Traditional Chinese medicine composition for treating lung cancer with syndrome of vital qi deficiency and toxic stagnation and application of traditional Chinese medicine composition

Abstract

The invention belongs to the field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating small cell lung cancer with syndrome of vital qi deficiency and toxin stagnation and application thereof. According to the invention, the bottleneck problem of small cell lung cancer clinical treatment is positioned, based on the general character of'deficiency of body resistance and toxic stagnation 'of small cell lung cancer patients, on the basis of the big method of'tonifying qi, detoxifying and activating blood' of lung cancer treatment, the'body resistance strengthening and detoxifying formula 'is taken as the main prescription of the treatment agreement of small cell lung cancer people, and the prescription conversion and clinical application are promoted; the efficacy-enhancing and toxicity-reducing effects of traditional Chinese medicine empirical formulas such as a formula for strengthening body resistance and detoxifying and western medicine treatment are exerted, and the clinical treatment choices of patients are broadened.

Description

TECHNICAL FIELD

[0001] The application belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating small cell lung cancer of deficiency of vital energy and accumulation of toxic materials and application thereof. BACKGROUND

[0002] Lung cancer is mainly divided into non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) according to pathological types. Small cell lung cancer (SCLC) is a high-grade neuroendocrine carcinoma, accounting for about 15% of all lung cancers. It is characterized by rapid growth, easy metastasis and recurrence, and drug resistance after radiotherapy and chemotherapy (Lee JH, Saxena A, Giaccone G. Advancements in small cell lung cancer. Semin Cancer Biol. 2023 Aug; 93: 123-128.). Due to the lack of specific symptoms, most patients have distant metastasis at the first diagnosis, and cannot receive radical treatment. Therefore, the 5-year survival rate of SCLC patients is less than 5% (Megyesfalvi Z, Gay CM, Popper H, et al. Clinical insights into small cell lung cancer: Tumor heterogeneity, diagnosis, therapy, and future directions. CA Cancer J Clin. 2023 Nov-Dec; 73(6): 620-652.). Current lung cancer mainly adopts comprehensive treatment measures, mainly including surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy and traditional Chinese medicine treatment, etc. Traditional Chinese medicine plays an important clinical role in the treatment of lung cancer. It can not only improve the symptoms of patients, reduce the side effects and adverse reactions of western medicine treatment such as radiotherapy and chemotherapy, and improve the quality of life of patients, but also has certain advantages and good curative effect in stabilizing lesions and prolonging survival period, etc., and can play a role in reducing toxicity and increasing efficiency. Therefore, traditional Chinese medicine has a wide clinical application in the treatment of lung cancer.

[0003] Although there is no lung cancer in the ancient Chinese medical books, the understanding of lung cancer can be traced back to the period of Huangdi Neijing. TCM believes that the causes of lung cancer are not more than two ends of deficiency and excess, and the formation of lung cancer is due to the combination of deficiency and excess. Among them, deficiency is the leading factor, just as Suwen Yipian Cifalun said: “Zhenqi stores inside, evil cannot touch; evil gathers where the qi is weak.” In addition, Jizengjian of Medical Classic also believes that accumulation is a syndrome of deficiency and excess, and it says “accumulation is caused by deficiency of Zhenqi, and then evil qi occupies it”. Combined with the physiological characteristics of the lung, lung cancer is mainly caused by lung qi deficiency and lung yin deficiency. The lung is the highest organ among the five Zang organs and six Fu organs, and it is directly connected with the outside world through the nose, so it is more easily affected by external evil qi. Deficiency of congenital endowment, external evil qi, and damage to the spleen and stomach, which can not transport the essence of water and grains to the lung, can lead to lung qi deficiency, and appear clinical manifestations such as fatigue and shortness of breath. The lung likes to be moist and hates dryness, and if the regulation is not proper, it will easily show the deficiency of yin fluid in the lung. If the patient smokes regularly, it will damage the yin fluid in the lung, and it is more likely to cause yin deficiency, and thus appear symptoms such as dry cough, hoarse voice, and dry mouth. The excess syndrome is mainly phlegm-dampness, blood stasis, and heat-toxicity. The lung qi is damaged, the descending regulation is disordered, the lung loses the water channel, and the phlegm and blood stasis are formed, and the phlegm-dampness and blood stasis syndromes are formed. As recorded in Zhibingyuanzhu Xiyu Source of Accumulation, Swelling, Mass, and Mass: “evil accumulates in the chest, blocks the airway, and the air does not spread, which is phlegm, food, and blood, all of which are in conflict with the normal, and the evil wins, and the normal cannot be controlled, and eventually forms a mass”. Phlegm and blood stasis often cause symptoms such as cough, expectoration, and chest pain. Phlegm and blood stasis can form heat-toxicity if they are long-term, and can cause symptoms such as oral and body heat, and even coughing up a large amount of sputum and blood.

[0004] As a means of small cell lung cancer treatment, traditional Chinese medicine emphasizes the analysis of etiology and pathogenesis, syndrome differentiation and treatment, and many clinical studies have shown that the combination of traditional Chinese and Western medicine can prolong the survival period compared with simple Western medicine treatment, and has the effects of enhancing short-term efficacy, delaying drug resistance, reducing side effects and improving quality of life. In terms of traditional Chinese medicine treatment, referring to the syndrome differentiation and medication scheme of 'Lung Cancer Diagnosis and Treatment Scheme (2017)' of the State Administration of Traditional Chinese Medicine, there are Sha Shen Mai Men Dong Decoction, Liu Jun Zi Decoction, Mai Wei Di Huang Decoction, Si Wu Decoction, Er Chen Decoction and other prescriptions. For small cell lung cancer, the following experiences are mainly used in traditional Chinese medicine treatment: ①Strengthening the body to consolidate the foundation. Professor Xu Zhenye and Professor Hua Baogold proposed that tonifying qi and nourishing essence, supporting the body and consolidating the foundation should be throughout the whole process; the commonly used prescriptions include Si Jun Zi Decoction, etc. ②Increasing the strength of anticancer and eliminating evil. Professor Lin Hongsheng believes that in addition to supporting the body and consolidating the foundation, we should also pay attention to clearing the source and preventing changes at all times; Professor Yu Renzong proposed that the dose of anticancer drugs should be increased, and when the main problem is deficiency of vital energy, we should support the body; Professor Wang Xiaomin often uses Longsheyangquan Decoction and Lianshe Jiedu Decoction to resist cancer and detoxify, resolve phlegm and remove blood stasis. Professor Xu Zhenye proposed that the strength of clearing heat and resolving toxins should be increased, and Shancigu, She Liugu and other herbs can be used up to 45 parts. ③Treatment in stages. Professor Hua Baogold believes that during the radiotherapy and chemotherapy stage, we should harmonize the stomach and reverse adverse flow, nourish the liver and kidney, and detoxify to enhance efficacy. After radiotherapy and chemotherapy, we should cultivate the earth to generate gold, activate blood and detoxify to reduce recurrence. However, the above traditional Chinese medicine prescriptions for small cell lung cancer are all derived from diagnosis and treatment schemes or expert treatment experiences, and their individuality and subjectivity limit their clinical application. At present, there is no consensus prescription for small cell lung cancer patients with 'deficiency of vital energy and accumulation of toxins'. SUMMARY

[0005] The present application positions the clinical treatment bottleneck of small cell lung cancer, is based on the commonness of 'deficiency of vital energy and accumulation of toxins' of small cell lung cancer patients, is based on the 'tonifying qi and resolving toxins' method of lung cancer treatment, takes 'Fuzheng Jiedu Decoction' as the treatment agreement main prescription for small cell lung cancer population, promotes the prescription landing transformation and clinical application, and plays the synergistic effect of 'Fuzheng Jiedu Decoction' and other traditional Chinese medicine experience prescriptions and Western medicine treatment, and broadens the treatment options of patients in clinical practice. Based on this, the present application is completed.

