Pharmaceutical composition for treating rectal cancer low resection syndrome

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and provides a pharmaceutical composition for treating rectal cancer low resection syndrome. The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 20 to 40 parts of radix astragali seu hedysari, 5 to 15 parts of radix ginseng, 4 to 8 parts of rhizoma cimicifugae, 5 to 15 parts of radix angelicae sinensis, 5 to 15 parts of radix aucklandiae, 20 to 40 parts of fructus aurantii, 20 to 40 parts of fructus aurantii immaturus, 5 to 15 parts of rhizoma coptidis and 20 to 40 parts of herba taraxaci. The symptoms of the low-position pre-resection syndrome are weakness, anus heavy falling, inexhaustible defecation, abdominal distension, tenesmus, frequent defecation, difficult defecation, loose stool and the like; the syndrome type is spleen deficiency and no rising of clear yang; and a treatment method: harmonizing lifting. After a rectal cancer operation, after radiotherapy and chemotherapy, qi and blood deficiency, spleen and stomach injury, qi and blood biochemical deficiency, dampness pathogen, blood stasis and cancer toxin are deficient in the body, the intestinal tract is firstly invaded to cause difficulty in defecation, in addition, various pathogens invade various parts of a human body, or deficiency of qi and blood can cause various symptoms, so that the main effects of tonifying middle-jiao, ascending and descending and regulating qi activity are achieved, and finally the symptoms are relieved; the curative effect is good.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a pharmaceutical composition for treating low resection syndrome of rectal cancer. Background Art

[0002] Low anterior resection syndrome (LARS) refers to any change in defecation status after anal sphincter preservation surgery for rectal cancer, mainly manifested as fecal incontinence, frequent defecation, incomplete emptying, tenesmus, and difficulty in defecation. According to statistics, the rate of anal preservation surgery for rectal cancer is 62.0%-85.0%, among which the anal preservation rate for low rectal cancer is 50.0-79.0%, but the incidence of LARS is as high as 60-90%, and common symptoms are fecal incontinence (97%), frequent defecation (80%), flatus incontinence (70%), urgency (67%), and emptying dysfunction (47%). LARS can be divided into two types: urge incontinence type and emptying disorder type. The urge incontinence type is mainly manifested by increased defecation frequency and difficulty in controlling gas and feces; the emptying disorder type is mainly manifested by emptying disorder, difficulty in defecation, and tenesmus. Modern medical treatments for LARS include: adjusting diet, antidiarrheal drugs, laxatives, pelvic floor rehabilitation, anal irrigation, sacral nerve stimulation, etc., which are empirical and limited, and therefore are critical to the relief of LARS symptoms after rectal cancer surgery. In recent years, the combination of traditional Chinese medicine and Western medicine in the treatment of LARS has shown great advantages, and the long-term efficacy and cure rate of LARS have been greatly improved. LARS belongs to the category of "diarrhea", "dysentery" and "constipation" in traditional Chinese medicine. Summary of the invention

[0003] The invention provides a pharmaceutical composition for treating rectal cancer low resection syndrome.

[0004] The present invention is achieved by the following technical scheme: a pharmaceutical composition for treating low resection syndrome of rectal cancer, comprising the following raw materials in parts by weight: 20-40 parts of astragalus, 5-15 parts of ginseng, 4-8 parts of cimicifuga, 5-15 parts of angelica, 5-15 parts of costusroot, 20-40 parts of fructus aurantii, 20-40 parts of immature bitter orange, 5-15 parts of coptis chinensis, and 20-40 parts of dandelion.

[0005] Furthermore, the composition comprises the following raw materials in parts by weight: 25-35 parts of astragalus, 8-12 parts of ginseng, 5-7 parts of cimicifuga, 8-12 parts of angelica, 8-12 parts of costusroot, 25-35 parts of fructus aurantii, 25-35 parts of immature bitter orange, 8-12 parts of coptis root, and 25-35 parts of dandelion.

[0006] Furthermore, the invention comprises the following raw materials in parts by weight: 30 parts of astragalus, 10 parts of ginseng, 6 parts of cimicifuga, 10 parts of angelica, 10 parts of costusroot, 30 parts of fructus aurantii, 30 parts of immature bitter orange, 10 parts of coptis root and 30 parts of dandelion.

[0007] The medicine of the present invention is conventionally decocted in water, one dose per day, decocted in water 200 ml, taken warm 100 ml each morning and evening, one week as a course of treatment, and the efficacy is observed after one course of treatment.

