Traditional Chinese medicine composition for treating chemotherapy-related vomiting, preparation method and use thereof

Abstract

The present invention belongs to the technical field of Chinese medicine research, and specifically relates to a Chinese medicine composition for treating chemotherapy-related vomiting, and a preparation method and use thereof. The Chinese medicine composition is composed of the following raw materials by weight: 17-23 parts of Codonopsis pilosula, 17-23 parts of Atractylodes macrocephala, 17-20 parts of Poria cocos, 9-15 parts of Licorice root, 9-15 parts of Tangerine peel, 9-15 parts of Pinellia tuber, 17-23 parts of Magnolia officinalis, 17-23 parts of Citrus aurantium, 17-23 parts of Aucklandia lappa, 3-9 parts of Amomum villosum, 17-23 parts of Clove, 12-18 parts of Cinnamon bark, 12-18 parts of Dry ginger, and 17-23 parts of Radish seed. The Chinese medicine composition can significantly improve chemotherapy-related vomiting and alleviate the adverse reactions caused by triple drug treatment.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicine research, and particularly relates to a traditional Chinese medicine composition for treating chemotherapy-related vomiting, and a preparation method and use thereof. Background Art

[0002] Chemotherapy is one of the main treatments for lung cancer patients. Chemotherapy drugs such as cisplatin are of great significance for the treatment of patients with advanced lung cancer with distant metastasis. Chemotherapy drugs reach the corresponding tissues and organs through blood circulation to exert their effects, but such drugs cannot identify cancer cells and normal cells, often causing damage to normal cells, and producing organ toxicity, blood toxicity, gastrointestinal reactions and other side effects. Chemotherapy-induced nausea and vomiting (CINV) is a gastrointestinal side effect such as nausea and vomiting, anorexia, abdominal pain and diarrhea after the use of chemotherapy drugs. The vomiting rate of cisplatin is as high as 90%, so improving CINV is an important prerequisite for the complete implementation of chemotherapy regimens for cancer patients. At present, Western medicine treatment for CINV caused by cisplatin mainly follows the triple drug therapy principle (5-hydroxytryptamine receptor antagonist + dexamethasone + neurokinin-1 receptor antagonist) recommended in the 2019 version of the "Chinese Expert Consensus on the Prevention and Treatment of Nausea and Vomiting Related to Cancer Drug Therapy", but in clinical practice, since most cancer patients are in the advanced stage of cancer and the clinical situation is complicated, the actual significance has not yet achieved the ideal effect.

[0003] The ointment therapy is based on the basic theory of traditional Chinese medicine, with the principle of holistic concept and syndrome differentiation and treatment. The prescription after syndrome differentiation is made into ointment, applied to the treatment part, and then treated with massage. It is one of the external treatment methods of traditional Chinese medicine that combines traditional Chinese medicine with massage. There are many literatures reporting that the Chinese medicine abdominal ointment Chinese medicine massage therapy is a traditional Chinese medicine external treatment method for treating diseases created after thousands of years of exploration and practice. Medical scientists of all dynasties in my country have attached great importance to this therapy, accumulated rich practical experience, and passed it on to the world through continuous summary, collation and development. According to literature records, most ancient massages were used in conjunction with drugs, which was called ointment. It began with the "Golden Chamber" by Zhang Zhongjing, the medical saint of the Eastern Han Dynasty, "When the limbs feel heavy and sluggish, they should... apply ointment, and do not let the nine orifices be blocked." It was popular in the Tang and Song Dynasties. The "Thousand Golden Prescriptions" by the King of Medicine Sun Simiao recorded more than 80 ointment methods, covering a variety of diseases such as internal and external women, children, and the five senses. Ointment can not only increase the comfort of massage, but also increase the absorption of drugs by the skin and improve clinical efficacy. Therefore, the present invention intends to provide a drug for combined ointment therapy to improve nausea and vomiting caused by cisplatin or other chemotherapy-related therapeutic drugs, and alleviate the adverse reactions caused by triple drug therapy in the prior art. Summary of the invention

[0004] In order to solve the problem of poor clinical effect of triple drug treatment of CINV caused by cisplatin in the prior art, the present invention provides a Chinese medicine composition, which can significantly improve chemotherapy-related vomiting and alleviate the adverse reactions caused by triple drug treatment.

[0005] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating chemotherapy-related vomiting, which is composed of the following raw materials by weight: 17-23 parts of Codonopsis pilosula, 17-23 parts of Atractylodes macrocephala, 17-20 parts of Poria cocos, 9-15 parts of Licorice, 9-15 parts of Tangerine peel, 9-15 parts of Pinellia, 17-23 parts of Magnolia officinalis, 17-23 parts of Citrus aurantium, 17-23 parts of Costus root, 3-9 parts of Amomum villosum, 17-23 parts of Cloves, 12-18 parts of Cinnamon bark, 12-18 parts of Dried ginger, and 17-23 parts of Radish seeds.

[0006] Preferably, the Chinese medicine composition is composed of the following raw materials by weight: 20 parts of Codonopsis pilosula, 20 parts of Atractylodes macrocephala, 20 parts of Poria cocos, 12 parts of Licorice, 12 parts of Tangerine peel, 12 parts of Pinellia, 20 parts of Magnolia officinalis, 20 parts of Citrus aurantium, 20 parts of Costus root, 6 parts of Amomum villosum, 20 parts of Cloves, 15 parts of Cinnamon bark, 15 parts of Dried ginger, and 20 parts of Radish seeds.

