Traditional Chinese medicine composition for treating chronic obstructive pulmonary disease

Abstract

The invention provides a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. The traditional Chinese medicine composition is characterized by being prepared from the following components in parts by weight: 8-14 parts of radix astragali preparata, 3-7 parts of herba cistanche, 3-7 parts of fructus alpiniae oxyphyllae, 3-7 parts of rhizoma polygonati, 3-7 parts of radix dipsaci, 4-8 parts of rhizoma atractylodis macrocephalae fried with bran, 4-8 parts of radix salviae miltiorrhizae, 1-5 parts of semen brassicae, 2-6 parts of fructus perillae, 1-5 parts of semen lepidii, 1-5 parts of fructus trichosanthis, 1-5 parts of scorpio, 3-7 parts of earthworm, 1-5 parts of periostracum cicada, 1-5 parts of herba asari, 2-6 parts of radix saposhnikoviae and 2-6 parts of schizonepeta spike. The traditional Chinese medicine composition has the effects of regulating and tonifying lung and kidney, relieving cough and asthma, reducing phlegm and removing blood stasis, and is suitable for chronic obstructive pulmonary disease, chronic pulmonary heart disease, wheeze, chest distress and shortness of breath, aggravated motility, spontaneous perspiration and aversion to wind, cough, expectoration and other symptoms.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease. Background Technology

[0002] Chronic obstructive pulmonary disease (COPD), known in Traditional Chinese Medicine as "lung distension," is a common and heterogeneous disease characterized by persistent airflow limitation and respiratory symptoms such as cough, sputum production, and wheezing. As the disease progresses, pathological changes gradually occur in the airways and / or alveoli. COPD patients have a high baseline mortality rate, placing a heavy burden on the socioeconomic system. Current modern medical treatments for COPD include inhaled bronchodilators, corticosteroids, long-term home oxygen therapy, and pulmonary rehabilitation exercises. While these methods can relieve symptoms in the short term, their effectiveness in long-term clinical relief remains unsatisfactory, and the prognosis is often poor. Summary of the Invention

[0003] The technical problem to be solved by the present invention is to provide a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, which addresses the shortcomings of the prior art. This traditional Chinese medicine composition has significant clinical efficacy in relieving symptoms such as wheezing and shortness of breath in COPD patients, and is also effective in improving patients' quality of life (CAT score), improving dyspnea condition (mMRC), and improving lung function. It is beneficial to improve patients' quality of life, has good clinical application value, and is worthy of clinical promotion.

[0004] To solve the above-mentioned technical problems, the technical solution adopted by the present invention is: a traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, made from the following components in parts by weight: 8-14 parts of roasted Astragalus membranaceus, 3-7 parts of Cistanche deserticola, 3-7 parts of Alpinia oxyphylla, 3-7 parts of Polygonatum sibiricum, 3-7 parts of Dipsacus asper, 4-8 parts of stir-fried Atractylodes macrocephala, 4-8 parts of Salvia miltiorrhiza, 1-5 parts of Sinapis alba, 2-6 parts of Perilla frutescens, 1-5 parts of Lepidium apetalum, 1-5 parts of Trichosanthes kirilowii, 1-5 parts of Buthus martensii, 3-7 parts of Pheretima aspergillum, 1-5 parts of Cicadae periostracum, 1-5 parts of Asarum heterotropoides, 2-6 parts of Saposhnikovia divaricata, and 2-6 parts of Schizonepeta tenuifolia.

[0005] Preferably, it is made from the following components in parts by weight: 10-12 parts roasted Astragalus membranaceus, 4-6 parts Cistanche deserticola, 4-6 parts Alpinia oxyphylla, 4-6 parts Polygonatum sibiricum, 4-6 parts Dipsacus asper, 5-7 parts stir-fried Atractylodes macrocephala, 5-7 parts Salvia miltiorrhiza, 1-3 parts white mustard seed, 3-5 parts Perilla frutescens seed, 2-4 parts Lepidium apetalum, 2-4 parts Trichosanthes kirilowii, 2-4 parts Buthus martensii, 4-6 parts earthworm, 2-4 parts Cicadae periostracum, 1-3 parts Asarum heterotropoides, 3-5 parts Saposhnikovia divaricata, and 3-5 parts Schizonepeta tenuifolia.

