A pharmaceutical composition for preventing and treating myelosuppression caused by lung cancer platinum-containing chemotherapy

Abstract

The present application relates to the technical field of traditional Chinese medicine, and provides a kind of drug composition for preventing and treating bone marrow suppression caused by lung cancer containing platinum chemotherapy, which is composed of oral composition and external intervention system.The oral composition contains Dangshen, Huangqi, Ejiao, Shudihuang, Danggui, Baizhu, Fuling, Buguzhi, Xianhecao, Gouqizi, Nuzhizi, Jixueteng and Zhigancao.The external intervention system is ginger moxibustion, and the selected acupoints are Qihai, Xuehai, Pishu, Shenshu and Ganshu.Based on the theory of essence-blood homology, the present application can prevent and treat by tonifying qi and nourishing blood, tonifying kidney and marrow production through oral traditional Chinese medicine, warming meridians and unblocking collaterals, strengthening the body resistance and consolidating the foundation through ginger moxibustion.The present application can significantly reduce the incidence of grade 3 or higher neutropenia after chemotherapy, shorten the recovery time of neutrophils, reduce the incidence of febrile neutropenia, improve the quality of life of patients, and has good safety, providing an effective treatment scheme of traditional Chinese and western medicine combination for lung cancer patients.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine, in particular to a pharmaceutical composition for preventing and treating myelosuppression caused by platinum-containing chemotherapy for lung cancer. Background Art

[0002] Lung cancer is one of the malignant tumors with the highest morbidity and mortality, and chemotherapy is the main treatment for patients with stage III-IV lung cancer. While killing tumor cells, platinum-containing chemotherapy regimens often cause severe myelosuppression, which is manifested as a significant reduction in neutrophils, platelets and hemoglobin. Myelosuppression not only causes complications such as decreased immunity, infection, anemia and bleeding, but also leads to delay or interruption of chemotherapy, which seriously affects the quality of life and prognosis of patients. At present, Western medicine supportive treatments such as granulocyte colony-stimulating factor, platelet transfusion, and erythropoietin are mainly used in clinical practice. However, these methods have adverse reactions such as bone pain, fever, arrhythmia and thrombosis, and long-term use may cause exhaustion of bone marrow function, and have limited effect on restoring the potential hematopoietic function of bone marrow.

[0003] Existing traditional Chinese medicine has obvious deficiencies in the treatment of post-chemotherapy myelosuppression. Listed Chinese patent medicines such as Diyu Shengbai Tablets, Shengblood Platelet Capsules, Compound Zaofan Pills have single curative effect, only targeting one of the indicators of white blood cells, platelets or red blood cells, which is difficult to meet the clinical demand of patients with simultaneous decrease of multiple line blood cells. Although traditional Chinese medicine compound prescriptions have certain effects, they lack unified curative evaluation standards and standardized treatment schemes, and clinical medication is mostly based on personal experience, which is difficult to popularize and apply. More importantly, there is currently a lack of integrated Chinese and Western medicine synergistic prevention and treatment scheme that organically combines oral administration of traditional Chinese medicine with external therapy of traditional Chinese medicine, which makes it difficult to exert the synergistic efficiency advantage of integrated Chinese and Western medicine. There is an urgent need to develop a safe and effective multi-target regulation prevention and treatment scheme integrating Chinese and Western medicine. Summary of the Invention

[0004] In view of the deficiencies of the prior art, the present invention provides a pharmaceutical composition for preventing and treating myelosuppression caused by platinum-containing chemotherapy for lung cancer, which solves the problem of lack of a safe and effective integrated Chinese and Western medicine prevention and treatment scheme for severe myelosuppression caused by platinum-containing chemotherapy for lung cancer.

