 2) Add 8 times the weight of water to the remaining dregs from step 1) and boil for 30-35 minutes, then pour out the liquid;

[0014] 3) Add 5 times the weight of water to the remaining dregs from step 2) and boil for 30-35 minutes, then pour out the liquid;

[0015] 4) Combine the three decoctions from steps 1), 2), and 3), and concentrate them to 400 mL over a low flame or using a rotary evaporator under reduced pressure to obtain the "Weishi Qingjin Fang" traditional Chinese medicine decoction.

[0016] Furthermore, the application of the aforementioned traditional Chinese medicine compound in the preparation of a medicine for treating phlegm-heat obstructing the lungs in adults with community-acquired pneumonia.

[0017] Furthermore, the method of taking the medicine is as follows: one dose per day, taken in the morning and evening, after meals.

[0018] Furthermore, the drug is used to treat adult patients with non-severe community-acquired pneumonia and phlegm-heat obstructing the lungs who are using β-lactam, quinolone, or β-lactam combined with quinolone antibiotics.

[0019] Furthermore, the drug is used to treat non-smoking adult patients with non-severe community-acquired pneumonia and phlegm-heat obstructing the lungs.

[0020] Furthermore, the drug is a drug used in combination with conventional Western medicine treatment.

[0021] Compared with the prior art, the present invention has the following advantages:

[0022] (1) To treat CAP with phlegm-heat obstructing the lungs, this invention selects "Ma Xing Shi Gan Tang" and "Qian Jin Wei Jing Tang" according to the principles of treatment. After multiple demonstrations by experts in the province, the composition and dosage of the drugs were adjusted, and it was finally named "Wei Shi Qing Jin Fang". The "Wei Shi Qing Jin Fang" of this invention has significant effects in improving clinical symptoms such as cough, and has significant effects on the absorption of lung inflammation on imaging in some populations.

[0023] (2) The "Weishi Qingjin Formula" of the present invention can effectively reduce the hospitalization costs, Chinese herbal medicine and antibiotic costs of CAP patients, and has economic advantages while ensuring the clinical recovery of CAP patients with phlegm-heat obstructing the lungs. Detailed Implementation

[0024] The present invention will be further illustrated below with reference to specific embodiments. These embodiments are implemented based on the technical solutions of the present invention, and 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.

[0025] Example 1

[0026] This embodiment provides a method for preparing a traditional Chinese medicine compound for treating phlegm-heat obstructing the lungs syndrome in adults with community-acquired pneumonia, including the following steps:

[0027] (1) Mix 30 parts of raw gypsum, 30 parts of reed stem, 6 parts of processed ephedra, 9 parts of trichosanthes peel, 6 parts of scutellaria, 12 parts of fritillaria thunbergii, 15 parts of houttuynia cordata, 9 parts of bitter almond, 9 parts of platycodon grandiflorus, 6 parts of processed pinellia ternata, and 6 parts of raw licorice. Soak in 10 times the weight of water for more than 3 hours. Take the gypsum and decoct for 30-35 minutes. Add the remaining herbs and boil for 30-40 minutes. Pour out the liquid.

[0028] (2) Add 8 times the weight of water to the remaining dregs from step (1) and boil for 30-35 minutes, then pour out the liquid.

[0029] (3) Add 5 times the weight of water to the remaining dregs from step (2) and boil for 30-35 minutes, then pour out the liquid.

[0030] (4) Combine the three medicinal liquids from steps (1), (2) and (3), and concentrate the medicinal liquid to 400 mL over a low flame or using a rotary evaporator with reduced pressure to obtain a traditional Chinese medicine decoction for treating phlegm-heat obstructing the lungs in adults with community-acquired pneumonia.

