A Chinese medicine composition for preventing and treating subsolid pulmonary nodules, and its preparation method and application

Abstract

The present invention provides a Chinese medicine composition for preventing and treating subsolid pulmonary nodules, and a preparation method and application thereof. The Chinese medicine composition comprises platycodon, inula flower, raw liquorice, scutellaria, apricot kernel, salvia miltiorrhiza, chuanxiong, honeycomb, scorpion, and chicken's gizzard lining. The Chinese medicine composition is screened for Chinese medicine prescriptions according to the theory of traditional Chinese medicine and the theory of syndrome differentiation and treatment, and has a rigorous formula. The Chinese medicine composition is targeted at patients with subsolid pulmonary nodules with syndrome differentiation of phlegm and blood stasis, and has the effects of regulating qi, removing blood stasis and resolving phlegm, detoxifying, attacking and dispersing nodules, and can effectively inhibit the progression of pulmonary nodules, reduce the trend of increasing the number of pulmonary nodules, and significantly improve the clinical symptoms of patients such as expectoration and chest tightness, and has no obvious drug-related adverse reactions.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and specifically comprises a traditional Chinese medicine composition for preventing and treating subsolid pulmonary nodules, and a preparation method and application thereof. Background Art

[0002] "Preventing disease before it occurs" is a principle that traditional Chinese medicine has always advocated. It is the most effective strategy for controlling tumors and the most cost-effective measure. Subsolid pulmonary nodules are in a waiting and observation state of "easy to detect but difficult to treat". They have a high risk of malignancy and there is still a lack of effective treatment methods or drugs to inhibit the progression of subsolid pulmonary nodules and reduce the size of nodules. Therefore, under the guidance of the concept of preventing disease before it occurs, the development of drugs for preventing medium- and high-risk pulmonary nodules is of great value for effectively preventing the occurrence of lung cancer in the early stages and moving the threshold of tumor treatment forward, thereby reducing the mortality rate of patients and prolonging their survival time. Summary of the invention

[0003] In view of the above problems existing in the prior art, the first object of the present invention is to provide a Chinese medicine composition for preventing and treating subsolid pulmonary nodules. The Chinese medicine composition has significant efficacy in treating subsolid pulmonary nodules (SSN), can effectively inhibit the progression of pulmonary nodules, reduce the trend of increasing the number of pulmonary nodules, and significantly improve the clinical symptoms of patients such as expectoration and chest tightness, and has no obvious drug-related adverse reactions.

[0004] The second object of the present invention is to provide a method for preparing the above-mentioned Chinese medicine composition.

[0005] The third object of the present invention is to provide a medicine comprising the Chinese medicine composition as described above.

[0006] The fourth object of the present invention is to provide a use of the above-mentioned traditional Chinese medicine composition in the preparation of a medicine for preventing and treating subsolid pulmonary nodules.

[0007] To achieve the above first object, the technical solution adopted by the present invention includes:

[0008] The invention discloses a traditional Chinese medicine composition for preventing and treating subsolid pulmonary nodules. The traditional Chinese medicine composition comprises platycodon, inula flower, raw liquorice, scutellaria baicalensis, apricot kernel, salvia miltiorrhiza, chuanxiong, honeycomb, scorpion and chicken's gizzard lining.

[0009] According to the theory of traditional Chinese medicine, the abnormal metabolism of body fluid and blood under the disorder of the ascending and descending qi of the lungs gradually evolves into pathological products such as "dampness, phlegm, stasis and toxins", which is the basic pathogenesis of lung nodules and early lung cancer. If the lungs fail to ascend and descend, cough and chest tightness will occur. If the lungs are responsible for regulating the flow of body fluids and the fluids condense into phlegm, coughing up phlegm will occur. If the ascending and descending are disordered and the qi is blocked, chest discomfort or distension and pain will occur. The lungs are connected to all the meridians and regulate the blood circulation throughout the body. If the disorder leads to blood stasis, there will be stabbing pain and even purple lips and dark tongue in severe cases. Therefore, treatment should take into account both "regulating qi" and "detoxification".