[0005] To achieve the above objectives, the present invention is implemented through the following technical solution: a pharmaceutical composition for preventing and treating bone marrow suppression caused by platinum-based chemotherapy in lung cancer, comprising an oral composition and an external intervention system; the oral composition is made from the following raw materials in parts by weight: Codonopsis pilosula 10-20 parts, Astragalus membranaceus 10-20 parts, Colla corii asini 3-9 parts, Rehmannia glutinosa 10-20 parts, Angelica sinensis 8-15 parts, Atractylodes macrocephala 8-15 parts, Poria cocos 10-20 parts, Psoralea corylifolia 8-15 parts, Agrimonia pilosa 10-20 parts, Lycium barbarum 8-15 parts, Ligustrum lucidum 8-15 parts, Spatholobus suberectus 10-20 parts, and Glycyrrhiza uralensis 3-9 parts; the external intervention system is ginger-separated moxibustion, and the selected acupoints are: Qihai, Xuehai, Pishu, Shenshu, and Ganshu.

[0006] Preferably, the oral composition is made from the following raw materials in parts by weight: 15 parts Codonopsis pilosula, 15 parts Astragalus membranaceus, 6 parts donkey-hide gelatin, 15 parts Rehmannia glutinosa, 10 parts Angelica sinensis, 10 parts Atractylodes macrocephala, 15 parts Poria cocos, 10 parts Psoralea corylifolia, 15 parts Agrimonia pilosa, 10 parts Lycium barbarum, 10 parts Ligustrum lucidum, 15 parts Spatholobus suberectus, and 6 parts Glycyrrhiza uralensis (processed).

[0007] Preferably, the operation steps of the ginger-separated moxibustion are as follows: cut fresh ginger into thin slices with a thickness of 2-4 mm, prick several holes in the middle, and place them on the skin surface of the acupoint; ignite a moxa stick with a length of 1.5-2.5 cm and place it on the ginger slice for fumigation, moxibustion for 30 minutes per acupoint each time, 3 times a week, for 2 consecutive chemotherapy cycles.

[0008] Preferably, the oral composition is modified according to the TCM syndrome differentiation: for deficiency of both heart and spleen, add longan pulp and jujube seed; for deficiency of both qi and yin, add ophiopogon japonicus and schisandra chinensis; for deficiency of both liver and kidney yin, add tortoise shell glue, deer antler glue and cornus officinalis; for deficiency of both spleen and kidney yang, add aconite, cinnamon and yam; for deficiency of both yin and yang, add deer antler glue, tortoise shell and wolfberry.

[0009] Preferably, the pharmaceutical composition is used to reduce the incidence of grade ≥3 absolute neutropenia in the first cycle of chemotherapy and to shorten the recovery time of the lowest neutrophil count to 1.8 × 10⁻⁶. 9 The time required to reach / L or higher reduces the incidence of neutropenia accompanied by fever.

[0010] Preferably, the dosage form of the oral composition is a decoction, granules, capsules, or oral liquid; the decoction is to be taken on the day of chemotherapy, and then taken warm half an hour after breakfast and dinner during the chemotherapy cycle, with each bag containing 150-200mL.

[0011] Preferably, the acupoints for moxibustion with ginger are located as follows: Qihai is located 1.5 cun below the navel; Xuehai is located 2 cun above the upper inner border of the patella; Pishu is located 1.5 cun lateral to the spinous process of the 11th thoracic vertebra; Shenshu is located 1.5 cun lateral to the spinous process of the 2nd lumbar vertebra; and Ganshu is located 1.5 cun lateral to the spinous process of the 9th thoracic vertebra.

[0012] Preferably, the pharmaceutical composition is suitable for patients with pathologically confirmed stage III-IV lung cancer who are scheduled to receive platinum-based first-line chemotherapy, have an ECOGPS score of 0-2, and are expected to survive for ≥3 months.

[0013] This invention provides a pharmaceutical composition for preventing and treating bone marrow suppression induced by platinum-based chemotherapy in lung cancer. It possesses the following beneficial effects: 1. This invention combines the internal administration of the Yijing Yangxue formula with the external application of ginger moxibustion, which can significantly reduce the incidence of grade III or higher neutropenia after platinum-based chemotherapy for lung cancer, effectively shorten the neutrophil recovery time, reduce the occurrence of febrile neutropenia, thereby ensuring that chemotherapy proceeds smoothly as planned and reducing the risk of chemotherapy delay or interruption due to bone marrow suppression.