[0007] The second aspect of the present invention provides a method for preparing the Chinese medicine composition, comprising the following steps:

[0008] Weigh codonopsis pilosula, atractylodes macrocephala, poria cocos, liquorice, tangerine peel, pinellia tuber, magnolia bark, immature bitter orange, costusroot, amomum villosum, clove, cinnamon bark, dried ginger, and radish seed according to weight;

[0009] The weighed medicinal materials are mixed, and water is added to boil the liquid to obtain the traditional Chinese medicine composition.

[0010] Preferably, the decoction with water is to add 8 to 10 times the amount of water to the medicinal material mixture, decoct for 2 to 3 times, each time for 1.0 to 2.0 hours, combine the decoctions, filter, and concentrate to obtain the Chinese medicine composition. The filtration here is to filter out the solid drug residues in the decoction to separate the decoction, and the concentration is carried out in a pharmaceutically acceptable manner, such as using a rotary evaporator, and concentrated to a suitable relative density as needed, such as preparing granules, which can be concentrated into a fluid extract.

[0011] The third aspect of the present invention provides a use of the traditional Chinese medicine composition in preparing a medicine for treating chemotherapy-related nausea and vomiting.

[0012] Preferably, the chemotherapy-related nausea and vomiting is caused by cisplatin.

[0013] In a fourth aspect, the present invention provides a traditional Chinese medicine preparation for treating chemotherapy-related vomiting, which comprises the traditional Chinese medicine composition and a pharmaceutically acceptable excipient or carrier.

[0014] Preferably, the pharmaceutical preparation is a granule, and the granule is prepared according to the following steps:

[0015] Weigh Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Licorice root, Tangerine peel, Pinellia tuber, Magnolia officinalis, Citrus aurantium, Aucklandia lappa, Amomum villosum, Clove, Cinnamon bark, Dry ginger, Radish seed;

[0016] The weighed medicinal materials are mixed, and water is added to the decoction to obtain the Chinese medicine composition;

[0017] Add auxiliary materials to the Chinese medicine composition, prepare soft materials, granulate, dry, and granulate to obtain a granule pharmaceutical preparation. The auxiliary materials can be selected from commonly used wetting agents, dextrin, starch and other substances, and can be specifically selected as needed. Granulation can be carried out by wet granulation or dry granulation commonly used in granule preparation.

[0018] Preferably, the pharmaceutical preparation is an ointment, which is prepared by dissolving the prepared granules in water, adding vaseline and stirring evenly. According to the above weight parts, each part is 1g, after the granules are prepared according to the above preparation method, 50ml of warm water is added to completely dissolve them (if necessary, microwave heating can be performed for 3 minutes), and then 130g of white vaseline is added and stirred evenly to obtain an ointment.

[0019] Chemotherapy-related nausea and vomiting (CINV) is a series of gastrointestinal symptoms such as nausea and vomiting that occur after the use of chemotherapy drugs. According to its characteristics, it is divided into five categories: acute, explosive, delayed, refractory and expected. Among them, cisplatin-containing regimens cause about 90% of acute vomiting and about 36% to 62% of delayed vomiting. Severe nausea and vomiting can cause dehydration, electrolyte imbalance, and even malnutrition in patients, and may also be accompanied by mental factors such as anxiety and fear. The above adverse reactions often cause patients to resist chemotherapy, thereby reducing their compliance, causing patients to reduce medication during treatment, postpone treatment, or even terminate treatment.

[0020] Traditional Chinese medicine believes that CINV is mostly caused by severe cold drug toxicity that attacks the spleen and stomach, damages the spleen yang, causes stomach disharmony, blocks the turbid yin, causes turbid qi to rise, and causes qi disorder. Since the tumor patient's own positive qi is insufficient, yang qi is insufficient after chemotherapy, the body loses warmth, qi and blood are unable to circulate, and qi disorder induces nausea and vomiting. Therefore, the present invention selects prescriptions and medicines that reduce adverse reactions and stop vomiting, and replenish qi and strengthen the spleen for treatment.

[0021] The Chinese medicine composition provided by the present invention comprises codonopsis, atractylodes macrocephala and poria cocos, which have the effects of invigorating qi and strengthening spleen, strengthening the body and eliminating evil, and are the main medicines; dried ginger and cinnamon bark warm the middle and dispel cold, and amomum villosum warms the middle and transforms dampness, which strengthen the warming and nourishing power of the main medicines, and are the ministerial medicines. Pinellia tuber, dried tangerine peel and poria cocos are compatible, and play the effects of warming and drying and transforming dampness, light penetration and removing dampness, and descending adverse and stopping vomiting; Pinellia tuber and atractylodes macrocephala complement each other, and strengthen the spleen qi, dry spleen dampness, transform phlegm and fluid, and descend qi adverse; Magnolia bark and Citrus aurantium regulate qi mechanism, play the effect of descending qi and widening the middle, and promote gastrointestinal motility recovery; Pinellia tuber, dried tangerine peel are compatible with Magnolia bark, Citrus aurantium, costus root and clove, and dry spleen dampness, transform phlegm and fluid, and descend qi adverse, and can be used for CINV of spleen and stomach qi deficiency, qi mechanism disorder and phlegm and fluid internal obstruction caused by chemotherapy, and are the guiding medicines. The prescription makes good use of aromatic Qi-promoting ingredients, using their "clear and healthy Qi" to transform the "Yin turbidity" inside and outside the body. Clove, Magnolia officinalis, Tangerine peel, and Citrus aurantium are pungent and aromatic drugs that can not only promote drug transdermal absorption, but also open the meridians and penetrate the tendons and bones, improve the permeability of drugs, and promote the body's absorption of drugs. Licorice harmonizes the various drugs, and Radish seeds regulate the Qi of the middle Jiao. The two are adjuvants to increase the efficacy of the drugs. The above formula has the effects of promoting Qi and harmonizing the stomach, drying dampness and strengthening the spleen, and strengthening the body and removing evil.

