A traditional Chinese medicine composition for treating low anterior resection syndrome and use thereof

Abstract

This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for treating low anterior rectal resection syndrome and its uses. By weight, the traditional Chinese medicine composition consists of 18-30 parts of Atractylodes macrocephala, 12-18 parts of Atractylodes lancea, 12-18 parts of Coix lacryma-jobi, 18-30 parts of Poria cocos, 12-20 parts of Galla chinensis, 12-16 parts of Scutellaria baicalensis, 20-30 parts of Paeonia lactiflora, 9-12 parts of Mentha haplocalyx, 9-18 parts of Astragalus membranaceus, 12-18 parts of Pulsatilla chinensis, 12-18 parts of Prunus mume, 12-18 parts of Cimicifuga foetida, 10-15 parts of Phellodendron chinense, and 10-16 parts of Paeonia lactiflora. These fourteen herbs work together to tonify the spleen and stomach, clear damp-heat, and astringe the intestines, and can be used to prepare a medicine for treating low anterior rectal resection syndrome.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine, specifically relating to a traditional Chinese medicine composition for treating low anterior rectal resection syndrome and its uses. Background Technology

[0002] Low Anterior Resection Syndrome (LARS) refers to bowel dysfunction following anterior resection for rectal cancer. Specific symptoms include increased frequency of bowel movements, changes in stool shape, urgency to defecate, and even fecal incontinence and difficulty emptying the bowels. Currently, surgical treatment is the primary approach for rectal cancer, with approximately 73.3% to 77.0% of patients opting for sphincter-preserving surgery. Studies show that as many as 60% to 90% of patients experience varying degrees of bowel dysfunction, which affects normal physiological function, increases psychological stress, and ultimately leads to a decline in social function and significantly reduces the patient's quality of life.

[0003] The pathological mechanism of LARS is not yet clear. Modern research suggests it is related to changes in rectal anatomy (insufficient residual rectal volume after surgery leading to weakened rectal stool storage function and decreased intestinal compliance), pelvic nerve injury and dysregulation (rectal motility disorder), and gut microbiota imbalance (the impact of patient's dietary habits and pre- and post-operative radiotherapy and chemotherapy on the gut microbiota). Based on clinical manifestations, LARS is classified into three types: stool storage disorder, emptying disorder, and mixed type. Stool storage disorder is characterized by significant urgency, frequent defecation, and a marked decrease in control over gas and feces (especially loose stools); emptying disorder is characterized by difficulty in defecation, a feeling of incomplete evacuation, and the need for assisted defecation.

[0004] Currently, treatment for low anterior resection syndrome (LARS) mainly falls into two categories: modern medical treatment and traditional Chinese medicine (TCM). Modern medical treatment primarily involves dietary adjustments, medication (antidiarrheal medication for diarrhea, laxatives for constipation), pelvic floor rehabilitation (biofeedback therapy, rectal balloon training, etc.), anal irrigation, and sacral nerve stimulation. If conservative treatment is ineffective, surgical treatment (J-pouch anal canal anastomosis, coloplasty, colostomy, etc.) may be considered. TCM considers LARS to fall under the categories of "diarrhea," "constipation," and "fecal incontinence," with its pathogenesis mainly related to spleen deficiency and qi sinking, damp-heat accumulation, and qi stagnation and blood stasis. Traditional Chinese medicine (TCM) internal treatment employs syndrome differentiation and treatment, administering compound TCM formulas orally to alleviate symptoms. External TCM therapies include moxibustion (gentle moxibustion, thunder-fire moxibustion; the key to moxibustion is the arrival of Qi, and sufficient moxibustion dosage is a prerequisite for Qi attainment), acupuncture (acupuncture, electroacupuncture, press needles; improvement of LARS may be related to stimulation of the sacral and tibial nerves), auricular acupressure (unblocking corresponding viscera and meridians, regulating Qi and blood, and bidirectionally regulating gastrointestinal function), and external TCM washes and retention enemas (medications act directly on the rectal mucosa, improving inflammatory responses and edema, and promoting blood circulation). TCM treatment of LARS has the advantages of holistic regulation and fewer side effects.

[0005] However, modern medicine primarily focuses on symptomatic and supportive treatment, which can alleviate symptoms in the short term but cannot fundamentally improve the patient's pathological state of spleen deficiency and damp-heat. Furthermore, long-term medication carries the risk of side effects, while invasive treatments face the problems of high cost and complications. Although traditional Chinese medicine (TCM) has certain advantages, current TCM treatment plans lack an effective herbal combination for treating low anterior resection syndrome. Summary of the Invention

[0006] To address the aforementioned problems, this invention provides a traditional Chinese medicine composition for treating low anterior rectal resection syndrome and its uses. This composition has the effects of tonifying the spleen and stomach, clearing damp-heat, and astringing the intestines. It can be used to improve symptoms such as difficulty defecating, increased defecation, incontinence, and burning discomfort in the anus. In application, this invention combines oral administration with retention enema to achieve effective synergy between systemic regulation and local treatment. Oral administration allows the drug to be absorbed through the spleen and stomach, regulating the overall function of the internal organs to treat the root cause. Retention enema allows the drug to act directly on the rectal mucosa, clearing local damp-heat to treat the symptoms. Through the synergistic effect of oral administration and retention enema, systemic regulation and local treatment are achieved simultaneously, improving local rectal symptoms while regulating the overall state of the body, thereby effectively treating low anterior rectal resection syndrome.

