Traditional Chinese medicine composition for treating thrombocytopenia caused by tumor treatment as well as preparation and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating thrombocytopenia caused by tumor treatment as well as a preparation and application of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw material medicines: raw astragalus membranaceus, angelica sinensis, pyrrosia lingua, dendrobe, hairyvein agrimony, madder, raw pollen typhae, selaginella tamariscina, fructus forsythiae and cynomorium songaricum. The invention further discloses a preparation of the traditional Chinese medicine composition and application of the traditional Chinese medicine composition in preparation of drugs for treating thrombocytopenia caused by tumor treatment. Compared with a single tonifying method, the traditional Chinese medicine composition can more accurately improve double obstacles of platelet generation and release, can obviously increase the number of platelets of tumor patients clinically, and is especially suitable for the symptoms of vital qi deficiency, marrow consumption and stasis-toxin intermingled after tumor treatment.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine. More particularly, it relates to a traditional Chinese medicine composition for treating thrombocytopenia caused by tumor treatment, as well as preparation and application thereof. BACKGROUND

[0002] Cancer therapy induced thrombocytopenia (CTIT) is a common hematological adverse reaction in the development and treatment of malignant tumors, which not only significantly increases the risk of bleeding and thrombosis, but also seriously interferes with anti-tumor treatment, and even endangers life. At present, chemotherapy, targeted therapy and immunotherapy can all cause decreased platelet production or increased platelet destruction, among which chemotherapy-induced thrombocytopenia (CIT) is the most significant. Previous literature reported that the proportion of chemotherapy drug-related thrombocytopenia (CIT) was about 21%, and the incidence of grade 3-4 was about 3%. In addition, other anti-tumor treatments can also induce thrombocytopenia, such as immune checkpoint inhibitors (ICIs) can cause platelet destruction due to excessive activation of the immune system, and transarterial chemoembolization (TACE) and liver surgery can cause platelet loss due to local damage or coagulation disorders. Part of the elderly or multi-line treatment patients belong to the high-risk group of thrombocytopenia, and are more likely to progress to severe thrombocytopenia, with poor clinical prognosis, which brings great challenges to the follow-up supportive treatment. Therefore, early intervention of thrombocytopenia caused by tumor treatment is crucial to improve the prognosis.

[0003] The mechanism of thrombocytopenia caused by tumor treatment is not clear, and the direct toxicity of drugs to bone marrow or platelets, the degree of tumor cell invasion of bone marrow, and the immune microenvironment can all affect the occurrence and severity of thrombocytopenia. At present, the clinical intervention of thrombocytopenia caused by tumor treatment still faces multiple treatment limitations. For example, although platelet transfusion can quickly increase the platelet content, the duration of the effect is limited, repeated transfusion can induce homologous immune response, and is accompanied by the risk of allergic reaction and blood-borne infection. Secondly, the existing clinical application of thrombopoietin (TPO) and its receptor agonist drugs can effectively promote platelet production, but their mechanism of action does not target the specific pathological link of thrombocytopenia. At the same time, the application of such drugs is associated with an increased risk of venous thrombosis in patients with solid tumors. In addition, long-term use of TPO drugs can induce drug resistance, and some patients may progress to refractory thrombocytopenia. Such treatment limitations not only affect the continuity of anti-tumor treatment, but also significantly reduce the quality of life of patients. Therefore, effective intervention of thrombocytopenia caused by tumor treatment, reduction of refractory thrombocytopenia, and reduction of platelet transfusion are the urgent problems to be solved in clinical practice. SUMMARY

[0004] In view of the above technical problems, one object of the present application is to provide a new traditional Chinese medicine composition, which can improve the dual obstacles of platelet production and release, and can significantly increase the platelet content of tumor patients in clinical practice, especially for the syndrome of 'deficiency of the spleen and marrow consumption, and mutual knotting of blood stasis and toxin' after tumor treatment.

[0005] Another object of the present application is to provide various traditional Chinese medicine preparations of the above-mentioned traditional Chinese medicine composition.

[0006] Still another object of the present application is to provide the use of the above-mentioned traditional Chinese medicine composition and traditional Chinese medicine preparation in the preparation of a drug for thrombocytopenia caused by tumor treatment.

[0007] To achieve the above-mentioned objects, the present application adopts the following technical solutions:

[0008] In a first aspect, the present application provides a traditional Chinese medicine composition for thrombocytopenia caused by tumor treatment, which comprises the following raw medicinal materials: Astragalus, Angelica, Pyrrosia, Dendrobium, Agrimony, Safflower, Selaginella, Forsythia, and Cynomorium.

[0009] Preferably, the traditional Chinese medicine composition is prepared from the following raw medicinal materials by weight: 30-60 parts of raw radix astragali, 6-9 parts of angelica, 10-20 parts of pyrrosia, 10-20 parts of dendrobium, 10-20 parts of agrimonia eupatoria, 10-20 parts of madder, 10-15 parts of raw curcuma, 10-15 parts of selaginella, 9-15 parts of forsythia, 10-15 parts of cynomorium.