[0006] In the first aspect, the present application provides a traditional Chinese medicine composition, which is made from the following weight parts of traditional Chinese medicines:

[0007] The monarch drug is composed of one or more of the following: 30-60 parts of Astragalus root, 20-45 parts of Herba Hedyotis Diffusae and / or 20-45 parts of Herba Hedyotis Diffusae;

[0008] The ministerial medicinal herbs are composed of one or more of the following: Dangshen 10-30 parts, Baizhu 10-30 parts, Fuling 10-30 parts, Xiacucao 10-30 parts, Maozhaocao 10-35 parts, Zixu 10-30 parts, Baiqian 10-30 parts, Zhimobu 10-30 parts, Nansha 10-35 parts, Mishisangbai 10-35 parts, Qianhu 5-25 parts, Jiegeng 5-25 parts, Nvzhenzi 10-30 parts, Shanyao 5-25 parts, Sharen 2-12 parts, and / or Wuweizi 5-20 parts;

[0009] The auxiliary medicinal herbs are composed of one or more of the following: Guijian 10-30 parts, Luhuang 1-10 parts, Quanxie 1-10 parts, Tuobie 2-12 parts, Mubiezi 5-20 parts, Longkui 10-35 parts, Muxiang 5-25 parts, Zhike 5-25 parts, Lugen 10-35 parts, and / or Shengyiyiren 20-45 parts;

[0010] The ministerial medicinal herbs are composed of one or more of the following: Dangshen 10-30 parts, Baizhu 10-30 parts, Fuling 10-30 parts, Xiacucao 10-30 parts, Maozhaocao 10-35 parts, Zixu 10-30 parts, Baiqian 10-30 parts, Zhimobu 10-30 parts, Nansha 10-35 parts, Mishisangbai 10-35 parts, Qianhu 5-25 parts, Jiegeng 5-25 parts, Nvzhenzi 10-30 parts, Shanyao 5-25 parts, Sharen 2-12 parts, and / or Wuweizi 5-20 parts;

[0011] Preferably, the traditional Chinese medicine composition is made of the following weight parts of traditional Chinese medicine:

[0012] The monarch medicinal herbs are composed of one or more of the following: Shenghuangqi 40-60 parts, Banzhi 20-40 parts, and / or Baihuashexie 20-40 parts;

[0013] The ministerial medicinal herbs are composed of one or more of the following: Dangshen 10-20 parts, Baizhu 10-25 parts, Fuling 10-25 parts, Xiacucao 10-25 parts, Maozhaocao 10-30 parts, Zixu 10-25 parts, Baiqian 10-25 parts, Zhimobu 10-25 parts, Nansha 10-30 parts, Mishisangbai 10-30 parts, Qianhu 5-20 parts, Jiegeng 5-20 parts, Nvzhenzi 10-25 parts, Shanyao 5-20 parts, Sharen 3-10 parts, and / or Wuweizi 5-20 parts;

[0014] The auxiliary medicinal herbs are composed of one or more of the following: Guijian 10-25 parts, Luhuang 2-8 parts, Quanxie 2-8 parts, Tuobie 3-10 parts, Mubiezi 5-15 parts, Longkui 10-30 parts, Muxiang 5-20 parts, Zhike 5-20 parts, Lugen 10-30 parts, and / or Shengyiyiren 20-40 parts;

[0015] The auxiliary medicinal herbs are composed of one or more of the following: Guijian 10-25 parts, Luhuang 2-8 parts, Quanxie 2-8 parts, Tuobie 3-10 parts, Mubiezi 5-15 parts, Longkui 10-30 parts, Muxiang 5-20 parts, Zhike 5-20 parts, Lugen 10-30 parts, and / or Shengyiyiren 20-40 parts;

[0016] More preferably, the traditional Chinese medicine composition is made of the following weight parts of traditional Chinese medicine:

[0017] The monarch medicinal herbs are composed of one or more of the following: Shenghuangqi 40-50 parts, Banzhi 20-35 parts, and / or Baihuashexie 20-35 parts;

[0018] The ministerial medicine is composed of one or more of the following: Dangshen 10-20 parts, Baizhu 10-20 parts, Fuling 10-20 parts, Xiacucao 10-20 parts, Maozhaocao 10-25 parts, Zixu 10-20 parts, Baiqian 10-20 parts, Zhimobu 10-20 parts, Nansha 10-25 parts, Mishangbaipi 10-25 parts, Qianhu 5-15 parts, Jiegeng 5-15 parts, Nvzhenzi 10-20 parts, Shanyao 5-15 parts, Sharen 4-8 parts, and / or Wuweizi 5-20 parts;

[0019] The auxiliary medicine is composed of one or more of the following: Guijian 10-20 parts, Luhuang 3-6 parts, Quanxie 3-6 parts, Tuobichong 4-8 parts, Mubiezi 5-10 parts, Longkui 10-25 parts, Muxiang 5-15 parts, Zhike 5-15 parts, Lugen 10-25 parts, and / or Shengyiyiren 20-35 parts;

[0020] The auxiliary medicine is composed of one or more of the following: Guijian 10-20 parts, Luhuang 3-6 parts, Quanxie 3-6 parts, Tuobichong 4-8 parts, Mubiezi 5-10 parts, Longkui 10-25 parts, Muxiang 5-15 parts, Zhike 5-15 parts, Lugen 10-25 parts, and / or Shengyiyiren 20-35 parts;

[0021] In an embodiment of the present application, the traditional Chinese medicine composition is composed of Shenghuangqi 30-60 parts, Banzhi 20-45 parts, Baihuasheshecao 20-45 parts, Dangshen 10-30 parts, Baizhu 10-30 parts, Fuling 10-30 parts, Xiacucao 10-30 parts, Maozhaocao 10-35 parts, Guijian 10-30 parts, Luhuang 1-10 parts, Quanxie 1-10 parts, and Tuobichong 2-12 parts.

[0022] In an embodiment of the present application, the traditional Chinese medicine composition is composed of Shenghuangqi 30-60 parts, Banzhi 20-45 parts, Baihuasheshecao 20-45 parts, Dangshen 10-30 parts, Baizhu 10-30 parts, Fuling 10-30 parts, Xiacucao 10-30 parts, Maozhaocao 10-35 parts, Guijian 10-30 parts, Luhuang 1-10 parts, Quanxie 1-10 parts, Tuobichong 2-12 parts, and Shuijij 1-6 parts.

[0023] In an embodiment of the present application, the traditional Chinese medicine composition is composed of Shenghuangqi 30-60 parts, Banzhi 20-45 parts, Baihuasheshecao 20-45 parts, Dangshen 10-30 parts, Baizhu 10-30 parts, Fuling 10-30 parts, Xiacucao 10-30 parts, Maozhaocao 10-35 parts, Zixu 10-30 parts, Baiqian 10-30 parts, Zhimobu 10-30 parts, Guijian 10-30 parts, Luhuang 1-10 parts, Quanxie 1-10 parts, Tuobichong 2-12 parts, and Zhigancao 5-25 parts.

[0024] In one embodiment of the present application, the traditional Chinese medicine composition is composed of Radix Astragali 30-60 parts, Herba Lophatheri 20-45 parts, Herba Hedyotis Diffusae 20-45 parts, Radix Codonopsis 10-30 parts, Rhizoma Atractylodis Macrocephalae 10-30 parts, Poria 10-30 parts, Prunella Vulgaris 10-30 parts, Ranunculus Japonicus 10-35 parts, Perilla Fruit 10-30 parts, Radix Adenophorae 10-35 parts, Fructus Mori 10-35 parts, Radix Paeoniae Alba 5-25 parts, Anisodus Jatamansi 5-25 parts, and Radix Glycyrrhizae 5-25 parts.

[0025] In one embodiment of the present application, the traditional Chinese medicine composition is composed of Radix Astragali 30-60 parts, Herba Lophatheri 20-45 parts, Herba Hedyotis Diffusae 20-45 parts, Radix Codonopsis 10-30 parts, Rhizoma Atractylodis Macrocephalae 10-30 parts, Poria 10-30 parts, Prunella Vulgaris 10-30 parts, Ranunculus Japonicus 10-35 parts, Herba Lycopodii 10-35 parts, and Rhizoma Rehmanniae 20-45 parts.

[0026] In one embodiment of the present application, the traditional Chinese medicine composition is composed of Radix Astragali 30-60 parts, Herba Lophatheri 20-45 parts, Herba Hedyotis Diffusae 20-45 parts, Radix Codonopsis 10-30 parts, Rhizoma Atractylodis Macrocephalae 10-30 parts, Poria 10-30 parts, Prunella Vulgaris 10-30 parts, Ranunculus Japonicus 10-35 parts, Herba Lycopodii 10-35 parts, and Rhizoma Rehmanniae 20-45 parts.