[0007] To achieve the above objectives, the specific technical solution of the present invention is as follows: The first aspect of this invention provides a traditional Chinese medicine composition for treating low anterior rectal resection syndrome, comprising the following raw materials in parts by weight: Atractylodes macrocephala 18-30 parts, Atractylodes lancea 12-18 parts, Coix lacryma-jobi 12-18 parts, Poria cocos 18-30 parts, Gallnut 12-20 parts, Scutellaria baicalensis 12-16 parts, Paeonia lactiflora 20-30 parts, Mentha haplocalyx 9-12 parts, Astragalus membranaceus 9-18 parts, Pulsatilla chinensis 12-18 parts, Prunus mume 12-18 parts, Cimicifuga foetida 12-18 parts, Phellodendron chinense 10-15 parts, Paeonia lactiflora 10-16 parts.

[0008] Atractylodes macrocephala has a bitter and sweet taste, is warm in nature, and enters the spleen and stomach meridians. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis. It can be used to treat symptoms such as spleen deficiency with poor appetite, abdominal distension and diarrhea, phlegm retention and dizziness. Clinical studies have shown that Atractylodes macrocephala plays a positive role in the prevention and treatment of intestinal diseases. Atractylodes macrocephala can significantly reduce the levels of inflammatory factors such as interleukin IL-6, IL-1β, and tumor necrosis factor-α, thereby inhibiting intestinal mucosal damage, injury and inflammatory infiltration, and improving the continuity and integrity of the intestinal mucosa. Atractylodes macrocephala contains atractylodes lactones I, II and III, which can significantly inhibit the activity of HT29 and HCT15 cells at the same concentration, and all in a dose-dependent manner. Among them, atractylodes macrocephala II has the strongest inhibitory ability, suggesting that atractylodes macrocephala II may be an important material basis for anti-colorectal cancer. Atractylodes macrocephala I is the pharmacological material basis for promoting the growth and repair of IEC-6 small intestinal crypt epithelial cells to normal physiological levels. Atractylodes macrocephala can also promote the abundance of intestinal probiotics. Atractylodes macrocephala volatile oil mainly has an antidiarrheal effect on diarrheal rats by inhibiting gastrointestinal motility.

[0009] Atractylodes lancea has a pungent and bitter taste, is warm in nature, and enters the spleen, stomach, and liver meridians. Its functions include drying dampness and strengthening the spleen, dispelling wind and cold, and improving eyesight and eliminating foulness. Clinically, it is mainly used for dampness obstructing the middle jiao, diarrhea and edema, rheumatic pain, night blindness, and blurred vision. Modern pharmacological studies have found that Atractylodes lancea oil can reduce the levels of IL-6, IL-10, TNF-α, 5-hydroxytryptamine, and various aquaporins, alleviating intestinal inflammation and intestinal barrier damage, and reducing fecal water content. Atractylodes lancea contains the same atractylodes lactones I and II as Atractylodes macrocephala, which regulate mitochondrial function, induce apoptosis, inhibit cell proliferation, and thus have anti-inflammatory and anti-tumor effects.

[0010] Job's tears are cool in nature and sweet and bland in taste. They are a diuretic and dampness-removing herb, characterized by their ability to strengthen the spleen and remove dampness without harming yin. They have the effects of promoting diuresis and removing dampness, strengthening the spleen and stopping diarrhea, relieving numbness, draining pus, and detoxifying and dispersing nodules. Job's tears and its active ingredients mainly regulate intestinal flora imbalance to improve immune abnormalities, repair damaged intestinal mucosa, inhibit inflammation, and achieve anti-tumor effects by inhibiting the proliferation of colorectal cancer cell line 116 and inducing apoptosis.

[0011] Poria cocos has the effects of promoting diuresis and eliminating dampness, strengthening the spleen and calming the mind. Clinically, it is used to treat edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, loose stools and diarrhea, restlessness, palpitations and insomnia. The poria acid contained in Poria cocos can effectively inhibit the proliferation and cell activity of colorectal cancer cells, and promote cell apoptosis by inhibiting glycolysis, while also inhibiting the expression levels of proteins related to the PI3K / AKT / mTOR pathway. Poria cocos polysaccharides can protect damaged intestinal mucosa by improving colonic physiological state, reducing intestinal permeability, inhibiting epithelial cell apoptosis, and increasing intestinal mucosal immunity.

[0012] Gallnut has a sour and astringent taste, is cold in nature, and enters the lung, large intestine, and kidney meridians. Gallnut is rich in tannins, which are one of the active compounds that resist Escherichia coli and have an inhibitory effect on secretory diarrhea caused by enterotoxins. Tannins have been shown to inhibit the transmembrane conductance-dependent secretion of Cl- in cystic fibrosis of human clonal colon adenocarcinoma Caco2 cells, rat thyroid FRT cells, T84 cells of colon adenocarcinoma lung metastases, and colonic epithelial HT29-CL19A cells. Gallic acid, ellagic acid, methyl gallate, β-sitosterol, 1,2,3,4,6-penta-O-galloyl-β-D-glucose, and flavonoids in gallnut have been reported to have anticancer activity in vitro or in vivo. When tannins come into contact with blood, they absorb a large amount of fibrin, converting fibrinogen into insoluble fibrin clots, further inducing thrombin-catalyzed coagulation to achieve hemostasis, and have a significant relieving effect on bleeding caused by mucosal damage.