[0022] Compared with the prior art, the beneficial effects of the present invention are:

[0023] The Chinese medicine composition provided by the present invention can significantly improve the effective control rate of acute and delayed CINV caused by cisplatin, promote dietary intake after chemotherapy, and improve the patient's resistance; at the same time, it can relieve the patient's psychological emotions, improve the patient's dependence, and alleviate the adverse reactions after the use of triple antiemetic drugs. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 is a comparison of SDSAT scores; Note: * represents P < 0.05; ** represents P < 0.01;

[0025] Figure 2 is the comparison of PA (mg / L) content before and after treatment; Note: ** represents P < 0.01 within the group; ## represents P < 0.01 between groups;

[0026] Figure 3 Comparison of ALB (g / L) content before and after treatment; Note: ** represents P < 0.01 within the group; ## represents P < 0.01 between groups;

[0027] Figure 4 It is the comparison of the psychological SAS of patients before and after treatment. Note: ** represents P < 0.01 within the group; ## represents P < 0.01 between groups;

[0028] Figure 5 It is the comparison of the psychological SDS of patients before and after treatment; Note: ** represents P < 0.01 within the group; ## represents P < 0.01 between groups;

[0029] Figure 6 is the comparison of QOL scores between the two groups before and after treatment; ** represents P < 0.01 within the group; ## represents P < 0.01 between the groups;

[0030] Figure 7 It is the comparison of KPS scores after treatment; Note: ** represents P < 0.01 within the group; ## represents P < 0.01 between groups;

[0031] Figure 8 is the comparison of abdominal distension scores after treatment;

[0032] Fig. 9 is the comparison of appetite loss scores after treatment;

[0033] Fig.10 is the comparison of constipation scores after treatment;

[0034] Fig.11 is the comparison of fatigue scores after treatment;

[0035] Fig.12 is the comparison of serum SP content (p / ml) after treatment; Note: ** represents P < 0.01 within the group; ## represents P < 0.01 between groups;

[0036] Fig.13 Comparison of serum SP content (p / ml) after treatment; Note: ** represents P < 0.01 within the group; ## represents P < 0.01 between groups. DETAILED DESCRIPTION

[0037] The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention. If no specific techniques or conditions are specified in the examples, the techniques or conditions described in the literature in the art or the product instructions are used. If the manufacturer of the reagents or instruments used is not specified, they are all conventional products that can be purchased through regular channels.

[0038] Example 1

[0039] A traditional Chinese medicine composition for treating chemotherapy-related vomiting, which is composed of the following raw materials: 20g of Codonopsis pilosula, 20g of Atractylodes macrocephala, 20g of Poria cocos, 12g of Licorice root, 12g of Tangerine peel, 12g of Pinellia tuber, 20g of Magnolia officinalis, 20g of Citrus aurantium, 20g of Costus root, 6g of Amomum villosum, 20g of Clove, 15g of Cinnamon bark, 15g of Dry ginger, and 20g of Radish seed.

[0040] Example 2

[0041] A traditional Chinese medicine composition for treating chemotherapy-related vomiting, which is composed of the following raw materials: 17g of Codonopsis pilosula, 17g of Atractylodes macrocephala, 17g of Poria cocos, 9g of Licorice root, 9g of Tangerine peel, 9g of Pinellia tuber, 17g of Magnolia officinalis, 17g of Citrus aurantium, 17g of Aucklandia lappa, 3g of Amomum villosum, 17g of Clove, 12g of Cinnamon bark, 12g of Dry ginger, and 17g of Radish seed.

[0042] Example 3

[0043] A traditional Chinese medicine composition for treating chemotherapy-related vomiting, which is composed of the following raw materials: 23g of Codonopsis pilosula, 23g of Atractylodes macrocephala, 20g of Poria cocos, 15g of Licorice root, 15g of Tangerine peel, 15g of Pinellia tuber, 23g of Magnolia officinalis, 23g of Citrus aurantium, 23g of Aucklandia lappa, 9g of Amomum villosum, 23g of Clove, 18g of Cinnamon bark, 18g of Dry ginger, and 23g of Radish seed.

[0044] Example 4

[0045] A traditional Chinese medicine composition for treating chemotherapy-related vomiting, which is composed of the following raw materials: 17g of Codonopsis pilosula, 23g of Atractylodes macrocephala, 20g of Poria cocos, 15g of Licorice root, 15g of Tangerine peel, 9g of Pinellia tuber, 23g of Magnolia officinalis, 17g of Citrus aurantium, 23g of Costus root, 3g of Amomum villosum, 23g of Clove, 18g of Cinnamon bark, 18g of Dry ginger, and 17g of Radish seed.