[0010] According to the Clinical Management Expert Consensus on Thrombocytopenia Related to Cancer Therapy, the combination of traditional Chinese medicine and western medicine has become an important strategy for thrombocytopenia caused by cancer treatment. Among them, traditional Chinese medicine mainly uses the method of invigorating the spleen and kidney, and uses Huangqi and Baizhu to enhance the function of the spleen in blood circulation. Or, the method of tonifying qi and nourishing blood is used to improve the bone marrow microenvironment and promote platelet production with Gushu Decoction or Danggui Buxue Decoction. Or, fill the essence and blood, based on Zuogui Pill, combined with Xuemushi products, to regulate body function from multiple targets to prevent and treat thrombocytopenia.

[0011] The team of inventors of the present application puts forward the five-stage evolution theory of malignant tumors, with "deficiency-cold-toxicity-obstruction-decline, and stagnation throughout" as the pathogenesis evolution program. Under this theoretical framework, the present application proposes that the core pathogenesis of thrombocytopenia caused by cancer treatment is rooted in "deficiency of the spleen and kidney": the core link is the deficiency of the spleen and kidney. Specifically: the deficiency of the spleen leads to the lack of source of essence and blood, and the failure of the spleen to control blood leads to the failure of qi to control blood; the deficiency of kidney essence leads to the failure of the marrow to be nourished. The above pathological processes work together to eventually lead to the suppression of bone marrow hematopoietic stem cell proliferation and the deficiency of TPO synthesis. On the other hand, as the key pathological link of tumor-related thrombocytopenia, the combination of toxicity and stasis is caused by the mutual interweaving of "drug toxicity" left by chemotherapy, targeted therapy or immunotherapy, "heat toxicity" caused by radiation damage and endogenous "cancer toxicity", which jointly damage the bone marrow microvascular endothelium, trigger an inflammatory factor storm, and form a vicious cycle of toxicity and stasis, and marrow obstruction. This process not only inhibits the maturation and differentiation of megakaryocytes, but also accelerates the destruction of peripheral platelets, and is often characterized by normal or increased number of bone marrow megakaryocytes and persistent low platelet count in clinical practice. Therefore, the present application proposes the main principles of tonifying the spleen and kidney, resolving toxicity and unblocking the collaterals.

[0012] In the present application, Huangqi is sweet and slightly warm, and belongs to the lung and spleen meridians. It is good at tonifying the primordial qi and supporting toxicity to generate muscle, and is a tonic for qi. "Newly Compiled Materia Medica" records: "Huangqi is a tonic for qi … … The blood cannot be quickly generated, and the qi must be obtained to generate it." Patients with low platelets often have symptoms of qi deficiency and lack of food. Huangqi can tonify the spleen and lung qi, enhance the function of the spleen and stomach, and support the body to generate blood. It is especially suitable for patients with qi deficiency and blood deficiency, and is the monarch herb of the whole prescription.

[0013] Angelica sinensis is sweet and pungent in flavor and warm in nature. It enters the liver and spleen meridians, tonifying and activating blood circulation. It is a sacred medicine for blood circulation and serves as a key ingredient in the entire formula. When combined with astragalus, it nourishes liver blood and nourishes liver qi. When liver qi is sufficient, blood circulation is naturally controlled and stops. It has excellent clinical efficacy in preventing tumor-related bleeding. The "Medical Compendium" states: "Its clear qi tonifies blood while promoting qi circulation; its strong flavor promotes qi circulation while also tonifying blood." In tumor-induced syndromes characterized by deficiency of vital energy and excessive toxicity, Angelica sinensis not only tonifies blood and regenerates new blood, but also promotes qi circulation and blood circulation. It is particularly suitable for those with blood deficiency accompanied by stasis and poor qi and blood circulation. Combined with astragalus, it forms Angelica sinensis Blood-Replenishing Decoction, a crucial ingredient for cancer patients to nourish qi and blood, and support vital energy. It serves as a key ingredient in the entire formula.

[0014] Selaginella ternata tastes bitter and sweet, with a cooling nature. It enters the lung and bladder meridians, promoting diuresis and relieving stranguria, clearing heat, cooling blood, and arresting bleeding. It is often used for symptoms of heat-toxic stasis and premature bleeding. "Bielu" (Beilu) states that it "relieves restlessness and purifies qi...tonifies the five fatigue organs, soothes the five internal organs, and benefits essence and qi." It has the effects of tonifying deficiency and strengthening vital energy, while also boosting essence and qi and promoting blood production. Furthermore, when combined with heat-clearing and detoxifying herbs, it can help clear heat, resolve blood stasis, cool blood, and arrest bleeding, clearing the upper source and cleansing the lower flow, alleviating the effects of tumors, phlegm, stasis, and toxins, making it a valuable adjuvant for the entire formula.

[0015] Dendrobium is sweet in flavor and slightly cold in nature. It enters the stomach and kidney meridians, benefiting the stomach, promoting fluid production, and nourishing yin and clearing heat. The Compendium of Materia Medica states: "Dendrobium... stimulates appetite, benefits the spleen and stomach, and benefits the heart and kidneys." Dendrobium nourishes yin and blood, moistens dryness, and promotes fluid production, making it a key herb for nourishing yin, clearing heat, cooling blood, and stopping bleeding. It also strengthens spleen yin and supports spleen qi, nourishing the source of nutrient and hygienic function, making it a valuable adjuvant in comprehensive prescriptions.

