Traditional Chinese medicine vigor-cultivating and sneezing-stopping decoction for treating vigor deficiency type allergic rhinitis

Abstract

The invention relates to a traditional Chinese medicine vigor-cultivating and sneezing-stopping decoction for treating vitality deficiency type allergic rhinitis, which can effectively solve the problem of medication for treating vitality deficiency type allergic rhinitis. The preparation method comprises the following steps: adding water into ginseng, stir-fried Chinese yam, prepared rehmannia root, eucommia ulmoides, angelica sinensis, dogwood, medlar, honey-fried licorice root, magnolia flower, cocklebur fruit and angelica dahurica, soaking at room temperature, decocting with strong fire, decocting with slow fire, filtering to obtain filtrate, and concentrating to obtain the finished product of the traditional Chinese medicine vigor-cultivating and sneezing-stopping decoction. According to the main and secondary relation of monarch, minister, assistant and guide, compatibility is scientific and reasonable, mutual support is achieved, the traditional Chinese medicine composition has the effects of reinforcing vital essence, tonifying qi, opening orifices and stopping sneezing, is effectively used for treating vitality deficiency type allergic rhinitis, is good in effect and safe in medication, is a great innovation in medicine for treating vitality deficiency type allergic rhinitis, and has actual clinical application and popularization value.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a traditional Chinese medicine formula called Peiyuan Zhiti Decoction for treating allergic rhinitis caused by deficiency of vital energy. Background Technology

[0002] Allergic rhinitis (AR) is a common clinical disease, referring to an atopic disease of the nasal mucosa caused by a type 1 hypersensitivity reaction mediated by immunoglobulin E (IgE) after an individual's exposure to allergens. It is closely related to factors such as genetics, inhaled allergens, maternal and infant diet, and climate change. Symptoms include frequent sneezing, runny nose, and nasal congestion / blockage. It is estimated that the incidence of allergic rhinitis in adults in China is 19%, and in children, it is 22%. The global prevalence is 10%–40%, indicating a huge number of patients, and the trend is increasing worldwide. Although AR does not lead to death, it imposes a heavy socioeconomic burden on patients and seriously impairs their quality of life. Modern medical treatment for AR mainly focuses on preventative measures such as reducing allergen exposure, using medications such as corticosteroids and antihistamines, and specific immunotherapy. These methods can control symptoms to some extent, but the treatment course is long, and common side effects include nasal irritation, nasal pain, and nasal discharge. Furthermore, the effectiveness of nasal administration is limited, making a complete cure difficult. It significantly impacts patients' normal lives, and long-term use of hormones in children can affect their growth and development.

[0003] Allergic rhinitis (AR) falls under the category of "nasal congestion" in Traditional Chinese Medicine (TCM). TCM possesses unique advantages in treating various diseases. The basic pathogenesis of AR is deficiency of vital energy and predominance of wind-cold, with insufficient primordial qi being the root cause of its development. Therefore, the Da Bu Yuan Jian formula, with modifications, is used as a base to nourish primordial qi, clear the nasal passages, and stop sneezing, showing good results in treating allergic rhinitis. The Pei Yuan Zhi Ti Tang formula has been used to treat nasal congestion due to insufficient primordial qi, and its therapeutic mechanism has been explored, but no publicly reported studies have been published to date. Summary of the Invention

[0004] In view of the above situation and to overcome the shortcomings of the existing technology, the purpose of this invention is to provide a traditional Chinese medicine formula called Peiyuan Zhiti Decoction for treating allergic rhinitis caused by deficiency of vital energy, which can effectively solve the problem of medication for treating allergic rhinitis caused by deficiency of vital energy.

[0005] The technical solution provided by this invention is a traditional Chinese medicine formula for treating allergic rhinitis caused by deficiency of vital energy, namely, Peiyuan Zhiti Decoction, which is made from the following raw materials by weight: ginseng 8-12g, stir-fried yam 5-7g, prepared rehmannia root 8-10g, eucommia bark 5-7g, angelica root 8-10g, cornus officinalis 2-4g, wolfberry 8-10g, prepared licorice root 5-7g, magnolia flower 8-10g, cocklebur fruit 8-10g, and angelica dahurica 8-10g. The above-mentioned medicinal materials are soaked in water at room temperature for 30 minutes (weight and volume refer to g for solids and mL for liquids) at 8 times their weight volume. The mixture is then brought to a boil over high heat and simmered over low heat for 30-40 minutes. The first filtrate is obtained by filtration. Then, 6 times their weight volume of water is added, and the mixture is brought to a boil over high heat and simmered over low heat for 20-30 minutes. The second filtrate is obtained by filtration. The two filtrates are combined, mixed well, and concentrated to 400ml to obtain the finished Peiyuan Zhiti Decoction.

