A traditional Chinese medicine composition for treating spasmodic cough in children and its application

Abstract

This invention relates to a traditional Chinese medicine composition for treating spasmodic cough in children. The composition is made from the following raw materials in parts by weight: honeysuckle 10-14 parts, earthworm 7-11 parts, cicada slough 4-8 parts, belamcanda chinensis 7-11 parts, scutellaria baicalensis 7-11 parts, honey-processed coltsfoot flower 7-11 parts, lily bulb 7-11 parts, ginger-processed bamboo shavings 7-11 parts, and licorice root 1-5 parts. This invention also provides the application of this traditional Chinese medicine composition in the preparation of a drug for treating spasmodic cough in children. In this formula, honeysuckle and earthworm are the principal herbs; cicada slough, scutellaria baicalensis, and belamcanda chinensis are the assistant herbs; ginger-processed bamboo shavings, coltsfoot flower, and lily bulb are the adjuvant herbs; and licorice root is the guiding herb. This formula treats cough with phlegm belonging to the wind-cold transforming into heat type. This invention promotes lung function, eliminates phlegm, relieves spasms, and stops cough. Main indications: spasmodic cough caused by pertussis, bronchitis, asthma, etc.

Description

Technical Field

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

[0002] Spasmodic cough is a common respiratory symptom, usually caused by diseases such as pertussis, adenovirus infection, senile asthma, pneumonia, Haemophilus influenzae pneumonia in children, tuberculosis, and lung tumors. It presents as a spasmodic cough. The main symptoms may include continuous coughing, difficulty breathing, dry heaving, and wheezing sounds in the throat.

[0003] Chinese patent document CN115089689A discloses a traditional Chinese medicine composition for treating spasmodic cough, its preparation method, and its application, belonging to the field of traditional Chinese medicine technology. The composition, by weight, comprises the following components: Bupleurum chinense 6-12 parts, Paeonia lactiflora 6-10 parts, Citrus aurantium 6-12 parts, Glycyrrhiza uralensis 3-9 parts, Morus alba root bark 10-15 parts, Lycium chinense root bark 10-15 parts, Zingiber officinale 3-6 parts, Schisandra chinensis 6-10 parts, Phragmites communis rhizome 10-20 parts, Inula japonica 6-10 parts, Prunus armeniaca seed 10-15 parts, Ephedra sinica 5-10 parts, Cicadae periostracum 6-10 parts, and Bombyx mori 10-15 parts. This invention has a better therapeutic effect on spasmodic cough in infants and children, significantly improving the frequency and duration of cough attacks, reducing the recurrence rate, and decreasing the occurrence of severe cases. Furthermore, it is lower in cost and has fewer side effects compared to Western medicine treatments.

[0004] Chinese patent document CN102008603A discloses a traditional Chinese medicine composition for treating spasmodic cough in pertussis. This composition is prepared from the following raw materials in parts by weight: 3-6 parts of Solidago virgaurea, 6-12 parts of Eriocaulon buergerianum, 3-6 parts of Nandina domestica, 6-12 parts of Pyrrosia lingua, 6-12 parts of Paeonia lactiflora, 3-6 parts of stir-fried Bombyx mori, 6-9 parts of Eriobotrya japonica leaf, 6-12 parts of Rhodiola rosea, 0.5-1 part of borax, and 3-6 parts of prepared Glycyrrhiza uralensis. The traditional Chinese medicine composition for treating spasmodic cough in pertussis provided by this invention has the advantages of definite efficacy, rapid onset of action, high cure rate, simple usage, no toxic side effects, and mild taste. Moreover, the medicinal resources are abundant and the price is low. This traditional Chinese medicine composition is particularly suitable for the treatment of spasmodic cough in pertussis.

[0005] There are many traditional Chinese medicine compositions for treating spasmodic cough, but they all have more or less drawbacks, such as too many ingredients, difficulty in sourcing materials, high prices, and unclear efficacy and poor treatment results. Therefore, there is an urgent need for a traditional Chinese medicine composition that is effective in treating spasmodic cough in children, has fewer ingredients, is practical to use, has high compliance, and is safe and effective. Summary of the Invention

[0006] The purpose of this invention is to address the shortcomings of existing technologies by providing a traditional Chinese medicine composition for treating spasmodic cough in children and its application.