[0031] Example 2

[0032] The clinical trials of a traditional Chinese medicine compound for treating phlegm-heat obstructing the lungs in adults with community-acquired pneumonia are as follows:

[0033] 1. Clinical trial methods

[0034] Case Source: This multicenter, real-world retrospective cohort study selected 2138 cases of patients with non-severe CAP (phlegm-heat obstructing the lungs) diagnosed at the respiratory departments of ten traditional Chinese medicine (TCM) hospitals from September 1, 2023 to December 31, 2024. These included 525 cases from Jiangsu Provincial Hospital of Traditional Chinese Medicine, 82 cases from Yancheng Municipal Hospital of Traditional Chinese Medicine, 589 cases from Suzhou Municipal Hospital of Traditional Chinese Medicine, 286 cases from Nanjing Integrated Traditional Chinese and Western Medicine Hospital, 131 cases from Nantong Municipal Hospital of Traditional Chinese Medicine, 124 cases from the Second Affiliated Hospital of Jiangsu Provincial Hospital of Traditional Chinese Medicine, 249 cases from Jiangsu Provincial Hospital of Integrated Traditional Chinese and Western Medicine, 117 cases from Jiangyin Municipal Hospital of Traditional Chinese Medicine, 3 cases from Zhangjiagang Municipal Hospital of Traditional Chinese Medicine, and 32 cases from Taicang Municipal Hospital of Traditional Chinese Medicine. Patients were divided into an exposed group (647 cases) and a non-exposed group (1491 cases) based on whether they took TCM according to the treatment plan.

[0035] Western Medicine Diagnostic Criteria: The Western medicine diagnostic criteria for CAP are formulated with reference to the "Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Chinese Adults (2016 Edition)," "Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Traditional Chinese Medicine (2018 Revised Edition)," and "ATS / IDSA Clinical Practice Guidelines: Diagnosis and Treatment of Community-Acquired Pneumonia in Adults (2019 Edition)": 1) Community onset; 2) Pneumonia-related clinical manifestations: ① Newly developed cough, sputum production, or worsening of pre-existing respiratory symptoms, with or without purulent sputum, chest pain, dyspnea, and hemoptysis; ② Fever; ③ Signs of pulmonary consolidation and / or audible moist rales; ④ Peripheral blood leukocyte count > 10 × 10⁻⁶. 9 / L or <4×10 9 / L, with or without left shift of cell nuclei; 3) Chest imaging shows newly appearing patchy infiltrates, lobar or segmental consolidation, ground-glass opacities, or interstitial changes, with or without pleural effusion. If any one of criteria 1, 3, and 2 is met, and pulmonary tuberculosis, lung tumors, non-infectious interstitial lung disease, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophilic infiltration, and pulmonary vasculitis are excluded, CAP can be diagnosed. The diagnostic criteria for non-severe adult CAP refer to the Chinese Guidelines for the Diagnosis and Treatment of Community-Acquired Pneumonia in Adults (2016 edition).

[0036] Traditional Chinese Medicine (TCM) diagnostic criteria: The TCM diagnostic criteria for phlegm-heat obstructing the lungs are formulated with reference to the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes" and the "Guidelines for TCM Diagnosis and Treatment of Community-Acquired Pneumonia (2018 Revised Edition)" of the Pulmonary Diseases Branch of the Chinese Association of Traditional Chinese Medicine: Main symptoms: (1) Cough, even chest pain; (2) Yellow or white, dry and sticky phlegm; Secondary symptoms: (1) Fever, thirst; (2) Constipation, or abdominal distension; (3) Tongue and pulse: Red tongue, yellow or yellow and greasy tongue coating, rapid or slippery pulse; If two of the above main symptoms are present, plus one of the secondary symptoms, and the tongue and pulse are referenced, a diagnosis can be made.

[0037] Inclusion criteria: 1) Meets the above-mentioned diagnostic criteria for non-severe CAP and is aged 18-80 years; 2) Meets the TCM syndrome differentiation criteria for phlegm-heat obstructing the lungs; 3) Receives systematic and standardized TCM intervention, i.e., continuously uses Weishi Qingjin Fang for ≥5 days; 4) The clinical symptoms must be accurately recorded in the medical records, and those with follow-up records within one month must have complete records.