[0006] The components of this invention are scientifically and rationally formulated according to the principal, assistant, adjuvant, and guide relationships, and support each other. They have the effects of nourishing the original qi, clearing the orifices, and stopping sneezing. They are effective in treating allergic rhinitis caused by deficiency of vital energy, with good results and safe use. This invention represents a major innovation in the treatment of allergic rhinitis caused by deficiency of vital energy and has practical clinical application value. Detailed Implementation

[0007] The specific implementation of the present invention will be described in detail below with reference to examples and specific circumstances. Example

[0008] This invention relates to a traditional Chinese medicine formula for treating allergic rhinitis caused by deficiency of vital energy, namely, Peiyuan Zhiti Decoction, which is made from the following raw materials by weight: 10g ginseng, 6g stir-fried yam, 9g prepared rehmannia root, 6g eucommia bark, 9g angelica root, 3g cornus officinalis, 9g wolfberry, 6g prepared licorice root, 9g magnolia flower, 9g cocklebur fruit, and 9g angelica dahurica. The above-mentioned medicinal materials are soaked in water at 8 times their weight volume at room temperature for 30 minutes, brought to a boil over high heat, simmered over low heat for 35 minutes, and filtered to obtain the first filtrate. Then, 6 times their weight volume of water is added to the first filtrate, brought to a boil over high heat, simmered over low heat for 25 minutes, and filtered to obtain the second filtrate. The two filtrates are combined, mixed well, and concentrated to 400ml to obtain the finished Peiyuan Zhiti Decoction. Example

[0009] This invention relates to a traditional Chinese medicine formula for treating allergic rhinitis caused by deficiency of vital energy, namely, Peiyuan Zhiti Decoction, which is made from the following raw materials by weight: ginseng 8g, stir-fried yam 5g, prepared rehmannia root 8g, eucommia bark 5g, angelica root 8g, cornus officinalis 2g, wolfberry 8g, prepared licorice root 5g, magnolia flower 8g, cocklebur fruit 8g, and angelica dahurica 8g. The above-mentioned medicinal materials are soaked in water at room temperature for 30 minutes with 8 times their weight volume, brought to a boil over high heat, simmered over low heat for 30 minutes, and filtered to obtain the first filtrate. Then, 6 times their weight volume of water is added to the first filtrate, brought to a boil over high heat, simmered over low heat for 20 minutes, and filtered to obtain the second filtrate. The two filtrates are combined, mixed well, and concentrated to 400ml to obtain the finished Peiyuan Zhiti Decoction. Example

[0010] This invention relates to a traditional Chinese medicine formula for treating allergic rhinitis caused by deficiency of vital energy, namely, Peiyuan Zhiti Decoction, which is made from the following raw materials by weight: ginseng 12g, stir-fried yam 7g, prepared rehmannia root 10g, eucommia bark 7g, angelica root 10g, cornus officinalis 4g, wolfberry 10g, prepared licorice root 7g, magnolia flower 10g, cocklebur fruit 10g, and angelica dahurica 10g. The above-mentioned medicinal materials are soaked in water at 8 times their weight volume at room temperature for 30 minutes, brought to a boil over high heat, and simmered over low heat for 40 minutes. The first filtrate is obtained by filtration. Then, 6 times their weight volume of water is added to the first filtrate, brought to a boil over high heat, and simmered over low heat for 30 minutes. The second filtrate is obtained by filtration. The two filtrates are combined, mixed well, and concentrated to 400ml to obtain the finished Peiyuan Zhiti Decoction. Example

[0011] This invention relates to a traditional Chinese medicine formula for treating allergic rhinitis caused by deficiency of vital energy, namely, Peiyuan Zhiti Decoction, which is made from the following raw materials by weight: ginseng 8g, stir-fried yam 7g, prepared rehmannia root 8g, eucommia bark 7g, angelica root 8g, cornus officinalis 4g, wolfberry 8g, prepared licorice root 7g, magnolia flower 8g, cocklebur fruit 10g, and angelica dahurica 8g. The above-mentioned medicinal materials are soaked in water at room temperature for 30 minutes with 8 times their weight volume, brought to a boil over high heat, and simmered over low heat for 35 minutes. The first filtrate is obtained by filtration. Then, 6 times their weight volume of water is added to the first filtrate, brought to a boil over high heat, and simmered over low heat for 25 minutes. The second filtrate is obtained by filtration. The two filtrates are combined, mixed well, and concentrated to 400ml to obtain the finished Peiyuan Zhiti Decoction. Example

[0012] This invention relates to a traditional Chinese medicine formula for treating allergic rhinitis caused by deficiency of vital energy, namely, Peiyuan Zhiti Decoction, which is made from the following raw materials by weight: 12g ginseng, 5g stir-fried yam, 10g prepared rehmannia root, 5g eucommia bark, 10g angelica root, 2g cornus officinalis, 10g wolfberry, 5g prepared licorice root, 10g magnolia flower, 10g cocklebur fruit, and 8g angelica dahurica. The above-mentioned medicinal materials are soaked in water at 8 times their weight volume at room temperature for 30 minutes, brought to a boil over high heat, simmered over low heat for 35 minutes, and filtered to obtain the first filtrate. Then, 6 times their weight volume of water is added to the first filtrate, brought to a boil over high heat, simmered over low heat for 25 minutes, and filtered to obtain the second filtrate. The two filtrates are combined, mixed well, and concentrated to 400ml to obtain the finished Peiyuan Zhiti Decoction.

