Application of traditional Chinese medicine composition in preparation of medicine for postoperative treatment of colorectal cancer

Abstract

The invention discloses an application of a traditional Chinese medicine composition in preparation of a medicine for postoperative treatment of colorectal cancer. The traditional Chinese medicine composition is prepared from the following raw material medicines: raw astragalus membranaceus, rhizoma anemarrhenae, curcuma zedoary, fried fructus aurantii, radix paeoniae rubra, achyranthes bidentata, radix actinidiae chinensis, polygonum cuspidatum and campsis grandiflora. The traditional Chinese medicine composition disclosed by the invention is suitable for colorectal cancer postoperative patients, particularly II-stage and III-stage colorectal cancer postoperative patients, has certain advantages in the aspects of inhibiting tumor proliferation, preventing and treating colorectal cancer postoperative recurrence and metastasis and prolonging disease-free lifetime, can effectively improve uncomfortable symptoms of the patients during postoperative and postoperative adjuvant therapy, and improves life quality.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of traditional Chinese medicine. More particularly, it relates to the use of a traditional Chinese medicine composition in the preparation of a medicament for the treatment of colorectal cancer after surgery. BACKGROUND

[0002] Colorectal cancer (CRC) is one of the most common malignant tumors worldwide. In 2022, there were nearly 20 million new cancer cases worldwide, of which about 1.926 million were colorectal cancer, accounting for 9.6%. The number of new cases ranks third in the world; the number of deaths was about 904,000, accounting for 9.3% of the total number of cancer deaths, ranking second. In China, the incidence and mortality of colorectal cancer are also at a high level. Statistics in 2022 show that there were about 517,000 new cases of colorectal cancer in China, ranking second in the number of new cases in the country; the number of deaths was about 240,000, ranking fourth. The incidence and mortality of colorectal cancer are high, which seriously endangers people's health, so the secondary prevention of early detection, early diagnosis and early treatment is an effective measure to improve the survival rate of patients with colorectal cancer.

[0003] At present, surgery is the main treatment for patients with non-metastatic colorectal cancer, but the high rate of postoperative recurrence and metastasis will seriously affect the survival time of patients. Statistics show that for CRC patients who are disease-free after radical resection, follow-up found that the recurrence-free survival rate of patients with stage II and III was about 77.1% at 2 years after surgery, and about 72.1% at 3 years. The SEER database shows that when colorectal cancer spreads to nearby lymph nodes but does not metastasize to distant organs, the 5-year survival rate varies depending on the extent of lymph node involvement (N1 or N2), ranging from 65% to 75%. If the cancer cells have metastasized to distant organs such as the liver and lungs, the 5-year survival rate is usually between 12% and 18%. Therefore, preventing and treating postoperative recurrence and metastasis, prolonging the disease-free survival and overall survival of patients is an important issue and research focus in current clinical practice.

[0004] Traditional Chinese medicine has shown significant clinical value in preventing and treating postoperative recurrence and metastasis of colorectal cancer and prolonging the survival of patients. It has the unique advantages of safety, high efficiency and wide application, and when combined with chemotherapy, immunotherapy and other anti-tumor treatments, it can play a detoxification and synergistic role. There are many traditional Chinese medicine compounds in the prior art for preventing and treating metastasis of colorectal cancer, but most of them are aimed at advanced colorectal cancer, metastasis after chemotherapy, etc., and there are relatively few traditional Chinese medicine compounds for postoperative manifestations and prevention and treatment of recurrence and metastasis of colorectal cancer. Therefore, it is of great significance to develop a traditional Chinese medicine composition for preventing and treating postoperative recurrence and metastasis of colorectal cancer and improving the clinical symptoms of patients after colorectal cancer surgery. SUMMARY

[0005] In view of the above deficiencies in the prior art, the purpose of the present application is to provide the use of a traditional Chinese medicine composition in the preparation of a medicament for the treatment of colorectal cancer after surgery.