[0008] In the pharmaceutical composition for treating low resection syndrome of rectal cancer described in the present invention: Astragalus is warm in nature, sweet in taste, and belongs to the lung meridian and spleen meridian. It can replenish qi and consolidate the exterior, support toxins and discharge pus, promote diuresis, and promote tissue regeneration. It is used for qi deficiency and fatigue, chronic diarrhea and prolapse of the anus, spontaneous sweating, edema, prolapse of the uterus, proteinuria of chronic nephritis, diabetes, and wounds that do not heal for a long time. Ginseng enters the spleen meridian and lung meridian; it greatly replenishes the vital energy, consolidates the body fluid, and calms the mind. It can treat fatigue due to overwork, poor appetite, fatigue, nausea and vomiting, loose stools, weak cough and shortness of breath, spontaneous sweating and sudden loss of body fluid, palpitations, forgetfulness, dizziness and headache, impotence, frequent urination, thirst, metrorrhagia in women, slow fright in children, and long-term deficiency and all signs of insufficient qi, blood and body fluid. Cimicifuga enters the lung meridian, spleen meridian, and stomach meridian. It can raise yang, release the exterior, clear rashes, and detoxify. Treat epidemic diseases, headache, cold and heat, sore throat, mouth sores, macules that do not penetrate; sinking of middle qi, chronic diarrhea and dysentery, prolapse of the anus, metrorrhagia, leucorrhea, uterine prolapse in women; carbuncle, swelling and ulcer. Angelica sinensis is sweet; pungent; bitter; warm in nature, and enters the liver meridian; heart meridian; spleen meridian; replenishes blood and activates blood circulation, regulates menstruation and relieves pain, and moistens the intestines and promotes bowel movements. It is used for blood deficiency and sallow complexion, dizziness and palpitations, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to deficiency and cold, constipation due to dry intestines, rheumatic arthralgia, injuries due to falls, carbuncle, ulcers and ulcers. Wood fragrance is pungent; bitter; warm in nature; enters the gallbladder meridian; stomach meridian; large intestine meridian; triple burner meridian; lung meridian; promotes qi and relieves pain, warms the middle and harmonizes the stomach. It treats middle cold and qi stagnation, chest and abdominal distension and pain, vomiting, diarrhea, dysentery, tenesmus, and cold hernia. Citrus aurantium is the dried immature fruit of the Rutaceae plant sour orange and its cultivated varieties. Treats phlegm stagnation in the chest and diaphragm, chest distension, flank distension, food accumulation, belching, vomiting, heaviness after diarrhea, rectal prolapse, and uterine prolapse; enters the lung meridian, spleen meridian, liver meridian, stomach meridian, and large intestine meridian; breaks qi, promotes phlegm, and eliminates accumulation. Treats phlegm stagnation in the chest and diaphragm, chest distension, flank distension, food accumulation, belching, vomiting, heaviness after diarrhea, rectal prolapse, and uterine prolapse. Zhishi is bitter in nature and cold in taste. Enters the spleen meridian and stomach meridian. Breaks qi, disperses lumps, clears phlegm, and eliminates accumulation. Treats chest and abdominal distension, chest pain, lumps, edema, food accumulation, constipation, gastroptosis, uterine prolapse, and rectal prolapse. Coptis chinensis is bitter in nature and cold in taste; enters the heart meridian, liver meridian, stomach meridian, and large intestine meridian; clears fire, dries dampness, detoxifies, and kills insects. It can treat seasonal heat toxins, typhoid fever, excessive heat and restlessness, fullness and vomiting, bacillary dysentery, abdominal pain due to hot diarrhea, lung stagnation, vomiting, epistaxis, bleeding, thirst, malnutrition, ascariasis, whooping cough, sore throat, fire eyes, mouth sores, carbuncle, eczema, and burns caused by hot water or fire. Dandelion tastes bitter and sweet; it is cold in nature; it enters the liver meridian and stomach meridian; it clears away heat and detoxifies, and is diuretic and dispersing. It can treat acute mastitis, lymphadenitis, scrofula, carbuncle, acute conjunctivitis, fever due to cold, acute tonsillitis, acute bronchitis, gastritis, hepatitis, cholecystitis, and urinary tract infection.

[0009] The symptoms of low anterior resection syndrome include fatigue, heaviness in the anus, feeling of incomplete defecation, abdominal distension, tenesmus, frequent defecation, difficulty in defecation, loose stools, etc.; Syndrome type: spleen deficiency and failure of clear yang to rise; Treatment method: harmonize the rise and fall.

