Traditional Chinese medicine composition for conditioning postoperative patient after radical treatment of colon cancer and sachet preparation of traditional Chinese medicine composition

Abstract

The invention relates to a traditional Chinese medicine composition for conditioning postoperative patients after radical treatment of colon cancer and a sachet preparation of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by weight: 5 to 10 parts of cortex cinnamomi, 5 to 10 parts of radix angelicae, 15 to 20 parts of raw radix astragali seu hedysari, 15 to 20 parts of sandalwood, 3 to 6 parts of radix et rhizoma rhei, 5 to 10 parts of rhizoma nardostachyos, 5 to 10 parts of rhizoma acori graminei, 5 to 10 parts of rhizoma chuanxiong, 5 to 10 parts of radix aucklandiae, 5 to 10 parts of fructus aurantii immaturus, 5 to 10 parts of cortex magnoliae officinalis, 5 to 10 parts of rhizoma atractylodis macrocephalae, 5 to 10 parts of rhizoma atractylodis, 1 to 3 parts of fructus tsaoko, 10 to 15 parts of pericarpium citri reticulatae, 5 to 10 parts of radix polygalae, 10 to 15 parts of herba eupatorii , 5-10 parts of rose, 5-10 parts of lavender, and 5-10 parts of licorice. The traditional Chinese medicine sachet can help patients after the colorectal cancer operation to improve related symptoms, has the effects of promoting qi circulation, relaxing bowel, eliminating cold to stop pain, inducing resuscitation, relieving convulsion and soothing the nerves, and can obviously improve gastrointestinal dysfunction or disorder and other symptoms of the patients after the colorectal cancer operation and promote recovery and balance of gastrointestinal functions when being prepared into the sachet.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine compositions, and in particular to a Chinese medicine composition and a sachet preparation thereof for conditioning patients after radical resection of colon cancer, for promoting postoperative recovery of colorectal cancer and preventing related complications. Background Art

[0002] Gastrointestinal dysfunction after colorectal cancer surgery is the most common and frequent disease, especially in most people with low immunity and poor resistance. Severe cases can lead to gastrointestinal failure, prolong hospitalization, and increase mortality. There are different names for postoperative gastrointestinal dysfunction. Common clinical names include: postoperative gastrointestinal dysfunction, postoperative gastrointestinal dysfunction, postoperative functional emptying disorder, gastroparesis, gastroparesis, etc. The definition of postoperative gastrointestinal dysfunction refers to a functional gastrointestinal dysfunction disease after surgery in which mechanical obstruction is excluded. Its main clinical symptoms include early satiety, nausea, vomiting, abdominal distension and pain, weakened or disappeared bowel sounds, and cessation of anal flatulence and defecation. [1, 2] . Its etiology and pathogenesis may include postoperative gastrointestinal hormone secretion disorder, postoperative gastrointestinal nerve dysfunction (caused by abnormal production and regulation of neuropeptides and gastrointestinal hormones, etc.), surgical and postoperative stress response (stress response causes autonomic dysfunction, inhibits smooth muscle cell contraction function and leads to delayed gastric emptying), postoperative infection (enterogenic infection, paralytic ileus, intestinal adhesion, etc.), perioperative pain and use of anesthetic drugs (pain causes autonomic dysfunction and anesthetic analgesics inhibit gastrointestinal function), mental factors (autonomic dysfunction causes gastric emptying disorder), perioperative care (perioperative water and electrolyte disorder causes gastric emptying disorder), etc. If the patient's condition persists after surgery, it is easy to cause psychological burden on the patient, which in turn leads to insomnia, anxiety and depression, and brings mental burden to the patient and the patient's family.

[0003] At present, Western medicine is mostly used for relevant symptomatic treatment, including gastrointestinal decompression with indwelling gastric tube, correction of water and electrolyte imbalance, correction of complications, early open enteral nutrition support, use of prokinetic drugs, and secondary surgery for refractory gastroparesis. However, some drugs have adverse reactions, and their contraindications and adverse reactions should be noted when used; another part of patients do not respond well to drug treatment, causing gastroparesis patients to suffer physical and mental pain and economic burden. Therefore, we need to clarify the etiology and pathogenesis as early as possible in the clinic, combine prevention with treatment, and find more appropriate drugs and technical means to alleviate patients' suffering.

