A Chinese medicine composition for treating gastric cancer of blood stasis and toxicity stagnation type and its application

Abstract

The invention relates to the technical field of Chinese medicine compositions, and discloses a Chinese medicine composition for treating gastric cancer of stasis and toxicity. The Chinese medicine composition comprises honeysuckle, stir-fried angelica, Scrophularia, roasted Astragalus, Salvia miltiorrhiza, raw liquorice, St. John's wort, Curcuma, stir-fried tangerine peel, Polygonum cuspidatum root, Pyrus elegans root, Aquilaria sinensis root, and Aquilaria sinensis. The Chinese medicine composition is relatively mild, supports positive energy to drive out evil spirits, can effectively alleviate TCM syndrome indicators of patients with gastric cancer of stasis and toxicity, improve sleep quality, and relieve anxiety and depression symptoms.

Description

Technical Field

[0001] The present invention relates to the technical field of Chinese medicine compositions, in particular to a Chinese medicine composition for treating gastric cancer of the stasis-toxicity-stagnation type and application thereof. Background Art

[0002] Gastric cancer is a malignant tumor originating from the gastric mucosal epithelium and is one of the most common malignant tumors that endanger human health. Tumor invasion and metastasis are the main causes of death in gastric cancer patients. Currently, there are surgery, chemotherapy, immunotherapy and traditional Chinese medicine treatments for gastric cancer patients. Regardless of surgery, chemotherapy or immunotherapy, they all have a serious impact on the patient's own immunity.

[0003] Studies have found that "stasis, toxicity and depression" is the core pathogenesis of gastric cancer. Clinical studies have shown that the prevalence of depression in gastric cancer is 29.7%, showing stasis, toxicity and depression, which increases the risk of death by 2.6 times. Ye Tianshi of the Qing Dynasty believed that stomach diseases were all caused by "emotional depression." Zhang Xichun proposed that gastric cancer was caused by blood stasis, and Zhou Zhongying, a master of traditional Chinese medicine, first proposed that cancer toxicity in the stomach is one of the key pathogenesis of gastric cancer. The inventor's previous research first discovered that "stasis, toxicity and depression" are the most common in the evolution of gastric cancer pathogenesis elements from ancient times to the present, showing the corresponding disease characteristics of "stasis, toxicity and depression". At the same time, it was found that the evolution trajectory is "blood stasis, toxicity caused by stasis, and depression caused by disease." Early small-sample clinical studies have found that the combination of Western medicine basic treatment and traditional Chinese medicine "equal emphasis on form and spirit, stasis, toxicity and depression" can improve patients' symptoms, improve quality of life, reduce adverse reactions, and prolong survival.

[0004] Therefore, it is particularly necessary to develop traditional Chinese medicine to treat gastric cancer of the blood stasis and toxicity type, which has important practical significance and application value. Summary of the invention

[0005] In view of the deficiencies in the prior art, the present invention provides a traditional Chinese medicine composition for treating gastric cancer of the stasis-toxicity type, which solves the problems raised in the above-mentioned background technology.

[0006] To achieve the above object, the present invention provides the following technical solutions:

[0007] A traditional Chinese medicine composition for treating gastric cancer of the stagnation type, comprising honeysuckle, stir-fried angelica, Scrophularia, roasted Astragalus, Salvia, raw licorice, St. John's wort, Curcuma, stir-fried tangerine peel, Polygonum cuspidatum root, Pyrus trichosanthis root, Polygonum multiflorum root, and Aquilaria sinensis.

[0008] Furthermore, the Chinese medicine composition for treating gastric cancer of the type of stasis and toxicity is composed of the following raw materials in parts by weight: 10-20 parts of honeysuckle, 10-15 parts of stir-fried angelica, 10-15 parts of Scrophularia, 30-35 parts of roasted Astragalus, 15-20 parts of Salvia, 5-10 parts of raw licorice, 3-6 parts of St. John's wort, 10-14 parts of Curcuma, 6-10 parts of stir-fried tangerine peel, 15-20 parts of Polygonum cuspidatum root, 15-20 parts of Pyrus truncatula root, 15-20 parts of Aquilaria, and 6-10 parts of Aquilaria.