[0038] Exclusion criteria: 1) Patients with serious diseases of the heart, brain, liver, kidney, respiratory, nervous, immune, or hematological systems, infectious diseases, or malignant tumors; 2) Pregnant or lactating women.

[0039] Dropout criteria: 1) Failure to follow up on time as scheduled according to the follow-up plan; 2) Failure to follow the treatment plan; 3) Use of medications other than those in the treatment plan.

[0040] Exclusion criteria: 1) Cases with severely deficient data quality that cannot meet the analysis requirements.

[0041] Treatment methods: 1) The exposed group received "Weishi Qingjin Fang" in addition to routine Western medicine treatment. Prescription: Gypsum 45g, reed stem 30g, honey-processed ephedra 6g, Zhejiang fritillary bulb 9g, platycodon root 9g, trichosanthes peel 9g, houttuynia cordata 30g, prepared pinellia ternata 9g, licorice root 6g, wine-processed scutellaria baicalensis 9g, bitter almond 9g. Dosage: One dose daily, taken in the morning and evening, preferably after meals. 2) The non-exposed group received other traditional Chinese medicine compound prescriptions in addition to routine Western medicine treatment.

[0042] 2. Clinical trial results

[0043] (1) Comparison of clinical efficacy indicators between the two groups of patients

[0044] Table 1 shows that in the exposed group, 342 cases (60%) experienced cough relief, and 409 cases (63.2%) experienced sputum quality improvement. In the non-exposed group, the corresponding symptom relief rates were 654 cases (48.9%) and 861 cases (57.7%), respectively. There were statistically significant differences in these two indicators between the two groups (P < 0.05). However, there were no statistically significant differences between the two groups in terms of improvement in sputum volume, sputum color, abnormal CRP levels, abnormal WBC counts, and absorption of pulmonary inflammation on imaging (P > 0.05).

[0045] Table 1. Comparison of cough relief, sputum relief, fever relief, CRP decrease, WBC decrease, and absorption of lung inflammation on imaging between the two groups of patients after treatment.

[0046]

[0047] (2) Subgroup analysis of clinical symptom relief rate

[0048] In non-smokers, and in individuals using β-lactams, quinolones, or a combination of β-lactams and quinolones, the clinical symptom relief rate was significantly higher in the exposed group than in the unexposed group, and the differences were statistically significant (P < 0.05), as shown in Table 2 below.

[0049] Table 2. Subgroup analysis results of clinical symptom relief rate

[0050]

[0051] (3) Subgroup analysis of pulmonary inflammation imaging absorption

[0052] This application also conducted subgroup analysis on CT data, generating corresponding subgroups based on age, sex, presence or absence of hypertension, and type of antibiotics: 1) Based on age: <45 years old group (181 people), [45, 64) group (120 people), ≥65 years old group (75 people); 2) Based on sex: female group (164 people), male group (213 people); 3) Based on hypertension status: no hypertension group (295 people), hypertension group (80 people); 4) Based on antibiotic use: β-lactam antibiotics (45 people), β-lactam antibiotics combined with quinolones (174 people), quinolones (39 people), other antibiotics (67 people), no antibiotics (51 people). See Table 3 below.

[0053] Table 3. Subgroup analysis results of pneumonia imaging absorption rate

[0054]

[0055] (4) Cost-effectiveness analysis between the two groups

[0056] Table 4 shows that the average treatment cost per person in the exposed group was 6526.5 yuan, the cough relief rate was 60.0%, and the CER was 10877.6 yuan / %); the cost in the non-exposed group was 8198.5 yuan, the cough relief rate was 48.9%, and the CER was 16773.1 yuan / %). This indicates that compared to the non-exposed group, the exposed group requires 5895.5 yuan less to achieve a unit cough relief rate, demonstrating a superior cost-effectiveness advantage.

