Traditional Chinese medicine composition for treating adenoid hypertrophy and preparation method thereof

Abstract

The invention relates to the field of traditional Chinese medicines, and provides a traditional Chinese medicine composition for treating adenoid hypertrophy and a preparation method thereof, the traditional Chinese medicine composition comprises the following raw materials: 40-60g of pogostemon cablin, 40-60g of thunberg fritillary bulb, 40-60g of coix seed, 80-120g of calcined oyster shell, 40-60g of loofah sponge, 40-60g of platycodon grandiflorum and 24-36g of liquorice. Or pericarpium citri reticulatae, fructus xanthii or herba eupatorii and radix paeoniae rubra can be further added according to needs to replace liquorice, the whole formula has the effects of inducing resuscitation with fragrance, tonifying the spleen, eliminating dampness, reducing phlegm and resolving masses, and the good curative effect on adenoid hypertrophy is achieved.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of traditional Chinese medicine, in particular to a traditional Chinese medicine composition for treating adenoid hypertrophy in children and a preparation method thereof. BACKGROUND

[0002] Adenoid hypertrophy (AH) is one of the common diseases in pediatrics, which is mainly seen in children aged 2-12 years. It refers to the pathological hyperplasia and hypertrophy of adenoid due to repeated inflammatory stimulation, and a series of symptoms caused by it [1] . AH mainly manifests as snoring during sleep, mouth breathing, nasal congestion, and in severe cases, sleep apnea, leading to obstructive sleep apnea syndrome in children, and long-term hypoxia can cause poor mental state, learning difficulties, and slow growth and development in children, resulting in "adenoid face". Studies have shown that the prevalence of AH in children and adolescents is about 46.42%, and the incidence is on the rise [2] .

[0003] Current western medicine treatments include oral leukotriene receptor antagonists, nasal corticosteroids, and adenoidectomy. Clinically, AH children often have chronic tonsillitis, sinusitis and other diseases, which are difficult to cure and have a high incidence of complications, so surgical treatment has become the preferred treatment [1] . However, the incidence of complications of adenoidectomy is as high as 2-10% [3] , of which bleeding is the most common, and there are also sore throat, ear pain, fever, dehydration, etc. [4] In addition, the problems of recurrence and secondary surgery cannot be ignored. Two to five years after adenoidectomy in children, 26% of patients have nasal airway obstruction symptoms [5] , 19.1% of children have adenoid tissue regeneration after adenoidectomy [6] , and 9% of patients need to undergo adenoidectomy again due to symptoms recurrence after an average interval of 16 months [7] . Based on the concern about surgical trauma and disease recurrence, parents tend to conservative treatment. In recent years, traditional Chinese medicine treatment has been increasingly applied in pediatrics, and its small side effects, non-invasive advantages have attracted much attention. Studies have shown that traditional Chinese medicine has advantages in relieving symptoms, reducing enlarged adenoids, improving quality of life, and partially replacing surgery, and has good safety [8] . Therefore, it is of great practical significance and medical value to find and develop a compound preparation from traditional Chinese medicine that is convenient to use, safe and effective, and can significantly improve the clinical symptoms of children and reduce the size of enlarged adenoids. However, there are some defects in the treatment of adenoid hypertrophy with traditional Chinese medicine, such as weak phlegm-dissolving and knot-dissolving, insufficient dampness-eliminating and spleen-strengthening, and neglecting to open the orifice and unblock the collaterals. SUMMARY

[0004] The present application aims at the deficiency of prior art, and provides a traditional Chinese medicine composition for treating adenoid hypertrophy in children and a preparation method thereof.

[0005] In view of the defects of weak phlegm-dissolving and knot-dissolving, insufficient dampness-removing and spleen-strengthening, and neglecting opening orifice and dredging collaterals in treating adenoid hypertrophy in children by traditional Chinese medicine, the present application provides a traditional Chinese medicine composition with aromatic opening orifice, effective phlegm-dissolving and knot-dissolving, and dampness-removing and spleen-strengthening, so as to shorten the treatment course, improve the curative effect, and ensure the safety of the medicine.

