Thyroid-astragalus mongholicus patch and selenium yeast tablet combined medicine composition and application thereof

Abstract

The invention discloses a combined medicine composition of a thyroid Qixia patch and a selenium yeast tablet and application of the combined medicine composition, and belongs to the technical field of medicines. The composition is composed of a thyroid and astragalus mongholicus summer patch and a selenium yeast tablet, the thyroid and astragalus mongholicus summer patch is prepared by grinding astragalus mongholicus, selfheal, radix clematidis, turmeric, airpotato yam and semen brassicae as raw materials, and adding vaseline to prepare paste. The selenium yeast tablet is used for oral administration and is matched with the thyroid qi-summer patch for external application on the neck, and the treatment course is 3 months. Clinical verifications show that the total effective rate of the composition reaches 87.80%, the composition can effectively improve symptoms such as anterior cervical mass, dysphoria, irritability and the like, reduce the level of serum TPOAb, reduce thyroid and nodule volumes and improve nodule blood flow, the safety is good, the curative effect is superior to that of pure western medicine treatment, and an effective treatment scheme is provided for related diseases.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medicine, in particular to a combined medication composition of a thyroid astragalus paste and selenium yeast tablets and uses thereof. BACKGROUND

[0002] Hashimoto's thyroiditis (HT) is a common autoimmune disease characterized by lymphocyte infiltration and autoantibody formation in the thyroid gland. It has an insidious onset, a prolonged course, and is prone to relapse. The prevalence rate in the adult population in China is relatively high, accounting for about 22.5% of all thyroid diseases. It is more common in women, and some patients may eventually develop hypothyroidism. During the pathological progression, persistent inflammation and repair can lead to fibrous tissue proliferation, and some patients may develop thyroid nodules.

[0003] Thyroid nodules are abnormal local hyperplasia of thyroid tissue. Their occurrence is related to gender, age, iodine intake, ionizing radiation exposure, obesity, metabolic syndrome, and immunity. Patients with HT combined with thyroid nodules often have no obvious symptoms in the early stage, and are often discovered during physical examination. Some may have local symptoms such as swelling in the front of the neck, a foreign body sensation in the neck, and swallowing discomfort. As the disease progresses, it may also cause hypothyroidism, enlarged nodules compressing surrounding tissues, and systemic manifestations such as anxiety, depression, and fatigue, which severely affect the patient's quality of life.

[0004] Currently, the main treatment methods for HT combined with thyroid nodules in Western medicine include selenium preparations, vitamin D supplementation, immunosuppression, and surgical resection. Among them, selenium yeast tablets, as a commonly used selenium preparation, are widely used in clinical practice. However, their effect on reducing serum anti-thyroid peroxidase antibodies (TPOAb) and anti-thyroglobulin antibodies (TgAb) is limited when used alone, and they are prone to relapse after discontinuation. Some patients may also experience adverse reactions such as palpitations, sweating, and hair loss, and the long-term efficacy is controversial. Surgical treatment is only suitable for suspicious malignancies or particularly large nodules that produce significant compression symptoms, and is not suitable for all patients.

[0005] Traditional Chinese medicine has unique advantages in the treatment of HT combined with thyroid nodules. According to traditional Chinese medicine theory, this disease belongs to the category of "goiter", "goiter", and "goiter", and its pathogenesis is often related to liver stagnation and phlegm accumulation. Therefore, the treatment should focus on soothing the liver, clearing heat, invigorating the spleen, resolving phlegm, and softening and resolving nodules. Traditional Chinese medicine external treatment, as an important part of traditional Chinese medicine, has the characteristics of directly acting on the disease and having few adverse reactions. In recent years, it has received much attention in the treatment of thyroid diseases. Based on this, the present application proposes a combined medication composition of a thyroid astragalus paste and selenium yeast tablets, aiming to exert the synergistic effect of combined traditional Chinese and Western medicine treatment and improve the treatment effect. SUMMARY

[0006] The present application aims at the problems of limited curative effect, easy recurrence and adverse reactions in the existing western medicine treatment of Hashimoto's thyroiditis combined with thyroid nodules, and provides a combined medication composition of a thyroid astragalus and spirea ulmaria paste and selenium yeast tablets, which combines traditional Chinese medicine external treatment and western medicine oral administration, can effectively improve the clinical symptoms of patients, reduce the related antibody level, reduce the volume of thyroid and nodules, and has good safety.

