Traditional Chinese medicine decoction for treating cancerous fatigue and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine decoction for treating cancerous fatigue and a preparation method of the traditional Chinese medicine decoction. The traditional Chinese medicine decoction comprises the following components: 5-15g of sun-dried ginseng, 10-20g of poria cocos, 5-15g of roasted rhizoma atractylodis macrocephalae, 3-8g of honey-fried licorice root, 5-15g of radix bupleuri, 5-15g of rhizoma pinellinae praeparata, 25-35g of astragalus membranaceus, 10-20g of lucid ganoderma, 10-15g of fried hawthorn, 10-20g of fried malt, 15-25g of lily, 5-15g of platycodon grandiflorum, 5-15g of medlar, 5-15g of herba epimedii, 5-15g of caulis bambusae in taeniam and 5-15g of semen cuscutae. Putting the raw materials into a decoction pot, and soaking the raw materials in clear water for half an hour until the water just submerges the medicinal materials; decocting with big fire for 15 minutes, and then decocting with small fire for 30 minutes. The problem that in the prior art, the curative effect on cancer-related fatigue is slow is solved.

Description

Technical Field

[0001] The invention belongs to the technical field of medicine, and particularly relates to a Chinese medicinal decoction for treating cancer fatigue and a preparation method thereof. Background Art

[0002] Cancer-related fatigue refers to the persistent physical and mental fatigue caused by the disease or treatment, which is mainly manifested by weakness, fatigue, difficulty concentrating, depression, etc. It may even affect the patient's mental health and cognitive level and hinder daily life. Studies have shown that up to 90% of cancer patients will experience varying degrees of cancer fatigue. Currently, relevant research on the treatment of cancer fatigue mainly focuses on health education, nursing intervention, Chinese herbal decoctions, exercise therapy, psychological intervention, etc.

[0003] Li Liang'e used auricular acupoint pressing to intervene in 120 patients with advanced malignant tumors according to the principles and methods of traditional Chinese medicine. The experiment showed that on the 12th day after the intervention, the patients in the auricular acupoint pressing group had improvements in physiological dysfunction, psychological dysfunction, daily activity impact, and social dysfunction, and their satisfaction with the treatment was also high. Huang Huan's study on the intervention of cancer-related fatigue in gastric cancer patients using auricular acupoint pressing combined with Ba Duan Jin also showed that Ba Duan Jin combined with auricular acupoint pressing and acupoint sticking can reduce cancer-related fatigue in gastric cancer chemotherapy patients and reduce the occurrence of adverse reactions to chemotherapy. Chen Meiling's study on cancer-related fatigue and quality of life in 84 patients undergoing lung cancer chemotherapy showed that moxibustion combined with auricular acupoint pressing and acupoint sticking can reduce the degree of cancer-related fatigue in patients undergoing lung cancer chemotherapy and improve the quality of life and patient satisfaction. Ding Juxiang selected 65 cancer chemotherapy patients admitted to Jiangsu Provincial Hospital of Traditional Chinese Medicine and randomly divided them into two groups according to the random number table method. The control group of 32 cases was given aerobic exercise; the observation group of 33 cases was given aerobic exercise combined with auricular acupoint pressing. The effect of the intervention was evaluated by comparing the degree of fatigue relief and the improvement of quality of life between the two groups. After completing a one-month course of treatment, the observation group had a significant effect on fatigue relief and improvement of quality of life compared with the control group.

[0004] As a core treatment method in traditional Chinese medicine, the research on Chinese herbal decoctions in the treatment of cancer-related fatigue is more comprehensive and abundant than that on auricular acupoint pressure therapy.

[0005] Cancer-related fatigue often occurs in the terminal stage of the disease, or after chemotherapy, when the body is weak due to long-term illness and the body functions decline due to treatment. Therefore, the related etiology, pathogenesis and clinical manifestations are most similar to asthenia. Asthenia, also known as deficiency, is a general term for a variety of chronic diseases with internal organs deficiency, qi, blood, yin and yang deficiency, and long-term deficiency that cannot be restored to fatigue as the main pathogenesis, and deficiency of the five internal organs as the main clinical symptoms. It is the most widely involved disease in Chinese internal medicine. The Yellow Emperor's Classic of Internal Medicine summarizes the definition of asthenia as "deficiency due to loss of essence and qi". Zhang Zhongjing first coined the name of "asthenia", believing that asthenia is caused by deficiency and damage, and accumulated damage leads to fatigue. He also divided asthenia into yang deficiency, yin deficiency, and yin and yang deficiency, and the treatment focuses on warming and tonifying the spleen and kidneys. Later generations gradually developed the theory of asthenia, especially after the Jin and Yuan Dynasties, the concept of asthenia was expanded, the treatment principles were more detailed, and the explanations of asthenia flourished. Among them, Zhang Jingyue established the treatment principle of "seeking yang in yin and seeking yin in yang", which inspired later generations. There was even a special book on asthenia in the Ming Dynasty. Therefore, the research on the treatment of cancer-related fatigue with Chinese herbal decoctions is more comprehensive.