[0006] The present application provides a traditional Chinese medicine composition for treating adenoid hypertrophy in children, characterized in that the raw medicine mainly comprises: 40-60g of pachystachys juttah, 40-60g of fritillaria thunbergii, 40-60g of coicis semen, 80-120g of calcined oyster shell, 40-60g of luffa, and 40-60g of platycodon.

[0007] Glycyrrhiza uralensis is often added in traditional Chinese medicine compound as a harmonizing medicine, and the above traditional Chinese medicine composition raw medicine can further comprise: 24-36g of Glycyrrhiza uralensis to harmonize the medicines.

[0008] The present application provides a traditional Chinese medicine composition for treating adenoid hypertrophy in children, characterized in that the raw medicine mainly comprises: 40-60g of pachystachys juttah, 40-60g of fritillaria thunbergii, 40-60g of coicis semen, 80-120g of calcined oyster shell, 40-60g of luffa, and 40-60g of platycodon.

[0009] The pathogenesis theory of "deficiency of vital energy and stagnation of qi" believes that due to deficiency of primordial qi and disharmony of qi and blood, the running of qi and blood and body fluid is not smooth, and the stagnation of blood and phlegm is formed in the body. In terms of adenoid hypertrophy in children, the core pathogenesis can be attributed to deficiency of lung, spleen and kidney qi, and the dysfunction of qi transformation, and the phlegm and dampness are not transformed into normal state, and stagnate in nasopharynx, and the phlegm and blood stasis are combined for a long time, and the adenoid tissue hyperplasia is difficult to eliminate, and the "deficiency of vital energy and stagnation of qi" is combined. Based on the theory of "deficiency of vital energy and stagnation of qi", the inventors advocate the combination of tonifying deficiency and promoting qi and removing stagnation to treat adenoid hypertrophy in children. The inventors believe that the adenoid hypertrophy in children is a syndrome of deficiency in the root and excess in the branch, and the deficiency of vital energy is responsible for lung, spleen and kidney, and the excess is responsible for phlegm, dampness and blood stasis, and the external evil invasion is the inducing factor and aggravating factor. Children are often deficient in lung, spleen and kidney, and the external evil is easy to invade due to the deficiency of lung and the dysfunction of spleen and kidney. The phlegm and dampness are easy to be generated due to the deficiency of spleen, and the blood stasis is difficult to be transformed due to the deficiency of kidney. The deficiency of lung, spleen and kidney is superimposed, and the clear yang fails to ascend and the turbid yin fails to descend, and the qi movement is not smooth, and the pivot is not beneficial, and the phlegm, dampness and blood stasis stagnate in nasopharynx, and are combined in the adenoid, so that the adenoid hypertrophy is caused. Based on the understanding of the adenoid hypertrophy in children with "deficiency of vital energy as the root and stagnation of qi as the branch", the inventors combine years of clinical experience, and take "tonifying deficiency and removing stagnation and regulating qi movement" as the basic therapeutic principle to treat the adenoid hypertrophy. The aromatic Chinese medicine is yang, and the qi is easy to reach the head, eyes, muscles and skin, so the aromatic nature of Chinese medicine is used to regulate the running of qi and blood in the treatment of the disease, so as to regulate the lung, spleen and kidney, and treat the phlegm, dampness and blood stasis.

[0010] Based on the above TCM theory and years of clinical practice, the Chinese medicine composition of the application, also known as Xiangbei Yili Formula, is obtained. In the formula, pachouli is used for aroma and opening the orifices, and waking up the spleen and transforming turbid, and promoting qi movement. Zhebeimu is used for clearing heat and transforming phlegm, and softening and resolving, and opening and promoting lung qi. The two are used as monarchs, and are used for regulating the upper and middle Jiaojiao, and directly aiming at the core pathogenesis of "phlegm and blood stasis aggregation" of adenoid hypertrophy. Yiyiren is sweet and bland, and can invigorate the spleen and transport, and prevent the generation of dampness, and can also penetrate and drain water and dampness, so that phlegm and turbidity are excreted through urine. Muli is cold and salty, and is good at softening phlegm and resolving, and is a softening and astringent agent. The two are used as ministers, and can drain dampness and resolve, and remove stagnation and open the orifices. With the addition of siliquae, blood circulation and collateral are activated, and phlegm is resolved. Jiegeng is used for promoting lung and benefiting throat, and is a boat and rudder agent, and carries the medicine upward, so that the medicinal effect reaches the disease site. Gancao is used for regulating all medicines. The whole formula can open the orifices, invigorate the spleen and eliminate dampness, and resolve phlegm and resolve, so as to achieve the purpose of treating the root and branch.

