Use of Pingxiao tablets in the preparation of drugs for treating pulmonary nodule

Abstract

The application belongs to the technical field of drug use, and particularly relates to application of Pingxiao tablets in preparation of drugs for treating pulmonary nodule. The application discloses application of the Pingxiao tablets in preparation of the drugs for treating the pulmonary nodule. The application also discloses application of the Pingxiao tablets and Chaihu Shugan pills in combination in preparation of the drugs for treating the pulmonary nodule. The test results show that the Pingxiao tablet treatment group and the Pingxiao tablet combined with the Chaihu Shugan pill treatment group are lower than the control group in scores of chest pain, chest tightness, shortness of breath, cough and sputum; the pulmonary nodule size, the pulmonary nodule area and the pulmonary nodule volume are smaller than those of the control group; the total effective rate is higher than that of the control group; the proportion of low-risk degree of the pulmonary nodule risk degree classification is higher than that of the control group; the proportions of medium-risk degree and high-risk degree are lower than those of the control group; and the incidence of adverse reactions is lower than that of the control group. The Pingxiao tablet or the Pingxiao tablet combined with the Chaihu Shugan pill has a significant treatment effect on pulmonary nodule of phlegm and blood stasis type compared with the treatment effect of the Chaihu Shugan pill.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical application technology, specifically relating to the application of Pingxiao tablets in the preparation of drugs for treating pulmonary nodules. Background Technology

[0002] Pulmonary nodules are a respiratory disease with a high clinical incidence. Occupational exposure and smoking are major risk factors. Pulmonary nodules are classified by size: less than 5mm in diameter: the probability of malignancy is usually less than 1%; 5–10mm in diameter: the probability of malignancy is 6%–28%; 11–20mm in diameter: the probability of malignancy is 33%–64%; and more than 20mm in diameter: the probability of malignancy is 64%–82%. The distinction between benign and malignant nodules is generally made through morphological characteristics combined with dynamic changes. Benign nodules only require regular follow-up examinations, while malignant nodules often require early surgical removal.

[0003] Early-stage pulmonary nodules often lack typical clinical manifestations and are easily overlooked. By the time typical clinical manifestations appear, the disease has already progressed to an advanced stage. Currently, laboratory tests, imaging studies, and pathological examinations are the main clinical diagnostic methods. Traditional Chinese medicine believes that the pathogenesis of pulmonary nodules is a combination of deficiency and excess, primarily involving blood stasis and phlegm. In recent years, clinical practice has confirmed that traditional Chinese medicine can shrink nodules, thereby preventing malignant transformation, reducing surgical risks, and improving patients' quality of life.

[0004] Current treatments for pulmonary nodules mainly involve using antibiotics to reduce inflammation. However, long-term, high-dose use of antibiotics to treat small nodular inflammatory lesions carries the risk of antibiotic abuse and is not very effective. Summary of the Invention

[0005] The purpose of this invention is to provide the application of Pingxiao tablets in the preparation of a medicament for treating pulmonary nodules.

[0006] Another object of the present invention is to provide the use of a combination of drugs in the preparation of a medicament for treating pulmonary nodules, said combination of drugs including Pingxiao tablets and Chaihu Shugan pills.

[0007] The prescription for Pingxiao tablets is as follows: 54g of turmeric, 54g of agrimony, 45g of trogopterus dung, 54g of alum, 54g of saltpeter, 18g of dried lacquer (processed), 90g of stir-fried immature bitter orange peel, and 36g of strychnos nux-vomica powder. It has the effects of promoting blood circulation, removing blood stasis, dispersing nodules and reducing swelling, detoxifying and relieving pain.

[0008] The prescription for Chaihu Shugan Wan (Bupleurum Liver-Soothing Pill) is as follows: Poria cocos 100g, stir-fried Citrus aurantium 50g, Amomum villosum 40g, Paeonia lactiflora (processed with wine) 50g, Glycyrrhiza uralensis 50g, Cyperus rotundus (processed with vinegar) 75g, Citrus reticulata 50g, Platycodon grandiflorus 50g, Magnolia officinalis (processed with ginger) 50g, Crataegus pinnatifida (processed with ginger) 50g, Saposhnikovia divaricata 50g, Massa fermentata (processed with ginger) 50g, Bupleurum chinense 75g, Scutellaria baicalensis 50g, Mentha haplocalyx 50g, Perilla frutescens stem 75g, Aucklandia lappa 25g, Areca catechu (processed with ginger) 75g, Sparganium stoloniferum (processed with vinegar) 50g, Rheum palmatum (processed with wine) 50g, Citrus reticulata (processed with green tangerine peel) 50g, Angelica sinensis 50g, Pinellia ternata (processed with ginger) 75g, Lindera strychnifolia 50g, Curcuma zedoaria (processed with vinegar) 50g. Indications: Soothes the liver and regulates qi, relieves bloating and pain. Used for liver qi stagnation, chest and rib fullness, indigestion, and vomiting of sour fluid.

[0009] Furthermore, the pulmonary nodules are of the phlegm-blood stasis type.