[0007] In order to achieve the above-mentioned purpose, the present application adopts the following technical solutions:

[0008] A combined medication composition comprises a thyroid astragalus and spirea ulmaria paste and selenium yeast tablets; the raw materials of the thyroid astragalus and spirea ulmaria paste consist of astragalus, spirea ulmaria, clematis, turmeric, radix xanthorrhoeae and white mustard seed.

[0009] The raw materials of the thyroid astragalus and spirea ulmaria paste are as follows in terms of weight parts: 40-50 parts of astragalus, 25-35 parts of spirea ulmaria, 12-18 parts of clematis, 12-18 parts of turmeric, 8-12 parts of radix xanthorrhoeae and 8-12 parts of white mustard seed, preferably 45 parts of astragalus, 30 parts of spirea ulmaria, 15 parts of clematis, 15 parts of turmeric, 10 parts of radix xanthorrhoeae and 10 parts of white mustard seed. The weight part range and the preferred ratio are determined based on the theory of traditional Chinese medicine, years of clinical experience and the results of pre-experiments, and each raw material can achieve the best synergistic effect under this ratio to achieve the effect of tonifying qi, clearing liver, resolving and eliminating goiter.

[0010] The preparation method of the thyroid astragalus and spirea ulmaria paste is as follows: grinding each raw material into powder, adding vaseline to make it into paste, and making it into a butterfly-shaped plaster. This shape is convenient for sticking to the corresponding body surface projection area of the anterior cervical thyroid region to ensure the targeting of drug action. The specification of the selenium yeast tablet is that each tablet contains selenium ≥100 μg, and the dosage is 100 μg / time, 2 times / day. This dosage is the effective dosage commonly used in clinical practice, which can reduce the risk of adverse reactions while ensuring the treatment effect.

[0011] The combined medication composition is used for treating liver stagnation and fire type Hashimoto's thyroiditis combined with thyroid nodules. The syndrome differentiation criteria of liver stagnation and fire type are formulated according to "goiter" in Internal Medicine of Traditional Chinese Medicine and "Guiding Principles for Clinical Research of New Drugs of Traditional Chinese Medicine": the main symptoms are anterior cervical enlargement, obstruction in the throat, irritability and irritability; the secondary symptoms are chest and hypochondrium distention and pain, dry mouth, insomnia, tongue red with yellow fur, and pulse string number, which ensures accurate syndrome differentiation and improves the targeting of medication.

[0012] The subjects suitable for the combined medication composition should meet the following criteria: the western medicine diagnosis meets the Hashimoto's thyroiditis standard in the Hashimoto's Thyroiditis Diagnosis and Treatment Guidelines of Traditional Chinese Medicine and Western Medicine (diffuse enlargement of the thyroid gland or with nodules, TPOAb and / or TgAb positive, and ultrasound image and puncture cytology examination if necessary), the thyroid nodules are confirmed to be benign by ultrasound evaluation and fine needle aspiration cytology; the age is 18-65 years old; no relevant drug treatment in the past 1 month; voluntarily participate in the study and sign the informed consent form to ensure the accuracy of the treatment effect and clinical data.

[0013] The subjects suitable for the combined medication composition are excluded from the following groups: those with thyroid surgery indications or suspicious malignant nodules; those with severe heart, liver, kidney and other functional disorders; those with other autoimmune diseases, malignant tumors and acute infections; pregnant or lactating women; those allergic to any component of the combined medication composition to avoid medication risks.