[0010] In this prescription, Platycodon grandiflorum and Inula flower are used as the main drugs. Platycodon grandiflorum can clear the lungs and eliminate phlegm, relieve sore throat and discharge pus, while Inula flower can lower qi and resolve phlegm, promote qi and promote diuresis. The two drugs are combined, and they are used together to promote qi and resolve pus. Apricot kernel, Salvia miltiorrhiza and Chuanxiong are the ministers. Apricot kernel can resolve phlegm and lower qi reversal, while Salvia miltiorrhiza can promote blood circulation and resolve blood stasis. The "Compendium of Materia Medica" records: "Salvia miltiorrhiza has the same function as the four herbs, which can remove blood stasis to generate new, and is good at treating wind and dispersing nodules." Chuanxiong is called the "Qi medicine in the blood" and can promote qi and relieve depression, promote blood circulation and relieve pain. The three drugs are ministers, assisting the main drugs to remove blood stasis and resolve phlegm. Once phlegm and blood stasis are formed, they will continue to glue and grow, gradually take shape over time, and easily turn into heat and generate toxins, so bee nest, scorpion, chicken gizzard lining are used to eliminate hardness and resolve nodules; raw licorice is used to clear heat and detoxify. The drugs in the whole prescription are properly matched, qi and blood are adjusted, and they are used together to promote qi, remove blood stasis and resolve phlegm, detoxify, attack and resolve nodules.

[0011] The functions and indications of the medicinal materials used in the formula of the present invention are as follows:

[0012] Platycodon: It tastes bitter and pungent, is neutral in nature, and enters the lung meridian. It has the functions of clearing the lungs and eliminating phlegm, relieving sore throat, draining pus, and can float and treat the upper part of the body, and raise the lung qi. It is the boat of many medicines.

[0013] Inula flower: sweet in nature and flavor, slightly warm, cold and sharp, enters the lung, liver, and stomach meridians, and is used to treat phlegm in the chest, fullness under the ribs, cough and asthma, hiccups, sticky saliva, hardness under the heart, belching, and abdominal edema.

[0014] Raw licorice: sweet in taste, neutral in nature, enters the heart, lung, spleen, and stomach meridians, has the effects of tonifying the spleen and replenishing qi, clearing away heat and detoxifying, and removing phlegm and relieving cough.

[0015] Scutellaria baicalensis: It is a plant of the Lamiaceae family and the genus Scutellaria. It is bitter and cold in nature. It enters the heart, lung, gallbladder, and large intestine meridians. It is used to purge excess fire, eliminate damp heat, stop bleeding, stabilize the fetus, and treat high fever and thirst, lung heat cough, damp-heat diarrhea, jaundice, red and swollen eyes, fetal movement disorder, carbuncles and furuncles.

[0016] Almond: It is the seed of apricot in the Rosaceae family. It tastes bitter and is slightly warm in nature. It enters the lung and large intestine meridians, reduces qi, stops cough and asthma, moistens the intestines and promotes bowel movements. It is used for cough and asthma, chest fullness and excessive phlegm, blood deficiency and dry body fluids, and dry intestines and constipation.

[0017] Salvia miltiorrhiza: bitter in nature and slightly warm, enters the heart and liver meridians, used for promoting blood circulation and removing blood stasis, tranquilizing the mind, discharging pus, and relieving pain, treating angina pectoris, irregular menstruation, dysmenorrhea, amenorrhea, metrorrhagia, leukorrhea, masses, accumulation, abdominal pain due to blood stasis, pain in joints, palpitations and insomnia, and malignant ulcers and swellings.

[0018] Ligusticum chuanxiong: pungent, warm, enters the liver, gallbladder, and pericardium meridians, promotes blood circulation and qi, dispels wind and relieves pain, and is used for chest pain, heart pain, stabbing pain in the chest and ribs, swelling and pain from falls, irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to lumps, headache, and rheumatic pain.

[0019] Beehive: It is mild in nature, sweet in taste, and belongs to the stomach meridian. It has the effects of dispelling wind, attacking toxins, killing insects, and relieving pain. It is often used for sores, swellings, mastitis, scrofula, stubborn skin tinea, goose foot wind, toothache, and rheumatic pain.

[0020] Scorpion: It is pungent and neutral in nature and belongs to the liver meridian. It has the effects of calming wind and relieving spasms, attacking toxins and dispersing nodules, and dredging meridians and relieving pain. It is used for infantile convulsions, convulsions and spasms, crooked mouth due to stroke, hemiplegia, tetanus, rheumatism, hemiplegia, sores, and scrofula.

[0021] Chicken Gizzard Stone: sweet and cold in nature, enters the spleen, stomach, small intestine, and bladder meridians. It is used to eliminate stagnation, strengthen the spleen and stomach, and treat food stagnation and fullness, vomiting and nausea, diarrhea, malnutrition, thirst, enuresis, throat numbness and milk moth, tooth decay and mouth ulcers.

[0022] Astragalus: sweet and warm, it enters the spleen and lung meridians. It has the effects of tonifying Qi and raising Yang, benefiting the Wei and strengthening the exterior, expelling toxins and promoting tissue regeneration, and promoting diuresis and reducing swelling. It is used to treat symptoms of spleen and lung Qi deficiency and sinking of the middle Qi.