[0013] Both Scutellaria baicalensis and Phellodendron chinense have the effects of clearing heat and drying dampness, purging fire and detoxifying. Scutellaria baicalensis is better at clearing damp-heat in the intestines, while Phellodendron chinense is better at clearing damp-heat in the lower burner. Phellodendron chinense has a stronger effect in purging fire and detoxifying than Scutellaria baicalensis. Phellodendron chinense can improve the diversity of intestinal flora, increase the concentration of short-chain fatty acids and serum endocrine peptides of intestinal microbial metabolites, enhance endocrine function, inhibit the expression of bacterial flagellar genes, and reduce the adhesion of Escherichia coli to intestinal epithelial cells, thus playing a role in stopping diarrhea. Phellodendron chinense is rich in berberine, which has anti-tumor activity. It may achieve its anti-tumor effect by regulating the PI3K / AKT signaling pathway and the p38 MAPK signaling pathway, inducing cancer cell apoptosis and arresting cell cycle. Baicalin in Scutellaria baicalensis can enhance the anti-tumor immunity of colorectal cancer by triggering mitochondrial-mediated apoptosis and inhibiting migration. It can also promote tumor cell apoptosis, inhibit tumor cell proliferation, and reduce the invasion and migration rate of tumor cells by inhibiting the expression of NF-κB and COX-2, thereby reducing the severity of ulcerative colon cancer. Baicalin exerts its anti-inflammatory effect by inhibiting the activity of cytokines. Baicalein maintains mitochondrial function by regulating glutathione and glucose and ammonia metabolism pathways closely related to mitochondrial function, thereby maintaining the stemness and self-renewal of intestinal stem cells and thus mitigating radiation-induced intestinal damage.

[0014] White peony root has a bitter and sour taste, and is slightly cold in nature. It nourishes blood and regulates menstruation, astringes yin and stops sweating, softens the liver and relieves pain, and calms liver yang. White peony root can protect the gastrointestinal mucosa and regulate gastrointestinal function. It is widely used to treat various types of pain, including visceral pain and cancer pain. Paeoniflorin can induce apoptosis and inhibit proliferation, invasion, and metastasis through different molecular mechanisms, such as transcription activator factors, the p53 / 14-3-3 signaling pathway, the transforming growth factor-β1 / Smads signaling pathway, and the mitogen-activated protein kinase signaling pathway, thereby achieving anti-tumor effects.

[0015] Peppermint, pungent and cool in nature, enters the lung and liver meridians, and has the effects of dispersing wind-heat, clearing the head and eyes, relieving sore throat and promoting rash eruption, and soothing the liver and regulating qi. Modern pharmacological studies have found that peppermint has anti-inflammatory, antibacterial, antiviral, analgesic, antioxidant, and antitumor effects. Among them, the ethanol extract, menthol, and piperonone in peppermint are the main components that produce analgesic effects, and the total flavonoid extract of peppermint has a significant scavenging effect on superoxide anions and hydroxyl free radicals. In addition, peppermint also has anti-radiation and antitumor effects. Its anti-radiation mechanism may be related to increasing the free radical scavenging rate and nitric oxide release. Its antitumor effect is mainly considered to be that it may act on targets such as tumor cell mitogen-activated protein kinase 14, regulate TNF signaling pathways to produce anticancer effects, and upregulate the activity of intestinal butyric acid-producing bacteria.

[0016] Astragalus membranaceus (Huangqi) is sweet in taste and slightly warm in nature, entering the lung and spleen meridians. It possesses the effects of tonifying qi and strengthening the exterior, replenishing qi and raising yang, promoting diuresis and reducing swelling, relieving stagnation and promoting blood circulation, and astringing sores and promoting tissue regeneration. Astragalus polysaccharides enhance the body's immunity by targeting and regulating the cells, cytokines, and extracellular matrix of the tumor microenvironment to regulate inflammation, induce apoptosis, and reverse chemotherapy resistance, thus playing an anti-tumor role. Purified astragalus saponin mixtures can reduce the activity and proliferation of tumor cells. Astragalusin can inhibit cancer development through inducing apoptosis, arresting the cell cycle, and targeting multiple pathways. It also enhances humoral and cellular immunity and regulates metabolism.

[0017] Pulsatilla chinensis is cold in nature and bitter in taste. It has the effects of clearing heat and detoxifying, cooling blood and stopping dysentery, drying dampness and killing parasites. Clinically, it is often used to treat dysentery caused by heat toxins, bacterial dysentery, and amoebic dysentery. The chemical components in Pulsatilla chinensis have anti-tumor and anti-inflammatory effects. Various effective components in Pulsatilla chinensis, such as betulinic acid, pulsatilla saponins, quercetin, and β-sitosterol, inhibit different pathways and reduce or increase the expression of related proteins and factors to achieve anti-tumor treatment. The n-butanol extract in Pulsatilla chinensis plays a therapeutic role in ulcerative colitis by restoring goblet cell differentiation function, maintaining the integrity of the mucosal barrier, and inhibiting inflammatory factors.

