Vomit-stopping bead plaster

Abstract

A vomit-stopping bead patch belongs to the technical field of medical supplies and comprises vomit-stopping beads and an acupoint patch. The vomit-stopping beads are thuja sutchuenensis medicine beads and are prepared by soaking thuja sutchuenensis scattered beads in a new liquid preparation formed by mixing traditional Chinese medicine extract, ginger juice and essential balm. The traditional Chinese medicine extract is prepared by decocting 100g of all-grass of aleppo akebia, 100g of cynanchum auriculatum, 100g of dutchmanspipe root, 100g of panax japonicus, 100g of akebia fruit, 100g of fructus evodiae, 100g of persimmon stem and 100g of ginger processed pinellia with water and concentrating; the thuja sutchuenensis loose beads are made of thuja sutchuenensis wood and are made into beads with the particle size of 0.5-0.7 mm. The thuja sutchuenensis loose beads have the beneficial effects that the vomit-stopping bead plaster is applied to and presses corresponding acupuncture points of a patient, vomiting and nausea of the chemotherapy patient can be effectively relieved, and the thuja sutchuenensis loose beads have good popularization and application values.

Description

Technical Field

[0001] The invention belongs to the technical field of medical supplies, in particular to an antiemetic bead patch. Background Art

[0002] Chemotherapy is a commonly used treatment for malignant tumors. One of the most common adverse reactions during chemotherapy is chemotherapy-induced nausea and vomiting (CINV). Without prophylactic antiemetic treatment, over 90% of patients may experience nausea and vomiting. Even with prophylactic antiemetics, over 60% experience nausea and vomiting. Nausea, in particular, can occur in as high as 70%-90% of patients. Approximately 20% of patients develop a fear of chemotherapy, which can lead to delays or refusal. Furthermore, CINV can lead to dehydration, electrolyte imbalances, and nutritional deficiencies, causing anxiety and compromising tolerance to chemotherapy drugs. This can negatively impact cancer patients' physical and mental health, social functioning, and overall function. Currently, Western medicine antiemetics primarily include 5-HT3 receptor antagonists, neurokinin-1 (NK-1) receptor antagonists, dopamine (DA) receptor antagonists, antihistamines, corticosteroids, and psychotropics. Long-term reliance on Western medicine antiemetics to control gastrointestinal symptoms is not only costly but also associated with numerous adverse reactions, including headaches, fatigue, constipation, abdominal pain, bloating, and elevated transaminases. CINV not only causes more pain to patients, but also seriously affects their nutritional supply.

[0003] There is no relevant description of CINV in traditional Chinese medicine. According to clinical symptoms, it can be classified as "vomiting". Scope. Diagnosis and treatment are mainly based on dialectical demonstration and Chinese medicine is taken orally. For patients with severe vomiting and difficulty taking medicine, they can also choose: 1. Acupuncture: Commonly used acupoints: Neiguan (key acupoint for stopping vomiting), Zusanli (regulating the spleen and stomach), Zhongwan (stomach-recruiting point), Gongsun (eight meridian intersection point, unblocking Chong meridian), Hegu, Taichong (opening the four gates, regulating Qi), Tianshu (regulating the stomach and intestines), Yifeng (tonifying Qi and Yang, clearing the orifices and refreshing the mind), etc.; 2. Acupoint pressing / massage: patients can press / massage themselves Pressing the Neiguan, Hegu and other acupoints can relieve nausea; 3. Ear acupoint pressing / patch: Commonly used ear acupoints include stomach, cardia, Shenmen, sympathetic, subcortical, spleen, liver, etc.; 4. Acupoint patch: Apply Chinese herbal powder with antiemetic effect (such as ginger juice mixed with Evodia powder, Pinellia powder, etc.) or preparations to the Shenque (navel), Neiguan, Zusanli and other acupoints; 5. Moxibustion: Suitable for patients with spleen and stomach deficiency and cold type, moxibustion can be used on the Shenque, Zhongwan, Zusanli and other acupoints to warm the middle and dispel cold and stop vomiting.

