A traditional Chinese medicine composition for treating recurrent sinusitis and application thereof

Abstract

This invention discloses a traditional Chinese medicine composition for treating recurrent sinusitis and its application, relating to the field of traditional Chinese medicine technology. The active ingredients of this composition are made from the following raw materials in parts by weight: Codonopsis pilosula 3-50 parts, Atractylodes macrocephala 5-50 parts, Poria cocos 5-50 parts, Glycyrrhiza uralensis (processed) 1-30 parts, Phragmites communis rhizome 2-40 parts, Coix lacryma-jobi 5-100 parts, and Benincasa hispida seed 2-100 parts. For patients with recurrent sinusitis accompanied by adenoid hypertrophy, the raw materials may also include Fritillaria thunbergii 5-20 parts and Ligusticum chuanxiong 5-30 parts. The formulation of this invention is based on the traditional Chinese medicine theory of "strengthening the spleen and removing dampness, clearing the lungs and opening the nasal passages." Clinical trials have confirmed that this traditional Chinese medicine composition can significantly improve nasal inflammation, shrink adenoids, improve cardiopulmonary function and sleep quality, and reduce serum inflammatory factor levels. The overall effective rate is significantly better than existing drugs, and it has high safety and good patient compliance. This invention provides a safe and effective treatment option for recurrent sinusitis and its associated adenoid hypertrophy.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, specifically to a traditional Chinese medicine composition for treating recurrent sinusitis and its application. Background Technology

[0002] Recurrent Acute Rhinosinusitis (RARS) is a common chronic inflammatory disease of the upper respiratory tract, defined as four or more episodes of acute sinusitis within one year, with complete symptom relief between episodes. This disease has a high incidence rate and severely impacts the quality of life of affected children, potentially leading to sleep disturbances, poor concentration, and even affecting cardiopulmonary function.

[0003] Currently, modern medicine primarily treats RARS using nasal corticosteroids, antibiotics, and nasal irrigation. However, these methods have significant limitations: (1) Treating the symptoms but not the root cause, and prone to relapse: Antibiotics and hormones are mainly used to control acute symptoms, but they are difficult to fundamentally change the child's susceptible constitution and the chronic inflammatory state of the nasal cavity, leading to repeated relapses.

[0004] (2) Long-term use has significant side effects: Long-term use of antibiotics can easily lead to dysbiosis and drug resistance; long-term use of nasal hormones may cause local adverse reactions such as dryness and bleeding of the nasal mucosa, and parents and clinicians have concerns about its long-term safety.

[0005] Furthermore, RARS often occurs concurrently with adenoid hypertrophy, especially in children, with the two mutually reinforcing each other, creating a vicious cycle. Repeated inflammation of the sinuses stimulates pathological hyperplasia of the adenoids, while the enlarged adenoids block the posterior nasal openings, further hindering sinus drainage, exacerbating inflammation, and leading to a prolonged and difficult-to-cure condition. For these children, conservative treatment with Western medicine is often ineffective, frequently requiring surgical intervention. However, surgery performed before the inflammation is controlled carries risks of significant intraoperative bleeding and a high postoperative recurrence rate.

[0006] Traditional Chinese medicine (TCM) has a long history and rich experience in treating rhinitis. However, current research mainly focuses on using TCM as an adjunct therapy in combination with Western medicine to achieve "enhanced efficacy and reduced toxicity." There is a lack of systematic development and validation of independent and effective formulas based on TCM theory for Rhinitis Respiratory Syndrome (RARS) and its complications (such as adenoid hypertrophy).

[0007] Therefore, there is an urgent need to develop a safe, effective, and well-defined traditional Chinese medicine compound that is suitable for adults as well as children, and can break the vicious cycle of sinusitis-adenoid hypertrophy, in order to meet the urgent clinical needs. Summary of the Invention

[0008] Although sinusitis in children is a modern medical term, its location is in the nasal passages, but its development is not limited to the nose. Traditional Chinese medicine believes that the spleen governs the transformation and transportation of fluids; if the spleen fails to function properly, phlegm and dampness will be generated internally, hence the saying "the spleen is the source of phlegm." The lungs govern the regulation of water passages; if the lungs fail to disperse and descend fluids, phlegm and turbidity will accumulate in the lungs, hence the saying "the lungs are the receptacle of phlegm." Spleen deficiency generates phlegm and dampness, which ascends to the lungs. Since the lungs open to the nose, phlegm and dampness affecting the nasal passages manifest as purulent nasal discharge, nasal congestion, and other symptoms, leading to sinusitis. Due to the physiological characteristic of children's "frequent spleen deficiency," coupled with irregular diets and a preference for raw and cold foods, exceeding the spleen's ability to transform and transport fluids, phlegm and dampness are generated internally. Furthermore, children's physiological characteristic of "frequent lung deficiency," with the lungs being a delicate organ easily affected by external pathogens, leads to phlegm from spleen deficiency ascending to the lungs, which over time transforms into heat. This phlegm and heat obstruct the nasal passages, resulting in sinusitis. Therefore, although childhood sinusitis manifests as nasal passage disorders, its root cause lies in spleen dysfunction and lung obstruction, while its manifestations include phlegm and dampness stagnation, which over time transforms into heat. It is a complex condition characterized by both deficiency and excess. The principle of regulating both the lung and spleen is based on this pathogenesis. A healthy spleen prevents dampness accumulation and phlegm production, while a clear lung ensures unobstructed passages and facilitates the elimination of pathogenic factors. Strengthening the spleen and eliminating dampness addresses the root cause, while clearing the lungs and unblocking the passages treats the manifestations. This approach, addressing both the root and the manifestations and regulating both the lung and spleen, aligns with the pathogenesis of childhood sinusitis.

[0009] The herbal composition of this invention is a compound formula formed on this theoretical basis. The inventors' research group adhered to the pathogenesis and formulated it using Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Glycyrrhiza uralensis (processed), Phragmites communis, Coix lacryma-jobi, and Benincasa hispida seeds. This is a self-developed empirical formula for the clinical treatment of pediatric sinusitis (chronic rhinitis). The treatment principle of this formula is: to strengthen the spleen and replenish qi, clear the lungs and resolve phlegm, promote diuresis and drain pus, and open the nasal passages. It is mainly used to treat spleen and lung qi deficiency, damp-heat accumulation in the lungs, and nasal congestion. The principal herbs are Codonopsis pilosula and Phragmites communis, which together strengthen the spleen and replenish qi to consolidate the root cause, and clear the lungs and drain pus to treat the symptoms. The assistant herbs are Atractylodes macrocephala, Poria cocos, and Coix lacryma-jobi, which together assist the principal herbs in strengthening the spleen, removing dampness, clearing the lungs and draining pus, thus strengthening the treatment of both the root cause and the symptoms. The adjuvant herb is Benincasa hispida seeds, which clear the lungs and resolve phlegm, promote diuresis and drain pus, and eliminate internal abscesses. The guiding herb is Glycyrrhiza uralensis (processed), which replenishes qi and strengthens the middle jiao, clears heat and detoxifies, and harmonizes the other herbs. This formula is characterized by its comprehensive approach, combining tonification and purgation, addressing both the root cause and symptoms, and balancing warming and cooling properties without harming the spleen and stomach. It strengthens the spleen and replenishes qi to address the root cause, while clearing the lungs, promoting diuresis, and draining pus to treat the symptoms. When the spleen is healthy, dampness cannot accumulate; when the lungs are clear, turbid fluids naturally descend; and when the nasal passages are unobstructed, purulent nasal discharge is eliminated. It is specifically designed for children with weak constitutions, recurrent sinusitis, spleen and lung deficiency, and damp-heat with phlegm. It is an excellent remedy for pediatric nasal diseases, supporting the body's resistance and eliminating pathogenic factors, treating both the root cause and symptoms. This product is derived from both food and medicine sources, ensuring high safety and no toxic side effects with long-term use.

[0010] Furthermore, regarding the above-mentioned medications for sinusitis, modern research indicates that this prescription has the following effects: 1. Immunomodulatory mechanism: Codonopsis pilosula inhibits excessive immune responses and reduces sinus mucosal inflammation by regulating the IL-18 signaling pathway; Coix lacryma-jobi contains components such as coixol, which can regulate the Th1 / Th2 balance and reduce allergic reactions. 2. Microcirculation improvement mechanism (PI3K-AKT signaling pathway): Atractylodes macrocephala can activate the PI3K-AKT signaling pathway and promote sinus mucosal repair. 3. Ion channel regulation mechanism (chloride ion channel): Poria cocos contains polysaccharides and triterpenoids, which can regulate chloride ion channel function and improve abnormal mucosal secretion; glycyrrhizic acid in Glycyrrhiza uralensis can stabilize cell membrane potential and regulate ion transport. 4. Anti-infection mechanism (ABC transporter pathway): Prepared Glycyrrhiza uralensis can enhance the function of ABC transporters and improve mucosal defense capabilities; Codonopsis pilosula can enhance phagocytic cell activity and improve local anti-infection capabilities. Reed rhizome, coix seed, and winter melon seed all have anti-inflammatory effects. Reed rhizome also has antimicrobial properties, while coix seed and winter melon seed reduce glandular secretion and promote mucus discharge. 5. Spleen-strengthening efficacy: Codonopsis pilosula and reed rhizome, combined, strengthen the spleen and replenish qi to consolidate the foundation, while clearing the lungs and draining pus to treat the symptoms; they are the principal herbs. The assistant herbs are Atractylodes macrocephala, Poria cocos, and coix seed, which assist the principal herbs in strengthening the spleen, removing dampness, clearing the lungs and draining pus, thus enhancing the treatment of both the root cause and symptoms. The adjuvant herb is winter melon seed, which clears the lungs, resolves phlegm, promotes diuresis, drains pus, and eliminates internal abscesses. The guiding herb is prepared licorice root, which replenishes qi, tonifies the middle jiao, clears heat and detoxifies, and harmonizes the other herbs. The entire formula works to strengthen the spleen, replenish qi, resolve dampness, and open the orifices, addressing the physiological characteristic of children's "frequent spleen deficiency," fundamentally improving the pathogenesis of recurrent sinusitis.