[0014] The use method of the combined medication composition is as follows: selenium yeast tablets are taken orally, and the thyroid Qixia patch is externally applied to the neck for 1.5-2.5 hours once a day (the time can be appropriately shortened when local allergic symptoms occur), and the treatment course is 3 months; during the treatment, the patients are given emotional counseling, dietary suggestions and other basic lifestyle guidance to assist in improving the treatment effect.

[0015] The observation indexes of the combined medication composition include: ① TCM syndrome score: according to the main symptoms of liver stagnation and fire in the Guiding Principles for Clinical Research on New Drugs of Traditional Chinese Medicine, the four symptoms of palpable mass in the neck, swelling sensation in the neck, foreign body sensation or swallowing discomfort in the throat, and irritability are scored according to the four levels of no (0 points), mild (2 points), moderate (4 points), and severe (6 points), and scored once before and after treatment; ② thyroid antibody function index: morning fasting venous blood is collected to detect serum TPOAb and TgAb levels; ③ thyroid and nodule ultrasound index: the left lobe, right lobe, isthmus, maximum diameter of thyroid nodules, blood flow resistance index (RI), and pulsatility index (PI) are recorded; ④ safety index: the occurrence of adverse reactions during treatment is recorded, and the incidence of adverse reactions is calculated.

[0016] The efficacy evaluation criteria of the combined medication composition are formulated according to the Diagnosis and Treatment Criteria for TCM Syndromes: clinical cure is the disappearance of symptoms, and the efficacy index is ≥90%; effective is that the symptoms are significantly improved, and 60%≤efficacy index<90%; improvement is that the symptoms are relieved, and 30%≤efficacy index<60%; ineffective is that the above criteria are not met or the symptoms are aggravated; and the efficacy index=(treatment before score-treatment after score) / treatment before score×100%, to ensure the objectivity and standardization of efficacy evaluation.

[0017] The combined medication composition of the present application combines the thyroid Qixia patch with selenium yeast tablets, and has the following beneficial effects:

[0018] This combined medication composition consists of a thyroid astragalus and summer-ripening patch and selenium yeast tablets. The raw materials for the thyroid astragalus and summer-ripening patch include astragalus, prunella vulgaris, clematis chinensis, turmeric, dioscorea bulbifera, and white mustard seed. These raw materials are mixed in specific weight proportions, ground into powder, and mixed with petroleum jelly to form a butterfly-shaped patch. This invention clarifies that the applicable population for this composition is patients with Hashimoto's thyroiditis complicated by thyroid nodules of the liver-stagnation-fire type. It establishes corresponding diagnostic criteria in both traditional Chinese medicine and Western medicine, methods for inclusion and exclusion, specifies the detailed medication method, treatment course, and basic lifestyle guidance, and clarifies observation items such as TCM syndrome scores, thyroid antibody levels, and ultrasound-related indicators, as well as standardized efficacy evaluation criteria. Clinical trials have demonstrated that the combined drug combination has an overall effective rate of 87.80%, significantly better than treatment with selenium yeast tablets alone. It can effectively improve symptoms such as cervical masses and irritability, reduce serum TPOAb levels, shrink thyroid and nodule volume, improve nodule blood flow parameters, and has good safety. It provides a standardized and effective integrated traditional Chinese and Western medicine treatment for Hashimoto's thyroiditis complicated with thyroid nodules of the liver stagnation and fire type, and has important clinical application value. Attached Figure Description

[0019] Figure 1 Ultrasound images of thyroid nodules in the observation group before treatment;

[0020] Figure 2 The ultrasound image shows the significant reduction in thyroid nodule size in the observation group patients after 3 months of treatment, with a marked decrease in nodule diameter. Detailed Implementation

[0021] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to specific embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0022] Example 1: Preparation of the combined drug composition

[0023] Preparation of Astragalus and Prunella vulgaris Patch for Thyroid Disease: Weigh out 45g of Astragalus membranaceus, 30g of Prunella vulgaris, 15g of Clematis chinensis, 15g of Curcuma longa, 10g of Dioscorea bulbifera, and 10g of Sinapis alba according to the following weight proportions. Crush each ingredient and pass it through an 80-mesh sieve. Add an appropriate amount of Vaseline, stir well to form a paste, and make it into a butterfly-shaped patch to obtain the Astragalus and Prunella vulgaris Patch for Thyroid Disease.