[0004] Medical staff generally apply medicine and press the patient's acupoints to relieve vomiting. However, manual pressing is inefficient and cannot work for a long time. Not only can it not maintain the continuity of massage and the accuracy of long-term acupoint pressing, but it also cannot guarantee the uniformity and depth of massage strength. Moreover, the patient may vomit and feel uncomfortable at any time, making it impossible for the patient to receive timely treatment. Therefore, using manual massage to relieve the vomiting caused by chemotherapy is inconvenient. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a patch that uses drug beads to press acupoints in order to prevent vomiting reactions in chemotherapy patients by pressing the corresponding acupoints of the patient for a long time.

[0006] In order to solve the above technical problems, the technical solution adopted by the present invention is an antiemetic bead patch, including antiemetic beads and acupoint patch. The antiemetic beads are Thuja juncea medicinal beads, which are prepared by soaking Thuja juncea loose beads in a new liquid preparation mixed with Chinese medicine extract + ginger juice + wind oil; the preparation method is: take 100g each of Baiweilian, Geshanxiao, Qingmuxiang, Japonica, August 15th, Wuyuzi (Evodia rutaecarpa), Shibingba (Persimmon calyx), and Zingiber officinale with water for decoction and extraction twice, combine the two extracts and concentrate them into 200-300g of thick extract; take 180-220ml of ginger juice and 450-550ml of wind oil, mix them evenly, and prepare a new liquid preparation. Beads with a particle size of 0.5-0.7 cm, called Thuja loose beads, are made from Thuja wood. 1,000 Thuja loose beads are soaked in a new liquid preparation for 15 days to obtain antiemetic beads. The acupoint application is a tape patch. The antiemetic beads are pasted on the acupoint application to make the antiemetic bead application.

[0007] Furthermore, the acupoint patch includes a base surface layer and a bead-adhesive soft plate, the bead-adhesive soft plate is frustum-shaped and is directly adhered to the center of the base surface layer, the base surface layer is coated with a skin-adhesive layer, a bead-adhesive arc groove is provided in the center of the bead-adhesive soft plate, the bead-adhesive arc groove is coated with a bead-adhesive layer, and the antiemetic beads are adhered to the bead-adhesive layer on the bead-adhesive arc groove.

[0008] Preferably, the antiemetic beads have a size of 0.6 cm.

[0009] The base surface layer is non-woven fabric.

[0010] The base surface layer and the bead-adhesive soft board are affixed with release paper.

[0011] The present invention is based on clinical symptoms and traditional Chinese medicine theory to classify chemotherapy-related nausea and vomiting into the category of "vomiting". Due to the disharmony and descent of the stomach and the upward reversal of qi, the gastric contents are vomited out from the mouth, often accompanied by symptoms such as fullness and pain in the epigastric area, poor appetite, and loose stools. Evil toxins invading the stomach, emotional disorders, and spleen and stomach deficiency are the main causes of CINV, and spleen and stomach deficiency is the most important cause. Its basic pathogenesis is nothing more than disharmony and descent of the stomach and upward reversal of stomach qi. The basic treatment principle should be to harmonize the stomach, descend the reverse, and stop vomiting. On the basis of the standard antiemetic regimen, homemade antiemetic beads are added to apply acupoint massage to treat chemotherapy-related vomiting. By implementing this technology, the gastrointestinal reactions of patients with malignant tumors due to chemotherapy are reduced, the quality of life and physical condition of patients are improved, and new diagnosis and treatment technologies are added to the construction of "vomiting-free wards" in our department, the diagnosis and treatment content is enriched, and new strategies and directions are provided for the treatment of CINV.

[0012] Its mechanism is to fully combine the theory of external treatment of traditional Chinese medicine with the theory of meridians on the basis of syndrome differentiation and treatment. By selecting specific acupoints and drugs, and utilizing the meridians and acupoints as channels for drug delivery, drugs can directly affect relevant organs. Due to the exopathic sensitivity and amplifying effects of meridians and acupoints to drugs, the combination of Chinese medicine and meridians allows drugs to penetrate the meridians and acupoints, creating a superimposed and amplified effect. "The principle of external treatment is the principle of internal treatment," removing the harmful qi caused by chemotherapy drugs, thereby improving spleen and stomach function. Combined with acupoint massage to dredge meridians, this can not only alleviate adverse digestive reactions caused by chemotherapy drugs, but also regulate the body's yin and yang balance, significantly improving not only symptoms but also quality of life.