[0016] Agrimony has a bitter and astringent taste and a neutral nature. It enters the Heart and Liver meridians and has excellent astringent and hemostatic properties, as well as detoxification and antimalarial properties. Modern Practical Chinese Medicine describes it as "a tonic astringent and hemostatic agent with cardiotonic properties." Bleeding symptoms are common in patients with tumor-related thrombocytopenia. Agrimony can stop bleeding without causing stasis, tonifying deficiency without contributing to pathogenic factors. It is effective in tonifying the spleen and stomach, replenishing Qi and blood to address the root cause, while also astringing and stopping bleeding to treat the symptoms. When combined with yin-nourishing and detoxifying herbs, it achieves detoxification and anticancer effects, addressing both the symptoms and the root cause. It not only inhibits tumor metastasis but also prevents and treats tumor-related thrombocytopenia, making it a valuable adjuvant in comprehensive prescriptions.

[0017] Rubia cordifolia is bitter and cold in nature, entering the Liver Meridian. It is known for cooling blood, activating blood circulation, and removing blood stasis. The "Medical Compendium" states: "Rubia cordifolia, red in color, enters the blood system. It purifies the liver, preventing blood stasis, and nourishes the heart, allowing blood to flow freely." Its blood-dispelling and hemostatic properties are particularly useful for cancer patients experiencing blood stasis and internal toxic accumulation. When combined with yin-nourishing herbs like Dendrobium officinale, it nourishes yin, clears heat, cools blood, harmonizes vital energy, and stops bleeding and dissolves stasis. When combined with qi-activating herbs like Astragalus membranaceus and Angelica sinensis, it promotes qi-dispersing and blood-activating, stopping bleeding, while dispersing stasis and disinfecting, protecting the meridians. Modern pharmacology has also confirmed its ability to promote platelet production, making it a valuable adjuvant in comprehensive prescriptions.

[0018] Pulvis is sweet, nature, liver, pericardium, good at stopping bleeding and blood stasis, and relieving pain. "Materia Medica" said: "The nature of the raw is cool, and the blood is consumed; Fried use is astringent, blood and stop." Raw pulvis is more effective in breaking blood and swelling, and is aimed at the mutual knotting of tumor stasis and blood stasis, which hinders the generation of new blood and causes thrombocytopenia. Raw pulvis can remove blood stasis, reduce swelling and pain, especially when combined with qi and blood circulation drugs. It also has the function of clearing heat, removing blood stasis, softening and activating blood, and treating phlegm and blood stasis, and inhibiting tumor progression, and is a medicine for the whole prescription.

[0019] Sempervivum is pungent, nature, liver, heart, raw blood, fried blood stasis. "Rihua Zi Materia Medica" said: "calm the heart, remove facial rash, headache, warm water." Sempervivum is good at breaking blood and removing blood stasis, and is especially suitable for patients with tumor stasis and blood stasis. Combined with pulvis, it can promote the dispersion of blood stasis, break blood and remove blood stasis, and new blood is generated. Its active ingredients can also significantly improve bone marrow cell recovery, thereby protecting the hematopoietic system, and can regulate immunity, and have certain anti-tumor effect, and are a medicine for the whole prescription.

[0020] Cynomys is sweet, warm, kidney, liver, large intestine, good at tonifying kidney yang and benefiting essence and blood. "Materia Medica" said: "It can tonify yin and blood, excite yang and solidify essence, strengthen yin and benefit marrow." Tumors consume the body's essence, and patients often have symptoms such as kidney yang deficiency and deficiency of essence and blood. Cynomys can warm and tonify kidney yang, and is a key drug for tonifying marrow and moistening dryness, assisting yang and benefiting yin. The kidney is the root of blood, and the spleen is the source of blood. Cynomys helps the kidney, so the kidney is strong and the essence is stored without leakage, the spleen and stomach are at ease, and the blood is generated. In addition, the whole prescription uses more cooling drugs to cool blood and nourish yin, and a few warming drugs, cold and warm together, less fire and yang and fire, which promotes the gradual growth of blood in patients with tumors, and is a medicine for the whole prescription.

[0021] Forsythia is bitter, slightly cold, lung, heart, small intestine, good at clearing heat and resolving toxins, and resolving and reducing swelling. "Materia Medica" said: "It is used for scrofula, carbuncle, sore, goiter, and heat." Forsythia is good at clearing heat and resolving toxins, and can stop disease transmission and resolve and reduce swelling. It is often combined with Huangqi and Shihu to clear heat and resolve toxins, and regulate blood. It can also help the blood on the basis of clearing heat and nourishing yin, so that the evil has an outlet, and promotes the external transmission of evil. Combined with Cynomys, one is warm and one is cold, cold and warm together, and is a medicine for the whole prescription.