[0011] From the perspective of traditional Chinese medicine's organ theory, the lungs govern the skin and hair, and control the opening and closing of the pores. The nasal mucosa, as the epithelial barrier of the respiratory tract, has an intrinsic consistency with the function of "lung defense" in terms of the integrity of its tight junctions. Strengthening the spleen and resolving dampness can prevent phlegm from disturbing the upper body, allowing the lung qi to circulate freely, thereby indirectly maintaining the homeostasis of the nasal mucosal barrier. Modern research has found that this formula's drug combination can directly activate the Wnt / β-catenin pathway to repair the physical barrier. This may be one of the microscopic material bases for "lung and spleen harmonizing to strengthen the nasal passages," and its possible mechanism of action is as follows: The nasal epithelial barrier is the body's first line of defense against external pathogens and allergens, and its structural and functional integrity is crucial for maintaining sinus mucosal homeostasis. Recent studies have shown that epithelial barrier dysfunction is a core mechanism for the occurrence and persistence of CRS. The nasal epithelial barrier can be divided into three levels: physical barrier, chemical barrier, and immune barrier. The physical barrier is composed of tight junctions (TJs) and adhesion junctions (AJs), while the Wnt / β-catenin signaling pathway is the core hub regulating the integrity of the physical barrier. Specifically: (1) Physical barriers and tight junctions: Tight junctions include transmembrane proteins (Claudins, Occludin, JAMs) and scaffold proteins (ZO family). The expression of Claudin1, Occludin, ZO1 and other proteins is significantly downregulated in the nasal mucosa of CRS patients, indicating disruption of tight junctions, increased interepithelial spaces and increased permeability.

[0012] (2) Regulatory mechanism of the Wnt / β-catenin pathway: The activity of this pathway depends on the stability of β-catenin in the cytoplasm. In the resting state, the "disruption complex" (Axin / APC / GSK3β / CK1) continuously phosphorylates β-catenin, causing it to be degraded and the pathway to close. When Wnt signaling is activated, the disruption complex is inhibited, β-catenin accumulates in the cytoplasm and translocates into the nucleus, binds to TCF / LEF, and initiates the transcription of target genes such as ZO1, Occludin, and Claudin1, promoting barrier repair. CRS patients often show increased GSK3β activity, reduced β-catenin nuclear translocation, and downregulated ZO1 expression in the nasal mucosa, indicating that this pathway is in an inhibited state.

[0013] (3) Negative feedback inhibition of the Wnt pathway by inflammatory factors: Th2 inflammatory factors (TNFα, IL4, IL13) can activate GSK3β, promote the degradation of β-catenin, and further inhibit the activity of the Wnt pathway. This explains why, although anti-inflammatory treatment alone can reduce the inflammatory burden, if the Wnt pathway cannot be activated at the same time, barrier repair cannot be completed and the risk of relapse still exists.

[0014] Chemical and Immune Barriers: The chemical barrier consists of mucus, mucin, and cilia; CRS patients have impaired ciliary clearance function. Regarding the immune barrier, epithelial cells secrete cytokines such as TSLP, IL25, and IL33, which can activate Th2-type immune responses. These factors, along with Wnt pathway inhibition, mutually reinforce each other, creating a vicious cycle.

[0015] In summary, the Wnt / β-catenin pathway is a core molecular switch regulating the repair of the nasal mucosal epithelial barrier. Inhibition of this pathway in CRS states leads to decreased expression of tight junction proteins and barrier damage. Current treatments, centered on "anti-inflammatory / anti-allergic" therapies, can quickly suppress symptoms but fail to activate the Wnt pathway to repair the barrier, resulting in a high relapse rate after drug discontinuation. This invention proposes a novel strategy to fundamentally reduce the recurrence rate of childhood sinusitis by synergistically activating the Wnt / β-catenin pathway through a combination of Codonopsis pilosula, Atractylodes macrocephala, Poria cocos, Glycyrrhiza uralensis (processed), Phragmites communis, Coix lacryma-jobi, and Benincasa hispida. This approach upregulates tight junction proteins such as ZO1 and Occludin, thereby repairing the nasal mucosal barrier.

[0016] Furthermore, the "Traditional Chinese Medicine Practice Guidelines for Childhood Adenoid Hypertrophy" points out that sinusitis and adenoid hypertrophy in children often occur simultaneously, and the two influence each other, which is a key factor leading to the low clinical efficacy, high recurrence rate, and difficulty in curing this disease. Changing this vicious cycle of mutual influence is of significant clinical importance for the treatment and improvement of the prognosis of sinusitis with adenoid hypertrophy in children.

[0017] Inflammation of the sinuses leads to inflammatory hyperplasia of the adenoids, which is the basic pathological change in this disease. The adenoids are located in the nasopharynx; when they enlarge and hyperplastic, they occupy the drainage space of the posterior nasal apertures. There are many causes of adenoid hypertrophy. Repeated inflammation of adjacent organs such as the nasal cavity, sinuses, and tonsils causes the adenoids to swell and enlarge, obstructing the airway. If a child suffers from sinusitis, the long-term, repeated stimulation of the nasal cavity by inflammation can cause reactive pathological hyperplasia of the adenoids, which in turn obstructs nasal drainage, ultimately leading to a vicious cycle of "sinusitis—adenoid hypertrophy—sinusitis." Thus, sinusitis and adenoid hypertrophy often jointly obstruct the child's airway, causing snoring and hypoxia to be more severe in these children than in children with only one disease. It can even cause maxillofacial deformities, slow reactions, and growth retardation, significantly impacting the child's life, learning, and development. Therefore, developing effective drugs for childhood sinusitis is also an effective way to prevent the recurrence and even surgery of adult sinusitis, which can significantly reduce patient suffering and achieve good economic and social benefits.

[0018] In this condition, besides surgical removal, modern medicine currently lacks a definitively effective conservative treatment. Due to the deep anatomical location of the adenoids, local medications for sinusitis are difficult to reach them, and there are no definitively effective oral medications that directly target the adenoids. When a child has enlarged adenoids and significant sinus inflammation, sinusitis is usually treated first, with surgery considered after the inflammation is controlled. However, adenoid hypertrophy and sinus inflammation often interact, making conservative treatment unsatisfactory and often leading to surgery. Due to these treatment challenges, in recent years, the indications and age for adenoid removal surgery in children have gradually relaxed. Clinical observations show that adenoid surgery in children with sinus inflammation presents disadvantages such as increased intraoperative bleeding due to severe local inflammation and a tendency for postoperative adenoid hyperplasia; furthermore, parents are concerned about general anesthesia and surgical risks, making them reluctant to undergo surgery. Therefore, it is essential to explore a safe, effective treatment method that can reduce the surgical risks for adult patients! Traditional Chinese medicine (TCM) has advantages in treating this disease. The patient group has unique characteristics, and there is no specific corresponding disease name in TCM. Observing the key pathological changes in this disease from a Western medical perspective, the main features are "sinusitis-adenoid hypertrophy-sleep apnea-hypopnea," which aligns with the TCM concepts of "nasal congestion" and "snoring-induced sleep apnea." The inventor believes that the pathogenesis of this disease can be summarized as phlegm-heat accumulation in the lungs or phlegm-blood stasis obstructing the nasal passages. Although from a modern medical perspective, nasal inflammation and adenoid inflammatory hyperplasia are the key pathological changes in this disease, and eliminating tissue inflammation and swelling is an important aspect of treatment, one should not blindly use heat-clearing and detoxifying methods simply to "reduce inflammation." Under the guidance of TCM theory, there are various treatment methods for inflammatory diseases, such as dispelling wind, dispersing cold, clearing heat, removing dampness, and resolving phlegm, but the core principle remains syndrome differentiation and treatment.

[0019] This invention has conducted a series of clinical studies on sinusitis in children, as the mechanisms of sinusitis in children are far more complex and the treatment more difficult than that in adults. With the increasing number of pediatric sinusitis cases treated clinically, the inventors unexpectedly discovered that this formula also achieves certain therapeutic effects in the treatment of a special type of sinusitis in children with adenoid hypertrophy. The reason for this is that, in terms of pathogenesis, if sinusitis is recurrent and persistent, purulent nasal discharge accumulates in the nasopharynx, leading to adenoid hyperplasia or even hypertrophy. Therefore, controlling sinusitis can also effectively control adenoid hypertrophy, achieving the goal of relieving snoring without surgery.

[0020] Furthermore, the treatment period for sinusitis with adenoid hypertrophy is generally 1-3 months, and the course of treatment is usually quite long. This formula has a fixed dosage, few constituent drugs, and most of them are pungent and sweet in nature, making them palatable and easily accepted by patients. Moreover, most of the selected drugs are food-grade medicinal materials, with no toxic side effects, and do not harm the spleen and stomach, making them suitable for long-term use and also conducive to meeting the required course of treatment for adenoid hypertrophy.

[0021] In summary, this invention provides a traditional Chinese medicine composition for treating recurrent sinusitis and its application. The technical solution adopted is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating recurrent sinusitis, wherein the active ingredients of the traditional Chinese medicine composition are made from the following raw materials in parts by weight: Codonopsis pilosula 3-50 parts, Atractylodes macrocephala 5-50 parts, Poria cocos 5-50 parts, Glycyrrhiza uralensis (processed) 1-30 parts, Phragmites communis 2-40 parts, Coix lacryma-jobi 5-100 parts, and Benincasa hispida 2-100 parts.