[0006] Preferably, it is made from the following components in parts by weight: 11 parts roasted Astragalus membranaceus, 5 parts Cistanche deserticola, 5 parts Alpinia oxyphylla, 5 parts Polygonatum sibiricum, 5 parts Dipsacus asper, 6 parts stir-fried Atractylodes macrocephala, 6 parts Salvia miltiorrhiza, 2 parts white mustard seed, 4 parts Perilla frutescens seed, 3 parts Lepidium apetalum seed, 3 parts Trichosanthes kirilowii fruit, 3 parts Buthus martensii, 5 parts earthworm, 3 parts Cicadae periostracum, 2 parts Asarum heterotropoides, 4 parts Saposhnikovia divaricata, and 4 parts Schizonepeta tenuifolia spike.

[0007] Compared with the prior art, the present invention has the following advantages:

[0008] 1. In this invention, roasted Astragalus membranaceus is sweet and slightly warm in nature, entering the Lung Meridian of Hand-Taiyin and the Spleen Meridian of Foot-Taiyin. It is good at tonifying the Qi of the Lung and Spleen, and strengthening the Wei Qi and consolidating the exterior. Cistanche deserticola is sweet and slightly warm, salty and moist, and warms and tonifies the Kidney Yang. The two herbs work together to tonify the Lung and benefit the Kidney, and together they are the principal herbs. Alpinia oxyphylla is pungent and warm in nature, and can warm the Spleen, warm the Kidney, and consolidate Qi. Polygonatum sibiricum is good at tonifying Qi and Yin, moistening the Lung and tonifying the Kidney. When the Lung and Kidney are in harmony, the essence and Qi are preserved. Dipsacus asper is sweet and warm to assist Yang, and pungent to disperse blood stasis and promote blood circulation. Atractylodes macrocephala stir-fried with wheat bran invigorates Qi and strengthens the Spleen to cut off the source of phlegm production. At the same time, it assists the transportation and transformation of the Middle Jiao to achieve the effect of nourishing the Spleen and generating Metal. The four herbs together are the assistant herbs. The combination of the four herbs is warm but not drying, nourishing but not greasy, and harmonizes the Lung, Spleen, and Kidney. White mustard seed, perilla seed, salvia miltiorrhiza, lepidium seed, trichosanthes fruit, scorpion, earthworm, and cicada slough are used as adjuvant herbs. White mustard seed is pungent and warm in nature, which can promote qi circulation and resolve phlegm, and is good at removing phlegm from the skin and membranes. Perilla seed is slightly pungent and can lower qi and eliminate phlegm. Salvia miltiorrhiza is bitter and can lower and drain into the blood, and is good at cooling the blood and removing blood stasis. The three herbs are used together with cold and warm properties, and the pungent and bitter properties can open up the qi and lower the qi, so that the phlegm and blood stasis can be eliminated. Lepidium seed can purge the lungs and relieve asthma, and remove phlegm and fluid in the chest. When the disease is prolonged, phlegm and blood stasis in the chest can turn into heat. Trichosanthes fruit is sweet and slightly bitter and cold in nature, and is good at widening the chest and dispersing stagnation, and clearing phlegm and heat in the chest. Earthworm and scorpion can unblock the collaterals and relieve asthma. The two herbs complement each other, which can penetrate and clear the meridians, so that the meridians are unblocked, the turbidity is removed and the stagnation is opened, and the evil is eliminated and the righteous is restored to relieve spasms and unblock the collaterals. Cicada slough can enhance the spasm-relieving effect of scorpion and earthworm. Asarum is pungent and warm, entering the lung and kidney meridians. It dispels wind and cold, warms the lungs and resolves phlegm, and also invigorates the true yang qi in the kidneys. Saposhnikovia divaricata, combined with stir-fried Atractylodes macrocephala and Astragalus membranaceus, strengthens the qi and protects the body from external pathogens, preventing sweating and blocking external evils from entering the body. At the same time, Saposhnikovia divaricata is also a "moisturizer of wind-dispelling drugs". Schizonepeta tenuifolia has a strong wind-dispelling effect and mainly enters the blood. The two drugs together dispel wind and release the exterior, helping the other drugs to tonify without causing stagnation. The above three herbs work together to regulate qi, blood and phlegm, and achieve the effect of tonifying the lungs and kidneys, resolving phlegm and removing blood stasis. The whole formula works to tonify the lungs and kidneys, stop cough and relieve asthma, and resolve phlegm and remove blood stasis.