[0006] The most commonly used decoction for the treatment of cancer-related fatigue is Buzhong Yiqi Decoction, followed by Sijunzi Decoction, Bazhen Decoction, Guipi Decoction, etc. Yu Jianhua took 60 patients with cancer-related fatigue as research subjects and divided them into a control group and a research group according to the random number table method, with 30 cases in each group. The control group was given conventional chemotherapy, and the research group was treated with Buzhong Yiqi Decoction on the basis of the control group. The results showed that Buzhong Yiqi Decoction can effectively reduce the fatigue level of patients, reduce the incidence of adverse gastrointestinal reactions such as nausea and vomiting, and improve the quality of life of patients. Professor Jiang Yilan, a Chinese medicine oncologist, is good at using Chinese medicine to treat cancer-related fatigue. Professor Jiang believes that the pathogenesis of cancer-related fatigue is spleen and kidney deficiency and liver qi stagnation. After surgery, radiotherapy, chemotherapy and other Western medicine treatments, patients further develop qi and blood deficiency, consume yin and damage qi, and finally both yin and yang are deficient, or even yin and yang are separated. On the basis of treating both the spleen and kidney, it proposes the basic treatment methods of strengthening the spleen and kidney, replenishing qi and blood, nourishing yin and promoting fluid production, and balancing yin and yang for the three different stages of surgery, radiotherapy and chemotherapy, and palliative symptomatic treatment of advanced tumors, and provides liver-soothing and depression-relieving treatment throughout the process, achieving good clinical results. The use of Chinese herbal medicine decoctions can also improve patients' psychological expectations, so that they can actively cooperate with treatment, reduce psychological pressure, and thus alleviate the mental blow and cognitive damage caused by cancer-related fatigue. Summary of the invention

[0007] The purpose of the present invention is to provide a Chinese medicinal decoction for treating cancer fatigue and a preparation method thereof, so as to solve the problem that the prior art has a slow therapeutic effect on treating cancer fatigue.

[0008] The technical solution adopted by the present invention is that the Chinese medicine decoction for treating cancer fatigue is composed of the following active ingredients of raw materials in terms of mass ratio:

[0009] Raw sun-dried ginseng 5-15g, Poria 10-20g, stir-fried Atractylodes 5-15g, roasted Licorice root 3-8g, Bupleurum 5-15g, Pinellia 5-15g, Astragalus 25-35g, Ganoderma lucidum 10-20g, stir-fried Hawthorn 10-15g, stir-fried malt 10-20g, Lilium 15-25g, Platycodon 5-15g, Lycium barbarum 5-15g, Epimedium 5-15g, Bamboo Shavings 5-15g, Cuscuta australis 5-15g.

[0010] Further, it is composed of the following active ingredients of raw materials:

[0011] 10g raw sun-dried ginseng, 15g Poria cocos, 10g stir-fried Atractylodes macrocephala, 5g roasted Licorice root, 10g Bupleurum, 10g Pinellia ternata, 30g Astragalus, 15g Ganoderma lucidum, 12g stir-fried Hawthorn, 15g stir-fried malt, 20g Lilium, 10g Platycodon grandiflorum, 10g Lycium barbarum, 10g Epimedium, 10g Bamboo Shavings, and 10g Cuscuta australis.

[0012] Another technical solution adopted by the present invention is a method for preparing a Chinese medicine decoction for treating cancer fatigue, which is carried out according to the following steps:

[0013] 1) Take each raw material according to the proportion, then put each raw material in a decoction pot and soak it in clean water for half an hour, with the water just covering the medicinal materials;

[0014] 2) Cook over high heat for 10-20 minutes, then turn to low heat and cook for 20-40 minutes;

[0015] 3) Divide each dose into two portions, each portion is about 140mL-160mL.

[0016] The beneficial effects of the present invention are as follows: the spleen and kidney prescription is based on Sijunzi Decoction, which is the basic prescription and conventional prescription for treating cancer-related fatigue. In addition to Sijunzi Decoction for tonifying the middle and replenishing qi, it is also added with spleen-tonifying drugs such as fried malt and fried hawthorn, and expectorant drugs such as pinellia and bamboo shavings, which can invigorate the spleen, effectively transport and transform qi and blood, and make the biochemical transformation of qi and blood active. It is also added with kidney-tonifying drugs, which emphasize both spleen and kidney tonifying, and is a spleen and kidney prescription. It can coordinate the innate and acquired, so that the essence and blood can be mutually generated, help each other, and strengthen the foundation. Therefore, the efficacy is better than the general prescriptions for treating cancer-related fatigue. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 This is a graph showing the polysaccharide content of Ganoderma lucidum fermented liquid containing astragalus and Ganoderma lucidum fermented liquid without astragalus. DETAILED DESCRIPTION

[0018] The following will be combined with the drawings in 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.

[0019] The mass proportions of the raw materials contained in the Chinese herbal decoction for treating cancer fatigue in this application are as follows:

[0020] Raw sun-dried ginseng 5-15g, Poria 10-20g, stir-fried Atractylodes 5-15g, roasted Licorice root 3-8g, Bupleurum 5-15g, Pinellia 5-15g, Astragalus 25-35g, Ganoderma lucidum 10-20g, stir-fried Hawthorn 10-15g, stir-fried malt 10-20g, Lilium 15-25g, Platycodon 5-15g, Lycium barbarum 5-15g, Epimedium 5-15g, Bamboo Shavings 5-15g, Cuscuta australis 5-15g.