[0013] The acupoints selected are bilateral Yifeng, Neiguan, and Hegu acupoints; the medicinal material selected is the Tujia specialty medicinal material Baige Fragrant soup, ginger juice, wind oil and Thuja juniper loose beads; among them:

[0014] Baigexiang Decoction, a Tujia specialty, combines Tujia herbs with modified Xiaobanxia Decoction from the "Golden Chamber Synopsis." Its main ingredients include Baiweilian, Geshanxiao, Qingmuxiang, Japonica, Bamboo Shoots, Wuyuzi (Evodia rutaecarpa), Shibing (Persimmon stalk), and Jiangbanxia. Its therapeutic principle is to regulate the balance of qi and blood in the body, promoting the coordination of the three vital organs and ensuring unobstructed qi and blood flow. Jiangbanxia and Qingmuxiang promote qi circulation, while Shibing (Persimmon stalk), Wuyuzi, and Baiweilian lower qi. Geshanxiao regulates qi, while Bamboo Shoots and Bamboo Shoots replenish qi.

[0015] The pharmaceutical ingredients of Fengyoujing (Fengyoujing) are menthol, camphor, eucalyptol, and methyl salicylate. Menthol can enhance the central nervous system inhibitory effects mediated by sodium pentobarbital, while camphor can stimulate breathing when the central nervous system is inhibited. Fengyoujing has a refreshing effect on patients with dysphagia after a stroke. At the same time, aromatherapy can be used to stimulate the olfactory sense of patients with dysphagia. By stimulating the sense of smell through small molecules in aromatic substances (aromatic small molecules), it can regulate and promote olfactory function. Menthol, the main ingredient of Fengyoujing, has a unique aromatic and stimulating odor that can provide strong olfactory stimulation in the mouth.

[0016] Thuja contains 16 high concentrations of aromatic monoterpenes, which enter the brain through the olfactory system and exert pharmacological effects on human tissue. These aromatic substances are absorbed by the body through massage, bathing, and drinking, and can regulate heart rate and blood pressure, and relieve symptoms such as anxiety, pain, nausea, and vomiting.

[0017] Compared with the prior art, the present invention has the following beneficial effects:

[0018] (1) The antiemetic beads used are made of Thuja arborvitae loose beads containing 16 high concentrations of monoterpenes as the base material, soaked in a new liquid preparation prepared by boiling extracts of Rhizoma Cyperi, Cyperus rotundus, Aucklandia lappa, Panax notoginseng, Rhizoma Atractylodis Macrocephalae, Evodia rutaecarpa (Evodia rutaecarpa), Persimmon stem (Persimmon calyx), and Pinellia ternata, and prepared with ginger juice and Fengyoujing. Applying the antiemetic beads to the corresponding acupoints of the patient can effectively relieve vomiting in chemotherapy patients; After testing, the nausea relief rate during the whole process of applying the antiemetic beads of the present invention was increased from 50% to 73.3%, the vomiting relief rate was increased from 60% to 80%, the appetite relief rate was increased from 53.3% to 73.3%, and the quality of life score was increased from 92.77 to 105.36; the comprehensive use effect was significantly improved, and the patient had good promotion value.

[0019] ⑵ The antiemetic beads can be pressed on the patient's acupuncture points for a long time through application, and the nursing staff no longer need to press continuously.

[0020] ⑶ Use adhesive material to stick the antiemetic beads into the arc groove on the soft adhesive plate of the applicator to prevent the antiemetic beads from sliding or falling off. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 It is a front oblique structural schematic diagram of the present invention.

[0022] Figure 2 It is a schematic diagram of the central section structure of the present invention.

[0023] Figure 3 This is a map of the locations of the Yifeng, Neiguan and Hegu acupoints that are needed for use.

[0024] In the figure: 1. Antiemetic beads, 2. Acupoint application, 3. Base layer, 4. Adhesive soft board, 5. Skin adhesive layer, 6. Bead sticking arc groove, 7. Bead sticking glue layer. DETAILED DESCRIPTION

[0025] The present invention will be further described below with reference to the examples. The following examples are intended to illustrate the present invention rather than to further limit the present invention, and should not be used to limit the scope of protection of the present invention.