[0013] The compositions given in the above embodiments can be used to prepare any amount of traditional Chinese medicine as needed. The given embodiments are only for illustrating specific implementation methods of the present invention and are not intended to limit the scope of protection of the present invention. The core technology protected by the present invention is the traditional Chinese medicine composition, which can also be made into other dosage forms permitted by medicine according to actual needs.

[0014] In the drug combinations given above, among which: Ginseng: Sweet and slightly bitter, warm in nature. Enters the spleen and lung meridians. Greatly replenishes vital energy, consolidates the body's defenses, generates fluids, and calms the mind.

[0015] Stir-fried yam: Also known as bran-fried yam, it is sweet and neutral in nature. It enters the spleen, lung, and kidney meridians. After processing, its medicinal properties become milder, and its spleen-strengthening, diarrhea-stopping, and astringent effects are enhanced, making it suitable for those with weak spleen and stomach.

[0016] Prepared Rehmannia Root: Sweet, slightly warm. It enters the liver and kidney meridians. It nourishes yin and blood, replenishes essence and marrow.

[0017] Eucommia ulmoides: Sweet, warm. It enters the liver and kidney meridians. It tonifies the liver and kidneys, strengthens tendons and bones, and calms the fetus.

[0018] Angelica sinensis: sweet, pungent, and warm. It enters the liver, heart, and spleen meridians. It nourishes and invigorates blood, regulates menstruation and relieves pain, and moistens the intestines to promote bowel movements.

[0019] Cornus officinalis: Sour, slightly warm. It enters the liver and kidney meridians. It nourishes the liver and kidneys, and has astringent and consolidating properties.

[0020] Goji berries: neutral in nature and sweet in taste. They nourish the liver and kidneys, benefit essence and improve eyesight.

[0021] Prepared licorice root: sweet, neutral. It enters the heart, lung, spleen, and stomach meridians. It tonifies the spleen and stomach, replenishes qi, and restores the pulse.

[0022] Magnolia flower: It is warm in nature and pungent in taste, and enters the lung and stomach meridians. It dispels wind and cold and clears the nasal passages.

[0023] Xanthium sibiricum: pungent, bitter, and warm in nature. Slightly toxic. It enters the lung meridian. It dispels wind-cold and clears the nasal passages.

[0024] Angelica dahurica: pungent, warm. It enters the stomach, large intestine, and lung meridians. It dispels wind and dampness, clears the orifices and relieves pain, reduces swelling and drains pus.

[0025] Based on the principles of Traditional Chinese Medicine, the above-mentioned components are arranged in a principal-secondary, minister-assistant-guide manner, with their functions interconnected and working together: Ginseng is the principal herb, greatly replenishing vital energy and tonifying the lungs and spleen; stir-fried yam and prepared rehmannia root are the minister herbs, tonifying kidney qi and enhancing the kidney's function of receiving qi; Eucommia bark, wolfberry, angelica root, cornus fruit, magnolia flower, cocklebur fruit, and angelica root are the assistant herbs. Eucommia bark and wolfberry nourish the liver and kidneys, replenish essence and vital energy, allowing the nasal passages to receive kidney qi and nourishment; angelica root and cornus fruit, one tonifying and the other astringent, ensure that qi and blood flow smoothly through the nasal passages without stagnation; magnolia flower "benefits the nine orifices and clears nasal congestion"; cocklebur fruit and angelica root dispel wind and dampness, clear the orifices and dispel cold, assisting magnolia flower in dispelling wind and cold evil and clearing nasal congestion; and prepared licorice root is the guiding herb, tonifying qi and strengthening the spleen, and harmonizing the effects of the other herbs.

[0026] The combined effects of these herbs nourish the body's vital energy, clear the nasal passages, and stop sneezing, making them effective in treating allergic rhinitis caused by deficiency of vital energy. The treatment is highly effective and efficient, and experiments have yielded very positive technical results. The relevant experimental materials are as follows (taking Example 1 as an example): I. Source of Cases This clinical trial included 60 patients who visited the Department of Otolaryngology at Henan Provincial Hospital of Traditional Chinese Medicine between June 2021 and December 2022 and met the criteria for allergic rhinitis (vital energy deficiency type).

