Traditional Chinese medicine composition for treating stomach cancer postoperative anemia and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for treating gastric cancer postoperative anemia and application thereof. The traditional Chinese medicine composition is prepared from the following raw material medicines: raw astragalus membranaceus, angelica sinensis, codonopsis pilosula, curcuma zedoary, ruddle, semen cuscutae, raw pollen typhae and silkworm excrement. The traditional Chinese medicine composition is scientific and reasonable in formula, has the effects of invigorating spleen and reinforcing stomach, reinforcing qi and nourishing blood, and strengthening body resistance and detoxifying, and has the advantages of promoting hematology index recovery of patients with gastric cancer postoperative anemia, improving clinical symptoms, improving life quality and the like.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine. More specifically, it relates to a traditional Chinese medicine composition for the treatment of anemia after gastric cancer surgery and its application. Background Technology

[0002] Currently, gastric cancer prevention and control strategies focus on eradicating Helicobacter pylori (Hp) infection and endoscopic screening of high-risk groups. However, due to the insidious nature of early symptoms and insufficient screening coverage, approximately 60%-70% of patients are already in the middle or late stages at initial diagnosis, resulting in a poor overall prognosis and a 5-year survival rate of only 35.1%. Surgical resection is a radical treatment for early and mid-stage gastric cancer, and postoperative complication management has become a clinical priority. Clinical studies show that anemia is a common complication after gastric cancer surgery, with an incidence rate as high as 61.4%. The pathogenesis is mainly attributed to iron absorption disorders caused by changes in the gastrointestinal anatomy after gastric cancer surgery. In addition, intraoperative blood loss can directly lead to a decrease in hemoglobin levels, and coupled with long-term insufficient nutritional intake caused by postoperative gastric digestive dysfunction, the combined effect exacerbates the degree of anemia. Postoperative anemia after gastric cancer surgery is not only a common clinical complication but also an independent risk factor affecting treatment efficacy and long-term prognosis. Anemia can cause symptoms mainly characterized by fatigue and palpitations, and some patients may also experience cognitive abnormalities such as decreased attention and slowed cognition, seriously affecting their quality of life. Meanwhile, anemia may also increase the risk of postoperative complications such as anastomotic leakage and thrombosis, reduce tolerance to chemotherapy, targeted therapy, and immunotherapy, affect treatment efficacy, seriously impact patient survival prognosis, and increase their overall mortality risk.

[0003] Furthermore, modern medicine has shortcomings in managing anemia after gastric cancer surgery, lacking effective treatment methods. Currently, anemia treatment mainly relies on blood transfusions, the use of erythropoietin (EPO) drugs, and supplementation of hematopoietic raw materials (iron, folic acid, vitamin B12). However, these treatment options have many limitations, such as causing adverse reactions like allergies and infections, and having a slow onset of action.

[0004] Therefore, promoting rapid recovery of patients after gastric cancer surgery, increasing hemoglobin levels, and improving quality of life are important issues and research priorities in current clinical practice. Summary of the Invention

[0005] One objective of this invention is to provide a traditional Chinese medicine composition for the treatment of anemia after gastric cancer surgery. This composition can treat patients with anemia after gastric cancer surgery who have spleen and stomach deficiency, qi and blood imbalance, and residual toxins, and can increase the hemoglobin content after gastric cancer surgery.

[0006] Another object of the present invention is to provide a traditional Chinese medicine preparation comprising the above-mentioned traditional Chinese medicine composition.

[0007] Another object of the present invention is to provide the use of the above-mentioned traditional Chinese medicine composition or preparation in the preparation of a medicament for the treatment of anemia after gastric cancer surgery.

[0008] To achieve the above objectives, the present invention adopts the following technical solution:

[0009] In a first aspect, the present invention provides a traditional Chinese medicine composition for the treatment of postoperative anemia in gastric cancer patients, comprising the following raw materials: raw astragalus, angelica, codonopsis, turmeric, hematite, cuscuta, raw cattail pollen, and silkworm excrement.

[0010] Furthermore, the traditional Chinese medicine composition of the present invention is made from the following raw materials in parts by weight: 30-60 parts raw Astragalus membranaceus, 6-9 parts Angelica sinensis, 15-30 parts Codonopsis pilosula, 9-15 parts Curcuma zedoaria, 15-30 parts hematite, 10-15 parts Cuscuta chinensis, 10-15 parts raw Typha orientalis, and 10-15 parts silkworm excrement.

[0011] Traditional Chinese medicine (TCM) believes that tumor-related anemia is mostly attributed to deficiency of Qi and blood. Therefore, the basic treatment principle in clinical practice is to replenish Qi and blood, often using formulas such as Gui Pi Tang and Ba Zhen Tang. However, the core pathogenesis of anemia after gastric cancer surgery lies in the damage to the middle Jiao (middle burner) caused by surgery, which not only directly depletes Qi and blood but also weakens the spleen and stomach's digestive function, leading to postoperative digestive dysfunction and impaired hemoglobin synthesis. Previous TCM treatments have lacked attention to the pathogenesis of "Qi and blood imbalance and residual toxins causing deficiency" after gastric cancer surgery. Therefore, based on clinical practice, this invention proposes that the core pathogenesis of post-gastric cancer anemia, especially the reduction in hemoglobin, is based on spleen and stomach deficiency, manifested as Qi and blood imbalance, and characterized by unresolved residual toxins. Based on this, the main treatment principles are: strengthening the spleen and stomach to replenish Qi, nourishing Qi and blood to support the body's resistance, and supporting the body's resistance and detoxifying to clear residual toxins. In this invention, Astragalus membranaceus, Angelica sinensis, and Codonopsis pilosula promote qi and blood circulation, and remove blood stasis. Curcuma zedoaria and Typha pollen are added to break up blood stasis, detoxify, and soften hardened masses. Cuscuta chinensis nourishes the kidneys and replenishes essence to address the root cause. Hematite and silkworm excrement are used as guiding herbs to direct the entire formula into the stomach meridian, achieving the combined effects of tonifying qi and blood, detoxifying, and removing blood stasis. The entire formula harmonizes qi and blood, tonifying while simultaneously attacking, treating both the symptoms and the root cause. It has the functions of strengthening the spleen and stomach, tonifying qi and blood, supporting the body's resistance, and detoxifying. It is especially suitable for anemic patients after gastric cancer surgery who suffer from spleen and stomach deficiency, qi and blood imbalance, and lingering toxins, providing a new TCM treatment strategy for the management of anemia patients after gastric cancer surgery.

