Traditional Chinese medicine composition for treating adenoid hypertrophy and application thereof
The Chinese medicine composition composed of honeysuckle and other Chinese medicine compositions are decocted and extracted into Chinese medicine preparations, which solves the safety and effectiveness of adenoid hypertrophy treatment and provides a new method to treat adenoid hypertrophy, significantly improving symptoms and reducing the volume of adenoid.
Patent Information
- Application Number
- CN202510810193.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-06-17
- Publication Date
- 2025-09-02
AI Technical Summary
Existing methods for treating adenoid hypertrophy, such as surgery and Western medicine, have risks, recurrence and side effects, and lack safe and effective conservative treatment plans. Traditional Chinese medicine treatment has the potential to improve symptoms and reduce adenoid volume.
A Chinese medicine composition composed of honeysuckle, forsythia, platycodon, light fermented black beans, licorice, bamboo leaves, schizonepeta, mint, reed root, and yam is used to prepare a Chinese medicine preparation through decoction and extraction, which is used to treat adenoid hypertrophy, and is combined with pharmaceutically acceptable excipients such as diluents, wetting agents, disintegrants, etc., to make a variety of dosage forms.
It significantly improves the treatment effect of adenoid hypertrophy, provides a new treatment path, has synergistic treatment effect, is significantly better than the use of original prescription Yinqiao Powder or additives alone, and has good clinical application prospects.
Smart Images
Figure BDA0005453749080000091 
Figure BDA0005453749080000101 
Figure BDA0005453749080000102
Abstract
Description
Technical Field
[0001] The present invention belongs to the technical field of traditional Chinese medicine, and in particular relates to a traditional Chinese medicine composition for treating adenoids hypertrophy and an application thereof. Background Art
[0002] Adenoid hypertrophy is a common upper respiratory tract disease in children, most commonly between the ages of 2 and 12, with an incidence rate as high as 30%-40%, and an increasing trend in recent years. Adenoids are located at the top of the nasopharynx. Excessive growth can obstruct the posterior nasal passages and the pharyngeal opening of the Eustachian tube, leading to symptoms such as nasal congestion, snoring, mouth breathing, and hearing loss. In severe cases, it can cause adenoid facies, growth retardation, and cognitive impairment. Currently, surgical resection (such as adenoidectomy) is the primary treatment, but surgery carries risks associated with anesthesia, postoperative recurrence (approximately 5%-10%), and trauma. Furthermore, surgical indications are difficult to determine for children with mild to moderate symptoms or those with recurrent respiratory infections. Furthermore, while Western medications (such as nasal corticosteroids and antihistamines) can alleviate symptoms, long-term use can affect children's endocrine system and is ineffective in fundamentally reversing adenoid hyperplasia. Therefore, there is an urgent need for new, safe, and effective conservative treatment options.
[0003] Adenoids hypertrophy falls under the category of "nasal congestion" and "snoring" in Traditional Chinese Medicine (TCM). Its causes are often related to lung and spleen qi deficiency, phlegm, dampness, and blood stasis. Traditional Chinese medicines are mostly natural, with fewer side effects, and are suitable for long-term use in children. For example, spleen-tonifying and qi-invigorating herbs such as Atractylodes macrocephala and Poria cocos can improve children's spleen deficiency and reduce recurrences. Acid-sweetening and yin-tonifying herbs such as Prunus mume and Licorice can relieve dry throat caused by long-term mouth breathing and avoid the risk of mucosal damage associated with Western medicine. The high incidence of adenoids hypertrophy and the limitations of existing treatments urgently require the development of safe and effective traditional Chinese medicine. Through syndrome differentiation and holistic conditioning, traditional Chinese medicine has significant potential in improving symptoms, reducing adenoid size, and preventing recurrences. It can also fill the gaps in conservative treatment in Western medicine, providing diversified treatment options for children with adenoids hypertrophy, and has important clinical and social significance. Summary of the Invention
[0004] In order to overcome the technical problems existing in the above-mentioned prior art, the purpose of the present invention is to provide a traditional Chinese medicine composition for treating adenoids hypertrophy and its application in the art, wherein the traditional Chinese medicine composition is composed of 10 raw materials, including honeysuckle, forsythia, platycodon, light fermented black beans, licorice, bamboo leaves, schizonepeta, mint, reed root, and yam.