[0009] Furthermore, the Chinese medicine composition for treating gastric cancer of blood stasis and toxicity stagnation type is preferably composed of the following raw materials in parts by weight:

[0010] 15 parts of honeysuckle, 10 parts of stir-fried angelica, 12 parts of figwort, 30 parts of roasted astragalus, 15 parts of salvia miltiorrhiza, 6 parts of raw liquorice, 3 parts of St. John's wort, 10 parts of curcuma, 6 parts of stir-fried tangerine peel, 15 parts of polygonum cuspidatum root, 15 parts of vine pear root, 15 parts of avenant root, and 6 parts of agarwood.

[0011] The present invention also provides the use of the traditional Chinese medicine composition for treating gastric cancer of the stasis-toxicity and depression type in preparing a medicine for treating gastric cancer of the stasis-toxicity and depression type.

[0012] The present invention also provides the use of the traditional Chinese medicine composition for treating gastric cancer of blood stasis and toxicity stagnation type in preparing medicine for treating stomachache, bloating, insomnia, anxiety and depression caused by gastric cancer of blood stasis and toxicity stagnation type.

[0013] The present invention also provides a Chinese medicine preparation for treating gastric cancer of the stasis and toxicity type prepared from the Chinese medicine composition for treating gastric cancer of the stasis and toxicity type.

[0014] The present invention also provides a Chinese medicine preparation for treating stomachache, bloating, insomnia, anxiety and depression caused by gastric cancer of blood stasis and toxicity, which is prepared from the Chinese medicine composition for treating gastric cancer of blood stasis and toxicity.

[0015] The dosage form of the Chinese medicine preparation includes tablets, capsules, granules, pills, pellets, decoctions or mixtures. The Chinese medicine preparation can be prepared according to conventional pharmacy processes and pharmaceutical excipients acceptable to humans.

[0016] In the present application, preferably, the Chinese medicine preparation can be a granule.

[0017] Further, the granules can be prepared by the following method:

[0018] S1. Take all the herbs except agarwood in the formula according to the weight ratio of 1:6-14 and soak for 30-90 minutes;

[0019] S2, decoct twice, the first decoction is 0.25-1 hour, the second decoction is added with 10-15 times the amount of water, decocts for 0.25-1 hour, filters, and combines the filtrate for standby use;

[0020] S3, the filtrate is concentrated into an extract, the dry extract yield is 24% to 49%, the relative density after concentration is 1.08 to 1.10 parts / ml, and dried; put into a grinder for grinding, and pass through a 100-mesh sieve to obtain a mixed fine powder;

[0021] S4, taking the agarwood slices according to the formula, drying them, crushing them, and sifting through a 100-mesh sieve to obtain agarwood fine powder;

[0022] S5. Add the mixed fine powder, agarwood fine powder and auxiliary materials maltodextrin and lactose, mix evenly, and granulate to obtain granules, each containing 5-8g of crude drug.

[0023] The Chinese medicine composition provided by the present invention is based on Simiao Yong'an Decoction (honeysuckle, Scrophularia, Angelica, Licorice) and adds roasted Astragalus, Polygonum cuspidatum root, St. John's wort, stir-fried Angelica, Pear root, Water Bayonne root, Agarwood, etc. Simiao Yong'an Decoction has the effects of clearing away heat and detoxification, promoting blood circulation and relieving pain. Studies have shown that it can improve the efficacy of gastric cancer when used in combination with other prescriptions. Jiedu Sangen Decoction (Polygonum cuspidatum root, Pear root, Water Bayonne root) is a commonly used prescription for clinical digestive tract tumors with definite clinical efficacy. Modern studies have shown that Jiedu Sangen Decoction has multiple effects such as regulating tumor-associated fibroblasts, inhibiting tumor cell migration and invasion, inhibiting tumor cell proliferation, inhibiting tumor angiogenesis, and regulating immunity. On the basis of removing blood stasis and detoxification, the present invention also selects St. John's wort, Curcuma, stir-fried tangerine peel, and Agarwood to regulate qi, soothe the liver and relieve depression. Many randomized placebo-controlled studies have confirmed the therapeutic effect of St. John's wort on depression of varying degrees. The control group uses 1 / 20 of the golden double ginseng flavored granules as a simulation agent. Therefore, under the treatment principle of removing blood stasis, detoxifying and relieving depression, this prescription has selected prescriptions and drugs that have proven clinical efficacy. Combined with the SOX regimen or the XELOX regimen, it can effectively improve the TCM syndrome indicators of patients with gastric cancer after surgery due to blood stasis, toxicity and depression, improve sleep quality, and have a significant improvement effect on anxiety and depression symptoms.