[0010] The beneficial effects of this invention are:

[0011] In this invention, the main effects of Curcuma longa in Pingxiao tablets are to invigorate blood circulation, relieve pain, regulate qi, and alleviate depression; the main effects of stir-fried Citrus aurantium are to regulate qi and break up qi stagnation; the main effects of Trogopterus xanthipes and processed lacquer are to invigorate blood circulation, remove blood stasis, disperse nodules, and relieve pain; the main effects of Strychnos nux-vomica are to unblock collaterals, reduce swelling, disperse nodules, and relieve pain; the main effects of potassium nitrate are to break up accumulations, detoxify, and reduce swelling; the main effect of alum is to detoxify; and the main effect of Agrimonia pilosa is to strengthen the body and replenish deficiency. Experimental results show that the scores for chest pain, chest tightness, shortness of breath, cough, and excessive sputum in the Pingxiao tablet treatment group and the Pingxiao tablet combined with Chaihu Shugan Wan treatment group were all lower than those in the control group; the size, area, and volume of pulmonary nodules were all smaller than those in the control group; the total effective rate was higher than that in the control group; the proportion of low-risk pulmonary nodules was higher than that in the control group; the proportions of medium-risk and high-risk pulmonary nodules were lower than those in the control group; and the incidence of adverse reactions was lower than that in the control group. The clinical efficacy of Pingxiao tablets or Pingxiao tablets combined with Chaihu Shugan Wan in treating phlegm-blood stasis type pulmonary nodules is significantly better than that of Chaihu Shugan Wan. Detailed Implementation

[0012] The present invention will be further described in detail below through specific embodiments. All drugs and reagents involved in the specific embodiments are commercially available.

[0013] Clinical trials

[0014] This study used patients with phlegm-blood stasis type pulmonary nodules as the research sample, and the collection period was from July 2022 to July 2024. The clinical efficacy of Pingxiao tablets and Pingxiao tablets combined with Chaihu Shugan pills in the treatment of phlegm-blood stasis type pulmonary nodules was observed.

[0015] 1. Materials and Methods

[0016] 1.1 General Information

[0017] One hundred and eighty patients with pulmonary nodules of the phlegm-blood stasis type were screened and divided into three groups: treatment group 1 (n=60) received Pingxiao tablets; treatment group 2 (n=60) received Pingxiao tablets and Chaihu Shugan pills in combination; and control group (n=60) received Chaihu Shugan pills.

[0018] The control group consisted of 35 males and 25 females, with an age range of 45–68 years (mean age 56.10 ± 9.30 years), a weight range of 49–74 kg (mean weight 62.34 ± 7.40 kg), and a body mass index range of 17–30 kg / m². 2 The average value was (23.56±3.47) kg / m³. 2 Lung nodule size range: 0.5–1.0 cm, mean (1.35±0.23) cm; Lung nodule area range: 11–58 mm. 2 The mean value was (27.87±4.25) mm. 2 Disease duration: 1–10 years, mean (5.26±1.35) years; Nodule type: multiple (34 cases), pure ground-glass opacity (10 cases), solid (8 cases), mixed solid (8 cases); Symptoms: cough (10 cases), excessive sputum (9 cases), shortness of breath (9 cases), chest tightness (8 cases), chest pain (8 cases), and at least two symptoms (16 cases).

[0019] The treatment group consisted of 30 males and 28 females, with an age range of 45–67 years (mean age 56.51 ± 9.31 years), a weight range of 48–74 kg (mean weight 62.23 ± 7.36 kg), and a body mass index range of 16–30 kg / m². 2 The average value was (23.12±3.45) kg / m³. 2 Lung nodule size range: 0.5–1.0 cm, mean (1.33±0.25) cm; Lung nodule area range: 12–58 mm. 2 The mean value was (28.36±4.21) mm. 2 Disease duration: 2–10 years, mean (5.35±1.37) years; Nodule type: multiple (35 cases), pure ground-glass opacity (9 cases), solid (8 cases), mixed solid (8 cases); Symptoms: cough (11 cases), excessive sputum (9 cases), shortness of breath (8 cases), chest tightness (7 cases), chest pain (8 cases), and at least two symptoms (17 cases).

[0020] The treatment group consisted of 33 males and 27 females, with an age range of 47–69 years (mean age 56.68 ± 9.35 years), a weight range of 48–75 kg (mean weight 62.56 ± 7.47 kg), and a body mass index range of 16–31 kg / m². 2 The average value was (24.12±3.55) kg / m³. 2 Lung nodule size range: 0.5–1.0 cm, mean (1.36±0.24) cm; Lung nodule area range: 12–58 mm.2 The mean value was (28.23±4.30) mm. 2 Disease duration: 2–10 years, mean (5.85±1.41) years; Nodule type: multiple (33 cases), pure ground-glass opacity (10 cases), solid (9 cases), mixed solid (8 cases); Symptoms: cough (10 cases), excessive sputum (9 cases), shortness of breath (8 cases), chest tightness (7 cases), chest pain (8 cases), and at least two symptoms (18 cases).

[0021] 1.2 Inclusion and Exclusion Criteria

[0022] Inclusion criteria: (1) All were diagnosed by imaging examinations such as chest CT; (2) All met the diagnostic criteria for pulmonary nodules.