[0009] 2. This invention has significant clinical efficacy in relieving symptoms such as wheezing and shortness of breath in patients with COPD, and is superior to the Western medicine control group. It also has efficacy in improving patients' quality of life (CAT score), improving dyspnea (mMRC), and improving lung function. It is beneficial to improve patients' quality of life and has good clinical application value, which is worthy of clinical promotion.

[0010] 3. This invention nourishes the lungs and kidneys, relieves cough and asthma, resolves phlegm and removes blood stasis. It is suitable for chronic obstructive pulmonary disease, chronic pulmonary heart disease, wheezing, chest tightness and shortness of breath, which worsen with exertion, spontaneous sweating and aversion to wind, cough and expectoration.

[0011] The present invention will be further described in detail below with reference to the embodiments. Detailed Implementation

[0012] Example 1

[0013] The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease in this embodiment is made from the following components in parts by weight: 11 parts of roasted Astragalus membranaceus, 5 parts of Cistanche deserticola, 5 parts of Alpinia oxyphylla, 5 parts of Polygonatum sibiricum, 5 parts of Dipsacus asper, 6 parts of stir-fried Atractylodes macrocephala, 6 parts of Salvia miltiorrhiza, 2 parts of white mustard seed, 4 parts of Perilla frutescens seed, 3 parts of Lepidium apetalum, 3 parts of Trichosanthes kirilowii, 3 parts of Buthus martensii, 5 parts of Pheretima aspergillum, 3 parts of Cicadae periostracum, 2 parts of Asarum heterotropoides, 4 parts of Saposhnikovia divaricata, and 4 parts of Schizonepeta tenuifolia spike.

[0014] The various Chinese herbal components in this embodiment are processed into pills through the following steps: selection of medicinal materials → cleaning of medicinal materials → air drying → processing and pulverizing → molding → shaping → selecting of the cap → drying → coating → polishing → quality inspection.

[0015] Patient Hong Quanyou, male, 59 years old. Before taking the medication, his symptoms included: cough with sputum, white and sticky sputum that was difficult to expectorate, chest tightness, shortness of breath, significant wheezing, night sweats, significant fatigue, fair appetite, poor sleep, and normal bowel movements. He took Bufei Nashen Wan (6g each time, 3 times / day, 30 minutes after breakfast and dinner) for 4 weeks. After 4 weeks of treatment, his symptoms were: cough basically disappeared, with occasional sputum; chest tightness and shortness of breath significantly improved; no significant wheezing at night; reduced night sweats; significant improvement in fatigue; good appetite; improved sleep; and normal bowel movements.

[0016] Example 2

[0017] The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease in this embodiment is made from the following components in parts by weight: 12 parts roasted Astragalus membranaceus, 4 parts Cistanche deserticola, 4 parts Alpinia oxyphylla, 6 parts Polygonatum sibiricum, 4 parts Dipsacus asper, 7 parts stir-fried Atractylodes macrocephala, 5 parts Salvia miltiorrhiza, 1 part white mustard seed, 5 parts Perilla frutescens seed, 2 parts Lepidium apetalum, 4 parts Trichosanthes kirilowii, 4 parts Buthus martensii, 4 parts Pheretima aspergillum, 4 parts Cicadae periostracum, 1 part Asarum heterotropoides, 5 parts Saposhnikovia divaricata, and 3 parts Schizonepeta tenuifolia.