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating spasmodic cough in children, the traditional Chinese medicine composition being made from the following raw materials in parts by weight: honeysuckle 10-14 parts, earthworm 7-11 parts, cicada slough 4-8 parts, belamcanda chinensis 7-11 parts, scutellaria baicalensis 7-11 parts, honey-processed coltsfoot flower 7-11 parts, lily bulb 7-11 parts, ginger-processed bamboo shavings 7-11 parts, and licorice 1-5 parts.

[0008] As a preferred example, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: honeysuckle 11-13 parts, earthworm 8-10 parts, cicada slough 5-7 parts, belamcanda chinensis 8-10 parts, scutellaria baicalensis 8-10 parts, honey-processed coltsfoot flower 8-10 parts, lily bulb 8-10 parts, ginger-processed bamboo shavings 8-10 parts, and licorice 2-4 parts.

[0009] As another preferred example, the traditional Chinese medicine composition is made from the following raw materials in parts by weight: 12 parts honeysuckle, 9 parts earthworm, 6 parts cicada slough, 9 parts belamcanda, 9 parts scutellaria, 9 parts honey-processed coltsfoot flower, 9 parts lily, 9 parts ginger-processed bamboo shavings, and 3 parts licorice.

[0010] Secondly, the present invention provides the application of a traditional Chinese medicine composition in the preparation of a drug for treating spasmodic cough in children.

[0011] As a preferred example, the spasmodic cough in children is a spasmodic cough of the wind-cold-heat type.

[0012] As another preferred example, the spasmodic cough in children is an acute spasmodic cough in children.

[0013] As another preferred example, the spasmodic cough in children is a spasmodic cough caused by pertussis, bronchitis, or asthma.

[0014] As another preferred example, the spasmodic cough in children is an acute wind-cold-heat type spasmodic cough caused by pertussis, bronchitis, or asthma.

[0015] Functions of this invention: Clears the lungs and eliminates phlegm, relieves spasms and stops cough. Indications: Spasmodic cough and phlegm caused by pertussis, bronchitis, asthma, etc., belonging to the wind-cold-heat type. Usage: Decocted twice daily, 100ml each time. Children aged 1-5 years: 50ml each time; children over 6 years old: 100ml each time, taken twice daily, morning and evening.

[0016] The advantages of this invention are as follows: The formula consists of honeysuckle and earthworm as the principal herbs; cicada slough, scutellaria, and belamcanda as the assistant herbs; prepared ginger, bamboo shavings, coltsfoot flower, and lily bulb as adjuvant herbs; and licorice as the guiding herb. This formula treats cough with phlegm belonging to the wind-cold transforming into heat type. For coughs caused by external pathogens that persist even after taking diaphoretic and lung-clearing medications, it is because wind-evil has invaded the lungs, impairing their cleansing function. Although the pathogens have been dispersed, the diaphoretic effect is incomplete, and the pathogens remain, resulting in persistent itchy throat and cough. At this point, the external pathogens are mostly eliminated, and some children may experience slight aversion to wind and fever. The treatment principle should be to clear the lungs, resolve phlegm, relieve spasms, and stop coughing, supplemented with dispersing herbs to expel the pathogens. Honeysuckle and earthworm are the principal herbs, both entering the lung meridian. Honeysuckle is good at clearing heat and detoxifying, dispersing wind-heat, and enters the lung, heart, and kidney meridians; it is warm but not hot in nature. Earthworm is salty and cold, clearing and draining, and promoting circulation. Entering the liver meridian, it can clear heat, extinguish wind, and stop spasms; entering the lung meridian, it can clear lung heat and relieve asthma; traversing the meridians, it can unblock the collaterals; entering the bladder meridian, it can promote urination. For cases where the pathogenic factors have not been completely eliminated, resulting in itchy throat and cough, the assistant herb, cicada slough, disperses wind-heat, soothes the throat, opens the voice, promotes rash eruption, improves vision, clears corneal opacity, extinguishes wind, and stops spasms. Other assistant herbs, Scutellaria baicalensis and Belamcanda chinensis, clear lung heat and resolve phlegm. Scutellaria baicalensis has a broad antibacterial spectrum; in vitro tests show inhibitory effects on bacilli and cocci, and it also has effects on influenza viruses and skin fungi. Clinically, it is used to treat viral eye diseases and upper respiratory tract infections with good efficacy. Belamcanda chinensis and coltsfoot flower both treat cough and shortness of breath, but Belamcanda chinensis is particularly good at clearing phlegm and purging fire to benefit the throat; therefore, Belamcanda chinensis is the assistant herb, and coltsfoot flower is the adjuvant herb. Bamboo shavings are a medicine for treating heat in the Lesser Yang organs. Their mild nature can dispel excess, and their cooling properties can clear heat. For vomiting caused by spleen and stomach deficiency or cold, roasted ginger and bamboo shavings can be used without harming the spleen and stomach; on the contrary, they can harmonize the stomach, strengthen the spleen, and promote digestion. Lily bulbs nourish Yin and moisten the lungs, clear the heart and calm the mind, and are effective in treating chronic cough with blood in the sputum. Licorice root harmonizes the effects of other herbs and also stops cough and resolves phlegm. Detailed Implementation