[0005] The present invention is the first to discover that a traditional Chinese medicine formula consisting of the original Yinqiao Powder and additives (reed rhizome and Chinese yam) has a synergistic therapeutic effect in the treatment of adenoids hypertrophy. This traditional Chinese medicine composition provided by the present invention has achieved unexpected technical benefits. This invention opens up a new approach to the treatment of adenoids hypertrophy and significantly improves its therapeutic efficacy.
[0006] In order to achieve the above-mentioned object of the invention, the present invention adopts the following technical solutions:
[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating adenoid hypertrophy.
[0008] Furthermore, the traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 grams of honeysuckle, 5-15 grams of forsythia, 5-15 grams of platycodon, 5-15 grams of light fermented black beans, 1-11 grams of licorice, 5-15 grams of bamboo leaves, 5-15 grams of schizonepeta, 5-15 grams of mint, 10-20 grams of reed root, and 15-25 grams of yam.
[0009] Furthermore, the Chinese medicine composition is composed of the following raw materials in parts by weight: 10 grams of honeysuckle, 10 grams of forsythia, 10 grams of platycodon, 10 grams of light fermented black beans, 6 grams of licorice, 10 grams of bamboo leaves, 10 grams of schizonepeta, 10 grams of mint, 15 grams of reed root, and 20 grams of yam.
[0010] In the above compositions, the weight of the medicinal materials is calculated based on the raw materials, and the proportions are based on parts by weight. These proportions can be increased or decreased during production. For example, large-scale production can use kilograms or tons, while small-scale production can use grams or milligrams. While the weights can be increased or decreased, the weight ratios of the raw materials in each component remain unchanged. The above weight ratios are scientifically selected. For special patient needs, such as those with severe or mild illnesses, or those who are obese or thin, the proportions of the components can be adjusted accordingly, with increases or decreases not exceeding 100% without changing the efficacy.
[0011] In the present invention, the reed rhizome is the fresh or dried rhizome of the grass plant reed, which is sweet and cold in nature, enters the lung and stomach meridians, has the effects of clearing heat and purging fire, promoting fluid production and quenching thirst, relieving restlessness and nausea, and promoting diuresis, and is widely used for symptoms such as heat disease damaging fluid, lung heat cough, etc.
[0012] In the present invention, the yam is the dried rhizome of Dioscorea zingiberensis, a plant of the Dioscoreaceae family. It is sweet and mild in nature, enters the spleen, lung and kidney meridians, has the effects of nourishing the spleen and stomach, promoting fluid production and benefiting the lungs, nourishing the kidneys and astringing essence, and is a classic medicinal material with both medicinal and edible properties.
[0013] In a second aspect, the present invention provides a traditional Chinese medicine preparation for treating adenoid hypertrophy.
[0014] Furthermore, the active ingredient of the traditional Chinese medicine preparation is the traditional Chinese medicine composition described in the first aspect of the present invention.
[0015] Furthermore, the traditional Chinese medicine preparation contains a pharmaceutically acceptable excipient.
[0016] Furthermore, the pharmaceutically acceptable excipient is a diluent, a wetting agent, a disintegrant, a flavoring agent, a coloring agent and / or a preservative.
[0017] In some embodiments, the diluent includes but is not limited to: starch (such as corn starch, pregelatinized starch, stable and inexpensive), powdered sugar (crystalline sucrose, sweetening and viscosity enhancing but highly hygroscopic), dextrin (good water solubility, often combined with starch to adjust hardness), lactose (non-hygroscopic, good fluidity, suitable for direct powder tableting but high cost), mannitol (cool taste, suitable for lozenges or chewable tablets), calcium sulfate dihydrate (suitable for dilution of traditional Chinese medicine extracts, stable properties but poor fluidity), calcium hydrogen phosphate (buffering effect, commonly used in chewable tablets or preparations with high stability requirements), etc.