[0018] The traditional Chinese medicine composition of this embodiment is made into pills.

[0019] Patient Zhu Wenying, female, 72 years old, presented with the following symptoms before taking the medication: chest tightness and shortness of breath, occasional chest fullness, accompanied by cough and sputum (small amount, white and thin), dizziness, excessive sweating, aversion to cold, lower abdominal pain and discomfort, fair appetite, fair sleep, and normal bowel movements. She took Bufei Nashen Wan (6g each time, 3 times / day, 30 minutes after breakfast and dinner) for 4 weeks. After 4 weeks, her symptoms were significantly relieved: chest tightness and shortness of breath were significantly relieved; occasional chest fullness occurred after activity; there was no significant cough or sputum; dizziness improved; excessive sweating and aversion to cold significantly improved; lower abdominal pain disappeared; appetite was good; sleep was fair; and bowel movements were normal.

[0020] Example 3

[0021] The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease in this embodiment is made from the following components in parts by weight: 10 parts roasted Astragalus membranaceus, 6 parts Cistanche deserticola, 6 parts Alpinia oxyphylla, 4 parts Polygonatum sibiricum, 6 parts Dipsacus asper, 5 parts stir-fried Atractylodes macrocephala, 7 parts Salvia miltiorrhiza, 3 parts white mustard seed, 3 parts Perilla frutescens seed, 4 parts Lepidium apetalum, 2 parts Trichosanthes kirilowii, 2 parts Buthus martensii, 6 parts earthworm, 2 parts Cicadae periostracum, 3 parts Asarum heterotropoides, 3 parts Saposhnikovia divaricata, and 5 parts Schizonepeta tenuifolia.

[0022] The traditional Chinese medicine composition of this embodiment is made into pills.

[0023] Patient Ma Chuntang, male, 60 years old. Before taking the medication, his symptoms included: cough with thin, white sputum that was difficult to expectorate, accompanied by chest tightness, shortness of breath, wheezing, and fatigue, especially after activity; a foreign body sensation in the throat; dry mouth and bitter taste; poor appetite; normal sleep; and normal bowel movements. He took Bufei Nashen Wan (6g each time, 3 times / day, 30 minutes after breakfast and dinner) for 4 weeks. After 4 weeks of treatment, his symptoms were: no significant cough; significant improvement in chest tightness, wheezing, and shortness of breath; disappearance of the foreign body sensation in the throat; significant improvement in fatigue; no dry mouth or bitter taste; normal appetite; normal sleep; and normal bowel movements.

[0024] Example 4

[0025] The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease in this embodiment is made from the following components in parts by weight: 8 parts roasted Astragalus membranaceus, 3 parts Cistanche deserticola, 3 parts Alpinia oxyphylla, 7 parts Polygonatum sibiricum, 7 parts Dipsacus asper, 4 parts stir-fried Atractylodes macrocephala, 8 parts Salvia miltiorrhiza, 5 parts white mustard seed, 6 parts Perilla frutescens seed, 5 parts Lepidium apetalum seed, 1 part Trichosanthes kirilowii fruit, 1 part scorpion, 7 parts earthworm, 5 parts Cicadae periostracum, 1 part Asarum heterotropoides, 2 parts Saposhnikovia divaricata, and 2 parts Schizonepeta tenuifolia spike.

[0026] The traditional Chinese medicine composition of this embodiment is made into pills.