[0022] Preferably, the raw materials are formulated in the following proportions by weight: Codonopsis pilosula 3-20 parts, Atractylodes macrocephala 6-25 parts, Poria cocos 7-30 parts, Glycyrrhiza uralensis (processed) 2-20 parts, Phragmites communis 5-20 parts, Coix lacryma-jobi 5-50 parts, and Benincasa hispida 5-48 parts.

[0023] More preferably, the raw materials are formulated in the following proportions by weight: Codonopsis pilosula 3-10 parts, Atractylodes macrocephala 7-12 parts, Poria cocos 8-15 parts, Glycyrrhiza uralensis (processed) 3-10 parts, Phragmites communis 8-15 parts, Coix lacryma-jobi 5-25 parts, and Benincasa hispida 8-25 parts.

[0024] More preferably, the raw materials are formulated in the following proportions by weight: Codonopsis pilosula 3-5 parts, Atractylodes macrocephala 8-10 parts, Poria cocos 10-12 parts, Glycyrrhiza uralensis (processed) 3-5 parts, Phragmites communis 8-10 parts, Coix lacryma-jobi 10-12 parts, and Benincasa hispida 10-12 parts.

[0025] Secondly, the present invention provides a traditional Chinese medicine composition for treating recurrent sinusitis with adenoid hypertrophy, the active ingredients of which are made from the following raw materials in parts by weight: Codonopsis pilosula 3-50 parts, Atractylodes macrocephala 5-50 parts, Poria cocos 5-50 parts, Glycyrrhiza uralensis (processed) 1-30 parts, Phragmites communis 2-40 parts, Coix lacryma-jobi 5-100 parts, Benincasa hispida 2-100 parts, Fritillaria thunbergii 5-20 parts, and Ligusticum chuanxiong 5-30 parts.

[0026] Preferably, the raw materials are formulated in the following proportions by weight: Codonopsis pilosula 3-20 parts, Atractylodes macrocephala 6-25 parts, Poria cocos 7-30 parts, Glycyrrhiza uralensis (processed) 2-20 parts, Phragmites communis 5-20 parts, Coix lacryma-jobi 5-50 parts, Benincasa hispida 5-48 parts, Fritillaria thunbergii 6-15 parts, and Ligusticum chuanxiong 6-20 parts.

[0027] More preferably, the raw materials are formulated in the following proportions by weight: Codonopsis pilosula 5-15 parts, Atractylodes macrocephala 7-12 parts, Poria cocos 8-15 parts, Glycyrrhiza uralensis (processed) 3-10 parts, Phragmites communis 8-15 parts, Coix lacryma-jobi 5-25 parts, Benincasa hispida 8-25 parts, Fritillaria thunbergii 6-10 parts, and Ligusticum chuanxiong 6-15 parts.

[0028] More preferably, the raw materials are formulated in the following proportions by weight: Codonopsis pilosula 11-13 parts, Atractylodes macrocephala 8-10 parts, Poria cocos 10-12 parts, Glycyrrhiza uralensis (processed) 3-5 parts, Phragmites communis 8-10 parts, Coix lacryma-jobi 10-12 parts, Benincasa hispida 10-12 parts, Fritillaria thunbergii 7-9 parts, and Ligusticum chuanxiong 7-9 parts.

[0029] Thirdly, the present invention provides a method for preparing a traditional Chinese medicine composition as described in the first or second aspect, comprising the following steps: mixing the raw materials according to the specified proportions, decocting and extracting with solvent, adding or not adding pharmaceutically acceptable excipients, and preparing a clinically acceptable formulation.

[0030] Optionally, the solvent includes, but is not limited to, water and / or ethanol; water is preferred.

[0031] Fourthly, the present invention provides the use of the traditional Chinese medicine composition described in the first aspect in the preparation of a medicament for treating recurrent sinusitis.

[0032] Optionally, the drug dosage form is a decoction, oral liquid, formulated granules, capsules, granules, tablets, or powder.

[0033] Preferably, the recurrent sinusitis is recurrent acute sinusitis.

[0034] Preferably, the drug is further used to improve at least one of the following symptoms or indicators: nasal inflammation, sleep quality, resting heart rate, heart rate variability, blood oxygen saturation, and serum inflammatory factor levels.

[0035] Fifthly, the present invention provides the use of the traditional Chinese medicine composition described in the second aspect in the preparation of a medicament for treating recurrent sinusitis with adenoid hypertrophy.

[0036] Preferably, the recurrent sinusitis is recurrent acute sinusitis with adenoid hypertrophy.

[0037] Preferably, the drug is further used to improve at least one of the following symptoms or indicators: nasal inflammation, sleep quality, resting heart rate, heart rate variability, blood oxygen saturation, and serum inflammatory factor levels.

[0038] Optionally, the drug dosage form is a decoction, oral liquid, formulated granules, capsules, granules, tablets, or powder.

[0039] In a sixth aspect, the present invention provides a medicine comprising the traditional Chinese medicine composition described in the first aspect or comprising the traditional Chinese medicine composition described in the second aspect.

[0040] Compared with the prior art, the present invention has the following beneficial effects: (1) The efficacy is definite and the overall effective rate is high: The traditional Chinese medicine composition of this invention is based on the principle of "regulating the lung and spleen and taking into account both deficiency and excess". Clinical trials have confirmed that its overall effective rate in treating recurrent sinusitis in children is 85.37%, which is significantly better than the 56.10% of the control group (mometasone furoate nasal spray) (P<0.05); in treating sinusitis in children with adenoid hypertrophy, the overall effective rate is 55.88%, which is significantly better than the 17.65% of the control group (eucalyptol) (P<0.05).

[0041] (2) Multidimensional improvement of clinical symptoms and signs: This invention can significantly reduce the Lund-Kennedy endoscopic score and VAS scores of nasal congestion, runny nose and headache in patients (P<0.05), and can effectively reduce the volume of adenoids and improve the degree of adenoid hypertrophy (P<0.05), showing the blocking effect on the vicious cycle of "sinusitis-adenoid hypertrophy".

[0042] (3) Improve cardiopulmonary function and sleep quality: Clinical data show that the present invention can significantly reduce patients' resting heart rate, increase heart rate variability (HRV-RMSSD) and blood oxygen saturation (SpO2) (P<0.05), and significantly reduce the total score of the Children's Sleep Habits Questionnaire (CSHQ) (P<0.05). It is confirmed from both objective indicators and subjective feelings that it can effectively improve patients' sleep breathing.

[0043] (4) Clear anti-inflammatory effect: This invention can significantly downregulate the levels of key inflammatory factors interleukin-6 (IL-6) and tumor necrosis factor-α (TNF-α) in the serum of patients, and reduce the eosinophil (EOS) count in nasal secretions (P<0.05), revealing its mechanism of treating recurrent sinusitis at the molecular level.

[0044] (5) High safety and compliance: The herbal composition of this invention is formulated with strict standards, and the selected medicinal materials are mostly food and medicine of the same origin, with mild medicinal properties. No abnormalities were observed in liver and kidney function or electrocardiogram during the clinical trial, and the adverse reactions were mild and self-limiting. At the same time, it can be prepared as a decoction-free granule, which is convenient to take and has an easy-to-accept taste, making it especially suitable for children who need long-term medication. Attached Figure Description

[0045] Figure 1 The nasal cavity and adenoid endoscopes are typical cases in Embodiment 4 of the present invention before treatment.

[0046] Figure 2 This is an endoscope of the nasal cavity and adenoids after treatment in a typical case in Embodiment 4 of the present invention.

[0047] Figure 3 The MOS score before treatment is shown in Example 4 of this invention.

[0048] Figure 4 The MOS score after treatment is shown in Example 4 of this invention for a typical case.

[0049] Figure 5 The images show nasal cavity and adenoid endoscopy before and after treatment in a typical case from Comparative Example 1 of this invention; where A and B correspond to before treatment; and C and D correspond to after treatment.

[0050] Figure 6 The images show nasal cavity and adenoid endoscopy before and after treatment in a typical case from Comparative Example 2 of this invention; where A and B correspond to before treatment; and C and D correspond to after treatment.

[0051] Figure 7 The images show nasal cavity and adenoid endoscopy before and after treatment in a typical case from Comparative Example 3 of this invention; where A and B correspond to before treatment; and C and D correspond to after treatment.

[0052] Figure 8 The images show nasal cavity and adenoid endoscopy before and after treatment in a typical case from Comparative Example 4 of this invention; where A and B correspond to before treatment; and C and D correspond to after treatment.

[0053] Figure 9 The images show nasal cavity and adenoid endoscopy before and after treatment in a typical case from Comparative Example 5 of this invention; where A and B correspond to before treatment; and C and D correspond to after treatment.

[0054] Figure 10 The images show nasal cavity and adenoid endoscopy before and after treatment in a typical case from Comparative Example 6 of this invention; where A and B correspond to before treatment; and C and D correspond to after treatment. Detailed Implementation

[0055] This invention provides a traditional Chinese medicine composition for treating recurrent sinusitis, specifically addressing this condition. The active ingredients of this composition are derived from the following raw materials in parts by weight: Codonopsis pilosula 3-50 parts, Atractylodes macrocephala 5-50 parts, Poria cocos 5-50 parts, Glycyrrhiza uralensis (processed) 1-30 parts, Phragmites communis 2-40 parts, Coix lacryma-jobi 5-100 parts, and Benincasa hispida 2-100 parts. This invention directly targets the core clinical challenge of reducing recurrence rates, focusing on repairing the nasal mucosal epithelial barrier, thus breaking through the previous approach of treating recurrence primarily through anti-inflammatory methods. The research findings will form a widely applicable treatment plan for pediatric sinusitis that addresses both the lung and spleen, directly benefiting children, reducing antibiotic use, and conserving medical resources. Simultaneously, by providing high-quality evidence-based support, it will promote the role of traditional Chinese medicine in the treatment of pediatric sinusitis from "adjunctive therapy" to "core therapy," filling the gap in current guidelines regarding the status of traditional Chinese medicine. Meanwhile, this invention closely integrates traditional Chinese medicine theory with clinical research to verify the causal chain of "strengthening the spleen, repairing the barrier, and reducing recurrence," providing a theoretical basis for barrier repair as a new target for the treatment of childhood sinusitis.