[0018] In some embodiments, the wetting agent includes but is not limited to: water (economical and readily available, suitable for drugs without special requirements, but prone to drug hydrolysis or mildew), ethanol (commonly used concentration of 30%-70%, suitable for drugs that are too viscous, easily decomposed or easily mildewed when exposed to water, and can adjust viscosity and reduce hygroscopicity), glycerin (strong viscosity, can increase drug viscosity and moisturizing properties, commonly used in topical preparations such as ointments, pastes, etc.), polysorbates (such as polysorbate 80, a non-ionic surfactant with strong wetting ability, suitable for hydrophobic drugs or for improving dispersibility when preparing emulsions and suspensions), sodium lauryl sulfate (anionic surfactant with strong wetting and emulsifying ability, which can reduce interfacial tension and promote drug dispersion), etc.
[0019] In some embodiments, the disintegrant includes, but is not limited to: dry starch (a classic disintegrant, suitable for water-insoluble or slightly soluble drugs, with strong water swelling), sodium carboxymethyl starch (CMS-Na, a high-efficiency disintegrant, which can expand several times in volume after absorbing water and has a significant disintegrating effect), low-substituted hydroxypropyl cellulose (L-HPC, which has both disintegrating and adhesive effects, and the fiber swelling after absorbing water promotes disintegration), cross-linked polyvinyl pyrrolidone (PVPP, which is insoluble when absorbing water and has excellent disintegrating performance, and is particularly suitable for hydrophobic drugs), cross-linked sodium carboxymethyl cellulose (CCNa, which has strong water swelling and fast and long-lasting disintegrating effect), effervescent disintegrant (composed of citric acid or tartaric acid and sodium bicarbonate, which reacts with water to produce carbon dioxide gas to promote tablet disintegration, and is suitable for effervescent tablets), etc.
[0020] In some embodiments, the flavoring agents include but are not limited to: sweeteners (such as sucrose, simple syrup, honey, aspartame, stevioside, etc., which can mask bitterness and improve taste, and are suitable for oral liquids, granules, etc.); aromatics (such as menthol, orange peel tincture, lemon essential oil, etc., which correct bad odors by volatile aroma, and are commonly used for flavoring liquid or solid preparations); mucilage agents (such as gum arabic, sodium carboxymethyl cellulose aqueous solution, etc., which can adhere to the mucosal surface to form a protective film, reduce the irritation of the drug to the mucosa and alleviate the odor); effervescent agents (composed of organic acids and sodium bicarbonate, which react with water to produce carbon dioxide, forming a cool feeling and masking the bitter taste, and are suitable for effervescent tablets or oral liquids); salty flavoring agents (such as sodium chloride, which can adjust the salty taste and is used to balance the bitter taste of certain Chinese medicines); glycerin (which has both sweetness and viscosity, can improve the taste of the preparation and increase stability).
[0021] In some embodiments, the colorant includes but is not limited to: natural pigments (such as plant-derived sodium copper chlorophyllin, turmeric, carotene, caramel, etc., which are highly safe and suitable for oral preparations, among which caramel is often used for brown coloring); synthetic pigments (such as amaranth, carmine, lemon yellow, brilliant blue, etc. for oral administration, which must comply with national food additive standards, have strong coloring power and bright colors but the dosage must be strictly controlled); mineral pigments (such as iron oxide (red, yellow, brown, etc.), titanium dioxide (white), which are stable in nature and are often used for coloring external preparations such as ointments).
[0022] In some embodiments, the preservatives include but are not limited to: alcohol preservatives (such as ethanol, which has a bactericidal effect at a concentration of 70%-90%, and is suitable for alcohol-containing preparations such as tinctures, fluid extracts, etc.); benzoic acid and its salts (such as sodium benzoate, which has a good preservative effect under acidic conditions, a common concentration of 0.1%-0.25%, and is suitable for oral liquid preparations); sorbic acid and its salts (such as potassium sorbate, which is effective under acidic to neutral conditions, a common concentration of 0.05%-0.2%, has a strong preservative effect and low toxicity). , suitable for a variety of liquid preparations); phenol derivatives (such as phenol and cresol, which have strong preservative power but certain toxicity, and are only used in external preparations such as ointments and lotions, etc.); parabens (parabens) (such as methyl ester, ethyl ester, propyl ester, with a wide antibacterial range, commonly used concentration of 0.01%-0.25%, can be used alone or in combination, suitable for oral and external preparations); trichlorobutanol (has both preservative and local anesthetic effects, commonly used concentration of 0.25%-0.5%, suitable for injections or eye drops, etc.).