[0006] To achieve the above-mentioned purposes, the present application adopts the following technical solutions:

[0007] The present application provides an application of a traditional Chinese medicine composition in the preparation of a drug for postoperative treatment of colorectal cancer, wherein the traditional Chinese medicine composition is prepared from the following raw medicinal materials: Astragalus membranaceus, Anemarrhena asphodeloides, Curcuma zedoaria, Fructus Aurantii Immaturus, Paeonia rubra, Cyathula officinalis, Smilax riparia, Polygonum cuspidatum, Campsis grandiflora.

[0008] Further, the drug for postoperative treatment of colorectal cancer comprises at least one of the following:

[0009] 1) a drug for improving the clinical symptoms of postoperative patients with colorectal cancer, wherein the clinical symptoms are based on the Guidelines for Diagnosis and Treatment of Colorectal Cancer in Combination with Traditional Chinese and Western Medicine (2023) and the Anderson Symptom Assessment Scale, and at least one of the following is included: abdominal distending pain, loss of appetite, change in bowel habits, mucous and purulent blood stool, tenesmus, fatigue, nausea and vomiting;

[0010] 2) a drug for prolonging the disease-free survival of postoperative patients with colorectal cancer, wherein the disease-free survival evaluation includes at least one of the following: 2-year disease-free survival (DFS) and 3-year DFS;

[0011] 3) a drug for preventing and treating postoperative recurrence and metastasis of colorectal cancer.

[0012] Further, the traditional Chinese medicine composition is prepared from the following raw medicinal materials by weight: 30-60 parts of Astragalus membranaceus, 6-10 parts of Anemarrhena asphodeloides, 6-9 parts of Curcuma zedoaria, 10-15 parts of Fructus Aurantii Immaturus, 10-15 parts of Paeonia rubra, 10-15 parts of Cyathula officinalis, 10-15 parts of Smilax riparia, 10-15 parts of Polygonum cuspidatum, and 10-15 parts of Campsis grandiflora.

[0013] In the present application, the following raw medicinal materials are used:

[0014] Astragalus membranaceus is sweet in taste, slightly warm in nature, and belongs to the lung and spleen meridians. It has the effects of tonifying qi and ascending yang, consolidating the exterior and stopping sweating, promoting water and relieving swelling, generating fluid and nourishing blood, removing stagnation and relieving arthralgia, and removing toxins and draining pus. It is believed in Benjing Fengyuan that it can "tonify qi and ascend yang, and consolidate the exterior and stop sweating". In addition, it is emphasized in Medical Records of Chinese and Western Medicine that Astragalus membranaceus has the nature of ascending in addition to tonifying qi, which not only can protect and tonify middle qi and invigorate the spleen, but also can ascend and promote qi and assist the spleen in ascending clear qi, which helps to restore the transportation and transformation function of the spleen to distribute essence and nourish the whole body, and is the monarch herb of the whole prescription. Modern research shows that Astragalus membranaceus can inhibit the proliferation of colorectal cancer cells, induce apoptosis, inhibit invasion and metastasis, and enhance immune function through its active components such as polysaccharides, saponins and flavonoids. Its mechanism may involve regulating the PI3K / Akt and nuclear factor-kappa B (NF-kappa B) signaling pathways, blocking tumor cell cycle progression, and down-regulating the expression of pro-inflammatory factors to improve the inflammatory microenvironment of tumors and play an anti-tumor role.

[0015] Zedoary Turmeric is pungent and bitter in flavor, warm in nature, and belongs to the liver and spleen meridians. It is pungent and bitter in nature, and warm in nature, and can enter the blood and qi. It has the effects of breaking blood and removing blood stasis, and activating blood and relieving pain. It is clinically used for treating stagnation and accumulation caused by blood stasis. In the processing application, Zedoary Turmeric is often used as a vinegar product. After vinegar processing, it can enhance its effect of entering the liver and blood, and further strengthen the function of breaking blood and removing blood stasis. Modern pharmacological studies have shown that the anti-tumor effect of Zedoary Turmeric and its active ingredients (such as volatile oil, zedoary alcohol, etc.) is mainly achieved by regulating the vascular endothelial growth factor (VEGF), NF-κB, signal transduction and transcription activator 3 (STAT3) and other signaling pathways. In addition, it can also inhibit the activity of casein kinase II (CKII), promote the release of apoptosis-inducing factor and cytochrome C, and activate the Caspase-3 protease cascade to induce apoptosis of human colon cancer cells.