[0056] Preferably, the raw materials are formulated in the following proportions by weight: Codonopsis pilosula 3-20 parts, Atractylodes macrocephala 6-25 parts, Poria cocos 7-30 parts, Glycyrrhiza uralensis (processed) 2-20 parts, Phragmites communis 5-20 parts, Coix lacryma-jobi 5-50 parts, and Benincasa hispida 5-48 parts. This formula is suitable for both adults and children.

[0057] More preferably, the raw materials are formulated in the following proportions by weight: 3-10 parts Codonopsis pilosula, 7-12 parts Atractylodes macrocephala, 8-15 parts Poria cocos, 3-10 parts prepared Glycyrrhiza uralensis, 8-15 parts Phragmites communis, 5-25 parts Coix lacryma-jobi, and 8-25 parts Benincasa hispida. This formula is more suitable for children.

[0058] For recurrent sinusitis with adenoid hypertrophy, the raw materials of the traditional Chinese medicine composition in certain embodiments of the present invention further include: 5-20 parts of Fritillaria thunbergii and 5-30 parts of Ligusticum chuanxiong. Fritillaria thunbergii resolves phlegm and dissipates nodules, while Ligusticum chuanxiong invigorates blood and promotes qi circulation. The combination of these two ingredients enhances the effect of clearing the nasal passages and draining pus, and has a synergistic effect with the basic formula.

[0059] Preferably, the raw materials contain 6-15 parts of Fritillaria thunbergii and 6-20 parts of Ligusticum chuanxiong.

[0060] For recurrent sinusitis in children, the optimal compounding method of the traditional Chinese medicine composition raw materials of the present invention according to the following weight parts is as follows: Codonopsis pilosula 3-5 parts, Atractylodes macrocephala 8-10 parts, Poria cocos 10-12 parts, Glycyrrhiza uralensis (processed) 3-5 parts, Phragmites communis 8-10 parts, Coix lacryma-jobi 10-12 parts, and Benincasa hispida 10-12 parts. For children with recurrent sinusitis accompanied by adenoid hypertrophy, the raw materials according to the following weight parts include: Codonopsis pilosula 11-13 parts, Atractylodes macrocephala 8-10 parts, Poria cocos 10-12 parts, Glycyrrhiza uralensis (processed) 3-5 parts, Phragmites communis 8-10 parts, Coix lacryma-jobi 10-12 parts, Benincasa hispida 10-12 parts, Fritillaria thunbergii 7-9 parts, and Ligusticum chuanxiong 7-9 parts.

[0061] Currently, the two most commonly used clinical dosage forms of the above-mentioned traditional Chinese medicine composition are decoction and granules. The preparation method of decoction is as follows: According to the dosage ratio of the traditional Chinese medicine composition, add 100-1000ml of water, soak in water for 30 minutes, bring to a boil over high heat, then simmer over low heat for 12-15 minutes, and transfer the decoction to a container; add 100-1000ml of water a second time, bring to a boil over high heat, then simmer over low heat for 15-18 minutes, transfer the decoction to a container, mix with the first decoction, and divide into three equal portions for oral administration, three times a day, before meals.

[0062] The preparation method of granules is as follows: the above-mentioned medicinal materials are formulated and mixed according to the prescription. Then, each Chinese medicine ingredient is prepared into granules according to the national drug standard for granules. All the Chinese medicine granules are then mixed to obtain granules. Each bag contains the equivalent amount of raw medicinal materials for one dose.

[0063] The approval numbers for the national drug standards (formula granules) are as follows: Codonopsis pilosula (YBZ-PFKL-2021171), Atractylodes macrocephala (YBZ-PFKL-2021161), Poria cocos (YBZ-PFKL-2025008), Glycyrrhiza uralensis (YBZ-PFKL-2021049), Phragmites communis (SCYPBZ(PFKL)-2025001), Coix lacryma-jobi (YBZ-PFKL-2025024), and Benincasa hispida (JXYBZ-PFKL-2023002).

[0064] It should be noted that, unless otherwise specified in the examples, the conditions should be performed under standard conditions or conditions recommended by the manufacturer. Reagents or instruments whose manufacturers are not specified are all commercially available products.

[0065] The following examples, using the most preferred formulation of the traditional Chinese medicine composition of this invention, further illustrate the invention in detail. These examples are intended to explain the invention and not to limit it. Therefore, the following examples are merely illustrative and should not be construed as limiting the scope of protection of this invention. Furthermore, it should be noted that, unless otherwise stated, the technical or scientific terms used in this application should have the ordinary meaning understood by those skilled in the art.

[0066] Example 1:

[0067] This embodiment provides a traditional Chinese medicine composition for treating recurrent sinusitis. The raw materials of the traditional Chinese medicine composition are: Codonopsis pilosula 4g, Atractylodes macrocephala 9g, Poria cocos 11g, Glycyrrhiza uralensis (processed) 4g, Phragmites communis 9g, Coix lacryma-jobi 11g, and Benincasa hispida 11g.

[0068] The above-mentioned method for preparing granules yields granules that do not require decoction, with each bag containing the equivalent amount of raw medicinal material for one dose.

[0069] Example 2:

[0070] This embodiment provides a traditional Chinese medicine composition for treating recurrent sinusitis with adenoid hypertrophy. The raw materials of the traditional Chinese medicine composition are: Codonopsis pilosula 12g, Atractylodes macrocephala 9g, Poria cocos 11g, Glycyrrhiza uralensis (processed) 4g, Phragmites communis 9g, Coix lacryma-jobi 11g, Benincasa hispida 11g, Fritillaria thunbergii 8g, and Ligusticum chuanxiong 8g.

[0071] The above-mentioned method for preparing granules yields granules that do not require decoction, with each bag containing the equivalent amount of raw medicinal material for one dose.

[0072] Example 3:

[0073] This embodiment uses the herbal composition granules prepared according to Example 1 for a clinical trial of RARS in children, as detailed below: 2.1 Research Subjects Eighty-two children with RARS (Respiratory Respiratory Syndrome) who were treated at the outpatient and inpatient departments of Sichuan Provincial Hospital of Integrated Traditional Chinese and Western Medicine from May 2023 to May 2025 were included in this study. They were randomly divided into an observation group (traditional Chinese medicine group) and a control group (mometasone furoate nasal spray group), with 41 cases in each group. There were no statistically significant differences in baseline data between the two groups (P>0.05), as shown in Table 1. This study was approved by the Ethics Committee of Sichuan Provincial Hospital of Integrated Traditional Chinese and Western Medicine.

[0074] Table 1. Baseline data statistics for the two groups of children. 2.2 Diagnostic criteria Western medicine diagnosis refers to the "European Guidelines for the Diagnosis and Treatment of Rhinosinusitis and Nasal Polyps (EPOS2022)" and the "Chinese Expert Consensus on the Diagnosis and Treatment of Rhinosinusitis in Children (2021)": ≥4 episodes of acute sinusitis within 12 months, with each episode lasting <12 weeks, and complete symptom relief during the interictal period; core symptoms: nasal congestion / obstruction or a feeling of fullness in the nose, green or purulent nasal discharge, decreased / loss of smell, facial pain or headache; at least 2 of these symptoms must be present.

[0075] The TCM diagnostic criteria refer to the "Spleen Deficiency with Dampness and Heat Attacking the Nasal Cavities" syndrome in the "Classification and Code of Diseases and Syndromes in Traditional Chinese Medicine" issued by the State Administration of Traditional Chinese Medicine. The main symptoms are nasal congestion, yellow or thick white nasal discharge, which may be accompanied by swelling and pain in the forehead or root of the nose; secondary symptoms are snoring and nighttime cough; the tongue is red or reddish, with a thin yellow or greasy coating, and the pulse is slippery and rapid. The diagnosis requires at least one of the main symptoms and any secondary symptoms, and must conform to the characteristics of the tongue and pulse.

[0076] 2.3 Inclusion Criteria (1) Meets the above diagnostic criteria of Western medicine and traditional Chinese medicine; (2) Children aged 3-14 years; (3) Guardians sign informed consent forms and voluntarily join the research process; (4) The children and their parents have high compliance and cooperate with the treatment.

[0077] 2.4 Exclusion Criteria (1) The child is allergic to the research drug; (2) Other related treatments have been performed within 1 week; (3) Other diseases of the nose or adjacent organs; (4) The wristband data is incomplete; (5) There is a history of nasal surgery; (6) Severe asthma requiring long-term oral hormones, cardiopulmonary insufficiency or liver and kidney damage.

[0078] 2.5 Elimination Criteria (1) The inclusion / exclusion criteria are not met after enrollment; (2) Poor compliance: <80% of the prescribed dose or ≥4 missed doses / course; (3) Unauthorized nasal hormones, antibiotics or other traditional Chinese medicine preparations are added during the course; (4) Serious adverse events occur and medication needs to be discontinued or the observation needs to be withdrawn; (5) Key follow-up data are missing (>20% of indicators cannot be evaluated) or the student withdraws from the study.

[0079] 2.6 Treatment methods Basic treatment: Both groups of children received nasal irrigation with 0.9% saline at 37℃, once in the morning and once in the evening, 200mL / nasal cavity. They were advised to avoid cold air stimulation and highly allergenic foods, and to ensure adequate sleep and physical activity.