[0024] The present invention provides a Chinese medicine composition for treating gastric cancer of the stasis-toxicity-stagnation type, which has the following beneficial effects:

[0025] The Chinese medicine composition of the present invention is relatively mild, supports the healthy energy to drive out the evil spirits, can treat gastric cancer patients, improve the survival rate and the toxic and side effects caused by chemotherapy, can effectively alleviate the TCM syndrome indicators of gastric cancer patients with blood stasis and toxicity, improve sleep quality, and relieve anxiety and depression symptoms. DETAILED DESCRIPTION

[0026] The following will be combined with the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0027] Example 1

[0028] The invention provides a technical scheme: a traditional Chinese medicine composition for treating gastric cancer of blood stasis and toxicity stagnation type, the traditional Chinese medicine composition comprising 15 parts of honeysuckle, 10 parts of stir-fried angelica, 12 parts of Scrophularia, 30 parts of roasted Astragalus, 15 parts of Salvia, 6 parts of raw licorice, 3 parts of St. John's wort, 10 parts of Curcuma, 6 parts of stir-fried tangerine peel, 15 parts of Polygonum cuspidatum root, 15 parts of Pyrus truncatula root, 15 parts of Aquilaria sinensis root and 6 parts of Aquilaria.

[0029] Granules are prepared as follows:

[0030] S1. Take all the herbs except agarwood in the formula according to the weight ratio of 1:10 and soak for 60 minutes;

[0031] S2, decoct twice, the first decoction is 0.5 hours, the second decoction is 12 times the amount of water, decoct for 7 hours, filter, and combine the filtrate for standby use;

[0032] S3, the filtrate is concentrated into an extract, the dry extract yield is 24% to 49%, the relative density after concentration is 1.08 to 1.10 parts / ml, and dried; put into a grinder for grinding, and pass through a 100-mesh sieve to obtain a mixed fine powder;

[0033] S4, taking the agarwood slices according to the formula, drying them, crushing them, and sifting through a 100-mesh sieve to obtain agarwood fine powder;

[0034] S5. Add the mixed fine powder, agarwood fine powder and auxiliary materials maltodextrin and lactose, mix evenly, and granulate to obtain granules, each containing 6.5g of crude drug.

[0035] Example 2

[0036] The invention provides a technical scheme: a traditional Chinese medicine composition for treating gastric cancer of blood stasis and toxicity stagnation type, the traditional Chinese medicine composition comprising 18 parts of honeysuckle, 12 parts of stir-fried angelica, 15 parts of Scrophularia, 30 parts of roasted Astragalus, 18 parts of Salvia, 9 parts of raw licorice, 6 parts of St. John's wort, 10 parts of Curcuma, 9 parts of stir-fried tangerine peel, 15 parts of Polygonum cuspidatum root, 15 parts of Pyrus truncatula root, 15 parts of Aquilaria sinensis root and 6 parts of Aquilaria.

[0037] Example 3

[0038] Clinical trial research information:

[0039] 1 Materials and methods

[0040] 1.1 Case source

[0041] A total of 120 patients with gastric cancer of the type of stasis and toxicity were admitted to the First Affiliated Hospital of Zhejiang University, the Second Affiliated Hospital of Zhejiang University, Zhejiang Cancer Hospital, and the First Affiliated Hospital of Zhejiang Chinese Medical University from March 2020 to December 2022 as observation subjects. The experimental group and the control group were allocated at a ratio of 1:1, with 60 cases in the experimental group and 60 cases in the control group.