[0027] In one embodiment of the present application, the traditional Chinese medicine composition is composed of Radix Astragali 30-60 parts, Herba Lophatheri 20-45 parts, Herba Hedyotis Diffusae 20-45 parts, Radix Codonopsis 10-30 parts, Rhizoma Atractylodis Macrocephalae 10-30 parts, Poria 10-30 parts, Prunella Vulgaris 10-30 parts, Ranunculus Japonicus 10-35 parts, Herba Lycopodii 10-35 parts, and Rhizoma Rehmanniae 20-45 parts.

[0028] In one embodiment of the present application, the traditional Chinese medicine composition is composed of Radix Astragali 30-60 parts, Herba Lophatheri 20-45 parts, Herba Hedyotis Diffusae 20-45 parts, Radix Codonopsis 10-30 parts, Rhizoma Atractylodis Macrocephalae 10-30 parts, Poria 10-30 parts, Prunella Vulgaris 10-30 parts, Ranunculus Japonicus 10-35 parts, Herba Lycopodii 10-35 parts, and Rhizoma Rehmanniae 20-45 parts.

[0029] In one embodiment of the present invention, the traditional Chinese medicine composition comprises 30-60 parts of raw Astragalus membranaceus, 20-45 parts of Scutellaria barbata, 20-45 parts of Hedyotis diffusa, 10-30 parts of Codonopsis pilosula, 10-30 parts of Atractylodes macrocephala, 10-30 parts of Poria cocos, 10-30 parts of Prunella vulgaris, 10-35 parts of Uncaria rhynchophylla, 10-30 parts of Ligustrum lucidum, 10-30 parts of Euonymus alatus, 1-10 parts of Vespa nidus, 1-10 parts of Buthus martensii, and 2-12 parts of Eupolyphaga sinensis.

[0030] In one embodiment of the present invention, the traditional Chinese medicine composition comprises 30-60 parts of raw Astragalus membranaceus, 20-45 parts of Scutellaria barbata, 20-45 parts of Hedyotis diffusa, 10-30 parts of Codonopsis pilosula, 10-30 parts of Atractylodes macrocephala, 10-30 parts of Poria cocos, 10-30 parts of Prunella vulgaris, 10-35 parts of Uncaria rhynchophylla, 5-20 parts of Momordica cochinchinensis, 10-35 parts of Solanum nigrum, 10-30 parts of Euonymus alatus, 1-10 parts of Vespa nidus, 1-10 parts of Buthus martensii, and 2-12 parts of Eupolyphaga sinensis.

[0031] Secondly, the present invention provides a traditional Chinese medicine preparation containing the traditional Chinese medicine composition described in the first aspect and pharmaceutically acceptable excipients.

[0032] Furthermore, the traditional Chinese medicine preparations include one or more of the following: pastes, pills, elixirs, decoctions, granules, capsules, powders, and / or tablets.

[0033] Furthermore, the excipients are pharmaceutical excipients that enhance the efficacy of the active pharmaceutical ingredient, reduce its toxicity, and / or alleviate its side effects.

[0034] Thirdly, the present invention provides the use of the traditional Chinese medicine composition described in the first aspect in the preparation of a medicament for treating lung cancer.

[0035] Furthermore, the lung cancer in question is small cell lung cancer.

[0036] Furthermore, the lung cancer described is small cell lung cancer with deficiency and toxicity syndrome.

[0037] The medicinal properties and effects of each Chinese medicinal herb in this invention are as follows:

[0038] Raw Astragalus: Sweet in taste and slightly warm in nature. It enters the Lung and Spleen meridians. It has the functions of tonifying Qi and raising Yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, generating fluids and nourishing blood, promoting circulation and relieving pain, promoting pus drainage and detoxification, and promoting wound healing and tissue regeneration. It is used for symptoms such as Qi deficiency and fatigue, poor appetite and loose stools, sinking of Qi, chronic diarrhea and rectal prolapse, hematochezia and metrorrhagia, spontaneous sweating due to exterior deficiency, edema due to Qi deficiency, internal heat and thirst, blood deficiency and chlorosis, hemiplegia, numbness and pain, carbuncles and boils that are difficult to heal, and chronic ulcers that do not heal.

[0039] Scutellaria barbata: pungent and bitter in taste, cold in nature. It enters the lung, liver, and kidney meridians. It has the effects of clearing heat and detoxifying, resolving blood stasis and promoting diuresis. It is used for boils and carbuncles, sore throat, traumatic injuries, edema, jaundice, snake and insect bites, etc.

[0040] Oldenlandia: sweet, light, cool, stomach, large intestine, small intestine. Has heat detoxification, diuretic, swelling, blood stasis pain. For intestinal abscess (appendicitis), sores, swelling, hot and cold, difficulty urinating, etc.; external use of sores, abscesses, snake bites.

[0041] Codonopsis: sweet, neutral, spleen, lung. Has the effect of spleen and lung, spleen and lung. For spleen and lung weakness, shortness of breath, loose stools, emaciation, emaciation, heat, etc.

[0042] Fried atractylodes: bitter, sweet, warm. Spleen, stomach. Has abdominal distension and diarrhea, phlegm, dizziness, edema, sweating, spleen and qi, dryness and water, stop sweating, an embryo. For spleen deficiency, fetal movement is not stable, etc.

[0043] Tuckahoe: sweet, light, neutral. Heart, lung, spleen, kidney. Has the effect of water and moisture, spleen, heart. For edema, oliguria, phlegm, dizziness, spleen deficiency, loose stools, emaciation, heart, restlessness, insomnia.

[0044] Summer grass: bitter, sweet, cold. Liver, gallbladder. Has the effect of clearing liver and fire, eyes, resolving and swelling. For red eyes, swelling, headache, dizziness, scrofula, goiter, mastitis, breast pain.

[0045] Cat's claw: sweet, bitter, warm. Liver, lung. Has the effect of phlegm and swelling, detoxification and swelling. For scrofula, phlegm, boils, snake bites.

[0046] Perilla: bitter, warm. Lung. Has the effect of phlegm and swelling, cough and asthma, moistening the intestines and defecation. For phlegm, cough and asthma, constipation.

[0047] White front: bitter, sweet, slightly warm. Lung. Has the effect of phlegm and swelling, cough and asthma. For phlegm, cough and asthma, chest fullness and shortness of breath.

[0048] Baked hundred: sweet, bitter, slightly warm. Lung. Has the effect of phlegm and swelling, cough and asthma, killing insects and lice. For cough, phthisis, cough, external use of head lice, body lice, pinworms, vaginal itching. Honey hundred phlegm and cough. For yin deficiency and cough.

[0049] South sand: sweet, slightly cold. Lung, stomach. Has the effect of yin and lung, stomach, phlegm, qi. For dry cough, yin deficiency, dry cough, phlegm, stomach, food, vomiting, qi, dry mouth.

[0050] Honey mulberry white skin: sweet, cold. Lung. Has the effect of phlegm and swelling, cough and asthma, phlegm and swelling. For phlegm and swelling, cough and asthma, water and swelling, urine and swelling.

[0051] Radix Peucedani: bitter and pungent in taste, and slightly cold in nature. It returns to the lung meridian. It has the function of reducing qi and phlegm, and dispelling wind and clearing heat. It is used for phlegm-heat cough, yellow and thick sputum, and wind-heat cough with much phlegm.

[0052] Radix Platycodi: bitter and pungent in taste, and neutral in nature. It returns to the lung meridian. It has the function of promoting lung and throat, eliminating phlegm, and discharging pus. It is used for cough with much phlegm, chest stuffiness, sore throat, hoarseness, and lung abscess with pus discharge.

[0053] Fructus Ligustri Lucidi: sweet and bitter in taste, and cool in nature. It returns to the liver and kidney meridians. It has the function of nourishing liver and kidney, and benefiting eyes and hair. It is used for liver and kidney yin deficiency, dizziness and tinnitus, weakness of waist and knees, premature graying of hair, blurred vision, internal heat and polydipsia, and bone steaming with heat.

[0054] Radix Dioscoreae: sweet in taste, and neutral in nature. It returns to the spleen, lung, and kidney meridians. It has the function of tonifying spleen and stomach, generating fluid and benefiting lung, and tonifying kidney and astringing essence. It is used for spleen deficiency with little food intake, chronic diarrhea, lung deficiency with cough, kidney deficiency with spermatorrhea, leukorrhagia, frequent urination, and heat consumption.

[0055] Fructus Amomi: pungent in taste, and warm in nature. It returns to the spleen, stomach, and kidney meridians. It has the function of eliminating dampness and promoting appetite, warming spleen and stopping diarrhea, regulating qi and securing fetus. It is used for dampness accumulation, abdominal fullness with no hunger, spleen and stomach deficiency with cold, vomiting and diarrhea, and pregnancy with nausea and vomiting, and unstable fetus.