[0046] Example 5

[0047] A traditional Chinese medicine composition for treating chemotherapy-related vomiting, which is composed of the following raw materials: 21g of Codonopsis pilosula, 20g of Atractylodes macrocephala, 20g of Poria cocos, 10g of Licorice root, 12g of Tangerine peel, 15g of Pinellia tuber, 21g of Magnolia officinalis, 23g of Citrus aurantium, 20g of Costus root, 5g of Amomum villosum, 18g of Clove, 15g of Cinnamon bark, 16g of Dry ginger, and 22g of Radish seed.

[0048] The Chinese medicine compositions provided in Examples 1 to 5 above are all prepared according to the following steps:

[0049] Weigh Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Licorice root, Tangerine peel, Pinellia tuber, Magnolia officinalis, Citrus aurantium, Aucklandia lappa, Amomum villosum, Clove, Cinnamon bark, Dry ginger, Radish seed;

[0050] The weighed medicinal materials were mixed, and water equivalent to 8 times of the medicinal material mixture was added to the medicinal material mixture, and the mixture was decocted twice, each time for 1.0 h, and the decoctions were combined, filtered, and concentrated to obtain a traditional Chinese medicine composition.

[0051] Example 6

[0052] A Chinese medicine composition for treating chemotherapy-related vomiting, which differs from Example 1 only in the preparation method, specifically:

[0053] Weigh Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Licorice root, Tangerine peel, Pinellia tuber, Magnolia officinalis, Citrus aurantium, Aucklandia lappa, Amomum villosum, Clove, Cinnamon bark, Dry ginger, Radish seed;

[0054] The weighed medicinal materials were mixed, and water equivalent to 10 times of the medicinal material mixture was added to the medicinal material mixture, and the mixture was decocted for 3 times, each time for 2.0 hours. The decoctions were combined, filtered, and concentrated to obtain a traditional Chinese medicine composition.

[0055] It should be noted that the Chinese medicine composition provided by the present invention can be prepared into oral preparations or external preparations according to a pharmaceutically acceptable method. Oral preparations include granules, capsules, tablets, and liquid preparations. External preparations include ointments, pastes, patches, gels, sprays, etc. During the specific preparation, suitable excipients or carriers such as wetting agents, diluents, regulators, flavoring agents, colorants, emulsifiers, surfactants, suspending agents, etc. can be added according to the selected dosage form.

[0056] The following lists granules that can be taken orally and ointments that can be used externally for explanation.

[0057] Example 7

[0058] A granule for treating chemotherapy-related vomiting is prepared according to the following steps:

[0059] Weigh 20g of Codonopsis pilosula, 20g of Atractylodes macrocephala, 20g of Poria cocos, 12g of Licorice root, 12g of Tangerine peel, 12g of Pinellia tuber, 20g of Magnolia officinalis, 20g of Citrus aurantium, 20g of Aucklandia lappa, 6g of Amomum villosum, 20g of Clove, 15g of Cinnamon bark, 15g of Dry ginger, and 20g of Radish seed;

[0060] The weighed medicinal materials are mixed, and water equivalent to 10 times of the medicinal material mixture is added to the medicinal material mixture, and the mixture is decocted for 3 times, each time for 2.0 hours. The decoctions are combined, filtered, and concentrated into a fluid extract, which is mixed with dextrin at a mass ratio of 1:2.5 to prepare a soft material, and an ethanol solution with a mass concentration of 80% is added to the obtained soft material, and the mixture is mixed evenly, granulated, dried at 55°C, granulated, and packaged.

[0061] Example 8

[0062] An ointment for treating chemotherapy-related vomiting is prepared according to the following steps:

[0063] Add 50 ml of warm water to the granules prepared in Example 7 to completely dissolve them, and then add 130 g of white vaseline and stir evenly to obtain a paste.

[0064] Since the effects of the Chinese medicine compositions or preparations prepared in Examples 1 to 8 are substantially the same, the effects are described below using only the Chinese medicine ointment prepared in Example 8 as an example.

[0065] 1. Methods

[0066] A total of 60 patients who met the inclusion criteria were selected from the Department of Traditional Chinese Medicine of Tangdu Hospital and were randomly divided into a treatment group and a treatment group, 30 cases in each group.

[0067] 1.1. Inclusion criteria

[0068] 1.1.1 Inclusion criteria

[0069] (1) Diagnostic criteria

[0070] Western medicine diagnostic criteria for CINV: Based on the definition in the "Chinese Expert Consensus on the Prevention and Treatment of Nausea and Vomiting Related to Cancer Drug Therapy": a disease in which nausea and vomiting occur as the main clinical manifestation during chemotherapy.

[0071] Diagnostic criteria for CINV in TCM: Based on the definition of "vomiting" in the fifth edition of "Chinese Internal Medicine" (People's Medical Publishing House): a disease characterized by gastric disharmony and upward reversal of gastric qi, resulting in gastric contents coming out of the mouth;

[0072] (2) Patients who meet the diagnostic criteria in the Guidelines for the Diagnosis and Treatment of Primary Lung Cancer (2022 Edition), are diagnosed with lung cancer by histological or cytological testing, and receive cisplatin-containing chemotherapy;

[0073] (3) Aged between 18 and 75 years old, regardless of gender;

[0074] (4) KPS score greater than 60 points;

[0075] (5) The expected survival period is greater than 6 months;

[0076] (6) Those whose laboratory examinations and electrocardiograms meet the chemotherapy conditions;

[0077] (7) Agree to accept this treatment plan, cooperate highly, and voluntarily sign the informed consent form.