[0042] 1.2 Western medicine diagnostic standards are based on the "Chinese Common Malignant Tumor Diagnosis and Treatment Guidelines Volume 4 Gastric Cancer" compiled by the National Cancer Prevention and Treatment Research Office and the Chinese Anti-Cancer Association, the "Gastric Cancer Diagnosis and Treatment Guidelines (2018 Edition)" and the "Clinical Diagnosis and Treatment Guidelines Tumor Volume" promulgated and implemented by the National Health Commission of the People's Republic of China, and are based on surgical pathology diagnosis. Innovative research and application of the clinical program of "giving equal importance to form and spirit, and treating both stasis and toxicity" for gastric cancer 9 Clinical pathological staging is performed according to the 2016 American Joint Committee on Cancer (AJCC) / International Union Against Cancer (UICC) 8th edition gastric cancer TNM staging criteria.

[0043] 1.3 Standards for TCM Syndrome Differentiation The syndrome differentiation is based on the syndrome of stasis, toxicity and depression, and is formulated in conjunction with the Guidelines for Clinical Research of New Chinese Medicines (Zheng Xiaoyu, China Medical Science and Technology Press, 2002), TCM Diagnosis and Treatment Program for Gastric Cancer (Trial) (Medical Administration Department of the State Administration of Traditional Chinese Medicine, 2011 edition), TCM Diagnosis (5th-7th editions), National Standard of the People's Republic of China: TCM Clinical Diagnosis and Treatment Terminology, Syndrome Part (GB / T16751.2-1997), and Guidelines for Clinical Research of New Chinese Medicines for the Treatment of Gastric Cancer (Compiled by the Ministry of Health of the People's Republic of China, "Guidelines for Clinical Research of New Chinese Medicines, Volume 3", 1997).

[0044] 1.4 Main symptoms: pain, distension or discomfort in the stomach, depression or irritability, abdominal distension, poor appetite, loose stools or constipation. Secondary symptoms: belching and acid regurgitation, sighing, bowel sounds and flatulence, nausea and vomiting, dry and bitter mouth, subcutaneous ecchymosis, and skin and nail disorder. Tongue coating and pulse: red or dark purple tongue or ecchymosis, thin white or yellow greasy coating, stringy and thin pulse or deep and astringent pulse or moist and rapid pulse. Refer to the main and secondary symptoms and tongue coating and pulse, and the patient can be diagnosed with the syndrome of blood stasis, toxicity and depression.

[0045] 1.5 Inclusion criteria Only those who meet all of the following conditions can be included in this study: 1) Pathologically diagnosed with TNM stage III gastric cancer, who have undergone D2 radical surgery and have not started chemotherapy after surgery; 2) TCM syndrome differentiation is blood stasis and toxicity syndrome; 3) Age 18-75 years old (including 18 and 75 years old), regardless of gender; 4) Generally in good condition, ECOG score ≤ 2 points; 5) Subjects must give their informed consent to the trial before the trial, fully understand the trial content, process and possible adverse reactions, and voluntarily sign a written informed consent.

[0046] 1.6 Exclusion criteria Patients who meet any of the following criteria are not eligible for inclusion in this study: 1) Patients with gastric cancer metastasis or recurrence, or patients with other tumors within 5 years; 2) Patients with an expected survival period of ≤ 3 months; 3) Patients with severe malnutrition and primary diseases of the heart, brain, lung, liver, kidney, endocrine, blood, nervous system, or other acute or chronic diseases that may significantly affect treatment and prognosis; 4) Patients with a history of epileptic seizures or risk of epileptic seizures; 5) Patients with dementia or severe mental disorders that make them unable to understand or express informed consent; 6) Patients with a current or previous history of alcohol or drug abuse or drug abuse; 7) Male subjects (or their partners) or female subjects who were 28 years old or younger before screening. 1) Those who have plans to have children or donate sperm and eggs within 6 days after the last dose of the study drug, and are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, contraceptive rings, partner sterilization, etc.) during the trial; 2) Patients who are preparing for pregnancy, pregnant or breastfeeding; 3) Those who are participating in other clinical studies; 4) Those who are allergic to the study drugs and their components; 5) Those who cannot swallow tablets or Chinese herbal decoctions, have malabsorption syndrome or any conditions that affect gastrointestinal absorption; 6) Those who have active pulmonary tuberculosis (TB), are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year before screening; 7) Those who are considered by the investigator to be unsuitable for participation in this study.

[0047] 2. Randomization and grouping

[0048] 2.1 Randomization SAS9.4 (or above) statistical software was used to generate the random table and the corresponding treatment group, and the random number was assigned by the electronic central random system for clinical trials (DASforIWRS, provided by the First Affiliated Hospital of Zhejiang Chinese Medical University).