[0004] There is no relevant description of postoperative gastrointestinal dysfunction in traditional Chinese medicine. According to traditional Chinese medicine, gastrointestinal dysfunction is classified as "intestinal paralysis" and "abdominal distension", which is related to postoperative muscle meridian damage, poor qi movement, and organ dysfunction. Its pathogenesis is mainly spleen and stomach ascending and descending disorder and gastrointestinal qi obstruction. Therefore, its treatment is mainly to regulate the qi of the middle jiao and promote qi and bowel movement.[3] . Based on the "brain-gut axis" theory, the stomach is closely related to the brain. The intestine mainly acts on the central nervous system through the afferent neurons, cytokines and neural, immune and endocrine information carried by intestinal cells, together with the molecular signals released by the intestinal flora to the brain, which can not only maintain the dynamic balance of the gastrointestinal tract, but also affect the functions of emotion and cognition. If the gastrointestinal tract is damaged and cannot absorb fine substances to fill the brain, the brain will lose its nourishment, the brain marrow will be empty, and normal mental activities cannot be maintained, leading to abnormal emotions. Therefore, in addition to the use of gastrointestinal drugs, certain tranquilizers and antidepressants can also be added during treatment. "If the stomach is not harmonious, you will not be able to sleep well." Gastrointestinal "harmony" can directly interfere with the mind and brain and affect sleep. Therefore, the appropriate addition of sedatives, hypnotic drugs, and liver-soothing and depression-relieving drugs can not only improve patients' gastrointestinal dysfunction problems, but also regulate patients' emotional problems during the perioperative period and improve their quality of life.

[0005] Many existing studies have shown that traditional Chinese medicine, including external treatment and internal treatment, has good efficacy in preventing and treating gastrointestinal dysfunction after radical resection of colorectal cancer, and has certain advantages, and is safe, economical and convenient. Early intervention after surgery can prevent and treat postoperative complications. Therefore, we believe that early patients who are unable to eat or take Chinese medicine after abdominal surgery can use aromatic medicine sachets for early intervention and prevention, which is economical, has few side effects, is non-drug dependent, and has good safety. At present, there is no literature reporting on the Chinese medicine composition and drug preparation of early external treatment sachets for the treatment of such diseases. Summary of the invention

[0006] The present invention is directed to the above-mentioned problems, and aims to provide a Chinese medicine composition that can be prepared into a sachet for conditioning patients after radical resection of colon cancer. It also provides a Chinese medicine sachet for treating postoperative complications that is economical, has few side effects, is drug-free, and has good safety. The sachet can be used to prevent or treat complications after radical resection of colon cancer.

[0007] Chinese herbal sachets originated from the traditional Chinese medicine "clothing therapy", which belongs to the category of external treatment in Chinese medicine. It is a method of wearing external treatment, which is to wear aromatic drugs on the body to achieve the purpose of preventing and treating diseases. Therefore, there has been a saying among the people since ancient times that "hanging a herbal sachet will prevent you from being harmed by five insects". Modern pharmacological research has proved that Chinese herbal sachets have the effects of inhibiting bacteria, resisting viruses and regulating immunity. It is used in the prevention and treatment of many diseases. It has the effects of soothing the liver and relieving depression, calming the nerves and helping sleep. At the same time, modern research shows that aromatic drugs contain volatile oils, which have multiple pharmacological effects such as stimulating brain nerves, dilating cardiovascular and cerebrovascular vessels, stimulating gastric juice secretion, sedation and hypnosis. . It has unique advantages in clinical prevention and treatment of diseases.

[0008] The inventor has found in long-term clinical practice that Chinese medicine sachets can help patients with colorectal cancer surgery improve related symptoms. The Chinese medicine composition with astragalus, rhubarb, sandalwood, nard, cinnamon, angelica, calamus, and chuanxiong as the main ingredients has the effects of promoting qi and clearing the bowels, dispelling cold and relieving pain, opening the orifices and calming the nerves. The preparation of the sachets can significantly improve the symptoms of gastrointestinal dysfunction or disorder in patients with rectal cancer surgery and promote the recovery and balance of gastrointestinal function.