[0023] Exclusion criteria: (1) Allergic constitution; (2) Serious primary disease; (3) Serious cardiopulmonary insufficiency.

[0024] 1.3 Methods

[0025] 1.3.1 Medicines

[0026] Pingxiao Tablets (National Drug Approval Number Z21021484, Shenyang Qinggong Pharmaceutical Group Co., Ltd.), the prescription for Pingxiao Tablets as recorded in the 2020 edition of the Chinese Pharmacopoeia is: Curcuma longa 54g, Agrimonia pilosa 54g, Trogopterus xanthipes 45g, Alum 54g, Saltpeter 54g, Dried lacquer (processed) 18g, Fried Citrus aurantium 90g, Strychnos nux-vomica powder 36g.

[0027] Chaihu Shugan Wan (National Medicine Approval Number Z13021543, Beijing Yushengtang Group Shijiazhuang Pharmaceutical Co., Ltd., each pill weighs 10g, large honey pill), the prescription for Chaihu Shugan Wan recorded in the 2020 edition of the Chinese Pharmacopoeia is as follows: Poria 100g, stir-fried Citrus aurantium 50g, Amomum villosum 40g, white peony root (processed with wine) 50g, licorice root 50g, vinegar-processed Cyperus rotundus 75g, tangerine peel 50g, Platycodon grandiflorus 50g, ginger-processed Magnolia officinalis 50g, stir-fried Crataegus pinnatifida 50g, Saposhnikovia divaricata 50g, stir-fried Shenqu (medicated leaven) 50g, Bupleurum chinense 75g, Scutellaria baicalensis 50g, Mentha haplocalyx 50g, Perilla frutescens stem 75g, Aucklandia lappa 25g, stir-fried Areca catechu 75g, vinegar-processed Sparganium stoloniferum 50g, wine-processed Rheum palmatum 50g, green tangerine peel (stir-fried) 50g, Angelica sinensis 50g, ginger-processed Pinellia ternata 75g, Lindera strychnifolia 50g, vinegar-processed Curcuma zedoaria 50g. 1.3.2 Administration Method

[0028] Treatment Group 1: Patients took Pingxiao tablets orally, 6 tablets each time, 3 times a day, for 12 weeks.

[0029] Treatment Group 2: Patients took Pingxiao tablets orally, 6 tablets each time, 3 times a day; at the same time, they took Chaihu Shugan pills, 1 pill each time, twice a day, for 12 weeks.

[0030] Control group: Patients took Chaihu Shugan Pills orally, one pill at a time, twice a day, for 12 weeks.

[0031] 1.3.3 Observation Indicators

[0032] (1) Traditional Chinese medicine syndrome score. It includes 5 items, each with a score of 0 to 6, indicating no to severe; (2) size, area and volume of pulmonary nodules; (3) risk level classification of pulmonary nodules. According to the 2016 edition of the "Guidelines for Classification, Diagnosis and Treatment of Pulmonary Nodules in China", nodules with a diameter of <5 mm, 5 to 15 mm or ≥5 mm or ≤8 mm, and 8 to 15 mm or >8 mm or ≥15 mm are respectively rated as low-risk, medium-risk and high-risk nodules; (4) incidence of adverse reactions.

[0033] 1.3.4 Efficacy Evaluation Criteria

[0034] Based on the nodule diameter, lengthening or shortening of the nodule by 0–24%, 25%–49%, and 50%–100% are respectively assessed as deterioration, non-absorption, partial absorption, and significant absorption.

[0035] 1.4 Results

[0036] The scores for chest pain, chest tightness, shortness of breath, cough, and excessive sputum in the Pingxiao tablet treatment group and the Pingxiao tablet combined with Chaihu Shugan pill treatment group were all lower than those in the control group; the size, area, and volume of pulmonary nodules were all smaller than those in the control group; the total effective rate was higher than that in the control group; the proportion of low-risk pulmonary nodules was higher than that in the control group; and the proportions of intermediate-risk and high-risk pulmonary nodules were lower than those in the control group; the incidence of adverse reactions was also lower than that in the control group. See Tables 1 to 5.

[0037]

[0038]

[0039]

[0040]

[0041]

[0042] In conclusion, Pingxiao tablets, or Pingxiao tablets combined with Chaihu Shugan pills, can effectively improve the clinical symptoms of TCM syndromes such as chest pain, chest tightness, shortness of breath, cough, and excessive phlegm. They can also effectively reduce the size of pulmonary nodules and lower the risk of malignancy. The clinical efficacy of Pingxiao tablets or Pingxiao tablets combined with Chaihu Shugan pills in treating phlegm-blood stasis type pulmonary nodules is significantly higher than that of Chaihu Shugan pills alone.

Claims

1. Application of Pingxiao tablets in the preparation of drugs for treating pulmonary nodules.

2. The application of combined drugs in the preparation of drugs for treating pulmonary nodules, characterized in that: The combined medications include Pingxiao tablets and Chaihu Shugan pills.

3. The application according to claim 1 or 2, characterized in that: The lung nodules are of the phlegm-blood stasis type.

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