[0014] 2. This invention, through a combination of internal and external application, can significantly improve patients' quality of life scores and significantly reduce TCM symptom scores. Patients' symptoms of weakness, dizziness, palpitations, aversion to cold, cold limbs, and loss of appetite are effectively improved. At the same time, it has good safety and reflects the therapeutic advantages of the synergistic effect and overall regulation of the combination of traditional Chinese and Western medicine. Detailed Implementation

[0015] The technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0016] Example 1: This embodiment provides an oral composition for preventing and treating bone marrow suppression caused by platinum-based chemotherapy in lung cancer, which is made from the following raw materials in parts by weight: Codonopsis pilosula 15 parts, Astragalus membranaceus 15 parts, donkey-hide gelatin 6 parts, Rehmannia glutinosa 15 parts, Angelica sinensis 10 parts, Atractylodes macrocephala 10 parts, Poria cocos 15 parts, Psoralea corylifolia 10 parts, Agrimonia pilosa 15 parts, Lycium barbarum 10 parts, Ligustrum lucidum 10 parts, Spatholobus suberectus 15 parts, and Glycyrrhiza uralensis 6 parts.

[0017] The preparation method is as follows: Take the above-mentioned raw materials by weight, and mix them after cleaning and drying, except for donkey-hide gelatin. Add 8 times the total weight of the raw materials in water, soak for 30 minutes, bring to a boil over high heat, then simmer over low heat for 40 minutes. Filter and collect the decoction. Add 6 times the amount of water to the dregs, bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter and collect the decoction. Combine the two decoctions, add donkey-hide gelatin to dissolve, stir evenly, and continue to concentrate until each milliliter contains the equivalent of 1 gram of raw herb. Divide the decoction into sterile vacuum bags, 200 ml per bag, seal tightly, and store at 4℃ for later use. Dosage: Discontinue use on the day of chemotherapy. During the chemotherapy cycle, take one bag warm half an hour after breakfast and dinner each day.

[0018] Example 2: This embodiment provides methods for preparing granules, capsules, and oral liquids of oral compositions.

[0019] Preparation of granules: Take the raw material as described in Example 1 by weight, clean and dry it, then pulverize it into coarse powder. Add 10 times the amount of water and decoct twice, the first time for 1.5 hours and the second time for 1 hour. Combine the decoctions, filter, and concentrate the filtrate under reduced pressure to a clear paste with a relative density of 1.10 to 1.15. After cooling, add ethanol to make the alcohol content reach 60%, let stand for 12 hours, take the supernatant to recover the ethanol, and concentrate to a thick paste with a relative density of 1.25 to 1.30. Add appropriate amounts of dextrin and stevioside, granulate, dry, granulate, and package into bags equivalent to 15 grams of raw drug per bag.

[0020] Preparation of capsules: The above-mentioned granules were filled into gelatin capsule shells, each containing 0.4 grams, equivalent to 2 grams of raw medicinal material. Preparation of oral liquid: The decoction described in Example 1 was mixed with 2% honey for flavoring, filled into 10 ml glass ampoules, sealed, and sterilized with flowing steam at 100°C for 30 minutes to obtain the oral liquid.

[0021] Example 3: This embodiment provides a specific method for performing ginger-separated moxibustion. The acupoints selected for ginger-separated moxibustion are: Qihai (CV6), Xuehai (SP10), Pishu (BL20), Shenshu (BL23), and Ganshu (BL18). The location standards for each acupoint are as follows: Qihai is located 1.5 cun below the umbilicus on the anterior midline of the lower abdomen; Xuehai is located 2 cun above the medial superior border of the patella when the knee is flexed, at the prominence of the medial head of the quadriceps femoris muscle; Pishu is located 1.5 cun lateral to the spinous process of the 11th thoracic vertebra; Shenshu is located 1.5 cun lateral to the spinous process of the 2nd lumbar vertebra; and Ganshu is located 1.5 cun lateral to the spinous process of the 9th thoracic vertebra.