[0078] 1.1.2 Exclusion criteria

[0079] (1) Those with severe digestive tract impairment;

[0080] (2) Pregnant, breastfeeding and mentally ill patients;

[0081] (3) history of vomiting within one day before chemotherapy;

[0082] (4) Patients with abdominal pain, skin ulcers, allergies to Chinese medicine, postoperative sites (within one month), pregnant women’s abdomen, lumbar sacral region, etc., who cannot tolerate abdominal massage;

[0083] (5) Exclude other causes of nausea and vomiting;

[0084] (6) Patients with severe damage to their heart, kidneys, liver and other organs;

[0085] (7) Participants in other clinical trials (within the past three months).

[0086] 1.1.3. Rejection and shedding standards

[0087] (1) Poor compliance and incomplete data;

[0088] (2) those who were unable to adhere to the treatment and voluntarily withdrew from the experiment;

[0089] (3) Those whose condition worsens or who die.

[0090] 1.2 Clinical Grouping

[0091] This study adopted the prospective and randomized principle and enrolled 60 patients with lung cancer who experienced nausea and vomiting after cisplatin-containing chemotherapy. They were divided into two groups using the random number table method, 30 cases in the control group and 30 cases in the treatment group.

[0092] Table 1 Comparison of general information

[0093]

[0094] Control group: According to the 2019 version of the "Chinese Expert Consensus on the Prevention and Treatment of Nausea and Vomiting Related to Cancer Drug Therapy", the first choice for the prevention of nausea and vomiting caused by high-risk chemotherapy regimens is 5-HT3 receptor blockers + dexamethasone + NK-1 receptor antagonists, namely palonosetron (palonosetron 0.25 mL, intravenous injection) + dexamethasone (5 mL) intravenous push + aprepitant (125 mg orally 1 hour before chemotherapy (day 1), and 80 mg orally once a day in the morning of the second and third days);

[0095] The treatment group was given Chinese medicine abdominal massage in addition to the control group for 3 consecutive days.

[0096] The specific operation process of ointment massage treatment is as follows:

[0097] Before the operation, the patient is advised to empty the bladder, take the supine position, bend both lower limbs, relax the abdomen, fully expose the ointment massage part, cover it with a screen if necessary, pay attention to keep warm, use the ointment provided by the present invention as a massage medium, heat the ointment and apply it evenly to the patient's abdomen with a radius of 10cm with the Shenque point as the center, with a thickness of about 1 to 2mm, and a dosage of about 50g each time. Press the abdominal wall with the palm of the right hand flat, rub it clockwise around the umbilicus, and gradually expand it to the entire abdomen. First, rub the palm around the umbilicus for about 1 minute, then massage the right lower abdomen clockwise for about 1 minute, push the Ren meridian 10 times, push the stomach meridian 10 times, push the spleen meridian 10 times, and then press Shangwan, Zhongwan, Tianshu, Xiawan, Qihai and Guanyuan points for 10 seconds each, and the intensity of pressing and rubbing is from light to heavy. The three operation combinations are repeated 5 times, about 15min. Massage the abdomen clockwise, and the order of kneading is Shangwan, Zhongwan, Xiawan, Tianshu, Qihai, Guanyuan. In order to ensure the warmth of the medicine, massage the abdomen clockwise 15 to 20 times between each acupoint. After the operation, clean the plaster on the patient's skin, assist with clothing, place the patient in a comfortable position, tidy up the bed sheets, conduct health education, organize the supplies, sign, and keep records.

[0098] According to the 11th edition of the textbook "Acupuncture and Moxibustion" (China Traditional Chinese Medicine Press), the acupoints are located as follows:

[0099] Zhongwan: 4 inches above the navel on the anterior midline.

[0100] Shangwan: 5 inches above the navel on the anterior midline.

[0101] Xiawan: 2 inches above the navel on the anterior midline.

[0102] Tianshu: Horizontally level with the umbilicus, 2 inches lateral to the anterior midline.

[0103] Qihai: 1.5 inches below the navel on the anterior midline.

[0104] Guanyuan: 3 inches below the navel on the anterior midline.

[0105] Care and precautions:

[0106] ①Observe the skin condition at the treatment site to see if any allergies occur.

[0107] ② Massage the tumor area with appropriate force to prevent the tumor from rupturing and bleeding.

[0108] ③For the elderly and children, massage should be gentle to avoid discomfort.

[0109] ④ Keep warm and cover exposed parts with clothes and blankets as much as possible.

[0110] ⑤The ointment should not be overheated, but kept at a suitable temperature to prevent burns.

[0111] ⑥ All items used must be cleaned and disinfected, and each person must be disinfected separately to avoid cross infection.

[0112] The degree of nausea and vomiting, brief dietary score, changes in nutritional indicators (prealbumin, albumin), psychological assessment (SAS / SDS score), KPS score, quality of life assessment (QOL) of tumor patients, adverse reactions after antiemetic drugs and changes in CINV-related factors (5-HT, substance P) were observed and compared between the two groups of patients.