[0017] The present invention will be further described below with reference to specific embodiments. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of the invention. Furthermore, it should be understood that after reading the description of this invention, those skilled in the art can make various alterations or modifications to the invention, and these equivalent forms also fall within the scope defined by the appended claims.

[0018] Example 1: A Traditional Chinese Medicine Composition for Treating Spasmodic Cough in Children (I)

[0019] Honeysuckle 12 parts, earthworm 9 parts, cicada molting 6 parts, belamcanda chinensis 9 parts, scutellaria baicalensis 9 parts, honey-processed coltsfoot flower 9 parts, lily bulb 9 parts, ginger-processed bamboo shavings 9 parts, licorice 3 parts.

[0020] Example 2: The traditional Chinese medicine composition of the present invention for treating spasmodic cough in children (II)

[0021] Honeysuckle 12 parts, earthworm 8 parts, cicada molting 7 parts, belamcanda chinensis 7 parts, scutellaria baicalensis 11 parts, honey-processed coltsfoot flower 9 parts, lily 8 parts, ginger-processed bamboo shavings 10 parts, licorice 1 part.

[0022] Example 3: The Traditional Chinese Medicine Composition for Treating Spasmodic Cough in Children (Part Three)

[0023] Honeysuckle 11 parts, earthworm 10 parts, cicada molting 4 parts, belamcanda chinensis 11 parts, scutellaria baicalensis 9 parts, honey-processed coltsfoot flower 8 parts, lily 10 parts, ginger-processed bamboo shavings 7 parts, licorice 5 parts.

[0024] Example 4: The Traditional Chinese Medicine Composition of the Present Invention for Treating Spasmodic Cough in Children (IV)

[0025] Honeysuckle 13 parts, earthworm 7 parts, cicada molting 8 parts, belamcanda chinensis 9 parts, scutellaria baicalensis 8 parts, honey-processed coltsfoot flower 10 parts, lily 7 parts, ginger-processed bamboo shavings 11 parts, licorice 3 parts.

[0026] Example 5: The Traditional Chinese Medicine Composition of the Present Invention for Treating Spasmodic Cough in Children (V)

[0027] Honeysuckle 10 parts, earthworm 11 parts, cicada molting 6 parts, belamcanda chinensis 8 parts, scutellaria baicalensis 10 parts, honey-processed coltsfoot flower 7 parts, lily 11 parts, ginger-processed bamboo shavings 9 parts, licorice 2 parts.

[0028] Example 6: The Traditional Chinese Medicine Composition of the Present Invention for Treating Spasmodic Cough in Children (VI)

[0029] Honeysuckle 14 parts, earthworm 9 parts, cicada molting 5 parts, belamcanda chinensis 10 parts, scutellaria baicalensis 7 parts, honey-processed coltsfoot flower 11 parts, lily 9 parts, ginger-processed bamboo shavings 8 parts, licorice 4 parts.

[0030] Example 7: The Traditional Chinese Medicine Composition of the Present Invention for Treating Spasmodic Cough in Children (VII)

[0031] Honeysuckle 12 parts, earthworm 10 parts, cicada molting 4 parts, belamcanda chinensis 11 parts, scutellaria baicalensis 9 parts, honey-processed coltsfoot flower 8 parts, lily 10 parts, ginger-processed bamboo shavings 7 parts, licorice 5 parts.