[0022] The above traditional Chinese medicine composition takes Huangqi as the monarch, supplements qi and nourishes blood, supports healthy qi and consolidates the foundation to produce blood; Danggui is the minister, regulates qi and blood, promotes blood circulation to remove blood stasis, and also nourishes liver qi to contain blood; Shiwewe and Shihu add yin and blood to assist the source of blood production and transformation, Xianhecao converges and stops bleeding to treat the symptoms, Erythrina herb, Puhuang and Jucaibai break blood and expel stasis, detoxify and soften to treat the root. Luoyang consolidates the marrow and moisturizes dryness, helps yang and yin, nourishes the spleen to produce and transform the source; Lianqiao leads the whole prescription into the blood, and has the functions of detoxifying and dredging collaterals, nourishing blood and moisturizing marrow. The two have warm and cold properties, and are both drugs. It can also promote the external manifestation of evil, dredge qi and make evil have an outlet. According to the key pathogenesis of marrow consumption and stasis and toxin accumulation caused by thrombocytopenia due to tumor treatment, the invention treats the main contradiction of the pathogenesis, mainly supports healthy qi and consolidates the marrow, detoxifies and dredges collaterals, and also considers various treatment methods such as promoting qi, supplementing blood, nourishing yin, etc. The whole prescription takes care of the spleen and kidney, uses cold and warm herbs, attacks and supplements, and treats the symptoms and the root. It has the functions of supporting healthy qi and consolidating the marrow, detoxifying and dredging collaterals, and is especially suitable for patients with marrow consumption and stasis and toxin accumulation.

[0023] Further, exemplarily, the traditional Chinese medicine composition for treating thrombocytopenia due to tumor treatment in the application is prepared from the following raw medicinal materials by weight: 30 parts of raw Huangqi, 6 parts of Danggui, 15 parts of Shiwewe, 15 parts of Shihu, 15 parts of Xianhecao, 15 parts of Erythrina herb, 10 parts of raw Puhuang, 10 parts of Jucaibai, 10 parts of Lianqiao, and 10 parts of Luoyang.

[0024] Exemplarily, the traditional Chinese medicine composition for treating thrombocytopenia due to tumor treatment in the application is prepared from the following raw medicinal materials by weight: 30 parts of raw Huangqi, 6 parts of Danggui, 15 parts of Shiwewe, 15 parts of Shihu, 15 parts of Xianhecao, 15 parts of Erythrina herb, 15 parts of raw Puhuang, 10 parts of Jucaibai, 10 parts of Lianqiao, and 10 parts of Luoyang.

[0025] Exemplarily, the traditional Chinese medicine composition for treating thrombocytopenia due to tumor treatment in the application is prepared from the following raw medicinal materials by weight: 30 parts of raw Huangqi, 6 parts of Danggui, 15 parts of Shiwewe, 15 parts of Shihu, 15 parts of Xianhecao, 10 parts of Erythrina herb, 10 parts of raw Puhuang, 10 parts of Jucaibai, 10 parts of Lianqiao, and 15 parts of Luoyang.

[0026] Exemplarily, the traditional Chinese medicine composition for treating thrombocytopenia due to tumor treatment in the application is prepared from the following raw medicinal materials by weight: 30 parts of raw Huangqi, 6 parts of Danggui, 15 parts of Shiwewe, 15 parts of Shihu, 15 parts of Xianhecao, 10 parts of Erythrina herb, 10 parts of raw Puhuang, 10 parts of Jucaibai, 10 parts of Lianqiao, and 10 parts of Luoyang.

[0027] Exemplarily, the traditional Chinese medicine composition for treating thrombocytopenia due to tumor treatment in the application is prepared from the following raw medicinal materials by weight: 45 parts of raw Huangqi, 9 parts of Danggui, 18 parts of Shiwewe, 18 parts of Shihu, 18 parts of Xianhecao, 18 parts of Erythrina herb, 15 parts of raw Puhuang, 15 parts of Jucaibai, 15 parts of Lianqiao, and 15 parts of Luoyang.

[0028] Exemplarily, the traditional Chinese medicine composition for treating thrombocytopenia caused by tumor treatment includes the following raw medicines in parts by weight: 60 parts of raw astragalus, 9 parts of angelica, 20 parts of stonecrop, 20 parts of dendrobium, 20 parts of agrimony, 20 parts of madder, 15 parts of raw pollen, 15 parts of selaginella, 15 parts of forsythia, and 15 parts of cynomorium.

[0029] Exemplarily, the traditional Chinese medicine composition for treating thrombocytopenia caused by tumor treatment includes the following raw medicines in parts by weight: 30 parts of raw astragalus, 6 parts of angelica, 10 parts of stonecrop, 10 parts of dendrobium, 10 parts of agrimony, 10 parts of madder, 10 parts of raw pollen, 10 parts of selaginella, 9 parts of forsythia, and 10 parts of cynomorium.

[0030] The raw materials of the above-mentioned traditional Chinese medicine composition of the present invention constitute the basic formula. During specific implementation, the above-mentioned traditional Chinese medicine composition can be adjusted based on clinical symptoms to achieve the purpose of treating thrombocytopenia in tumor patients and improving certain other clinical symptoms of tumor patients, further enhancing the adaptability of the present composition and improving the therapeutic effect. These adjustments based on the basic formula of the present invention are also within the scope of protection of this application.

[0031] In a second aspect, the present invention provides a traditional Chinese medicine preparation for treating thrombocytopenia caused by tumor treatment, wherein the raw materials of the traditional Chinese medicine preparation include the above-mentioned traditional Chinese medicine composition.