[0016] Hogfennel Rhizome is slightly bitter in taste, cold in nature, and belongs to the liver, gallbladder and lung meridians. As a root medicine, its shape is similar to the intestine, and its efficacy focuses on promoting blood circulation to relieve pain, clearing heat and detoxifying, removing blood stasis and removing dampness. It is good at clearing heat, removing dampness, and detoxifying, removing blood stasis and relieving pain, and has the effects of removing dampness and relieving pain, removing blood stasis and removing dampness. The book 'Special Records of Famous Doctors' states that it can 'break blood stasis' and highlights its ability to break blood and remove blood stasis. The 'Compendium of Materia Medica' believes that it can'suppress all heat and toxins' and embodies the three effects of clearing heat, removing dampness and activating blood. It has certain specific treatment significance for patients with colorectal cancer after surgery who have symptoms of qi deficiency and blood stasis, and dampness accumulation. Modern research shows that the resveratrol monomer extracted from Hogfennel Rhizome has a broad-spectrum inhibitory effect on tumor cell proliferation. Its active ingredient, polydatin, has antioxidant activity and may play a potential anticancer role by inhibiting cell proliferation, blocking cell cycle and inducing apoptosis.

[0017] Smilax China Root is slightly sweet and astringent in taste, cool in nature, and slightly toxic. It is used to clear heat and detoxify, remove swelling and nodules, treat carbuncle and sore, and has the effect of detoxifying without damaging the normal. Modern pharmacological research shows that Smilax China Root extract can inhibit the growth of tumor-bearing nude mice and induce tumor cell apoptosis, and can inhibit tumor cell proliferation by down-regulating Bcl-2 and up-regulating Bax and Caspase-3.

[0018] Anemarrhena asphodeloides Bunge is a perennial herb of the Anemarrhena family. It is bitter, sweet, and cold, and belongs to the lung, stomach, and kidney channels. It has the effects of clearing heat and reducing fire, nourishing yin and moistening dryness. It is often used to treat bone sweating, internal heat and diabetes, and dry constipation. Shennong's Herbal Classic says that it can treat diabetes, heat, and edema, and can supplement deficiency and benefit qi. Bencao Gangmu believes that it has the dual regulation of clearing lung fire and nourishing kidney yin. The Pharmacology of Medicinal Herbs adds its effect of promoting water and reducing swelling, and is used to treat damp-heat stagnation. Therefore, it is often used to treat postoperative wet retention and heat retention in patients with colorectal cancer. Modern research shows that Anemarrhena can inhibit angiogenesis, inhibit the proliferation, migration, and invasion of tumor cells, induce premature aging, apoptosis, and autophagy of tumor cells through PI3K / Akt and MAPK pathways, and has potential anti-tumor activity.

[0019] Campsis grandiflora is sweet and sour, cold, and belongs to the liver and pericardium channels. It enters the blood and has the effects of clearing heat and cooling blood, resolving stasis and dissolving masses. Bencao Gangmu says that it can clear blood and remove hidden fire. Bencao Diary adds that it can break blood and remove stasis. In addition, based on clinical practice, it is believed that Campsis grandiflora enters the liver channel and may have the effect of regulating blood. Modern research shows that Campsis grandiflora has antioxidant and anti-inflammatory effects. Radix Paeoniae Rubra is bitter and cold, and belongs to the liver channel. It has the effect of dispersing stasis and relieving pain. Bencao Qutu believes that it can remove evil and move blood, and can activate blood stasis in the blood. In different combinations, it can have multiple therapeutic effects such as tonifying qi and blood.