[0021] Preferably, each raw material is mixed according to the following mass proportions:

[0022] Raw sun-dried ginseng 10g±5g, Poria 15±1g, stir-fried Atractylodes 10±1g, roasted Licorice root 5±2g, Bupleurum 10±1g, Pinellia 10±1g, Astragalus 30±1g, Ganoderma lucidum 15±1g, stir-fried Hawthorn 12±2g, stir-fried malt 15±2g, Lilium 20±2g, Platycodon 10±1g, Lycium barbarum 10±2g, Epimedium 10±1g, Bamboo Shavings 10±1g, Cuscuta australis 10±1g.

[0023] The preparation method of the Chinese medicine decoction for treating cancer fatigue comprises the following specific steps:

[0024] 1) Place all the raw materials in a decoction pot and soak them in clean water for half an hour. The amount of water is 300mL-320mL, which should just cover the medicinal materials.

[0025] 2) Cook over high heat for 15 minutes, then turn to low heat and cook for 30 minutes;

[0026] 3) Divide each dose into two portions, one for warm consumption in the morning and one in the evening, each portion is approximately 140mL-160mL.

[0027] The method of taking the Chinese medicine decoction is: boil it with water into a total of 300ml of decoction, divide each dose into two portions, each portion is about 140mL-160mL, take one portion warm in the morning and evening, and take it continuously for 14 days.

[0028] Example 1

[0029] Take the following raw materials: 10g of raw sun-dried ginseng, 15g of Poria cocos, 10g of stir-fried Atractylodes macrocephala, 5g of roasted Licorice root, 10g of Bupleurum chinense, 10g of Pinellia ternata, 30g of Astragalus, 15g of Ganoderma lucidum, 12g of stir-fried Hawthorn, 15g of stir-fried Malt, 20g of Lilium, 10g of Platycodon grandiflorum, 10g of Lycium barbarum, 10g of Epimedium, 10g of Rhizoma Anemarrhenae, and 10g of Cuscuta chinensis.

[0030] Then put all the ingredients in a decoction pot, soak them in clean water for half an hour, with the water just covering the herbs; boil over high heat for 15 minutes, then turn to low heat and boil for 30 minutes; that's it.

[0031] Example 2

[0032] Take the following raw materials: 5g of raw sun-dried ginseng, 20g of Poria cocos, 5g of stir-fried Atractylodes macrocephala, 8g of roasted Licorice root, 5g of Bupleurum chinense, 15g of Pinellia ternata, 25g of Astragalus membranaceus, 20g of Ganoderma lucidum, 10g of stir-fried Hawthorn, 20g of stir-fried Malt, 15g of Lilium bulb, 15g of Platycodon grandiflorum, 5g of Lycium barbarum, 15g of Epimedium, 5g of Bamboo Shavings, and 15g of Cuscuta chinensis.

[0033] Then put all the ingredients in a decoction pot, soak them in clean water for half an hour, with the water just covering the herbs; boil over high heat for 40 minutes, then switch to low heat and boil for 40 minutes; that's it.

[0034] Example 3

[0035] Take the following raw materials: 15g sun-dried ginseng, 10g Poria, 15g stir-fried Atractylodes macrocephala, 3g roasted Licorice root, 15g Bupleurum, 5g Pinellia, 35g Astragalus, 10g Ganoderma, 5g stir-fried Hawthorn, 10g stir-fried Malt, 25g Lilium, 5g Platycodon, 15g Lycium barbarum, 5g Epimedium, 15g Rhizoma Anemarrhenae, 5g Cuscuta chinensis;

[0036] Then put all the ingredients in a decoction pot, soak them in clean water for half an hour, with the water just covering the herbs; boil over high heat for 20 minutes, then turn to low heat and boil for 20 minutes; that's it.

[0037] Pharmacology and efficacy:

[0038] The Chinese medicine decoction of the present invention is based on Sijunzi decoction. The existing Sijunzi decoction components are: 10g of Codonopsis pilosula, 10g of Poria cocos, 10g of stir-fried Atractylodes macrocephala, and 10g of roasted Licorice root. Existing studies have shown that for animals with spleen deficiency, Sijunzi decoction can increase the secretion of mucus glycoprotein on the surface of gastrointestinal cells, promote the renewal of intestinal epithelial cells, thereby enhancing the barrier function of gastrointestinal mucosa, and can also increase the content of zymogen granules in gastric chief cells of animals with spleen deficiency, increase serum D-xylose, promote the growth of intestinal epithelial cell microvilli, and improve the digestion, movement and absorption functions of the stomach and intestines; experiments also show that Sijunzi decoction can dilate the diameter of mesenteric arterioles, increase the number of open capillaries, and reduce the blood flow of gastric mucosa in mice with spleen deficiency caused by vinegar. The results showed that Sijunzi decoction increased the level of LPO in serum and increased the activity of superoxide dismutase (SOD). In addition, Sijunzi decoction adjusted the abnormal levels of motilin (MOT) and prostaglandin E2 in intestinal tissue and plasma and the pharmacokinetic parameters of rats with spleen deficiency treated with reserpine. For normal mice, Sijunzi decoction increased the gastric mucosal blood flow, providing a reliable material delivery channel for gastrointestinal cell protection. It also increased the activity of succinate dehydrogenase in mitochondria of gastrointestinal cells and Na+-K+-ATPase in jejunal cell membrane, providing the prerequisite for maintaining the integrity of the mucosa and improving the absorption of nutrients by jejunal absorptive epithelial cells. In addition, Sijunzi decoction had no significant effect on the gastric juice volume, gastric acid pH value and gastrointestinal motility of normal animals, but could increase the activity of pepsin in normal animals, and also adjusted the absorption function of the small intestine, with the effect of strengthening the spleen and replenishing qi.