[0080] Observation group: The herbal formula granules of this invention were taken orally, one dose per day, dissolved in 150mL of warm water, divided into three doses in the morning, noon and evening, for a course of 14 days; Control group: Mometasone furoate nasal spray, 50µg / spray, one spray per side, once in the morning and once in the evening; if necessary, acetaminophen can be taken orally for fever reduction.

[0081] 2.7 Observation Indicators It covers Lund-Kennedy score, VAS score, resting heart rate, HRV-RMSSD, SpO2, CSHQ score, IL-6, TNF-α, EOS, etc.

[0082] 2.7.1 Lund-Kennedy rating Before treatment, at 14 days of treatment, and at 30 days of follow-up, two ENT specialists independently and blindly assessed secretions and mucosal edema under 0° electronic nasal endoscopy. Secretions were categorized as: none (0 points), clear and thin (1 point), viscous or purulent (2 points); edema was categorized as: none (0 points), mild (1 point), severe (2 points). The scores for each nasal cavity were added together to obtain a total score (0–8 points), with higher scores indicating more severe mucosal lesions.

[0083] 2.7.2 Symptom Visual Analogue Scale (VAS) A 10cm line segment scale was used to have children indicate the subjective severity of nasal congestion, runny nose, and headache; 0cm represented no symptoms, and 10cm represented the most severe symptoms. Researchers took readings down to 0.1cm.

[0084] 2.7.3 Basic cardiopulmonary function indicators Resting heart rate (HR) was the average of 5 minutes and 1 minute in a seated position after waking up in the morning. Heart rate variability was expressed as RMSSD and calculated from 5-minute standardized ECG segments. Blood oxygen saturation (SpO2) was measured using a finger pulse oximeter. All tests were performed in a quiet environment at a constant temperature of 24°C.

[0085] 2.7.4 Children's Sleep Habits Questionnaire (CSHQ) Parents fill out the Chinese version of the CSHQ, with a total score of 0–99. The higher the score, the more sleep problems there are; Cronbach's α > 0.80.

[0086] 2.7.5 Inflammatory markers 3 mL of fasting venous blood was collected in the morning, and serum IL-6 and TNF-α were detected by ELISA. Nasal secretions were stained with Wright-Giemsa and eosinophils were counted under high magnification (EOS, cells / HPF). Ten fields of view were randomly selected from each smear and the mean value was taken.

[0087] 2.7.6 Efficacy Assessment The overall reduction in Lund-Kennedy combined with VAS at 14 days of treatment was calculated as follows: Clinically cured: reduction in both nasal congestion and VAS <1cm; Markedly effective: 70%–<90%; Effective: 30%–<70%; Ineffective: <30% or worsening of symptoms. Overall effective rate = (Clinically cured + Markedly effective + Effective) ÷ Total number of cases × 100%.

[0088] 2.7.7 Security Assessment Complete blood count, liver and kidney function, electrolytes, and electrocardiogram were measured at baseline, 14 days, and 30 days after treatment.

[0089] 2.8 Statistics and Methods Data analysis was performed using SPSS 26.0 software. Normally distributed continuous data were described using (Mean ± SD) and normality tests were conducted. tIf the data does not conform to a normal distribution, the Mann-Whitney U test should be used; for count data expressed as frequency (percentage), Fisher's exact test or X-ray test should be used. 2 test. P <0.05 indicates a statistically significant difference.

[0090] 2.9 Results 2.9.1 Comparison of treatment effects between the two groups of children The total effective rate in the observation group was 85.37% (35 / 41), which was higher than that in the control group (56.10% (23 / 41), and the difference was statistically significant (P<0.05), as shown in Table 2.

[0091] Table 2 Comparison of treatment efficacy between the two groups of children (number of cases, %) Note: # P To compare with the control group, P <0.05.

[0092] 2.9.2 Comparison of Lund-Kennedy scores and VAS scores for symptoms between the two groups of children After 14 days of treatment, the Lund-Kennedy scores and VAS scores for various symptoms in both groups decreased from baseline (P<0.05); the scores in the observation group were lower than those in the control group (P<0.05), as shown in Table 3.

[0093] Table 3 Comparison of Lund-Kennedy scores and VAS scores for symptoms between the two groups of children [( ),point] Note: *P indicates within-group comparison, P<0.05; #P indicates comparison with the control group, P<0.05.

[0094] 2.9.3 Comparison of baseline cardiopulmonary function between the two groups of children After 14 days of treatment, both groups showed a decrease in heart rate (HR) and an increase in HRV-RMSSD and SpO2 (P<0.05). The observation group had a lower HR and higher HRV-RMSSD and SpO2 than the control group, with statistically significant differences (P<0.05), as shown in Table 4.

[0095] Table 4 Comparison of basic cardiopulmonary function in children ( ) Note:* P For comparison within the group before and after, P <0.05; #P To compare with the control group, P <0.05.

[0096] 2.9.4 Comparison of CSHQ scores between the two groups of children After 14 days of treatment, the CSHQ scores in both groups decreased compared to baseline. P The value of the test result was <0.05, and the value of the test result in the observation group was lower than that in the control group, with a statistically significant difference. P <0.05), see Table 5.

[0097] Table 5 Comparison of CSHQ scores among children [( ),point] Note:* P For comparison within the group before and after, P <0.05; # P To compare with the control group, P <0.05.

[0098] 2.9.5 Comparison of inflammatory markers between the two groups of children After 14 days of treatment, IL-6, TNF-α, and EOS levels decreased in both groups compared to baseline. P <0.05, and the above indicators in the observation group were all lower than those in the control group, with statistically significant differences. P <0.05). See Table 6.

[0099] Table 6 Comparison of inflammatory markers among the groups of children ( ) Note:* P For comparison within the group before and after, P <0.05; # P To compare with the control group, P <0.05.

[0100] 2.9.6 Security Assessment During treatment, all 82 children underwent liver and kidney function tests, complete blood counts, electrolyte tests, and electrocardiogram monitoring. All indicators remained within the normal reference range, and there were no statistically significant differences within or between groups (P>0.10). No cases showed ALT or Cr levels exceeding 1.5 × ULN, nor were QTc prolongation, ventricular arrhythmias, or other ECG abnormalities observed. In the control group, 3 cases (7.32%) experienced mild adverse reactions, including transient nasal dryness (2 cases) and mild gastrointestinal discomfort (1 case); in the observation group, 2 cases (4.88%) experienced mild adverse reactions, manifested as a bitter taste (1 case) and transient drowsiness (1 case). All adverse reactions were WHO-UMC Class I (mild) and resolved spontaneously without special treatment. The incidence of adverse reactions was compared between the two groups. 2 =0.213, P=0.322. No cases of dosing interruption, serious adverse events, or deaths were reported during the study, and no drug-related hepatotoxicity, nephrotoxicity, or allergic reactions were observed.

[0101] The clinical trial results of Example 3 showed that the observation group (orally administered the herbal formula granules of this invention) was significantly more effective than the control group (mometasone furoate nasal spray) in treating recurrent sinusitis in children. The total effective rate in the observation group was 85.37%, which was higher than 56.10% in the control group, and the difference was statistically significant (P<0.05). In terms of Lund-Kennedy scores and VAS scores for nasal congestion, rhinorrhea, and headache, both groups showed significant reductions from baseline after treatment, and the observation group's scores were significantly lower than the control group's (P<0.05). The observation group also showed better improvement in basic cardiopulmonary function indicators (reduced resting heart rate, increased HRV-RMSSD, and increased blood oxygen saturation) than the control group (P<0.05). Simultaneously, the observation group showed more significant improvement in CSHQ sleep scores, and the decreases in serum IL-6, TNF-α, and nasal secretion EOS counts were greater than those in the control group (P<0.05). Safety assessment showed that no serious adverse events occurred in either group, and the adverse reactions were mild with no statistically significant difference in incidence, indicating that the traditional Chinese medicine composition is safe and effective in treating recurrent sinusitis in children.

[0102] Example 4 This embodiment further utilizes the herbal composition granules prepared according to Example 2 for a clinical efficacy and outcome observation study of sinusitis with adenoid hypertrophy in children, as detailed below: 3.1 Research Subjects We selected 68 children aged 3-14 years with sinusitis and adenoid hypertrophy admitted to our department from December 2022 to May 2024 and collected their general clinical data, including age, gender, course of disease, treatment plan, TCM clinical symptoms, nasal endoscopy, endoscopic adenoid hypertrophy grading, MOS score, and prognosis.

[0103] 3.2 Inclusion and Exclusion Criteria Inclusion criteria: (1) Meeting the relevant criteria in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine - Standards for Diagnosis of Otorhinolaryngology in Traditional Chinese Medicine" and "Clinical Practice Guidelines for the Diagnosis and Treatment of Acute Infectious Rhinitis and Sinusitis in Children", and also meeting the definition criteria in the "Traditional Chinese Medicine Practice Guidelines for Adenoid Hypertrophy in Children"; (2) Children aged 3-14 years (including 3 and 14 years); (3) Informed consent signed by the guardian, voluntarily joining the study process, and the child and parents have high compliance and cooperate with the treatment; (4) The study subjects have the following main symptoms: snoring, mouth breathing, nasal congestion, and turbid nasal discharge; with or without secondary symptoms: cough, ear fullness, headache or nasal and facial pain, postnasal drip, and decreased sense of smell; (5) Nasal endoscopy shows mucopurulent secretions in the middle nasal meatus, common nasal meatus, posterior nasal cavity or nasopharynx, and adenoid hypertrophy; (6) Previously healthy, with no history of mental and neurological diseases, normal physical examinations, healthy systems, and no obvious physical and mental symptoms such as pain or depression within one week before the experiment.