[0020] Radix Achyranthis Bidentatae is bitter, sweet, and sour, and belongs to the liver and kidney channels. It can guide blood downward and has the effect of removing stasis and unblocking channels. Fructus Aurantii is bitter, pungent, and sour, and belongs to the spleen and stomach channels. It is good at regulating qi, unblocking, and resolving stasis and distension. Modern pharmacological research shows that Fructus Aurantii can enhance gastrointestinal peristalsis and relieve smooth muscle spasm, which helps to promote the smoothness of qi and play a role in resolving middle jiao dampness. Both Fructus Aurantii and Radix Achyranthis Bidentatae are downward, and each has its own emphasis. Fructus Aurantii is good at regulating qi, unblocking, and resolving stasis and distension, and is good at descending stomach qi. Radix Achyranthis Bidentatae is good at removing stasis and unblocking blood vessels, and can guide stasis and blood downward, so that blood does not stagnate in the chest and stasis and heat do not disturb. The combination of the two drugs can regulate the flow of qi. Fructus Aurantii can remove dampness and resolve stasis, and Radix Achyranthis Bidentatae can guide the downward penetration of Fructus Aurantii, achieving the synergistic effect of qi flowing and dampness resolving.

[0021] The whole prescription warms the middle and supplements deficiency, removes stasis and resolves stagnation. Warming the middle has the effect of moistening, and supplementing the middle has the effect of moving. Radix Astragali is the monarch drug, Cynanchum bungei, Polygonum cuspidatum, and Curcuma zedoary are the ministerial drugs, Anemarrhena asphodeloides, Campsis grandiflora, and Radix Paeoniae Rubra are the auxiliary drugs, and Radix Achyranthis Bidentatae and Fructus Aurantii are the ministerial drugs. Warming can warm the interior to dispel cold, and moving can move qi to relieve pain. Taking the supplement means to benefit qi and supplement deficiency, unblock channels and collaterals, and harmonize blood vessels. Taking the active means to unblock blood vessels, and taking the moistening means to unblock the intestines. It is suitable for patients after colorectal cancer surgery.

[0022] According to the specific embodiment of the present application, the traditional Chinese medicine composition of the present application is made of the following raw medicinal materials by weight: 30 parts of raw Huangqi, 10 parts of Zimu, 9 parts of E'zhu, 10 parts of Fried Shuizhi, 15 parts of Chishao, 15 parts of Huai Niuxi, 15 parts of Tengshenegen, 15 parts of Hujiang, and 15 parts of Lingxiaohua.

[0023] Alternatively, the traditional Chinese medicine composition is made of the following raw medicinal materials by weight: 45 parts of raw Huangqi, 6 parts of Zimu, 9 parts of E'zhu, 12 parts of Fried Shuizhi, 15 parts of Chishao, 10 parts of Huai Niuxi, 10 parts of Tengshenegen, 10 parts of Hujiang, and 10 parts of Lingxiaohua.

[0024] Alternatively, the traditional Chinese medicine composition is made of the following raw medicinal materials by weight: 60 parts of raw Huangqi, 10 parts of Zimu, 6 parts of E'zhu, 10 parts of Fried Shuizhi, 10 parts of Chishao, 15 parts of Huai Niuxi, 15 parts of Tengshenegen, 15 parts of Hujiang, and 15 parts of Lingxiaohua.

[0025] Alternatively, the traditional Chinese medicine composition is made of the following raw medicinal materials by weight: 30 parts of raw Huangqi, 6 parts of Zimu, 6 parts of E'zhu, 15 parts of Fried Shuizhi, 10 parts of Chishao, 10 parts of Huai Niuxi, 10 parts of Tengshenegen, 15 parts of Hujiang, and 10 parts of Lingxiaohua.

[0026] Further, in the present application, the traditional Chinese medicine composition can be added with pharmaceutically acceptable adjuvants and prepared into a medicine for postoperative treatment of colorectal cancer according to the conventional preparation method in the art.

[0027] Illustratively, the dosage form of the medicine includes water decoction, tablet, granule, pill, powder, capsule or powder.

[0028] Further, the traditional Chinese medicine composition of the present application is mainly applied to patients with stage II or stage III colorectal cancer after operation.

[0029] In addition, each raw medicinal material of the traditional Chinese medicine composition in the present application can be commercially available unless otherwise specified, and any range recited in the present application includes the end values and any numerical value between the end values, and any sub-range of the traditional Chinese medicine composition formed by any numerical value between the end values or the end values can achieve the purpose of controlling colorectal cancer.