[0009] The first aspect of the present invention provides a traditional Chinese medicine composition for conditioning patients after radical surgery for colon cancer. The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-10 parts of cinnamon, 5-10 parts of angelica dahurica, 15-20 parts of raw astragalus, 15-20 parts of sandalwood, 3-6 parts of rhubarb, 5-10 parts of nard, 5-10 parts of calamus, 5-10 parts of ligusticum chuanxiong, 5-10 parts of costusroot, 5-10 parts of immature bitter orange, 5-10 parts of magnolia bark, 5-10 parts of atractylodes, 5-10 parts of atractylodes, 1-3 parts of tsaoko, 10-15 parts of tangerine peel, 5-10 parts of polygala, 10-15 parts of eupatorium, 5-10 parts of julibrissin, 5-10 parts of rose, 5-10 parts of lavender, and 5-10 parts of licorice.

[0010] Preferably, the optimal formula of the Chinese medicine composition is as follows: 10 parts of cinnamon, 10 parts of angelica dahurica, 15 parts of raw astragalus, 15 parts of sandalwood, 6 parts of rhubarb, 10 parts of nard, 10 parts of calamus, 10 parts of ligusticum chuanxiong, 10 parts of costusroot, 10 parts of immature bitter orange, 10 parts of magnolia bark, 10 parts of atractylodes, 10 parts of atractylodes, 3 parts of tsaoko, 15 parts of tangerine peel, 10 parts of polygala, 15 parts of eupatorium, 10 parts of julibrissin, 10 parts of rose, 10 parts of lavender, and 10 parts of licorice.

[0011] The treatment principles of this prescription and the relationship between the main, auxiliary, and adjuvant ingredients are as follows:

[0012] Treatment principles: Promoting qi and clearing the bowels, dispelling cold and relieving pain, opening the orifices and calming the nerves.

[0013] Sovereign, minister, assistant and envoy: Astragalus, rhubarb, sandalwood, nard, cinnamon, angelica dahurica, calamus and ligusticum chuanxiong are sovereign drugs; immature bitter orange, magnolia bark, tangerine peel, costusroot, atractylodes macrocephala and atractylodes are assistant drugs; polygala, perilla, julibrissin, rose and lavender are adjuvant drugs; licorice is the envoy drug.

[0014] The properties, flavors, meridians and functions of the various drugs in the formula of the present invention are as follows:

[0015] King: Astragalus nourishes Qi and raises Yang, replenishes Qi and consolidates the exterior; Rhubarb is bitter and cold in nature, it moves but does not stay, cleanses the stomach and intestines, and brings in the old and the new. It has the power to "break through the gates and seize the door", and clears out gastrointestinal stagnation; Sandalwood regulates Qi and harmonizes the stomach, dispels cold and relieves pain; Nardostachys grandiflora regulates Qi and relieves pain, relieves depression and invigorates the spleen; Rhubarb, sandalwood and Nardostachys grandiflora are used together to regulate the Qi of the middle burner, promote Qi and unblock the bowels; cinnamon and angelica dahurica can both help sleep and inhibit bacteria. Angelica dahurica is used as a medicine with its root, which has the effects of promoting blood circulation and relieving pain, and removing dampness. It can also dispel wind and relieve exterior symptoms when used with Astragalus; cinnamon has the effects of warming and expelling cold, calming the mind and tranquilizing the mind. Acorus calamus can clear phlegm and open the orifices, its aromatic flavor can clear turbidity, its pungent flavor can open the bowels, and its warmth can overcome cold and dampness. It can clear the orifices for phlegm and fluid accumulation, dampness and turbidity, chest pain and qi stagnation, and thick, greasy and dirty tongue coating. Chuanxiong is pungent in taste and yang in nature. Its qi is good at moving without the stagnant and sticky state of yin. It can dispel all kinds of wind and regulate all kinds of qi. It is also an important medicine for qi and blood, and can promote blood circulation and remove blood stasis, and promote qi and blood circulation in the brain.