[0104] Exclusion criteria: (1) Other related treatments have been received within 1 week; (2) Guardians of children who cannot understand or sign the informed consent form for the trial; (3) Patients with other diseases of the nose or adjacent organs, such as bronchial asthma / nasal polyps / allergic rhinitis / tonsillitis; (4) Patients with a history of nasal surgery; (5) Patients with serious cardiovascular and cerebrovascular diseases; patients with liver, kidney, or blood system diseases or malignant tumors; patients with mental illness, diabetes, or bleeding tendencies; (8) Female children during menstruation.

[0105] 3.3 Treatment methods (1) Experimental group: Chinese medicine composition granules without decoction: Codonopsis pilosula 12g, Atractylodes macrocephala 9g, Poria cocos 11g, Glycyrrhiza uralensis 4g, Phragmites communis 9g, Coix lacryma-jobi 11g, Benincasa hispida 11g, Fritillaria thunbergii 8g, Ligusticum chuanxiong 8g (the method for preparing granules without decoction is described in Example 1). 150ml of boiling water was dissolved in the solution and taken orally, one dose per day, divided into three doses.

[0106] (2) Control group: Eucalyptus and Limonene enteric-coated soft capsules, the dosage per kilogram of body weight was calculated according to the instructions (10-35kg: 1 capsule / time, 2 times / day, 35kg and above: 1 capsule / time, 3-4 times / day), 3 times / day, taken with cool boiled water half an hour before meals (Note: Do not take with hot water, do not open / chew before taking).

[0107] 3.4 Observation Indicators (1) Compare the TCM syndrome scores and VAS scores of the two groups before and after treatment. The TCM syndrome score scale mainly collected the following symptoms: snoring, mouth breathing, nasal congestion, and nasal discharge. It was divided into four levels: asymptomatic (0 points), mild (2 points), moderate (4 points), and severe (6 points). The changes in scores before and after treatment and the improvement rate of scores were observed in both groups (=[score before treatment - score after treatment) ÷ score before treatment] × 100%). The VAS symptom score mainly collected the following symptoms: snoring, mouth breathing, nasal congestion, and nasal discharge. Mild: VAS score of 0-3 points; moderate: VAS score of 3-7 points; severe: VAS score of 7-10 points. The changes in scores before and after treatment were observed in both groups.

[0108] (2) Compare the nasal endoscopy scores before and after treatment in the two groups. Scoring criteria: clear and thin nasal discharge (1 point), thick and purulent nasal discharge (2 points), no nasal discharge (0 points); no edema (0 points), mild edema (1 point), severe edema (2 points).

[0109] (3) Compare the grading of adenoid hypertrophy under nasal endoscopy before and after treatment in the two groups. According to Cassano et al. (Cassano P, Gelardi M, Cassano M, et al. Adenoid tissue rhinopharyngeal obstructiongrading based on fiberendoscopic findings: a novel approach to therapeutic management[J]. Int J Pediatr Otorhinolaryngol,2003,67(12):1303-1309.), adenoids are classified into four grades under fiber endoscopic nasal endoscopy: Grade I, almost no adenoid tissue in the nasopharynx, or adenoid tissue hyperplasia, about 1 / 4 of the nasopharyngeal cavity is blocked, and the posterior nasal cavity is not blocked; Grade II, adenoid tissue hyperplasia, about 1 / 2 of the nasopharyngeal cavity is blocked; Grade III, about 3 / 4 of the nasopharyngeal cavity is blocked, and the posterior nasal cavity and the Eustachian tube opening are blocked; Grade IV, the nasopharynx is basically completely blocked, including the lower edge of the posterior nasal cavity and the Eustachian tube opening.

[0110] (4) Compare the pulse oxygenation test results before and after treatment in the two groups: MOS score, with reference to the recommendations of the "Guidelines for the Diagnosis and Treatment of Obstructive Sleep Apnea in Chinese Children (2020)" (see Table 7).

[0111] Table 7 MOS Scoring Criteria 3.5 Evaluation of therapeutic effect (1) Outcome indicators: The overall clinical effective rate was calculated as (cured + improved) / total number of patients × 100%. Cure: After 14 days of medication, clinical symptoms and signs disappeared or basically disappeared, and the improvement rate of TCM syndrome score was ≥95%. Significant effect: After 14 days of medication, clinical symptoms and signs significantly improved, with 90% > score improvement rate ≥70%. Effective: After 14 days of medication, clinical symptoms and signs improved, with 70% > score improvement rate ≥30%. Ineffective: After 14 days of medication, clinical symptoms and signs showed no significant change, or even worsened, with a score improvement rate <30%.

[0112] (2) Recurrence rate: Recurrence and aggravation: Follow-up for two months, the TCM syndrome score was followed up. If the score increased by more than 30% compared with the score after treatment, or more than 90% of the score before treatment, it was defined as recurrence and aggravation. The recurrence and aggravation of sinusitis with adenoid hypertrophy in the treatment group and the control group were statistically compared.

[0113] 3.6 Statistical Analysis Data were processed using SPSS 26.0 statistical software. Quantitative data were analyzed using... To indicate, perform a t-test or ANOVA; count data are expressed as % and expressed using the X-ray discrepancy (XPS). 2 Test. P < 0.05 is considered statistically significant.

[0114] 3.7 Results 3.7.1 Comparison of clinical efficacy and relapse / exacerbation rates The total effective rate in the experimental group was 55.88%, significantly higher than that in the control group (17.65%), with a statistically significant difference (P<0.05). The relapse and exacerbation rate in the experimental group was lower than that in the control group, with a statistically significant difference (P<0.05), as shown in Table 8.

[0115] Table 8 Comparison of Clinical Efficacy Note: "*" indicates a statistically significant difference compared to the control group (P<0.05). 3.7.2 Comparison of TCM symptom scores before and after treatment The TCM syndrome scores of the two groups of patients before and after treatment showed statistically significant differences (P < 0.05). After treatment, the TCM syndrome scores of the experimental group were lower than those of the control group, and the difference was statistically significant (P < 0.05), as shown in Table 9.

[0116] Table 9 Comparison of TCM syndrome scores Note: "*" indicates a statistically significant difference compared to the control group (P<0.05). "a" indicates a statistically significant difference compared to before treatment (P<0.05).

[0117] 3.7.3 Comparison of VAS scores before and after treatment The VAS scores of the two groups before and after treatment were significantly different (P < 0.05). After treatment, the VAS score of the experimental group was lower than that of the control group, and the difference was statistically significant (P < 0.05), as shown in Table 10.

[0118] Table 10 Comparison of VAS scores Note: "*" indicates a statistically significant difference compared to the control group (P<0.05). "a" indicates a statistically significant difference compared to before treatment (P<0.05).

[0119] 3.7.4 Comparison of adenoid grading before and after treatment (endoscopically) Comparison of endoscopic adenoid grading before and after treatment in the two groups showed a statistically significant difference in the experimental group (P < 0.05) and no statistically significant difference in the control group (p > 0.05). After treatment, the adenoid grading in the treatment group was lower than that in the control group, and the difference was statistically significant (P < 0.05), as shown in Table 11, typical case adenoids.

[0120] Table 11 Comparison of Adenoid Grading Note: "*" indicates a statistically significant difference compared to the control group (P<0.05). "a" indicates a statistically significant difference compared to before treatment (P<0.05).

[0121] 3.7.5 Comparison of MOS scores before and after treatment (based on blood oxygen monitoring) The differences in MOS scores of blood oxygen monitoring before and after treatment between the two groups were statistically significant (P < 0.05). After treatment, the MOS score of the experimental group was lower than that of the control group, and the difference was statistically significant (P < 0.05), as shown in Table 12.

[0122] Table 12 Comparison of MOS scores for blood oxygen monitoring Note: "*" indicates a statistically significant difference compared to the control group (P<0.05). "a" indicates a statistically significant difference compared to before treatment (P<0.05).

[0123] In summary, the clinical trial in Example 4, which involved a randomized controlled observation of 68 children, showed that the experimental group (Chinese herbal medicine granules) was significantly better than the control group (eucalyptus and limonene) in terms of overall efficacy, symptom improvement, adenoid shrinkage, and blood oxygenation.

[0124] Example 5 Typical clinical cases: Typical case: Li, male, 5 years old, with recurrent nasal congestion and purulent nasal discharge.+ The patient experienced a relapse and worsening of symptoms for 3 days. Based on TCM clinical symptoms, nasal endoscopy, endoscopic adenoid hypertrophy grading, and MOS score, the diagnosis was pediatric sinusitis with adenoid hypertrophy. Treatment was administered using the same formula as the no-decoction granules used in Example 4 (Formula 2), one dose daily, dissolved in 150ml of boiling water, divided into three administrations, for 14 consecutive days. The treatment outcome was significant efficacy (evaluation criteria same as Example 4). Figure 1 For the treatment of anterior nasal cavity and adenoid endoscopic procedures, Figure 2 For the treatment of posterior nasal cavity and adenoid endoscopic procedures, Figure 3 The MOS score before treatment. Figure 4 The MOS score after treatment was used to assess that the no-decoction granules used in the experimental group of Example 4 significantly improved symptoms, and there was no recurrence during the 1-year follow-up.

[0125] The present invention further collected the following cases for comparative investigation, as detailed below: Comparative Example 1 This comparative example provides a traditional Chinese medicine composition for treating recurrent sinusitis, which differs from Example 1 in that the key component "Poria cocos" is removed, and the dosage of Poria cocos is shared proportionally by the other six herbs.

[0126] Raw material composition: Codonopsis pilosula 4.9 parts, Atractylodes macrocephala 11.1 parts, Glycyrrhiza uralensis (processed) 4.9 parts, Phragmites communis rhizome 11.1 parts, Coix lacryma-jobi 13.5 parts, Benincasa hispida seed 13.5 parts. Preparation method: Refer to the granule preparation method in Example 1.