[0030] The beneficial effects of the present application are as follows:

[0031] The traditional Chinese medicine composition in the application is summarized according to years of clinical treatment experience of postoperative recurrence and metastasis of colorectal cancer, and verified by clinical trials. For patients with postoperative recurrence and metastasis of colorectal cancer, the traditional Chinese medicine composition can play the roles of strengthening body resistance, detoxifying and resisting cancer, preventing tumor recurrence and metastasis, and prolonging the survival period of patients. In addition, the traditional Chinese medicine composition in the application is mainly based on syndrome differentiation. According to the syndrome manifested by the disease, the etiology, pathogenesis, nature, and location of the disease in the current stage are analyzed. On the basis of syndrome differentiation and treatment, combined with modern pharmacological research of traditional Chinese medicine, the disease and syndrome combination method is adopted, and symptomatic treatment is also considered, so that the significant curative effect is achieved, and the most reasonable treatment strategy is presented. DETAILED DESCRIPTION

[0032] In order to more clearly illustrate the present application, the present application will be further described below in combination with preferred embodiments and statistical data. Those skilled in the art should understand that the specific description below is illustrative rather than limiting, and should not limit the protection scope of the present application.

[0033] Example 1

[0034] The preparation of the traditional Chinese medicine composition in the application is as follows: 30g of raw radix astragali, 10g of anemarrhena, 9g of curcuma, 10g of fried aurantii, 15g of red peony root, 15g of huaiyin achyranthis bidentatae, 15g of radix akebiae, 15g of giant knotweed, and 15g of campsis flowers are used as raw materials.

[0035] The water decoction is prepared according to the conventional process.

[0036] Example 2

[0037] The preparation of the traditional Chinese medicine composition in the application is as follows: 45g of raw radix astragali, 6g of anemarrhena, 9g of curcuma, 12g of fried aurantii, 15g of red peony root, 10g of huaiyin achyranthis bidentatae, 10g of radix akebiae, 10g of giant knotweed, and 10g of campsis flowers are used as raw materials.

[0038] The granules are prepared according to the conventional process.

[0039] Example 3

[0040] The preparation of the traditional Chinese medicine composition in the application is as follows: 60g of raw radix astragali, 10g of anemarrhena, 6g of curcuma, 10g of fried aurantii, 10g of red peony root, 15g of huaiyin achyranthis bidentatae, 15g of radix akebiae, 15g of giant knotweed, and 15g of campsis flowers are used as raw materials.

[0041] The water decoction is prepared according to the conventional process.

[0042] Example 4

[0043] The preparation of the traditional Chinese medicine composition in the application is as follows: 30g of raw radix astragali, 6g of anemarrhena, 6g of curcuma, 15g of fried aurantii, 10g of red peony root, 10g of huaiyin achyranthis bidentatae, 10g of radix akebiae, 15g of giant knotweed, and 10g of campsis flowers are used as raw materials.

[0044] The water decoction is prepared according to a conventional process.

[0045] Clinical statistical data of patients using the traditional Chinese medicine composition of the present application

[0046] Study I: Traditional Chinese medicine intervention study on recurrence and metastasis and survival of postoperative patients with stage II-III colorectal cancer

[0047] 1. Study design

[0048] This study included 60 patients with advanced colorectal cancer after surgery who visited the outpatient department of the Tumor Department of Guang'anmen Hospital of China Academy of Chinese Medical Sciences from June 2022 to May 2023. All patients were clinically diagnosed and given the traditional Chinese medicine composition of the present application (see Example 1 for specific formula) intervention. The clinical efficacy of this formula in reducing postoperative recurrence and metastasis of colorectal cancer was observed.

[0049] 2. Study criteria

[0050] The patients were evaluated by 2-year disease-free survival (DFS) rate and 3-year DFS rate, and the first occurrence of postoperative recurrence and metastasis and death was used as the criterion.