[0011] The Chinese medicine composition of the application has the effects of aroma and opening the orifices, invigorating the spleen and eliminating dampness, and resolving phlegm and resolving. It is mainly used for treating adenoid hypertrophy in children, and the symptoms are nasal obstruction, snoring during sleep, mouth breathing, and mental fatigue, poor appetite, inattention and other symptoms caused by adenoid hypertrophy.

[0012] In order to further strengthen the phlegm and consolidate the knot, the spleen and open the orifice, the application can further add Perilla frutescens, Xanthium sibiricum, i.e. the application is used for treating the adenoid hypertrophy, and the raw material medicine can further comprise: Perilla frutescens 40-60g, Xanthium sibiricum 40-60g.

[0013] In order to further strengthen the aromatic turbidity and promote the blood circulation, the application can further add Perilla frutescens and Red Peony Root, i.e. the application is used for treating the adenoid hypertrophy, and the raw material medicine can further comprise: Perilla frutescens 40-60g, Red Peony Root 40-60g.

[0014] The application further provides a traditional Chinese medicine preparation, which is characterized by being prepared from the aforementioned traditional Chinese medicine composition.

[0015] The preparation method of the traditional Chinese medicine preparation is characterized by comprising the following steps: soaking and decocting the traditional Chinese medicine raw materials together for 2-3 times, 1-2 hours each time, combining the decoction, filtering, concentrating the filtrate, and preparing a decoction, an oral liquid, a granule, a tablet or a capsule.

[0016] The application further provides the use of the aforementioned traditional Chinese medicine composition in the preparation of a medicine for treating the adenoid hypertrophy of children.

[0017] The medicine of the application is administered orally, and after being absorbed through the digestive tract, the effective components of the medicine can be distributed in the whole body and play a role through multiple targets. The main action mechanisms include: directly acting on the lesion, the medicine components of Zhejiang Fritillaria, calcined oyster shell and Platycodon grandiflorum can directly act on the hyperplastic lymphoid tissue of the nasopharynx, play the roles of anti-inflammation, anti-hyperplasia and promoting tissue shrinkage; regulating the whole body and local immunity, Pogostemonis Herba, Coicis Semen and Licorice can regulate the whole body immune function of the body and regulate the local immune microenvironment of the nasopharynx, reduce the excessive immune response, reduce the release of inflammatory factors such as IL-6 and TNF-α, so as to control the pathological hyperplasia of the adenoid.

[0018] The previous clinical observation shows that the prescription can not only obviously improve the discomfort symptoms such as nasal congestion and snoring of the children with adenoid hypertrophy, but also obviously reduce the volume of the adenoid of part of the children with adenoid hypertrophy.

[0019] The pharmacological research shows that the multiple medicinal materials in the prescription have definite anti-inflammatory, anti-allergic and immune-regulating effects. For example, the alkaloids of Zhejiang fritillary bulb have anti-inflammatory, relieving cough and expectorant effects; the oil of adlay seed can resist allergy and regulate immunity; and the broadleaf palsticworts can enhance the non-specific immune function of the body. The prescription is an optimized combination selected under the guidance of the TCM theory and in combination with the modern pharmacological research, and has definite synergistic effect and targets the core of pathogenesis. DETAILED DESCRIPTION

[0020] The technical solutions in the embodiments of the present application will be clearly and completely described below. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all the other embodiments obtained by those skilled in the art without creative work fall within the protection scope of the present application.

[0021] Embodiment 1 The Chinese medicinal material components are as follows: broadleaf palsticworts 50g, Zhejiang fritillary bulb 50g, adlay seed 50g, calcined oyster shell 100g, silk gourd retinervus 50g, platycodon 50g and licorice 30g.