[0127] The traditional Chinese medicine composition of Comparative Example 1 was used in a clinical case. Patient: Wang, male, 6 years old. Chief complaint: Recurrent nasal congestion and yellow purulent nasal discharge for 2 years, with recurrence and worsening for 4 days. Endoscopic examination of the nose (e.g.) Figure 5 Based on the results of the Chinese Medicine (A and B) assessment, Lund-Kennedy score, VAS score, and TCM syndrome differentiation (spleen and lung qi deficiency, damp-heat accumulation in the lungs), the diagnosis was recurrent sinusitis. Before treatment, the Lund-Kennedy score was 6.5, nasal congestion VAS score was 7.2, rhinorrhea VAS score was 6.8, and serum IL-69.8 pg / mL. -1 .

[0128] The Chinese medicine composition of Comparative Example 1 was administered as a non-decoction granule, one dose per day, dissolved in boiling water at a concentration of 150 mL, divided into three doses, for 14 consecutive days.

[0129] Follow-up examination 14 days after treatment: Lund-Kennedy score 5.8 (decrease of 10.8%), nasal congestion VAS 4.5, rhinorrhea VAS 4.2, IL 68.1 pg / mL -1 Nasal endoscopy showed little improvement in symptoms (e.g.) Figure 5In cases C and D), the efficacy was deemed ineffective (total VAS reduction <30%). Compared to the complete formula in Example 1 (containing Poria), the latter, under the same conditions, saw its Lund-Kennedy score decrease from 6.41±1.19 to 4.65±1.16 (a decrease of 27.5%), with a significant decrease in VAS score. This suggests that Poria plays a core role in the formula by strengthening the spleen and eliminating dampness, regulating chloride ion channels, and improving nasal mucosal secretion. Without it, the ability to eliminate dampness and drain pus is sharply reduced, resulting in significantly poor efficacy.

[0130] Comparative Example 2 This comparative example provides a traditional Chinese medicine composition for treating recurrent sinusitis, which differs from Example 1 in that the principal herb "reed rhizome" is removed, and the dosage of reed rhizome is distributed proportionally among the other six herbs.

[0131] Raw material composition: Codonopsis pilosula 4.7 parts, Atractylodes macrocephala 10.6 parts, Poria cocos 13 parts, Glycyrrhiza uralensis (processed) 4.7 parts, Coix lacryma-jobi 13 parts, Benincasa hispida seed 13 parts. Preparation method: Refer to the granule preparation method in Example 1.

[0132] The traditional Chinese medicine composition of Comparative Example 2 was used in a clinical case. Patient: Ms. Li, 7 years old. Chief complaint: Recurrent nasal congestion, headache, and purulent nasal discharge for 1.5 years, occurring 5-6 times per year. Nasal endoscopy revealed a large amount of mucopurulent discharge in the middle nasal meatus (such as... Figure 6 (A and B), Lund-Kennedy score 7.0, headache VAS 6.5, nasal congestion VAS 7.5, serum IL-6 10.2 pg / mL -1 According to Traditional Chinese Medicine (TCM), this is diagnosed as damp-heat syndrome in the lung meridian.

[0133] The Chinese medicine composition of Comparative Example 2 was administered as a non-decoction granule, one dose per day, dissolved in 150mL of boiling water and taken in three divided doses, for 14 consecutive days.

[0134] After treatment: Lund-Kennedy score 6.2 (decrease of 11.4%), headache VAS 4.8 (decrease of 26.2%), nasal congestion VAS 5.6 (decrease of 25.3%), IL 68.9 pg / mL. -1 Nasal endoscopy showed little improvement in symptoms (e.g.) Figure 6(C and D). According to the efficacy evaluation criteria of Example 3 (a total reduction of <30% in Lund-Kennedy combined with VAS after 14 days of treatment is considered ineffective), the reduction in all indicators in this case did not reach 30%, and the reduction in Lund-Kennedy score was only 11.4%, so it was judged to be ineffective overall. Compared with Example 1, in Example 1, the headache VAS decreased from 5.85±1.86 to 1.20±0.60 (a reduction of 79.5%), and the nasal congestion VAS decreased from 6.95±1.23 to 2.11±0.46 (a reduction of 69.6%). In this comparative case, the absence of reed rhizome resulted in the loss of heat-clearing, pus-draining, and anti-pathogenic microorganism effects, uncleared lung heat, and difficulty in clearing purulent nasal discharge, leading to poor efficacy.

[0135] Comparative Example 3 This comparative example provides a traditional Chinese medicine composition for treating recurrent sinusitis, which differs from Example 1 in that "Coix seed" is omitted, and the dosage of Coix seed is shared proportionally by the other six ingredients.

[0136] Raw material composition: Codonopsis pilosula 4.9 parts, Atractylodes macrocephala 11.1 parts, Poria cocos 13.5 parts, Glycyrrhiza uralensis (processed) 4.9 parts, Phragmites communis 11.1 parts, Benincasa hispida seed 13.5 parts. Preparation method: Refer to the granule preparation method in Example 1.

[0137] The traditional Chinese medicine composition of Comparative Example 3 was used in a clinical case. Patient: Zhang, male, 5 years old. Chief complaint: Recurrent thick purulent nasal discharge and nocturnal cough for 2 years, worsening for 5 days. Physical examination: Nasal mucosa congestion and swelling, large amount of yellowish-green secretions in the nasal cavity (such as... Figure 7 (A and B in the middle). Lund-Kennedy score 6.8, runny nose VAS 7.0, cough VAS 5.5, serum TNF-α 2 2.5 pg·mL -1 .

[0138] The traditional Chinese medicine composition of Comparative Example 3 was administered as a non-decoction granule, one dose per day, dissolved in 150mL of boiling water and taken in three divided doses, for 14 consecutive days.

[0139] Post-treatment: Lund-Kennedy score 5.9 (reduction of 13.2%), rhinorrhea VAS 5.1 (reduction of 27.1%), cough VAS 4.0 (reduction of 27.3%), TNFα 19.1 pg / mL -1 Nasal endoscopy showed little improvement in symptoms (e.g.) Figure 7(C and D). According to the efficacy evaluation criteria of Example 3 (a total reduction of LundKennedy combined with VAS of <30% after 14 days of treatment is considered ineffective), the reductions in all categories in this case were less than 30%, with LundKennedy showing a reduction of only 13.2%, thus it was deemed ineffective. Compared with Example 1, after treatment in Example 1, TNFα decreased from 21.22±3.66 to 13.71±3.19 (a reduction of 35.4%), and VAS for rhinorrhea decreased from 6.59±1.02 to 2.21±0.16 (a reduction of 66.5%). In this comparative case, the absence of Coix seed resulted in decreased lung-clearing and pus-draining abilities and a decreased ability to regulate the Th1 / Th2 balance; the clearance of inflammatory factors and secretions was significantly inferior to that in Example 1.

[0140] Comparative Example 4 This comparative example provides a traditional Chinese medicine composition for treating recurrent sinusitis, which differs from Example 1 in that "winter melon seeds" are replaced with "pus-draining platycodon" which has similar pus-draining effects.

[0141] Raw material composition: Codonopsis pilosula 4 parts, Atractylodes macrocephala 9 parts, Poria cocos 11 parts, Glycyrrhiza uralensis (processed) 4 parts, Phragmites communis 9 parts, Coix lacryma-jobi 11 parts, Platycodon grandiflorus 11 parts. Preparation method: Refer to the granule preparation method in Example 1.

[0142] The traditional Chinese medicine composition of Comparative Example 4 was used in a clinical case. Patient: Liu, female, 8 years old. Chief complaint: Nasal congestion, headache, and decreased sense of smell for 1 year, which has worsened in the past 3 months. Nasal endoscopy revealed mucopurulent nasal discharge and grade I adenoid hypertrophy (e.g., ...). Figure 8 (A and B in the middle). Lund-Kennedy score 6.2, nasal congestion VAS 6.8, headache VAS 5.2, IL-69.2 pg·mL -1 .

[0143] The traditional Chinese medicine composition of Comparative Example 4 was administered as a non-decoction granule, one dose per day, dissolved in 150mL of boiling water and taken in three divided doses, for 14 consecutive days.

[0144] Post-treatment: Lund-Kennedy score 5.4 (decrease of 12.9%), nasal congestion VAS score 4.9 (decrease of 27.9%), headache VAS score 3.8 (decrease of 26.9%), IL 68.0 pg / mL. -1 Nasal endoscopy showed little improvement in symptoms (e.g.) Figure 8(C and D). According to the efficacy evaluation criteria of Example 3 (a total reduction of <30% in LundKennedy combined with VAS after 14 days of treatment is considered ineffective), the reduction in all categories in this case did not reach 30%, and the reduction in LundKennedy was only 12.9%, thus it was judged as ineffective. Compared with Example 1, in Example 1, the VAS of rhinorrhea decreased from 6.59±1.02 to 2.21±0.16 (a reduction of 66.5%), and IL6 decreased from 9.49±1.42 to 5.08±1.50 (a reduction of 46.5%). Winter melon seeds are good at promoting diuresis and draining pus, and eliminating internal abscesses, while Platycodon grandiflorus is more focused on clearing the lungs and eliminating phlegm but has no diuretic effect. After the replacement, the dampness was not eliminated and the phlegm was difficult to eliminate, and the efficacy was significantly worse than that of Example 1.

[0145] Comparative Example 5 This comparative example provides a typical traditional Chinese medicine formula commonly used in the prior art to treat sinusitis, in order to contrast its superiority with that of this case.

[0146] Composition of raw materials (modified from commonly used formulas in "Traditional Chinese Medicine Otorhinolaryngology"): Magnolia biondii 6 parts, Xanthium sibiricum 6 parts, Angelica dahurica 6 parts, Scutellaria baicalensis 9 parts, Gardenia jasminoides 6 parts, Houttuynia cordata 15 parts, Platycodon grandiflorus 6 parts, Mentha haplocalyx 6 parts, Glycyrrhiza uralensis 3 parts. Preparation method: Refer to the granule preparation method in Example 1.