[0056] Fructus Schisandrae: sour and sweet in taste, and warm in nature. It returns to the lung, heart, and kidney meridians. It has the function of astringing and tonifying, benefiting qi and generating fluid, and tonifying kidney and calming heart. It is used for chronic cough with shortness of breath, spermatorrhea, frequent urination, chronic diarrhea, spontaneous perspiration, night sweating, fluid consumption, internal heat and polydipsia, palpitation, and insomnia.

[0057] Radix et Rhizoma Aconiti: bitter and pungent in taste, and cold in nature. It returns to the liver meridian. It has the function of breaking blood and unblocking menstruation, detoxifying and dissipating swelling, and killing worms. It is used for amenorrhea, traumatic injury, postpartum abdominal pain, and abdominal pain due to worm accumulation.

[0058] Radix et Rhizoma Araliae: sweet in taste, and neutral in nature. It returns to the stomach meridian. It has the function of attacking toxin and killing worm, and dispelling wind and relieving pain. It is used for sores, abscesses, scrofula, stubborn skin disease, gecko palm, toothache, and rheumatic arthralgia.

[0059] Scorpion: pungent in taste, and neutral in nature, with toxicity. It returns to the liver meridian. It has the function of calming wind and relieving convulsion, unblocking collaterals and relieving pain, and attacking toxin and dissipating mass. It is used for internal liver wind, infantile convulsion, stroke, hemiplegia, tetanus, rheumatic arthralgia, headache, sores, and scrofula.

[0060] Eupolyphaga: salty in taste, and cold in nature, with small toxicity. It returns to the liver meridian. It has the function of breaking blood and expelling stasis, and connecting tendons and uniting bones. It is used for traumatic injury, tendon injury, bone fracture, blood stasis, postpartum abdominal pain, and fatigue mass

[0061] Semen Momordicae: bitter and slightly sweet in taste, and cool in nature, with toxicity. It returns to the liver, spleen, and stomach meridians. It has the function of dissipating mass and swelling, and attacking toxin and treating sores. It is used for sores, abscesses, scrofula, hemorrhoids, tinea, and alopecia areata.

[0062] Solanum nigrum: bitter, cold. There is a small poison. Bladder meridian. Has heat, detoxification, blood, swelling. Treatment of boils, abscesses, erysipelas, sprains and strains, chronic bronchitis, acute nephritis.

[0063] Costus root: bitter, warm. Spleen, stomach, large intestine, Sanjiao, gallbladder meridian. Has the effect of qi pain, spleen digestion. Used for chest and stomach, abdominal distension, diarrhea, food accumulation, not eating.

[0064] Immature Bitter Orange: bitter, sour, slightly cold. Spleen and stomach meridians. Has the effect of regulating qi, wide, stagnation and swelling. Used for chest and stomach, distension and pain, food accumulation, phlegm, internal retention, organ prolapse.

[0065] Rhizoma Phragmitis: sweet, cold. Lung and stomach meridians. Has the effect of clearing heat and reducing fire, producing saliva and stopping thirst, relieving restlessness, stopping vomiting, diuresis. Used for hot and thirsty, lung heat cough, lung abscess, stomach heat, hot and painful.

[0066] Raw Euryale Ferox: sweet, light, cool. Spleen, stomach, lung meridians. Has the effect of water and dampness, spleen and diarrhea, removing obstruction, pus, detoxification and dispersion. Used for edema, foot disease, spleen and diarrhea, dampness and joint pain, lung abscess, intestinal abscess, warts, cancer.

[0067] Leech: salty, bitter, neutral; There is a small poison. Liver meridian. Has the effect of breaking blood and unblocking menstruation, removing blood stasis and removing stasis. Used for blood stasis and amenorrhea, stasis and mass, stroke, sprains and strains.

[0068] Gancao: sweet, neutral. Heart, lung, spleen, stomach meridian. Has the effect of spleen and qi, clearing heat and detoxification, removing phlegm and stopping cough, relieving pain, regulating various drugs. Used for spleen and stomach weakness, fatigue, palpitations, cough and phlegm, abdominal and limb pain, abscesses, drug toxicity and virulence.

[0069] Schizonepeta: bitter, slightly warm. Lung and liver meridians. Has the effect of relieving the exterior and dispelling wind, removing rash, removing rash. Used for colds, headaches, measles, rash, sore.

[0070] Szechwan Lovage Root: bitter, sweet, slightly warm. Bladder, liver, spleen meridian. Has the effect of dispelling wind and relieving the exterior, removing dampness and relieving pain, relieving convulsions. Used for colds and headaches, rheumatism and pain, rash and itching, tetanus.

[0071] The principle in the application is:

[0072] The deficiency of vital qi is the basis of the occurrence of small cell lung cancer. The deficiency of lung and spleen qi leads to the deficiency of the warm and promoting function of qi, so that the metabolism of body fluid cannot be normal and becomes pathological product. The pathological change of body fluid in turn aggravates the disorder of qi, forms vicious cycle, and finally forms malignant tumor. The toxin is not only pathological product, but also important cause of small cell lung cancer. Therefore, the cause and pathogenesis of small cell lung cancer is mainly deficiency of vital qi, invasion of toxin into lung, and accumulation of phlegm and blood stasis, and the disease is mainly located in lung, spleen and kidney.

[0073] The Chinese medicine composition of the present application has Huangqi in the prescription to supplement lung qi and invigorate spleen qi to support healthy qi and consolidate the body resistance, and Banzhilyan and Baihuashexie to clear heat and resolve toxin, and to resist cancer, so they are the monarch drugs; Dangshen and Baizhu and Fuling to invigorate the spleen and tonify qi, which are the assistant drugs of the monarch drug Huangqi to strengthen the function of supporting healthy qi; Xiaakuca and Maozhaocao to resolve and dissipate stasis, which are the assistant drugs of Banzhilyan and Baihuashexie to reduce toxicity; Guijianyu to activate blood and resolve stasis, and Luhuabing to resolve toxin, and Quanxie to dredge collaterals to relieve pain, and Tuobiechen to guide into blood and break blood to remove stasis, which are the ministerial drugs to strengthen the function of removing evil (resolving toxin, resolving stasis, breaking blood, dredging collaterals) and to restrict the stagnation caused by Huangqi and Dangshen. The whole prescription has the functions of tonifying qi and supporting healthy qi, activating blood and resolving toxin, resolving stasis and resisting cancer.

[0074] For those with obvious blood stasis, further add Shuizhi to activate blood and dissipate stasis; for those with severe lung qi disorder, further add Zisusu, Baqian, Zhimaidu to promote lung qi, and Zhigancao to harmonize all drugs; for those with lung heat and adverse qi, further add Nanshenshen, Mishangbaipi, Zisusu, Qianhu, Jiegeng to clear lung and descend qi, and Zhigancao to harmonize all drugs; for those with internal accumulation of phlegm heat, add Lugen and Shengyiyiren to clear lung and resolve phlegm; for those with severe qi stagnation, add Muxiang and Zhike to soothe liver and regulate qi; for those with lung qi deficiency and skin itching, add Jingjie and Fangfeng to dispel wind-evil and disperse wind, and Wuyi to converge lung qi; for those with spleen qi deficiency, add Shanyao and Sharen to invigorate the spleen and tonify deficiency; for those with obvious deficiency of vital qi, increase the dosage of Dahuangqi and Dangshen, and add Nuzhenshi to assist the function of tonifying vital qi; for those with heavy toxin, increase the dosage of Guijianyu, and add Muhuibie and Longkui to resist cancer and resolve toxin.

[0075] Beneficial effects

[0076] 1. The present application is a pure traditional Chinese medicine prescription, which has mild drug nature, high safety, fast effect, good curative effect, wide drug source, and is suitable for clinical application.

[0077] 2. For "positive virtual toxic knot", the application adopts "Fuzheng Jiedu Decoction" to assist chemotherapy to prolong the progression-free survival of patients, wherein the mPFS of the treatment group is 8.60 months, and that of the control group is 6.83 months, HR=0.42 [95% CI: 0.187-0.955]. And "Fuzheng Jiedu Decoction" assisted chemotherapy has the trend of prolonging the overall survival of "positive virtual toxic knot" subgroup, wherein the mOS of the treatment group is 12.27 months, 95% CI: 6.51-18.03, and the mOS of the control group is 11.53 months, 95% CI: 4.30-18.76, HR=0.633 [95% CI: 0.26-1.57].