[0049] 2.2 The grouping adopts a two-level blind design. The first level of unblinding is to determine the group corresponding to each group of cases after the clinical trial data is locked, which is replaced by letters (such as Group A and Group B); the second level of unblinding is to determine the corresponding treatment group (such as experimental group and control group).

[0050] 3. Preparation of Drugs

[0051] The test group used the granules prepared in Example 1, and the control group used a control drug simulator, which was unrecognizable in appearance.

[0052] 4. Western medicine treatment plan

[0053] (1) SOX regimen: oxaliplatin: 130 mg / m 2 , intravenous infusion for 2-6 hours, D1; if the body surface area exceeds 2.0m 2 Researchers can use 2.0m according to clinical practice. 2 Calculate the dosage; S-1: The initial dose of S-1 is 40 mg / m 2 / dose (body surface area intervention);

[0054] (2) XELOX regimen Oxaliplatin: Refer to the SOX regimen. Capecitabine: The initial dose of oxaliplatin will be 1000 mg / m2 / dose. Capecitabine will be taken orally twice a day within 30 minutes after breakfast and dinner for 14 consecutive days, followed by a 7-day break. If capecitabine administration has already begun, administration will continue for a maximum of 14 days. If oxaliplatin is discontinued, Segalovirus or capecitabine can continue to be administered alone; however, if Segalovirus or capecitabine is discontinued, oxaliplatin should also be discontinued. SOX or XELOX treatment will continue for more than 1 treatment cycle. All subjects received one of the above chemotherapy regimens and the following drug treatments at the same time.

[0055] Both groups of patients were given standardized Western medicine treatment. The experimental group was combined with the granules of Example 1 (15 parts of honeysuckle, 10 parts of fried angelica, 12 parts of Scrophularia, 30 parts of roasted Astragalus, 15 parts of Salvia, 6 parts of raw licorice, 3 parts of St. John's wort, 10 parts of Curcuma, 6 parts of fried tangerine peel, 15 parts of Polygonum cuspidatum root, 15 parts of Pear root, 15 parts of Aquilaria root, 6 parts of Agarwood) on the basis of chemotherapy: produced by China Resources Sanjiu Pharmaceutical Co., Ltd.; specification: 17.125 parts / pack × 46 packs / box, 1 pack each time, 2 times a day. The experimental group was combined with a control drug simulant (1 / 20 of the active ingredient of the research drug) on ​​the basis of chemotherapy: unrecognizable in appearance, produced by Sanjiu Pharmaceutical Co., Ltd., specification: 17.125 parts / pack × 46 packs / box, 1 pack each time, 2 times a day. The subjects began to take the test drugs continuously for 24 weeks when they were enrolled.

[0056] 5. Clinical observation indicators

[0057] 5.1 TCM syndrome efficacy score;

[0058] Formulated with reference to the "Guidelines for Clinical Research of New Chinese Medicines" (Trial) 2002 Edition. The efficacy of TCM symptoms and signs (syndromes) is determined by the integral method, and the integral reduction (%) = (pre-treatment integral - post-treatment integral) / pre-treatment integral * 100%. Total effective rate = (clinically cured + markedly effective + effective) cases / total number of cases * 100%; clinically cured: the symptom integral value is reduced by ≥ 95%; markedly effective: 70% ≤ The symptom integral value is reduced by < 30%.

[0059] The TCM symptom efficacy evaluation table is shown in Table 1 below:

[0060]

[0061] 5.2 Pittsburgh Sleep Quality Index (PSQI)

[0062] The scale involves 7 components, and the scores of the 7 components are summed up to form a total score. The full score of PSQI is 21 points, and the lowest score is 0. A score equal to or lower than 7 points indicates good sleep quality, and a score higher than 7 points can be preliminarily determined as sleep disorder. The higher the total score, the worse the sleep quality.

[0063] 5.3 Hamilton Depression Rating Scale (HAMD-24)

[0064] The respondents were asked and recorded item by item, and scored to assess whether they were in a state of depression. The score included five factors: anxiety / somatization, weight, cognitive impairment, retardation, and sleep disorders. A total score greater than 7 was considered mild depression, greater than 17 was moderate depression, and greater than 24 was considered severe depression.