[0032] Example 8: The Traditional Chinese Medicine Composition of the Present Invention for Treating Spasmodic Cough in Children (VIII)

[0033] Honeysuckle 11 parts, earthworm 7 parts, cicada molting 8 parts, belamcanda chinensis 9 parts, scutellaria baicalensis 8 parts, honey-processed coltsfoot flower 10 parts, lily 7 parts, ginger-processed bamboo shavings 11 parts, licorice 3 parts.

[0034] Example 9: The Traditional Chinese Medicine Composition of the Present Invention for Treating Spasmodic Cough in Children (IX)

[0035] Honeysuckle 13 parts, earthworm 11 parts, cicada molting 6 parts, belamcanda chinensis 8 parts, scutellaria baicalensis 10 parts, honey-processed coltsfoot flower 7 parts, lily 11 parts, ginger-processed bamboo shavings 9 parts, licorice 2 parts.

[0036] Example 10: A Traditional Chinese Medicine Composition for Treating Spasmodic Cough in Children (X)

[0037] Honeysuckle 10 parts, earthworm 9 parts, cicada molting 5 parts, belamcanda chinensis 10 parts, scutellaria baicalensis 7 parts, honey-processed coltsfoot flower 11 parts, lily bulb 9 parts, ginger-processed bamboo shavings 8 parts, licorice 4 parts.

[0038] Example 11: The Traditional Chinese Medicine Composition of the Present Invention for Treating Spasmodic Cough in Children (XI)

[0039] Honeysuckle 14 parts, earthworm 8 parts, cicada molting 7 parts, belamcanda chinensis 7 parts, scutellaria baicalensis 11 parts, honey-processed coltsfoot flower 9 parts, lily 8 parts, ginger-processed bamboo shavings 10 parts, licorice 1 part.

[0040] Example 12 Animal Experiment

[0041] 1. Experimental materials:

[0042] 1.1 Experimental subjects and feeding: Seventy-two four-week-old SPF-grade female BALB / c mice with a body weight of (11.23±1.14)g were selected and fed for one week under normal conditions of (25±0.5)℃, (55±5)% relative humidity and natural light.

[0043] 1.2 Main experimental instruments: KC6700 microplate reader (Beijing Yuansenkaide Biotechnology Co., Ltd.); Auto40 flow cytometer (Shanghai Tianneng Technology Co., Ltd.).

[0044] 1.3 Reagents and Drugs: 1) Tohama I strain of Bordetella pertussis (Shanghai Jinpan Biotechnology Co., Ltd., batch number M1917B) was used to reactivate the virulence of Bordetella pertussis in mouse lungs, and then inoculated onto agar medium and cultured at 37℃ for 40 h. The culture containing colonies was then placed in centrifuge tubes under sterile room temperature conditions, centrifuged at 4000 r / min for 10 min, the medium was discarded, the bacterial suspension was collected, TE buffer was added to suspend the bacterial suspension, 80% glycerol was added, and the suspension was stored at -80℃. 2) Jinlong Antispasmodic Formula of this invention; 3) Roxithromycin tablets (batch number 20210326, Shijiazhuang Pharmaceutical Group Ouyi Pharmaceutical Co., Ltd.), prepared with distilled water to a concentration of 4 mg / L.

[0045] mL suspension. 4) Agar medium, mouse tumor necrosis factor-α (TNF-α)

[0046] Enzyme-linked immunosorbent assay (ELISA) kits for TNF-α, interleukin (IL)-1β, and IL-6; CD4-PE antibody; CD8-FITC antibody (batch numbers HB0109-3 and HB0402-7).