[0024] The combined drug composition consists of the thyroid Qixia patch prepared above and commercially available selenium yeast tablets (manufacturer: Mudanjiang Lingtai Pharmaceutical Co., Ltd., approval number: National Drug Approval Number 10940161, specification: 100μg selenium per tablet).

[0025] Example 2: Clinical trial of the combination drug composition

[0026] Subject selection:

[0027] (1) Diagnostic criteria: The Western medicine diagnosis meets the criteria for Hashimoto's thyroiditis in the "Guidelines for the Diagnosis and Treatment of Hashimoto's Thyroiditis by Integrated Traditional Chinese and Western Medicine". The thyroid nodules are confirmed to be benign by ultrasound evaluation and fine needle aspiration cytology. The TCM diagnosis meets the criteria for liver stagnation and fire, with the main symptoms being swelling in the front of the neck, a feeling of obstruction in the throat, irritability and anger, and the secondary symptoms being chest and rib pain, bitter taste in the mouth and dry throat, insomnia and dreaminess, red tongue with yellow coating, and wiry and rapid pulse.

[0028] (2) Inclusion criteria: meeting the above-mentioned diagnostic criteria of traditional Chinese medicine and Western medicine; aged 18 to 65 years; not receiving relevant drug treatment in the past month; voluntarily participating in the study and signing the informed consent form.

[0029] (3) Exclusion criteria: those with indications for thyroid surgery or suspected malignant nodules; those with severe heart, liver, kidney dysfunction, or other autoimmune diseases, malignant tumors, or acute infections; pregnant or lactating women; and those allergic to the drugs used in the study.

[0030] (4) A total of 82 patients who visited the Department of Thyroid Surgery at Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine from January 2024 to July 2025 were selected and randomly divided into a control group and an observation group, with 41 patients in each group. The control group consisted of 18 males and 23 females, aged 22–60 years, with a mean age of (38.58±5.89) years, a disease duration of 1–5 years, with a mean duration of (2.8±1.18) years, and a maximum nodule diameter of 4–25 mm, with a mean diameter of (11.81±4.83) mm. The observation group consisted of 19 males and 22 females, aged 23–58 years, with a mean age of (36.42±8.08) years, a disease duration of 1–5 years, with a mean duration of (2.91±1.32) years, and a maximum nodule diameter of 3–28 mm, with a mean diameter of (11.39±4.67) mm. There were no statistically significant differences in baseline data between the two groups (P>0.05), indicating comparability. This study was approved by the hospital's ethics committee (approval number: 2022-1211-148).

[0031] Treatment methods: Both groups received basic lifestyle guidance, including emotional support and dietary advice.

[0032] Control group: Oral selenium yeast tablets, 100μg / time, twice a day, for 3 months.

[0033] Observation group: In addition to the treatment of the control group, the thyroid Qixia patch prepared in Example 1 was applied to the neck, one patch per day, for two hours each time. When the patient experienced local allergic symptoms, the time was appropriately shortened. The treatment was continued for three months.

[0034] Observation indicators detection and recording:

[0035] (1) TCM syndrome score: Before and after treatment, the four-level scoring standard of four symptoms were used to score the symptoms: palpable mass in front of the neck, neck swelling, foreign body sensation or swallowing discomfort, and irritability.

[0036] (2) Thyroid antibody function indicators: Fasting venous blood was collected from patients in the morning before and after treatment to detect serum TPOAb and TgAb levels.

[0037] (3) Ultrasound indicators: Before and after treatment, ultrasound examinations were conducted to record the anteroposterior diameter of the left lobe of the thyroid gland, the anteroposterior diameter of the right lobe, the anteroposterior diameter of the isthmus, as well as the maximum diameter of the thyroid nodule, RI, and PI values.