[0022] The preparation method is as follows: all the Chinese medicinal materials are soaked and decocted with water for 2 times, 1 hour each time, the decoction liquid is combined, filtered, and the filtrate is concentrated to an appropriate amount to obtain the decoction.

[0023] Embodiment 2 The Chinese medicinal material components are as follows: broadleaf palsticworts 50g, Zhejiang fritillary bulb 50g, adlay seed 50g, calcined oyster shell 100g, silk gourd retinervus 50g, platycodon 50g and licorice 30g.

[0024] The preparation method is as follows: all the Chinese medicinal materials are soaked and decocted with water for 2 times, 1.5 hours each time, the decoction liquid is combined, filtered, and the filtrate is concentrated to an appropriate amount, and then appropriate flavoring agents and preservatives are added to prepare the oral liquid.

[0025] Embodiment 3 The Chinese medicinal material components are as follows: broadleaf palsticworts 60g, Zhejiang fritillary bulb 60g, adlay seed 80g, calcined oyster shell 80g, silk gourd retinervus 40g, platycodon 40g and licorice 24g.

[0026] The preparation method is as follows: all the Chinese medicinal materials are soaked and decocted with water for 3 times, 1 hour each time, the decoction liquid is combined, filtered, and the filtrate is concentrated to an appropriate amount to obtain the decoction.

[0027] Embodiment 4 The traditional Chinese medicine raw materials comprise: 50g of pachouli, 50g of Zhejiang fritillary bulb, 50g of coix seed, 100g of calcined oyster shell, 50g of luffa, 50g of platycodon, 50g of dried tangerine or orange peel, and 50g of xanthium sibiricum.

[0028] The preparation method comprises the following steps: soaking and decocting all the traditional Chinese medicine raw materials with water for 2 times, 2 hours each time, combining the decoction, filtering, concentrating the filtrate into thick paste with a density of 1.30-1.35 (60 DEG C), adding appropriate amount of lactose, granulating, and preparing into tablets according to the tablet preparation process.

[0029] Example 5 The traditional Chinese medicine raw materials comprise: 50g of pachouli, 50g of Zhejiang fritillary bulb, 50g of coix seed, 100g of calcined oyster shell, 50g of luffa, 50g of platycodon, 50g of pellitory, and 50g of red peony root.

[0030] The preparation method comprises the following steps: soaking and decocting all the traditional Chinese medicine raw materials with water for 3 times, 1 hour each time, combining the decoction, filtering, concentrating the filtrate into thick paste with a density of 1.30-1.35 (60 DEG C), adding appropriate amount of starch, granulating, drying, and preparing into capsules according to the capsule preparation process.

[0031] Example 6 The traditional Chinese medicine raw materials comprise: 50g of pachouli, 50g of Zhejiang fritillary bulb, 50g of coix seed, 100g of calcined oyster shell, 50g of luffa, 50g of platycodon, and 30g of liquorice.

[0032] The preparation method comprises the following steps: soaking and decocting all the traditional Chinese medicine raw materials with water for 2 times, 1.5 hours each time, combining the decoction, filtering, concentrating the filtrate into thick paste with a density of 1.30-1.35 (60 DEG C), adding appropriate amount of dextrin, granulating, drying, and dispensing to obtain granules.

[0033] Clinical effect experiment According to the literature report, the total effective rate of mometasone furoate nasal spray combined with montelukast sodium in improving the symptom score of children with moderate adenoid hypertrophy is 68.15% [9,10] . To verify the effect of the application, the team carried out a prospective, non-randomized controlled clinical study, and the results showed that the total effective rate of Xiangbeiyili prescription in treating children with moderate to severe adenoid hypertrophy reached 73.3%. The specific research scheme and results are as follows: 1. Overall design of the study To evaluate the effectiveness and safety of Xiangbe Yili Fang in improving the clinical symptoms of snoring, mouth breathing, nasal congestion, and reducing the volume of adenoid in children with AH. Cases from the First Affiliated Hospital of Yunnan University of Chinese Medicine who met the diagnostic criteria for severe AH in Practical Pediatrics of Zhu Futang (9th edition) (2022), Clinical Practice Guideline for Adenoid Hypertrophy in Children (2024), and Research Progress on Assessment and Classification of Adenoid Hypertrophy in Children were selected. They were divided into control and treatment groups according to the treatment wishes of parents and children. The control group was treated with mometasone furoate nasal spray combined with montelukast sodium chewable tablets, and the treatment group was treated with Xiangbe Yili Fang. Four weeks was a course of treatment, and both groups were treated for three courses. The improvement of clinical symptom scores, changes in adenoid volume, and adverse reactions were observed before and after treatment to evaluate the effectiveness and safety of Xiangbe Yili Fang in improving the clinical symptoms and reducing the volume of adenoid in children with severe AH.