[0012] In this invention, Astragalus membranaceus, sweet in taste and slightly warm in nature, enters the spleen and lung meridians. Its functions include tonifying qi and raising yang, strengthening the defensive qi and consolidating the exterior, tonifying qi and promoting detoxification, and promoting diuresis and reducing swelling. It is known as the "holy medicine for tonifying qi." Listed as a superior herb in the *Shennong Bencao Jing* (Shennong's Classic of Materia Medica), it is widely used clinically for symptoms such as qi deficiency, fatigue, and poor appetite. The *Bencao Xinbian* (New Compilation of Materia Medica) states: "Astragalus membranaceus is a holy medicine for tonifying qi… Tangible blood cannot be quickly generated; it must be generated by intangible qi." Astragalus membranaceus excels at tonifying intangible qi to generate tangible blood, making it an essential medicine for supporting the body's resistance, tonifying qi and nourishing blood. It is especially suitable for patients with qi and blood deficiency and depletion of vital energy after gastric cancer surgery, and is the principal herb in the entire formula.

[0013] Angelica sinensis, sweet and pungent in taste, warm in nature, and enters the liver and spleen meridians, is known as the "holy medicine of blood." Its main functions are to nourish and invigorate blood, regulate menstruation, and relieve pain. It effectively nourishes blood without causing stagnation and promotes blood circulation without harming it. The *Yilin Zuanyao* states, "Its qi is clear, nourishing blood while promoting qi circulation; its flavor is strong, promoting qi circulation while nourishing blood." Angelica sinensis is characterized by its clear yang and heavy yin, its ascending and descending properties, and its ability to regulate both qi and blood, making it particularly suitable for blood deficiency with blood stasis and poor qi and blood circulation. Combined with Astragalus membranaceus, it forms the Dang Gui Bu Xue Tang (Angelica Blood-Nourishing Decoction). Li Dongyuan, in his *Bianhuo Lun* (Treatise on Differentiation of Internal and External Injuries), proposed that Dang Gui Bu Xue Tang can be widely used for qi and blood deficiency, weakness of qi and blood deficiency, and is an important formula for regulating qi and blood and replenishing vital energy in cancer patients, serving as the assistant herb in the entire formula.

[0014] Codonopsis pilosula, sweet in taste and neutral in nature, enters the spleen and lung meridians. Its functions include tonifying the middle energizer and replenishing qi, strengthening the spleen and stomach, and generating fluids and nourishing blood. It is mainly used to treat spleen and lung qi deficiency, qi and blood deficiency, and qi and fluid depletion. Numerous studies have proven that this herb, guided by tonifying the spleen and regulating the stomach and based on replenishing qi and generating fluids, can protect gastrointestinal function and promote the generation of acquired qi and blood. The *Ben Cao Zheng Yi* states that it "strengthens the spleen without causing dryness, nourishes stomach yin without causing dampness, moistens the lungs without causing coldness, nourishes blood without being overly greasy, invigorates clear yang, and stimulates the middle energizer without causing dryness." Codonopsis pilosula is mild and gentle, able to tonify the middle energizer to strengthen the spleen and stomach, and nourish stomach yin without promoting dampness, making it an essential herb for treating general weakness. Modern pharmacological studies show that it plays an important role in regulating immunity and improving gastrointestinal inflammation, making it suitable for spleen and stomach weakness, qi deficiency with spontaneous sweating, fatigue, and blood deficiency, serving as an assistant herb in many prescriptions.

[0015] Curcuma zedoaria, bitter and pungent in taste, warm in nature, enters the liver and spleen meridians. Its functions include promoting qi circulation, breaking up blood stasis, eliminating masses, and relieving pain, making it a "key medicine for breaking up blood stasis." The *Compendium of Materia Medica* states, "Curcuma zedoaria enters the blood aspect of the liver meridian, breaking up blood stasis within the qi." Its effects of breaking up blood stasis and dispersing masses are particularly suitable for patients with gastric cancer of the type with internal accumulation of blood stasis and qi stagnation and blood stasis. By breaking up blood stasis and eliminating masses, it improves symptoms such as abdominal pain and abdominal masses in gastric cancer patients, and also achieves the effects of removing blood stasis, stopping bleeding, and promoting blood production, serving as an adjuvant medicine in the entire formula.

[0016] Cattail pollen, sweet in taste and neutral in nature, enters the liver and pericardium meridians. Its functions include cooling the blood and stopping bleeding, promoting blood circulation and removing blood stasis. The *Compendium of Materia Medica* states: "When used raw, it is cooling in nature, promoting blood circulation and removing blood stasis; when stir-fried, it is astringent in taste, regulating blood and stopping bleeding." Cattail pollen can both promote blood circulation and remove blood stasis, and stop bleeding without leaving blood stasis. It is not only suitable for gastric cancer patients with bleeding due to blood stasis and extravasation, but also effective in treating abdominal pain associated with gastric cancer. It is an essential medicine for promoting blood circulation, relieving pain, removing blood stasis, and promoting new blood production, and serves as an adjuvant in the overall prescription.