[0023] Furthermore, the dosage form of the traditional Chinese medicine preparation is an oral dosage form, a transdermal patch or an injection dosage form.
[0024] Furthermore, the dosage form of the Chinese medicine preparation is decoction, pill, powder, ointment, tablet, capsule, granule, oral solution, injection, pellet, patch, aerosol and / or sustained-release agent.
[0025] In some embodiments, the pharmaceutically acceptable excipient further comprises a buffer or a carrier.
[0026] In some embodiments, the buffer includes but is not limited to lactate, borate, citrate, phosphate, carbonate, acetate, tartrate, glycolate, cacodylate, MOBS, Tris, Hepes, HEPBS, Trizma, Bicine, Tricine, MOPS, CABS, CHES, MOPSO, MES, ACES, ADA, AMP, AMPD, AMPSO, BES, DIPSO, EPPS, ethanolamine, glycine, HEPPSO, imidazole, imidazole lactate, PIPES, SSC, SSPE, POPSO, TAPS, TABS, TAPSO, TES, etc.
[0027] In some embodiments, the carrier includes, but is not limited to, isotonicity agents, antioxidants, suspending agents, dispersing agents, emulsifiers, chelating agents, thickening agents, and solubilizing agents.
[0028] In some embodiments, the raw Chinese medicinal materials contained in the traditional Chinese medicine preparation can be directly prepared, or can be processed into pharmaceutical active substances by other means. Subsequently, the active substances are used as raw materials, and pharmaceutically acceptable buffers, carriers and / or excipients are added as needed to prepare suitable preparations according to conventional techniques of pharmaceutical preparation. The active substances can be obtained by the following methods, for example: by crushing, pressing, calcining, grinding, screening, percolation, extraction, water extraction, alcohol extraction, ester extraction, ketone extraction, chromatography, etc. These active substances can be substances in the form of extracts, which can be dry extracts or fluid extracts, and different concentrations can be determined according to the different needs of the preparation.
[0029] In some embodiments, the pharmaceutically acceptable excipient may additionally contain a liquid such as water, saline, glycerol, and ethanol. Additionally, auxiliary substances such as wetting agents or emulsifiers or pH buffering substances may be present in the composition. These carriers enable the pharmaceutical composition to be formulated into tablets, pills, dragees, capsules, liquids, gels, syrups, slurries, and suspensions for ingestion by the patient.
[0030] In some embodiments, the present invention does not particularly limit the specific dosage form of the traditional Chinese medicine preparation. In some embodiments, the traditional Chinese medicine preparation can be prepared into an oral preparation or an injectable dosage form, including decoctions, tablets, capsules, pills, suppositories, aerosols, oral liquid preparations, granules, powders, sustained-release preparations, nanoformulations, syrups, wine preparations, tinctures, lotions, and injections. Those skilled in the art can select a suitable dosage form known in the art according to actual needs (e.g., to improve the bioavailability of the drug, improve the patient's medication compliance, etc.).
[0031] In a third aspect, the present invention provides a method for preparing the traditional Chinese medicine composition described in the first aspect of the present invention.
[0032] Furthermore, the method comprises the following steps: weighing the raw materials according to the ratio of the Chinese medicinal materials, decocting them in water for extraction, filtering, and combining the extracts to prepare the Chinese medicinal composition.
[0033] In a fourth aspect, the present invention provides use of the traditional Chinese medicine composition described in the first aspect of the present invention in the preparation of a medicament for treating adenoid hypertrophy.
[0034] In a fifth aspect, the present invention provides use of the traditional Chinese medicine preparation described in the second aspect of the present invention in the preparation of a medicament for treating adenoid hypertrophy.
[0035] In addition, the present invention also provides a method for treating adenoid hypertrophy, comprising the following steps: administering a therapeutically effective amount of the pharmaceutical composition of the first aspect of the present invention or the traditional Chinese medicine preparation of the second aspect of the present invention to a subject in need.