[0032] According to actual needs, the Chinese medicine preparation may further include pharmaceutically acceptable excipients and may be prepared into various preparations such as decoctions, granules, pills, capsules, tablets, powders, oral liquids and the like according to conventional preparation processes.

[0033] In a third aspect, the present invention also provides the use of the above-mentioned Chinese medicine composition and Chinese medicine preparation in the preparation of a drug for treating thrombocytopenia caused by tumor treatment.

[0034] In addition, unless otherwise specified, the raw materials of the Chinese medicine composition of the present invention can be obtained commercially, and any range recorded in the present invention, including the end values ​​and any numerical values ​​between the end values, and any sub-range of Chinese medicine compositions composed of the end values ​​or any numerical values ​​between the end values, can achieve the purpose of treating thrombocytopenia caused by tumor treatment.

[0035] The beneficial effects of the present invention are as follows:

[0036] The traditional Chinese medicine composition is verified by clinical tests, aims at supporting healthy energy, benefiting marrow, detoxifying and dredging collaterals, has certain advantages in promoting the rehabilitation of patients with thrombocytopenia caused by tumor treatment, and has good drug safety. In addition, the traditional Chinese medicine composition of the application is formulated by combining disease and syndrome on the basis of traditional syndrome differentiation and treatment, combined with modern pharmacological research of traditional Chinese medicine. The core treatment advantage is that it can significantly and rapidly increase the number of platelets of tumor patients, and the curative effect is not significantly affected by tumor stage or the severity of thrombocytopenia. In addition, the traditional Chinese medicine composition shows significant effect on tumor patients with different tumor stages and different degrees of thrombocytopenia, which indicates that the traditional Chinese medicine composition has a broad-spectrum effect of increasing platelets, can effectively improve the hematological indexes of tumor patients, promote rehabilitation, and has significant clinical value. DETAILED DESCRIPTION

[0037] In order to more clearly illustrate the present application, the present application will be further described below in conjunction with preferred embodiments. Those skilled in the art should understand that the specific description below is illustrative rather than limiting, and should not limit the scope of protection of the present application.

[0038] Example 1

[0039] A traditional Chinese medicine composition for thrombocytopenia caused by tumor treatment is made of the following raw medicinal materials: 30g of raw astragalus, 6g of angelica, 15g of stone fern, 15g of dendrobium, 15g of herbaceous bamboo, 15g of madder, 10g of raw safflower, 10g of stonecrop, 10g of forsythia and 10g of cynomorium.

[0040] Example 2

[0041] A traditional Chinese medicine composition for thrombocytopenia caused by tumor treatment is made of the following raw medicinal materials: 45g of raw astragalus, 9g of angelica, 18g of stone fern, 18g of dendrobium, 18g of herbaceous bamboo, 18g of madder, 15g of raw safflower, 15g of stonecrop, 15g of forsythia and 15g of cynomorium.

[0042] Example 3

[0043] A traditional Chinese medicine composition for thrombocytopenia caused by tumor treatment is made of the following raw medicinal materials: 60g of raw astragalus, 9g of angelica, 20g of stone fern, 20g of dendrobium, 20g of herbaceous bamboo, 20g of madder, 15g of raw safflower, 15g of stonecrop, 15g of forsythia and 15g of cynomorium.

[0044] Example 4

[0045] A traditional Chinese medicine composition for treating thrombocytopenia caused by tumor treatment, which is made of the following raw medicinal materials: 30 g of raw astragalus, 6 g of angelica, 10 g of pyrrosia lingii, 10 g of dendrobium, 10 g of herba potentillae discolor, 10 g of madder, 10 g of raw safflower, 10 g of selaginella, 9 g of forsythia, and 10 g of cusparia.

[0046] Example 5: Hematological index improvement of traditional Chinese medicine intervention in patients with malignant tumor and platelet reduction

[0047] 1. Study design

[0048] From August 2024 to March 2025, 30 patients with platelet reduction of malignant tumor treated by traditional Chinese medicine in the Department of Oncology of Guang'anmen Hospital of China Academy of Chinese Medical Sciences were enrolled. According to the AJCC 8th edition of tumor TNM staging, 23 males and 7 females, aged 61.00 (56.75, 67.25) years old. All patients had completed adjuvant therapy of western medicine and the platelet level was lower than the World Health Organization classification standard (<100×10 9 g / L). After ≥4 weeks of standard treatment (including TPO receptor agonists, thrombopoietin, etc.), the efficacy was poor, and patients with other blood system diseases and severe liver and kidney function abnormalities were excluded. The traditional Chinese medicine composition was made into decoction, 1 dose per day, taken orally twice a day, and the platelet changes at 4 and 8 weeks after continuous treatment for 8 weeks were evaluated.

[0049] 2. Research criteria

[0050] (1) Platelet detection index

[0051] Platelet (PLT): platelet value at enrollment, 4 and 8 weeks after traditional Chinese medicine intervention.