[0047] 2. Experimental Methods:

[0048] 2.1 Modeling and Grouping: A pertussis model was established in 60 mice according to the reference (Gao Jingjing, Li Xin, Qiao Ruijie, et al. Establishment and application of a mouse respiratory infection model of pertussis [J]. Progress in Microbiology and Immunology, 2018, 46(5):28-35.). The experimental Tohama I strain (turbidity 3.8×10¹⁰ CFU / mL, volume 5mL) was nebulized for 30 min and infected for 7 days. All 60 mice showed signs of ruffled hair, lethargy, and easy startling. The cultured bacterial colonies increased significantly, indicating that the model was successfully established. The 60 mice were randomly divided into a model group, a positive group (40mg / kg roxithromycin suspension), and low, medium, and high dose groups of Jinlong Antispasmodic Formula in Example 1 of this invention (0.715, 1.43, 2.86g / kg, 0.5, 1, and 2 times the clinical equivalent dose), with 12 mice in each group; another 12 age-matched normal mice were used as the control group. Mice in each dose group of Jinlong Antispasmodic Formula were administered the drug twice daily by gavage, mice in the positive control group were administered the drug once daily by gavage, and mice in the control and model groups were administered an equal volume of distilled water by gavage daily for 3 consecutive days.

[0049] 2.2 General condition observation: After the administration of the drug, observe the general condition of the mice, including their mental state, movement, fur, diet and water intake.

[0050] 2.3 Sample Collection: 4 mL of blood was collected from the abdominal aorta of mice and divided into two portions. One portion was left to stand at room temperature for 1 hour, then centrifuged at 1000 rpm for 10 minutes. The supernatant was used for detecting inflammatory factor levels. The other portion was used for detecting the proportion of CD4+ and CD8+ T cells. After blood collection, the cervical vertebrae of the mice were dislocated. The skin was cut along the midline of the sternum at the xiphoid process, and the transverse bones on both sides of the lower edge of the ribs were cut. The sternum was lifted to expose both lungs, which were carefully removed. The left lung was fixed in 4% paraformaldehyde, and the right lung was stored in a -80℃ refrigerator.

[0051] 2.4 ELISA Method for Detecting Serum TNF-α, IL-1β, and IL-6 Levels Serum TNF-α, IL-1β, and IL-6 levels in mice were strictly detected according to the ELISA kit instructions.

[0052] 2.5 Flow cytometry analysis of the proportion of CD4+ and CD8+ T cells in abdominal aortic blood: Blood was collected from mice in each group, and CD4-PE and CD8-FITC antibodies were added. The mixture was reacted in the dark for 30 min, centrifuged, resuspended, and placed in a flow cytometer to detect the proportion of CD4+ and CD8+ T cells.

[0053] 2. Statistical methods: Data were processed using SPSS 25.0 software. t-tests were performed on continuous data. Continuous data conforming to a normal distribution and homogeneous variance were expressed as (x±s). One-way ANOVA was used for comparisons among multiple groups, and the SNK-q test was used for pairwise comparisons between groups. P < 0.05 was considered statistically significant.

[0054] 3. Results

[0055] 3.1 Effects of the Jinlong Antispasmodic Formula of the Present Invention on the General Condition of Mice

[0056] The control group mice were in good spirits, active, with shiny fur, and normal food and water intake; the model group mice were in poor spirits, sluggish, with messy and dull fur, and decreased food intake; the positive group mice were in good spirits, with increased activity and appetite; the mice in each dose group of Jinlong Antispasmodic Formula gradually improved in spirits, with increased activity and appetite.

[0057] 3.2 Effects of Jinlong Antispasmodic Formula of the present invention on serum TNF-α, IL-1β, and IL-6 levels in mice: Compared with the control group, the serum TNF-α, IL-1β, and IL-6 levels in the model group mice were increased (P < 0.05); compared with the model group, the serum TNF-α, IL-1β, and IL-6 levels in each dose group of Jinlong Antispasmodic Formula were decreased (P < 0.05), and showed a dose-dependent effect; compared with the positive group, the serum TNF-α, IL-1β, and IL-6 levels in the low- and medium-dose groups of Jinlong Antispasmodic Formula were increased (P < 0.05), while the serum TNF-α, IL-1β, and IL-6 levels in the high-dose group were decreased (P < 0.05), as shown in Table 1.