[0039] Na+K+-ATPase (Na+K+-ATPase) is a transmembrane carrier protein for ion transport in mammalian cell membranes. It is widely distributed in plants, animals, microorganisms and cells, and can catalyze the hydrolysis of ATP to generate ADP and inorganic phosphorus. In addition to maintaining the balance of Na+-K+ electrochemical gradients inside and outside the cell membrane, Na+K+-ATPase has a certain influence on the maintenance of cell osmotic pressure, the regulation of cell volume, and the recovery and maintenance of the resting membrane potential of excitable cells. In addition, Na+K+-ATPase is also related to cell death and a variety of important diseases.

[0040] The Chinese medicine decoction in this application replaces the codonopsis in the Four Gentlemen Decoction with raw sun-dried ginseng. Codonopsis can replenish the middle qi, strengthen the spleen and benefit the lungs, and is used for spleen and lung weakness, shortness of breath and palpitations, poor appetite and loose stools, asthenia and cough, internal heat and thirst; while raw sun-dried ginseng greatly replenishes the vital energy, restores the pulse and consolidates the body, replenishes the spleen and benefits the lungs, promotes the production of body fluids, and calms the mind. It is used for physical weakness and weakness. The two have similar functions, but because raw sun-dried ginseng can greatly replenish the vital energy, it is more suitable for people with cancer-related fatigue who have been ill for a long time and are physically weak.

[0041] The combination of Bupleurum and Pinellia can soothe the liver and regulate qi. The combination of Bupleurum and Pinellia will have 103 active ingredients, which can act on 149 candidate targets for the treatment of gastritis. It can regulate signal pathways such as the nervous system, endocrine system, and chemokine pathways, and play an anti-gastritis effect.

[0042] Lingzhi and Astragalus can strengthen the body, replenish qi and tonify deficiency. Lingzhi has been proven to protect the liver, fight tumors and regulate immunity. When Astragalus and Lingzhi are used together, Astragalus can greatly increase the polysaccharide content of Lingzhi fermented liquid. Figure 1 After adding Astragalus, Ganoderma lucidum polysaccharides have stronger immune enhancement activity and inhibitory effect on tumor cell proliferation, enhancing the immune activity and anti-tumor activity of fungal polysaccharides.

[0043] Fried hawthorn and fried malt are a spleen-strengthening combination that can adjust gastrointestinal motility and gastric acid secretion. They can also promote the health of intestinal flora, improve intestinal digestive function, and facilitate the absorption of vitamins.

[0044] The combination of bamboo shavings and lily can replenish qi and produce body fluid, and can significantly improve fatigue symptoms and water metabolism function in patients with qi and yin deficiency.

[0045] Platycodon grandiflorum has the effect of clearing the lungs and discharging pus.

[0046] Lycium barbarum-Cuscuta australis can strengthen the kidney and produce sperm, and is effective in reproduction and anti-osteoporosis.

[0047] Epimedium can replenish kidney yang, strengthen muscles and bones, and also has a beneficial effect in the treatment of liver cancer.

[0048] Toxicology test:

[0049] Toxicological experiments on Astragalus membranaceus alone have shown that it has no obvious long-term, acute toxic side effects on experimental animals such as mice, rats, and New Zealand rabbits. Its drug safety is relatively high, and the risk factor of short-term and large-dose use is low. However, long-term use of large doses may cause certain organ toxicity, mutagenic effects, and reproductive and developmental toxicity.

[0050] Bupleurum saponins in Bupleurum can increase the levels of aspartate aminotransferase, alanine aminotransferase and total bilirubin in the blood, reduce bilirubin metabolism and increase the permeability of liver cell membranes, leading to liver cell damage or even necrosis.

[0051] Studies have shown that calcium oxalate raphides formed by the combination of calcium oxalate and protein in Pinellia ternata can cause severe edema and congestion in the eyes of rabbits. Toxic raphides and lectin proteins in Pinellia ternata can induce macrophages to release a large number of inflammatory factors. Macrophages can ingest toxic raphides in Pinellia ternata, and lectin proteins can cause significant swelling of macrophages, ultimately leading to damage to the cell membrane and death.

[0052] The experiment of gavage-feeding mice with Lycium barbarum polysaccharide showed that it had no obvious acute toxic reaction.

[0053] Epimedium may generate metabolites through icaritin, leading to apoptosis or necrosis of liver cells, but its toxicity can be significantly reduced through processing or drug combination; roasting of epimedium with sheep fat can reduce the risk of idiosyncratic hepatotoxicity caused by epimedium; using it with Morinda officinalis can slow down the metabolic rate of the main flavonoid components of epimedium (such as epimedin C), and the accompanying toxicity is also reduced.