[0113] 2. Results

[0114] 2.1 Comparison of nausea and vomiting control

[0115] The control of nausea and vomiting in the treatment group during both the acute and delayed phases was statistically significant (P < 0.05), indicating that abdominal ointment massage is effective in treating CINV.

[0116] A total of 60 patients with lung cancer who received cisplatin-containing chemotherapy were collected. The degree of nausea in the two groups of patients in the acute phase was compared. The rank sum test showed that Z=-2.976, P=0.003<0.05, which was statistically significant, indicating that the use of Chinese medicine abdominal ointment can relieve the nausea of ​​patients in the acute phase; the degree of nausea in the two groups of patients in the delayed phase was compared. The rank sum test showed that Z=-2.274, P=0.023<0.05, which was statistically significant, and the effect of the treatment group was better than that of the control group. In summary, the research results show that Chinese medicine abdominal ointment can relieve the nausea symptoms of tumor patients in the acute and delayed phases after chemotherapy.

[0117] (See Table 2)

[0118] Table 2 Comparison of nausea levels after chemotherapy

[0119]

[0120] Comparing the vomiting control of the two groups of patients, the total effective control rate of the control group in the acute phase was 56.67%, and the total effective control rate of the treatment group was 83.33%. After the rank sum test, Z = -2.428, P = 0.015 < 0.05, there was a significant statistical difference, indicating that the use of Chinese medicine abdominal paste can relieve the vomiting of patients in the acute phase; in the delayed phase, the vomiting control of the two groups of patients was compared. The total effective rate of the control group was 66.67%, and the total effective rate of the treatment group was 90.00%. After the rank sum test, Z = -2.18, P = 0.029 < 0.05, there was statistical significance, indicating that the antiemetic effect of the treatment group was better than that of the control group. In summary, the results of the above studies show that Chinese medicine abdominal paste can relieve the vomiting symptoms of cancer patients in the acute and delayed phases after chemotherapy. (See Table 3)

[0121] Table 3 Control of vomiting in patients after chemotherapy

[0122]

[0123] 2.2 Comparison of Simple Dietary Scores

[0124] There was no statistical difference between the two groups of patients before chemotherapy (d0) (P>0.05). There was no statistical difference in SDSAT scores between the two groups on the day of chemotherapy and 2 days after chemotherapy (d1-3) and the control group (P>0.05). However, after the third day of chemotherapy (d4-8), the treatment group had a significant effect (P<0.05), indicating that Chinese medicine abdominal massage can promote patients' appetite and improve their eating habits.

[0125] The SDSAT scores of patients were compared one day before chemotherapy (d0), on the day of chemotherapy, and 7 days after chemotherapy (d1-8). The two groups of patients before chemotherapy (d0) showed no statistical difference by two independent sample t-tests, P>0.05, and they could be compared; the SDSAT scores on the day of chemotherapy and 7 days after chemotherapy (d1-8) showed no significant difference between the two groups of patients on d1-3 by two independent sample t-tests; d4-8 showed obvious changes, and the treatment group had a significant effect compared with the control group (P<0.05), indicating that the use of Chinese medicine abdominal paste massage can promote patients' appetite, especially after the third day of chemotherapy, as shown in detail. Figure 1 .

[0126] 2.3 Comparison of nutritional indicators (prealbumin and albumin content)

[0127] There was no statistical difference in the levels of prealbumin and albumin between the two groups of patients before treatment (P>0.05). After treatment, compared with the control group, the prealbumin in the treatment group was statistically significant (P<0.01), and the albumin was not statistically different (P>0.05). However, after treatment, the albumin value in the control group decreased and was lower than the normal range, and that in the treatment group decreased slightly. The above indicates that ointment massage treatment may increase the level of prealbumin in patients and reduce the rate of decline of albumin levels.

[0128] Comparison of prealbumin content ( Figure 2 ): Before treatment, the prealbumin content of the control group was compared with that of the treatment group. The result of two independent sample t-test was P>0.05, indicating that there was no significant difference in the prealbumin content between the two groups of patients before treatment and the results could be compared. After treatment, the prealbumin content of the control group was compared with that of the treatment group. The result of two independent sample t-test was P<0.05, which was statistically significant. Compared with the control group, the combination of Chinese medicine abdominal ointment and western medicine treatment could increase the prealbumin level in patients.

[0129] Comparison of albumin content ( Figure 3 ): Comparison of albumin levels between the control group and the treatment group before treatment was performed by two independent sample t-test, P>0.05, indicating that there was no significant difference in albumin content before treatment; comparison of albumin levels between the control group and the treatment group after treatment was performed by two independent sample t-test, P>0.05, which was not statistically significant. Compared with the control group, the values ​​in the treatment group decreased slowly and fluctuated within the normal range.

[0130] 2.4 Comparison of psychological assessment

[0131] There was no significant difference in the psychological assessment (SAS, SDS) between the two groups of patients before treatment (P>0.05). After treatment, the treatment group had a significant effect compared with the control group (P<0.01), indicating that Chinese medicine abdominal massage can improve the psychological condition of patients and reduce their anxiety.