[0027] II. Diagnostic Criteria 2.1 Western Medicine Diagnostic Criteria: The diagnostic criteria for allergic rhinitis (AR) were established based on the "Guidelines for the Diagnosis and Treatment of Allergic Rhinitis" revised in 2015 by the Chinese Society of Otorhinolaryngology-Head and Neck Surgery. ① Symptoms: Two or more symptoms such as sneezing, clear nasal discharge, nasal itching, and nasal congestion, lasting for more than 1 hour daily, may be accompanied by ocular symptoms such as itchy eyes, tearing, and red eyes; ② Physical examination: Pale and edematous nasal mucosa and watery nasal discharge may be observed; ③ Allergen testing: Positive for at least one allergen SPT and / or serum specific IgE.

[0028] 2.2 Traditional Chinese Medicine Diagnostic Criteria: Based on the "Standards for Diagnosis and Treatment of Diseases and Syndromes in Traditional Chinese Medicine" formulated by the State Administration of Traditional Chinese Medicine in 1994, the diagnostic criteria for rhinitis due to deficiency of vital energy are as follows: ① Primary symptoms: Itchy nose, frequent sneezing, copious and clear nasal discharge, nasal congestion, with sudden onset and recurrence; ② Secondary symptoms: Aversion to wind and cold, shortness of breath, cough, cold limbs, and weakness in the limbs; ③ Physical signs: Pale nasal mucosa, edema of the nasal turbinates. Pale tongue, white or thin white coating, floating or weak or deep and thready pulse.

[0029] 2.2 Inclusion Criteria ① Meets the diagnostic criteria for AR using both traditional Chinese and Western medicine; ② According to traditional Chinese medicine diagnosis, the patient's condition is of the "Qi deficiency" type; ③ Age 10-70 years old, gender not limited; ④ Patient provides informed consent and participates voluntarily.

[0030] 2.3 Exclusion Criteria ① Individuals under 10 years of age or over 70 years of age; ② Individuals with severe cardiovascular, cerebrovascular, or other systemic diseases; ③ Individuals unable to attend follow-up appointments as required or on time; ④ Pregnant or breastfeeding women; ⑤ Individuals currently using other medications; ⑥ Individuals allergic to any of the drugs or components related to this experiment.

[0031] 2.4. Standards for shedding, rejection, and termination of testing ① Failure to administer medication as specified in the trial protocol; ② Experiencing serious adverse reactions; ③ Withdrawal from the trial voluntarily.

[0032] III. Experimental Grouping Sixty patients were randomly assigned to a treatment group (traditional Chinese medicine group) (n=30) and a control group (Western medicine group) (n=30) in a 1:1 ratio using a computer-generated randomization method. During the treatment process, a designated person was responsible for receiving and following up with the patients.

[0033] IV. Treatment Plan Treatment group: The herbal decoction of this invention was used for treatment. The prescription dosage was considered as one dose, with each dose containing 400ml of decocted liquid. 200ml was taken twice daily, warm. One course of treatment lasted 7 days, and the efficacy was assessed after 28 days.

[0034] Control group: The western medicine group received levocetirizine hydrochloride (manufactured by [Company Name], batch number: [Batch Number], specification: 5mg×14 tablets) orally, 5mg once daily. One course of treatment was 7 days, and efficacy was assessed after 28 days. For patients with severe symptoms, mometasone furoate nasal spray was added, one spray per nostril once daily.

[0035] V. Observation Indicators and Methods 5.1 Symptom score: According to the 2022 Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis, the severity of nasal itching, sneezing, runny nose, and nasal congestion was assessed using the TNSS method before treatment and 28 days after treatment. The improvement of eye itching and throat itching was assessed using the Rhinitis Accompanying Symptoms Score (TNNSS). Symptoms were scored as 1, 2, 3, and 4 points, respectively, for none, mild, moderate, and severe symptoms. The higher the score, the more severe the symptoms.

[0036] 5.2 Comparison of overall syndrome scores: The overall symptom score was used to quantify the symptoms and signs of the two groups of patients before treatment and 28 days after treatment, and the improvement was compared and evaluated. The score included nine items such as fatigue, mental fatigue, and shortness of breath. The score was inversely proportional to the degree of recovery. Symptoms were scored as 1, 2, 3, and 4 points, respectively, for none, mild, moderate, and severe symptoms. The higher the score, the more severe the symptoms.

[0037] 5.3 Comparison of total scores: The overall recovery of the two groups of patients was assessed based on the comparison of systemic symptom scores before treatment and 28 days after treatment. The total score was used to reflect the degree of improvement of the patients' overall symptoms, and the score was inversely proportional to the degree of improvement.

[0038] 5.4 Visual Analogue Scale (VAS): Before and 28 days after treatment, the VAS score was used to assess the severity of patients' subjective quantitative rhinitis symptoms. Patients marked the severity of their overall allergic rhinitis symptoms on a 10cm scale, with 0 indicating no symptoms and 10 indicating the most severe symptoms.