[0034] 2. Test population Cases aged 3-12 years old from the First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Province Hospital of Traditional Chinese Medicine) who met the diagnostic criteria for severe AH in Practical Pediatrics of Zhu Futang (9th edition) (2022), Clinical Practice Guideline for Adenoid Hypertrophy in Children (2024), and Research Progress on Assessment and Classification of Adenoid Hypertrophy in Children.

[0035] (1) Diagnostic criteria The diagnostic criteria for severe AH in children were developed based on Practical Pediatrics of Zhu Futang (9th edition) (2022), Clinical Practice Guideline for Adenoid Hypertrophy in Children (2024), and Research Progress on Assessment and Classification of Adenoid Hypertrophy in Children: ① Clinical manifestations: Main manifestations include loud snoring during sleep, mouth breathing, nasal congestion, and various ear, nose, throat, or lower respiratory symptoms such as ear congestion, nasal congestion, rhinorrhea, throat discomfort, throat clearing, repeated coughing, and systemic symptoms such as poor concentration, memory loss, learning difficulties, hyperactivity, anxiety, depression, sleepiness, and slow growth and development.

[0036] ② Auxiliary examination: X-ray nasopharyngeal lateral film (A / N value grading method): A / N≤0.60 is normal, 0.61-0.70 is mild hypertrophy, 0.71-0.80 is moderate hypertrophy, and 0.80 or more is severe hypertrophy.

[0037] (2) Inclusion criteria ① Meet the diagnostic criteria for severe AH in children and are unwilling to undergo surgical treatment; ② Age 3-12 years old, gender not limited; ③Informed consent process is in line with the provisions of the legal guardian or with the participating children (> 8 years old) jointly signed informed consent.

[0038] 1.3 Exclusion criteria (1) who have received adenoidectomy; (2) who have severe deviation of nasal septum, nasal polyps, nasal mass, laryngeal and tracheal diseases, etc. causing respiratory distress; (3) who have suffered from acute upper and lower respiratory tract infection within the past 2 weeks; (4) who have metabolic or immunodeficiency diseases, and severe dysfunction of important organs such as heart, liver, kidney, brain, etc.; (5) who have used corticosteroids, antibiotics or immunomodulatory drugs within the past 4 weeks; (6) who are allergic to the test drugs; (7) who have surgical indications such as recurrent acute otitis media or secretory otitis media, severe sleep apnea syndrome, cardiopulmonary complications, etc.; (8) who, in the judgment of the researchers, have other diseases or conditions that reduce the likelihood of enrollment or complicate enrollment, such as unstable living environment, inconvenient transportation, etc. which may cause loss of follow-up.

[0039] 3. Sample size and grouping method This study is an exploratory study, with two groups of 15 cases each. According to the order of treatment and the parents' treatment wishes, they are divided into two groups.

[0040] 4. Intervention program (1) Test drug name and specification ① Test drug: Xiangbe Yuli Decoction prepared according to Example 1, provided by the Traditional Chinese Medicine Pharmacy of Yunnan Province Traditional Chinese Medicine Hospital.

[0041] ② Control drug: According to the principle of recognized effectiveness, safety and comparability, mometasone furoate nasal spray combined with montelukast sodium chewable tablets is chosen as the control drug.

[0042] Mometasone furoate nasal spray: Trade name: Nishuna; Manufacturer: Merck & Co.; Approval number: GMP H20140100; Specification: 60 clicks per bottle, each click contains 50 ug of mometasone furoate, the drug concentration is 0.05% (g / g).

[0043] Mometasone furoate nasal spray: Trade name: Nishuna; Manufacturer: Merck & Co.; Approval number: GMP H20140100; Specification: 60 clicks per bottle, each click contains 50 ug of mometasone furoate, the drug concentration is 0.05% (g / g).