[0038] (4) Safety indicators: During the treatment period, the occurrence of adverse reactions in the two groups of patients was closely observed and recorded, and the incidence of adverse reactions was calculated.

[0039] Therapeutic efficacy evaluation: Referring to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine", the clinical cure, effectiveness, improvement and ineffectiveness levels are determined based on the efficacy index.

[0040] Statistical methods: All data were analyzed using SPSS 25.0. Normally distributed continuous data were expressed as mean ± standard deviation (x ± s). Independent samples tests were used for comparisons between groups, and paired t-tests were used for comparisons within groups. Categorical data were expressed as percentages (%), and chi-square tests were used for comparisons between groups. P < 0.05 was considered statistically significant.

[0041] Experimental results:

[0042] (1) Clinical efficacy: After treatment, the total effective rate of the observation group was 87.80%, which was significantly higher than that of the control group (53.65%). The difference between the groups was statistically significant (P<0.05). The specific results are shown in Table 1.

[0043] Table 1. Comparison of clinical efficacy between the two groups of patients [n(%)]

[0044]

[0045] (2) TCM syndrome score: There was no significant difference in TCM syndrome score between the two groups before treatment (P>0.05). After treatment, the scores of both groups decreased significantly (P<0.05), and the score of the observation group was significantly lower than that of the control group (P<0.05). The specific results are shown in Table 2.

[0046] Table 2 Comparison of TCM syndrome scores before and after treatment in the two groups (x±s, scores)

[0047]

[0048] Note: Compared with the pre-treatment level in this group, P<0.05; compared with the post-treatment level in the control group, #P<0.05

[0049] (3) Thyroid antibody function indicators: There was no significant difference in TPOAb and TgAb levels between the two groups before treatment (P>0.05). After treatment, TPOAb levels in both groups decreased significantly (P<0.05), and the TPOAb level in the observation group was significantly lower than that in the control group after treatment (P<0.05). There was no significant difference in TgAb levels between the two groups after treatment (P>0.05). The specific results are shown in Table 3.

[0050] Table 3 Comparison of changes in thyroid antibody function before and after treatment in the two groups (x±s, IU / ml)

[0051]

[0052] Note: Compared with the pre-treatment level in this group, P<0.05; compared with the post-treatment level in the control group, #P<0.05

[0053] (4) Thyroid volume: After treatment, ultrasound showed that the anteroposterior diameter of the left and right lobes and isthmus of the thyroid gland in both groups was shortened compared with that before treatment (P<0.05), and the improvement in the observation group was significantly better than that in the control group (P<0.05). The specific results are shown in Table 4.

[0054] Table 4 Comparison of thyroid volume before and after treatment in the two groups (x±s, mm)

[0055]

[0056] Note: Compared with the pre-treatment level in this group, P<0.05; compared with the post-treatment level in the control group, #P<0.05

[0057] (5) Ultrasound indicators of thyroid nodules: After treatment, the diameter of the largest nodule in both groups was smaller than before treatment (P<0.05), and the RI and PI values ​​were significantly lower than before treatment (P<0.05). The decrease was more significant in the observation group than in the control group, and the difference was statistically significant (P<0.05). See Table 5 for details.

[0058] Table 5 Comparison of the largest nodules before and after treatment in the two groups (x±s)

[0059]

[0060] Note: Compared with the group before treatment, *P<0.05; compared with the control group after treatment, #P<0.05

[0061] like Figure 1 and Figure 2 The thyroid nodules in the observation group showed significant shrinkage after 3 months of treatment.

[0062] (6) Safety evaluation: Two patients in the observation group developed mild local skin erythema, which resolved spontaneously without special treatment; one patient in the control group developed hair loss, which resolved after a one-week suspension of selenium yeast administration, and the patient continued treatment. No serious adverse events such as liver or kidney damage occurred in either group, and the incidence of adverse reactions was not statistically significant (P>0.05).

[0063] The above clinical trial results show that the combined drug composition of the present invention is significantly effective in treating Hashimoto's thyroiditis complicated with thyroid nodules of the liver stagnation and fire type, can effectively improve patients' clinical symptoms and related indicators, and has good safety.