[0010] After surgery for rectal cancer and radiotherapy and chemotherapy, the Qi and blood are deficient, the spleen and stomach are also damaged, and the Qi and blood are lacking in source. In addition, dampness, blood stasis, and cancer toxins take advantage of the deficiency and first invade the intestines, causing difficulty in defecation. In addition, various evils invade various parts of the body, or insufficient Qi and blood can cause various complications. Therefore, the main treatment is to tonify the middle and raise and lower, regulate Qi, and eventually the symptoms are relieved with a very good effect.

[0011] The clinical application of the Chinese medicine of the present invention is as follows: Western medicine diagnostic criteria: Diagnosis of rectal cancer: patients with rectal cancer confirmed by pathology or cytology; Diagnosis of low anterior resection syndrome: refer to the international consensus definition of LARS proposed by the LARS International Collaborative Group in 2020: patients must have undergone anterior resection (sphincter-sparing proctectomy) and have at least one of the consequences caused by one of the symptoms: (1) Symptoms: frequent bowel movements; urgency; incontinence; fecal contamination; difficulty emptying; changes in stool consistency; recurrent anal pain; unpredictable changes in bowel function; (2) Consequences: Toilet dependence; excessive focus on bowel function; dissatisfaction with bowel function; seeking countermeasures and compromises; affecting mental and emotional state; affecting social daily life; affecting intimate relationships; affecting image commitment and responsibility.

[0012] TCM diagnostic criteria: refer to the "Guidelines for Clinical Research of New Chinese Medicines". TCM syndrome differentiation belongs to the type of insufficient Qi in the middle: Main symptoms: fatigue; heaviness in the anus; feeling of incomplete defecation; Secondary symptoms: abdominal distension; tenesmus; frequent defecation; difficult defecation; loose stools; Tongue and pulse: pale and fat tongue, thin white fur, and thin pulse. If two of the main symptoms and one of the secondary symptoms are present, the diagnosis can be made in combination with the tongue and pulse.

[0013] Inclusion criteria: (1) clear pathological diagnosis of rectal cancer; (2) patients who underwent low anterior resection for rectal cancer, with intact anus, no preventive stoma, and resumed normal diet; (3) met the LARS diagnostic criteria; (4) were diagnosed as insufficient middle qi in TCM syndrome differentiation; (5) aged ≥ 18 years, regardless of gender; (6) had basic communication and comprehension skills, and were able to cooperate with examinations, treatment, and follow-up; (7) voluntarily participated in this study and signed the informed consent form.

[0014] Exclusion criteria: patients with distant tumor metastasis and an estimated survival period of less than 3 months; patients receiving neoadjuvant chemoradiotherapy before surgery; patients with complications such as anastomotic leakage, anastomotic bleeding, stenosis, intestinal perforation after surgery; patients with repeated intestinal obstruction after surgery, or patients who cannot eat a normal diet regularly due to various other reasons; patients with anal sphincter injury, anal malformation, inflammatory bowel disease or other diseases that cause anorectal dysfunction before surgery; patients undergoing pelvic or anal surgery; patients with severe heart, lung, kidney and other systemic diseases; patients receiving other LARS-related treatments within one month before enrollment; patients participating in other clinical trials; patients with a history of allergy to the drugs used in this study.

[0015] Exclusion and dropout criteria: failure to use medication and treatment as prescribed; natural loss of follow-up or dropout; voluntary withdrawal of subjects during the study; occurrence of intolerable adverse reactions; no patients who do not meet the conditions were found when the cases were included, and they should be promptly excluded if found.

[0016] Treatment method: 30g of Astragalus, 10g of Ginseng, 6g of Cimicifuga, 10g of Angelica, 10g of Costusroot, 30g of Citrus aurantium, 30g of Citrus aurantium, 10g of Coptis chinensis, and 30g of Taraxacum mongolicum; take one dose of the above medicine daily, decocted in 200ml of water, and taken warm 100ml each morning and evening. One week is one course of treatment, and the efficacy is observed after one course of treatment.

[0017] Indications: Low anterior resection syndrome (Qi deficiency type). Symptoms: fatigue, heaviness in the anus, feeling of incomplete defecation, abdominal distension, tenesmus, frequent defecation, difficult defecation, loose stools, pale and fat tongue, thin white fur, and thin pulse.

[0018] Observation indicators: TCM symptom score evaluation was performed before treatment, and after 1, 2, 3, and 4 weeks of medication.

[0019] Main efficacy indicators: Evaluation of TCM symptom score: With reference to the Guiding Principles for Clinical Research of New Chinese Medicines and combined with the actual clinical manifestations of patients with qi deficiency type LARS, a TCM symptom score grading and quantitative evaluation table was developed (see Table 1). It mainly includes eight symptoms and signs such as fatigue, anal heaviness, feeling of incomplete defecation, abdominal distension, tenesmus, frequent defecation, difficult defecation, and loose stools as observation indicators, and is divided into four levels of "never, sometimes, often, and always", and each is given a score of 0-3 points.