[0022] The specific operating steps are as follows: The patient lies on their side, fully exposing the acupuncture site. Take fresh ginger, cut it into 3 mm thick slices, prick several holes in the center of the ginger slices with a needle, and place the ginger slices on the skin surface of the acupuncture points. Take pure moxa wool and make a conical moxa cone with a base diameter of 1 cm and a height of 2 cm. Light the moxa cone and place it on the ginger slices for fumigation. The treatment should be carried out until the patient's local skin feels warm but not burning. Closely observe the skin temperature to prevent burns. Moxibustion should be performed for 30 minutes per acupoint each time, 3 times a week, for 2 consecutive chemotherapy cycles, for a total of 18 treatments. If rashes, itching, blisters, or other symptoms occur during moxibustion, stop the moxibustion immediately and apply an appropriate amount of burn ointment.

[0023] Example 4: This embodiment provides a scheme for adjusting the oral composition according to the different TCM syndromes of patients.

[0024] For patients with deficiency of both heart and spleen, characterized by symptoms such as fatigue, dizziness, palpitations, insomnia, poor appetite, loose stools, pale tongue with thin white coating, and weak, thready pulse, add 10 grams of longan pulp and 15 grams of jujube seed to the basic formula described in Example 1 to nourish the heart and calm the mind.

[0025] For patients with Qi and Yin deficiency syndrome, characterized by symptoms such as fatigue, shortness of breath, dry cough with little phlegm, spontaneous sweating and night sweats, dry mouth with little thirst, hot flashes in the palms, soles, and chest, red tongue with little coating, and weak pulse, add 10 grams of Ophiopogon japonicus and 6 grams of Schisandra chinensis to the basic formula described in Example 1 to replenish Qi and nourish Yin.

[0026] For patients with liver and kidney yin deficiency syndrome, symptoms include dizziness and tinnitus, soreness and weakness of the lower back and knees, night sweats, dry throat and mouth without thirst, dry cough without phlegm, five-center heat, insomnia and dreaminess, constipation, red tongue with little coating, and thready and rapid pulse. In addition to the basic formula described in Example 1, add 6 grams of tortoise shell glue, 6 grams of deer antler glue, and 10 grams of cornus officinalis to nourish the liver and kidneys.

[0027] For patients with spleen and kidney yang deficiency syndrome, symptoms include aversion to cold, cold limbs, pale complexion, dizziness, fatigue, poor appetite, cold pain in the lower back and knees, clear and copious urine, loose stools, pale and swollen tongue with teeth marks, and deep and thready pulse. In addition to the basic formula described in Example 1, add 6 grams of Aconitum carmichaelii, 3 grams of Cinnamomum cassia, and 15 grams of Dioscorea opposita to warm and tonify the spleen and kidney.

[0028] For patients with Yin-Yang deficiency syndrome, characterized by symptoms such as aversion to cold, cold limbs, pale complexion, hot flashes in the palms, soles, and chest, dry throat and tongue, dry cough with little phlegm, pale red tongue with white and moist coating, and weak pulse, add 6 grams of deer antler glue, 10 grams of tortoise shell, and 10 grams of wolfberry to the basic formula described in Example 1 to replenish both Yin and Yang.

[0029] Example 5: Patient Zhang, female, 58 years old. In March 2025, she was diagnosed with stage IV adenocarcinoma of the right lung by pathological examination. She had no prior history of cancer treatment. Her physical condition score in the Eastern Oncology Collaborative Group was 1, and her expected survival was greater than 6 months. Traditional Chinese medicine diagnosis indicated Qi and Yin deficiency, with symptoms including fatigue, shortness of breath, reluctance to speak, dry cough with little phlegm, dry mouth and throat, five-center heat (palms, soles, and chest), red tongue with little coating, and a thready and rapid pulse. Laboratory tests showed a platelet count of 125 × 10⁻⁶ / L before chemotherapy. 9 One patient met the inclusion criteria. The patient was scheduled to receive first-line platinum-based chemotherapy, specifically pemetrexed combined with carboplatin, with each cycle lasting 21 days, for a total of 2 cycles.