[0017] Cuscuta seed, with a pungent and sweet taste and neutral nature, enters the liver, kidney, and spleen meridians. Its main functions are to tonify the kidneys and replenish essence, nourish the liver and improve eyesight. The *Shennong Bencao Jing* records that it "treats injuries, replenishes deficiencies, strengthens qi and energy, and promotes robust health." The *Bencao Huiyan* states that it can "tonify the kidneys and nourish the liver, warm the spleen and assist the stomach." Cuscuta seed enters the kidney meridian, making it particularly suitable for blood deficiency, chlorosis, dizziness, and tinnitus caused by kidney essence deficiency. It also enters the spleen meridian, strengthening the middle jiao to support the production of qi and blood, making it an essential medicine for tonifying the spleen and kidneys, replenishing essence and generating blood. Modern research shows that it is rich in flavonoids, polysaccharides, and trace elements such as iron and zinc, and can improve anemia by activating the proliferation and differentiation of hematopoietic stem cells and promoting erythropoietin secretion. It can be combined with Angelica sinensis to replenish essence and blood, or with Codonopsis pilosula to strengthen the spleen and generate blood, exerting a synergistic effect of "benefiting fire and generating earth, and the mutual transformation of essence and blood" in the overall formula.

[0018] Hematite, bitter and sweet in taste, cold in nature, enters the liver, stomach, and heart meridians. Its functions include calming the liver and suppressing yang, sedating and descending rebellious qi, cooling the blood and stopping bleeding. The *Bielu* records that it "nourishes blood and qi, removes heat from the blood vessels of the five internal organs, treats blood stasis and blood obstruction." The *Bencao Zaixin* states that it can "treat blood stasis and promote new blood production." Hematite enters the stomach meridian and is effective for vomiting and esophageal obstruction caused by qi stagnation in patients with malignant gastric tumors. It also effectively enters the blood, cooling the blood and stopping bleeding to nourish blood and qi, making it a commonly used drug for harmonizing qi and blood and descending rebellious qi. Modern medicine shows that its main chemical component is ferric oxide, which can be decomposed through the gastrointestinal mucosa to form ferrous ions, thereby promoting hemoglobin synthesis. Hematite is often combined with qi-tonifying herbs such as Codonopsis pilosula and Astragalus membranaceus, which can indirectly promote iron absorption by improving spleen and stomach function, making it a key ingredient in many prescriptions.

[0019] Silkworm excrement, sweet and pungent in taste, warm in nature, enters the liver, spleen, and stomach meridians. Its functions include dispelling wind and dampness, promoting blood circulation, and relieving pain. The *Ben Cao Zai Xin* states that it is also suitable for treating blood stasis and deficiency. Silkworm excrement is particularly suitable for cancer patients with dampness obstructing the meridians, qi and blood stagnation, and blood stasis and deficiency, and is often used to treat postoperative blood stasis in cancer patients. Its effective extract is organic iron, which can indirectly supplement hemoglobin levels. Furthermore, silkworm excrement has bone marrow hematopoietic stimulation and antioxidant protective functions, and is effective in improving iron-deficiency anemia, making it a key ingredient in many prescriptions.

[0020] In summary, the herbal composition of this invention uses Astragalus membranaceus as the principal ingredient to replenish qi and blood, strengthen the body's resistance, and promote blood production. Angelica sinensis and Codonopsis pilosula are the assistant ingredients to promote qi and blood circulation, remove blood stasis, strengthen the spleen and stomach to nourish blood. Curcuma zedoaria and Typha pollen are used as adjuvant ingredients to break up blood stasis, detoxify, and soften hardened masses, while Cuscuta chinensis nourishes the kidneys and replenishes essence to address the root cause. Hematite and silkworm excrement are used as guiding ingredients to enter the stomach meridian, working together to replenish qi and blood, detoxify, and remove blood stasis. The entire formula harmonizes qi and blood, combining tonification with purgation, treating both the symptoms and the root cause. It has the functions of strengthening the spleen and stomach, replenishing qi and blood, strengthening the body's resistance, and detoxifying. It is especially suitable for anemic patients who have undergone gastric cancer surgery and suffer from spleen and stomach deficiency, qi and blood imbalance, and lingering toxins.

[0021] Furthermore, by way of example, the traditional Chinese medicine composition of the present invention is made from the following raw materials in parts by weight: 30 parts raw Astragalus membranaceus, 6 parts Angelica sinensis, 15 parts Codonopsis pilosula, 9 parts Curcuma zedoaria, 15 parts hematite, 15 parts Cuscuta chinensis, 10 parts raw Typha orientalis, and 15 parts silkworm excrement.

[0022] For example, the traditional Chinese medicine composition of the present invention is made from the following raw materials in parts by weight: 45 parts raw Astragalus membranaceus, 6 parts Angelica sinensis, 15 parts Codonopsis pilosula, 10 parts Curcuma zedoaria, 20 parts hematite, 15 parts Cuscuta chinensis, 15 parts raw Typha orientalis, and 15 parts silkworm excrement.

[0023] For example, the traditional Chinese medicine composition of the present invention is made from the following raw materials in parts by weight: 60 parts raw Astragalus membranaceus, 9 parts Angelica sinensis, 30 parts Codonopsis pilosula, 10 parts Curcuma zedoaria, 30 parts hematite, 15 parts Cuscuta chinensis, 15 parts raw Typha pollen, and 15 parts silkworm excrement.

[0024] For example, the traditional Chinese medicine composition of the present invention is made from the following raw materials in parts by weight: 30 parts raw Astragalus membranaceus, 6 parts Angelica sinensis, 15 parts Codonopsis pilosula, 10 parts Curcuma zedoaria, 15 parts hematite, 10 parts Cuscuta chinensis, 15 parts raw Typha pollen, and 15 parts silkworm excrement.