[0057] Table 4 Cost-Effectiveness Analysis Between the Two Groups

[0058]

[0059] The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine compound for treating adult community-acquired pneumonia with phlegm-heat obstructing lung syndrome, characterized in that, The traditional Chinese medicine compound is made from the following raw materials in parts by weight: 15-45 parts of raw gypsum, 15-30 parts of reed stem, 3-6 parts of processed ephedra, 6-9 parts of trichosanthes peel, 6-9 parts of scutellaria, 6-12 parts of fritillaria thunbergii, 15-30 parts of houttuynia cordata, 6-9 parts of bitter almond, 6-9 parts of platycodon grandiflorus, 3-9 parts of processed pinellia ternata, and 3-6 parts of raw licorice.

2. The traditional Chinese medicine compound of claim 1, wherein the traditional Chinese medicine compound is used for treating adult community-acquired pneumonia with phlegm-heat obstructing lung syndrome. The traditional Chinese medicine compound is made from the following raw materials in parts by weight: 15-45 parts of raw gypsum, 20-30 parts of reed stem, 5-6 parts of processed ephedra, 7-9 parts of trichosanthes peel, 7-9 parts of scutellaria, 9-12 parts of fritillaria thunbergii, 15-30 parts of houttuynia cordata, 7-9 parts of bitter almond, 7-9 parts of platycodon grandiflorus, 6-9 parts of processed pinellia ternata, and 5-6 parts of raw licorice.

3. The traditional Chinese medicine compound of claim 2, wherein the traditional Chinese medicine compound is used for treating adult community-acquired pneumonia with phlegm-heat obstructing lung syndrome. The traditional Chinese medicine compound is made from the following raw materials in parts by weight: 45 parts gypsum, 30 parts reed stem, 6 parts processed ephedra, 9 parts trichosanthes peel, 9 parts scutellaria, 9 parts fritillaria thunbergii, 30 parts houttuynia cordata, 9 parts bitter almond, 9 parts platycodon, 9 parts processed pinellia, and 6 parts raw licorice.

4. The traditional Chinese medicine compound for treating adult community-acquired pneumonia with syndrome of phlegm-heat obstructing lung according to claim 1 or 2 or 3, characterized in that: The traditional Chinese medicine compound "Weishi Qingjin Fang" is prepared in the form of decoction, oral liquid, granules, tablets or capsules.

5. The preparation method of the traditional Chinese medicine compound for treating adult community-acquired pneumonia with phlegm-heat obstructing lung syndrome according to any one of claims 1-4, characterized in that: Includes the following steps: 1) Mix the medicinal materials, add 10 times the weight of water and soak for more than 3 hours. Take the gypsum and decoct for 30-35 minutes. Add the remaining medicinal materials and boil for 30-40 minutes. Pour out the liquid. 2) Add 8 times the weight of water to the remaining dregs from step 1) and boil for 30-35 minutes, then pour out the liquid; 3) Add 5 times the weight of water to the remaining dregs from step 2) and boil for 30-35 minutes, then pour out the liquid; 4) Combine the three decoctions from steps 1), 2), and 3), and concentrate them to 400 mL over a low flame or using a rotary evaporator under reduced pressure to obtain the "Weishi Qingjin Fang" traditional Chinese medicine decoction.

6. The use of the traditional Chinese medicine compound according to any one of claims 1 to 4 in the preparation of a medicine for treating community-acquired pneumonia in adults with phlegm-heat obstructing the lungs.

7. Use according to claim 6, characterized in that: The medication is to be taken once a day, twice a day, after meals.

8. Use according to claim 6, characterized in that: The drug is used to treat adult patients with non-severe community-acquired pneumonia and phlegm-heat obstructing the lungs who are receiving β-lactam, quinolone, or β-lactam antibiotics in combination with quinolone antibiotics.

9. Use according to claim 6, characterized in that: The drug is used to treat non-smoking adult patients with non-severe community-acquired pneumonia and phlegm-heat obstructing the lungs.

10. The use according to claim 6, characterized in that: The medication mentioned is used in combination with conventional Western medicine treatment.

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