[0054] Wistar rats were orally given polysaccharides extracted from Ganoderma lucidum fruiting bodies for 28 consecutive days, and their body weight, food intake, hematological and serum biochemical indices were tested, and no obvious abnormalities were found. SD rats were fed with a high dose of 1.5 g / kg of Juncao Ganoderma lucidum spore powder mixed with feed for 30 days, and their body weight, food intake, blood routine, histopathology and other indices were tested, and no obvious abnormalities were found.

[0055] After mice were gavaged with hawthorn extract, all groups of mice showed no abnormalities in eating, drinking, and behavior, thus concluding that hawthorn extract is first-class non-toxic.

[0056] Mice were gavage-fed twice within 24 hours at the maximum dose (the maximum dose was 160 times the designed human dose) using a compound extract of Panax notoginseng flower, Ziziphus jujuba seeds and lily and observed for two weeks. The results showed that none of the mice showed any acute adverse reactions such as convulsions, diarrhea, piloerection and proneness after administration, and no mice died. There was no significant change in the body weight of all mice. After the experiment, no visible tissue or organ damage was found after anatomical observation of the mice, indicating that lily is non-toxic.

[0057] An oral toxicity experiment was conducted on Platycodon grandiflorum water extract. SD rats were given three dose groups of Platycodon grandiflorum water extract, namely low, medium and high dose groups of 500, 1000 and 3000 mg / (kg·d), respectively. No toxicological changes in major organs were found in each dose group, indicating that oral administration of Platycodon grandiflorum water extract at doses below 3000 mg / (kg·d) is not toxic.

[0058] The acute toxicity test of bamboo shavings showed that the oral median lethal dose (LD50) of bamboo shavings for mice and rats was greater than 10g / kg body weight. According to the acute toxicity classification standard, it is a non-toxic drug.

[0059] Normal doses of licorice have no obvious toxic side effects, but it should not be used with Euphorbia, Rhizoma Glehniae, and Gentiana dahurica, which may increase the toxic side effects of the drugs. The dose and compatibility of licorice in the present invention will not cause toxic side effects; the acute toxicity and long-term toxicity experiments of licorice show that it has no obvious damage to liver and kidney function. Licorice can also reduce the damage to the liver caused by drugs such as Aconite, Dioscorea bulbifera, Tripterygium wilfordii, and Strychnos nux vomica.

[0060] Large doses of Atractylodes macrocephala may cause certain nephrotoxicity, which may cause nausea, vomiting, or chronic kidney poisoning in clinical practice. The dosage of Atractylodes macrocephala in the present invention is a safe dosage; general toxicological studies on Atractylodes macrocephala show that mice gavaged with Atractylodes macrocephala extract and the control group had no obvious adverse reactions, and there were no significant differences in blood and organ tissue biopsy. According to the acute toxicity classification, Atractylodes macrocephala extract is a non-toxic substance. Its subacute toxicity experiment also shows that Atractylodes macrocephala is a non-toxic substance, but it has an inhibitory effect on the weight gain of mice.

[0061] Poria contains pachymic acid, pachycoside, etc. These ingredients have the effect of contracting the uterus. If pregnant women eat Poria during pregnancy, it may cause excessive uterine contraction, thereby inducing miscarriage. The Chinese medicine decoction of the present invention is not suitable for pregnant women; the acute toxicity test results of the compound Poria and Licorice Decoction (containing Poria, Licorice, Fritillaria cirrhosa, etc.) show that its maximum tolerance is equivalent to 100 times the clinical daily oral dose of adults, and the long-term toxicity test results show that the pathological examination of major organs is normal. The experimental results suggest that the clinical dose of the compound Poria and Licorice Decoction is safe for oral administration and has no cumulative toxicity. Other compound studies on Poria can also show that Poria has no obvious toxic and side effects.

[0062] Cuscuta seeds, roasted malt, and raw sun-dried ginseng have no obvious toxic side effects.

[0063] 1. Animal efficacy and toxicity experiments:

[0064] 1. Grouping:

[0065] A total of 180 rats were randomly divided into three batches for the experiment. Each batch of rats was randomly divided into three groups, with 20 rats in each group, half of which were male and half were female.

[0066] Blank control group: After the cancer-induced fatigue model was established, distilled water was gavaged at a dose of 2 ml / 200 g / time to prevent leakage, once in the morning and once in the evening every day.

[0067] The control group of Sijunzi Decoction in this article: After the cancer-induced fatigue model was established, 2 ml / 200 g / time of Sijunzi Decoction was gavaged to prevent leakage, once in the morning and once in the evening every day.

[0068] Research group: After the cancer-related fatigue model was established, the Pi Shen Fang decoction was gavaged at a dose of 2 ml / 200 g / time to prevent leakage, once in the morning and once in the evening every day.