[0051] 3. Research results

[0052] 3.1 General characteristics

[0053] This study included 60 patients, and the general characteristics are shown in Table 1.

[0054] Table 1. General characteristics of included patients

[0055]

[0056]

[0057] 3.2 Main outcomes

[0058] This study excluded 8 patients, all due to loss of follow-up, with a dropout rate of 13%; the median follow-up time for the 52 patients finally included in the analysis was 38 months. At the time of follow-up to 3 years, 17 patients were censored because the follow-up time had not reached 3 years, and the risk concentration still included 35 patients. Accordingly, the results showed that the 2-year DFS rate of postoperative patients with stage II-III colorectal cancer receiving the traditional Chinese medicine composition of the present application (see Example 1 for specific formula) intervention was 92.31%, and the 3-year DFS rate was 82.86%. The number of patients with recurrence and metastasis and the DFS rate are shown in Table 2.

[0059] Table 2. Number of patients with recurrence and metastasis and DFS rate

[0060]

[0061] 4. Conclusion

[0062] This study is a single-center, single-arm, small-sample exploratory study without a control group. Previous multicenter studies have shown that the 2-year DFS rate of postoperative patients with stage II and III colorectal cancer treated with long-term traditional Chinese medicine syndrome differentiation therapy was 87.0%, and the 3-year DFS rate was 81.1%. Another study included patients with stage II and III CRC who underwent surgery from 2019 to 2022 showed that the 2-year DFS rate of patients treated with XELOX was 81.82%. After intervention with the traditional Chinese medicine composition of the present application, the 2-year and 3-year DFS rates of patients were increased by about 5.31% and 1.76% compared with the DFS rate of the control group in the previous traditional Chinese medicine syndrome differentiation therapy study, and increased by about 10.49% compared with the DFS rate of chemotherapy combined with DC-CIK immunotherapy in the same period. It can be considered that the traditional Chinese medicine composition of the present application can effectively reduce the recurrence and metastasis of postoperative patients with stage II-III colorectal cancer after intervention. The increased DFS rate after intervention of the traditional Chinese medicine composition of the present application compared with the above studies proves that the formula has significant efficacy in preventing and treating postoperative recurrence and metastasis of colorectal cancer.

[0063] Study two: Traditional Chinese medicine intervention on the quality of life of postoperative patients with stage II-III colorectal cancer

[0064] 1. Study design

[0065] The same as study one.

[0066] 2. Study criteria

[0067] 2.1 KPS, ECOG score

[0068] KPS refers to the literature report, with a total score of 100 points, of which 0 points indicate death, 10 points indicate critical condition, and near death; 20 points indicate severe illness, requiring hospitalization and active support treatment; 30 points indicate severe self-care; 40 points indicate self-care, requiring special care and assistance; 50 points indicate constant care; 60 points indicate that most of the life can be self-care, but occasionally need help; 70 points indicate that life can be self-care, but cannot maintain normal life or work; 80 points indicate that normal activities can be performed with some symptoms or signs; 90 points indicate that normal activities can be performed with mild symptoms and signs; 100 points indicate normal, no symptoms and signs.

[0069] ECOG score refers to the literature report, which is divided into 5 levels, of which level 5 indicates death; level 4 indicates bedridden and unable to care for oneself; level 3 indicates the need for bed, with more than 50% of daytime bedridden or wheelchair; level 2 indicates occasional bedridden, but daytime bedridden time is not more than 50%; level 1 indicates symptoms, but almost completely free to move; level 0 indicates normal activity.

[0070] 2.2 Anderson Symptom Assessment Scale

[0071] The M.D Anderson Symptom Inventory-Chinese version (MDASI-TCM, MDASI-GI) was used to evaluate the clinical symptoms of the patients. The scale included two parts, 15 items for the evaluation of the symptoms of the patients and 6 items for the evaluation of the degree of the disturbance of the patients, and a total of 21 items. All the items were scored by 0-10 points, and the higher the score, the more serious the symptoms. The first part of the scale evaluated the 15 symptoms (pain, fatigue, nausea, sleep disturbance, distress, shortness of breath, forgetfulness, loss of appetite, drowsiness, dry mouth, sadness, vomiting, numbness, constipation, and diarrhea) experienced by the patients in the past; the second part evaluated the degree of disturbance of the patients' life, including 6 items (general activity, emotion, work, relationship with others, walking, and life pleasure).