[0044] (2) Method of taking medicine The treatment group was given Xiangbe Yuli Decoction orally, and the control group was given mometasone furoate nasal spray combined with montelukast sodium chewable tablets orally.

[0045] ① Xiangbeiyili Decoction: 76 g per dose, water decoction, 2 / 3 of the dose for children aged 3-6 years, and the full dose for children aged 7-12 years.

[0046] ② Mometasone furoate nasal spray: 1 click (50 ug per click, total 100 ug) per nostril for children aged 3-12 years, 1 time per day, in the morning; montelukast sodium chewable tablets: 4 mg per time for children aged 3-6 years, 5 mg per time for children aged 7-12 years, 1 time per day, taken orally before sleep.

[0047] (3) Course setting According to the inventor's experience in clinical use of traditional Chinese medicine and the relevant clinical research reports of western medicine, the treatment of traditional Chinese medicine in this study is set as 4 weeks as a course, and 3 courses (12 weeks in total) of continuous treatment.

[0048] 5. Efficacy evaluation (1) Improvement criteria for clinical symptoms ① Main clinical symptom score: Refer to the "Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine (Trial)", "Otolaryngology of Traditional Chinese Medicine" edited by Liu Peng, and "2014 Expert Consensus on Diagnosis and Treatment of Children's Adenoid Hypertrophy Induced Sleep Disordered Breathing" to formulate the main efficacy indicators, which are snoring, mouth breathing, and nasal congestion, divided into four grades of no, mild, moderate, and severe, respectively marked as 0, 2, 4, and 6 points.

[0049] Table 1. Main symptom score table Main symptoms Degree classification Symptoms Score Score before and after treatment Snoring during sleep Normal No snoring 0 points Mild No snoring, snoring induced by factors such as cold 2 points Moderate Intermittent snoring, snoring sound weakened or disappeared by changing body position 4 points Severe Persistent snoring, independent of body position, affecting sleep 6 points Mouth breathing Normal No mouth breathing 0 points Mild Occasional mouth breathing induced by other factors 2 points Moderate Intermittent mouth breathing, no choking during sleep 4 points Severe Persistent mouth breathing, possibly accompanied by choking during sleep 6 points Nasal congestion Normal No nasal congestion 0 points Mild Occasional nasal congestion induced by other factors 2 points Moderate Long-lasting nasal congestion, nasal tone, heavy sleep breathing 4 points Severe Persistent nasal congestion, heavy nasal tone 6 points (2) Adenoid hypertrophy degree determination standard The degree of adenoid hypertrophy is evaluated according to the A / N value of the nasopharynx lateral X-ray film.

[0050] Table 2. Classification table of adenoid hypertrophy in children Classification A / N ratio Pre-treatment and post-treatment ratio Normal ≤0.60 Mild 0.61-0.70 Moderate 0.71-0.80 Severe >0.80% (3) Efficacy determination standard Refer to the efficacy determination standard of "Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine (Trial)", and use the nimodipine method to calculate: efficacy index (n) = [(total clinical symptom score before treatment - total clinical symptom score after treatment) / total clinical symptom score before treatment] x 100%.

[0051] Cure: clinical symptoms and signs completely disappear or basically disappear, n≥90%; Markedly effective: clinical symptoms and signs significantly improved, 70%≤n<90%; Effective: clinical symptoms and signs show improvement trend, 30%≤n<70%; Invalid: no obvious improvement in clinical symptoms and signs, n < 30%.

[0052] (4) Safety evaluation During treatment, the researcher should observe the occurrence of adverse symptoms such as skin allergy, poor appetite, nausea, vomiting, diarrhea, etc. in the children, and take appropriate measures to handle them in a timely manner. The symptoms of adverse reactions, the time of occurrence, and the possible related factors should be observed, and the treatment measures and results should be recorded. In severe cases, seek medical treatment in a timely manner.