[0058] Table 1 Comparison of serum TNF-α, IL-1β, and IL-6 levels in mice of different groups (pg / mL, x±s, n=12)

[0059]

[0060]

[0061] 3.3 Effects of the Jinlong Antispasmodic Formula of the present invention on the proportion of CD4+ and CD8+ T cells in the abdominal aorta of mice: Compared with the control group, the proportion of CD4+ T cells in the abdominal aorta of mice in the model group was decreased (P<0.05), and the proportion of CD8+ T cells was increased (P<0.05); compared with the model group, the proportion of CD4+ T cells in the abdominal aorta of mice in each dose group of Jinlong Antispasmodic Formula was increased (P<0.05), and the proportion of CD8+ T cells was decreased (P<0.05), showing a dose-dependent effect; compared with the positive group, the proportion of CD4+ T cells in the abdominal aorta of mice in the low and medium dose groups of Jinlong Antispasmodic Formula of the present invention was decreased (P<0.05), and the proportion of CD8+ T cells was increased (P<0.05), while the proportion of CD4+ T cells in the abdominal aorta of mice in the high dose group was increased (P<0.05), and the proportion of CD8+ T cells was decreased (P<0.05), as shown in Table 2.

[0062] Table 2 Comparison of the proportions of CD4+ T and CD8+ T cells in the abdominal aortic blood of mice in each group (x±s, n=12)

[0063]

[0064] Example 13 Clinical Trial:

[0065] 1. Materials and Methods

[0066] 1.1 Case Source: All cases observed in this study were children with wind-cold-heat type pertussis who visited the pediatric outpatient clinic of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine between May 2023 and May 2024.

[0067] 1.2 Diagnostic criteria:

[0068] Western medicine diagnostic criteria: The inclusion criteria were based on the 2017 "Recommendations for the Diagnosis and Treatment of Pertussis in Chinese Children" (hereinafter referred to as the "Recommendations"). (Infectious Diseases Group of the Pediatrics Branch of the Chinese Medical Association, Editorial Board of the Chinese Journal of Pediatrics. Recommendations for the Diagnosis and Treatment of Pertussis in Chinese Children. Chinese Journal of Pediatrics 2017, 55(8):568–572.)

[0069] (1) Symptoms such as spasmodic cough, croaking echo, and worsening symptoms at night, or a history of suspected pertussis exposure; (2) Laboratory test positive for Bordetella pertussis PCR (+).

[0070] Traditional Chinese Medicine (TCM) diagnostic criteria: Based on the book *Traditional Chinese Medicine Pediatrics* (edited by Wang Shouchuan) published by China Traditional Chinese Medicine Press, and according to the classification of syndrome types, combined with the physiological and pathological characteristics of children and clinical treatment experience, the diagnostic criteria for children with wind-cold transforming into heat type pertussis are formulated as follows:

[0071] Main symptoms: Uncomfortable cough, accompanied by runny nose and tears, nasal congestion with yellow nasal discharge, and sneezing;

[0072] Secondary symptoms: fever, thirst, thick yellow phlegm that is difficult to cough up, red or itchy throat;

[0073] Tongue appearance: Red tongue body, thin yellow coating;

[0074] Pulse characteristics: Floating and rapid;

[0075] Fingerprint: purplish.

[0076] If a patient presents with two or more of the above primary symptoms, along with two or more secondary symptoms, and the tongue, pulse, or fingerprint patterns are basically consistent with these symptoms, they can be diagnosed with pertussis of the wind-cold-heat type.

[0077] 1.3 Inclusion criteria:

[0078] (1) Meets the diagnostic criteria for pertussis in Western medicine;

[0079] (2) Meets the diagnostic criteria for wind-cold transforming into heat type in children according to traditional Chinese medicine;

[0080] (3) Age 0-14 years;

[0081] (4) The course of illness is within 15 days

[0082] (5) Basic information is complete;

[0083] (6) Has signed the informed consent form and is able to actively cooperate with the doctor's instructions for treatment.

[0084] 1.4 Exclusion Criteria

[0085] (1) Does not meet the inclusion criteria;

[0086] (2) The child is already receiving interventional treatment;

[0087] (3) Those who are over 14 years old;

[0088] (4) Incomplete data that affects subsequent investigations and TCM syndrome differentiation;

[0089] (5) Individuals infected with other pathogens;

[0090] (6) Children with primary immunodeficiency diseases;

[0091] (7) Children with congenital respiratory tract malformations;

[0092] (8) Children with heart, liver, kidney and hematopoietic system diseases;

[0093] (9) Children who have an allergic reaction to the drugs used in this study;

[0094] 1.5 Rejection and Shedding Criteria

[0095] (1) Poor subject compliance affects the assessment of efficacy and clinical safety;