[0025] For example, the traditional Chinese medicine composition of the present invention is made from the following raw materials in parts by weight: 30 parts raw Astragalus membranaceus, 6 parts Angelica sinensis, 15 parts Codonopsis pilosula, 10 parts Curcuma zedoaria, 15 parts hematite, 10 parts Cuscuta chinensis, 15 parts raw Typha orientalis, and 10 parts silkworm excrement.

[0026] From the perspective of formulation principles, the herbal composition of this invention addresses the disease, syndrome, and symptoms simultaneously, aiming to alleviate anemia symptoms in patients with post-gastric cancer surgery suffering from spleen and stomach deficiency, qi and blood imbalance, and lingering toxins. It serves as a core prescription for diagnosing anemia after gastric cancer surgery. Clinically, when used according to syndrome differentiation, it has the effects of strengthening the spleen and stomach, replenishing qi and blood, and supporting healthy qi and detoxifying. It not only promotes hemoglobin production but also facilitates the recovery of gastrointestinal function after gastric cancer surgery, improves anemia symptoms, and enhances the patient's quality of life.

[0027] The basic formula of the above-mentioned traditional Chinese medicine composition of the present invention can be adjusted according to clinical symptoms during specific implementation to improve the clinical symptoms of patients with reduced hemoglobin levels after gastric cancer surgery, further enhancing the adaptability of the composition of the present invention and improving the therapeutic effect. These adjustments made based on the basic formula of the present invention are also within the scope of protection of this application.

[0028] Secondly, the present invention provides a traditional Chinese medicine preparation for the treatment of anemia after gastric cancer surgery. The preparation is made from the above-mentioned traditional Chinese medicine composition as raw material. Optionally, pharmaceutically acceptable excipients may be added during preparation according to the actual needs of the preparation.

[0029] The dosage forms of the traditional Chinese medicine preparations include decoctions, tablets, granules, pills, powders, capsules, or powders.

[0030] Thirdly, the present invention provides the use of the above-mentioned traditional Chinese medicine composition or preparation for the treatment of postoperative anemia in gastric cancer in the preparation of any of the following drugs;

[0031] 1) Medications to improve clinical symptoms in patients with anemia after gastric cancer surgery;

[0032] 2) Medications to improve the quality of life of patients with anemia after gastric cancer surgery;

[0033] 3) Medications that improve hematological parameters in patients with anemia after gastric cancer surgery, especially those that increase hemoglobin levels.

[0034] In addition, unless otherwise specified, all raw materials of the traditional Chinese medicine composition of the present invention can be obtained commercially available. Any traditional Chinese medicine composition of any range described in the present invention, including any value between the endpoints and any sub-ranges formed by the endpoints or any value between the endpoints, can achieve the purpose of treating anemia.

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

[0036] The traditional Chinese medicine composition of this invention has been verified through clinical trials. It targets the core pathogenesis of "spleen and stomach deficiency, qi and blood imbalance, and residual toxins" in patients with anemia after gastric cancer surgery. It aims to strengthen the spleen and stomach, replenish qi and blood, and support the body's resistance and detoxify. It has certain advantages in promoting the increase of hemoglobin, improving symptoms, and improving the quality of life in patients with anemia after gastric cancer surgery. Moreover, the drug has good safety. Detailed Implementation

[0037] To more clearly illustrate the present invention, the following description, in conjunction with preferred embodiments and statistical data, further clarifies the invention. Those skilled in the art should understand that the specific description below is illustrative rather than restrictive and should not be construed as limiting the scope of protection of the present invention.

[0038] Example 1

[0039] A traditional Chinese medicine composition for the treatment of anemia after gastric cancer surgery, comprising the following raw materials: 30g raw Astragalus membranaceus, 6g Angelica sinensis, 15g Codonopsis pilosula, 9g Curcuma zedoaria, 15g hematite, 15g Cuscuta chinensis, 10g raw Typha orientalis, and 15g silkworm excrement.

[0040] Example 2

[0041] A traditional Chinese medicine composition for the treatment of anemia after gastric cancer surgery, comprising the following raw materials: 45g raw Astragalus membranaceus, 6g Angelica sinensis, 15g Codonopsis pilosula, 10g Curcuma zedoaria, 20g hematite, 15g Cuscuta chinensis, 15g raw Typha orientalis, and 15g silkworm excrement.

[0042] Example 3

[0043] A traditional Chinese medicine composition for the treatment of anemia after gastric cancer surgery, comprising the following raw materials: 60g raw Astragalus membranaceus, 9g Angelica sinensis, 30g Codonopsis pilosula, 10g Curcuma zedoaria, 30g hematite, 15g Cuscuta chinensis, 15g raw Typha pollen, and 15g silkworm excrement.

[0044] Example 4

[0045] A traditional Chinese medicine composition for the treatment of anemia after gastric cancer surgery, comprising the following raw materials: 30g raw Astragalus membranaceus, 6g Angelica sinensis, 15g Codonopsis pilosula, 10g Curcuma zedoaria, 15g hematite, 10g Cuscuta chinensis, 15g raw Typha pollen, and 15g silkworm excrement.

[0046] Example 5

[0047] A traditional Chinese medicine composition for the treatment of anemia after gastric cancer surgery, comprising the following raw materials: 30g raw Astragalus membranaceus, 6g Angelica sinensis, 15g Codonopsis pilosula, 10g Curcuma zedoaria, 15g hematite, 10g Cuscuta chinensis, 15g raw Typha orientalis, and 10g silkworm excrement.