[0030] Patients were randomly assigned to the treatment group. In addition to routine chemotherapy and Western medical supportive care, the drug composition of this invention was used in combination. The oral composition was administered according to the formula described in Example 1, with 200 ml taken warm half an hour after breakfast and dinner daily during the chemotherapy cycle, and discontinued on the day of chemotherapy. Moxibustion with ginger was performed according to the method described in Example 3, three times a week from the start of chemotherapy, with 30 minutes of moxibustion per acupoint each time, for two consecutive chemotherapy cycles, totaling 18 treatments.

[0031] Treatment Results: Complete blood counts were performed on days 3, 7, 10, 14, and 20 after the first cycle of chemotherapy. Grade ≥3 neutropenia did not occur after the first cycle of chemotherapy; the lowest absolute neutrophil count was 1.2 × 10¹² / L.9 One case appeared on day 10 after chemotherapy, but did not meet the grade 3 criteria. The lowest absolute neutrophil count recovered to 1.8 × 10⁻⁶ per liter. 9 The required time for more than one cycle of chemotherapy is 5 days. The patient did not experience neutropenia accompanied by fever. After the first cycle of chemotherapy, hemoglobin remained above 105 g / L, and the lowest platelet count was 95 × 10⁻⁶ / L. 9 No grade 2 or higher bone marrow suppression was observed. The grade of bone marrow suppression did not worsen after the second cycle of chemotherapy compared to the first cycle. Quality of life was assessed using the Lung Cancer Treatment Functional Assessment Scale, 4th Edition. The pre-treatment score was 72 points, and the score on day 14 after the second cycle of chemotherapy was 89 points, with the most significant improvement observed in the physical condition dimension. The TCM symptom score was 23 points before treatment and decreased to 8 points after treatment, with significant improvement in symptoms such as fatigue, dry mouth and throat, and hot flashes in the palms, soles, and chest. No adverse reactions related to moxibustion occurred during the treatment period, and no serious adverse events occurred.

[0032] Example 6: Patient Li, male, 67 years old. Diagnosed with stage IIIB squamous cell carcinoma of the left lung via bronchoscopic biopsy in June 2025, he had not previously received anti-tumor treatment. His physical condition score from the Eastern Oncology Collaborative Group was 2, with an expected survival of more than 4 months. Traditional Chinese medicine diagnosis indicated spleen and kidney yang deficiency, with symptoms including aversion to cold, cold limbs, soreness and weakness of the lower back and knees, fatigue, poor appetite, loose stools, clear and copious urine, pale and swollen tongue with teeth marks, and a deep and thready pulse. Laboratory tests showed a pre-chemotherapy platelet count of 115 × 10⁻⁶ / L. 9 One patient met the inclusion criteria. The patient was scheduled to receive first-line platinum-based chemotherapy, specifically gemcitabine combined with cisplatin, with each cycle lasting 21 days, for a total of 2 cycles.

[0033] Patients were randomly assigned to the treatment group. In addition to routine chemotherapy and supportive Western medicine treatment, the drug composition of this invention was used in combination. The oral composition adopted the modified formula for spleen and kidney yang deficiency syndrome in Example 4, that is, adding 6 grams of Aconitum carmichaelii, 3 grams of Cinnamomum cassia, and 15 grams of Dioscorea opposita to the basic formula to warm and tonify the spleen and kidneys. The method of administration was the same as in Example 1. Ginger-separated moxibustion was performed using the method described in Example 3.