[0016] Ministers: Zhishi and Houpo are auxiliary drugs, which can promote qi and relieve fullness; Chenpi is pungent, warm and aromatic, especially good at moving around, and is the best at promoting qi. Muxiang promotes qi and relieves pain, strengthens the spleen and harmonizes the stomach; Baizhu is an important drug for supporting the spleen and stomach, dispersing dampness and removing numbness; Atractylodes is pungent, warm and aromatic, dries dampness and strengthens the spleen, and is bitter and warm to reduce turbidity and harmonize the stomach. "Yuzhou Yaojie" points out that Atractylodes can "ward off miasma in mountains and rivers"; the two are used together to dispel evil and strengthen the body. Amomum villosum is pungent and aromatic, dispels filth and stops vomiting, and clears away latent evil.

[0017] Adjuvants: Polygala is a heart-nourishing and tranquilizing medicine, which has the functions of tranquilizing the mind, improving intelligence and soothing the heart. Polygala is combined with Acorus calamus to work together to open up the mind, awaken the mind and improve intelligence; Cymbidium enliven the spleen and regulate qi, cleanse the sweet and fat, can strengthen the spleen, digest food and stimulate the appetite, and can also expel foul and bad air; aromatic medicines such as rose and julibrissin have the effects of relieving depression and tranquilizing the mind, soothing the liver and promoting qi, and regulating qi and removing blood stasis; lavender has the effects of calming the mind, relieving spasms and relieving pain.

[0018] To make: Use licorice to harmonize the various medicines and make the best use of their strengths.

[0019] The second aspect of the present invention provides a sachet for conditioning patients after radical resection of colon cancer. The preparation method is as follows: the above-mentioned medicine is subjected to high temperature treatment and disinfection and then thoroughly washed and impurities are removed, and then placed in an oven, ventilated and dried and disinfected under a high temperature environment of 60°C, mixed according to proportion, ground into fine powder (particle size 100-200 mesh) and then mixed evenly. If it is too fine, it is easy to leak from the gap of the cloth and be inhaled by the respiratory tract. If it is too coarse, the fragrance of the medicine is difficult to emit and it will also wear the skin. The crushed powder is packaged into 3.5-5 grams per bag and put into a sachet to make a sachet bag.

[0020] When using, place it at the head of the bed or beside the pillow. After using the sachet for 1 to 2 weeks, the smell of the medicine will fade, and the medicine in the sachet should be replaced in time. Patients who are allergic to certain medicinal materials in the formula should not use it. If allergic symptoms occur after wearing it, it should also be discontinued.

[0021] Modern pharmacological research on this prescription has proved that the sachet has a certain antibacterial effect on intestinal bacteria such as Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. Cinnamon and Angelica dahurica both have antibacterial effects on Staphylococcus aureus, Escherichia coli and Pseudomonas aeruginosa. Cinnamon volatile oil can change the permeability of bacterial cell membranes, destroying the structure of bacteria, thereby achieving the effect of killing bacteria. [6, 7] . Sandalwood can be used for serum anti-inflammatory, calming and soothing; it has an inhibitory effect on Staphylococcus aureus. Nardostachys grandiflora can regulate gastrointestinal motility, promote the recovery and balance of gastrointestinal function; it has a certain sedative effect, which helps to relieve emotional problems such as anxiety and tension; it also has an anti-cerebral ischemia effect, and can improve learning and memory abilities to a certain extent. Costus root can significantly inhibit physical and chemical pain, and its extract has the effect of promoting small intestinal peristalsis. In modern pharmacology, lavender can not only calm the nerves, relieve spasms and relieve pain, but also has antibacterial and anti-inflammatory effects and promotes wound healing. The volatile oil components in Acorus calamus can improve memory recall deficits and enhance cognitive function. [8] Polygala has anticonvulsant and central nervous system sedative effects and is often used to treat depression and insomnia. [9] Polygala has also been shown to improve sleep and promote the regulation of mental state to a certain extent.

[10] .

[0022] The Chinese medicine sachet of the present invention has excellent effects in relieving abdominal distension, abdominal pain, sleep, and anxiety, and has a significant effect on improving the TCM syndrome score of patients after radical surgery for colorectal cancer, as follows:

[0023] In terms of relieving abdominal distension, there was no significant difference in the degree of abdominal distension on the first day after surgery between the experimental group using the sachet and the control group not using the sachet (p>0.05); there was a significant difference on the third and seventh days after surgery (p<0.05);

[0024] Regarding the relief of abdominal pain, there was no significant difference in the degree of abdominal pain between the experimental group and the control group on the first day after surgery (p>0.05); there was a significant difference on the third and seventh days after surgery (p<0.05);

[0025] In terms of sleep improvement, after 7 days of treatment with Chinese herbal sachets, the Athens Insomnia Scale scores of the two groups of patients were significantly different (p < 0.05); the Athens Insomnia Scale scores of those who did not use Chinese herbal sachets were significantly higher than those who did, indicating that Chinese herbal sachets have a certain promoting effect on the improvement of sleep quality in patients after radical resection of colorectal cancer.