[0078] 3. The application positions the clinical treatment bottleneck problem of small cell lung cancer, is based on the commonness of "positive virtual toxic knot" of small cell lung cancer patients, is based on the "Yiqi Jiedu Huoxue" method of lung cancer treatment, takes "Fuzheng Jiedu Decoction" as the treatment agreement main prescription of small cell lung cancer population, promotes the prescription landing transformation and clinical application, plays the synergistic effect of "Fuzheng Jiedu Decoction" and other traditional Chinese medicine experience prescriptions and western medicine treatment, and broadens the treatment selection of patients in clinic. BRIEF DESCRIPTION OF DRAWINGS

[0079] Figure 1 Blind coding for drugs.

[0080] Figure 2 Progression-free survival for all patients.

[0081] Figure 3 Progression-free survival for "Fuzheng Jiedu Decoction" subgroup.

[0082] Figure 4 Overall survival for all patients. DETAILED DESCRIPTION

[0083] The specific embodiments of the application will be further described below. It should be noted that the description of these embodiments is used to help understand the application, but does not constitute a limitation on the application. In addition, the technical features involved in the following described embodiments can be combined with each other as long as they do not conflict with each other.

[0084] The experimental methods in the following examples are all conventional methods unless otherwise specified. The test materials used in the following examples are all commercially available unless otherwise specified.

[0085] Traditional Chinese medicine composition in Example 1

[0086] Fuzheng Jiedu Decoction: Radix Astragali 50 parts, Herba Lysimachiae 30 parts, Herba Hedyotis Diffusae 30 parts, Radix Codonopsis 15 parts, Rhizoma Atractylodis 15 parts, Poria 15 parts, Prunella Vulgaris 15 parts, Herba Ranunculi Ternati 20 parts, Herba Smilacis Glabrae 15 parts, Periostracum Margaritiferae 5 parts, Scorpio 5 parts, Eupolyphaga 6 parts.

[0087] For blood stasis: raw Huangqi 50 parts, Ban Zhi Lian 30 parts, Baihua Sheche 30 parts, Dangshen 15 parts, Baizhu 15 parts, Fuling 15 parts, Xiaakucao 15 parts, Maowucao 20 parts, Guijianyan 15 parts, Luhongfang 5 parts, Quanxie 5 parts, Tuobiechong 6 parts, Shuijia 3 parts.

[0088] For lung qi dysfunction: raw Huangqi 50 parts, Ban Zhi Lian 30 parts, Baihua Sheche 30 parts, Dangshen 15 parts, Baizhu 15 parts, Fuling 15 parts, Xiaakucao 15 parts, Maowucao 20 parts, Guijianyan 15 parts, Luhongfang 5 parts, Quanxie 5 parts, Tushu 15 parts, Baqian 15 parts, Zhimaiyin 15 parts, Zhigancao 12 parts.

[0089] For lung heat and adverse qi: raw Huangqi 50 parts, Ban Zhi Lian 30 parts, Baihua Sheche 30 parts, Dangshen 15 parts, Baizhu 15 parts, Fuling 15 parts, Xiaakucao 15 parts, Maowucao 20 parts, Guijianyan 15 parts, Luhongfang 5 parts, Quanxie 5 parts, Nansha 20 parts, Mihesha 20 parts, Zisu 15 parts, Qianhu 12 parts, Jiegeng 12 parts, Zhigancao 10 parts.

[0090] For phlegm heat: raw Huangqi 50 parts, Ban Zhi Lian 30 parts, Baihua Sheche 30 parts, Dangshen 15 parts, Baizhu 15 parts, Fuling 15 parts, Xiaakucao 15 parts, Maowucao 20 parts, Guijianyan 15 parts, Luhongfang 5 parts, Quanxie 5 parts, Tuobiechong 6 parts, Lugen 20 parts, Shengyiyi 30 parts.

[0091] For qi stagnation: raw Huangqi 50 parts, Ban Zhi Lian 30 parts, Baihua Sheche 30 parts, Dangshen 15 parts, Baizhu 15 parts, Fuling 15 parts, Xiaakucao 15 parts, Maowucao 20 parts, Guijianyan 15 parts, Luhongfang 5 parts, Quanxie 5 parts, Tuobiechong 6 parts, Muxiang 12 parts, Zhishu 12 parts.

[0092] For lung qi deficiency and skin itching: raw Huangqi 50 parts, Ban Zhi Lian 30 parts, Baihua Sheche 30 parts, Dangshen 15 parts, Baizhu 15 parts, Fuling 15 parts, Xiaakucao 15 parts, Maowucao 20 parts, Guijianyan 15 parts, Luhongfang 5 parts, Quanxie 5 parts, Tuobiechong 6 parts, Jingjie 15 parts, Fangfeng 15 parts, Wuyi 9 parts.

[0093] For spleen qi deficiency: raw Huangqi 50 parts, Ban Zhi Lian 30 parts, Baihua Sheche 30 parts, Dangshen 15 parts, Baizhu 15 parts, Fuling 15 parts, Xiaakucao 15 parts, Maowucao 20 parts, Guijianyan 15 parts, Luhongfang 5 parts, Quanxie 5 parts, Tuobiechong 6 parts, Shanyao 12 parts, Sharen 6 parts.

[0094] Severe deficiency of vital energy: raw Huangqi 50 parts, Ban Zhilian 30 parts, Baihua Sheche 30 parts, Dangshen 15 parts, Baishu 15 parts, Fuling 15 parts, Xiaakucao 15 parts, Maocao 20 parts, Guijian 15 parts, Luhongfang 5 parts, Quanxie 5 parts, Tuobie 6 parts, Nuzhensi 15 parts.

[0095] Severe toxic evil: raw Huangqi 50 parts, Ban Zhilian 30 parts, Baihua Sheche 30 parts, Dangshen 15 parts, Baishu 15 parts, Fuling 15 parts, Xiaakucao 15 parts, Maocao 20 parts, Guijian 15 parts, Luhongfang 5 parts, Quanxie 5 parts, Tuobie 6 parts, Muhexi 10 parts, Longkui 20 parts.

[0096] Preparation method: the above medicinal materials are put into a boiling pot, soaked with appropriate amount of water for 30-60 min, with the water level being 2-5 cm higher than the medicinal materials, first boiled with strong fire and then boiled with weak fire for 20-25 min, the second time, add appropriate amount of water, with the water level being 1-2 cm higher than the medicinal materials, first boiled with strong fire and then boiled with weak fire for 15-20 min, combine the medicinal liquid and filter to obtain.

[0097] Example 2 clinical research

[0098] (I) Research plan

[0099] 1. Research method

[0100] The research is a prospective, multi-center, randomized, single-blind, placebo-controlled clinical study. The efficacy of the optimized TCM treatment scheme in the standardized clinical research on small cell lung cancer patients is verified.

[0101] 2. Research object

[0102] 2.1 Case source

[0103] Randomization is responsible by Peking University Clinical Research Institute, using central randomization method, with a ratio of 1:1.

[0104] Blinding uses single-blind design, with blind method set for patients. Drug coding process is responsible by Peking University (see Figure 1 ). Screening of extensive stage small cell lung cancer (ES-SCLC) patients is carried out in 13 sub-centers nationwide.

[0105] 2.2 Disease diagnosis standard

[0106] 2.2.1 Western medicine diagnosis standard

[0107] Patients diagnosed as small cell lung cancer by cytology or histology, with stage belonging to extensive stage (reference UICC eighth edition and American veterans staging).

[0108] 2.2.2 TCM syndrome diagnosis standard

[0109] Differential diagnosis was performed before chemotherapy every week, referring to the differential diagnosis scheme of National Administration of Traditional Chinese Medicine "Lung Cancer Diagnosis and Treatment Scheme (2017)", combined with the addition of "weakness and toxin accumulation" syndrome in clinic.

[0110] 2.3 Inclusion and exclusion criteria:

[0111] 2.3.1 Inclusion criteria:

[0112] (1) Patients with extensive stage small cell lung cancer diagnosed by cytology or histology (with distant organ metastasis and / or contralateral hilar lymph node metastasis by head MRI, chest CT, bone scan, abdominal CT or PET / CT);

[0113] (2) No radiotherapy, chemotherapy or surgery treatment, with evaluable lesions;

[0114] (3) ECOG score ≤2 points, and the expected survival time is >3 months;

[0115] (4) Age 18-75 years old, without serious diseases of heart, brain, kidney, liver, blood and other systems;

[0116] (5) Agree to participate in this study and sign the informed consent form.