[0147] The traditional Chinese medicine composition of Comparative Example 5 was used in a clinical case. Patient: Chen, male, 6 years old. Chief complaint: snoring, mouth breathing, nasal congestion, and purulent nasal discharge for 1 year, worsening for 2 weeks. Diagnosed as recurrent sinusitis (wind-heat invading the nose syndrome) (e.g. Figure 9 (A and B in the middle). Lund-Kennedy score 6.6, nasal congestion VAS 7.1, runny nose VAS 6.5, CSHQ total score 53.

[0148] The Chinese medicine composition of Comparative Example 5 was administered as a non-decoction granule, one dose per day, dissolved in 150mL of boiling water and taken in three divided doses, for 14 consecutive days.

[0149] Post-treatment: Lund-Kennedy score 5.7 (decrease of 13.6%), nasal congestion VAS 4.6 (decrease of 35.2%), rhinorrhea VAS 4.4 (decrease of 32.3%), CSHQ total score 49 (decrease of 7.5%). Nasal endoscopy showed minimal symptom improvement (e.g., Figure 9(C and D). According to the efficacy evaluation criteria of Example 3 (a total reduction of <30% in LundKennedy combined with VAS after 14 days of treatment is considered ineffective), although the VAS reduction for nasal congestion and rhinorrhea slightly exceeded 30% in this case, the LundKennedy score reduction was only 13.6%, and the improvement in endoscopic mucosal lesions was not significant, so it was judged as ineffective overall. Compared with Example 1, Example 1 had a total effective rate of 85.37% and could significantly reduce the total CSHQ score (from 52.06±6.66 to 43.20±5.48, a reduction of 17.0%). Although this comparative example can relieve nasal congestion and rhinorrhea in the short term, it lacks the core effect of "strengthening the spleen and replenishing qi, and repairing the nasal mucosal barrier" (failing to activate the Wnt / βcatenin pathway), and is prone to relapse after drug withdrawal, with poor total effective rate and sleep improvement.

[0150] Comparative Example 6 This comparative example directly adopts the formulation of Example 1 in the prior art document (CN119157931A) to demonstrate the essential difference and technical advantages of the key components (Poria cocos, Phragmites communis, Coix lacryma-jobi, and Benincasa hispida) in this case compared with the formulation in that document.

[0151] Composition of the active pharmaceutical ingredient (referring to Example 1 of CN119157931A): Codonopsis pilosula 7.5 parts, Astragalus membranaceus (processed) 7.5 parts, Atractylodes macrocephala (processed) 7.5 parts, Ligustrum lucidum 7.5 parts, Magnolia biondii 6 parts, Xanthium sibiricum (processed) 6 parts, Angelica dahurica 6 parts, Ligusticum chuanxiong (processed with wine) 6 parts, Platycodon grandiflorus 4.5 parts, Cinnamomum cassia 4.5 parts, Saposhnikovia divaricata 4.5 parts, Glycyrrhiza uralensis (processed) 3 parts, Asarum heterotropoides 1.5 parts. Preparation method: Prepared by decoction, concentration, and one-step granulation as described in the comparative document.

[0152] The traditional Chinese medicine composition of Comparative Example 6 was used in a clinical case. Patient: Zhao, male, 7 years old. Chief complaint: Recurrent sinusitis for 3 years, accompanied by grade II adenoid hypertrophy (e.g. Figure 10 (A and B) snoring and mouth breathing were obvious. Lund-Kennedy score 6.9, nasal congestion VAS 7.4, adenoid grade 2.5, MOS score 2.8, serum IL-6 10.5 pg / mL -1 .

[0153] The traditional Chinese medicine composition of Comparative Example 6 was given, and the traditional Chinese medicine composition granules were prepared according to the patented method. One dose was taken daily, 150 mL of boiling water was dissolved in water and taken in 3 divided doses, for 14 consecutive days.

[0154] Post-treatment: Lund-Kennedy score 6.1 (reduction of 11.6%), nasal congestion VAS score 5.8 (reduction of 21.6%), adenoid grade 2.3 (reduction of 8.0%), MOS score 2.5 (reduction of 10.7%), IL 69.1 pg / mL. -1 (A decrease of 13.3%), nasal endoscopy showed little improvement in symptoms (e.g.) Figure 10(C and D). According to the efficacy evaluation criteria of Example 3 (a total reduction of <30% in Lund Kennedy combined with VAS after 14 days of treatment is considered ineffective), the reduction of all indicators in this case was far below 30%, and the overall evaluation was ineffective. Compared with Example 1 and Example 4 (with the addition of Fritillaria thunbergii and Ligusticum chuanxiong), the total effective rate of Example 4 reached 55.88%, the adenoid grade decreased from 2.65±1.01 to 1.44±1.42 (a reduction of 45.7%), and the MOS score decreased from 2.24±1.07 to 1.50±0.93 (a reduction of 33.0%). The formula of Comparative Example 6 focuses on tonifying qi and consolidating the exterior, and dispersing and opening the orifices, but lacks the core "dampness-draining and pus-repairing, barrier-repairing" drug combination of Poria cocos, Phragmites communis, Coix lacryma-jobi, and Benincasa hispida. It is significantly inferior to the present invention in improving adenoid hypertrophy, reducing inflammatory factors, and improving blood oxygenation.

[0155] In summary, the research results indicate that the traditional Chinese medicine composition of this invention can effectively improve the clinical symptoms of recurrent sinusitis and even sinusitis with adenoid hypertrophy in children, reduce the recurrence rate, and has a certain effect on shrinking the adenoids and improving sleep ventilation. This formula clears the lungs and resolves phlegm, dispels blood stasis and disperses nodules, which can improve the treatment outcome of sinusitis with adenoid hypertrophy in children and promote the recovery of the disease. This formula can be taken for a long period, and the granule form improves the medication compliance of children. Therefore, this invention provides an alternative treatment for recurrent sinusitis and sinusitis with adenoid hypertrophy, and is worthy of further research and clinical application.

[0156] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A traditional Chinese medicine composition for treating recurrent sinusitis, characterized in that, The active ingredients of the traditional Chinese medicine composition are made from the following raw materials in parts by weight: Codonopsis pilosula 3-50 parts, Atractylodes macrocephala 5-50 parts, Poria cocos 5-50 parts, Glycyrrhiza uralensis (processed) 1-30 parts, Phragmites communis 2-40 parts, Coix lacryma-jobi 5-100 parts, and Benincasa hispida 2-100 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The raw materials are formulated in the following proportions by weight: Codonopsis pilosula 3-20 parts, Atractylodes macrocephala 6-25 parts, Poria cocos 7-30 parts, Glycyrrhiza uralensis (processed) 2-20 parts, Phragmites communis 5-20 parts, Coix lacryma-jobi 5-50 parts, and Benincasa hispida 5-48 parts.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The raw materials are formulated in the following proportions by weight: Codonopsis pilosula 3-10 parts, Atractylodes macrocephala 7-12 parts, Poria cocos 8-15 parts, Glycyrrhiza uralensis (processed) 3-10 parts, Phragmites communis 8-15 parts, Coix lacryma-jobi 5-25 parts, and Benincasa hispida 8-25 parts.

4. A traditional Chinese medicine composition for treating recurrent sinusitis with adenoid hypertrophy, characterized in that, Its active ingredients are made from the following raw materials in parts by weight: Codonopsis pilosula 3-50 parts, Atractylodes macrocephala 5-50 parts, Poria cocos 5-50 parts, Glycyrrhiza uralensis (processed) 1-30 parts, Phragmites communis 2-40 parts, Coix lacryma-jobi 5-100 parts, Benincasa hispida 2-100 parts, Fritillaria thunbergii 5-20 parts, and Ligusticum chuanxiong 5-30 parts.

5. The traditional Chinese medicine composition according to claim 4, characterized in that, The raw materials are formulated in the following proportions by weight: Codonopsis pilosula 3-20 parts, Atractylodes macrocephala 6-25 parts, Poria cocos 7-30 parts, Glycyrrhiza uralensis (processed) 2-20 parts, Phragmites communis 5-20 parts, Coix lacryma-jobi 5-50 parts, Benincasa hispida 5-48 parts, Fritillaria thunbergii 6-15 parts, and Ligusticum chuanxiong 6-20 parts.

6. The traditional Chinese medicine composition according to claim 5, characterized in that, The raw materials are formulated in the following proportions by weight: Codonopsis pilosula 5-15 parts, Atractylodes macrocephala 7-12 parts, Poria cocos 8-15 parts, Glycyrrhiza uralensis (processed) 3-10 parts, Phragmites communis 8-15 parts, Coix lacryma-jobi 5-25 parts, Benincasa hispida 8-25 parts, Fritillaria thunbergii 6-10 parts, and Ligusticum chuanxiong 6-15 parts.

7. A method for preparing a traditional Chinese medicine composition as described in any one of claims 1 to 6, characterized in that, The process includes the following steps: mixing the active pharmaceutical ingredient according to the specified ratio, adding solvent for decoction and extraction, adding or not adding pharmaceutically acceptable excipients, and preparing a clinically acceptable formulation.

8. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicament for treating recurrent sinusitis.

9. The use of the traditional Chinese medicine composition according to any one of claims 4 to 6 in the preparation of a medicament for treating recurrent sinusitis with adenoid hypertrophy.

10. A medicament comprising the traditional Chinese medicine composition according to any one of claims 4-6, for treating recurrent sinusitis; or comprising the traditional Chinese medicine composition according to claim 4 or 5, for treating recurrent sinusitis with adenoid hypertrophy.

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