[0027] Patient Liu Jinting, male, 65 years old, presented with the following symptoms before taking the medication: cough with sputum, white frothy sputum, chest tightness and shortness of breath, worsening with activity, accompanied by right-sided chest and back pain, significant fatigue, blurred vision, fair appetite, dry stools (once every 3 days), normal urination, and fair sleep. He took Bufei Nashen Wan (6g each time, 3 times / day, 30 minutes after breakfast and dinner) for 4 weeks. After 4 weeks, his symptoms were significantly relieved: cough with sputum, improved chest tightness and shortness of breath, significantly improved right-sided chest and back pain, improved fatigue, but still had blurred vision, good appetite, normal bowel movements, and fair sleep.

[0028] Example 5

[0029] The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease in this embodiment is made from the following components in parts by weight: 14 parts roasted Astragalus membranaceus, 7 parts Cistanche deserticola, 7 parts Alpinia oxyphylla, 3 parts Polygonatum sibiricum, 3 parts Dipsacus asper, 8 parts stir-fried Atractylodes macrocephala, 4 parts Salvia miltiorrhiza, 1 part white mustard seed, 2 parts Perilla frutescens seed, 1 part Lepidium apetalum seed, 5 parts Trichosanthes kirilowii fruit, 5 parts Buthus martensii, 3 parts Pheretima aspergillum, 1 part Cicadae periostracum, 5 parts Asarum heterotropoides, 6 parts Saposhnikovia divaricata, and 6 parts Schizonepeta tenuifolia spike.

[0030] The traditional Chinese medicine composition of this embodiment is made into pills.

[0031] Patient Hu Jianming, male, 55 years old, presented with the following symptoms before taking the medication: chest tightness, shortness of breath, and wheezing, with worsening shortness of breath after exertion, accompanied by coughing up yellow-white sputum that was difficult to expectorate, occasional dizziness, good appetite, fair sleep, normal urination, and loose stools twice a day. He took Bufei Nashen Wan (6g each time, 3 times / day, 30 minutes after breakfast and dinner) for 4 weeks. After 4 weeks of treatment, his symptoms significantly improved: chest tightness, shortness of breath, and wheezing; occasional coughing up of sputum that was easily expectorated; no dizziness; good appetite; good sleep; and normal bowel movements.

[0032] Example 6

[0033] Clinical trials were conducted using the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease of the present invention.

[0034] 1. Clinical Data

[0035] 1.1 General Information

[0036] We selected 168 patients with stable COPD of the lung and kidney qi deficiency and phlegm and blood stasis syndrome who met the inclusion criteria and visited the outpatient department of the Department of Pulmonary Diseases of Ningxia Hui Autonomous Region Traditional Chinese Medicine Hospital and Research Institute from December 2021 to October 2022.

[0037] Patients were randomly divided into two groups, with 84 patients in each group. The treatment group consisted of 47 males and 37 females, with an average age of 61.57 ± 8.601 years; the control group consisted of 48 males and 36 females, with an average age of 61.63 ± 8.064 years. There were no significant differences in gender or age between the two groups (P>0.05), making them comparable.

[0038] 1.2 Diagnostic criteria

[0039] 1.2.1 Western Medicine Diagnostic Criteria

[0040] The Western medicine diagnostic criteria refer to the diagnostic, staging, and grading standards of the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)" and the "2023 GOLD Global Strategy for the Diagnosis, Treatment and Prevention of Chronic Obstructive Pulmonary Disease". The staging is stable and the grading is moderate.

[0041] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0042] The diagnostic criteria for Traditional Chinese Medicine (TCM) were formulated with reference to the diagnostic criteria in the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease in Traditional Chinese Medicine (2011 Edition)". The syndrome of lung and kidney qi deficiency with phlegm and blood stasis obstructing the collaterals presents with: Primary symptoms: wheezing, shortness of breath, aggravated by exertion, cough, expectoration; Secondary symptoms: aversion to wind, fatigue, spontaneous sweating, chest tightness, soreness and weakness of the lower back and knees, frequent bowel movements, nocturia, or cough with urinary incontinence; Tongue and pulse: pale / dark red tongue with petechiae, white tongue coating, deep and thready or thready and hesitant pulse.