[0132] SAS score comparison ( Figure 4): Before treatment, the SAS scores of the control group and the treatment group were compared. The result of two independent sample t-test was P>0.05, indicating that there was no significant difference in the anxiety level of the two groups of patients before treatment; after treatment, the SAS scores of the control group and the treatment group were compared. The result of two independent sample t-test was P<0.05, indicating that the use of Chinese medicine abdominal massage can relieve patients' anxiety.

[0133] SDS score comparison ( Figure 5 ): Before treatment, the SDS scores of the control group and the treatment group were compared. After two independent sample t-tests, P=0.180>0.05, indicating that there was no significant difference in the degree of depression between the two groups of patients before treatment and that they could be compared. After treatment, the SDS scores of the control group and the treatment group were compared. After two independent sample t-tests, P<0.05, there was a significant difference, indicating that the use of Chinese medicine abdominal paste massage can relieve patients' depression.

[0134] 2.5 Comparison of KPS and QOL scores

[0135] Intra-group comparison: The KPS scores and QOL scores of the two groups of patients after treatment were statistically significant (P < 0.01), proving that the quality of life of CINV patients can be improved regardless of whether Western medicine alone or combined with Chinese medicine abdominal massage is used.

[0136] Comparison between groups: There was no significant difference between the two groups of patients before treatment (P>0.05). After treatment, the treatment group had a significant effect compared with the control group (P<0.01), indicating that Chinese medicine abdominal massage can improve the physical condition of CINV patients and improve their quality of life.

[0137] Intra-group comparison: The QOL scores of the control group were compared before and after treatment. The paired t-test showed that P < 0.01, which was statistically significant, indicating that the use of simple Western medicine treatment can improve the quality of life of patients; the QOL scores of the treatment group were compared before and after treatment. The paired t-test showed that P < 0.01, which was statistically significant, indicating that the combination of Chinese herbal abdominal ointment and Western medicine treatment can improve the quality of life.

[0138] Comparison between groups: The QOL scores of the two groups of patients before treatment were compared. The result of two independent sample t-test was P>0.05, indicating that there was no significant difference in the QOL scores of the two groups of patients before treatment and they were comparable. The QOL scores of the two groups of patients after treatment were compared. The result of two independent sample t-test was P<0.01, which was statistically significant. Compared with the control group, the use of Chinese medicine abdominal plaster massage can better improve the quality of life of patients. Figure 6 .

[0139] Intra-group comparison: The KPS scores of the control group were compared before and after treatment. The paired t-test showed that P < 0.01 was statistically significant, indicating that the use of simple Western medicine treatment can improve the quality of life of patients; the KPS scores of the treatment group were compared before and after treatment. The paired t-test showed that P < 0.01 was statistically significant, indicating that the combination of Chinese herbal abdominal ointment and Western medicine treatment can improve the patient's physical fitness and quality of life.

[0140] Comparison between groups: Before treatment, the KPS scores of the two groups of patients were compared. After two independent sample t-tests, P>0.05, indicating that there was no significant difference in the KPS scores of the two groups of patients before treatment, and they were comparable; after treatment, the KPS scores of the two groups of patients were compared. After two independent sample t-tests, P<0.01, there was a statistical difference. Compared with the control group, the use of Chinese medicine abdominal ointment massage can better improve the quality of life of patients. Figure 7 .

[0141] 2.6 Comparison of adverse reactions after treatment

[0142] After the two groups of patients used antiemetics, compared with the control group, the patients in the treatment group had improved abdominal distension, poor appetite, constipation, and fatigue (P < 0.05), indicating that the use of Chinese medicine abdominal plaster massage can reduce the adverse reactions after the use of triple antiemetics and make patients more cooperative with the treatment. Figures 8 to 11 .

[0143] A total of 60 patients with lung cancer who received chemotherapy containing cisplatin were collected and the changes in adverse reactions such as abdominal distension, fatigue, poor appetite, and constipation after using antiemetic drugs were compared between the two groups of patients. The adverse reactions of the two groups of patients were compared by rank sum test, P < 0.05, indicating that the use of Chinese medicine abdominal paste massage can improve adverse reactions after medication and help improve the patient's physical condition.

[0144] 2.7 Comparison of serum SP and 5-HT levels

[0145] Intra-group comparison: There were no significant differences in serum SP and 5-HT levels in the control group after treatment (P>0.05), while there were significant differences in serum SP and 5-HT levels in the treatment group after treatment (P<0.01).

[0146] Comparison between groups: There was no statistical difference in serum SP and 5-HT levels between the two groups of patients before and after treatment (P>0.05). After treatment, the treatment group was compared with the control group, with statistical significance (P<0.01). It is believed that Chinese medicine abdominal paste massage can change the content of SP and 5-HT in CINV patients.

[0147] Intra-group comparison: The serum SP content of the control group was compared before and after treatment. The paired t-test showed that P>0.05, with no significant statistical difference, indicating that the use of Western medicine treatment had no obvious change in the serum SP content of patients; the serum SP content of the treatment group was compared before and after treatment. The paired t-test showed that P<0.01, with statistical significance, indicating that Chinese medicine abdominal ointment combined with Western medicine treatment can reduce the serum SP content of the human body.