[0020] The efficacy was determined by referring to the "Clinical Guidance for New Chinese Medicines" to compare whether there were differences in the symptom scores and the total score of TCM symptoms after treatment. The efficacy index = [(symptom score before treatment - symptom score after treatment) / symptom score before treatment] × 100%, and the evaluation results were divided into the following categories: ① Clinical cure: symptoms basically disappeared, efficacy index > 95%; ② Significant effect: symptoms significantly improved, 95% ≥ efficacy index > 70%; ③ Effective: symptoms improved, 70% ≥ efficacy index > 30%; ④ Ineffective: symptoms did not improve significantly, efficacy index ≤ 30%.

[0021] Table 1: LARS TCM symptom score grading quantitative evaluation table Treatment results: A total of 30 patients were included, including 19 males with an average age of 63.4 years old and 11 females with an average age of 64.8 years old.

[0022] The results of TCM symptom efficacy evaluation are shown in Tables 2, 3, 4, and 5.

[0023] Table 2: Evaluation of efficacy after taking the medicine for 1 week Table 3: Evaluation of efficacy after 2 weeks of medication Table 4: Evaluation of efficacy after 3 weeks of medication Table 5: Evaluation of efficacy after 4 weeks of medication Typical cases: 1. Ren, female, 52 years old, chief complaint: rectal cancer surgery for more than 5 years; current medical history: the patient went to Shanxi Provincial Anorectal Hospital for treatment on June 5, 2018 due to blood in stool for more than 5 months, colonoscopy diagnosis: rectal cancer. Pathology: adenocarcinoma grade 2, some of which are signet ring cell carcinoma. Preoperative chemotherapy for 1 cycle, oxaliplatin + capecitabine + apatinib. Radiotherapy 25 times.

[0024] On September 19, 2018, he underwent rectal cancer fistula surgery at the Provincial People's Hospital. Postoperative pathology showed that a small amount of moderately differentiated tubular adenocarcinoma remained in the tumor bed (rectum after radiotherapy), and the tumor invaded the surrounding intestinal tissue with a large amount of acellular mucus lakes, which met the tumor regression grade 1, and periintestinal lymph node metastasis (2 / 12). He received 2 cycles of chemotherapy after surgery, using lobaplatin + capecitabine. In September 2023, he underwent rectal fistula reduction surgery.

[0025] First visit on November 3, 2023: Conscious fatigue, anal prolapse, difficulty in defecation, frequent stool, 3-5 times a day, thin stool. Pale red tongue, thin white fur, stringy and fine pulse. Prescription: Astragalus 30g, Ginseng 10g, Cimicifuga 6g, Angelica 10g, Aucklandia 10g, Citrus aurantium 30g, Citrus aurantium 30g, Coptis chinensis 10g, Taraxacum mongolicum 30g. One dose per day, decoct 500ml in water, take 250ml warm in the morning and evening, one week as a course of treatment, observe the efficacy after one course of treatment.

[0026] On November 10, 2023, fatigue improved, anal prolapse improved, defecation difficulty relieved, defecation frequency reduced, 2-3 times a day, pale and fat tongue, thin white fur, and stringy pulse. Continue to take the medicine for one course of treatment and observe the efficacy.

[0027] On November 18, 2023, the patient was in good spirits, had occasional difficulty defecating, had bowel movements twice a day, had a pale and fat tongue, a thin white coating, and a stringy and fine pulse. Continue taking the medicine for one course of treatment and observe the efficacy.

[0028] On November 26, 2023, the feeling of difficulty in defecation disappeared, the spirit was good, the anal prolapse disappeared, the bowel movement was once a day, the tongue was pale red with thin white coating, and the pulse was stringy and thin.

[0029] The patient had rectal cancer surgery and there was residual tumor. After multiple rounds of radiotherapy and chemotherapy, the spleen and stomach were injured, resulting in spleen deficiency and failure of the clear yang to rise, and dysfunction of ascending and descending. When he was diagnosed on November 3, 2023, he showed fatigue, anal prolapse, difficulty in defecation, and frequent defecation.