[0039] 5.5 Laboratory Indicator Detection: Fasting venous blood was drawn from the elbow of the patient before treatment and on the morning of day 28 of treatment. Serum immunoglobulin E (IgE), interleukin (IL)-33, and transforming growth factor (TGF)-β were detected by ELISA.

[0040] VI. Clinical efficacy evaluation criteria: Clinical efficacy was assessed by the difference in total VAS scores before and after treatment. The efficacy index (N) was calculated as: (Total score before treatment - Total score after treatment) / Total score before treatment × 100%. N≥65% indicates significant effect; 25% < N < 65% is considered valid; N≤25% is invalid.

[0041] VII. Statistical Processing Data analysis was performed using SPSS 17.0 software. Overall symptom scores and nasal sub-symptom scores before and after treatment were expressed as mean ± standard deviation. The results indicate that, for comparisons before and after treatment, the chi-square test was used for count data and the t-test was used for measurement data, with p < 0.05 considered statistically significant.

[0042] The actual number of cases observed was 16 males and 14 females in the treatment group, with a mean age of (34.81±8.69) years; and 19 males and 11 females in the control group, with a mean age of (31.8±9.46) years. There were no statistically significant differences in gender, age, and symptoms between the two groups (p>0.05), indicating that they were comparable.

[0043] Table 1 shows the comparison of nasal symptom scores between the two groups of patients before treatment and 28 days after treatment; Table 2 shows the comparison of the systemic syndrome scores of the two groups of patients before treatment and 28 days after treatment. Table 3 shows the comparison of the total symptom scores of the two groups of patients before treatment and after 28 days of treatment. Table 4 shows the comparison of VAS scores between the two groups of patients before treatment and at 28 days after treatment. Table 5 shows the comparison of nasal function between the two groups of patients before treatment and 28 days after treatment. Table 6 shows the comparison of serum inflammatory factor levels in the two groups of patients before treatment and on day 28 of treatment; Table 1 Comparison of nasal symptom scores between the two groups of patients ( )

[0044] Note: Within-group comparisons, *P < 0.05, **P < 0.01; Between-group comparisons, #P < 0.05, ##P < 0.01.

[0045] Table 2 Comparison of systemic syndrome scores between the two groups of patients ( )

[0046] Note: Within-group comparisons, *P < 0.05, **P < 0.01; Between-group comparisons, #P < 0.05, ##P < 0.01.

[0047] Table 3 Comparison of total symptom scores between the two groups of patients ( )

[0048] Note: Within-group comparisons, *P < 0.05, **P < 0.01; Between-group comparisons, #P < 0.05, ##P < 0.01.

[0049] Table 4 Comparison of VAS scores between the two groups of patients ( )

[0050] Note: Within-group comparisons, *P < 0.05, **P < 0.01; Between-group comparisons, #P < 0.05, ##P < 0.01.

[0051] Table 5 Comparison of nasal function between the two groups of patients ( )

[0052] Note: Within-group comparisons, *P < 0.05, **P < 0.01; Between-group comparisons, #P < 0.05, ##P < 0.01.

[0053] Table 6 Comparison of serum inflammatory factor levels between the two groups of patients ( )

[0054] Note: For within-group comparisons, *P<0.05, **P<0.01; for between-group comparisons, #P<0.05, ##P<0.01. Before treatment, there were no statistically significant differences in serum IL-33, TGF-β, and IgE levels between the two groups (P>0.05). After 28 days of treatment, serum TGF-β and IgE levels in both groups decreased compared to before treatment (P<0.05), and the serum TGF-β and IgE levels in the traditional Chinese medicine group were significantly lower than those in the Western medicine group (P<0.05).

[0055] VIII. Statistical Results Statistical analysis was performed on the efficacy after 28 days of treatment. In the traditional Chinese medicine group, 16 cases showed significant improvement, 5 cases showed improvement, and 9 cases showed no improvement, with a total effective rate of 70%. In the Western medicine group, 10 cases showed significant improvement, 6 cases showed improvement, and 14 cases showed no improvement, with a total effective rate of 53.33%. Total number of people Effective efficient invalid Overall efficiency Treatment group 30 16（53.3%） 5（16.7%） 9（30%） 70% control group 30 10（33.3%） 6（20%） 14（46.7%） 53.3% A follow-up study 14 days after stopping the medication revealed that two people in the control group relapsed, but no one in the treatment group relapsed. Furthermore, after treatment with traditional Chinese medicine, the physical condition of the nine people in the treatment group who had not responded to the treatment improved compared to before, and their symptoms of nasal itching, sneezing, runny nose, and nasal congestion all showed continuous improvement.

[0056] During the treatment and follow-up periods, no intervention-related adverse reactions or events were reported in the 60 patients.