[0043] 1.3 Inclusion Criteria

[0044] ① Age 35-75 years, gender not limited; ② Meets the Western medicine diagnosis, staging and traditional Chinese medicine disease and syndrome differentiation criteria for COPD; ③ Lung function is at grade II (moderate); ④ Has not participated in other drug clinical trials within one month prior to enrollment.

[0045] 1.4 Exclusion Criteria

[0046] ① Patients with serious primary diseases of the heart, liver, kidneys, brain, hematopoietic system, immune system, etc.; ② Patients with respiratory failure requiring mechanical ventilation; ③ Patients with tuberculosis, tumors, and other lung diseases; ④ Patients with allergic constitution or known allergies to the components of the test formula.

[0047] 2. Treatment methods

[0048] Control group: Budesonide / Formoterol inhaler (trade name: Symbicort, manufactured by AstraZeneca AB, import drug registration certificate number: H20140458, specification: 160ug / 4.5ug, 60 inhalations), once in the morning and once in the evening, one inhalation each time. Rinse mouth with water after taking the medicine.

[0049] Treatment group: The traditional Chinese medicine composition of the present invention (processed Astragalus membranaceus, Cistanche deserticola, Alpinia oxyphylla, Polygonatum sibiricum, Dipsacus asper, stir-fried Atractylodes macrocephala, Salvia miltiorrhiza, Sinapis alba, Perilla frutescens, Lepidium apetalum, Trichosanthes kirilowii, Buthus martensii, Pheretima aspergillum, Cicadae periostracum, Asarum heterotropoides, Saposhnikovia divaricata, Schizonepeta tenuifolia) was prepared into pills by the preparation room of Ningxia Traditional Chinese Medicine Hospital and Research Institute. The dosage was 6g each time, 3 times a day, taken 30 minutes after breakfast and dinner.

[0050] Both groups underwent 28-day treatments, and both received COPD health education and smoking cessation.

[0051] 3. Observation of therapeutic effects

[0052] 3.1 Observation Indicators

[0053] ① Traditional Chinese Medicine (TCM) symptom scoring: Referring to the 2002 edition of the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs (Trial Implementation)," quantitative scoring was used to compare the primary and secondary symptoms of COPD. Both primary and secondary symptoms were scored on a 4-point scale: primary symptom: 6 points for severe, 4 points for moderate, 2 points for mild, and 0 points for normal; secondary symptom: 3 points for severe, 2 points for moderate, 1 point for mild, and 0 points for normal. TCM syndrome scores were recorded before and after treatment. ② Total quality of life score: Referring to the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)," the COPD assessment test (CAT) was used, including 8 questions, with a total score range of 0–40 points (see appendix table). Scores were recorded before and after treatment. ③ Assessment of dyspnea: Referring to the "Guidelines for the Diagnosis and Treatment of Chronic Obstructive Pulmonary Disease (2021 Revised Edition)," the modified UK Medical Research Council Respiratory Questionnaire (mMRC) was used. Scores were recorded before and after treatment. ④ Lung function indicators: Under the guidance of a professional physician, the subjects performed chronic lung disease and forced lung ventilation tests according to the operation steps of the pulmonary function instrument, and recorded the relevant results of FEV1%Pred and FEV1 / FVC before and after treatment.

[0054] 3.2 Efficacy Criteria

[0055] Clinical control: Clinical symptoms and signs disappear or basically disappear, efficacy index ≥ 95%; Marked effect: Clinical symptoms and signs are significantly improved, 70% ≤ efficacy index < 95%; Effective: Clinical symptoms and signs are improved, 30% ≤ efficacy index < 70%; Ineffective: Clinical symptoms and signs are not significantly improved, efficacy index < 30%. Efficacy index = (TCM symptom score before treatment - TCM symptom score after treatment) / TCM symptom score before treatment × 100% (Nimodipine method).