[0064] In summary, this invention provides a comprehensive and clear set of applicable standards, including diagnostic criteria for both traditional Chinese and Western medicine, TCM syndrome differentiation criteria, inclusion and exclusion criteria, dropout criteria, medication methods, observation indicators, and efficacy evaluation criteria. This provides a unified and standardized approach for clinical application, avoiding blind medication use and improving treatment accuracy and operability.

[0065] Significant and multidimensional therapeutic effects: Clinical trials have verified that the total effective rate of this combination drug for treating Hashimoto's thyroiditis with thyroid nodules of the liver-stagnation and fire type reached 87.80%, which is significantly higher than the 53.65% achieved by using selenium yeast tablets alone. It can effectively improve the TCM symptoms of patients such as cervical mass, neck swelling, foreign body sensation in the throat, and irritability, significantly reduce serum TPOAb levels, reduce the anteroposterior diameter of the left and right thyroid lobes and the isthmus, reduce the maximum diameter of thyroid nodules, and reduce the blood flow resistance index (RI) and pulsatility index (PI) of nodules, thus achieving multidimensional improvement in patients' symptoms, antibody levels, thyroid and nodule morphology and function.

[0066] The synergistic effect is prominent: In the Astragalus and Prunella vulgaris patch for thyroid glands, Astragalus has an immunomodulatory effect, which can inhibit the production of autoantibodies and improve thyroid lymphocyte infiltration; Prunella vulgaris can clear liver fire, disperse stagnation, and inhibit thyroid cell proliferation; Clematis chinensis invigorates blood and unblocks collaterals, Dioscorea bulbifera disperses nodules and relieves pain, Sinapis alba reduces swelling and resolves phlegm, and Curcuma longa is pungent and warm to unblock the meridians to suppress the bitter and cold nature of Prunella vulgaris. The combination of these herbs works together to invigorate qi, clear the liver, disperse nodules and eliminate goiter; when used in combination with selenium yeast tablets, the synergistic effect of traditional Chinese and Western medicine makes up for the shortcomings of Western medicine treatment alone and significantly improves the treatment effect.

[0067] Good safety profile: In clinical application, only 2 patients in the observation group developed mild local skin erythema, and 1 patient in the control group developed hair loss. Neither case required special treatment or was relieved after a short discontinuation of the medication. No serious adverse events such as liver or kidney damage occurred in either group. The incidence of adverse reactions was low and the severity was mild, and patients tolerated the symptoms well.

[0068] Convenient to use and with high compliance: Thyroid Qixia Patch is an external application with a simple preparation process and a shape designed to fit the neck, making it easy to use; Selenium Yeast Tablets are an oral preparation, making them easy to take; The course of treatment is clearly defined as 3 months, and the basic lifestyle guidance during the treatment period is easy to follow, which helps to improve patients' treatment compliance.

[0069] Precautions

[0070] The combination drug composition of the present invention is only applicable to patients who meet the above-mentioned diagnostic criteria of traditional Chinese and Western medicine and the syndrome differentiation of liver stagnation and fire. Before use, patients must be strictly screened according to the inclusion and exclusion criteria to avoid misuse.

[0071] The Astragalus and Astragalus Patch for Thyroid is a topical preparation and should not be taken orally. When using it, it should be accurately applied to the corresponding projection area on the body surface of the thyroid region on the front of the neck. If the patient experiences a severe allergic reaction to the local skin, the medication should be discontinued immediately and appropriate symptomatic treatment should be given.

[0072] Selenium yeast tablets should be taken strictly according to the prescribed dosage. Do not increase or decrease the dosage without authorization, so as not to affect the treatment effect or aggravate adverse reactions.

[0073] During treatment, patients should strictly follow basic lifestyle guidelines, maintain emotional stability, eat a reasonable diet, and avoid affecting the treatment effect due to improper lifestyle habits; at the same time, they need to have relevant indicators checked regularly in order to monitor changes in their condition and adjust the treatment plan in a timely manner.