[0036] In some embodiments, the subject refers to any animal, including humans and non-human animals. Non-human animals include all vertebrates, for example, mammals, such as non-human primates (particularly higher primates), sheep, dogs, rodents (such as mice or rats), guinea pigs, goats, pigs, cats, rabbits, cows, and any livestock or pets; as well as non-mammals, such as chickens, amphibians, reptiles, etc. In a specific embodiment of the present invention, the subject is preferably a human.
[0037] In some embodiments, the administration can refer to, for example, treatment, pharmacokinetics, diagnosis, research and experimental methods, and when the treatment is applied to humans, veterinary medicine or research subjects, it refers to therapeutic treatment, prophylaxis or preventative measures, research and diagnostic applications. In specific embodiments of the invention, the administration refers to therapeutic treatment, prophylaxis or preventative measures.
[0038] In some embodiments, the treatment refers to preventing and reducing the occurrence or development of the disease, so that the development or aggravation of the disease course can be inhibited, contained, alleviated, improved, slowed down, stopped, delayed or reversed. The various indicators of the disease, disorder or pathological state described in the maintenance and / or medication include alleviating or reducing the symptoms or complications of a specific disease, or curing or eliminating the disease, disorder or condition. Therefore, the treatment of adenoids hypertrophy described in the present invention includes preventing, alleviating and / or treating adenoids hypertrophy.
[0039] In some embodiments, the therapeutically effective amount refers to the dosage of the specific pharmacological action that one or more drugs are administered. It should be emphasized that a therapeutically effective amount is not always effective in achieving the desired effect in a given subject, even if the dosage is considered to be a therapeutically effective amount by those skilled in the art. Those skilled in the art can adjust such an amount according to the standard practice required for treating a specific subject. A therapeutically effective amount can vary based on route of administration and dosage form, age and body weight of the subject, and / or the severity of the subject's condition. For example, it will be understood by those skilled in the art that a therapeutically effective amount for treating a small individual can be different from a therapeutically effective amount for treating a large individual.
[0040] In some embodiments, the suitable dosage of the pharmaceutical composition or traditional Chinese medicine preparation can be prescribed in a variety of ways according to factors such as the formulation method, administration method, patient's age, weight, gender, morbidity, diet, administration time, administration route, excretion rate and reaction sensitivity. A skilled doctor can usually easily determine the prescription and the dosage that is effective for the desired treatment.
[0041] In the present invention, the present invention proves through Jin's method that the traditional Chinese medicine composition described in the first aspect of the present invention, which is composed of the original formula Yinqiao Powder and additives (reed root, yam), has a synergistic therapeutic effect (CI>1.15) on the treatment of adenoids hypertrophy, that is, the traditional Chinese medicine composition provided by the present invention has achieved unexpected technical effects.
[0042] Among them, the King's method is a method that is widely used to calculate the combined efficacy of drugs. Taking drug A and drug B as an example, the drug effects of drug A and drug B are regarded as independent events, and the probability formula P is used. AB =P A +P B -P A *P B , and use this formula as the calculation formula E for the expected additive effect of combined drug use AB =E A +E B -E A *E B The ratio of the actual efficacy value to the calculated value of the formula is CI. The CI value between 0.85-1.15 is simple addition; between 1.15-20 is synergy, and >20 is significant synergy; the CI value between 0.85-0.55 is antagonism, and <0.55 is obvious antagonism.
[0043] Compared with the prior art, the present invention has the following advantages and beneficial effects:
[0044] (1) The present invention provides, for the first time, a Chinese herbal formula comprising ten raw materials, namely, honeysuckle, forsythia, platycodon, light fermented black beans, liquorice, bamboo leaves, schizonepeta, mint, reed root, and Chinese yam. Clinical studies have shown that the formula has a significant therapeutic effect on adenoid hypertrophy. Furthermore, comparative experiments have demonstrated that the formula is significantly more effective than the original formula Yinqiao Powder and its additives (reed root and Chinese yam).