[0065] 5.4 Hamilton Anxiety Scale (HAMA-14);

[0066] The respondents were asked questions item by item, recorded, and scored to assess whether they were in an anxious state. The 14 evaluation indicators included anxious mood, tension, fear, insomnia, cognitive function, depressed mood, physical anxiety, cardiovascular system symptoms, respiratory system symptoms, gastrointestinal symptoms, reproductive and urinary nervous system symptoms, autonomic nervous system symptoms, and behavioral performance during the interview. A HAMA standard score greater than 14 was considered an anxious state.

[0067] The cut-off value is 14 points.

[0068] The total score is 7 points: no anxiety symptoms. Total score > 7 points: possible anxiety. Total score > 14 points: definitely anxious. Total score > 21 points: definitely obvious anxiety. Total score > 29 points: possible severe anxiety.

[0069] 6. Statistical analysis methods

[0070] 6.1 Statistical analysis will be performed using SAS9.4 (or above) software. Statistical tests will be performed using two-sided tests, and a P value less than or equal to 0.05 will be considered statistically significant (unless otherwise specified).

[0071] 6.2 Efficacy analysis

[0072] ① Describe the pre-treatment data and compare the two groups. Comparability comparison mainly uses c2 test or exact probability calculation, t test and non-parametric test.

[0073] ② For the efficacy indicators, the monotonic regression analysis with the center effect controlled was used, and the comparison of the changes before and after treatment was done by paired t-test or covariance analysis with the center effect controlled.

[0074] ③ For the comparison of the secondary efficacy indicators between the two groups, the C2 test or exact probability calculation, t test and non-parametric test were used according to the data situation.

[0075] 7. Results

[0076] Among the 120 enrolled patients, 106 patients completed 24 weeks of medication and did not drop out, including 59 patients in the trial group and 47 patients in the placebo group.

[0077] 7.1 TCM Syndrome Efficacy Scoring

[0078] As shown in Table 2, the total effective rate of the experimental group was higher than that of the placebo group (67.79% vs 53.19%).

[0079] Table 2 Comparison of TCM symptoms and signs (syndromes) efficacy

[0080]

[0081] 7.2 Pittsburgh Sleep Quality Rating

[0082] ① The Pittsburgh sleep quality score of the experimental group was lower than that of the screening period (before treatment). Among them, the Pittsburgh sleep quality score of the experimental group after 12 weeks and 24 weeks of medication was statistically significant compared with the screening period (P<0.05); there was no statistically significant difference between the 6th and 18th weeks of medication and the screening period (P>0.05). ② The Pittsburgh sleep quality score of the placebo group was lower than that of the screening period (before treatment). However, there was no statistically significant difference between the Pittsburgh sleep quality score after 6, 12, 18 and 24 weeks of medication and the screening period (P>0.05). See Table 3.

[0083] Table 3 Pittsburgh sleep quality score comparison table

[0084]

[0085] *p<0.05vs screening period of experimental group

[0086] 7.3 Hamilton Depression Scale

[0087] ① The Hamilton depression score of the experimental group was lower than that of the screening period (before treatment). Among them, the Hamilton depression score of the experimental group after 18 weeks of medication was statistically significant compared with the screening period (P<0.05); there was no statistically significant difference between the 6-week, 12-week and 24-week medication and the screening period (P>0.05). ② The Hamilton depression score of the placebo group was lower than that of the screening period (before treatment). However, there was no statistically significant difference between the Hamilton depression score after 6, 12, 18 and 24 weeks of medication and the screening period (P>0.05). See Table 4.

[0088] Table 4 Comparison of Hamilton Depression Scores

[0089]

[0090] *p<0.05vs screening period of experimental group

[0091] 7.4 Hamilton Anxiety Score

[0092] ① The Hamilton anxiety score in the experimental group was lower than that in the screening period (before treatment). Among them, the Hamilton anxiety score in the experimental group after 24 weeks of medication was statistically significant compared with the screening period (P<0.05); there was no statistically significant difference between the 6-week, 12-week and 18-week medication and the screening period (P>0.05). ② The Hamilton anxiety score in the placebo group was lower than that in the screening period (before treatment). However, there was no statistically significant difference between the Hamilton anxiety score after 6, 12, 18 and 24 weeks of medication and the screening period (P>0.05). See Table 5.