[0117] 2.3.2 Exclusion criteria

[0118] (1) A large amount of pleural, peritoneal or pericardial effusion, causing dyspnea;

[0119] (2) Symptomatic bone metastasis requiring radiotherapy;

[0120] (3) Brain metastasis;

[0121] (4) Pregnant or lactating women, or with serious diseases of heart, lung, liver, kidney, blood and other systems;

[0122] (5) Patients known to be allergic to the drugs used in the study;

[0123] (6) Patients undergoing other drug trials.

[0124] 2.3.3 Withdrawal of subjects

[0125] (1) Patients during treatment apply Chinese medicine, decoction or injection with anti-tumor effect outside the study scheme;

[0126] (2) Patients during treatment received radiotherapy, immunotherapy and other western medicine anti-tumor treatment;

[0127] (3) In clinical trials, subjects develop certain complications or comorbidities, which are not suitable for continuing the trial;

[0128] (4) Occurrence of serious adverse events, inappropriate to continue the trial;

[0129] (5) Poor subject compliance, affecting the effectiveness and safety judgment;

[0130] (6) The subject voluntarily withdraws from the trial for any reason;

[0131] (7) Misclassification after enrollment (serious violation of the inclusion and exclusion criteria), should be withdrawn in time;

[0132] (8) The researcher believes that there are safety reasons to terminate or suspend the clinical study;

[0133] (9) The subject is lost to follow-up.

[0134] 3. Grouping and treatment methods

[0135] 3.1 Grouping method

[0136] Test group: Chinese medicine granules + standard chemotherapy for small cell lung cancer;

[0137] Control group: placebo granules + standard chemotherapy for small cell lung cancer, placebo consists of 95% dextrin and 5% real medicine to ensure the similarity of appearance, smell, texture and taste.

[0138] Both start taking on the 6th day of chemotherapy, 1 bag each morning and evening, and take with warm water, for 15 consecutive days, which is 1 cycle. The course of treatment is 4-6 chemotherapy cycles, at least 4 cycles.

[0139] 3.2 Treatment method

[0140] Chinese medicine granules are differentiated before chemotherapy every week, according to the National Administration of Traditional Chinese Medicine "Lung Cancer Diagnosis and Treatment Scheme" (2017), combined with clinical experience, to make diagnosis and treatment. For patients with deficiency and toxin knot syndrome, use the Fuzheng Jiedu recipe, the syndrome differentiation and prescription composition are as follows:

[0141] Deficiency and toxin knot syndrome: main symptoms: fatigue, cough, asthma, rapid tumor progression; secondary symptoms: poor appetite, weight loss, chest pain, fever, hemoptysis, self-sweating. Dark tongue, thick or greasy fur, stringy pulse.

[0142] Fuzheng Jiedu recipe: Shenghuangqi, Banzhi lian, Baihuasheshecao, Dangshen, Baishu, Fuling, Xiaakucaocao, Miaozhaocao, Guijianyan, Luhuobing, Quanxie, Tuobiechong.

[0143] NCCN Small Cell Lung Cancer Clinical Practice Guidelines Recommended Chemotherapy Regimens (2018 Second Edition) and China's Primary Lung Cancer Diagnosis and Treatment Guidelines (2018 Edition) are etoposide or irinotecan combined with platinum regimens, and the recommended first choice is EP regimen (etoposide + cisplatin).

[0144] 4. Observation index

[0145] 4.1 Primary efficacy index: Progression-free survival (PFS);

[0146] 4.2 Secondary efficacy index: Overall survival (OS);

[0147] To compare the progression-free survival and overall survival of the Fu-zheng Jie-du Fang subgroup.

[0148] 4.3 To record and evaluate the safety index.

[0149] 5. Data management and statistical analysis

[0150] 5.1 Primary outcome index:

[0151] PFS: Kaplan-Meier curve was drawn to describe PFS, and Logrank test was used for comparison between the two groups. If there was a statistically significant difference in baseline between the test group and the control group, Cox proportional hazards model was used to calculate HR and its 95% CI to control the influence of confounding factors, and HR confidence interval was used to verify the efficacy difference between the test group and the control group. The comparison between groups controls the center effect.

[0152] 5.2 Secondary outcome index:

[0153] OS: Kaplan-Meier curve was drawn to describe OS, and Logrank test was used for comparison between the two groups. If there was a statistically significant difference in baseline between the test group and the control group, Cox proportional hazards model was used to calculate HR and its 95% CI to control the influence of confounding factors, and HR confidence interval was used to verify the efficacy difference between the test group and the control group. The comparison between groups controls the center effect.

[0154] For measurement data, first examine whether the data meet the normality and homogeneity of variance, if meet, then use independent sample t test, if not meet, then use Mann-Whitney U to compare the difference of the same period between the two groups of research objects. Categorical data were analyzed by CMH test.

[0155] 5.3 Safety evaluation

[0156] Describe the number and number of cases and adverse events and adverse reactions of the two groups, and the incidence of adverse events, serious adverse events, adverse reactions, and serious adverse reactions.

[0157] 6 Analysis dataset method

[0158] 6.1 Full Analysis Set (FAS)

[0159] All randomized subjects who received at least one dose of study treatment and had at least one post-baseline efficacy assessment. Patients were analyzed according to the treatment group to which they were randomized.

[0160] 6.2 Safety Set (SS)

[0161] All patients who received at least one dose of study treatment and had at least one post-baseline safety assessment. Patients were analyzed according to the treatment actually received.

[0162] 7. Results

[0163] A total of 38 patients involved in the application of Fuzheng Jiedu Decoction were compared in terms of overall survival and progression-free survival, and KM curves were drawn, as shown in the following results.

[0164] The multi-center randomized controlled clinical study on the efficacy evaluation of TCM regimen in extensive small cell lung cancer (SCLC) compared the efficacy of TCM regimen combined with chemotherapy with that of simple chemotherapy in the treatment of extensive small cell lung cancer (ES-SCLC) through large-scale, multi-center, prospective randomized controlled trial method. The data collected on September 4, 2023 were statistically analyzed, and a total of 259 patients were included in the FAS set for analysis of progression-free survival and overall survival. A total of 38 patients were included in the sub-group of deficiency toxin knot syndrome type taking Fuzheng Jiedu Decoction for analysis of progression-free survival and overall survival.

[0165] 7.1 Progression-free survival

[0166] The results show that the TCM regimen assisted chemotherapy in the application can prolong the progression-free survival of SCLC patients HR=0.74 [95% CI: 0.56-0.98], P<0.05( Figure 2 ). Analysis of 38 cases of ES-SCLC of deficiency toxin knot syndrome type taking Fuzheng Jiedu Decoction also shows that Fuzheng Jiedu Decoction assisted chemotherapy can significantly prolong the progression-free survival of ES-SCLC of deficiency toxin knot syndrome type. Among them, the mPFS of the treatment group was 8.60 months, 95% CI: 6.82-10.39, and the mPFS of the control group was 6.83 months, 95% CI: 5.49-8.18. HR=0.422 [95% CI: 0.187-0.955], P<0.05( Figure 3 ).

[0167] 7.2 Overall survival

[0168] Results showed that the TCM regimen assisted chemotherapy in the application has a trend of prolonging the overall survival period of SCLC: HR = 0.77 [95% CI: 0.57-1.05] Figure 4 ). For the 38 cases of ES-SCLC in the positive deficiency and toxic knot syndrome type taking "Fuzheng Jiedu Decoction", analysis showed that "Fuzheng Jiedu Decoction" assisted chemotherapy has a trend of prolonging the overall survival period of the positive deficiency and toxic knot syndrome subgroup. Among them, the mOS of the control group was 11.53 months, 95% CI: 4.30-18.76, and the mOS of the treatment group was 12.27 months, 95% CI: 6.51-18.03. HR = 0.633 [95% CI: 0.26-1.57].

[0169] 7.3 Safety results

[0170] The data cutoff date was September 04, 2023, and the number of cases and episodes of adverse events in both groups during treatment and within 90 days after the last dose or before any subsequent treatment began, as well as the incidence and severity of treatment-related adverse events, were counted. Safety analysis was conducted for each adverse event classification, 3-4 grade adverse reaction events, and the evaluation results showed that there was no statistical difference in the incidence of adverse reactions between the two groups, suggesting that TCM combined with chemotherapy for the treatment of extensive stage small cell lung cancer does not increase adverse reaction events, and its safety is overall controllable.