[0023] Poria: sweet and light in taste, neutral in nature, enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and stomach, and calming the mind and tranquilizing the nerves.

[0024] Ginseng: It tastes bitter, is sweet, and slightly warm in nature. It enters the heart, lung, spleen, and kidney meridians. It is a Qi-tonifying medicine and has the effects of replenishing vital energy, nourishing the spleen and lungs, promoting fluid production and quenching thirst, and calming the mind and improving intelligence.

[0025] Atractylodes: bitter, sweet, warm, non-toxic, and enters the spleen and stomach meridians. It has the effects of tonifying Qi and strengthening the spleen, drying dampness and promoting diuresis, stopping sweating, and calming the fetus.

[0026] Radish seeds: spicy, sweet, and neutral in nature, they have the effects of helping digestion, relieving bloating, and lowering qi and resolving phlegm.

[0027] Cyperus rotundus: It is pungent, slightly bitter, slightly sweet, and neutral in nature. It enters the liver, spleen, and triple burner meridians. It has the effects of relieving depression, regulating menstruation and relieving pain.

[0028] Furthermore, by weight, the Chinese medicine composition includes 10-20 parts of Platycodon grandiflorum, 10-20 parts of Inula japonica, 6-10 parts of raw licorice, 3-10 parts of Scutellaria baicalensis, 6-10 parts of Apricot kernel, 6-15 parts of Salvia miltiorrhiza, 6-15 parts of Ligusticum chuanxiong, 6-9 parts of Beehive, 1-3 parts of Scorpio, and 10-30 parts of Chicken Gizzard Stone.

[0029] Furthermore, when treating patients with subsolid pulmonary nodules accompanied by lung and spleen qi deficiency, the composition can be prepared according to the following formula: by weight, the Chinese medicine composition includes 10-20 parts of Platycodon grandiflorum, 10-20 parts of Inula japonica, 6-10 parts of raw licorice, 3-10 parts of Scutellaria baicalensis, 6-10 parts of Apricot kernel, 6-15 parts of Salvia miltiorrhiza, 6-15 parts of Ligusticum chuanxiong, 6-9 parts of Beehive, 1-3 parts of Scorpio, 10-30 parts of Chicken gizzard lining, 15-30 parts of raw Astragalus, 10-20 parts of Poria, 10-15 parts of Ginseng, and 10-15 parts of Atractylodes macrocephala.

[0030] Furthermore, when treating patients with subsolid pulmonary nodules accompanied by liver depression and qi stagnation, the composition can be prepared according to the following formula: in parts by weight, the Chinese medicine composition includes 10-20 parts of Platycodon grandiflorum, 10-20 parts of Inula japonica, 6-10 parts of raw licorice, 3-10 parts of Scutellaria baicalensis, 6-10 parts of Apricot kernel, 6-15 parts of Salvia miltiorrhiza, 6-15 parts of Ligusticum chuanxiong, 6-9 parts of Beehive, 1-3 parts of Scorpio, 10-30 parts of Chicken Gizzard Stone, 10-20 parts of Radish Seed, and 10-15 parts of Cyperus rotundus.

[0031] Furthermore, in parts by weight, the Chinese medicine composition includes 20 parts of Platycodon grandiflorum, 15 parts of Inula japonica, 6 parts of raw licorice, 10 parts of Scutellaria baicalensis, 10 parts of Apricot kernel, 15 parts of Salvia miltiorrhiza, 10 parts of Ligusticum chuanxiong, 6 parts of Beehive, 3 parts of Scorpio, and 20 parts of Chicken Gizzard Stone.

[0032] Furthermore, when treating patients with subsolid pulmonary nodules accompanied by lung and spleen qi deficiency, the Chinese medicine composition includes, by weight, 20 parts of Platycodon grandiflorum, 15 parts of Inula japonica, 6 parts of raw licorice, 10 parts of Scutellaria baicalensis, 10 parts of Apricot kernel, 15 parts of Salvia miltiorrhiza, 10 parts of Ligusticum chuanxiong, 6 parts of Beehive, 3 parts of Scorpio, 20 parts of Chicken Gizzard Stone, 15 parts of raw Astragalus, 12 parts of Poria, 10 parts of Ginseng, and 12 parts of Atractylodes macrocephala.