[0018] Ume (dried plum) has a sour and astringent taste, is neutral in nature, and enters the liver, spleen, lung, and large intestine meridians. It is often used for symptoms such as chronic cough due to lung deficiency, chronic diarrhea, vomiting and abdominal pain due to ascariasis, and thirst due to deficiency heat. Ume is rich in organic acids, sterols, and flavonoids. These active ingredients can exert anti-tumor effects through multiple pathways, including inhibiting tumor cell proliferation and migration, regulating the cell cycle, inducing apoptosis, autophagy, pyroptosis, and ferroptosis, and improving the tumor microenvironment. Ume can inhibit the phosphorylation of proteins in the mitogen-activated protein kinase (MEK) / extracellular signal-regulated kinase (ERK) signaling pathway, downregulate the levels of inflammatory cytokines, and restore the expression of tight junction proteins in intestinal epithelium; it exerts an astringent and antidiarrheal effect by inhibiting the excitability of gastrointestinal smooth muscle; the effective active ingredients of ume can significantly inhibit the release of inflammatory factors and reduce intestinal histological damage and inflammatory response.

[0019] Cimicifuga rhizome is sweet, pungent, and slightly cold in nature. It enters the lung, spleen, large intestine, and stomach meridians. The active components in Cimicifuga rhizome can selectively act on tumor cells, inhibiting the levels of cyclin B1 and cyclin-dependent kinase 1, causing cell cycle arrest during division, inhibiting cyclooxygenase-2 expression, and thus inducing apoptosis. Alternatively, it can induce endogenous apoptosis by damaging mitochondria and lowering membrane potential, triggering a caspase cascade reaction.

[0020] Red peony root is bitter and slightly cold in nature. It enters the liver meridian. It excels at clearing heat and cooling the blood, promoting blood circulation and removing blood stasis. Total glycosides of red peony root may inhibit the proliferation, apoptosis, and migration of colorectal cancer cells by regulating the miR-338-3p / GMFB signaling pathway. When combined with red peony root in Huangqin Decoction, it can significantly improve colonic shortening and histopathological changes in model mice, reduce the expression of inflammatory factors interleukin-6 and neurogenic locus nick homolog 1, and has an anti-ulcerative colitis effect.

[0021] The above fourteen herbs form a traditional Chinese medicine composition, currently used for low anterior resection syndrome following rectal cancer resection. This composition primarily targets patients with low anterior resection syndrome who experience significantly increased bowel movements, anal tenesmus, and burning discomfort in the anus. The pathogenesis is as follows: surgical blades damage the large intestine meridians and qi and blood, leading to dysfunction of large intestine conduction and abnormal opening and closing of the anus; furthermore, perioperative radiotherapy and chemotherapy exposure to ionizing radiation cause intestinal qi and blood disorders, qi deficiency, and insufficient blood retention, resulting in blood leakage and hematochezia; abnormal body fluid metabolism leads to watery stools; heat toxin accumulation, combined with dampness, causes difficulty in defecation, increased bowel movements, and even stool leakage, along with burning discomfort in the anus.

[0022] The *Suwen* states that "the Pomen (the gate of the anus) is also the messenger of the five viscera." This means that the function of the Pomen depends on the spleen and stomach's ascending of clear qi and excretion of turbid qi, the kidney's warming and consolidating effect, the liver's smooth and regulating function, the lung's dispersing and descending function, and the heart's governing function. If the functions of the five viscera are imbalanced, the opening and closing of the Pomen will become irregular. If the spleen fails to ascend clear qi, the transformation and transportation of food essence will be impaired, resulting in frequent bowel movements and loose stools; if the kidney's yang is insufficient, the Pomen will lack warmth, resulting in urgent and incontinent bowel movements; if the liver's qi is stagnant, the transmission of waste will be disordered, resulting in irregular bowel movements; if the lung's qi is congested, waste excretion will be obstructed, resulting in difficult bowel movements; if the heart is not nourished, the Pomen will lose its governing function, resulting in fecal incontinence. The process of waste excretion to the anus is closely related to the stomach and small intestine. If the stomach fails to descend properly, waste transport is obstructed, leading to impaired emptying. If the small intestine's separation of clear and turbid substances is disrupted, diarrhea and undigested food in stool will occur. Furthermore, the function of the stomach and small intestine depends on the internal-external relationship of the five internal organs. Therefore, the treatment of LARS should address this from multiple dimensions and the coordination of organ function. Although cancer manifests in the large intestine, it is an external pathogen that damages the patient's vital energy, causing dysfunction of the spleen and stomach in digestion and transformation.

[0023] The spleen and stomach are the foundation of postnatal health, so this Chinese herbal medicine composition is based on the principles of tonifying the spleen and stomach, clearing damp heat, and astringing the intestines, and is modified accordingly.

[0024] The formula uses Atractylodes macrocephala and Poria cocos as the principal herbs to invigorate the spleen, replenish qi, dry dampness, and promote diuresis. Atractylodes lancea and Coix lacryma-jobi are the assistant herbs to enhance the spleen-invigorating and dampness-drying functions of Atractylodes macrocephala and Poria cocos. Pulsatilla chinensis, Scutellaria baicalensis, and Phellodendron chinense, as assistant herbs, work together to clear heat and dry dampness, clearing damp-heat in the intestines and astringing to stop diarrhea. Prunus mume, Paeonia lactiflora, Paeonia veitchii, and Galla chinensis are the adjuvant herbs. Prunus mume and Galla chinensis primarily astringe and consolidate the intestines to stop bleeding, while Paeonia lactiflora and Paeonia veitchii regulate both qi and blood, nourishing blood and yin while promoting blood circulation without stagnation, replenishing yin and blood and promoting qi circulation without harming the body's vital energy. Astragalus membranaceus, Mentha haplocalyx, and Cimicifuga foetida are the guiding herbs, all designed to raise yang and assist the spleen's function of ascending clear qi. Astragalus membranaceus also tonifies the middle jiao and promotes circulation, supporting the body's resistance and eliminating pathogens. Mentha haplocalyx promotes qi circulation, and Cimicifuga foetida enters the large intestine meridian to clear heat and promote diuresis. These fourteen herbs combined work to tonify the spleen and stomach, clear damp-heat, and astringe the intestines.