[0026] In terms of anxiety relief, after 5 days of treatment with Chinese medicine sachets, the scores of the anxiety self-rating scale of the two groups of patients were significantly different, p < 0.05. Chinese medicine sachets have a certain promoting effect on the improvement of anxiety symptoms of patients after radical resection of colorectal cancer.

[0027] In terms of improvement in TCM syndrome scores, after 5 days of treatment with Chinese medicine sachets in the observation group, there was a significant difference in the TCM syndrome scores between the two groups of patients, p < 0.05, indicating that Chinese medicine sachets have a significant effect on improving the TCM syndrome scores of patients after radical surgery for colorectal cancer. DETAILED DESCRIPTION

[0028] The following examples and experimental examples are provided to further illustrate the present invention and should not be construed as limiting the present invention. The examples do not include a detailed description of conventional methods, which are well known to those skilled in the art and are described in many publications.

[0029] Unless otherwise defined, all professional and scientific terms used herein have the same meanings as those familiar to those skilled in the art. In addition, any methods and materials similar or equivalent to those described herein can be applied to the present invention, and the preferred implementation methods and materials described in the specific embodiments are for demonstration purposes only.

[0030] The experimental methods in the following examples that do not specify specific conditions are usually carried out under conventional conditions or under conditions recommended by the manufacturer. The medicinal materials used in the examples of the present invention can be obtained from Chinese medicinal material sales companies unless otherwise specified. The medicinal materials obtained are Chinese medicinal material slices unless otherwise specified. The slices can be obtained from sales companies or processed after being obtained.

[0031] Clinical efficacy observation:

[0032] 1 Study Plan

[0033] 1.1 General Information

[0034] A total of 60 patients who underwent elective colorectal cancer surgery in the Department of Surgery and Critical Care Medicine of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine from September 2023 to November 2024 were selected as the research subjects. The patients were randomly divided into a control group (conventional treatment group) and an observation group (traditional Chinese medicine sachet group) according to random numbers, with 30 cases in each group. Before enrollment, each patient and his / her family were informed in detail of the surgery and the relevant treatment measures of this study, and they were educated and signed informed consent.

[0035] 1.2 Diagnostic criteria

[0036] Western medicine diagnostic standards refer to the "Chinese Colorectal Cancer Diagnosis and Treatment Guidelines (2020 Edition)" The diagnostic criteria for TCM syndrome differentiation refer to the "Guidelines for Clinical Research of New Chinese Medicines" diagnostic criteria.

[0037] 1.3 Inclusion criteria

[0038] ① Meet the above-mentioned diagnostic criteria of traditional Chinese medicine and Western medicine; ② All participants meet the surgical indications; ③ Aged > 18 years old and with complete medical records; ④ Patients who voluntarily participate in this study and sign the informed consent form; ⑤ No assisted sleep intervention has been received in the past 3 months.

[0039] 1.4 Exclusion criteria

[0040] ① Patients with gastrointestinal dysfunction before surgery; ② Patients with other serious primary diseases; ③ Patients with serious postoperative complications; ④ Patients with serious mental disorders; ⑤ Patients with extreme weakness; ⑥ Patients with poor compliance; ⑦ Patients who cannot tolerate general anesthesia; ⑧ Patients who cannot take care of themselves; ⑨ Patients whose surgical method is changed during surgery due to other reasons; ⑩ Patients with a history of allergy to traditional Chinese medicine; ⑪ Patients who died after surgery; ⑫ Patients who take sleep aids for a long time and have habitual insomnia; ⑬ Patients with a history of anxiety and long-term use of anti-anxiety drugs.