[0033] Furthermore, when treating patients with subsolid pulmonary nodules accompanied by liver depression and qi stagnation, the Chinese medicine composition includes, by weight, 20 parts of Platycodon grandiflorum, 15 parts of Inula japonica, 6 parts of raw licorice, 10 parts of Scutellaria baicalensis, 10 parts of Apricot kernel, 15 parts of Salvia miltiorrhiza, 10 parts of Ligusticum chuanxiong, 6 parts of Beehive, 3 parts of Scorpio, 20 parts of Chicken Gizzard Stone, 10 parts of Radish Seed, and 10 parts of Cyperus rotundus.

[0034] To achieve the above second purpose, the technical solution adopted by the present invention includes:

[0035] The present invention discloses a method for preparing the above-mentioned traditional Chinese medicine composition, comprising the following steps:

[0036] Weigh each Chinese medicinal ingredient according to the prescribed amount, add water to boil, filter, concentrate the filtrate into an extract, and dry it to obtain the extract.

[0037] To achieve the third objective, the technical solution adopted by the present invention includes:

[0038] The present invention discloses a medicine for preventing and treating subsolid pulmonary nodules, comprising the traditional Chinese medicine composition as described above.

[0039] Furthermore, the drug also includes pharmaceutically acceptable excipients.

[0040] Furthermore, the dosage form of the drug is selected from tablets, decoctions, granules, capsules, powders, oral liquids, soups or pastes.

[0041] To achieve the fourth objective, the technical solution adopted by the present invention includes:

[0042] The present invention discloses an application of the above-mentioned traditional Chinese medicine composition in preparing a medicine for preventing and treating subsolid pulmonary nodules.

[0043] Beneficial effects of the present invention:

[0044] The invention discloses a Chinese medicine composition for preventing and treating subsolid pulmonary nodules. The Chinese medicine composition is screened for Chinese medicine formula according to the theory of traditional Chinese medicine and the theory of syndrome differentiation and treatment, has a rigorous formula, and is targeted at patients with subsolid pulmonary nodules with syndrome differentiation of phlegm and blood stasis. The Chinese medicine composition has the effects of regulating qi, removing blood stasis and resolving phlegm, detoxifying, attacking and dispersing nodules, and can effectively inhibit the progression of subsolid pulmonary nodules, prevent early lung cancer, reduce the trend of increasing the number of pulmonary nodules, and significantly improve the clinical symptoms of patients with medium and high risk pulmonary nodules such as cough, sputum, shortness of breath, chest and flank distension or pain, tingling, purple lips, dark red tongue with white greasy fur, and thin, astringent or slippery pulse, and has no obvious drug-related adverse reactions. DETAILED DESCRIPTION

[0045] In order to explain the present invention more clearly, the present invention is further described below in conjunction with preferred embodiments. It should be clear that the described embodiments are only part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0046] Example 1

[0047] The formula of the Chinese medicine composition is as follows:

[0048] Platycodon 20g, Inula 15g, Raw Licorice 6g, Scutellaria 10g, Apricot 10g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 10g, Beehive 6g, Scorpion 3g, Chicken Gizzard 20g.

[0049] According to the above formula, weigh platycodon, inula, raw licorice, scutellaria, apricot, salvia miltiorrhiza, chuanxiong, honeycomb, scorpion and chicken gizzard lining, add water and boil, filter, concentrate the filtrate into an extract, dry and granulate to obtain the extract, which is named as the Qi-regulating and Detoxifying Formula.

[0050] Example 2

[0051] When treating patients with subsolid pulmonary nodules accompanied by lung and spleen deficiency, the formula of the Chinese medicine composition is as follows:

[0052] Platycodon 20g, Inula 15g, raw licorice 6g, Scutellaria 10g, Apricot 10g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 10g, Beehive 6g, Scorpio 3g, Chicken Gizzard 20g, raw Astragalus 15g, Poria 12g, Ginseng 10g, Atractylodes 12g.

[0053] According to the above formula, weigh platycodon, inula, raw licorice, scutellaria, apricot, salvia miltiorrhiza, chuanxiong, honeycomb, scorpion, chicken gizzard lining, raw astragalus, poria, ginseng, and atractylodes, add water and boil, filter, concentrate the filtrate into an extract, and dry and granulate to obtain the extract.

[0054] Example 3

[0055] When treating patients with subsolid pulmonary nodules accompanied by liver depression and qi stagnation, the formula of the Chinese medicine composition is as follows:

[0056] Platycodon 20g, Inula 15g, raw licorice 6g, Scutellaria 10g, Apricot 10g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 10g, Beehive 6g, Scorpion 3g, Chicken Gizzard 20g, Radish Seed 10g, Cyperus rotundus 10g.