[0034] Treatment results: On day 7 after the first cycle of chemotherapy, the absolute neutrophil count dropped to its lowest value, at 0.9 × 10⁻⁶ per liter. 9 One case was classified as grade 3 neutropenia. However, this condition was short-lived, lasting only 2 days before starting to recover. The incidence of grade 3 neutropenia was 1 in 1 cycle after the first chemotherapy cycle. By day 14 after chemotherapy, the absolute neutrophil count had recovered to 2.1 × 10¹² per liter. 9 The patient recovered in 4 days. No febrile neutropenia occurred. The platelet count reached its lowest value of 78 × 10⁸ / L on day 10 after the first cycle of chemotherapy. 9The number of cases did not meet the criteria for grade 3 thrombocytopenia. The improvement rate of bone marrow suppression grade after the second cycle of chemotherapy was significantly higher than that after the first cycle, and the lowest absolute neutrophil count increased by 0.3 × 10⁻⁶ per liter compared to the first cycle. 9 The patient's quality of life score was 68 before treatment and 86 on day 20 after the second cycle of chemotherapy. The TCM symptom score was 26 before treatment and decreased to 10 after treatment, with significant improvement in symptoms such as cold limbs, lower back and knee weakness, and loose stools. No serious adverse events related to medication or moxibustion occurred during treatment, and patient compliance was good.

[0035] Example 7: Patient Wang, female, 52 years old. In September 2025, she was diagnosed with stage IIIC limited-stage small cell lung cancer via CT-guided lung biopsy. She had not previously received chemotherapy. Her physical condition score from the Eastern Oncology Collaborative Group was 1, with an expected survival of more than 6 months. Traditional Chinese medicine diagnosis indicated deficiency of both heart and spleen, with symptoms including fatigue, dizziness, palpitations, insomnia, poor appetite, abdominal distension, sallow complexion, pale tongue with a thin white coating, and a deep, thready, and weak pulse. Laboratory tests showed a pre-chemotherapy platelet count of 138 × 10⁻⁶ / L. 9 One patient met the inclusion criteria. The patient was scheduled to receive first-line platinum-based chemotherapy, specifically etoposide combined with carboplatin, with each cycle lasting 21 days, for a total of 2 cycles.

[0036] Patients were randomly assigned to the treatment group. In addition to routine chemotherapy and Western supportive care, the drug composition of this invention was used in combination. The oral composition adopted the modified formula for spleen and heart deficiency syndrome described in Example 4, that is, adding 10 grams of longan pulp and 15 grams of jujube seed to the basic formula to nourish the heart and calm the mind. Ginger-separated moxibustion was performed using the method described in Example 3.

[0037] Treatment results: Blood routine tests during the first cycle of chemotherapy and on days 3, 7, 10, 14, and 20 after chemotherapy showed that the patient's absolute neutrophil count remained at 1.6 × 10⁻⁶ per liter. 9 More than 100 patients were treated, and no grade neutropenia of any degree was observed. The incidence of grade ≥3 neutropenia after the first cycle of chemotherapy was 0. The lowest absolute neutropenia count during the first cycle of chemotherapy was 1.6 × 10⁶ cells / L. 9 On day 10 after the second cycle of chemotherapy, the lowest absolute neutrophil count dropped to 1.3 × 10⁶ per liter. 9 The patient had grade 2 neutropenia, but recovered rapidly, returning to normal levels within 3 days. The lowest platelet count was 102 × 10⁶ / L. 9The patient did not meet the diagnostic criteria for thrombocytopenia. The lowest hemoglobin level was 108 grams per liter, showing only a slight decrease. The quality of life score was 74 before treatment and decreased to 92 on day 18 after the second cycle of chemotherapy, with particularly significant improvements in emotional and functional status. The TCM symptom score was 18 before treatment and decreased to 4 after treatment, with symptoms such as dizziness, palpitations, insomnia, and fatigue largely disappearing. The patient did not experience any gastrointestinal adverse reactions such as nausea, vomiting, constipation, or diarrhea during treatment and rated the treatment regimen of this invention as very satisfactory.