[0171] Example 3 typical case

[0172] Patient: LB, female, 66 years old.

[0173] Medical history:

[0174] Since October 2019, intermittent cough has appeared and gradually worsened, and in December of the same year, chest CT showed a space-occupying lesion near the hilum of the left lung, with mediastinal and left hilar lymph node enlargement. After symptomatic sputum treatment, the cough was relieved.

[0175] In February 2020, the patient had paroxysmal cough and sputum, paroxysmal palpitations, dyspnea and transient hypertension, and was treated in Chaoyang Hospital. The chest CT result was roughly the same as before, and the patient did not receive hospital treatment due to bed problems.

[0176] In March of the same year, the patient developed wheezing, and was admitted to the emergency department of the Chinese People's Liberation Army General Hospital. Chest CT showed: left lung mass roughly the same as before, with left pleural effusion and left lower lobe atelectasis. Tumor: CA125: 100.80u / ml, NSE: 284ng / ml. Subsequently, chest drainage was performed, and a total of 2800ml of bloody chest fluid was drained intermittently. Chest fluid pathology showed: a small amount of naked nucleus atypical cell degeneration was seen in the smear, suspected to be tumor cells. Immunohistochemistry: Syn(+), CgA(-), CD56(+), CD3(+) with more background lymphocytes, CD20(+) with more background lymphocytes, CK7(few+), anti-mesothelioma(-), WT(-), TTF-1(+). Combined with the immunohistochemical results, it was considered to be small cell lung cancer.

[0177] On March 20, a review of chest CT at Beijing University of Chinese Medicine Hospital showed a large mass in the left upper lobe of the lung, with a maximum cross-section of about 12.3*8.4cm. The mass surrounded the aorta and left pulmonary artery, and the boundary with the right pulmonary artery was unclear. Multiple lymph node enlargement was observed in the left supraclavicular region, with a larger diameter of about 2.7cm, suggesting metastatic tumor.

[0178] Current symptoms include:

[0179] Paroxysmal cough and sputum, paroxysmal palpitations and wheezing, fatigue and shortness of breath, normal appetite, restless sleep, one bowel movement per day, and normal urination.

[0180] Tongue appearance:

[0181] Dark red tongue with white fur.

[0182] Pulse:

[0183] None.

[0184] Diagnosis:

[0185] Western medical diagnosis: extensive stage small cell lung cancer at left hilum, secondary malignant tumor in left hilar lymph node, secondary malignant tumor in mediastinal lymph node, malignant pleural effusion, and atelectasis.

[0186] Chinese medical diagnosis: lung cancer with deficiency of vital energy and accumulation of toxins

[0187] Treatment:

[0188] Benefiting qi, strengthening body resistance, and resolving toxins

[0189] Prescription:

[0190] Fuzheng Jiedu Decoction: Radix Astragali seu Hedysari 50g, Radix Codonopsis 15g, Rhizoma Atractylodis Macrocephalae 15g, Poria 15g, Herba Lycopi 30g, Herba Lycopi 30g, Herba Prunellae 15g, Herba Ranunculi Ternati 20g, Herba Scindiae 15g, Periostracum Margaritiferae 5g, Scorpio 5g, Eupolyphaga 6g.

[0191] Usage and dosage:

[0192] 15 doses in total, one dose per day, decocted in water and taken warm, one time dosage: 200 mL.

[0193] Subsequent treatment and follow-up:

[0194] On March 20, April 14, May 11, June 2, June 29, and July 21, the patient received 6 cycles of EC regimen chemotherapy. During chemotherapy, the patient received symptomatic white blood cell count increase, vomiting relief, hydration, and liver protection treatment.

[0195] On March 25, April 19, May 16, June 7, July 4, and July 26, the patient started taking oral Fuzheng Jiedu Decoction for 15 consecutive days. After 2 cycles of review and evaluation, the patient achieved PR (partial remission), after 4 cycles, the patient achieved SD (stable disease), and after 6 cycles, the patient achieved SD (stable disease).

[0196] On September 20, 2020, the patient underwent chest radiotherapy for 25 times and head prophylaxis for 10 times at the China-Japan Friendship Hospital. After that, the patient underwent comprehensive review every 3 months. During the review period, the patient adhered to oral Chinese medicine decoction for consolidation treatment. The review results showed that the patient's condition was stable, and there was no obvious tendency of recurrence and metastasis.

[0197] In February 2023, the patient's test results were as follows: tumor markers: CA724: 4.52 U / ml, CA242: 2.00 U / ml, NSE: 10.20 ng / ml, SCC: 0.79 ng / ml, CYFRA-211: 2.34 ng / ml. Chest CT: soft tissue density mass in the left upper lobe mediastinum and left main bronchus anterior wall, about 3.4*1.4 cm in size; significantly reduced compared to the previous one, localized atelectasis in the left lower lobe; left pleural effusion and uneven thickening of the pleura; multiple small lymph nodes in the mediastinum, the larger one with a short diameter of about 7 mm. Bone scan: no obvious bone metabolism abnormalities. Abdominal and pelvic enhanced CT: gallbladder adenomyosis, esophageal hiatus hernia, right kidney microcalculi, multiple diverticula in the colon.

[0198] Current symptoms: cough and sputum have significantly decreased, there is no obvious palpitation, shortness of breath, or dyspnea, occasional fatigue, normal sleep, and regular bowel movements.

Claims

1. A traditional Chinese medicine composition, said traditional Chinese medicine composition being made from the following traditional Chinese medicines in parts by weight: The principal ingredient is composed of one or more of the following: 30-60 parts of raw Astragalus membranaceus, 20-45 parts of Scutellaria barbata and / or 20-45 parts of Hedyotis diffusa. The auxiliary medicine is composed of one or more of the following: Codonopsis pilosula 10-30 parts, Atractylodes macrocephala 10-30 parts, Poria cocos 10-30 parts, Prunella vulgaris 10-30 parts, Uncaria rhynchophylla 10-35 parts, Perilla frutescens 10-30 parts, Cynanchum paniculatum 10-30 parts, Stemona japonica (processed) 10-30 parts, Adenophora stricta 10-35 parts, Morus alba (processed) 10-35 parts, Peucedanum praeruptorum 5-25 parts, Platycodon grandiflorus 5-25 parts, Ligustrum lucidum 10-30 parts, Dioscorea opposita 5-25 parts, Amomum villosum 2-12 parts, and / or Schisandra chinensis 5-20 parts. The adjuvant medicine consists of one or more of the following: 10-30 parts of Euonymus alatus, 1-10 parts of Vespa nidus, 1-10 parts of Scorpion, 2-12 parts of Eupolyphaga sinensis, 5-20 parts of Momordica cochinchinensis, 10-35 parts of Solanum nigrum, 5-25 parts of Aucklandia lappa, 5-25 parts of Citrus aurantium, 10-35 parts of Phragmites communis, and / or 20-45 parts of Coix lacryma-jobi. The medicine is composed of one or more of the following: leech 1-6 parts, prepared licorice root 5-25 parts, schizonepeta 10-30 parts and / or saposhnikovia root 10-30 parts.

2. The traditional Chinese medicine composition as described in claim 1, wherein the traditional Chinese medicine composition is made from the following traditional Chinese medicines in parts by weight: The principal ingredient is composed of one or more of the following: 40-60 parts of raw Astragalus membranaceus, 20-40 parts of Scutellaria barbata and / or 20-40 parts of Hedyotis diffusa. The auxiliary medicine is composed of one or more of the following: Codonopsis pilosula 10-20 parts, Atractylodes macrocephala 10-25 parts, Poria cocos 10-25 parts, Prunella vulgaris 10-25 parts, Uncaria rhynchophylla 10-30 parts, Perilla frutescens 10-25 parts, Cynanchum paniculatum 10-25 parts, Stemona japonica (processed) 10-25 parts, Adenophora stricta 10-30 parts, Morus alba (processed) 10-30 parts, Peucedanum praeruptorum 5-20 parts, Platycodon grandiflorus 5-20 parts, Ligustrum lucidum 10-25 parts, Dioscorea opposita 5-20 parts, Amomum villosum 3-10 parts, and / or Schisandra chinensis 5-20 parts. The adjuvant medicine consists of one or more of the following: 10-25 parts of Euonymus alatus, 2-8 parts of Vespa nidus, 2-8 parts of Scorpion, 3-10 parts of Eupolyphaga sinensis, 5-15 parts of Momordica cochinchinensis, 10-30 parts of Solanum nigrum, 5-20 parts of Aucklandia lappa, 5-20 parts of Citrus aurantium, 10-30 parts of Phragmites communis, and / or 20-40 parts of Coix lacryma-jobi. The medicine is composed of one or more of the following: leech 2-5 parts, prepared licorice root 5-20 parts, schizonepeta 10-25 parts and / or saposhnikovia root 10-25 parts.