[0025] Furthermore, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 30 parts of Atractylodes macrocephala, 12 parts of Atractylodes lancea, 12 parts of Coix lacryma-jobi, 30 parts of Poria cocos, 18 parts of Galla chinensis, 16 parts of Scutellaria baicalensis, 30 parts of Paeonia lactiflora, 10 parts of Mentha haplocalyx, 18 parts of Astragalus membranaceus, 12 parts of Pulsatilla chinensis, 18 parts of Prunus mume, 18 parts of Cimicifuga foetida, 10 parts of Phellodendron chinense, and 15 parts of Paeonia lactiflora.

[0026] The second aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition: weigh the raw materials of the traditional Chinese medicine composition according to the weight parts, mix them, soak them in water, decoct them 2 to 3 times, combine the decoctions and filter the residue, collect the filtrate, and obtain the composition.

[0027] Furthermore, the soaking time is 25 min to 35 min, and the simmering method is to bring it to a boil over high heat and then simmer over low heat for 15 min to 20 min.

[0028] A third aspect of the present invention provides the use of the above-described traditional Chinese medicine composition in the preparation of a medicament for treating low anterior rectal resection syndrome.

[0029] Furthermore, the low anterior rectal resection syndrome is characterized by urgency to defecate, increased defecation, stool leakage, and burning discomfort in the anus.

[0030] The fourth aspect of the present invention provides a medicament for treating low anterior rectal resection syndrome, wherein the medicament has the traditional Chinese medicine composition or an aqueous extract of the traditional Chinese medicine composition as the main active ingredient.

[0031] Furthermore, the drug comprises an oral solution and / or an enema solution.

[0032] Furthermore, the oral liquid and enema liquid are prepared by the following steps: weigh the raw materials of the traditional Chinese medicine composition according to the weight parts, mix them, soak them in water, decoct them 2 to 3 times, combine the decoctions, filter the dregs, collect the filtrate, and divide the filtrate into oral liquid and enema liquid stock solution at a volume ratio of 2:1. The enema liquid stock solution is used as an enema liquid after being either not concentrated or after being concentrated by 1 to 3 times.

[0033] Furthermore, the soaking time is 25 min to 35 min, and the simmering is to bring to a boil over high heat and then reduce to a simmer for 15 min to 20 min.

[0034] Furthermore, the volume ratio of the oral liquid to the enema liquid is 6:1~3.

[0035] The oral solution is for oral administration, and the enema solution is for rectal administration; the two are used in combination.

[0036] Furthermore, the method of using the enema solution is as follows: the patient lies on their left side, the enema bag containing the solution is gently inserted into the tube 8cm to 12cm so that the solution is retained in the remaining rectum, and the patient continues to lie on their left side for 1h to 1.5h.

[0037] Furthermore, the oral liquid is taken after meals, twice a day, 150 mL each time; the enema liquid is used before bedtime, once a day, with a dosage of 50 mL to 150 mL each time.

[0038] Furthermore, the drug for treating low anterior rectal resection syndrome is administered in an intermittent, cyclical manner: each cycle is administered continuously for 9 days, followed by a 9-day break, for a total of 4 cycles.

[0039] Compared with the prior art, the beneficial effects of the present invention are as follows: This invention provides a traditional Chinese medicine composition for treating low anterior rectal resection syndrome. By weight, the composition consists of 18-30 parts of Atractylodes macrocephala, 12-18 parts of Atractylodes lancea, 12-18 parts of Coix lacryma-jobi, 18-30 parts of Poria cocos, 12-20 parts of Galla chinensis, 12-16 parts of Scutellaria baicalensis, 20-30 parts of Paeonia lactiflora, 9-12 parts of Mentha haplocalyx, 9-18 parts of Astragalus membranaceus, 12-18 parts of Pulsatilla chinensis, 12-18 parts of Prunus mume, 12-18 parts of Cimicifuga foetida, 10-15 parts of Phellodendron chinense, and 10-16 parts of Paeonia lactiflora. The formula uses Atractylodes macrocephala and Poria cocos as the principal herbs to invigorate the spleen, replenish qi, dry dampness, and promote diuresis. Atractylodes lancea and Coix lacryma-jobi are the assistant herbs to enhance the spleen-invigorating and dampness-drying functions of Atractylodes macrocephala and Poria cocos. Pulsatilla chinensis, Scutellaria baicalensis, and Phellodendron chinense, as assistant herbs, work together to clear heat and dry dampness, clearing damp-heat in the intestines and astringing to stop diarrhea. Prunus mume, Paeonia lactiflora, Paeonia veitchii, and Galla chinensis are the adjuvant herbs. Prunus mume and Galla chinensis primarily astringe and consolidate the intestines to stop bleeding, while Paeonia lactiflora and Paeonia veitchii regulate both qi and blood, nourishing blood and yin while promoting blood circulation without stagnation, replenishing yin and blood and promoting qi circulation without harming the body's vital energy. Astragalus membranaceus, Mentha haplocalyx, and Cimicifuga foetida are the guiding herbs, all designed to raise yang and assist the spleen's function of ascending clear qi. Astragalus membranaceus also tonifies the middle jiao and promotes circulation, supporting the body's resistance and eliminating pathogens. Mentha haplocalyx promotes qi circulation, and Cimicifuga foetida enters the large intestine meridian to clear heat and promote diuresis. These fourteen herbs combined work to tonify the spleen and stomach, clear damp-heat, and astringe the intestines.