[0026] As shown in the figure, an antiemetic bead patch is prepared, which includes antiemetic beads 1 and acupoint patch 2. The antiemetic beads 1 are Thuja medicinal beads made from Thuja loose beads with a diameter of 0.5-0.7 cm, preferably Thuja beads with a diameter of 0.6 cm; the antiemetic beads are prepared by soaking Thuja loose beads in a mixture of Chinese medicine extract + ginger juice + wind oil essence; specifically, 100 g each of Baiweilian, Geshanxiao, Qingmuxiang, Bamboo Shoots, August Zha, Wuxuzi (Evodia rutaecarpa), Shibianba (Persimmon Calyx), and Jiangbanxia are taken with water for decoction and extraction twice, and the two extracts are combined and concentrated into a thick extract 200-300g; 180-220ml of ginger juice and 450-550ml of feng balm are mixed evenly to prepare a new liquid preparation. Beads with a particle size of 0.5-0.7cm are made from thuja wood, called thuja loose beads. 1000 thuja loose beads are soaked in the new liquid preparation for 15 days to obtain the antiemetic beads. The acupoint application 2 includes a base surface layer 3 and a bead-adhesive soft plate 4. The bead-adhesive soft plate 4 is truncated and directly adhered to the center of the base surface layer 3. The base surface layer 3 is coated with a skin-adhesive layer 5. The bead-adhesive soft plate 4 has a bead-adhesive arc groove 6 in the center, and the bead-adhesive arc groove 6 is coated with a bead-adhesive layer 7. The antiemetic beads 1 are adhered to the bead-adhesive layer 7 on the bead-adhesive arc groove 6 to form the antiemetic bead application.

[0027] In this embodiment, the base surface layer 3 is made of non-woven fabric material, and the base surface layer is 5 cm thick. ×5cm square patch.

[0028] The base surface layer 3 and the soft bead adhesive board 4 on the finished antiemetic beads are pasted with release paper.

[0029] The method of use is:

[0030] Skin cleaning: Wipe the skin at the acupoints with an alcohol cotton ball to remove grease and dirt and enhance the adsorption of the patch.

[0031] Apply the antiemetic beads patch: Apply the antiemetic beads patch to the selected acupuncture points, press lightly to fix, and leave it in place for 4-6 hours.

[0032] Acupoint massage: During the application period or after it takes effect, press with the tip of your thumb and rub in a clockwise direction. The strength should be enough to feel soreness and swelling. The pressing order is: first press Neiguan for 2-3 minutes, then press Hegu for 3-5 minutes, and finally press Yifeng for 2-3 minutes.

[0033] Use comparative tests:

[0034] 1. Subjects: 60 patients with lung cancer who received first-line platinum-based therapy at our department between January and June 2025. Thirty patients received acupoint massage with a homemade antiemetic bead application (bilateral Yifeng, Neiguan, and Hegu acupoints) during chemotherapy as an observation group, and 30 patients who did not receive the homemade antiemetic bead application during chemotherapy served as a control group.

[0035] 2. Diagnostic criteria for TCM syndrome (Spleen Deficiency and Stomach Reversal): Refer to "Internal Medicine of Traditional Chinese Medicine" [Wu Mianhua, Wang Xinyue..Internal Medicine of Traditional Chinese Medicine [M]. Beijing: China Medical Science and Technology Press, 2002: 361-362.], main symptoms: loss of appetite, abdominal distension with poor appetite, fatigue, limb fatigue, frequent belching, or hiccups, nausea, vomiting (or vomiting of clear water), and abdominal distension; secondary symptoms: sallow or pale complexion, pale tongue, fat tongue or tongue with teeth marks, greasy or thin white tongue coating, weak or thready pulse, heartburn, noisy pulse. Two of the above main symptoms, or main symptoms If one of the following symptoms is present plus two of the following symptoms, the patient can be diagnosed with spleen deficiency and stomach reversal syndrome.

[0036] 3. Inclusion criteria: Patients met the diagnostic criteria for lung cancer and spleen deficiency and stomach inversion syndrome; were eligible for chemotherapy and received platinum-containing treatment regimens; were first-line treatments; were aged 18-70 years; and had an Eastern Cooperative Oncology Group (ECOG) score of 0-1.