[0048] Study 1: Efficacy study of hematological indicators in treating patients with anemia after gastric cancer surgery

[0049] 1. Research Design

[0050] Thirty patients who underwent radical gastrectomy for gastric cancer and developed postoperative anemia, and who received traditional Chinese medicine treatment at the Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, between August 2024 and March 2025, were included in this study. According to the AJCC 8th edition TNM staging for gastric cancer, they were classified as stages I-IV. All patients had completed adjuvant Western medicine treatment, and their postoperative hemoglobin levels were below the WHO normal reference values ​​for anemia in adults (males <130 g / L, non-pregnant women <120 g / L). Patients whose anemia did not respond well to iron, folic acid, vitamin B12, or other traditional Chinese medicine treatments were excluded. Patients with other hematological diseases and severe liver or kidney dysfunction were excluded. A decoction (the traditional Chinese medicine composition of Example 1) was prepared using the traditional Chinese medicine composition of this invention. One dose was administered orally twice daily for at least four weeks, after which hematological indicators and changes in quality of life were assessed.

[0051] 2. Research Standards

[0052] (1) Hematological markers related to anemia

[0053] ① Hemoglobin (Hgb): Hemoglobin value at enrollment and after traditional Chinese medicine intervention.

[0054] ②Red blood cells (RBC): Red blood cell count at enrollment and after traditional Chinese medicine intervention.

[0055] ③Hematocrit (HCT): Hematocrit at enrollment and after intervention with traditional Chinese medicine.

[0056] (2) Statistical methods

[0057] Baseline data analysis: For count data, the basic statistical description is expressed using frequency tables, percentages, or proportions. For continuous data that conforms to a normal distribution, the mean ± standard deviation (SD) is used. For non-normally distributed data, the median and interquartiles (P25, P75) are used for description.

[0058] Within-group comparisons: For continuous data that meet the normality test, the T-test is used; for those that do not meet the normality test, the nonparametric rank-sum test is used. The significance level is set at α = 0.05. If P > 0.05, the difference is considered to be statistically insignificant.

[0059] 3. Research Results

[0060] (1) Baseline data

[0061] A total of 30 patients with postoperative anemia after gastric cancer surgery were included. Their general information is shown in Table 1.

[0062] Table 1. Baseline information of included patients

[0063]

[0064]

[0065] *Stage IV patients are those who have experienced recurrence and metastasis after radical gastrectomy for gastric cancer. WHO anemia severity classification standards: Mild anemia: Males: 100-129 g / L, Females: 100-119 g / L; Moderate anemia: 70-99 g / L; Severe anemia: 40-69 g / L; Very severe anemia: <40 g / L

[0066] (2) Changes in hematological parameters

[0067] After treatment with the traditional Chinese medicine composition of this invention, the patients' hemoglobin, red blood cell count, and hematocrit all increased significantly (P<0.05), and the differences were statistically significant (see Table 2).

[0068] Table 2. Changes in hematological indicators of anemia in patients treated with the herbal composition of the present invention before and after treatment.

[0069]

[0070] * indicates that the difference between the two values ​​is less than 0.01.

[0071] Study 2: A comparative study on the efficacy of the herbal composition of this invention and the control drug in treating hematological indicators in patients with postoperative anemia after gastric cancer surgery.

[0072] Traditional Chinese medicine (TCM) often considers the primary pathogenesis of anemia associated with malignant tumors to be deficiency of Qi and blood, and the treatment principle is mainly to replenish Qi and blood. Clinically, Astragalus membranaceus, Angelica sinensis, and Codonopsis pilosula are commonly used in treatment based on syndrome differentiation. However, anemia patients after gastric cancer surgery suffer from multiple contributing factors, including postoperative blood loss, impaired absorption of hematopoietic elements such as iron, folic acid, and vitamin B12 after gastrectomy, impaired spleen and stomach function leading to insufficient production of essential nutrients, and the consumption of Qi and blood by cancer toxins. Clinically, this presents a complex, characteristic, and representative anemia. Therefore, anemia in patients after gastric cancer surgery exhibits a unique pathogenesis of spleen and stomach deficiency, Qi and blood imbalance, and lingering toxins. This invention uses Astragalus membranaceus, Angelica sinensis, and Codonopsis pilosula as principal and assistant herbs, aiming to invigorate qi and nourish blood. Given that postoperative anemia in gastric cancer patients is closely related to lingering toxins and the continuous depletion of qi and blood by the tumor, the formula also includes Curcuma zedoaria, Hematite, Cuscuta chinensis, Typha orientalis, and Bombyx mori excrement as adjuvant herbs to promote blood circulation, remove blood stasis, fight cancer and detoxify, promote tissue regeneration, and replenish blood and essence. Modern pharmacological research also suggests that this formula can supplement hematopoietic elements, thus addressing both the symptoms and the root cause. To highlight the unique efficacy of this combination, this study included a control group of patients treated with a traditional Chinese medicine decoction containing Astragalus membranaceus, Angelica sinensis, and Codonopsis pilosula, but lacking Curcuma zedoaria, Typha orientalis, and Hematite, to compare and illustrate the therapeutic characteristics of the combination of this invention.

[0073] 1. Research Design

[0074] From January 2015 to March 2025, 15 patients who underwent radical gastrectomy for gastric cancer and developed postoperative anemia, and who received traditional Chinese medicine treatment at the Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, were included as the control group. This group received a decoction of traditional Chinese medicine composed of the principal and assistant herbs (Astragalus membranaceus, Angelica sinensis, and Codonopsis pilosula) and other herbs, without any adjuvant or guiding herbs. The specific medication used was: 30g raw Astragalus membranaceus, 6g Angelica sinensis, 15g Codonopsis pilosula, 15g Atractylodes macrocephala, 15g Poria cocos, 6g prepared Glycyrrhiza uralensis, 15g Paeonia lactiflora, and 15g Rehmannia glutinosa. Thirty patients were included in the group receiving the traditional Chinese medicine composition of this invention (the composition of Example 1), with the same patient group as in Study 1. Both groups received one dose orally daily, divided into two administrations, for at least four weeks. The improvement in hematological indicators was compared to assess the efficacy of the traditional Chinese medicine composition of this invention and the control drug in treating postoperative anemia in patients with gastric cancer.