3. The traditional Chinese medicine composition as described in claim 1, wherein the traditional Chinese medicine composition is made from the following traditional Chinese medicines in parts by weight: The principal ingredient is composed of one or more of the following: 40-50 parts of raw Astragalus membranaceus, 20-35 parts of Scutellaria barbata and / or 20-35 parts of Hedyotis diffusa. The ministerial medicine is composed of one or more of the following: 10-20 parts of radix codonopsis, 10-20 parts of rhizoma atractylodis macrocephalae, 10-20 parts of poria cocos, 10-20 parts of prunella vulgaris, 10-25 parts of cat's claw, 10-20 parts of perilla frutescens, 10-20 parts of radix bupleuri, 10-20 parts of fried radix stachydis, 10-25 parts of radix adenosma, 10-25 parts of white mulberry bark, 5-15 parts of radix peucedani, 5-15 parts of radix platycodi, 10-20 parts of ligustrum lucidum, 5-15 parts of dioscorea, 4-8 parts of amomum villosum and / or 5-20 parts of schisandra chinensis; The assistant medicine is composed of one or more of the following: 10-20 parts of radix campylotropidis, 3-6 parts of melissae, 3-6 parts of scolopendra, 4-8 parts of eupolyphaga, 5-10 parts of semen pharbitidis, 10-25 parts of herba solani nigri, 5-15 parts of radix aucklandiae, 5-15 parts of aurantii, 10-25 parts of radix et rhizoma rhizomatis and / or 20-35 parts of coicis. The medicine is composed of one or more of the following: 3-5 parts of leech, 5-15 parts of fried licorice, 10-20 parts of schizonepeta and / or 10-20 parts of levisticus.

4. The traditional Chinese medicine composition of claim 1, in an embodiment of the present application, the traditional Chinese medicine composition is composed of 30-60 parts of radix astragali, 20-45 parts of herba barbatae, 20-45 parts of herba oldenlandiae, 10-30 parts of radix codonopsis, 10-30 parts of rhizoma atractylodis macrocephalae, 10-30 parts of poria cocos, 10-30 parts of prunella vulgaris, 10-35 parts of cat's claw, 10-30 parts of radix campylotropidis, 1-10 parts of melissae, 1-10 parts of scolopendra and 2-12 parts of eupolyphaga.

5. The traditional Chinese medicine composition of claim 1, in an embodiment of the present application, the traditional Chinese medicine composition is composed of 30-60 parts of radix astragali, 20-45 parts of herba barbatae, 20-45 parts of herba oldenlandiae, 10-30 parts of radix codonopsis, 10-30 parts of rhizoma atractylodis macrocephalae, 10-30 parts of poria cocos, 10-30 parts of prunella vulgaris, 10-35 parts of cat's claw, 10-30 parts of radix campylotropidis, 1-10 parts of melissae, 1-10 parts of scolopendra, 2-12 parts of eupolyphaga and 1-6 parts of leech; In an embodiment of the present application, the traditional Chinese medicine composition is composed of 30-60 parts of radix astragali, 20-45 parts of herba barbatae, 20-45 parts of herba oldenlandiae, 10-30 parts of radix codonopsis, 10-30 parts of rhizoma atractylodis macrocephalae, 10-30 parts of poria cocos, 10-30 parts of prunella vulgaris, 10-35 parts of cat's claw, 10-30 parts of perilla frutescens, 10-30 parts of radix bupleuri, 10-30 parts of radix campylotropidis, 1-10 parts of melissae, 1-10 parts of scolopendra, 2-12 parts of eupolyphaga and 5-25 parts of fried licorice; In an embodiment of the present application, the traditional Chinese medicine composition is composed of 30-60 parts of radix astragali, 20-45 parts of herba barbatae, 20-45 parts of herba oldenlandiae, 10-30 parts of radix codonopsis, 10-30 parts of rhizoma atractylodis macrocephalae, 10-30 parts of poria cocos, 10-30 parts of prunella vulgaris, 10-35 parts of cat's claw, 10-30 parts of perilla frutescens, 10-35 parts of radix adenosma, 10-35 parts of white mulberry bark, 5-25 parts of radix peucedani, 5-25 parts of radix platycodi, 10-30 parts of radix campylotropidis, 1-10 parts of melissae, 1-10 parts of scolopendra, 2-12 parts of eupolyphaga and 5-25 parts of fried licorice; In an embodiment of the present application, the traditional Chinese medicine composition is composed of Astragalus 30-60 parts, Hedyotis 20-45 parts, Oldenlandia 20-45 parts, Codonopsis 10-30 parts, Atractylodes 10-30 parts, Poria 10-30 parts, Prunella 10-30 parts, Ranunculus 10-35 parts, Ilex 10-30 parts, Melia 1-10 parts, Scorpion 1-10 parts, Tenodera 2-12 parts, Phyllium 5-20 parts, Phragmites 10-35 parts, and Coicis 20-45 parts; In an embodiment of the present application, the traditional Chinese medicine composition is composed of Astragalus 30-60 parts, Hedyotis 20-45 parts, Oldenlandia 20-45 parts, Codonopsis 10-30 parts, Atractylodes 10-30 parts, Poria 10-30 parts, Prunella 10-30 parts, Ranunculus 10-35 parts, Ilex 10-30 parts, Melia 1-10 parts, Scorpion 1-10 parts, Tenodera 2-12 parts, Wood 5-25 parts, and Citrus 5-25 parts; In an embodiment of the present application, the traditional Chinese medicine composition is composed of Astragalus 30-60 parts, Hedyotis 20-45 parts, Oldenlandia 20-45 parts, Codonopsis 10-30 parts, Atractylodes 10-30 parts, Poria 10-30 parts, Prunella 10-30 parts, Ranunculus 10-35 parts, Ilex 10-30 parts, Melia 1-10 parts, Scorpion 1-10 parts, Tenodera 2-12 parts, Wood 5-25 parts, and Citrus 5-25 parts; In an embodiment of the present application, the traditional Chinese medicine composition is composed of Astragalus 30-60 parts, Hedyotis 20-45 parts, Oldenlandia 20-45 parts, Codonopsis 10-30 parts, Atractylodes 10-30 parts, Poria 10-30 parts, Prunella 10-30 parts, Ranunculus 10-35 parts, Ilex 10-30 parts, Melia 1-10 parts, Scorpion 1-10 parts, Tenodera 2-12 parts, Wood 5-25 parts, and Citrus 5-25 parts; In an embodiment of the present application, the traditional Chinese medicine composition is composed of Astragalus 30-60 parts, Hedyotis 20-45 parts, Oldenlandia 20-45 parts, Codonopsis 10-30 parts, Atractylodes 10-30 parts, Poria 10-30 parts, Prunella 10-30 parts, Ranunculus 10-35 parts, Ilex 10-30 parts, Melia 1-10 parts, Scorpion 1-10 parts, Tenodera 2-12 parts, Wood 5-25 parts, and Citrus 5-25 parts; In an embodiment of the present application, the traditional Chinese medicine composition is composed of Astragalus 30-60 parts, Hedyotis 20-45 parts, Oldenlandia 20-45 parts, Codonopsis 10-30 parts, Atractylodes 10-30 parts, Poria 10-30 parts, Prunella 10-30 parts, Ranunculus 10-35 parts, Ilex 10-30 parts, Melia 1-10 parts, Scorpion 1-10 parts, Tenodera 2-12 parts, Wood 5-25 parts, and Citrus 5-25 parts; 6. A traditional Chinese medicine preparation containing the traditional Chinese medicine composition of claim 1 and a pharmaceutically acceptable adjuvant.

7. Use of the traditional Chinese medicine composition of claim 1 in the preparation of a medicament for treating lung cancer.

8. The use of claim 7, wherein the lung cancer is small cell lung cancer.

9. The use of claim 7, wherein the lung cancer is small cell lung cancer with deficiency of vital energy and accumulation of toxic material.

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