[0037] 4. Exclusion criteria: patients with gastrointestinal obstruction, brain metastasis and symptoms of increased intracranial pressure or other potential diseases that may cause and / or aggravate nausea and vomiting (such as metabolic disorders); patients who are currently receiving or need to undergo upper abdominal or cranial radiotherapy within 2-7 days after taking the drug; patients who cannot eat for any reason; patients with underlying diseases that require the use of glucocorticoids; patients with poor compliance, or unable to cooperate with treatment and describe treatment response; patients with severe allergies to study drugs (traditional Chinese medicine, acupoint patch excipients, etc.).

[0038] 5. Both the observation and control groups received a triple-drug regimen for preventing vomiting before chemotherapy, including ondansetron (for patients with a history of delayed vomiting, palonosetron was allowed to be given after enrollment), dexamethasone, and aprepitant or fosaprepitant. In addition to the above treatment, the observation group received an antiemetic bead patch starting half an hour before chemotherapy on the day of chemotherapy. The patch was changed daily for 8 hours per day, with a course of 5 days. The patches were applied to the bilateral Yifeng, Neiguan, and Hegu acupoints. During the application period or after the effect of the patch, the thumb pads were used to press and knead in a clockwise direction, with the appropriate pressure to feel soreness and swelling. The pressing order was: first press Neiguan for 2-3 minutes, then press Hegu for 3-5 minutes, and finally press Yifeng for 2-3 minutes. Massage was performed once every 2 hours, and the antiemetic bead patch (optionally at the Hegu acupoint) was applied for 10-15 minutes.

[0039] 6. Observation indicators: Clinical data collection records the clinical characteristics of the enrolled patients and the vomiting risk assessment before chemotherapy, including age, gender, ECOG score, pathological type, clinical stage, chemotherapy regimen, chemotherapy course, whether anti-angiogenic targeted therapy is used in combination, whether immunotherapy is used in combination, etc. The occurrence of nausea and vomiting, loss of appetite, hemoglobin, and albumin levels of the patients from 0 to 120 hours after chemotherapy are collected. FLIE questionnaire survey was conducted on the 1st and 5th day after chemotherapy (follow-up by telephone).

[0040] 7. Efficacy observation indicators: (1) CINV diagnostic criteria, refer to the "Chinese Expert Consensus on the Prevention and Treatment of Nausea and Vomiting Related to Cancer Drug Therapy (2019 Edition)"; acute phase CINV: CINV that occurs within 24 hours after chemotherapy; delayed phase CINV: CINV that occurs between the 2nd and 5th day after chemotherapy. Whole-process CINV: CINV that occurs from the start of chemotherapy to the 5th day after chemotherapy. Observe the time, number, frequency and severity of CINV. (2) Refer to the evaluation criteria CTCAE 4.0 developed by the National Institutes of Health to assess the patient's loss of appetite; acute phase loss of appetite: loss of appetite that occurs within 24 hours after chemotherapy; delayed phase loss of appetite: loss of appetite that occurs between the 2nd and 5th day after chemotherapy. Whole-process CINV: loss of appetite that occurs from the start of chemotherapy to the 5th day after chemotherapy.

[0041] 8. Safety indicators (adverse reactions related to acupoint application): Observe the occurrence of adverse reactions related to acupoint application on the first day before chemotherapy and within 8 days after chemotherapy, and record the number of people who experience them, symptoms, and relief after symptomatic treatment.

[0042] 9. Statistical analysis was performed using SPSS 21.0. The method indicates that The t-test was used, the enumeration data were expressed as percentages, and the chi-square test was used. P < 0.05 was considered statistically significant.

[0043] The results are as follows: Table 1: Baseline results As shown in Table 1, there was no statistically significant difference in baseline characteristics such as age, gender, ECOG score, pathological type, clinical stage, and chemotherapy regimen between the observation group and the control group.