[0148] Comparison between groups: Comparison of serum SP content between the two groups of patients before treatment, by two independent sample t test, P>0.05, indicating that there was no significant difference in serum SP content between the two groups of patients before treatment, and they were comparable; comparison of serum SP content between the two groups of patients after treatment, by two independent sample t test, P<0.01, was statistically significant, and compared with the control group, the use of Chinese medicine abdominal paste massage can better regulate the SP content in the human body. Fig.12 .

[0149] Intra-group comparison: The serum 5-HT content of the control group was compared before and after treatment. The paired t-test showed that P>0.05, with no significant statistical difference, indicating that the use of Western medicine treatment had no obvious change in the serum SP content in patients; the serum 5-HT content of the treatment group was compared before and after treatment. The paired t-test showed that P<0.01, with statistical significance, indicating that Chinese medicine abdominal ointment combined with Western medicine treatment can reduce the serum SP content in the human body.

[0150] Comparison between groups: Comparison of serum 5-HT content between the two groups of patients before treatment, after two independent sample t test, P>0.05, indicating that there was no significant difference in serum 5-HT content between the two groups of patients before treatment, and they were comparable; comparison of serum 5-HT content between the two groups of patients after treatment, after two independent sample t test, P<0.01, was statistically significant, and compared with the control group, the use of Chinese medicine abdominal paste massage can better regulate the 5-HT content in the human body. Fig.13 .

[0151] The above results show that Chinese herbal abdominal ointment combined with palonosetron, dexamethasone and aprepitant can improve the effective control rate of acute and delayed CINV caused by cisplatin, promote dietary intake after chemotherapy, improve patient resistance, increase prealbumin levels, and reduce the rate of albumin decline. At the same time, it can relieve patients' psychological emotions (SAS, SDS), improve patients' dependence, and improve KPS and QOL scores, improve patients' quality of life, relieve adverse reactions after the use of triple antiemetic drugs, make patients more cooperative with treatment, have good safety, reduce the release of SP and 5-HT in the body, reduce vomiting reflex, and reduce the occurrence of vomiting.

[0152] Although the present invention has been described in detail above with general descriptions and specific embodiments, it is obvious to those skilled in the art that some modifications or improvements may be made thereto based on the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection claimed by the present invention.

Claims

1. A Chinese medicine composition for treating chemotherapy-related vomiting, characterized in that: The Chinese medicine composition is composed of the following raw materials by weight: 17-23 parts of Codonopsis pilosula, 17-23 parts of Atractylodes macrocephala, 17-20 parts of Poria cocos, 9-15 parts of Licorice root, 9-15 parts of Tangerine peel, 9-15 parts of Pinellia tuber, 17-23 parts of Magnolia officinalis, 17-23 parts of Citrus aurantium, 17-23 parts of Aucklandia lappa, 3-9 parts of Amomum villosum, 17-23 parts of Cloves, 12-18 parts of Cinnamon bark, 12-18 parts of Dry ginger and 17-23 parts of Radish seeds. The Chinese medicine composition is used for treating chemotherapy-related vomiting and relieving depression and anxiety in chemotherapy patients.

2. The Chinese medicine composition according to claim 1, characterized in that: The invention is composed of the following raw materials by weight: 20 parts of codonopsis pilosula, 20 parts of atractylodes macrocephala, 20 parts of poria, 12 parts of liquorice, 12 parts of dried tangerine peel, 12 parts of pinellia tuber, 20 parts of magnolia bark, 20 parts of immature bitter orange, 20 parts of costus root, 6 parts of amomum villosum, 20 parts of cloves, 15 parts of cinnamon bark, 15 parts of dried ginger and 20 parts of radish seeds.

3. A method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The following steps are involved: Weigh Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Licorice root, Tangerine peel, Pinellia tuber, Magnolia officinalis, Citrus aurantium, Aucklandia lappa, Amomum villosum, Clove, Cinnamon bark, Dry ginger, Radish seed; The weighed medicinal materials are mixed, and water is added for decoction to obtain the traditional Chinese medicine composition.

4. The preparation method according to claim 3, characterized in that: The decoction with water is to add water equivalent to 8 to 10 times of the medicinal material mixture, decoct for 2 to 3 times, each time for 1.0 to 2.0 hours, combine the decoctions, filter and concentrate to obtain the Chinese medicine composition.

5. Use of the traditional Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating chemotherapy-related nausea and vomiting.

6. The use according to claim 5, characterized in that The chemotherapy-related nausea and vomiting was caused by cisplatin.

7. A pharmaceutical preparation for treating chemotherapy-related nausea and vomiting, characterized in that: The invention is composed of the Chinese medicine composition according to claim 1 or 2 and pharmaceutically acceptable auxiliary materials.

8. The pharmaceutical preparation according to claim 7, characterized in that The pharmaceutical preparation is a granule, and the granule is prepared according to the following steps: Weigh Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Licorice root, Tangerine peel, Pinellia tuber, Magnolia officinalis, Citrus aurantium, Aucklandia lappa, Amomum villosum, Clove, Cinnamon bark, Dry ginger, Radish seed; The weighed medicinal materials are mixed, and boiled with water to obtain the traditional Chinese medicine composition; Add auxiliary materials to the traditional Chinese medicine composition, prepare soft materials, granulate, dry and granulate to obtain a granule pharmaceutical preparation.

9. The pharmaceutical preparation according to claim 8, characterized in that The pharmaceutical preparation is an ointment, which is prepared by dissolving the prepared granules in water, adding vaseline and stirring evenly.

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