[0053] 6. Statistical method SPSS software (Ver. 24.0) was used for data processing and analysis. P<0.05 was considered statistically significant. Count data was analyzed by chi-square test, and measurement data was expressed as mean ± standard deviation (x ± S). For data that met the normal distribution, paired t-test was used for intragroup comparison, and independent sample t-test was used for intergroup comparison. Other data were analyzed by willcoxon rank sum test and Mann-Whitney U test, respectively.

[0054] 7. Results (1) Total effective rate The total effective rate of the treatment group was 73.3%, higher than that of the control group (66.7%). In terms of marked improvement rate, the treatment group (53.3%) was also higher than the control group (33.3%). See the table below for details.

[0055] Group Number of cases Recovery Effective Effective Ineffective Total effective rate Treatment group 15 2 6 3 4 73.3% Control group 15 1 4 5 5 66.7% (2) Main symptom score Intragroup comparison showed that the symptom scores of the treatment group and the control group after treatment were significantly lower than those before treatment (P<0.05), indicating that both treatment regimens were effective. Inter-group comparison showed that the symptom score decrease in the treatment group was significantly greater than that in the control group (P<0.05), indicating that Xiangbe Yili Fang was significantly better than the conventional western medicine treatment regimen in improving core symptoms.

[0056] Group Number of cases Total score before treatment Total score after treatment Intra-group comparison (paired t-test) Score decrease Inter-group comparison (independent sample t-test) Treatment group 15 16.5 ± 2.2 6.8 ± 1.9 t = 17.14, P < 0.001 9.7 ± 2.1 t = 2.42, P = 0.021 Control group 15 16.3 ± 2.4 8.5 ± 2.2 t = 12.81, P < 0.001 7.8 ± 2.3 (3) Adenoid volume (A / N ratio) Intragroup comparison showed that the A / N ratio of the treatment group and the control group after treatment was significantly lower than that before treatment (P<0.05), indicating that both treatment regimens could effectively reduce adenoid volume. Inter-group comparison showed that the A / N ratio decrease in the treatment group was significantly greater than that in the control group (P<0.05), indicating that Xiangbe Yili Fang was significantly better than the conventional western medicine treatment regimen in reducing adenoid volume.

[0057] Group Number of cases A / N before treatment A / N after treatment Intra-group comparison (paired t-test) A / N decrease Inter-group comparison (independent sample t-test) Treatment group 15 0.79 ± 0.07 0.64 ± 0.06 t = 11.62, P < 0.001 0.15 ± 0.05 t = 2.72, P = 0.010 Control group 15 0.78 ± 0.06 0.69 ± 0.05 t = 8.37, P < 0.001 0.09 ± 0.04 (5) Safety evaluation During treatment, one patient (6.7%) in the treatment group experienced mild diarrhea; two patients (13.3%) in the control group experienced mild nausea, and one patient (6.7%) experienced nosebleed. None of these events affected the treatment progress. There was no statistically significant difference in the incidence of adverse events between the two groups.

[0058] 8. Conclusion ①The total effective rate of Xiangbei Yili Formula in treating moderate to severe adenoid hypertrophy in children reached 73.3%, which was better than the 66.7% of the conventional Western medicine treatment group.

[0059] ②The treatment group showed better improvement than the control group in the scores of major symptoms such as nasal congestion, snoring during sleep, and mouth breathing.

[0060] ③ The treatment group was superior to the control group in reducing the volume of adenoids.

[0061] ④ The present invention has good safety, with mild adverse reactions and a low incidence.

[0062] The clinical efficacy results of this invention show that the traditional Chinese medicine composition obtained based on the theoretical basis and clinical practice of this invention is reasonable and has a definite curative effect, providing a good treatment option for the treatment of adenoid hypertrophy in children with traditional Chinese medicine.