[0075] 2. Research Standards

[0076] (1) Hematological markers related to anemia

[0077] ① Hemoglobin (Hgb): Hemoglobin value at enrollment and after traditional Chinese medicine intervention.

[0078] ②Red blood cells (RBC): Red blood cell count at enrollment and after traditional Chinese medicine intervention.

[0079] ③Hematocrit (HCT): Hematocrit at enrollment and after intervention with traditional Chinese medicine.

[0080] (2) Statistical methods

[0081] Baseline data analysis: For count data, the basic statistical description is expressed using frequency tables, percentages, or proportions. For continuous data that conforms to a normal distribution, the mean ± standard deviation (SD) is used. For non-normally distributed data, the median and interquartiles (P25, P75) are used for description.

[0082] Within-group comparisons: For continuous data that meet the normality test, the T-test is used; for those that do not meet the normality test, the nonparametric rank-sum test is used. The significance level is set at α = 0.05. If P > 0.05, the difference is considered to be statistically insignificant.

[0083] For intergroup comparisons, the T-test was used for continuous data that met the normality test, and the nonparametric rank-sum test was used for those that did not meet the normality test. The significance level was set at α = 0.05, and P > 0.05 was considered to be statistically insignificant.

[0084] 3. Research Results

[0085] (1) Baseline data

[0086] A total of 45 patients with anemia after gastric cancer surgery were included. 30 patients were treated with the traditional Chinese medicine composition of this invention, and 15 patients were treated with only the control group's drugs. There were no significant differences in the general characteristics of the two groups (see Table 3).

[0087] Table 3. Baseline characteristics and comparisons between the two groups of patients.

[0088]

[0089]

[0090] *Stage IV patients are those who have experienced recurrence and metastasis after radical gastrectomy for gastric cancer. WHO anemia severity classification standards: Mild anemia: Males: 100-129 g / L, Females: 100-119 g / L; Moderate anemia: 70-99 g / L; Severe anemia: 40-69 g / L; Very severe anemia: <40 g / L

[0091] (2) Changes in hematological parameters

[0092] No increase in hemoglobin, erythrocytes, or hematocrit was observed in the control group after treatment with the traditional Chinese medicine composition (P>0.05, see Table 4).

[0093] Table 4. Changes in hematological parameters of anemia before and after treatment in the control group.

[0094]

[0095] The efficacy analysis of the traditional Chinese medicine composition group and the control group of the present invention showed that the traditional Chinese medicine composition group of the present invention was significantly better than the control group in terms of improvement in multiple hematological indicators (hemoglobin, red blood cells, hematocrit), indicating that the traditional Chinese medicine composition of the present invention has a more significant efficacy than the ordinary traditional Chinese medicine control group (see Table 5).

[0096] Table 5. Comparison of hematological indicators of anemia before and after treatment in the two groups of patients.

[0097]

[0098] Note: a) Comparison between the control group and the patent group before treatment: P>0.05; b) Comparison between the control group before and after treatment: P>0.05; c) Comparison between the patent group before and after treatment: P<0.05; d) Comparison between the patent group and the control group after treatment: P<0.05.

[0099] Study 3: A study on changes in quality of life and symptoms in patients with anemia after gastric cancer surgery.

[0100] 1. Research Design: Same as Study 1.

[0101] 2. Research Standards:

[0102] (1) Quality of life and symptom scale: PGSAS-45 post-gastrectomy syndrome assessment scale at enrollment and after Chinese medicine intervention.

[0103] (2) Statistical methods

[0104] Baseline data analysis: For count data, the basic statistical description is expressed using frequency tables, percentages, or proportions. For continuous data that conforms to a normal distribution, the mean ± standard deviation (SD) is used. For non-normally distributed data, the median and interquartiles (P25, P75) are used for description.

[0105] Within-group comparisons: For continuous data that meet the normality test, the T-test is used; for those that do not meet the normality test, the nonparametric rank-sum test is used. The significance level is set at α = 0.05. If P > 0.05, the difference is considered to be statistically insignificant.

[0106] 3. Research Results:

[0107] The PGSAS-45 Post-Gastectomy Syndrome Assessment Scale includes 8 items from the Short Form Health Surgery (SF-8), 15 items from the Gastrointestinal Symptom Rating Scale (GSRS), and 22 additional items selected by 47 surgeons from questionnaires reviewed from 1777 patients. These items best reflect the patients' post-gastrectomy symptoms. The scale objectively and comprehensively assesses post-gastrectomy patients' comorbidities, work-life balance, and quality of life. The PGSAS-45 includes 8 items assessing health-related quality of life, 8 items related to eating, 1 item related to work status, 3 items reflecting post-operative daily life satisfaction, and 25 items related to post-operative symptoms. The 25 symptom-related items reflect seven aspects of symptoms, including: gastroesophageal reflux symptoms, abdominal pain, eating-related disturbances, indigestion, diarrhea, constipation, and dumping syndrome. Items 1-8 and 38-45 were scored using the Likert 5 subscale, while items 9-28 and 30-32 were scored using the Likert 7 subscale. These can be summarized into 10 key observation indicators: Quality of Life Subscale, Gastroesophageal Reflux Symptoms Subscale, Abdominal Pain Symptoms Subscale, Eating-Related Discomfort Symptoms Subscale, Indigestion Symptoms Subscale, Diarrhea Symptoms Subscale, Constipation Symptoms Subscale, Dumping Syndrome Subscale, Food Quality Subscale, and Life Dissatisfaction Subscale.

[0108] Before and after treatment, the drug significantly improved patients' quality of life, relieved symptoms such as gastroesophageal reflux, abdominal pain, food-related discomfort, indigestion, and dumping syndrome, and improved quality of life scores and reduced life dissatisfaction scores (see Table 6).

[0109] Table 6. Changes in quality of life and symptoms before and after treatment in included patients.