[0057] While conducting experiments on Example 1, the same experiments were also conducted on other examples, and the same or similar results as those in Example 1 were obtained. These results will not be listed here, indicating that the present invention has good effects and stable and reliable therapeutic effects.

[0058] IX. Conclusion In Traditional Chinese Medicine (TCM), allergic rhinitis falls under the category of "nasal congestion." While the nasal congestion is located in the nose, it is actually closely related to the dysfunction of the lungs, spleen, and kidneys. For example, the lungs govern the nose, which is both the orifice and the organ of the lungs. Our team believes that the lungs govern the dispersing and descending of Qi, dispersing defensive Qi through the nose to warm and nourish the nasal passages, strengthening their defenses against external pathogens. If lung Qi is weak, as stated in the *Ling Shu* (Spiritual Pivot), "When lung Qi is weak, the nose becomes congested and short of breath," allowing wind-cold pathogens to invade and stagnate in the nasal passages. The spleen is the foundation of acquired constitution, the source of life and transformation, and the pivot of ascending and descending Qi. Smooth nasal breathing depends on the spleen's Qi distribution, and the Stomach Meridian of Foot Yangming originates on the side of the nose and runs alongside it. The Qi and blood of the spleen meridian nourish the nose through the stomach meridian; when the spleen's Qi and blood are sufficient, the clear Qi ascends and the turbid Qi descends, nourishing all the nasal passages. If the spleen is deficient and fails to maintain its protective function, the nose will lack nourishment, leading to the retention of pathogenic factors and the development of nasal congestion. As stated in the *Suwen* (Plain Questions), "The spleen is a solitary organ… its deficiency will cause the nine orifices to become blocked." The *Suwen* also states, "The kidney is responsible for yawning and sneezing." The kidney is the root of qi; the lung governs exhalation, and the kidney governs inhalation. The nourishment of the nasal passages depends on the replenishment of essence and qi in the kidney. The kidney meridian intersects with the Du meridian, which runs from the bridge of the nose to the tip. Therefore, the kidney's Yang qi ascends to warm and nourish the nasal passages. If the kidney (Du meridian) is deficient, and the Yang qi is weak, the nose will lack warmth and nourishment, resulting in weakened external defense. Pathogenic factors such as wind and cold will invade the nasal passages, causing stagnation and obstruction of the clear orifices, leading to nasal congestion.

[0059] Nasal congestion is persistent and recurrent, especially in winter, as described in the *Book of Rites* (Liji), "In winter, when the body is resting and suffering misfortune, many people experience nasal congestion and sneezing." During an attack, the nose feels cold and the nasal discharge is clear and watery. This is all due to insufficient vital energy (Qi) and the upward invasion of cold pathogens. Therefore, based on literature and clinical research, our team proposes that allergic rhinitis is caused by impaired Qi transformation in the lungs, spleen, and kidneys, leading to superficial deficiency and subsequent invasion of pathogenic factors. The basic pathogenesis is insufficient vital energy and excessive wind-cold pathogens. The treatment principle is to nourish vital energy and clear the nasal passages to stop sneezing.

[0060] Based on years of clinical experience, the applicant has modified the Da Bu Yuan Jian formula to create Pei Yuan Zhi Ti Tang: Ginseng 10g, stir-fried yam 6g, prepared rehmannia root 9g, eucommia bark 6g, angelica root 9g, cornus fruit 3g, wolfberry 9g, prepared licorice root 6g, magnolia flower 9g, cocklebur fruit 9g, angelica root 9g. In this formula, ginseng is the chief ingredient, greatly replenishing vital energy and tonifying the lungs and spleen. Stir-fried yam and prepared rehmannia root tonify kidney qi, enhancing the kidney's function of receiving qi. Eucommia bark and wolfberry nourish the liver and kidneys, replenishing essence and vital energy, allowing the nasal passages to receive kidney qi and nourishment. Angelica root and cornus fruit, one tonifying and the other astringent, ensure that qi and blood flow smoothly through the nasal passages, replenishing without stagnation. Magnolia flower "benefits the nine orifices and clears nasal congestion," while cocklebur fruit and angelica root dispel wind and dampness, clear the orifices and dispel cold, assisting magnolia flower in dispelling wind-cold and clearing nasal congestion. Prepared licorice root tonifies qi, strengthens the spleen, and harmonizes the other herbs.