[0072] 3. Results of the study

[0073] 3.1 General characteristics

[0074] In this study, 60 patients were included, and 8 patients were excluded due to loss of follow-up. The general characteristics were the same as those in Table 1.

[0075] 3.2 Primary outcomes

[0076] The KPS score, KEGG classification and Anderson symptom score did not conform to the normal distribution, so the quartiles were described, and the non-parametric test was used. The results of the study are shown in Table 3. The KPS scores at 2 years and 3 years were slightly lower than the median at 1 year, but the difference was not statistically significant. The ECOG score did not change significantly. The Anderson symptom score at 2 years and 3 years was lower than that at baseline, and the Anderson symptom score at 3 years was lower than that at 2 years, and the differences were statistically significant (p<0.05).

[0077] Table 3 Clinical symptoms of patients

[0078]

[0079] Note: *p<0.05 compared with baseline, #p<0.05 compared with 2 years.

[0080] 4. Conclusion

[0081] The traditional Chinese medicine composition of the present application can improve the quality of life of patients after colorectal cancer surgery and improve the clinical symptoms of the patients.

[0082] Study three: typical cases and curative effects

[0083] Case one:

[0084] Xin, male, 54 years old, first diagnosed on January 18, 2023, the patient underwent laparoscopic sigmoid colectomy on June 29, 2022, and postoperative pathology showed mucous gland carcinoma, with a small part of the area showing low differentiated adenocarcinoma, pathological stage pT4N2M0, stage IIIc, and 6 cycles of postoperative chemotherapy. At present: no abdominal pain and abdominal distension, no acid reflux and heartburn, dry mouth, slight nausea, occasional hiccups, sleep well, 1 daily stool, shaped, sticky, not completely discharged, normal urination, pale red tongue, slightly yellowish and greasy fur, slow and slippery pulse. Western medical diagnosis: malignant tumor of sigmoid colon, TCM diagnosis: intestinal fungus, deficiency of both qi and blood, and internal accumulation of damp-heat.

[0085] Traditional Chinese medicine prescription: Huangqi 30g, Zhimu 10g, E'zhu 9g, Hujiateng 10g, Tenglishigen 15g, Lingxiaohua 15g, Fried Jujube 10g, Beipaijiangcao 15g, Chishao 15g, Baihuashexiecao 15g, Heye 15g, Chubencao 15g, Huai Niuxi 15g.

[0086] Decoction, 1 dose per day, morning and evening.

[0087] The patient regularly visits the outpatient clinic for TCM treatment, and on March 18, 2025, the patient's 10th visit, the patient's condition is stable, the symptoms of dry mouth and nausea are significantly relieved, and the stool is not sticky and not completely discharged. There was no recurrence or metastasis from the postoperative period to the last visit.

[0088] Case Two:

[0089] Liu J, male, 52 years old, first diagnosed on February 24, 2021, the patient underwent laparoscopic-assisted anterior resection of rectal cancer on March 12, 2019, and postoperative pathology showed moderately differentiated adenocarcinoma of the rectum with low differentiated tumor cell clusters, pathological stage pT3N2bM0, stage IIIc, and 8 cycles of postoperative concurrent radiotherapy. At present: 3-4 daily stools, shaped, sticky, not completely discharged, sometimes defecation without fecal discharge, fear of heat, five heart heat, white skin fungus on both elbow joints, no abdominal pain and abdominal distension, sleep well, normal urination. Dark red tongue with teeth marks, thin yellow fur, slow and fine pulse. Western medical diagnosis: malignant tumor of rectum, TCM diagnosis: intestinal fungus, deficiency of both qi and blood, and internal accumulation of damp-heat

[0090] Traditional Chinese medicine prescription: Huangqi 30g, Zhimu 10g, E'zhu 9g, Xuan 15g, Chishao 15g, Shengdihuang 15g, Huai Niuxi 15g, Hujiateng 10g, Lingxiaohua 15g, Tenglishigen 15g, Fried Jujube 10g, Muxiang 6g.