[0052] (2) Statistical method

[0053] Baseline data analysis: frequency table, percentage or constituent ratio for basic statistical description of count data, mean (Mean) ± standard deviation (Standard Deviation, SD) for normally distributed measurement data, and median and quartile (P75, P25) for non-normally distributed data;

[0054] Intra-group comparison: paired sample t-test for normally distributed measurement data; non-parametric test (such as Wilcoxon signed rank test) for non-normally distributed measurement data, with α=0.05 as the test level, P>0.05 indicating no statistically significant difference.

[0055] Group comparison: For normally distributed measurement data, group t test was used for comparison between two groups, and ANOVA was used for comparison among multiple groups, and further pairwise comparison was performed using Tukey test. For non-normally distributed measurement data, Mann-Whitney U test was used for comparison between two groups, and Kruskal-Wallis H test was used for comparison among multiple groups, and further pairwise comparison was performed using Dunn test. The test level was set at α=0.05, and P>0.05 was considered to have no statistically significant difference.

[0056] 3. Research results

[0057] (1) Baseline data

[0058] A total of 30 patients with thrombocytopenia due to malignant tumors treated with traditional Chinese medicine in our department from August 2024 to March 2025 were included (see Table 1).

[0059] Table 1 Baseline data of included patients

[0060]

[0061] WHO thrombocytopenia classification: Grade I: blood platelet normal value lower limit-≥75×10 9 g / L; Grade II: blood platelet 50×10 9 g / L-74×10 9 g / L; Grade III: blood platelet 25×10 9 g / L-49×10 9 g / L; Grade IV: blood platelet <25×10 9 g / L.

[0062] (2) Changes in platelet indicators

[0063] After 4 weeks of treatment, the patient's platelet count increased significantly, with a pre-treatment platelet count of 79.50 (64.75, 93.50) ×10 9 g / L and a post-treatment platelet count of 110.00 (87.00, 128.25) ×10 9 g / L. The non-parametric test result was Z=-4.50, P<0.001, and the difference was statistically significant (see Table 2). Further analysis showed that the platelet count of patients with different stages of tumors increased after treatment, especially for patients with stage II and III malignant tumors, the platelet count increased significantly, and there was no significant difference in treatment efficacy between patients with different stages, and all patients could get good efficacy (see Tables 3-1 and 3-2). In addition, based on the "WHO thrombocytopenia classification" to determine the platelet classification of patients at baseline, the platelet count of patients with different classifications increased after treatment, especially for patients with grade I and II, the platelet count increased significantly, and there was no significant difference in treatment efficacy between patients with different classifications, and all patients could get good efficacy (see Tables 4-1 and 4-2).

[0064] Table 2 Changes of platelet count in patients before and after treatment (4 weeks)

[0065]

[0066] Table 3-1 Changes of platelet count in patients with different tumor stages before and after treatment (4 weeks)

[0067]

[0068] Table 3-2 Differences of platelet count between groups in patients with different tumor stages before and after treatment (4 weeks)

[0069]

[0070] Table 4-1 Changes of platelet count based on "WHO platelet reduction classification" (4 weeks)

[0071]

[0072] Table 4-2 Differences of platelet count between groups based on "WHO platelet reduction classification" (4 weeks)

[0073]

[0074] After 8 weeks of treatment, the platelet count of patients increased significantly, with a baseline platelet count of 79.50 (64.75, 93.50) x 10 9 g / L and a post-treatment platelet count of 122.50 (94.75, 146.75) x 10 9 g / L. The non-parametric test result was Z = -4.72, P < 0.001, and the difference was statistically significant (see Table 5). Further analysis showed that the platelet count of patients with different tumor stages increased after treatment, especially for patients with stage II and III malignant tumors, the platelet count increased significantly, and there was no significant difference in treatment efficacy between patients with different stages, and all patients could get good efficacy (see Tables 6-1 and 6-2). In addition, based on the "WHO platelet reduction classification", the platelet classification of patients at baseline was determined, and the platelet count of patients in different classifications increased after treatment, especially for patients with grade I and II, the platelet count increased significantly, and there was no significant difference in treatment efficacy between patients in different classifications, and all patients could get good efficacy (see Tables 7-1 and 7-2).

[0075] Table 5 Changes of platelet count in patients before and after treatment (8 weeks)

[0076]

[0077] Table 6-1 Changes of platelet count in patients with different tumor stages before and after treatment (8 weeks)

[0078]

[0079] Table 6-2 Differences in platelet count between groups before and after treatment (8 weeks) for patients with different tumor stages

[0080]

[0081] Table 7-1 Changes in platelet count based on "WHO platelet reduction classification" (8 weeks)

[0082]

[0083] Table 7-2 Differences in platelets between groups based on "WHO platelet reduction classification" (8 weeks)

[0084]

[0085] 4. Conclusion

[0086] The traditional Chinese medicine composition in the present application can significantly improve the platelet levels of patients with multiple cancers, different stages, and different platelet reduction classifications (P<0.05). This result suggests that the traditional Chinese medicine composition can effectively correct platelet reduction in tumor patients and promote patient recovery, and has clinical value.