[0041] 1.5 Research Methods

[0042] The control group received conventional treatment after surgery, including nutritional support, analgesia, antibiotics, preventive anti-infection, maintenance of water and electrolyte balance and fluid replacement, and the patients were guided in diet and exercise, and gastrointestinal decompression was performed as appropriate.

[0043] The observation group was treated with Chinese medicine sachets on the basis of the control group. The prescription was as follows: 10g cinnamon bark, 10g angelica dahurica, 15g raw astragalus, 15g sandalwood, 6g rhubarb, 10g nardus, 10g calamus, 10g ligusticum, 10g costusroot, 10g immature bitter orange, 10g magnolia bark, 10g atractylodes, 10g atractylodes, 3g tsaoko, 15g tangerine peel, 10g polygala, 15g perilla, 10g albizzia, 10g rose, 10g lavender, 10g licorice. The above drugs were mixed in proportion, ground into fine powder and then mixed well. The crushed powder was packaged into 3.5-5g / bag and put into sachets to make sachets. Place it at the head of the bed or pillow. The use time should not exceed 2 weeks.

[0044] 1.6 Observation indicators

[0045] (1) Record the time of the first flatus and defecation after surgery for both groups (the patient or the patient's family member or the nurse or caregiver should promptly and accurately record the time from the end of surgery to the first flatus or defecation after surgery). Note: The time of completion of surgery shall be based on the surgical record sheet.

[0046] (2) Observe the number and severity of abdominal pain and bloating 1, 3, and 7 days after surgery; record the Athens Insomnia Scale (AIS) test for each patient 24 hours before surgery, before treatment, and 7 days after treatment.

[0047] ① Criteria for judging the degree of abdominal distension:

[0048] Grade 0 (0 points): no feeling of abdominal distension;

[0049] Grade 1 (1 point): mild abdominal distension, slight abdominal tension, and no incision pain;

[0050] Grade 2 (2 points): moderate abdominal distension, strong abdominal wall tension, and surgical incision pain, which is still tolerable;

[0051] Grade 3 (3 points): Severe abdominal distension, high tension in the abdominal wall, postoperative incision pain, which will affect sleep and rest.

[0052] ② Criteria for judging the degree of abdominal pain (refer to the Prince-Henry scoring method for postoperative pain):

[0053] Grade 0 (0 points): No abdominal pain occurs when coughing;

[0054] Grade 1 (1 point): Abdominal pain occurs only when coughing;

[0055] Grade 2 (2 points): No abdominal pain occurs at rest, but abdominal pain occurs when taking a deep breath;

[0056] Grade 3 (3 points): Abdominal pain occurs even at rest, but the pain is mild and the patient can tolerate it.

[0057] Grade 4 (4 points): Severe abdominal pain occurs even at rest and is unbearable for the patient.

[0058] ③ Athens Insomnia Scale (AIS):

[0059] Level 0 (< 4 points): no sleep disorder;

[0060] Level 1 (4-6 points): mild insomnia;

[0061] Grade 2 (> 6 points): Insomnia.

[0062] (3) Observe the patients' Self-Rating Anxiety Scale (SAS) before treatment and 5 days after treatment;

[0063] (4) Before treatment and 5 days after treatment, the TCM syndrome score was evaluated in accordance with the Guiding Principles for Clinical Research of New Chinese Medicines. The score included abdominal distension, epigastric pain, nausea and vomiting, abnormal bowel movements, poor appetite, and fatigue. The score was 0, 2, 4, and 6, with a range of 0 to 36. The higher the score, the more severe the symptom.

[0064] 1.7 Statistical methods

[0065] SPSS 25.0 software was used to analyze the statistical data. All quantitative data were expressed as mean ± standard deviation ( ±S) and t test; count data are expressed as [n (%)]; χ 2The Wilcoxon rank sum test was used for rank data. P < 0.05 was considered statistically significant.