[0045] (2) The present invention first discovered that the above-mentioned traditional Chinese medicine formula composed of the original formula Yinqiao Powder and the additives (reed root and Chinese yam) has a synergistic therapeutic effect in the treatment of adenoids hypertrophy. In other words, the traditional Chinese medicine formula provided by the present invention has achieved unexpected technical effects. The traditional Chinese medicine formula provided by the present invention has been repeatedly tested in long-term and extensive clinical practice and provides a new idea and strategy for the technical field of adenoids hypertrophy treatment, with good clinical application prospects. DETAILED DESCRIPTION
[0046] The present invention will be further described below with reference to specific embodiments. The following specific embodiments are intended only to illustrate the present invention and are not to be construed as limiting the present invention. Those skilled in the art will appreciate that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the present invention. The scope of the present invention is defined by the claims and their equivalents.
[0047] The drugs, reagents, raw materials, and experimental consumables used in the present invention are readily available to those of ordinary skill in the art and, unless otherwise specified, can be obtained commercially. Experimental methods for which specific conditions are not specified in the present invention are generally tested under conventional conditions or under conditions recommended by the manufacturer. In particular, the following examples are intended only to illustrate the present invention and should not limit the scope of the present invention in any way. It should be noted that the experimental conditions and results described in the following examples are intended only to illustrate the present invention and should not, and will not, limit the present invention described in detail in the claims.
[0048] Example Preparation of a Chinese medicine composition for treating adenoids hypertrophy and study of its pharmacological effects
[0049] 1. Experimental Grouping
[0050] (1) Negative control group (no treatment).
[0051] (2) The original formula Yinqiao Powder (honeysuckle, forsythia, platycodon, light fermented black beans, liquorice, bamboo leaves, schizonepeta, mint) group.
[0052] (3) Additive (reed root, Chinese yam) group.
[0053] (4) Improved prescription (all components, including honeysuckle, forsythia, platycodon, light fermented black beans, liquorice, bamboo leaves, schizonepeta, mint, reed root, and yam, a total of 10 kinds) group.
[0054] The original formula of Yinqiao Powder comprises the following ingredients by weight: 10 grams of honeysuckle, 10 grams of forsythia, 10 grams of platycodon, 10 grams of light fermented black beans, 6 grams of licorice, 10 grams of bamboo leaves, 10 grams of schizonepeta, and 10 grams of mint. The preparation method is as follows: first, soak the herbs for 30 minutes, using enough water to cover the surface of the herbs. Then, boil for 20 minutes and pour out the decoction. Then, add more water and boil for 20 minutes. Pour out the decoction. Remove the residue from the two decoctions, filter them thoroughly, and mix them. Then, take them twice, one in the morning and one in the evening, half an hour after meals.
[0055] The additive comprises the following raw materials by weight: 15 grams of reed root and 20 grams of Chinese yam. The preparation method is as follows: first, soak the herbs for 30 minutes, using enough water to cover the surface of the herbs. Then, boil the herbs for 20 minutes and pour out the decoction. Then, add more water and boil for 20 minutes. Pour out the decoction. Remove the residue from the two decoctions, filter them thoroughly, and mix them. Then, take the decoction twice, once in the morning and once in the evening, half an hour after meals.
[0056] The improved recipe comprises the following ingredients by weight: 10 grams of honeysuckle, 10 grams of forsythia, 10 grams of platycodon, 10 grams of light fermented black beans, 6 grams of liquorice, 10 grams of bamboo leaves, 10 grams of schizonepeta, 10 grams of mint, 15 grams of reed rhizome, and 20 grams of yam. The preparation method is as follows: first, soak the herbs for 30 minutes, using enough water to cover the surface of the herbs, then boil for 20 minutes, and pour out the decoction; then, add more water and boil for 20 minutes, pour out the decoction, remove the residue from the two decoctions, filter them thoroughly, and mix them before taking them in two doses, one in the morning and one in the evening, half an hour after meals.
[0057] 2. Source of cases
[0058] This study included 140 patients with adenoid hypertrophy, all of whom provided signed informed consent. The gender ratios of the groups are shown in Table 1 below. The interventions for each group were as follows:
[0059] (1) Negative control group: no treatment.
[0060] (2) Original Yinqiao Powder Group: The patients were treated with the above-mentioned original Yinqiao Powder Chinese herbal decoction (oral) for 4 weeks.