[0056] 3.3 Statistical Methods

[0057] ① Data were analyzed using SPSS 26.0 statistical software. ② All statistical tests used P ≤ 0.05 as the criterion for significant differences and were two-tailed tests. ③ If the measurement samples met the conditions of normal distribution and homogeneity of variance, a t-test was used; otherwise, a non-parametric rank-sum test was used. Normal distribution was expressed as X ± S, and skewed distribution was expressed as M(Q25, Q75). ④ Count data were described statistically using frequency (proportion) and X-ray diffraction (XRD). 2 Test; ⑤ For ordinal data, the rank-sum test is used for count samples.

[0058] 3.4 Treatment Results

[0059] 3.4.1 Comparison of the effectiveness rates of the two groups

[0060] After 4 weeks of treatment, the overall effective rate in the treatment group (94.0%) was higher than that in the budesonide / formoterol group (78.6%), and the difference was statistically significant after comparison using the rank-sum test (P<0.001<0.05). (See Table 1)

[0061] Table 1 Comparison of Effectiveness Results

[0062]

[0063] 3.4.2 Comparison of TCM symptom scores between the two groups

[0064] Before treatment, there were no significant differences in the scores of wheezing and shortness of breath (primary symptoms) and nocturia, aversion to wind, spontaneous sweating, and chest tightness (secondary symptoms) between the treatment group and the budesonide / formoterol group (P>0.05), indicating comparability. After 28 days of treatment, both the treatment group and the budesonide / formoterol group showed improvement in the above symptoms (P<0.05), demonstrating a statistically significant difference. After treatment, the scores of primary and secondary symptoms in the treatment group and the budesonide / formoterol group showed that the treatment group was superior to the budesonide / formoterol group in terms of improvement in wheezing, shortness of breath, chest tightness, spontaneous sweating, aversion to wind, and urinary frequency (P<0.05), indicating a statistically significant difference. Furthermore, the total symptom score in the treatment group was also better than that in the budesonide / formoterol group (P<0.05), indicating that the treatment group had a more significant overall improvement in symptoms. (See Table 2)

[0065] Table 2 Comparison of primary and secondary symptom scores in Traditional Chinese Medicine (M(Q25, Q75))

[0066]

[0067]

[0068] 3.4.3 Comparison of FEV1%Pred

[0069] There was no statistically significant difference in FEV1%Pred values ​​between the treatment group and the budesonide / formoterol group before treatment (P = 0.749 > 0.05), allowing for comparison. After 28 days of treatment, FEV1%Pred values ​​in both groups significantly increased compared to before treatment, with a statistically significant difference (P < 0.05), indicating that both the treatment group and budesonide / formoterol improved pulmonary ventilation function; and the treatment group showed a more significant effect in improving airflow limitation after treatment (P < 0.05).

[0070] (See Table 3)

[0071] Table 3 Comparison of FEV1% and Pred in lung function

[0072]

[0073] 3.4.4 Comparison of FEV1 / FVC (%) in lung function

[0074] Before treatment, there was no significant difference in FEV1 / FVC (%) between the treatment group and the budesonide / formoterol group (P = 0.914 > 0.05), indicating comparability. After 28 days of treatment, the first second rate increased in both groups (P < 0.05), demonstrating the effectiveness of both the treatment group and budesonide / formoterol in improving lung function indicators; the treatment group showed better improvement in the first second rate after treatment (P = 0.001 < 0.05). (See Table 4)

[0075] Table 4 Comparison of FEV1 / FVC in lung function

[0076]

[0077] 3.4.5 Comparison of CAT Quality of Life Scores

[0078] There was no statistically significant difference in quality of life scores between the treatment group and the budesonide / formoterol group before treatment (P = 0.758 > 0.05), indicating comparability. After 28 days of treatment, both the treatment group and the budesonide / formoterol group significantly improved patients' quality of life, with statistically significant differences (P < 0.05). Furthermore, the quality of life score in the treatment group was lower than that in the budesonide / formoterol group after treatment (P < 0.05), suggesting that the treatment group was more effective in improving patients' quality of life (see Table 5).