[0057] According to the above formula, weigh platycodon, inula, raw liquorice, scutellaria, apricot, salvia miltiorrhiza, chuanxiong, honeycomb, scorpion, chicken gizzard lining, radish seed and cyperus rotundus, add water and boil, filter, concentrate the filtrate into an extract, dry and granulate to obtain the extract.

[0058] Clinical trials

[0059] 1 Clinical Data

[0060] 1.1 Research subjects

[0061] The research cases of this clinical trial are patients with SSN (5-8mm) phlegm and blood stasis syndrome who visited the cancer prevention clinic of the Oncology Department of Guang'anmen Hospital, China Academy of Chinese Medical Sciences between January and June 2022.

[0062] 1.2 Diagnostic criteria

[0063] 1.2.1 Western medicine diagnostic criteria

[0064] Western medicine diagnostic criteria: According to the SSN diagnostic criteria in the "Chinese Expert Consensus on the Diagnosis and Treatment of Pulmonary Nodules (2018 Edition)": Imaging manifestations are focal, rounded, increased density, subsolid lung shadows, which may be isolated or multiple, without atelectasis, hilar lymphadenopathy, and pleural effusion.

[0065] 1.2.2 TCM syndrome diagnostic criteria

[0066] TCM diagnostic criteria: The diagnostic criteria for subsolid pulmonary nodules with phlegm and blood stasis syndrome were formulated with reference to the Guiding Principles for Clinical Research of New Chinese Medicines and TCM Internal Medicine and combined with clinical practice:

[0067] Main symptoms: ① expectoration; ② dark purple lips and nails;

[0068] Secondary symptoms: ① chest tightness; ② dizziness; ③ vomiting phlegm; ④ fullness and stuffiness in the stomach; ⑤ stabbing pain;

[0069] Tongue and pulse: dark purple tongue, greasy coating, deep and rough or stringy and slippery pulse.

[0070] If the patient meets 2 main symptoms and ≥1 secondary symptom, or ≥1 main symptom and ≥2 secondary symptoms, combined with the tongue and pulse, the patient can be diagnosed with phlegm and blood stasis syndrome.

[0071] 1.3 Inclusion criteria

[0072] ① Unlimited gender, age 18-85 years old; ② Patients who meet the diagnostic criteria for SSN in the guidelines, and TCM syndrome of phlegm and blood stasis; ③ SSN (5mm-8mm) guidelines recommend follow-up observation; ④ Patients who have not undergone surgery; ⑤ Volunteer to participate in this study and sign the informed consent.

[0073] 1.4 Exclusion criteria

[0074] ① Patients with lung cancer and other tumor diseases; ② Patients with impaired liver and kidney function; ③ Pregnant and breastfeeding patients; ④ Patients with incomplete medical records; ⑤ Patients who are allergic to the Chinese medicine they take; ⑥ Participants in other clinical research.

[0075] 1.5 Shedding and rejection criteria

[0076] ① Patients who experience serious adverse events and stop the trial; ② Patients who refuse to accept follow-up; ③ Patients who cannot be contacted for various reasons; ④ Patients whose information is incomplete and affects the final evaluation; ⑤ Subjects request to withdraw from the study.

[0077] 2 Research content and methods

[0078] This study has been registered with the International Traditional Medicine Clinical Registry (registration number: ITMCTR2022000072) and reviewed by the Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences (ethics approval number: 2022-149-KY). A pragmatic randomized controlled trial (pRCT) was used to collect SSN patients who met the inclusion criteria from January 2022 to June 2022, fill in case report forms, establish an Excel database, summarize the patients' baseline data, medical history data, medication status, and examination and testing information. SSN patients who met the inclusion criteria were enrolled in a pragmatic randomized controlled trial (pRCT). ) was a randomized controlled trial (PRPP) method based on patient preference. First, patients were asked whether they had obvious preferences for the intervention measures they received. When the enrolled patients had obvious preferences, they could be grouped according to their wishes without randomization. When the patients had no obvious preferences, they were numbered according to the order of their visits and divided into a Qi-regulating and Detoxifying Prescription group (hereinafter referred to as the treatment group) and a control group using a random number table. A total of 74 patients were included. The changes in the maximum diameter and number of nodules in the two groups were observed after 24 weeks, and the changes in nodules before and after treatment were evaluated. The changes in the TCM syndrome scores and adverse drug reactions of the patients were observed every 12 weeks.

[0079] 2.1 Treatment options

[0080] (1) Control group: According to clinical guidelines, SSN (5-8 mm) was followed up regularly by CT scan for 6 months.

[0081] (2) Treatment group: On the basis of regular follow-up observation, the patients were given the prescription granules prepared in Example 1, 1 bag each time, 2 times a day, with warm water after meals in the morning and evening.