[0069] 2. Quantification of fatigue:

[0070] The activity of rats was observed for 3, 5, 7, 14, and 21 days after continuous gavage, and the time for the rats to stop struggling was recorded by the tail suspension test to evaluate the degree of fatigue of the rats. After continuous gavage for 3 weeks, the rats were killed by cervical dislocation and the gastrocnemius muscles were dissected and separated. The content of Drp1 and Mfn1 proteins in skeletal muscle was detected by WB method. 0.025g tissue was cut, the tissue was washed with pre-cooled PBS, 250μL RIPA lysis buffer was added to grind, lysed for 10min, centrifuged, protein was extracted, 10% separation gel was prepared, gel was poured, and the gel was sealed with isopropanol. After gelation, 4.8% concentrated gel was prepared, gel was poured, 160μL protein supernatant was taken, 40μL 5× loading buffer was added to mix, boiled in boiling water for 5min, and quickly cooled for use. Load 10 μL of denatured protein, start electrophoresis at a constant voltage of 75V and a time of 130min, cut the gel Drp1 (83KD), Mfn1 (86KD), β-actin (42KD) respectively, give 300mA continuous current transfer, Drp1, Mfn1 about 100min, β-actin about 60min, prepare 5% skim milk powder for blocking, primary antibody and secondary antibody incubation, ECL chemiluminescent solution and membrane incubation for 1min for color development, expose with X-film in a dark box for 5-20 minutes, and develop and rinse.

[0071] ELISA method was used to detect the levels of ATP, MDA, and GSH in skeletal muscle: the tissue was ground to extract ATP in skeletal muscle, and the operation was performed according to the instructions of the ATP, MDA, and GSH test kits. Then, the concentrations of ATP, MDA, and GSH in skeletal muscle of each group were calculated based on the mitochondrial protein concentration.

[0072] 3. Statistical Analysis

[0073] SPSS Statistics 26.0 software package was used for statistical analysis. The measurement data were expressed as mean ± standard deviation, and one-way analysis of variance was used for comparison among multiple groups. LSD or SNK test was used for multiple comparisons between groups. P < 0.05 was considered statistically significant, and P < 0.01 was considered statistically significant.

[0074] 4. Results:

[0075] Compared with the blank control group and the Sijunzi decoction control group, the ATP content in the gastrocnemius muscle of the rats in the study group was higher, and the difference was statistically significant (P < 0.05). Compared with the blank control group and the Sijunzi decoction control group, the MDA values ​​in the skeletal muscle of the study group were increased and the GSH values ​​were decreased, and the difference was statistically significant (P < 0.05).

[0076] Animal short-term toxicity test:

[0077] 5.1 Research content:

[0078] The appearance, activity, eating, defecation, etc. of 20 rats in the research group and the blank control group were recorded, and the body weight was measured once a week. The body weight change curve was drawn.

[0079] Hematological index detection: After the animals are killed, whole blood is collected to detect red blood cell count, hemoglobin quantification, white blood cell count and classification, etc.

[0080] Blood biochemical index detection: After the animals were killed, whole blood was collected to detect alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, blood urea nitrogen, creatinine, blood glucose, etc.

[0081] Pathological examination①Systematic autopsy: Comprehensively examine the size, shape, color, texture, and pathological changes such as bleeding, congestion, and exudation of each tissue and organ.②Organ coefficient: Weigh the body weight of rats before killing, remove the heart, liver, spleen, lung, kidney, stomach, adrenal gland, pituitary gland, thyroid gland, ovary, testis and other tissues, and immediately use filter paper to absorb the surface moisture and weigh the weight to calculate the organ coefficient.③Histological examination: 10% formaldehyde (formalin) solution fixed paraffin embedded sections and stained with hematoxylin-eosin (HE) for observation under a light microscope.

[0082] 5.2 Experimental Results

[0083] The fur gloss, eating and defecation of the 20 mice in the study group were better than those in the blank control group. The weight of the rats in the study group increased, while the weight of the rats in the blank control group decreased. There was no statistically significant difference in the hematological indicators between the study group and the blank control group (P>0.05). Pathological examination showed a variety of pathological manifestations under the microscope due to different cancer types and metastasis conditions.

[0084] According to the drug toxicity classification, Pishen Fang is a short-term non-toxic drug.

[0085] 2. Clinical Trials:

[0086] Case selection: According to the diagnostic criteria for cancer-related fatigue of the 10th International Classification of Diseases Revision Conference, 90 patients with cancer-related fatigue who visited our hospital from September 2021 to October 2022 were selected. All patients were diagnosed with spleen and kidney deficiency according to TCM syndrome differentiation. The patients were divided into the experimental group, the Chinese medicine control group and the study group using the random number method. The general data of the three groups were compared, and the difference was not statistically significant (P>0.05).

[0087] The control group received radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc. The experimental group received oral administration of Pishen Fang on the basis of conventional radiotherapy, chemotherapy and targeted immunotherapy. The research group received conventional radiotherapy, chemotherapy and targeted immunotherapy, and oral administration of Pishen Fang, and auricular acupoint pressing QOD treatment. The Piper fatigue scale score and KPS score sheet were completed 1 week before treatment, 1 week after medication, 2 weeks after medication, 1 month after medication, and 2 months after medication. T lymphocyte examination was completed 1 week before treatment, 1 month after treatment, and 2 months after treatment.

[0088] Experimental results:

[0089] Compared with the other two groups, the KPS scores of the patients in the study group were significantly lower after treatment than those before treatment (P<0.05), and the cancer fatigue scores of the patients in the study group were significantly lower than those in the control group and the experimental group (P<0.05). In terms of KPS scores, the three groups increased significantly after treatment than before treatment (P<0.05), and the KPS scores of the patients in the study group were significantly higher than those in the control group and the experimental group (P<0.05).