[0040] This traditional Chinese medicine composition uses widely available raw materials, has a scientific formulation, and a simple preparation process, making it suitable for industrial production. It can be prepared into a drug for treating low anterior rectal resection syndrome, showing broad application prospects. Its aqueous extracts are prepared into oral and enema solutions. Oral administration exerts a systemic regulatory effect, while rectal administration achieves direct treatment of local lesions. The combined use of these two methods forms a synergistic "systemic + local" intervention model, achieving both symptomatic and root-cause treatment. Clinical data show that the combined treatment regimen is significantly more effective than oral or retention enema administration of traditional Chinese medicine alone, and no recurrence or worsening of symptoms over time has been observed. This indicates that the traditional Chinese medicine composition provided by this invention has comprehensive advantages in treating low anterior rectal resection syndrome, including definite efficacy, good stability, simple preparation, and broad application prospects. Detailed Implementation

[0041] The specific embodiments of the present invention are described in detail below, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Unless otherwise specified, the experimental methods described in the embodiments of the present invention are conventional methods, and the materials and reagents used in the following embodiments are commercially available unless otherwise specified.

[0042] Example 1: A traditional Chinese medicine composition for treating low anterior rectal resection syndrome is prepared by the following steps: Weigh out 30g of Atractylodes macrocephala, 12g of Atractylodes lancea, 12g of Coix lacryma-jobi, 30g of Poria cocos, 18g of Galla chinensis, 16g of Scutellaria baicalensis, 30g of Paeonia lactiflora, 10g of Mentha haplocalyx, 18g of Astragalus membranaceus, 12g of Pulsatilla chinensis, 18g of Prunus mume, 18g of Cimicifuga foetida, 10g of Phellodendron chinense, and 15g of Paeonia lactiflora. Mix all the raw herbs and put them into a container. Add cold water to cover the herbs and soak for 30 minutes. Then decoct the herbs by bringing them to a boil over high heat and then simmering over low heat for 20 minutes. Decoction is done three times in total. Combine the three decoctions, filter out the dregs, and collect the filtrate.

[0043] Example 2: A traditional Chinese medicine composition for treating low anterior rectal resection syndrome is prepared by the following steps: Weigh out 24g of Atractylodes macrocephala, 15g of Atractylodes lancea, 15g of Coix lacryma-jobi, 24g of Poria cocos, 16g of Galla chinensis, 14g of Scutellaria baicalensis, 25g of Paeonia lactiflora, 9g of Mentha haplocalyx, 14g of Astragalus membranaceus, 15g of Pulsatilla chinensis, 15g of Prunus mume, 15g of Cimicifuga foetida, 13g of Phellodendron chinense, and 16g of Paeonia lactiflora. Mix all the raw herbs and put them in a container. Add cold water to cover the herbs and soak for 25 minutes. Then decoct the herbs by bringing them to a boil over high heat and then simmering over low heat for 20 minutes. Decoction twice in total. Combine the two decoctions, filter out the dregs, and collect the filtrate.

[0044] Example 3: A traditional Chinese medicine composition for treating low anterior rectal resection syndrome is prepared by the following steps: Weigh out 18g of Atractylodes macrocephala, 12g of Atractylodes lancea, 12g of Coix lacryma-jobi, 18g of Poria cocos, 12g of Galla chinensis, 12g of Scutellaria baicalensis, 20g of Paeonia lactiflora, 9g of Mentha haplocalyx, 9g of Astragalus membranaceus, 12g of Pulsatilla chinensis, 12g of Prunus mume, 12g of Cimicifuga foetida, 10g of Phellodendron chinense, and 10g of Paeonia lactiflora. Mix all the raw herbs and put them into a container. Add cold water to cover the herbs and soak for 35 minutes. Then decoct the herbs by bringing them to a boil over high heat and then simmering over low heat for 15 minutes. Decoction is done three times in total. Combine the three decoctions, filter out the dregs, and collect the filtrate.

[0045] Example 4: A traditional Chinese medicine composition for treating low anterior rectal resection syndrome is prepared by the following steps: Weigh out 30g of Atractylodes macrocephala, 18g of Atractylodes lancea, 18g of Coix lacryma-jobi, 30g of Poria cocos, 20g of Galla chinensis, 16g of Scutellaria baicalensis, 30g of Paeonia lactiflora, 12g of Mentha haplocalyx, 18g of Astragalus membranaceus, 18g of Pulsatilla chinensis, 18g of Prunus mume, 18g of Cimicifuga foetida, 15g of Phellodendron chinense, and 16g of Paeonia lactiflora. Mix all the raw herbs and put them into a container. Add cold water to cover the herbs and soak for 30 minutes. Then decoct the herbs by bringing them to a boil over high heat and then simmering over low heat for 15 minutes. Decoction is done three times in total. Combine the three decoctions, filter out the dregs, and collect the filtrate.

[0046] Examples 1 to 4 have similar effects. For the convenience of subsequent discussion and reference, the results of Example 1 are used as an example. The following is an analysis of the efficacy of the traditional Chinese medicine composition on low anterior rectal resection syndrome.