[0082] 2.2 Observation indicators

[0083] 2.2.1 Main efficacy indicators

[0084] Before and after treatment, CT scans of the same hospital were used to measure the maximum diameter and number of lung nodules in the two groups of patients as the main efficacy indicators. The clinical efficacy was determined based on the changes in target nodules in the "Screening and Prevention and Treatment Program for Early Lung Cancer with Traditional Chinese Medicine" formulated by the Oncology Department of Guang'anmen Hospital, China Academy of Chinese Medical Sciences: Effective rate = number of SSN (significantly effective + effective) cases / total number of cases × 100%.

[0085] Markedly effective: The target nodules were completely absorbed and no longer visible on LDCT re-examination.

[0086] Effective: The target nodule is partially absorbed, the target nodule is visible upon reexamination, there is no indication of target nodule progression, and one of the following conditions is met: (1) the average diameter of the target nodule is 5-9 mm, and the average diameter is reduced by ≥30% compared with before treatment; (2) the CT value of the target nodule is reduced; (3) the solid component of the target nodule is reduced.

[0087] Stable: The target nodule is stable and the target nodule does not meet the indications of progression or complete absorption or partial absorption.

[0088] Deterioration: Target nodules progress. If any of the following conditions are met, it can be considered as target nodule progression: (1) the average diameter of the target nodules is 5-9 mm, and the average diameter increases by ≥30% compared with the previous value; (2) the CT value of the target nodules increases; (3) the average diameter of the solid component of the target nodules increases by >1.5 mm; (4) the target nodules show malignant signs such as lobulation, spiculation, pleural indentation, and vascular bundle signs;

[0089] Note: The average diameter of a nodule refers to the sum of the maximum long diameter of the solid part of the nodule and the longest short diameter perpendicular to the maximum long diameter (maximum short diameter) divided by 2.

[0090] 2.2.2 Secondary efficacy indicators

[0091] TCM syndrome scoring: The TCM syndrome scoring scale was formulated with reference to the Guiding Principles for Clinical Research of New Chinese Medicines. The main symptoms such as expectoration and purple lips and nails were divided into 4 levels according to the severity of the symptoms, and recorded as severe (6 points), moderate (4 points), mild (2 points), and none (0 points). The secondary symptoms such as chest tightness, dizziness, vomiting of sputum, fullness and tingling in the stomach were divided into 4 levels according to the severity of the symptoms, and recorded as severe (3 points), moderate (2 points), mild (1 point), and none (0 points). The changes in the TCM syndrome scores of the two groups of patients before and after treatment were observed and recorded.

[0092] 2.2.3 Safety indicators

[0093] Record in detail any adverse reactions related to treatment, such as abnormal liver and kidney function, gastrointestinal reactions, etc.

[0094] 2.2.4 Follow-up time and method

[0095] Follow-up will be conducted through outpatient review, online platform, telephone inquiries, etc. The follow-up period starts from the patient's enrollment. Clinical symptoms, blood routine, liver and kidney function, etc. will be followed up every 12 weeks. CT imaging evaluation will be performed after the 24th week. The study will end if nodule deterioration or surgery is performed. The follow-up deadline is January 20, 2023.

[0096] 2.3 Statistical methods

[0097] SPSS 26.0 software was used for statistical analysis, and the mean ± standard deviation was used. Describe the measurement data, and use frequency and percentage to describe the count data. The inter-group comparison of measurement data was performed using the grouped t test (normality, equal variance) or Wilcoxon rank sum test (non-normality, unequal variance), and the intra-group comparison was performed using the paired t test (normality) or Wilcoxon signed rank sum test (non-normality); the count data were tested using the chi-square test or Fisher's exact probability method. All statistical analysis tests used two-sided hypothesis tests, and the hypothesis test level was set at α = 0.05, that is, P < 0.05 was considered to be statistically significant.

[0098] 3 Results

[0099] 3.1 Baseline information

[0100] 3.1.1 Case completion status

[0101] A total of 74 SSN patients were enrolled in this study, with 37 cases in the treatment group and 37 cases in the control group. Among them, 2 cases dropped out of the treatment group (discontinuing medication during treatment), and 3 cases dropped out of the control group (1 patient did not cooperate with the test, and 2 patients withdrew on their own). Finally, there were 35 cases in the treatment group and 34 cases in the control group. A total of 69 patients completed the treatment and follow-up, as shown in Table 1.

[0102] Table 1 Patients completing the study

[0103]

[0104] 3.1.2 Comparison of baseline data

[0105] A total of 69 subjects were included in this study, including 35 in the treatment group and 34 in the control group. There was no significant difference in the baseline data between the two groups (P>0.05), and they were comparable (see Table 2).