[0096] (2) During the observation and treatment period, if the patient develops other chronic progressive diseases, or other complications and special physiological changes, and is not suitable to continue to receive subsequent trials;

[0097] (3) Subjects who are lost to follow-up for any reason and no longer receive the prescribed medication and testing;

[0098] 1.6 Experimental Grouping

[0099] Children were randomly divided into a control group and an observation group, with 30 cases in each group. In the control group, there were 17 males and 13 females, with a mean age of (8.40±2.89) years and a disease duration of 8–36 days, with a mean of (15.19±4.91) days. In the observation group, there were 16 males and 14 females, with a mean age of (8.51±2.95) years and a disease duration of 7–39 days, with a mean of (16.29±4.81) days. There were no statistically significant differences in gender, age, and disease duration between the two groups (P>0.05). Informed consent was obtained from the children's families through this study.

[0100] 1.7 Experimental Methods

[0101] The control group received routine Western medicine treatment: oral administration of erythromycin cyclophosphamide tablets (produced by Aomei Pharmaceutical (Hainan) Co., Ltd.), at a dose of 15 mg·kg / time, taken every 12 hours; nebulized inhalation of budesonide suspension (produced by AstraZeneca Pharmaceutical Co., Ltd.) and salbutamol sulfate inhalation solution (produced by Zhejiang Furui Pharmaceutical Co., Ltd.), with a dose of 1 mg / time for budesonide suspension and a dose of 2.5 mg / time for salbutamol sulfate inhalation solution, both twice a day. In addition to the above-mentioned routine treatment, the children in the observation group were treated with the Jinlong Antispasmodic Formula of this invention. The formula consists of: honeysuckle 12g, earthworm 9g, cicada slough 6g, belamcanda chinensis 9g, scutellaria baicalensis 9g, honey-processed coltsfoot flower 9g, lily bulb 9g, ginger-processed bamboo shavings 9g, and licorice root 3g (all are Chinese herbal medicine granules provided by Jiangyin Tianjiang Pharmaceutical Co., Ltd.). The formula can be adjusted according to the patient's condition: for phlegm-dampness, add pinellia ternata 10-12g; for lung yin deficiency, add glehnia littoralis 12-15g, ophiopogon japonicus 12-15g, and polygonatum odoratum 12-15g; for phlegm-heat, add bamboo shavings 10-12g; and for constipation, add rhubarb 6-9g. One dose is taken daily, dissolved in 80-100ml of boiling water, after breakfast and dinner, for one week.

[0102] 1.8 Experimental Observation Indicators

[0103] The disappearance time of positive symptoms, changes in serum inflammatory factors and intestinal mucosal barrier function before and after treatment were observed in two groups of children. (1) The disappearance time of positive symptoms after treatment included the disappearance time of fever, wheezing, spasmodic cough, and lung rales. (2) Serum inflammatory factor indicators included interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), and interferon-γ (INF-γ), which were detected by enzyme-linked immunosorbent assay (ELISA). The test kits used for the above indicators were purchased from Shenzhen Jingmei Biotechnology Co., Ltd. (3) Indicators of intestinal mucosal barrier function include advanced glycation end products (AGEs), endotoxin (ETX), and diamine oxdase (DAO). AGEs were detected by enzyme-linked immunosorbent assay (ELISA), ETX was detected by spectrophotometry, and BAD was detected by the horseshoe crab reagent azo dye matrix method. The detection kits for AGEs and ETX were purchased from Genmde, and the BAD detection kit was purchased from Xiamen Horseshoe Crab Reagent Experimental Factory Co., Ltd.

[0104] 1.9 Efficacy criteria and statistical methods

[0105] 1.9.1 The efficacy evaluation criteria refer to the relevant literature standards: (1) Marked effect: The child's symptoms disappear or are significantly relieved, and chest X-ray shows that the lesions are completely or mostly absorbed; (2) Effective: The child's symptoms improve, and chest X-ray shows that the lesions are absorbed compared to before; (3) Ineffective: The child's symptoms and imaging results show no significant improvement or aggravation. Total effective rate = Marked effect rate + Effective rate.

[0106] 1.9.2 Statistical Methods SPSS 26.0 statistical software was used for statistical analysis. t-tests were performed on continuous data; chi-square tests were performed on categorical data; and rank-sum tests were used for ordinal data. A p-value < 0.05 was considered statistically significant.