[0061] (3) Supplement group: The patients were treated with the above-mentioned Chinese herbal decoction (oral) for 4 weeks.
[0062] (4) Improved prescription group: The patients were treated with the above improved prescription (10g of honeysuckle, 10g of forsythia, 10g of platycodon, 10g of light fermented black beans, 6g of liquorice, 10g of bamboo leaves, 10g of schizonepeta, 10g of mint, 15g of reed root, 20g of yam) as a Chinese herbal decoction (oral administration) for 4 weeks.
[0063] Table 1 Gender ratio and grouping
[0064] Gender / Group Negative control group Original formula Yinqiaosan group Additive Group Improved group male 21 20 22 21 female 14 15 13 14
[0065] 3. Patient's general information
[0066] The age of patients in each group is shown in Table 2 below, the course of disease of patients in each group is shown in Table 3 below, and the condition of patients in each group is shown in Table 4 below.
[0067] Table 2 Age of patients in each group
[0068]
[0069]
[0070] Table 3 Disease course of patients in each group
[0071] Course of disease / grouping Negative control group Original prescription Wen Dan Tang group Additive Group Improved group < 6 months 17 18 16 16 6-12 months 17 15 17 18 >12 months 1 2 2 1
[0072] Table 4 Conditions of patients in each group
[0073]
[0074]
[0075] 4. Diagnostic criteria
[0076] Western medicine diagnostic criteria: Based on Zhu Futang's Practical Pediatrics (8th Edition) and Zhang Yamei's Practical Pediatric Otorhinolaryngology (2011 Edition), the following detailed diagnostic criteria were developed:
[0077] Nasal symptoms: nasal congestion, sneezing, runny nose, blockage nasal sounds, etc.
[0078] Ear symptoms: ear pain, stuffy ears, tinnitus, hearing loss, etc.
[0079] Symptoms of the pharynx, larynx and lower respiratory tract: itchy throat, throat clearing movements, coughing, etc.
[0080] OSAHS related symptoms: snoring at night, mouth breathing, breath holding, etc.
[0081] Systemic symptoms: delayed growth and development, inattention, etc.
[0082] Physical examination: adenoids, facial features, etc.
[0083] Ancillary examinations: A lateral nasopharyngeal X-ray is performed to assess the degree of adenoid hypertrophy by measuring the ratio of adenoid thickness (A) to nasopharyngeal width (N). An A / N ratio ≤ 0.60 is considered normal; an A / N ratio between 0.60 and 0.70 indicates moderate hypertrophy; and an A / N ratio greater than 0.70 indicates pathological hypertrophy. The diagnosis is confirmed by supporting ancillary examinations and associated clinical symptoms.
[0084] Traditional Chinese Medicine (TCM) Diagnostic Criteria: Based on the "Traditional Chinese Medicine Otorhinolaryngology and Stomatology (2nd Edition)" edited by Wang Yongqin and "Traditional Chinese Medicine Otorhinolaryngology (2nd Edition)" edited by Ruan Yan, as well as related literature, the criteria for Wind-Heat Stagnation Type are as follows: Primary symptoms: Nasal congestion, snoring, and mouth breathing. Concomitant symptoms: Cough, runny nose, dry throat and lips, hearing loss, dry stools, and swollen tonsils. Tongue and pulse: Red tongue with a thin yellow coating, and a floating or rapid pulse.
[0085] 5. Inclusion and exclusion standards
[0086] (1) Inclusion criteria: ① Personal and / or family history of allergic rhinitis; ② Meet the above-mentioned diagnostic criteria of traditional Chinese and Western medicine; ③ Age between 3 and 10 years old, regardless of gender; ④ The patient and his / her family have given informed consent, have good medication compliance, and can effectively cooperate in completing treatment and subsequent follow-up.
[0087] (2) Exclusion criteria: ① Patients who have allergic reactions to the drugs used in the study or have difficulty taking oral Chinese medicine; ② Children and their families who have low cooperation during the medication process or may not be able to persist in completing the entire study process; ③ Patients with systemic diseases or acute infectious diseases; ④ Patients who are currently participating in clinical trials of other related drugs.