[0087] Example 6 Typical cases and efficacy:

[0088] Case 1: Postoperative chemotherapy of intestinal cancer secondary to thrombocytopenia

[0089] Yao, male, 42 years old. Initial diagnosis on December 10, 2024. The patient underwent left hemicolectomy in October 2023, and the postoperative pathology showed tubular adenocarcinoma. Pathological stage: PT4aN1M0, stage III. After surgery, the patient received XELOX regimen for 8 cycles. Symptoms: clear consciousness, subjective muscle weakness, joint pain, poor appetite, poor sleep, and frequent dreams. Stool is adjusted, occasional intestinal rumbling and gas, 2-3 times of nocturia. Pale red tongue, white and thick greasy fur, slippery pulse. Blood routine showed (2024-12-6): PLT: 73 x 10 9 g / L. Western medicine diagnosis: postoperative colon malignant tumor, thrombocytopenia. TCM diagnosis: intestinal fungus, differentiated as deficiency of the spleen and marrow consumption, and mutual knotting of blood stasis and toxin. Treatment: tonifying the spleen and marrow, resolving toxin and dredging collaterals.

[0090] Prescription: Radix Astragali 30g, Angelica 6g, Pyrrosia 15g, Dendrobium 15g, Agrimony 15g, Madder 15g, Fresh Pulsatilla (bagged and decocted) 15g, Selaginella 10g, Forsythia 10g, Cynomorium 10g, Cherry Fruit 15g, Ficus 15g, Cyathula 15g. Total 28 doses, 1 dose per day, decocted with water, taken in the morning and evening.

[0091] Second visit: physical strength improved significantly, increased, sleep improved, two sides adjusted, no other discomfort. Blood routine showed (2025-1-9): PLT: 102×10 9 g / L, continue to take the upper part.

[0092] Third visit: belching disappeared, occasional intestinal rumbling. Can eat, sleep improved, difficulty falling asleep disappeared, joint pain improved, two sides adjusted. Tongue dark red with tooth marks, thick and greasy moss, pulse string. Blood routine showed (2025-4-16): PLT: 104×10 9 g / L. The patient was followed up in the outpatient department after the prescription was added and subtracted, and the quality of life improved significantly.

[0093] Case two: treatment of postoperative thrombocytopenia in liver cancer

[0094] Song, male, 66 years old, first visit on April 2, 2025. Partial hepatectomy + cholecystectomy on November 8, 2022, postoperative pathology: (right liver) hepatocellular carcinoma, immunohistochemical results: Ki67 (10% +), P53 (-), AFP (-), EGFR (+), VEGF (+), HepPar (focal +). Recovered well after surgery, did not undergo chemotherapy. He has had chronic hepatitis B for more than 30 years and has been diagnosed with cirrhosis for more than 2 years. Current symptoms: occasional tinnitus and blurred vision, sleep is acceptable, dreams are common. Night urine 3 times, can eat, defecate 2 times a day, texture is dry. Tongue is pale and dark, thin yellow moss, edge has tooth marks, pulse string. Blood routine showed (2025-3-26): PLT: 75×10 g / L. Western medicine diagnosis: liver malignancy, thrombocytopenia; TCM diagnosis: liver accumulation, deficiency of the spleen, marrow consumption, and mutual knotting of blood stasis and toxin. TCM therapy: tonifying the spleen and marrow, detoxifying and dredging the collaterals. Prescription: raw Huangqi 30g, Danggui 6g, Shivei 15g, Shihach 15g, Xianhecao 15g, Qiancao 10g, raw Puhuang (bag decoction) 10g, Juanchai 10g, Lianqiao 10g, Suoyang 15g, Chishao 15g, Lingxiaohua 15g.

[0095] Second visit, the patient complained of improved physical strength, can eat, sleep improved, still occasional tinnitus and blurred vision, two sides adjusted, no other significant discomfort, blood routine showed (2025-4-28): PLT: 101×10 9 g / L. The patient was followed up in the outpatient department after the prescription was added and subtracted, and the quality of life improved significantly.

[0096] Case three: secondary thrombocytopenia after postoperative chemotherapy of gastric cancer

[0097] Zhu, female, 56 years old. Initial diagnosis on August 28, 2024. The patient underwent subtotal gastrectomy for gastric malignancy in April 2023, and the pathology showed: flat low differentiated adenocarcinoma with a small amount of signet ring cell carcinoma, infiltrating to the subserosal layer. Pathological stage: PT3N0Mx. After surgery, the patient received SOX regimen for 4 cycles, and S-1 monotherapy for 4 cycles. The patient stopped chemotherapy due to decreased platelets during chemotherapy. The last chemotherapy time was December 28, 2023. Current symptoms: general appetite, acid reflux when eating greasy food, occasional abdominal distension and discomfort. Frequent belching, with bowel sounds. Dry mouth and bitter taste at night, poor sleep, frequent dreams, easy to wake up, difficult to fall asleep again after waking up. One stool per day, sticky in texture, urine is normal. The patient feels less energetic, both feet are cold, and the whole body is cold. Dark red tongue with tooth marks, thin white fur, cracks, wiry pulse. Blood routine (2024-8-27): platelets: 30 x 10 9 g / L. Western medicine diagnosis: postoperative gastric malignancy, thrombocytopenia. TCM diagnosis: stomach accumulation, differentiated as deficiency of the spleen and marrow consumption, and mutual knotting of blood stasis and toxin. Treatment: tonifying the spleen and marrow, detoxifying and dredging collaterals.