[0107] 2. Research Results

[0108] 2.1 Comparison of symptom improvement between the two groups of children with pertussis: The time for fever to disappear, wheezing to disappear, spasmodic cough to disappear, and lung rales to disappear in the observation group were shorter than those in the control group, and the differences were statistically significant (P<0.001). See Table 3.

[0109] Table 3 Comparison of symptom improvement between the two groups of children with pertussis Unit: d

[0110]

[0111] 2.2 Comparison of changes in serum inflammatory factors between the two groups of children with pertussis. Before treatment, there were no statistically significant differences in serum IL-2, IL-4, IL-6, TNF-α, and INF-γ levels between the two groups (P>0.05). After treatment, serum IL-4, IL-6, TNF-α, and INF-γ levels decreased compared to before treatment (control group: t=5.282, 4.855, 5.744, 3.572; observation group: t=10.487, 8.543, 9.541, 7.058, P<0.001), and the observation group had lower levels than the control group (P<0.001). After treatment, serum IL-2 levels increased compared to before treatment (control group: t=11.083; observation group: t=12.173, P<0.001), and the observation group had higher levels than the control group (P<0.001). See Table 4.

[0112] Table 4 Comparison of changes in serum inflammatory factors between the two groups of children with pertussis

[0113]

[0114] 2.3 Comparison of intestinal mucosal barrier function between the two groups of children with pertussis. Before treatment, there were no statistically significant differences in serum AGEs, ETX, and DAO levels between the two groups (P>0.05). After treatment, serum AGEs, ETX, and DAO levels (control group: t=5.737, 5.253, 4.514; observation group: t=9.267, 11.676, 8.393, P<0.001) decreased compared to before treatment (P<0.001), and the levels in the observation group were also lower than those in the control group (P<0.001). See Table 5.

[0115] Table 5 Comparison of intestinal mucosal barrier function between the two groups of children with pertussis

[0116]

[0117] 2.4 Comparison of the efficacy of the two groups of pertussis treatment: The overall efficacy of the observation group was better than that of the control group, with a total effective rate of 93.33%, which was higher than that of the control group (73.33%). The difference was statistically significant (P<0.05). See Table 6.

[0118] Table 6. Comparison of treatment efficacy between two groups of children with pertussis (unit: cases (%))

[0119]

[0120] The above description is only a preferred embodiment of the present invention. It should be noted that those skilled in the art can make several improvements and additions without departing from the method of the present invention, and these improvements and additions should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating spastic cough in children, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: honeysuckle 10-14 parts, earthworm 7-11 parts, cicada slough 4-8 parts, belamcanda chinensis 7-11 parts, scutellaria baicalensis 7-11 parts, honey-processed coltsfoot flower 7-11 parts, lily bulb 7-11 parts, ginger-processed bamboo shavings 7-11 parts, and licorice 1-5 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: honeysuckle 11-13 parts, earthworm 8-10 parts, cicada slough 5-7 parts, belamcanda chinensis 8-10 parts, scutellaria baicalensis 8-10 parts, honey-processed coltsfoot flower 8-10 parts, lily bulb 8-10 parts, ginger-processed bamboo shavings 8-10 parts, and licorice 2-4 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition is made from the following raw materials in parts by weight: 12 parts honeysuckle, 9 parts earthworm, 6 parts cicada slough, 9 parts belamcanda, 9 parts scutellaria, 9 parts honey-processed coltsfoot flower, 9 parts lily, 9 parts ginger-processed bamboo shavings, and 3 parts licorice.

4. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a medicine for treating spasmodic cough in children.

5. The application according to claim 4, characterized in that, The aforementioned childhood spasmodic cough is a type of childhood spasmodic cough caused by wind-cold transforming into heat.

6. The application according to claim 4, characterized in that, The aforementioned childhood spasmodic cough refers to acute childhood spasmodic cough.

7. The application according to claim 4, characterized in that, The spasmodic cough in children refers to spasmodic cough caused by pertussis, bronchitis, or asthma.

8. The application according to claim 4, characterized in that, The aforementioned childhood spasmodic cough refers to an acute wind-cold-heat type of childhood spasmodic cough caused by pertussis, bronchitis, or asthma.

Images