[0090] Jiang Yilan's experience in treating breast cancer with spleen and kidney prescriptions: Li, female, 54 years old. The patient found a lump in the right breast in April 2021 and underwent B-ultrasound examination at the local community hospital: a low-echo mass in the right breast (BI-RADS level 4), and lymph nodes were visible in the right axilla. On May 16, a further B-ultrasound examination was performed at a hospital in Hunan Province, showing a huge solid heterogeneous mass in the right breast (BI-RADS level 5), with a high possibility of breast cancer. Multiple enlarged lymph nodes in the right axilla and bilateral supraclavicular regions, considering the possibility of metastasis. Puncture biopsy showed: invasive ductal carcinoma grade II. The patient underwent 3 cycles of chemotherapy from May 20 to July 2. On July 5, a bone scan was performed due to pain in the left ribs: bone metabolism in some ribs on the left was slightly active, and bone metastasis was considered. The patient refused to continue chemotherapy due to the serious toxic and side effects of chemotherapy, so he came to the inventor for treatment. Initial diagnosis on July 8: dull pain in the left hypochondrium, fatigue, shortness of breath, dizziness, pale complexion, depression, sighing, belching, poor appetite and sleep, normal bowel movements, bitter taste in the mouth. Pale red tongue, thin white fur, deep and fine pulse. Routine blood test: red blood cells 2.56×1012 / L, white blood cells 2.53×109 / L, platelets 71×109 / L. The syndrome was diagnosed as spleen and kidney deficiency, insufficient qi and blood, and liver qi stagnation. Treatment was to strengthen the spleen and replenish qi, nourish the kidney and nourish blood, and relieve liver depression, and the spleen and kidney prescription was added and subtracted. Prescription: 10g of raw sun-dried ginseng, 30g of astragalus, 9g of French pinellia, 10g of white atractylodes, 15g of poria, 15g of ganoderma lucidum, 10g of wolfberry, 10g of dodder seed, 10g of epimedium, 6g of roasted licorice, 10g of bupleurum, 10g of stir-fried hawthorn, 15g of stir-fried malt, 18g of lily, 10g of bamboo shavings, 10g of platycodon. 15 doses, 1 dose per day, decocted in water, taken warm after meals in the morning and evening. Second visit on July 26: The patient had dull pain in the left ribs, fatigue and shortness of breath improved compared with before, dizziness from time to time, depression, sighing, belching improved compared with before, sleep improved, bowel movements were normal, no dry mouth and bitter taste. The tongue was pale red, the coating was thin and white, and the pulse was stringy and thin. The prescription was continued for 15 doses, 1 dose per day, and the decocted method was the same as before. The patient was asked to have a blood routine check. Third visit on August 9: The patient had dull pain in the left ribs, a little fatigue, occasional dizziness, a bad mood, sometimes sighing, no belching, improved appetite and sleep, normal bowel movements, no dry mouth and bitter taste. Pale red tongue, thin white fur, stringy and fine pulse. Routine blood test: 3.08×1012 / L red blood cells, 2.75×109 / L white blood cells, 87×109 / L platelets. Add 10g of Prunella vulgaris, 15g each of Scutellaria barbata and Hedyotis diffusa to the prescription for the first visit. 15 doses, 1 dose per day, decoction method is the same as before. Fourth visit on August 24: The patient had dull pain in the left ribs, a little fatigue, occasional dizziness, a bad mood, sometimes sighing, no belching, improved appetite and sleep, normal bowel movements, no dry mouth and bitter taste. Pale red tongue, thin white fur, stringy and fine pulse. Blood routine: red blood cells 3.08×1012 / L, white blood cells 2.75×109 / L, platelets 87×109 / L. Continue to take 15 doses of the original prescription on July 8. Add 10g of Bupleurum, 10g of stir-fried hawthorn, and 15g of stir-fried malt to the four-diagnosis prescription, and give 30 doses, 1 dose per day, decoction method is the same as before. Last visit on September 27: The patient's above symptoms have improved significantly compared with before.Blood routine: red blood cells 3.94×1012 / L, white blood cells 3.67×109 / L, platelets 104×109 / L. The patient was given 30 doses of the four-diagnosis prescription and was asked to have blood routine checked regularly. After the blood routine returned to normal, chemotherapy could be continued with Chinese medicine.