[0093] Table 5 Comparison of Hamilton Anxiety Scores

[0094]

[0095] ##p<0.01vs the screening period of the experimental group

[0096] in conclusion

[0097] At present, the sleep quality of gastric cancer patients during chemotherapy is poor, and anxiety and depression are one of the important causes of gastric cancer recurrence and metastasis. The Chinese medicine syndrome efficacy scoring scale, Pittsburgh sleep quality scoring scale, Hamilton depression scoring scale, and Hamilton anxiety scoring scale are all scoring scales with high international recognition, which are sufficient to reflect the patient's true situation. Chinese medicine constitution is closely related to sleep quality, anxiety, and depression. The experimental results show that improving Chinese medicine constitution can help improve the poor sleep and excessive anxiety and depression of patients during chemotherapy for gastric cancer. The Chinese medicine syndrome efficacy scoring scale is the basis for clarifying the patient's Chinese medicine constitution. The results of the Chinese medicine syndrome efficacy scoring scale support that taking the present invention helps to improve the constitution. The results of the latter three scales support that the Chinese medicine composition of the present invention has the effect of improving the sleep quality, anxiety, and depression of patients with gastric cancer of the stasis and toxicity type during chemotherapy.

[0098] It should be noted that, in this article, relational terms such as first and second, etc. are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device.

[0099] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Chinese medicine composition for improving the symptoms of postoperative chemotherapy of gastric cancer of blood stasis and toxicity stagnation type, characterized in that The Chinese medicine composition is prepared from the following raw materials in parts by weight: 10-20 parts of honeysuckle, 10-15 parts of stir-fried angelica, 10-15 parts of Scrophularia, 30-35 parts of roasted Astragalus, 15-20 parts of Salvia, 5-10 parts of raw licorice, 3-6 parts of St. John's wort, 10-14 parts of Curcuma, 6-10 parts of stir-fried tangerine peel, 15-20 parts of Polygonum cuspidatum root, 15-20 parts of Pyrus elegans root, 15-20 parts of Aquilaria, and 6-10 parts of Aquilaria.

2. The Chinese medicine composition according to claim 1, characterized in that The Chinese medicine composition is made from the following raw materials in parts by weight: 15 parts of honeysuckle, 10 parts of stir-fried angelica, 12 parts of figwort, 30 parts of roasted astragalus, 15 parts of salvia miltiorrhiza, 6 parts of raw liquorice, 3 parts of St. John's wort, 10 parts of curcuma, 6 parts of stir-fried tangerine peel, 15 parts of polygonum cuspidatum root, 15 parts of vine pear root, 15 parts of avenant root, and 6 parts of agarwood.

3. Use of the Chinese medicine composition for improving the symptoms of gastric cancer postoperatively during chemotherapy as claimed in any one of claims 1 to 2 in the preparation of a medicament for improving the symptoms of gastric cancer postoperatively during chemotherapy as claimed in any one of claims 1 to 2.

4. The use according to claim 3, characterized in that The Chinese medicine composition for improving the symptoms of gastric cancer with stasis and toxicity during postoperative chemotherapy is used in the preparation of a medicine for improving stomach pain, bloating, insomnia, anxiety and depression during postoperative chemotherapy of gastric cancer with stasis and toxicity.

5. A Chinese medicine preparation for improving the symptoms of gastric cancer after surgery during chemotherapy, prepared from the Chinese medicine composition for improving the symptoms of gastric cancer after surgery during chemotherapy of the type of gastric cancer after surgery due to stasis and toxicity as claimed in any one of claims 1 to 2.

6. A Chinese medicine preparation for improving stomachache, bloating, insomnia, anxiety and depression, which are symptoms of gastric cancer after surgery during chemotherapy, prepared by the Chinese medicine composition for improving the symptoms of gastric cancer after surgery during chemotherapy, which is characterized by blood stasis and toxicity.

7. The Chinese medicine preparation according to claim 5, characterized in that The dosage form of the Chinese medicine preparation is tablets, capsules, granules, dripping pills, micropills, decoctions or mixtures.

Images