[0030] The spleen and stomach are the source of Qi and blood biochemical transformation. After surgery, radiotherapy and chemotherapy, the patient's spleen and stomach are damaged, the vital energy is deficient and the Qi and blood biochemical transformation is lacking. The Qi is weak and unable to push the dregs, resulting in fatigue, difficulty in defecation, and the failure of the clear Yang to rise, resulting in anal prolapse and frequent defecation. Astragalus and ginseng are used to replenish the middle Qi, Cimicifuga and Bupleurum to raise the middle Qi, and Angelica to nourish blood and activate blood circulation. In addition, Aucklandia promotes Qi, Citrus aurantium breaks Qi, and Citrus aurantium lifts, so that the rise and fall are regulated and the Qi mechanism is raised. In addition, Coptis chinensis is used to remove the evil accumulation in the intestines.

[0031] The prescription is mainly for harmonizing and ascending and descending, and is combined with products that regulate qi and promote qi movement. Ultimately, the patient's symptoms of fatigue, anal prolapse, difficulty in defecation and frequent defecation after rectal cancer surgery were cured and the symptoms disappeared.

[0032] 2. Wang, female, 59 years old, chief complaint: more than 2 years after rectal cancer surgery; current medical history: in November 2021, she went to the hospital for tenesmus during defecation and was diagnosed with rectal cancer. She underwent rectal cancer surgery. No special treatment was performed after surgery. No recurrence or metastasis was found during regular follow-up. On July 7, 2023, she went to the hospital for treatment: weakness in both lower limbs, feeling of incomplete defecation, accompanied by abdominal distension, tenesmus, pale and fat tongue, white fur, and deep and fine pulse.

[0033] Prescription: Astragalus 30g, Ginseng 10g, Cimicifuga 6g, Angelica 10g, Aucklandia 10g, Citrus aurantium 30g, Citrus aurantium 30g, Coptis chinensis 10g, Taraxacum mongolicum 30g. One dose per day, decoct in 500ml of water, take warm in the morning and evening, 250ml each, one week as a course of treatment, observe the efficacy after one course of treatment.

[0034] On July 15, 2023, weakness in both lower limbs, feeling of incomplete defecation, abdominal distension, and tenesmus were all relieved. The tongue was pale and fat, the coating was thin and yellow, and the pulse was deep and fine. Continue to take the medicine for one course of treatment and observe the efficacy.

[0035] On July 23, 2023, fatigue, incomplete defecation, abdominal distension disappeared, tenesmus disappeared, tongue was pale, fat, white fur, and pulse was thin and stringy. Continue to take the medicine for one course of treatment and observe the efficacy.

[0036] The operation was performed in November 2021, and no special treatment was performed after the operation. In July 2023, the patient developed weakness in both lower limbs, incomplete defecation, and a feeling of tenesmus during defecation. The reason is that the patient's spleen and stomach are weak, and the surgical injury makes the qi of the middle-jiao spleen and stomach even weaker. In addition, there is invisible damp-heat evil accumulated in the body, resulting in symptoms such as incomplete defecation and tenesmus. Astragalus and ginseng are used to strengthen the spleen and replenish qi, nourish the middle-jiao, Cimicifuga and Bupleurum to raise the qi of the middle-jiao, Angelica to nourish blood and activate blood circulation, with Citrus aurantium, Aucklandia lappa, and Citrus aurantium to help promote qi, and Coptis chinensis to clear the damp-heat evil in the intestines.

[0037] On July 15, 2023, all symptoms were alleviated, and the feeling of urgency and heaviness after defecation was alleviated.

[0038] On July 23, 2023, fatigue, incomplete bowel movements, and abdominal distension disappeared, tenesmus during bowel movements disappeared, and the symptoms were cured.

[0039] 3. Li, male, 61 years old. Chief complaint: 3 years after chemotherapy and radiotherapy for rectal cancer, there is a feeling of incomplete defecation. Current medical history: Visited our hospital on May 21, 2024. Current symptoms: fatigue, feeling of anal prolapse, feeling of incomplete defecation, difficulty in defecation, stool once every 2-3 days, slightly sticky; pale and fat tongue, thin white fur, and stringy pulse. Prescription: 30 parts of Astragalus, 10 parts of Ginseng, 6 parts of Cimicifuga, 10 parts of Angelica, 10 parts of Aucklandia, 30 parts of Citrus aurantium, 30 parts of Citrus aurantium, 10 parts of Coptis chinensis, and 30 parts of Taraxacum. One dose per day, decoct 500ml in water, take 250ml warm in the morning and evening, 1 week as a course of treatment, and observe the efficacy after one course of treatment.

[0040] On May 29, 2024, fatigue was relieved, and the difficulty in defecation and the feeling of anal prolapse improved. The feeling of incomplete defecation was the same as before, and the taste was strong. The efficacy was observed after continuing to take the medicine for two courses.