[0047] Take 450 mL of the total decoction prepared in Example 1, of which 300 mL is used as oral liquid and the remaining 150 mL is used as enema stock solution. Based on the residual rectal volume after the patient's surgery, concentrate the enema stock solution to 50 mL to 150 mL to obtain the enema solution to be used.

[0048] Thirty patients who underwent anterior rectal resection and developed anterior rectal resection syndrome at Hanzhong Municipal Hospital of Traditional Chinese Medicine between January 2024 and June 2025, and received oral and retention enema administration of traditional Chinese medicine compositions, were selected as the study subjects. Their clinical data were retrospectively analyzed. All subjects signed informed consent forms before being included in this study.

[0049] 1. Materials and Methods Clinical Data: Thirty patients with low anterior resection syndrome were selected, including 18 males and 12 females, with a mean age of (52.9±11.6) years. All patients met the diagnostic criteria for anterior resection syndrome in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines" and were diagnosed with spleen deficiency and damp-heat syndrome by traditional Chinese medicine. Diagnostic criteria: Primary symptoms included anal distension and burning sensation, increased frequency of bowel movements, sticky and unsatisfactory stools, and tenesmus; secondary symptoms included loss of appetite, dry mouth, and bitter taste; tongue and pulse were pale with a white or yellow greasy coating and a slippery pulse.

[0050] Treatment method: A dual administration route of oral solution combined with enema is used.

[0051] Oral liquid: Take after meals, twice a day, 150mL each time; Enema solution: Use before bedtime, once daily. The dosage is 50mL-150mL per administration, depending on the patient's remaining rectal volume after surgery. During the procedure, the patient should lie on their left side. Gently insert the enema bag 10cm into the rectum to retain the solution. Maintain the left lateral position for 1 hour, then slowly get up. Try to retain the solution for 5-8 hours.

[0052] The treatment uses an intermittent cyclical regimen: administration is carried out continuously for 9 days, with an interval of 9 days between each cycle, for a total of 4 cycles.

[0053] Observation indicators: (1) TCM syndrome scoring: A TCM syndrome scoring table was developed with reference to TCM syndromes.

[0054] Scoring criteria: Includes 5 primary symptoms and 3 secondary symptoms. Each symptom is scored as follows: none (0 points), mild (1 point), moderate (2 points), severe (3 points), with a total score of 0-24 points. The higher the score, the more severe the symptom.

[0055] Assessment milestones: before treatment (baseline), 9 days of treatment (end of cycle 1), 27 days of treatment (end of cycle 2), 45 days of treatment (end of cycle 3), and 63 days of treatment (end of cycle 4).

[0056] Patient numbers: marked as 1-30, all of whom are patients with low anterior rectal resection syndrome of spleen deficiency and damp-heat type, with a total of 30 cases.

[0057] Based on the efficacy evaluation criteria, and combined with the changes in the total score at each follow-up point compared to the baseline, the efficacy was evaluated as follows: a total score decrease of ≥70% from the baseline was considered significantly effective; a total score decrease of ≥30% but less than 70% from the baseline was considered effective; and a total score decrease of <30% from the baseline was considered ineffective.

[0058] (2) Low anterior resection syndrome (LARS) score: Refer to the LARS score scale (Table 1).

[0059] Table 1 LARS Rating Scale Scoring criteria: Covers 5 core symptoms (increased frequency of defecation, fecal incontinence, feeling of incomplete emptying, tenesmus, and difficulty in defecation), and scores are assigned according to the symptoms, with a total score of 0-42 (the scores of each symptom are added together).

[0060] Assessment milestones: before treatment (baseline), 9 days of treatment (end of cycle 1), 27 days of treatment (end of cycle 2), 45 days of treatment (end of cycle 3), and 63 days of treatment (end of cycle 4).

[0061] Patient numbers: marked as 1-30, all of whom are patients with low anterior rectal resection syndrome of spleen deficiency and damp-heat type, with a total of 30 cases.

[0062] Efficacy assessment: Based on changes in the total score at each stage, the criteria for "significantly effective, effective, and ineffective" were applied. A total score decrease of ≥70% from baseline was considered significantly effective; a total score decrease of ≥30% but less than 70% from baseline was considered effective; and a total score decrease of <30% from baseline was considered ineffective, strictly adhering to the established statistical results.

[0063] (3) Adverse reactions: Statistics on adverse reactions such as abdominal distension, abdominal pain, nausea and vomiting, and allergic reactions that occurred during the treatment period.

[0064] 2. Results Table 2 summarizes the clinical symptom scores and efficacy of the 30 patients at each stage according to the TCM syndrome scoring table. Table 3 summarizes the LARS scores and efficacy of the 30 patients at each stage. Table 4 and Table 5 summarize the overall clinical efficacy of the patients at each stage of treatment.