[0063] References: [1] Yuan Bin, Jiang Zhiyan, Ma Huaan, et al. Clinical practice guidelines of traditional Chinese medicine for adenoid hypertrophy in children [J]. Journal of Nanjing University of Traditional Chinese Medicine, 2024, 40 (02): 76-81. [2]Pereira L, Monyror J, Almeida FT, et al. Prevalence of adenoidhypertrophy: A systematic review and meta-analysis. Sleep medicine reviews.2018, 38: 101-112. [3]Ryczer T, Zawadzka-Głos L, Czarnecka P, et al. Bleeding as themain complication after adenoidectomy and adenotonsillotomy[J]. New Medicine, 2015, 19: 125-129. [4] Randall D A, Hoffer M E. Complications of tonsillectomy and adenoidectomy[J]. Otolaryngology--Head and Neck Surgery, 1998, 118(1): 61-68. [5] Buchinsky F J, Lowry M A, Isaacson G. Do adenoids regrow after excision?[J]. Otolaryngology–Head and Neck Surgery, 2000, 123(5): 576-581. [6] Lesinskas E, Drigotas M. The incidence of adenoidal regrowth after adenoidectomy and its effect on persistent nasal symptoms[J]. European archives of oto-rhino-laryngology, 2009, 266: 469-473. [7] Thomas K, Boeger D, Buentzel J, et al. Pediatric adenoidectomy: a population-based regional study on epidemiology and outcome[J]. International journal of pediatric otorhinolaryngology, 2013, 77(10): 1716-1720. [8]Sun Y L, Zheng H T, Tao J L, et al. Effectiveness and safety of Chinese herbal medicine for pediatric adenoid hypertrophy: A meta - analysis[J]. International Journal of Pediatric Otorhinolaryngology, 2019, 119: 79-85. [9] Shi D, Ma W. Efficacy of montelukast sodium combined with mometasone furoate in the treatment of adenoidal hypertrophy in children[J]. Inner Mongolia Journal of Medicine, 2016, 48(03): 294-296.

[10] Yu Y, Wu W, Liu J, et al. Efficacy of mometasone furoate nasal spray combined with montelukast sodium in the treatment of adenoidal hypertrophy in children[J]. Chinese Journal of Otorhinolaryngology in Combination of Traditional Chinese and Western Medicine, 2014, 22(01): 32-33+63.

Claims

1. A traditional Chinese medicine composition for treating adenoid hypertrophy, characterized in that, The raw medicine mainly comprises: 40-60g of pachystachys jothamii, 40-60g of fritillaria thunbergii, 40-60g of coix lachryma-jobi, 80-120g of calcined oyster shell, 40-60g of luffa, and 40-60g of platycodon grandiflorum.

2. The traditional Chinese medicine composition for treating adenoid hypertrophy according to claim 1, characterized in that, The raw medicine further comprises: 24-36g of licorice.

3. The traditional Chinese medicine composition for treating adenoid hypertrophy according to claim 2, characterized in that, The raw medicine comprises: 45-55g of pachystachys jothamii, 45-55g of fritillaria thunbergii, 45-55g of coix lachryma-jobi, 90-100g of calcined oyster shell, 45-55g of luffa, 45-55g of platycodon grandiflorum, and 27-33g of licorice.

4. The traditional Chinese medicine composition for treating adenoid hypertrophy according to claim 3, characterized in that, The raw medicine comprises: 45-55g of pachystachys jothamii, 45-55g of fritillaria thunbergii, 45-55g of coix lachryma-jobi, 90-100g of calcined oyster shell, 45-55g of luffa, 45-55g of platycodon grandiflorum, and 27-33g of licorice.

5. The traditional Chinese medicine composition for treating adenoid hypertrophy according to claim 1, characterized in that, The raw medicine further comprises: 40-60g of perilla frutescens and 40-60g of radix et rhizoma artemisiae scopariae.

6. The traditional Chinese medicine composition for treating adenoid hypertrophy according to claim 1, characterized in that, The raw medicine further comprises: 40-60g of perilla frutescens and 40-60g of radix et rhizoma artemisiae scopariae.

7. A traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine composition of any one of claims 1-6 is used as raw material.

8. The traditional Chinese medicine preparation of claim 7, which is in the form of a decoction, an oral liquid, granules, tablets or capsules.

9. The preparation method of the traditional Chinese medicine preparation according to claim 8, characterized in that, The method comprises the following steps: soaking and decocting the traditional Chinese medicine raw materials together for 2-3 times, each time for 1-2 hours, combining the decoction, filtering, concentrating the filtrate, and preparing a decoction, an oral liquid, granules, tablets or capsules.

10. Use of the traditional Chinese medicine composition of any one of claims 1-6 in the preparation of a medicament for treating adenoid hypertrophy.