[0038] Example 8: To further verify the efficacy and safety of the pharmaceutical composition of the present invention in preventing and treating bone marrow suppression caused by platinum-based chemotherapy in lung cancer, this embodiment was designed as a prospective, multicenter, randomized controlled trial, which included 228 patients with stage III-IV lung cancer. They were randomly divided into a treatment group and a control group, with 114 patients in each group. The treatment group received conventional chemotherapy and Western medicine supportive care in addition to the oral composition of the present invention and ginger-separated moxibustion, while the control group received only conventional chemotherapy and Western medicine supportive care.

[0039] The primary efficacy endpoint was the incidence of grade ≥3 neutropenia in the first cycle of chemotherapy. This incidence was 29.8% in the treatment group and 50.0% in the control group, a 20.2% reduction in the treatment group (P < 0.05). Regarding secondary efficacy endpoints: the duration of grade ≥3 neutropenia in the second cycle was 1.2 ± 0.5 days in the treatment group, significantly shorter than the 2.8 ± 0.7 days in the control group; the incidence of neutropenia accompanied by fever was 6.1% in the treatment group and 18.4% in the control group; the lowest absolute neutropenia count in the first cycle in the treatment group was 1.05 ± 0.32 × 10⁻⁶ / L. 9 The control group had a concentration of 0.72 ± 0.28 × 10⁶ cells / liter. 9 The lowest absolute neutrophil count in the treatment group recovered to 1.8 × 10⁶ per liter. 9 The time required for more than one sample was 3.5 ± 1.2 days, while the control group took 5.8 ± 1.6 days.

[0040] Quality of life was assessed using the Lung Cancer Treatment Functional Assessment Scale, 4th Edition. In the treatment group, the score was 88.6±6.4 points on days 14-20 after the second cycle of chemotherapy, an increase of 16.8 points from baseline; the score in the control group was 76.2±7.1 points, an increase of 5.5 points from baseline. The difference between the two groups was statistically significant. Regarding TCM symptom scores, the treatment group's score decreased by 14.2±3.6 points after treatment compared to before treatment, while the control group's score decreased by 5.8±2.9 points.

[0041] Safety evaluation results showed that in the treatment group, the main adverse reactions related to moxibustion included local skin redness in 11 cases, mild itching in 5 cases, and small blisters in 2 cases. All of these were transient reactions and disappeared after symptomatic treatment. No serious adverse reactions such as infection or abscess occurred. Among the adverse reactions related to the oral composition, there were mild nausea in 3 cases, abdominal distension in 2 cases, and diarrhea in 1 case. No serious adverse events such as liver or kidney damage occurred. There was no significant difference in the incidence of serious adverse events between the treatment group and the control group.

[0042] The above clinical trial results show that the pharmaceutical composition provided by the present invention can significantly reduce the incidence of grade ≥3 absolute neutropenia caused by platinum-based chemotherapy for lung cancer, shorten the neutrophil recovery time, reduce the occurrence of febrile neutropenia, and improve patients' quality of life and TCM symptom scores, demonstrating good safety and clinical application value.

[0043] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A pharmaceutical composition for preventing and treating bone marrow suppression induced by platinum-based chemotherapy in lung cancer, characterized in that, It consists of an oral composition and an external intervention system; the oral composition is made from the following raw materials in parts by weight: Codonopsis pilosula 10-20 parts, Astragalus membranaceus 10-20 parts, Colla corii asini 3-9 parts, Rehmannia glutinosa 10-20 parts, Angelica sinensis 8-15 parts, Atractylodes macrocephala 8-15 parts, Poria cocos 10-20 parts, Psoralea corylifolia 8-15 parts, Agrimonia pilosa 10-20 parts, Lycium barbarum 8-15 parts, Ligustrum lucidum 8-15 parts, Spatholobus suberectus 10-20 parts, Glycyrrhiza uralensis 3-9 parts; the external intervention system is ginger-separated moxibustion, and the selected acupoints are: Qihai, Xuehai, Pishu, Shenshu, and Ganshu.