[0065] Table 2 Summary of Clinical Symptom Scores and Treatment Efficacy at Each Stage in 30 Patients Table 3. Summary of LARS scores and treatment efficacy at each stage in 30 patients. Table 4. Evaluation of overall clinical efficacy of patients at different stages of treatment based on TCM syndrome scores. Table 5. LARS scores evaluating the overall clinical efficacy of patients at each stage of treatment. The data in Tables 2-5 show that after oral administration and retention enema with the traditional Chinese medicine composition provided by this invention, the symptoms of 30 patients improved significantly with treatment time, and all achieved effective or significant therapeutic effects in the third treatment cycle. Traditional Chinese medicine syndrome scoring evaluation showed that after 9 days of treatment, 18 cases (60%) were effective and 12 cases (40%) were ineffective; after 27 days of treatment, the ineffective cases disappeared, and the total effective rate was 100%; by 45 days of treatment, the significant effective rate increased significantly to 22 cases (73.3%), and the effective rate was 8 cases (26.7%), maintaining a total effective rate of 100%; after 63 days of treatment, the number of cases with significant effects increased to 30 cases (100%). LARS score evaluation showed that after 9 days of treatment, 16 cases (53.3%) were effective and 14 cases (46.7%) were ineffective; after 27 days of treatment, only 2 cases (6.7%) remained ineffective, and 7 cases (23.3%) showed significant improvement; by 45 days of treatment, ineffective cases disappeared, the overall effective rate was 100%, the significant improvement rate increased significantly to 19 cases (63.3%), and the effective rate was 11 cases (36.7%), maintaining an overall effective rate of 100%; after 63 days of treatment, 25 cases (83.3%) showed significant improvement, and the remaining 5 cases (16.7%) were effective. Subsequent follow-up showed that the efficacy was maintained after the patients completed 4 treatment cycles. These results indicate that the efficacy of this regimen continues to increase, and no recurrence or worsening of symptoms was observed over time, confirming its effectiveness.

[0066] 3. Adverse reactions: No adverse reactions such as recurrence or worsening of symptoms were observed in the patient during the 3-month follow-up period.

[0067] Because this traditional Chinese medicine composition is used in municipal TCM hospitals with clinical efficacy as the primary treatment goal, randomized controlled trials cannot be conducted. However, in the early stages of treatment, oral administration or retention enema of this TCM composition alone was used. It was found that patients who only took the TCM composition orally did not experience significant relief from anal prolapse and burning symptoms. A small number of patients who only received retention enema did not experience significant relief from abdominal distension and dull abdominal pain. Therefore, to ensure the treatment effect, oral administration and retention enema were administered simultaneously, and the results showed better efficacy, which was significantly better than single treatment. This combined treatment method has been used clinically ever since.

[0068] It should be noted that when numerical ranges are involved in this invention, it should be understood that both endpoints of each numerical range and any value between the two endpoints can be selected. Since the steps and methods used are the same as in the embodiments, preferred embodiments are described here to avoid redundancy. Although preferred embodiments of the invention have been described, those skilled in the art, once they understand the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments as well as all changes and modifications falling within the scope of this invention.

[0069] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A traditional Chinese medicine composition for treating low anterior rectal resection syndrome, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: Atractylodes macrocephala 18-30 parts, Atractylodes lancea 12-18 parts, Coix lacryma-jobi 12-18 parts, Poria cocos 18-30 parts, Gallnut 12-20 parts, Scutellaria baicalensis 12-16 parts, Paeonia lactiflora 20-30 parts, Mentha haplocalyx 9-12 parts, Astragalus membranaceus 9-18 parts, Pulsatilla chinensis 12-18 parts, Prunus mume 12-18 parts, Cimicifuga foetida 12-18 parts, Phellodendron chinense 10-15 parts, Paeonia lactiflora 10-16 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition consists of the following raw materials in parts by weight: 30 parts of Atractylodes macrocephala, 12 parts of Atractylodes lancea, 12 parts of Coix lacryma-jobi, 30 parts of Poria cocos, 18 parts of Galla chinensis, 16 parts of Scutellaria baicalensis, 30 parts of Paeonia lactiflora, 10 parts of Mentha haplocalyx, 18 parts of Astragalus membranaceus, 12 parts of Pulsatilla chinensis, 18 parts of Prunus mume, 18 parts of Cimicifuga foetida, 10 parts of Phellodendron chinense, and 15 parts of Paeonia lactiflora.

3. A method for preparing the traditional Chinese medicine composition according to claim 4, characterized in that, Weigh the raw materials of the Chinese herbal medicine composition according to the stated weight proportions, mix them, soak them in water, decoct them 2 to 3 times, combine the decoctions and filter out the dregs, collect the filtrate, and you will get the final product.

4. The method for preparing the traditional Chinese medicine composition according to claim 3, characterized in that, The soaking time is 25 min to 35 min, and the simmering is to bring to a boil over high heat and then reduce to a simmer for 15 min to 20 min.

5. Use of the traditional Chinese medicine composition according to claim 1 in the preparation of a medicament for treating low anterior rectal resection syndrome.

6. A drug for treating low anterior rectal resection syndrome, characterized in that, The drug uses the traditional Chinese medicine composition of claim 1 or the water extract of the traditional Chinese medicine composition as its main active ingredient.

7. The drug according to claim 6, characterized in that, The medicine comprises an oral liquid and / or an enema solution; the oral liquid and enema solution are prepared by the following steps: weighing the raw materials of the traditional Chinese medicine composition according to the specified weight parts, mixing them, soaking them in water, decocting them 2 to 3 times, combining the decocted liquids, filtering the dregs, collecting the filtrate, and dividing the filtrate into oral liquid and enema solution stock solutions at a volume ratio of 2:

1. The enema solution stock solution is used as an enema solution after being either not concentrated or after being concentrated by 1 to 3 times.

8. The medicament according to claim 7, characterized in that, The soaking time is 25 min to 35 min, and the simmering is to bring to a boil over high heat and then reduce to a simmer for 15 min to 20 min.

9. The drug according to claim 7, characterized in that, The volume ratio of the oral solution to the enema solution in the drug is 6:1~3.

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