[0091] Case 2: Huang, female, 57 years old. On May 13, 2021, she underwent abdominal MRI in a hospital in Shaoyang City, Hunan Province due to "lower abdominal distension and pain for more than 1 month". It showed cystic and solid masses in the bilateral adnexa. Ovarian mucinous cystadenocarcinoma was considered to invade the uterine body muscle layer and pelvic cavity, and lymph node metastasis was likely; there was a small amount of pelvic effusion. Ovarian tumor cytoreductive surgery was performed on June 10. Postoperative pathology showed: poorly differentiated adenocarcinoma (stage ⅢC), high-grade serous carcinoma was considered, and intravascular tumor thrombus was seen, and multiple lymph node metastases in the abdominal cavity and pelvic cavity were found. After surgery, cisplatin (60mg) intraperitoneal hot perfusion was performed twice on June 12 and 13 respectively. Chemotherapy was performed later. After 2 cycles of chemotherapy, poor spirit, fatigue, poor appetite, and loose stools appeared. Blood routine: red blood cells 2.09×1012 / L, white blood cells 2.2×109 / L, platelets 66×109 / L. The patient refused to undergo the third cycle of chemotherapy and came to our clinic for treatment. Initial diagnosis on August 5: pale complexion, fatigue, nausea, hot flashes, night sweats, poor appetite, good sleep, dry mouth without bitterness, loose stools, good urination, red tongue, less coating, and fine pulse. The syndrome was spleen and kidney deficiency, insufficient qi and blood, and deficiency of both qi and yin. The treatment was to strengthen the spleen and kidney, replenish qi and nourish blood, and nourish yin, and add and subtract spleen and kidney prescriptions. Prescription: American ginseng 10g, astragalus 30g, white atractylodes 10g, Poria 15g, wolfberry 10g, dodder seed 10g, Ligustrum lucidum 10g, Eclipta prostrata 10g, epimedium 10g, licorice 6g, ophiopogon 15g, raw rehmannia glutinosa 15g, dendrobium 10g, coix seed 30g, kudzu root 30g, stir-fried hawthorn 10g, stir-fried malt 15g. 15 doses, 1 dose per day, decoct in water, take warm after meals in the morning and evening. Second visit on August 27: The patient's face is pale, fatigue, loose stools are better than before, hot flashes and night sweats are less than before, appetite is still good, sleep is restless, tongue is light red, less fur, pulse is thin and stringy. Add 30g of Polygonum multiflorum, 15g each of Ganoderma lucidum and Ziziphus jujuba seeds to the prescription of the first visit. 15 doses, 1 dose per day, decoction method is the same as before. Third visit on September 13: The patient's face is ruddy than before, the stool can be formed, fatigue is significantly improved, occasional nausea and vomiting, occasional hot flashes and night sweats, a small amount of sputum, appetite is good, sleep is not good, tongue is light red, thin white fur, pulse is thin and stringy. Blood routine: red blood cells 2.60×1012 / L, white blood cells 2.75×109 / L, platelets 79×109 / L. On the basis of the second diagnosis prescription, 10g of American ginseng was replaced with 10g of sun-dried ginseng, and Ligustrum lucidum, Eclipta prostrata, Ophiopogon japonicus, Radix Rehmanniae, Dendrobium officinale, Semen Coix, and Radix Puerariae were removed; Bupleurum chinense, Pinellia ternata, Lilium bulbiferum, Platycodon grandiflorum, and Rhizoma Anemarrhenae were added. 30 doses, 1 dose per day, decoction method is the same as before. Fourth diagnosis on October 15: ruddy complexion, slightly weak, no hot flashes, occasional night sweats, formed stools, regular urine, good appetite and sleep, pale red tongue, thin white fur, thin and stringy pulse. Blood routine: red blood cells 3.75×1012 / L, white blood cells 3.50×109 / L, platelets 90×109 / L. Continue to take the third diagnosis prescription to consolidate the treatment.

[0092] The Chinese herbal decoction in the present application is based on Sijunzi Decoction, with the addition of kidney-tonifying and liver-soothing drugs, which has the effects of strengthening the spleen and kidney, soothing the liver and relieving depression, and has a good therapeutic effect on cancer-related fatigue with the pathogenesis of spleen and kidney deficiency and liver qi stagnation.

[0093] Each embodiment in this specification is described in a related manner, and the same or similar parts between the embodiments can be referred to each other, and each embodiment focuses on the differences from other embodiments. In particular, for the system embodiment, since it is basically similar to the method embodiment, the description is relatively simple, and the relevant parts can be referred to the partial description of the method embodiment.

[0094] The above description is only a preferred embodiment of the present invention and is not intended to limit the protection scope of the present invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention are included in the protection scope of the present invention.

Claims

1. A Chinese medicinal decoction for treating cancer fatigue, characterized in that: By mass ratio, it is composed of the following active ingredients of raw materials: Raw sun-dried ginseng 5-15g, Poria 10-20g, stir-fried Atractylodes 5-15g, roasted Licorice root 3-8g, Bupleurum 5-15g, Pinellia 5-15g, Astragalus 25-35g, Ganoderma lucidum 10-20g, stir-fried Hawthorn 10-15g, stir-fried malt 10-20g, Lilium 15-25g, Platycodon 5-15g, Lycium barbarum 5-15g, Epimedium 5-15g, Bamboo Shavings 5-15g, Cuscuta australis 5-15g.

2. The Chinese medicinal decoction for treating cancer fatigue according to claim 1, characterized in that: It is composed of the following active ingredients: 10g raw sun-dried ginseng, 15g Poria cocos, 10g stir-fried Atractylodes macrocephala, 5g roasted Licorice root, 10g Bupleurum, 10g Pinellia ternata, 30g Astragalus, 15g Ganoderma lucidum, 12g stir-fried Hawthorn, 15g stir-fried malt, 20g Lilium, 10g Platycodon grandiflorum, 10g Lycium barbarum, 10g Epimedium, 10g Bamboo Shavings, and 10g Cuscuta australis.

3. The method for preparing the Chinese medicinal decoction for treating cancer fatigue according to claim 1 or 2, characterized in that: Follow these steps: 1) Take each raw material according to the proportion, then put each raw material in a decoction pot and soak it in clean water for half an hour, with the water just covering the medicinal materials; 2) Cook over high heat for 10-20 minutes, then turn to low heat and cook for 20-40 minutes; 3) Divide each dose into two portions, each portion is about 140mL-160mL.

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