2. The pharmaceutical composition for preventing and treating bone marrow suppression induced by platinum-based chemotherapy for lung cancer according to claim 1, characterized in that, The oral composition is made from the following raw materials in parts by weight: Codonopsis pilosula 15 parts, Astragalus membranaceus 15 parts, donkey-hide gelatin 6 parts, Rehmannia glutinosa 15 parts, Angelica sinensis 10 parts, Atractylodes macrocephala 10 parts, Poria cocos 15 parts, Psoralea corylifolia 10 parts, Agrimonia pilosa 15 parts, Lycium barbarum 10 parts, Ligustrum lucidum 10 parts, Spatholobus suberectus 15 parts, and Glycyrrhiza uralensis 6 parts.

3. The pharmaceutical composition for preventing and treating bone marrow suppression induced by platinum-based chemotherapy for lung cancer according to claim 1, characterized in that, The operation steps of ginger-separated moxibustion are as follows: cut fresh ginger into thin slices with a thickness of 2-4mm, prick several holes in the middle, and place them on the skin surface of the acupoint; ignite a moxa stick with a length of 1.5-2.5cm and place it on the ginger slice for fumigation, moxibustion for 30 minutes per acupoint each time, 3 times a week, for 2 consecutive chemotherapy cycles.

4. The pharmaceutical composition for preventing and treating bone marrow suppression caused by platinum-based chemotherapy for lung cancer according to claim 1, characterized in that, The oral composition is modified according to the TCM syndrome differentiation: for deficiency of both heart and spleen, add longan pulp and jujube seed; for deficiency of both qi and yin, add ophiopogon japonicus and schisandra chinensis; for deficiency of both liver and kidney yin, add tortoise shell glue, deer antler glue and cornus officinalis; for deficiency of both spleen and kidney yang, add aconite, cinnamon and yam; for deficiency of both yin and yang, add deer antler glue, tortoise shell and wolfberry.

5. The pharmaceutical composition for preventing and treating bone marrow suppression induced by platinum-based chemotherapy in lung cancer according to claim 1, characterized in that, The pharmaceutical composition is used to reduce the incidence of grade ≥3 absolute neutropenia during the first cycle of chemotherapy and to shorten the recovery time of the lowest neutrophil count to 1.8 × 10⁻⁶. 9 The time required to reach / L or higher reduces the incidence of neutropenia accompanied by fever.

6. The pharmaceutical composition for preventing and treating bone marrow suppression induced by platinum-based chemotherapy for lung cancer according to claim 1, characterized in that, The dosage form of the oral composition is decoction, granules, capsules or oral liquid; the decoction is to be discontinued on the day of chemotherapy, and taken warm half an hour after breakfast and dinner during the chemotherapy cycle, 150-200mL per bag.

7. The pharmaceutical composition for preventing and treating bone marrow suppression induced by platinum-based chemotherapy for lung cancer according to claim 1, characterized in that, The acupoints for ginger-separated moxibustion are located as follows: Qihai is located 1.5 cun below the navel; Xuehai is located 2 cun above the upper inner border of the patella; Pishu is located 1.5 cun lateral to the spinous process of the 11th thoracic vertebra; Shenshu is located 1.5 cun lateral to the spinous process of the 2nd lumbar vertebra; and Ganshu is located 1.5 cun lateral to the spinous process of the 9th thoracic vertebra.

8. The pharmaceutical composition for preventing and treating bone marrow suppression induced by platinum-based chemotherapy for lung cancer according to claim 1, characterized in that, The pharmaceutical composition is suitable for patients with pathologically confirmed stage III-IV lung cancer who are scheduled to receive platinum-based first-line chemotherapy, have an ECOGPS score of 0-2, and are expected to survive for ≥3 months.

9. The use of the pharmaceutical composition according to any one of claims 1-8 in the preparation of a medicament for preventing and treating grade III-IV myelosuppression caused by platinum-based chemotherapy for lung cancer.