[0098] Prescription: raw astragalus 30g, angelica 6g, stoneve 15g, dendrobium 15g, xianhecao 15g, madder 10g, raw ephedra (bagging) 10g, sellaginella 10g, forsythia 10g, cynomorium 10g, white pyrethrum 10g, albizia 15g, gancao 10g, morindae 15g. 14 doses, 1 dose per day, decocted with water, taken in the morning and evening.

[0099] Follow-up: The patient's energy has improved significantly, appetite has improved, sleep has improved, and bowel and bladder function is normal. Recheck blood routine (24-10-28): PLT: 81 x 10 9 g / L. After that, the patient was followed up in the outpatient clinic, and the symptoms improved significantly, the quality of life improved significantly, and the number of platelets continued to increase.

[0100] Obviously, the above embodiments of the present application are only examples for clearly illustrating the present application, and are not a limitation on the embodiments of the present application. For ordinary skilled persons in the art, other different forms of changes or variations can be made on the basis of the above description, and it is impossible to enumerate all the embodiments here. Any obvious changes or variations derived from the technical solutions of the present application still fall within the protection scope of the present application.

Claims

1. A Chinese medicine composition for treating thrombocytopenia caused by tumor treatment, characterized in that: The traditional Chinese medicine composition comprises the following raw materials: raw astragalus, angelica, pyrrosia, dendrobium, agrimony, madder, raw pollen, selaginella, forsythia, and cynomorium songaricum.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition comprises the following raw medicines in parts by weight: 30 to 60 parts of raw astragalus, 6 to 9 parts of angelica, 10 to 20 parts of pyrrosia, 10 to 20 parts of dendrobium, 10 to 20 parts of agrimony, 10 to 20 parts of madder, 10 to 15 parts of raw pollen, 10 to 15 parts of selaginella, 9 to 15 parts of forsythia, and 10 to 15 parts of cynomorium.

3. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition comprises the following raw medicines in parts by weight: 30 parts of raw astragalus, 6 parts of angelica, 15 parts of pyrrosia, 15 parts of dendrobium, 15 parts of agrimony, 15 parts of madder, 10 parts of raw pollen, 10 parts of selaginella, 10 parts of forsythia, and 10 parts of cynomorium; Alternatively, 30 parts of raw Astragalus, 6 parts of Chinese Angelica, 15 parts of Pyrrosia, 15 parts of Dendrobium, 15 parts of Agrimoniae, 15 parts of Rubia cordifolia, 15 parts of raw Pollen Typhae, 10 parts of Selaginella, 10 parts of Forsythia, and 10 parts of Cynomorium songaricum; Alternatively, 30 parts of raw Astragalus, 6 parts of Chinese Angelica, 15 parts of Pyrrosia, 15 parts of Dendrobium, 15 parts of Agrimoniae, 10 parts of Rubia cordifolia, 10 parts of raw Pollen Typhae, 10 parts of Selaginella, 10 parts of Forsythia, and 15 parts of Cynomorium songaricum; Alternatively, 30 parts of raw astragalus, 6 parts of angelica, 15 parts of stonewort, 15 parts of dendrobium, 15 parts of agrimony, 10 parts of madder, 10 parts of raw pollen, 10 parts of selaginella, 10 parts of forsythia, and 10 parts of cynomorium.

4. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition comprises the following raw medicines in parts by weight: 45 parts of raw astragalus, 9 parts of angelica, 18 parts of pyrrosia, 18 parts of dendrobium, 18 parts of agrimony, 18 parts of madder, 15 parts of raw pollen, 15 parts of selaginella, 15 parts of forsythia, and 15 parts of cynomorium.

5. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition comprises the following raw medicines in parts by weight: 60 parts of raw astragalus, 9 parts of angelica, 20 parts of pyrrosia, 20 parts of dendrobium, 20 parts of agrimony, 20 parts of madder, 15 parts of raw pollen, 15 parts of selaginella, 15 parts of forsythia, and 15 parts of cynomorium.

6. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition comprises the following raw medicines in parts by weight: 30 parts of raw astragalus, 6 parts of angelica, 10 parts of pyrrosia, 10 parts of dendrobium, 10 parts of agrimony, 10 parts of madder, 10 parts of raw pollen, 10 parts of selaginella, 9 parts of forsythia, and 10 parts of cynomorium.

7. A traditional Chinese medicine preparation for treating thrombocytopenia caused by tumor treatment, characterized in that: The raw materials of the traditional Chinese medicine preparation include the traditional Chinese medicine composition according to any one of claims 1 to 6.

8. The Chinese medicine preparation according to claim 7, characterized in that The raw materials of the traditional Chinese medicine preparation also include pharmaceutically acceptable excipients.

9. The Chinese medicine preparation according to claim 7 or 8, characterized in that The dosage forms of the traditional Chinese medicine preparation include decoction, tablets, granules, pills, powders, capsules or powders.

10. Use of the traditional Chinese medicine composition according to any one of claims 1 to 6 or the traditional Chinese medicine preparation according to any one of claims 7 to 8 in the preparation of a medicament for treating thrombocytopenia caused by tumor treatment.

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