[0066] 2 Research results

[0067] 2.1 Comparison of general data between the two groups

[0068] In this study, the general data of the two groups were comparable (p>0.05). There were 14 males and 16 females in the observation group, with an average age of (69.93 ± 6.346) years old ranging from 58 to 84 years old. There were 15 males and 14 females in the control group, with an average age of (68.76 ± 6.973) years old ranging from 55 to 81 years old. Surgical method: laparoscopic radical resection of rectal cancer, 4 cases in the control group and 4 cases in the observation group, with no statistical significance between the two groups (p=0.96 > 0.05); laparoscopic radical resection of colon cancer, 4 cases in the control group and 4 cases in the observation group, with no statistical significance between the two groups (p=0.76 > 0.05); open radical resection of colon cancer, 11 cases in the control group and 10 cases in the observation group, with no statistical significance between the two groups (p=0.86 > 0.05); open radical resection of rectal cancer, 10 cases in the control group and 11 cases in the observation group, with no statistical significance between the two groups (p=0.72 > 0.05).

[0069] During this study, one patient in the observation group dropped out due to anxiety on the day after surgery and refused the Chinese medicine sachet treatment. A total of 30 patients in the control group completed this study as required, and a total of 29 patients in the observation group completed this study as required. There was no significant difference in the dropout rate between the two groups.

[0070] 2.2 Comparison of the first flatus and defecation time between the two groups

[0071] The first flatus time after surgery in the observation group was 49.80 ± 6.34h, and that in the control group was 53.10 ± 5.84h, with statistical significance between the two groups (p < 0.05); the first defecation time in the observation group was 62.73 ± 7.16h, and that in the control group was 67.14 ± 7.98h, with statistical significance between the two groups (p < 0.05). See Table 1 below for details:

[0072] Table 1 Comparison of time to first flatus and defecation after surgery between the two groups (h, ±S)

[0073]

[0074] 2.3 Comparison of abdominal distension between the two groups on days 1, 3, and 7 after surgery

[0075] There was no significant difference in the degree of abdominal distension between the experimental group and the control group on the first day after surgery, p>0.05; there was a significant difference on the third and seventh days after surgery, p<0.05. See Table 2 for details:

[0076] Table 2 Comparison of abdominal distension scores between the two groups on days 1, 3, and 7 after surgery (cases)

[0077]

[0078] 2.4 Comparison of abdominal pain severity between the two groups on days 1, 3, and 7 after surgery

[0079] There was no significant difference in the degree of abdominal pain between the experimental group and the control group on the first day after surgery, p>0.05; there was a significant difference on the third and seventh days after surgery, p<0.05. See Table 3 for details:

[0080] Table 3 Comparison of abdominal pain scores between the two groups on days 1, 3, and 7 after surgery (cases)

[0081]

[0082] 2.5 Comparison of sleep quality scores between the two groups

[0083] After comparison, there was no significant difference in the scores of the Athens Insomnia Scale between the observation group and the control group within 24 hours before surgery and before treatment, p>0.05. After 7 days of treatment with Chinese medicine sachets, the scores of the Athens Insomnia Scale between the two groups of patients were significantly different, p<0.05 (Table 4). The Athens Insomnia Scale scores of those who did not use Chinese medicine sachets were significantly higher than those who did, that is, Chinese medicine sachets have a certain effect on improving the sleep quality of patients after radical surgery for colorectal cancer.

[0084] Table 4 Comparison of Athens Insomnia Scale scores between the two groups (points, ±S)

[0085]

[0086] 2.6 Comparison of the results of the anxiety self-rating scale between the two groups

[0087] After comparison, there was no significant difference in the scores of the anxiety self-rating scale between the observation group and the control group before treatment, p>0.05. After 5 days of treatment with Chinese medicine sachets, there was a significant difference in the scores of the anxiety self-rating scale between the two groups of patients.

[0088] p<0.05 (Table 5). That is, Chinese herbal sachets have a certain promoting effect on the improvement of anxiety symptoms in patients after radical surgery for colorectal cancer.

[0089] Table 5 Comparison of anxiety self-rating scale scores between the two groups (points, ±S)

[0090]

[0091] 2.7 Comparison of TCM syndrome scores between the two groups before and after treatment

[0092] After comparison, there was no significant difference in the TCM syndrome scores of the observation group before treatment compared with the control group, p>0.05. After 5 days of treatment with Chinese medicine sachets, there was a significant difference in the TCM syndrome scores of the two groups of patients, p<0.05 (Table 6). Chinese medicine sachets have a significant effect on improving the TCM syndrome scores of patients after radical resection of colorectal cancer.