[0061] In the evaluation of the efficacy of traditional Chinese medicine in treating AR, in addition to the evaluation of the main nasal symptoms, comprehensive evaluations are also carried out on non-nasal systemic symptoms, disease control, etc., in order to comprehensively and truly reflect the treatment effect. The results of this study showed that after treatment, the nasal symptom scores, systemic symptom scores, total scores, VAS scores and nasal function in the traditional Chinese medicine group and the western medicine group were significantly improved. With the increase of the treatment time, Peiyuan Zhiti Decoction could better improve nasal symptoms such as runny nose, nasal congestion, nasal itching, and nasal accompanying symptoms such as itchy throat and itchy eyes. For allergic rhinitis of qi deficiency type, Peiyuan Zhiti Decoction could significantly improve symptoms and signs such as fear of cold, diarrhea, shortness of breath, spontaneous sweating and tongue quality while improving nasal symptoms, improve the quality of life of patients, and no adverse reactions were seen during the treatment process. The short-term efficacy was stable after drug withdrawal.

[0062] In the clinical study of AR, considering the common accompanying symptoms such as itchy throat and itchy eyes in AR patients, the nasal symptom score including these symptoms was used as the key outcome index to evaluate the efficacy, so as to directly reflect the core changes of nasal symptoms. The systemic symptom score was used to evaluate the overall recovery of patients, reflected in the more extensive symptom control and the improvement of quality of life; the total score was used to judge the level of symptom control and improvement, and was often used as an important outcome index in clinical studies. This study added the follow-up situation 14 days after treatment on the basis of the scores before and after treatment, suggesting that Peiyuan Zhiti Decoction can not only more effectively relieve the core nasal symptoms compared with levocetirizine hydrochloride and other western medical treatments, but also has a more extensive symptom control and improvement of quality of life, showing the potential of Peiyuan Zhiti Decoction to maintain long-term efficacy.

[0063] Allergic reactions (AR), a type I hypersensitivity disorder dominated by IgE and helper T cells (Th cells), are fundamentally driven by Th cell immune imbalance, which is the core mechanism of AR inflammation. The imbalance between type 1 helper T cells (Th1) and Th2 cells forms the immunological basis of AR. Studies have shown that prolonged exposure to allergens can lead to the polarization of naive T lymphocytes into Th2 cells by inflammatory factors such as IL-4. IL-33 can amplify Th2 cell activation. Th2 cells secrete cytokines such as IL-4 and IL-6, which simultaneously stimulate B cell differentiation into plasma cells, ultimately promoting IgE production. When IgE antibodies bind to receptors on mast cells and eosinophils, inflammatory cytokines are released, inducing a Th2 response and sensitizing the body. In this sensitized state, mast cells degranulate, releasing histamine, IL-4, and other inflammatory factors. These stimulate sensory nerve endings in the nasal mucosa, causing vasodilation and increased glandular secretion, resulting in symptoms such as nasal itching, sneezing, and runny nose. Although TGF-β typically has anti-inflammatory effects, the abnormally elevated TGF-β levels during this process may reflect a compensatory anti-inflammatory response. Furthermore, TGF-β can promote fibrosis or tissue remodeling, possibly related to nasal mucosal thickening and goblet cell proliferation in acute rheumatoid arthritis (AR). This study observed a decrease in serum IL-33, TGF-β, and IgE levels in both treatment groups. Moreover, the traditional Chinese medicine group showed significantly better therapeutic effects than the Western medicine group in both short-term treatment and long-term observation, suggesting that Peiyuan Zhiti Decoction may exert its therapeutic effect by inhibiting the release of pro-inflammatory cytokines and improving the Th1 / Th2 cell imbalance.

[0064] In summary, the traditional Chinese medicine Peiyuan Zhiti Decoction of this invention can effectively improve the clinical symptoms of AR patients, significantly improve their quality of life, significantly reduce the expression level of related inflammatory factors in the serum of AR patients with insufficient vital energy, and improve Th cell immune imbalance. It provides evidence-based medical support for promoting the clinical application of traditional Chinese medicine and is a major innovation in the treatment of allergic rhinitis with insufficient vital energy, with practical clinical application value.

Claims

1. A traditional Chinese medicine, Peiyanzhiniu Decoction, for treating qi deficiency type allergic rhinitis, characterized in that, The following weight of raw materials is prepared: 8-12g of ginseng, 5-7g of fried yam, 8-10g of prepared rehmannia, 5-7g of eucommia, 8-10g of angelica, 2-4g of dogwood, 8-10g of medlar, 5-7g of fried licorice, 8-10g of magnolia flower, 8-10g of xanthium and 8-10g of white peony root. The above traditional Chinese medicine raw materials are soaked in 8 times the weight volume of water at room temperature for 30 minutes, decocted with strong fire, and then decocted with weak fire for 30-40 minutes. The first filtrate is obtained by filtration. Then 6 times the weight volume of water is added to the traditional Chinese medicine raw materials, which are decocted with strong fire and then with weak fire for 20-30 minutes. The second filtrate is obtained by filtration. The two filtrates are combined, mixed uniformly, and concentrated to 400ml to obtain the finished product of the traditional Chinese medicine Buyuan Zhiniu Decoction.