[0106] Table 2 Demographic data and clinical characteristics of the two groups of patients

[0107]

[0108] 3.2 Efficacy analysis

[0109] 3.2.1 Primary efficacy analysis

[0110] (1) Changes in the maximum diameter of SSN before and after treatment

[0111] As shown in Table 3, there was no significant difference in the baseline distribution of the maximum diameter of SSN between the treatment group and the control group (P>0.05), which was comparable. After 24 weeks, the maximum diameter of SSN in the control group increased significantly compared with that in the treatment group (P<0.05), and the difference in the maximum diameter of SSN before and after treatment in the treatment group was significantly better than that in the control group (P<0.05).

[0112] Intra-group comparison between the treatment group and the control group: After 24 weeks, the maximum diameter of SSN in the treatment group was significantly reduced (P<0.05), while the maximum diameter of SSN in the control group was significantly increased, and the difference was statistically significant (P<0.05).

[0113] Table 3 Comparison of the maximum diameter of nodules in the two groups of patients before and after treatment (mm)

[0114] Group Treatment Group Control group t P Before treatment 6.74±1.27 6.75±1.26 -0.449 0.655 After treatment <![CDATA[5.80±1.59 * ]]> <![CDATA[7.32±1.63 *△ ]]> -3.937 0.000 Difference -0.94±1.26 <![CDATA[0.57±1.18 △ ]]> -5.156 0.000

[0115] Note: Compared with the group before treatment, * P<0.05; compared with the control group, △ P<0.05.

[0116] (2) Changes in the number of SSNs before and after treatment:

[0117] As shown in Table 4, there was no significant difference in the baseline distribution of the number of SSNs between the treatment group and the control group before treatment (P>0.05), which was comparable. After 24 weeks, the number of nodules in the control group was significantly higher than that in the treatment group, and the difference was statistically significant (P<0.05), but there was no significant difference in the difference in the number of nodules between the two groups before and after treatment (P>0.05).

[0118] Intra-group comparison between the treatment group and the control group: There was no significant difference in the number of SSNs in the treatment group before and after treatment (P>0.05), while the number of SSNs in the control group increased significantly, and the difference before and after treatment was statistically significant (P<0.05).

[0119] Table 4 Comparison of the number of nodules in the two groups of patients before and after treatment

[0120] Group Treatment Group Control group t P Before treatment 1.83±1.10 2.41±1.50 -1.847 0.069 After treatment 1.80±1.13 <![CDATA[2.62±1.46 *△ ]]> -2.607 0.011 Difference 0.00±0.82 0.21±0.54 -1.156 0.256

[0121] Note: Compared with the group before treatment, * P<0.05; compared with the control group, △ P<0.05.

[0122] (3) Comparison of overall efficacy between the two groups of patients:

[0123] The clinical efficacy was comprehensively judged based on nodule size, CT value, solid component, malignant signs, etc., as shown in Tables 5 and 6. Compared with the control group, the total effective rate of the treatment group was 22.9%, and the total effective rate of the control group was 2.9%. The rank sum test between the two groups showed Z=-3.268, P=0.01, and the difference was statistically significant, indicating that the clinical efficacy of the treatment group was better than that of the control group.

[0124] Table 5 Comparison of imaging features between the two groups of patients after treatment

[0125]

[0126] Table 6 Comparison of the efficacy of the two groups of patients before and after treatment

[0127] Group n Significant effect efficient Stablize deterioration Effectiveness (%) Treatment Group 35 0(0) 8(22.9) 25(71.4) 2(5.7) <![CDATA[22.9 * ]]> Control group 34 0(0) 1(2.9) 23(67.6) 10(29.4) 2.9

[0128] Note: Compared with the control group, * P<0.05.

[0129] 3.2.2 Secondary efficacy analysis

[0130] Comparison of TCM syndrome scores between the two groups of patients before and after treatment

[0131] As shown in Table 7, after 12 weeks of treatment, the total score of the TCM syndrome scale and the symptoms of epigastric fullness and stuffiness in the treatment group were significantly improved compared with before (P < 0.05), and the improvement of the total score of the TCM syndrome scale and the purple lips and nails was significantly better than that in the control group (P < 0.05).

[0132] After 24 weeks of treatment, the total score of the TCM syndrome scale, epigastric fullness, sputum, and chest tightness in the treatment group were significantly improved (P < 0.05), and the improvement of the total score of the TCM syndrome scale, sputum, purple lips and nails, and chest tightness was significantly better than that in the control group (P < 0.05). Although there was no statistical difference in the changes of other symptoms, they showed an overall stable and alleviated trend.