[0093] Table 6 Comparison of TCM syndrome scores between the two groups of patients (points, ±S)

[0094]

[0095] In summary, the Chinese medicine sachet of the present invention has excellent effects in relieving abdominal distension, abdominal pain, sleep and anxiety, and has a significant effect on improving the TCM syndrome score of patients after radical surgery for colorectal cancer.

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[0108]

[12] Zheng Xiaoyu. Guiding principles for clinical research of new Chinese medicines[S]. China Medical Science and Technology Press, 2002:124-129.

[0109] The unexplained parts involved in the present invention are the same as the prior art or are implemented by the prior art. The applicant declares that the present invention illustrates the detailed method of the present invention through the above-mentioned embodiments, but the present invention is not limited to the above-mentioned detailed method, that is, it does not mean that the present invention must rely on the above-mentioned detailed method to be implemented. Those skilled in the art should understand that any improvement of the present invention, the equivalent replacement of the raw materials of the product of the present invention, the addition of auxiliary components, the selection of specific methods, etc., all fall within the protection scope and disclosure scope of the present invention.

Claims

1. A Chinese medicine composition for conditioning patients after radical resection of colon cancer, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-10 parts of cinnamon bark, 5-10 parts of angelica dahurica, 15-20 parts of raw astragalus, 15-20 parts of santalin, 3-6 parts of rhubarb, 5-10 parts of nardostachys grandiflora, 5-10 parts of calamus calamus, 5-10 parts of ligusticum chuanxiong, 5-10 parts of costusroot, 5-10 parts of immature bitter orange, 5-10 parts of magnolia bark, 5-10 parts of atractylodes macrocephala, 5-10 parts of atractylodes lancea, 1-3 parts of tsaoko, 10-15 parts of tangerine peel, 5-10 parts of polygala tenuifolia, 10-15 parts of perilla frutescens, 5-10 parts of julibrissin, 5-10 parts of rose, 5-10 parts of lavender and 5-10 parts of liquorice.

2. The Chinese medicine composition for conditioning patients after radical resection of colon cancer according to claim 1, characterized in that: The Chinese medicine composition is composed of the following raw materials in parts by weight: 10 parts of cinnamon bark, 10 parts of angelica dahurica, 15 parts of raw astragalus, 15 parts of santalin, 6 parts of rhubarb, 10 parts of nardostachys grandiflora, 10 parts of calamus, 10 parts of ligusticum chuanxiong, 10 parts of costusroot, 10 parts of immature bitter orange, 10 parts of magnolia bark, 10 parts of atractylodes macrocephala, 10 parts of atractylodes, 3 parts of tsaoko, 15 parts of tangerine peel, 10 parts of polygala tenuifolia, 15 parts of perilla frutescens, 10 parts of flos julibrissin, 10 parts of rose, 10 parts of lavender and 10 parts of liquorice.

3. The Chinese medicine composition for conditioning patients after radical resection of colon cancer according to claim 1 or 2, characterized in that: In the traditional Chinese medicine composition, astragalus, rhubarb, sandalwood, nard, cinnamon, angelica dahurica, calamus, and ligusticum chuanxiong are main drugs; immature bitter orange, magnolia bark, tangerine peel, costusroot, atractylodes macrocephala, and atractylodes are assistant drugs; polygala, perilla, julibrissin, rose, and lavender are adjuvant drugs; and liquorice is a guiding drug.

4. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of sachets for conditioning patients after radical resection of colon cancer.

5. A sachet for conditioning patients after radical resection of colon cancer, characterized in that: Contains the Chinese medicine composition according to claim 1 or 2.

6. The method for preparing the sachet for conditioning patients after radical resection of colon cancer according to claim 5, characterized in that: The preparation method is as follows: after high-temperature treatment and disinfection and sterilization, the above-mentioned drugs are thoroughly washed and impurities are removed, and then placed in an oven. After ventilation and drying and disinfection at a high temperature of 60°C, they are mixed according to proportion, ground into fine powder and then mixed evenly. After packaging, they are placed in sachets to make sachets.

7. The preparation method according to claim 6, characterized in that: The particle size of the fine powder is 100 mesh to 200 mesh.

8. The preparation method according to claim 6, characterized in that: The particle size of the fine powder is such that the drug content in each sachet is 3.5-5 g / bag.

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