2. The Chinese medicine of treating allergic rhinitis of deficiency of primordial qi in claim 1, characterized in that, The following weight of raw materials is prepared: 10g of ginseng, 6g of fried yam, 9g of prepared rehmannia, 6g of eucommia, 9g of angelica, 3g of dogwood, 9g of medlar, 6g of fried licorice, 9g of magnolia flower, 9g of xanthium and 9g of white peony root. The above traditional Chinese medicine raw materials are soaked in 8 times the weight volume of water at room temperature for 30 minutes, decocted with strong fire, and then decocted with weak fire for 35 minutes. The first filtrate is obtained by filtration. Then 6 times the weight volume of water is added to the traditional Chinese medicine raw materials, which are decocted with strong fire and then with weak fire for 25 minutes. The second filtrate is obtained by filtration. The two filtrates are combined, mixed uniformly, and concentrated to 400ml to obtain the finished product of the traditional Chinese medicine Buyuan Zhiniu Decoction. 3.The Chinese medicine of treating allergic rhinitis due to deficiency of primordial qi according to claim 1, characterized in that, The following weight of raw materials is prepared: 8g of ginseng, 5g of fried yam, 8g of prepared rehmannia, 5g of eucommia, 8g of angelica, 2g of dogwood, 8g of medlar, 5g of fried licorice, 8g of magnolia flower, 8g of xanthium and 8g of white peony root. The above traditional Chinese medicine raw materials are soaked in 8 times the weight volume of water at room temperature for 30 minutes, decocted with strong fire, and then decocted with weak fire for 30 minutes. The first filtrate is obtained by filtration. Then 6 times the weight volume of water is added to the traditional Chinese medicine raw materials, which are decocted with strong fire and then with weak fire for 20 minutes. The second filtrate is obtained by filtration. The two filtrates are combined, mixed uniformly, and concentrated to 400ml to obtain the finished product of the traditional Chinese medicine Buyuan Zhiniu Decoction.

4. The Chinese medicine of treating allergic rhinitis of deficiency of primordial qi in claim 1, characterized in that, The following weight of raw materials is prepared: 12g of ginseng, 7g of fried yam, 10g of prepared rehmannia, 7g of eucommia, 10g of angelica, 4g of dogwood, 10g of medlar, 7g of fried licorice, 10g of magnolia flower, 10g of xanthium and 10g of white peony root. The above traditional Chinese medicine raw materials are soaked in 8 times the weight volume of water at room temperature for 30 minutes, decocted with strong fire, and then decocted with weak fire for 40 minutes. The first filtrate is obtained by filtration. Then 6 times the weight volume of water is added to the traditional Chinese medicine raw materials, which are decocted with strong fire and then with weak fire for 30 minutes. The second filtrate is obtained by filtration. The two filtrates are combined, mixed uniformly, and concentrated to 400ml to obtain the finished product of the traditional Chinese medicine Buyuan Zhiniu Decoction.

5. The Chinese medicine of treating allergic rhinitis of deficiency of primordial Qi according to claim 1, characterized in that, The following raw medicinal materials are prepared by weight: 8g of ginseng, 7g of fried Chinese yam, 8g of prepared rehmannia, 7g of eucommia, 8g of angelica, 4g of dogwood, 8g of medlar, 7g of baked licorice, 8g of magnolia flower, 10g of xanthium, and 8g of white peony root. The above-mentioned traditional Chinese medicine raw materials are soaked in 8 times the weight volume of water at room temperature for 30 minutes, boiled with a strong fire, and then simmered for 35 minutes with a weak fire. The first filtrate is obtained by filtration. Then 6 times the weight volume of water is added to the traditional Chinese medicine raw materials, which are boiled with a strong fire, and then simmered for 25 minutes with a weak fire. The second filtrate is obtained by filtration. The two filtrates are combined, mixed, and concentrated to 400ml to obtain the finished product of the traditional Chinese medicine Buyuan Zhiniu Decoction.

6. The Chinese medicine of treating allergic rhinitis of deficiency of primordial Qi according to claim 1, characterized in that, The following raw medicinal materials are prepared by weight: 12g of ginseng, 5g of fried Chinese yam, 10g of prepared rehmannia, 5g of eucommia, 10g of angelica, 2g of dogwood, 10g of medlar, 5g of baked licorice, 10g of magnolia flower, 10g of xanthium, and 8g of white peony root. The above-mentioned traditional Chinese medicine raw materials are soaked in 8 times the weight volume of water at room temperature for 30 minutes, boiled with a strong fire, and then simmered for 35 minutes with a weak fire. The first filtrate is obtained by filtration. Then 6 times the weight volume of water is added to the traditional Chinese medicine raw materials, which are boiled with a strong fire, and then simmered for 25 minutes with a weak fire. The second filtrate is obtained by filtration. The two filtrates are combined, mixed, and concentrated to 400ml to obtain the finished product of the traditional Chinese medicine Buyuan Zhiniu Decoction.

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