[0110]

[0111] Δ indicates P < 0.05 compared to before treatment, and * indicates P < 0.01 compared to before treatment.

[0112] 4. Conclusion

[0113] The traditional Chinese medicine composition of this invention can significantly increase the hemoglobin level in patients after gastric cancer surgery (P<0.05). This result suggests that the traditional Chinese medicine composition of this invention can effectively correct postoperative anemia, promote patient recovery, and has clinical application value.

[0114] Study 4: Typical Cases

[0115] Case 1: Moderate anemia after chemotherapy following gastric cancer surgery

[0116] Mr. Hu, male, 53 years old. First visit on August 21, 2024. The patient underwent gastric malignancy resection in September 2023. Postoperative pathology showed poorly differentiated adenocarcinoma of the gastric antrum. Pathological staging: cT4bN0M0 stage III. Postoperatively, he received 7 cycles of the SOX regimen. He had previously received traditional Chinese medicine treatment for anemia, but the improvement in related hematological indicators did not meet expectations. Current symptoms: abdominal distension and borborygmus, hiccups and flatulence, normal appetite and sleep. Weakness in both lower limbs, bitter taste in the mouth and dry mouth. Sensitivity to cold in the stomach, numbness in the toes, loose stools once a day, and nocturia twice a night. Pale red tongue with white coating, wiry pulse. Blood routine test (August 2024): HGB: 75g / L. Western medicine diagnosis: Postoperative anemia after gastric malignancy resection. Traditional Chinese medicine diagnosis: Gastric cancer, general weakness, differentiated as spleen and stomach deficiency, qi and blood imbalance, and residual toxins. Treatment: Strengthen the spleen and stomach, replenish qi and blood, and support the body's resistance to detoxification.

[0117] Prescription: Astragalus membranaceus 30g, Angelica sinensis 6g, Codonopsis pilosula 15g, Curcuma zedoaria 9g, Hematite 15g, Bombyx mori excrement 15g, Typha orientalis pollen 10g, Cuscuta chinensis 15g, Angelica dahurica 15g, Citrus aurantium (fried with wheat bran) 10g, Ligusticum chuanxiong 10g. Decoct in water and take one dose daily, divided into two doses after breakfast and dinner.

[0118] Second visit: Flatulence lessened, but dry mouth and bitter taste persisted, along with lower limb weakness. Appetite was fair, sleep improved, bowel movements were initially dry then loose, and nocturia occurred 2-3 times. Tongue was pale and dark with a white, greasy coating. Blood routine test (October 2024): HGB: 117g / L. Subsequent outpatient follow-up showed significant improvement in symptoms and a marked increase in quality of life.

[0119] Case 2: Moderate anemia after chemotherapy following gastric cancer surgery

[0120] Mr. Lu, male, 62 years old, first visited on August 21, 2024. He underwent gastric malignancy resection in December 2023. Postoperative pathology showed poorly differentiated adenocarcinoma. Pathological stage: pT4aN0M0 stage III. He received 5 cycles of the SOX regimen postoperatively. He had previously taken Shengxuebao compound, but his anemia-related indicators did not show significant improvement. Current symptoms: no stomach pain or bloating, no acid reflux or heartburn, occasional diarrhea, frequent flatulence. Good appetite, good sleep, good energy, twice daily loose stools, normal urination. Numbness and cold sensation in hands and feet. Red tongue with yellow coating, wiry pulse. Blood routine test (August 19, 2024): HGB: 98g / L. Western medicine diagnosis: Postoperative anemia after gastric malignancy resection. Traditional Chinese medicine diagnosis: Gastric cancer, general weakness, differentiated as spleen and stomach deficiency, qi and blood imbalance, and residual toxins. Traditional Chinese Medicine Treatment: Strengthen the spleen and stomach, replenish qi and blood, and support the body's resistance to detoxification. Prescription: Astragalus membranaceus 30g, Angelica sinensis 6g, Codonopsis pilosula 15g, Curcuma zedoaria 9g, Typha orientalis pollen 10g, Bombyx mori excrement 15g, Cuscuta chinensis 15g, Artemisia capillaris 30g, Bambusa textilis 10g, Cinnamomum cassia 10g, Pheretima aspergillum 10g. Decoct in water and take one dose daily, divided into two doses after breakfast and dinner.

[0121] Second visit on October 22, 2024: The patient reported increased appetite, no significant abdominal discomfort, but still frequent borborygmus and flatulence, and numbness and coldness in the hands and feet. A repeat blood test (October 11, 2024) showed: HGB: 112 g / L. Third visit on February 19, 2025: The patient reported no stomach pain or bloating, no acid reflux or heartburn. Appetite and sleep were normal, and energy was good. The patient felt cold in the stomach, occasionally had loose stools, and experienced numbness in the soles of both feet and fingertips. The tongue was red with little coating, and the pulse was wiry and thready. A repeat blood test (February 2025) showed: HGB: 123 g / L. Fourth visit on April 16, 2025: No significant digestive discomfort symptoms, good appetite and sleep, slightly loose stools, no other significant discomfort, dark red tongue with a white, greasy coating, and a thready pulse. A repeat blood test (April 7, 2025) showed: HGB: 131 g / L. With adjustments made to the above, the quality of life has significantly improved.

[0122] Case 3: Severe anemia following chemotherapy for late-stage recurrence and metastasis of gastric cancer after surgery.