[0044] Table 2: Nausea and Loss of Appetite Results

[0045] As shown in Table 2, in terms of nausea, there was no statistical difference in the nausea remission rate in the acute phase (24 hours after chemotherapy) between the observation group and the control group (P>0.05), while the nausea remission rate in the delayed phase (2nd to 5th day after chemotherapy) and the whole process of chemotherapy (from the start of chemotherapy to the 5th day after chemotherapy) was significantly increased, with statistical difference (P<0.05); in terms of loss of appetite, there was no statistical difference in the nausea remission rate in the acute phase (24 hours after chemotherapy) and the delayed phase (2nd to 5th day after chemotherapy) between the observation group and the control group (P>0.05), while the nausea remission rate in the whole process of chemotherapy (from the start of chemotherapy to the 5th day after chemotherapy) was significantly increased, with statistical difference (P<0.05).

[0046] Table 3: Results of retching and vomiting (most patients had retching first and then vomiting or vomiting first and then retching, A few patients only have dry retching)

[0047] As shown in Table 3, in terms of retching, there was no statistical difference in the vomiting relief rate of the observation group (24 hours after chemotherapy) in the acute phase (24 hours after chemotherapy) compared with the control group (P>0.05), and the vomiting relief rate in the delayed phase (2-5 days after chemotherapy) and the whole process of chemotherapy (from the start of chemotherapy to the 5th day after chemotherapy) was significantly increased, with statistical differences (P<0.05); in terms of vomiting, there was no statistical difference in the vomiting relief rate of the observation group (24 hours after chemotherapy) compared with the control group (P>0.05), and the vomiting relief rate in the delayed phase (2-5 days after chemotherapy) and the whole process of chemotherapy (from the start of chemotherapy to the 5th day after chemotherapy) was significantly increased, with statistical differences (P<0.05).

[0048] Table 4: Quality of life scores

[0049] As shown in Table 4, the FLIE scale was used to evaluate patients based on the severity of nausea and vomiting, the degree of distress, and the impact on daily life. Higher scores indicate better quality of life. Compared with the control group, the FLIE score in the observation group was significantly higher, with a statistically significant difference (P < 0.05).

[0050] It can be seen that compared with the existing common acupoint application, the nausea relief rate of the antiemetic beads application of the present invention is increased from 50% to 73.3%, and the appetite relief rate is increased from 53.3% to 73.3%, the retching relief rate increased from 53.3% to 73.3%, the vomiting relief rate increased from 60% to 80%, and the quality of life score increased from 92.77 to 105.36; the comprehensive use effect was significantly improved, and it has good promotion value.

Claims

1. An antiemetic bead patch, characterized in that The invention comprises antiemetic beads and acupoint plasters; the antiemetic beads are Thuja chinensis medicinal beads, which are prepared by soaking Thuja chinensis loose beads in a new liquid preparation mixed with Chinese medicine extract, ginger juice and wind oil; the preparation method is as follows: take 100g each of Herba Lycopodii, Herba Glycyrrhizae, Herba Atractylodes, Herba Panacis Japonicae, Herba Atractylodes Rubrae, Herba Evodiae, Herba Dioscoreae, and Herba Pinelliae Rhizoma with water for decoction and extraction twice, combine the two extracts and concentrate them into 200-300g of thick extract; take 180-220ml of ginger juice and 450-550ml of wind oil, mix them evenly, and prepare the new liquid preparation; use Thuja chinensis wood to make beads with a particle size of 0.5-0.7mm, which are called Thuja chinensis loose beads, soak 1000 Thuja chinensis loose beads in the new liquid preparation for 15 days to obtain the antiemetic beads; the acupoint plaster is a tape patch; and the antiemetic beads are pasted on the acupoint plaster to obtain the antiemetic beads plaster.

2. The antiemetic bead patch according to claim 1, characterized in that The acupoint patch includes a base surface layer and a bead-adhesive soft plate. The bead-adhesive soft plate is frustum-shaped and is directly adhered to the center of the base surface layer. The base surface layer is coated with a skin-adhesive layer. A bead-adhesive arc groove is provided in the center of the bead-adhesive soft plate. The bead-adhesive arc groove is coated with a bead-adhesive layer. The antiemetic beads are adhered to the bead-adhesive layer on the bead-adhesive arc groove.

3. The antiemetic bead patch according to claim 2, characterized in that The specification of the antiemetic beads is 0.6 mm.

4. The antiemetic bead patch according to claim 3, characterized in that The base surface layer is non-woven fabric.

5. The antiemetic bead patch according to claim 4, characterized in that The base surface layer and the bead-adhesive soft board are affixed with release paper.

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