[0079] Table 5 Comparison of Total Quality of Life Scores

[0080]

[0081] 3.4.6 Comparison of assessments of dyspnea status (mMRC)

[0082] mMRC data are ordinal data. The rank-sum test showed no statistically significant difference in dyspnea severity between the treatment group and the budesonide / formoterol group (P = 0.444 > 0.05), indicating comparability. After 28 days of treatment, the dyspnea severity in both groups significantly decreased (P < 0.05), demonstrating statistical significance. This indicates that both the treatment group and budesonide / formoterol are effective in alleviating airflow limitation; moreover, the treatment group showed better improvement in dyspnea severity than the budesonide / formoterol group (P < 0.05). (See Table 6)

[0083] Table 6 Comparison of mMRC grading (examples)

[0084]

[0085] 3.5.5 Analysis of Two Sets of Safety Indicators

[0086] During the 28-day treatment period of the traditional Chinese medicine composition for treating chronic obstructive pulmonary disease and budesonide / formoterol in this invention, the patient experienced no allergic reactions or adverse events, and vital signs remained normal. Blood routine, liver and kidney function, electrocardiogram and other indicators showed no significant abnormal changes.

[0087] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention in any way. Any simple modifications, alterations, and equivalent changes made to the above embodiments based on the inventive essence shall still fall within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating chronic obstructive pulmonary disease, characterized in that, It is made from the following components in parts by weight: 8-14 parts roasted Astragalus membranaceus, 3-7 parts Cistanche deserticola, 3-7 parts Alpinia oxyphylla, 3-7 parts Polygonatum sibiricum, 3-7 parts Dipsacus asper, 4-8 parts stir-fried Atractylodes macrocephala, 4-8 parts Salvia miltiorrhiza, 1-5 parts white mustard seed, 2-6 parts Perilla frutescens seed, 1-5 parts Lepidium apetalum seed, 1-5 parts Trichosanthes kirilowii fruit, 1-5 parts Buthus martensii, 3-7 parts earthworm, 1-5 parts Cicadae periostracum, 1-5 parts Asarum heterotropoides, 2-6 parts Saposhnikovia divaricata, and 2-6 parts Schizonepeta tenuifolia spike.

2. The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease according to claim 1, characterized in that, It is made from the following components in parts by weight: 10-12 parts roasted Astragalus membranaceus, 4-6 parts Cistanche deserticola, 4-6 parts Alpinia oxyphylla, 4-6 parts Polygonatum sibiricum, 4-6 parts Dipsacus asper, 5-7 parts stir-fried Atractylodes macrocephala, 5-7 parts Salvia miltiorrhiza, 1-3 parts white mustard seed, 3-5 parts Perilla frutescens seed, 2-4 parts Lepidium apetalum, 2-4 parts Trichosanthes kirilowii, 2-4 parts Buthus martensii, 4-6 parts earthworm, 2-4 parts Cicadae periostracum, 1-3 parts Asarum heterotropoides, 3-5 parts Saposhnikovia divaricata, and 3-5 parts Schizonepeta tenuifolia.

3. The traditional Chinese medicine composition for treating chronic obstructive pulmonary disease according to claim 2, characterized in that, It is made from the following components in parts by weight: 11 parts roasted Astragalus membranaceus, 5 parts Cistanche deserticola, 5 parts Alpinia oxyphylla, 5 parts Polygonatum sibiricum, 5 parts Dipsacus asper, 6 parts stir-fried Atractylodes macrocephala, 6 parts Salvia miltiorrhiza, 2 parts white mustard seed, 4 parts Perilla frutescens seed, 3 parts Lepidium apetalum seed, 3 parts Trichosanthes kirilowii fruit, 3 parts Buthus martensii, 5 parts earthworm, 3 parts Cicadae periostracum, 2 parts Asarum heterotropoides, 4 parts Saposhnikovia divaricata, and 4 parts Schizonepeta tenuifolia spike.

Images