[0041] On June 12, 2024, all the above symptoms disappeared. Continue to take the medicine for one course of treatment and observe the efficacy.

[0042] On May 21, 2024, the patient was weak, had a feeling of anal prolapse, had difficulty defecating, and could not defecate completely. He felt that the anal prolapse was due to spleen deficiency, the failure of the clear yang to rise, and the disorder of the qi mechanism, resulting in obstruction of stool emptying. Astragalus, ginseng, Cimicifuga, and Bupleurum have the effects of strengthening the spleen and replenishing qi and lifting the middle qi. Angelica can invigorate blood circulation and moisten the intestines and relieve constipation. It is combined with Citrus aurantium, Citrus aurantium, and Aucklandia to regulate qi and promote qi circulation to help restore the qi in the body, and Coptis chinensis eliminates dampness and heat in the body. Eliminate evil and strengthen the body.

[0043] On May 29, 2024, fatigue was relieved, and the difficulty in defecation and anal prolapse were improved. On June 12, 2024, fatigue, difficulty in defecation, anal prolapse, and incomplete defecation were cured. Continue consolidation treatment.

[0044] 4. Li, male, 58 years old. He underwent minimally invasive rectal surgery in July 2022. Postoperative pathology showed adenocarcinoma, so he underwent colostomy. In October 2022, he underwent colostomy reduction. After the surgery, he suffered from repeated tenesmus, abdominal distension, and fatigue, and sought treatment from many sources with poor results.

[0045] On February 21, 2023, he went to the outpatient clinic for TCM treatment. The initial diagnosis showed: tenesmus, abdominal distension, excessive flatulence, fatigue, poor appetite, good sleep, normal urination, pale and fat tongue with teeth marks, thin white fur, and deep and fine pulse. TCM diagnosis was spleen deficiency and dysfunction of ascending and descending.

[0046] Prescription: 30 parts of Astragalus, 10 parts of Ginseng, 6 parts of Cimicifuga, 10 parts of Angelica, 10 parts of Aucklandia, 30 parts of Citrus aurantium, 30 parts of Citrus aurantium, 10 parts of Coptis chinensis, 30 parts of Taraxacum mongolicum. Take one dose per day, decoct 500ml of water, take 250ml warm on an empty stomach in the morning and evening, one week as a course of treatment, observe the efficacy after two courses of treatment.

[0047] On March 5, 2023, the second visit showed that the patient's fatigue and weakness had improved significantly, but he still felt tenesmus, but it was significantly reduced compared to before. His tongue was pale and fat, his fur was thin and white, and his pulse was deep and fine. The patient continued to take the medicine for two courses of treatment and observed the efficacy.

[0048] On the third visit on March 19, 2023, the feeling of tenesmus disappeared, the bowel movement was 2-3 times a day, the tongue was pale and fat, the coating was thin and white, and the pulse was deep and fine. Continue to take the medicine for two courses to observe the efficacy. After follow-up, the patient's feeling of tenesmus did not recur.

[0049] Although the patient underwent surgery to remove the visible accumulation, there were still invisible turbid evils such as qi stagnation, blood stasis, damp heat, and cancer toxins in the body. In addition, the patient's vital energy was severely damaged after surgery, and the spleen and stomach were weak, unable to raise the clear and lower the turbid, and the large intestine could not be nourished, and the turbid evil accumulated in the intestine could not be discharged normally; the accumulation of pathological factors hindered the operation of the qi mechanism, causing the qi mechanism to become more imbalanced, so the defecation was not smooth and there was a feeling of tenesmus. Buzhong Shengjiang Decoction was used for treatment. First, the patient's vital energy was deficient after surgery, so it was used to protect the spleen and stomach, nourish the vital energy, and restore the normal qi mechanism and spleen and stomach transportation of the human body; second, it was used to remove evil and disperse the knot, eliminating the invisible evil that was not eliminated during surgery. The patient's tenesmus was relieved in the second visit. The symptoms disappeared in the third visit.

[0050] 5. Zhang, male, 43 years old. He underwent radical resection for rectal cancer in September 2016. Postoperative pathology showed moderately differentiated adenocarcinoma of rectal ulcer type. He received 8 cycles of adjuvant chemotherapy with oxaliplatin + capecitabine after surgery. In July 2020, he underwent left lower lobectomy + mediastinal lymph node dissection. Postoperative pathology showed that he was consistent with metastatic adenocarcinoma, which may have originated from the colorectum. He received 6 cycles of chemotherapy after surgery.