[0133] The total score of the TCM Syndrome Scale of the control group tended to increase, and the difference in scores before and after treatment was statistically significant (P < 0.01). In terms of single symptoms, the purple and dark lips and nails of the patients worsened after 12 and 24 weeks (P < 0.05).

[0134] Table 7 Comparison of TCM syndrome scores between the two groups before and after treatment

[0135]

[0136] Note: Compared with before treatment, * P<0.05; compared with 12 weeks of treatment, △ P<0.05; compared with the control group, ** P<0.05.

[0137] 3.3 Adverse events in the two groups of patients during the experiment

[0138] As shown in Table 8, during the treatment, one patient in the treatment group had abnormal liver function (elevated ALT), and no adverse events occurred in the control group. The incidence of adverse reactions between the treatment group and the control group was compared, and the difference was not statistically significant (P>0.05) by Fisher's exact probability test.

[0139] Table 8 Comparison of the incidence of adverse reactions between the two groups

[0140]

[0141] Note: Fisher's exact probability method, no statistics.

[0142] In summary, for patients with subsolid pulmonary nodules, the Qi-regulating and detoxifying prescription can effectively inhibit the progression of nodules, reduce the risk of cancer, improve patients' clinical symptoms, and improve their quality of life. It is safe and feasible.

[0143] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not limitations on the implementation methods of the present invention. For ordinary technicians in the relevant field, other different forms of changes or modifications can be made based on the above description. It is impossible to list all the implementation methods here. All obvious changes or modifications derived from the technical solution of the present invention are still within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for preventing and treating subsolid pulmonary nodules, characterized in that: The traditional Chinese medicine composition is prepared by weight from 10-20 parts of platycodon, 10-20 parts of inula, 6-10 parts of raw licorice, 3-10 parts of scutellaria, 6-10 parts of apricot kernel, 6-15 parts of salvia miltiorrhiza, 6-15 parts of chuanxiong, 6-9 parts of honeycomb, 1-3 parts of scorpion and 10-30 parts of chicken gizzard lining.

2. The Chinese medicine composition according to claim 1, characterized in that: The traditional Chinese medicine composition is prepared by weight from 20 parts of platycodon grandiflorum, 15 parts of inula flower, 6 parts of raw liquorice, 10 parts of scutellaria baicalensis, 10 parts of apricot kernel, 15 parts of salvia miltiorrhiza, 10 parts of chuanxiong, 6 parts of honeycomb, 3 parts of scorpion and 20 parts of chicken gizzard lining.

3. A Chinese medicine composition for preventing and treating subsolid pulmonary nodules, characterized in that: The traditional Chinese medicine composition is prepared by weight from 10-20 parts of platycodon, 10-20 parts of inula flower, 6-10 parts of raw licorice, 3-10 parts of scutellaria, 6-10 parts of apricot kernel, 6-15 parts of salvia miltiorrhiza, 6-15 parts of chuanxiong, 6-9 parts of honeycomb, 1-3 parts of scorpion, 10-30 parts of chicken gizzard lining, 15-30 parts of raw astragalus, 10-20 parts of poria, 10-15 parts of ginseng and 10-15 parts of atractylodes.

4. A Chinese medicine composition for preventing and treating subsolid pulmonary nodules, characterized in that: The traditional Chinese medicine composition is prepared by weight from 10-20 parts of platycodon, 10-20 parts of inula flower, 6-10 parts of raw licorice, 3-10 parts of scutellaria, 6-10 parts of apricot kernel, 6-15 parts of salvia miltiorrhiza, 6-15 parts of chuanxiong, 6-9 parts of honeycomb, 1-3 parts of scorpion, 10-30 parts of chicken gizzard lining, 10-20 parts of radish seeds and 10-15 parts of cyperus rotundus.

5. The method for preparing the Chinese medicine composition according to any one of claims 1 to 4, characterized in that: The steps include: Weigh each Chinese medicinal ingredient according to the prescribed amount, add water to boil, filter, concentrate the filtrate into an extract, and dry it to obtain the extract.

6. A drug for preventing and treating subsolid pulmonary nodules, characterized in that: It includes the Chinese medicine composition according to any one of claims 1 to 4 or the Chinese medicine composition prepared by the preparation method according to claim 5.

7. The drug according to claim 6, characterized in that The drug also includes pharmaceutically acceptable excipients.

8. The drug according to claim 6, characterized in that The dosage form of the drug is selected from tablets, decoctions, granules, capsules, powders, oral liquids or ointments.

9. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a medicament for preventing and treating subsolid pulmonary nodules.

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