[0091] Decoction, 1 dose per day, morning and evening.

[0092] The patient regularly visits the clinic, and receives TCM treatment. On January 15, 2025, the patient visits the clinic for the 19th time. The patient's condition is stable, with 1-2 stools per day, shaped, non-sticky quality, and no feeling of incomplete evacuation. The five heat symptoms are obviously relieved compared with before, and there is no recurrence or metastasis from after the operation to the last visit.

[0093] Obviously, the above embodiments of the present application are only examples for clearly illustrating the present application, and are not intended to limit the embodiments of the present application. For those skilled 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. Use of a traditional Chinese medicine composition in the preparation of a medicament for postoperative treatment of colorectal cancer, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials: raw astragalus, rhizoma anemarrhenae, zedoaria, stir-fried fructus aurantii, red peony root, radix achyranthis Bidentatae, root of tenuifolia, polygonum cuspidatum and flos campsis.

2. The use according to claim 1, characterized in that The drug for postoperative treatment of colorectal cancer includes at least one of the following: 1) Drugs for improving clinical symptoms in patients after colorectal cancer surgery, wherein the clinical symptoms include at least one of abdominal distension and pain, loss of appetite, change in bowel habits, bloody and mucous stools, tenesmus, fatigue, and nausea and vomiting; 2) Drugs that prolong disease-free survival in patients after colorectal cancer surgery; 3) Drugs for preventing and treating recurrence and metastasis of colorectal cancer after surgery.

3. The use according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw medicines in parts by weight: 30-60 parts of raw astragalus, 6-10 parts of rhizoma anemarrhenae, 6-9 parts of zedoaria, 10-15 parts of stir-fried fructus aurantii, 10-15 parts of red peony root, 10-15 parts of rhizoma schoenopsis, 10-15 parts of rhizoma schoenopsis, 10-15 parts of rhizoma schoenopsis, 10-15 parts of rhizoma schoenopsis and 10-15 parts of camphor creeper.

4. The use according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw medicines in parts by weight: 30 parts of raw astragalus, 10 parts of rhizoma anemarrhenae, 9 parts of zedoaria, 10 parts of stir-fried fructus aurantii, 15 parts of red peony root, 15 parts of rhizoma cyperi, 15 parts of rhizoma polygonati, and 15 parts of flos campsis.

5. The use according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw medicines in parts by weight: 45 parts of raw astragalus, 6 parts of rhizoma anemarrhenae, 9 parts of zedoaria, 12 parts of stir-fried fructus aurantii, 15 parts of rapeseed, 10 parts of radix erythrorhizome, 10 parts of rhizoma strychnifoliae, 10 parts of rhizoma polygonati cuspidati, and 10 parts of flos campsis.

6. The use according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw medicines in parts by weight: 60 parts of raw astragalus, 10 parts of rhizoma anemarrhenae, 6 parts of zedoaria, 10 parts of stir-fried fructus aurantii, 10 parts of red peony root, 15 parts of radix polygoni cuspidati, 15 parts of rhizoma strychnifoliae, 15 parts of rhizoma polygonati and 15 parts of flos campsis.

7. The use according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw medicines in parts by weight: 30 parts of raw astragalus, 6 parts of rhizoma anemarrhenae, 6 parts of zedoaria, 15 parts of stir-fried fructus aurantii, 10 parts of red peony root, 10 parts of rhizoma cyperi, 10 parts of rhizoma schoenopsis, 15 parts of polygonum cuspidatum, and 10 parts of flos campsis.

8. The use according to claim 1, characterized in that The traditional Chinese medicine composition is added with pharmaceutically acceptable excipients to prepare a medicine for postoperative treatment of colorectal cancer.

9. The use according to claim 1, characterized in that The dosage form of the medicine includes decoction, tablet, granule, pill, powder, capsule or powder.

10. The use according to claim 1, characterized in that The colorectal cancer is stage II or stage III colorectal cancer.

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