[0051] On May 10, 2021, he was diagnosed in our hospital. Symptoms: fatigue, 7-8 stools per day, unformed, sticky, regular urine, good appetite and sleep, pale tongue with white fur, and weak pulse. The Chinese medicine dialectic is spleen deficiency and dysfunction of ascending and descending. The treatment is to harmonize ascending and descending. Prescription: 30 parts of Astragalus, 10 parts of Ginseng, 6 parts of Cimicifuga, 10 parts of Angelica, 10 parts of Aucklandia, 30 parts of Citrus aurantium, 30 parts of Citrus aurantium, 10 parts of Coptis chinensis, and 30 parts of Taraxacum. Conventional decoction, one dose per day, 500ml of decoction, 250ml warm in the morning and evening, one week as a course of treatment, observe the efficacy after one course of treatment.

[0052] Second visit on May 18, 2021: slightly fatigued, 5-6 bowel movements per day, sticky, regular urine, good appetite and sleep, pale tongue with white fur, weak pulse. Continue to take the medicine for three courses and observe the efficacy.

[0053] Third visit on June 9, 2021: Symptoms have basically disappeared, and consolidation treatment will continue. Continue to take the medicine for two courses and observe the efficacy.

[0054] After surgery, radiotherapy and chemotherapy, the patient suffered from fatigue and diarrhea. It was considered that the disease was located in the spleen, and the spleen was deficient in qi, the clear yang did not rise, and the diarrhea occurred. Buzhong Jiangsheng Decoction was used to invigorate qi and strengthen the spleen, and to harmonize the ascending and descending. The patient's diarrhea was slightly relieved at the second visit, and the treatment was continued. The diarrhea symptoms disappeared at the third visit, and the treatment was consolidated. Buzhong Jiangsheng Decoction can harmonize the ascending and descending, so that the spleen and stomach qi can run normally, and it has a good effect on low anterior resection syndrome. DETAILED DESCRIPTION

[0055] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all the embodiments; based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0056] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs, and the disclosure and materials cited therein are hereby incorporated by reference.

[0057] Technical equivalents to the specific embodiments described that are apparent to those skilled in the art using no more than routine experimentation are intended to be encompassed by this application.

[0058] Example 1: A pharmaceutical composition for treating low resection syndrome of rectal cancer, comprising the following raw materials by weight: 20g of Astragalus, 5g of Ginseng, 4g of Cimicifuga, 5g of Angelica, 5g of Aucklandia, 20g of Citrus aurantium, 20g of Citrus aurantium, 5g of Coptis chinensis, and 20g of Taraxacum. The above drugs are conventionally decocted in water, one dose per day, divided into two doses in the morning and evening, one week as a course of treatment, and the efficacy is observed after one course of treatment. The drug prepared in this embodiment also uses the above-mentioned diagnostic basis, efficacy criteria and treatment methods for clinical trials, and 38 patients (including 26 males and 12 females) are treated. The treatment results are: 35 cases are cured, accounting for 92.11%, and 3 cases are improved, accounting for 7.89%. The total effective rate is 100%.

[0059] Example 2: A pharmaceutical composition for treating low resection syndrome of rectal cancer, comprising the following raw materials by weight: 40g of Astragalus, 15g of Ginseng, 8g of Cimicifuga, 15g of Angelica, 15g of Aucklandia, 40g of Citrus Aurantii, 40g of Citrus Aurantii Immaturus, 15g of Coptis chinensis, and 40g of Taraxacum. The drug prepared in this example also uses the above-mentioned diagnostic basis, efficacy criteria and treatment methods for clinical trials, and treats 40 patients (30 males and 10 females). The treatment results are as follows: 38 cases were cured, accounting for 95%, and 2 cases were improved, accounting for 5%. The total effective rate reached 100%.

[0060] Example 3: A pharmaceutical composition for treating low resection syndrome of rectal cancer, comprising the following raw materials by weight: 23g of Astragalus, 6g of Ginseng, 4.5g of Cimicifuga, 7g of Angelica, 6g of Aucklandia, 23g of Citrus Aurantii Immaturus, 7g of Coptis Chinensis, and 23g of Taraxacum. The drug prepared in this example also uses the above-mentioned diagnostic basis, efficacy criteria and treatment methods for clinical trials, and 36 patients (including 20 males and 16 females) are treated. The treatment results are as follows: 33 cases are cured, accounting for 91.67%, and 3 cases are improved, accounting for 8.33%. The total effective rate is 100%.