[0088] 6. Evaluation criteria for the treatment effect of adenoid hypertrophy
[0089] Markedly effective: The child's symptoms of mouth breathing, nasal congestion, and snoring during sleep were significantly improved. After the clinical completion of the X-ray lateral nasopharyngeal film examination, it was found that the child's adenoids had been significantly reduced.
[0090] Effective: The child's symptoms of mouth breathing, nasal congestion, and snoring during sleep were improved. After the clinical completion of the X-ray lateral nasopharyngeal film examination, it was found that the child's adenoids had shrunk.
[0091] Ineffective: The child's symptoms of mouth breathing, nasal congestion, and snoring during sleep were not improved. After the clinical completion of the X-ray lateral nasopharyngeal film examination, it was found that the child's adenoids did not show any shrinkage.
[0092] 7. Experimental Results
[0093] The therapeutic efficacy results of each group are shown in Table 5 below. The results show that the improved prescription group prepared by the present invention has an efficacy of up to 94.29% for the treatment of adenoids hypertrophy, which is significantly better than the original prescription Yinqiao Powder group (71.43%) and the additive group (31.43%). The CI value calculated using King's formula is 94.29% / [71.43%+31.43%-(71.43%*31.43%)]=1.17262>1.15, indicating that the combination of the original prescription Yinqiao Powder and the additive has a synergistic therapeutic effect on the treatment of adenoids hypertrophy. This result is a technical effect that is unexpected by those skilled in the art based on the content disclosed in the prior art.
[0094] Table 5 Treatment efficacy results of each group
[0095] Group / treatment effect Significantly effective efficient invalid Efficiency Negative control group 2 7 26 25.71％ Original formula Yinqiaosan group 15 10 10 71.43％ Additive Group 4 7 24 31.43％ Improved group 21 12 2 94.29％
Claims
1. A Chinese medicine composition for treating adenoids hypertrophy, characterized in that: The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 5-15 grams of honeysuckle, 5-15 grams of forsythia, 5-15 grams of platycodon, 5-15 grams of light fermented black beans, 1-11 grams of liquorice, 5-15 grams of bamboo leaves, 5-15 grams of schizonepeta, 5-15 grams of mint, 10-20 grams of reed root, and 15-25 grams of yam.
2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is composed of the following raw materials in parts by weight: 10 grams of honeysuckle, 10 grams of forsythia, 10 grams of platycodon, 10 grams of light fermented black beans, 6 grams of liquorice, 10 grams of bamboo leaves, 10 grams of schizonepeta, 10 grams of mint, 15 grams of reed root, and 20 grams of yam.
3. A Chinese medicine preparation for treating adenoids hypertrophy, characterized in that: The effective ingredient of the traditional Chinese medicine preparation is the traditional Chinese medicine composition according to claim 1 or 2.
4. The Chinese medicine preparation according to claim 3, characterized in that The traditional Chinese medicine preparation comprises a pharmaceutically acceptable excipient.
5. The Chinese medicine preparation according to claim 4, characterized in that The pharmaceutically acceptable excipients are diluents, wetting agents, disintegrants, flavoring agents, coloring agents and / or preservatives.
6. The Chinese medicine preparation according to claim 3, characterized in that The dosage form of the traditional Chinese medicine preparation is an oral dosage form, a transdermal patch or an injection dosage form.
7. The Chinese medicine preparation according to claim 3, characterized in that The dosage form of the traditional Chinese medicine preparation is decoction, pill, powder, ointment, tablet, capsule, granule, oral solution, injection, dripping pill, patch, aerosol and / or sustained-release preparation.
8. A method for preparing the Chinese medicine composition according to claim 1 or 2, characterized in that: The method comprises the following steps: weighing the raw materials according to the ratio of the Chinese medicinal materials, decocting them in water for extraction, filtering, and combining the extracts to prepare the Chinese medicinal composition.
9. Use of the Chinese medicine composition according to claim 1 or 2 in the preparation of a medicament for treating adenoid hypertrophy.
10. Use of the Chinese medicine preparation according to any one of claims 3 to 7 in the preparation of a medicament for treating adenoid hypertrophy.