[0123] Ms. Liu, female, 37 years old, first visited on March 1, 2025. In December 2021, she underwent radical gastrectomy for distal gastric cancer. Postoperative pathology showed poorly differentiated adenocarcinoma of the stomach, partly with signet ring cell carcinoma structure. Pathological stage: pT3N2M0. She received 8 cycles of the SOX regimen postoperatively. A follow-up CT scan in May 2023 showed ovarian metastasis. In June 2023, she underwent bilateral salpingo-oophorectomy. Postoperative pathology showed metastasis consistent with gastric adenocarcinoma. She received oral S1 therapy postoperatively. A follow-up CT scan in December 2023 revealed postoperative changes in both ovaries following gastric antral cancer surgery. Localized thickening of the colonic wall with nodules was observed in the hepatic region, suggesting possible peritoneal metastasis involving the colon. She began 6 cycles of SOX+PD1 on January 16, 2024. Although she had previously received traditional Chinese medicine treatment for anemia, the improvement in her related hematological indicators did not meet expectations. Current symptoms: fatigue, cold hands and feet, dry mouth, hoarseness, dry ears and nose, dry and painful perioral area, fair sense of taste, occasional abdominal bloating, average appetite, poor sleep, easily awakened after falling asleep, but able to fall back asleep after waking up. Difficulty falling asleep, numbness in hands and feet, peeling and inflammation of fingertips, skin rash. Blurred vision, discharge, bowel movements once every 1-2 days, dry in consistency, difficult to defecate, blood in stool. Swelling of eyelids and lower limbs. Pale tongue with little coating, wiry and slippery pulse. Blood routine examination (2025-02-28): HGB: 65g / L. Western medicine diagnosis: postoperative gastric malignancy, anemia; Traditional Chinese medicine diagnosis: gastric cancer, general weakness, diagnosed as spleen and stomach deficiency, qi and blood imbalance, and residual toxins. Traditional Chinese medicine treatment: strengthen the spleen and stomach, replenish qi and blood, support the body's resistance and detoxify. Prescription: Astragalus membranaceus 30g, Angelica sinensis 6g, Codonopsis pilosula 15g, Bombyx mori excrement 15g, Typha orientalis pollen 10g, Curcuma zedoaria 9g, Hematite 5g, Cuscuta chinensis 15g, Anemarrhena asphodeloides 10g, Imperata cylindrica root 15g, Rehmannia glutinosa 15g. Decoct in water and take one dose daily, divided into two doses after breakfast and dinner.

[0124] Follow-up visit on April 15, 2025: The patient reported that the edema had largely subsided, numbness in the hands and feet, and significant relief from fingertip dermatitis. However, fatigue, cold hands and feet, poor appetite and sleep, difficulty falling asleep, and frequent awakenings persisted. Dry skin and mucous membranes, slightly sticky stools, normal urination, nocturnal abdominal distension, frequent bowel sounds and flatulence, dry mouth upon waking, and swollen and painful fingers were also observed. The tongue was dark red with little coating, and the pulse was wiry, thready, and weak. A repeat blood test (April 11, 2025) showed: HGB: 92 g / L. Subsequent outpatient follow-ups showed significant improvement in symptoms and a marked increase in quality of life.

[0125] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. For those skilled in the art, other variations or modifications can be made based on the above description. It is impossible to exhaustively list all the implementation methods here. All obvious variations or modifications derived from the technical solutions of the present invention are still within the protection scope of the present invention.

Claims

1. A traditional Chinese medicine composition for treating anemia after gastric cancer surgery, characterized in that, It is made from the following raw materials: raw astragalus, angelica, codonopsis, turmeric, hematite, dodder seed, raw cattail pollen, and silkworm excrement.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 30-60 parts raw Astragalus membranaceus, 6-9 parts Angelica sinensis, 15-30 parts Codonopsis pilosula, 9-15 parts Curcuma zedoaria, 15-30 parts hematite, 10-15 parts Cuscuta chinensis, 10-15 parts raw Typha orientalis, and 10-15 parts silkworm excrement.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 30 parts raw Astragalus membranaceus, 6 parts Angelica sinensis, 15 parts Codonopsis pilosula, 9 parts Curcuma zedoaria, 15 parts hematite, 15 parts Cuscuta chinensis, 10 parts raw Typha pollen, and 15 parts silkworm excrement.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 45 parts raw Astragalus membranaceus, 6 parts Angelica sinensis, 15 parts Codonopsis pilosula, 10 parts Curcuma zedoaria, 20 parts hematite, 15 parts Cuscuta chinensis, 15 parts raw Typha pollen, and 15 parts silkworm excrement.

5. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 60 parts raw Astragalus membranaceus, 9 parts Angelica sinensis, 30 parts Codonopsis pilosula, 10 parts Curcuma zedoaria, 30 parts hematite, 15 parts Cuscuta chinensis, 15 parts raw Typha pollen, and 15 parts silkworm excrement.

6. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 30 parts raw Astragalus membranaceus, 6 parts Angelica sinensis, 15 parts Codonopsis pilosula, 10 parts Curcuma zedoaria, 15 parts hematite, 10 parts Cuscuta chinensis, 15 parts raw Typha pollen, and 15 parts silkworm excrement.

7. The traditional Chinese medicine composition according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 30 parts raw Astragalus membranaceus, 6 parts Angelica sinensis, 15 parts Codonopsis pilosula, 10 parts Curcuma zedoaria, 15 parts hematite, 10 parts Cuscuta chinensis, 15 parts raw Typha pollen, and 10 parts silkworm excrement.

8. A traditional Chinese medicine preparation for treating anemia after gastric cancer surgery, characterized in that, The raw materials of the traditional Chinese medicine preparation include the traditional Chinese medicine composition according to any one of claims 1-7; Preferably, the raw materials of the traditional Chinese medicine preparation also include pharmaceutically acceptable excipients.

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

10. The use of the traditional Chinese medicine composition according to any one of claims 1-7 or the traditional Chinese medicine preparation according to any one of claims 8-9 in the preparation of any of the following drugs; 1) Medications to improve clinical symptoms in patients with anemia after gastric cancer surgery; 2) Medications to improve the quality of life of patients with anemia after gastric cancer surgery; 3) Drugs that improve hematological indicators in patients with anemia after gastric cancer surgery.

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