[0061] Example 4: A pharmaceutical composition for treating low resection syndrome of rectal cancer, comprising the following raw materials by weight: 25g of Astragalus, 8g of Ginseng, 5g of Cimicifuga, 8g of Angelica, 8g of Aucklandia, 25g of Citrus Aurantii Immaturus, 25g of Coptis chinensis, and 25g of Taraxacum. The drug prepared in this example also uses the above-mentioned diagnostic basis, efficacy criteria and treatment methods for clinical trials, and 32 patients (including 20 males and 12 females) are treated. The treatment results are as follows: 30 cases are cured, accounting for 93.75%, and 2 cases are improved, accounting for 6.25%. The total effective rate is 100%.

[0062] Example 5: A pharmaceutical composition for treating low resection syndrome of rectal cancer, comprising the following raw materials by weight: 30g of Astragalus, 10g of Ginseng, 6g of Cimicifuga, 10g of Angelica, 10g of Aucklandia, 30g of Citrus Aurantii, 30g of Citrus Aurantii Immaturus, 10g of Coptis chinensis, and 30g of Taraxacum. The drug prepared in this example also uses the above-mentioned diagnostic basis, efficacy criteria and treatment methods for clinical trials, and treats 42 patients (10 males and 32 females). The treatment results are as follows: 40 cases were cured, accounting for 95.24%, and 2 cases were improved, accounting for 4.76%. The total effective rate reached 100%.

[0063] Example 6: A pharmaceutical composition for treating low resection syndrome of rectal cancer, comprising the following raw materials by weight: 35g of Astragalus, 12g of Ginseng, 7g of Cimicifuga, 12g of Angelica, 12g of Aucklandia, 35g of Citrus Aurantii, 35g of Citrus Aurantii Immaturus, 12g of Coptis chinensis, and 35g of Taraxacum. The drug prepared in this example was also clinically tested using the above-mentioned diagnostic basis, efficacy criteria, and treatment methods, and 40 patients (26 males and 14 females) were treated. The treatment results showed that 38 patients were cured, accounting for 95%, and 2 patients were improved, accounting for 5%. The total effective rate was 100%.

[0064] Example 7: A pharmaceutical composition for treating low resection syndrome of rectal cancer, comprising the following raw materials by weight: 20g of Astragalus, 13g of Ginseng, 4g of Cimicifuga, 15g of Angelica, 5g of Aucklandia, 22g of Citrus Aurantii Immaturus, 38g of Citrus Aurantii Immaturus, 5g of Coptis Chinensis, and 38g of Taraxacum. The drug prepared in this example also uses the above-mentioned diagnostic basis, efficacy criteria and treatment methods for clinical trials, and treats 30 patients (16 males and 14 females). The treatment results are as follows: 28 cases were cured, accounting for 93.33%, and 2 cases were improved, accounting for 6.67%. The total effective rate reached 100%.

[0065] Example 8: A pharmaceutical composition for treating low resection syndrome of rectal cancer, comprising the following raw materials by weight: 37g of Astragalus, 7g of Ginseng, 6g of Cimicifuga, 13g of Angelica, 14g of Aucklandia, 37g of Citrus aurantium, 40g of Citrus aurantium, 15g of Coptis chinensis, and 20g of Taraxacum. The drug prepared in this example also uses the above-mentioned diagnostic basis, efficacy criteria and treatment methods for clinical trials, and treats 42 patients (10 males and 32 females). The treatment results are as follows: 40 cases were cured, accounting for 95.24%, and 2 cases were improved, accounting for 4.76%. The total effective rate reached 100%.

[0066] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A pharmaceutical composition for treating rectal cancer low resection syndrome, characterized in that: The invention comprises the following raw materials in parts by weight: 20-40 parts of astragalus, 5-15 parts of ginseng, 4-8 parts of cimicifuga, 5-15 parts of angelica, 5-15 parts of costusroot, 20-40 parts of fructus aurantii, 20-40 parts of immature bitter orange, 5-15 parts of coptis root and 20-40 parts of dandelion.

2. The pharmaceutical composition for treating low resection syndrome of rectal cancer according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 25-35 parts of astragalus, 8-12 parts of ginseng, 5-7 parts of cimicifuga, 8-12 parts of angelica, 8-12 parts of costusroot, 25-35 parts of fructus aurantii, 25-35 parts of immature bitter orange, 8-12 parts of coptis root and 25-35 parts of dandelion.

3. The pharmaceutical composition for treating low resection syndrome of rectal cancer according to claim 1, characterized in that: The invention comprises the following raw materials in parts by weight: 30 parts of astragalus, 10 parts of ginseng, 6 parts of cimicifuga, 10 parts of angelica, 10 parts of costusroot, 30 parts of fructus aurantii, 30 parts of immature bitter orange, 10 parts of coptis root and 30 parts of dandelion.

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