[0074] In clinical application, the observation indicators detection methods and efficacy evaluation standards specified in this invention should be strictly followed to ensure the scientific nature, reliability and comparability of clinical data.

[0075] The above description is only a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in the present invention, based on the technical solution and inventive concept of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A combination drug composition, characterized in that, The product includes Astragalus membranaceus patch for thyroid glands and selenium yeast tablets; the raw materials for the Astragalus membranaceus patch for thyroid glands are composed of Astragalus membranaceus, Prunella vulgaris, Clematis chinensis, Curcuma longa, Dioscorea bulbifera and Sinapis alba.

2. The combination drug composition according to claim 1, characterized in that, The raw materials of the thyroid Qixia patch are as follows by weight: Astragalus membranaceus 40-50 parts, Prunella vulgaris 25-35 parts, Clematis chinensis 12-18 parts, Curcuma longa 12-18 parts, Dioscorea bulbifera 8-12 parts, and Sinapis alba 8-12 parts, preferably Astragalus membranaceus 45 parts, Prunella vulgaris 30 parts, Clematis chinensis 15 parts, Curcuma longa 15 parts, Dioscorea bulbifera 10 parts, and Sinapis alba 10 parts.

3. The combination drug composition according to claim 1 or 2, characterized in that, The preparation method of the thyroid Qixia patch is as follows: grind each raw material into powder, add petroleum jelly to make a paste, and make a butterfly-shaped patch; the specification of the selenium yeast tablet is that each tablet contains ≥100μg of selenium, and the dosage is 100μg / time, twice a day.

4. The use of the combined drug composition according to any one of claims 1-3 in the preparation of a medicament for treating Hashimoto's thyroiditis complicated with thyroid nodules of the liver-stagnation-fire type, characterized in that, The diagnostic criteria for the liver stagnation and fire type are based on the "goiter" in "Internal Medicine of Traditional Chinese Medicine" and the "Guiding Principles for Clinical Research of New Chinese Medicines". The main symptoms are swelling in the front of the neck, a feeling of obstruction in the throat, irritability and anger. The secondary symptoms are distending pain in the chest and ribs, bitter taste in the mouth and dry throat, insomnia and dreaminess, red tongue with yellow coating, and wiry and rapid pulse.

5. The use according to claim 4, characterized in that, The target population for this medication must meet the following criteria: a Western medical diagnosis that meets the criteria for Hashimoto's thyroiditis in the "Guidelines for the Diagnosis and Treatment of Hashimoto's Thyroiditis by Integrated Traditional Chinese and Western Medicine," and thyroid nodules that are confirmed to be benign by ultrasound evaluation and fine-needle aspiration cytology; age 18-65 years, no prior drug treatment received in the past month, and a voluntary informed consent form signed.

6. The use according to claim 4, characterized in that, The following individuals are excluded from the indications for this drug: those with thyroid surgery indications or suspected malignant nodules, those with severe heart, liver, or kidney dysfunction, those with other autoimmune diseases, malignant tumors, or acute infections, pregnant or lactating women, and those allergic to any component of this combination drug.

7. The use according to claim 4, characterized in that, The method of using the medication is as follows: Selenium yeast tablets are taken orally, and the Astragalus membranaceus plaster is applied externally to the thyroid gland projection area on the neck, once a day, for 1.5-2.5 hours each time (the time can be shortened appropriately in case of local allergy). The course of treatment is 3 months. During the treatment period, patients will be given basic lifestyle guidance such as emotional counseling and dietary advice.

8. The use according to claim 4, characterized in that, The observation indicators for the drug include: TCM syndrome score (palpable mass in front of the neck, neck swelling, foreign body sensation in the throat or difficulty swallowing, irritability), serum TPOAb and TgAb levels, anteroposterior diameter of the left lobe of the thyroid gland, anteroposterior diameter of the right lobe, anteroposterior diameter of the isthmus, maximum diameter of the thyroid nodule, blood flow resistance index (RI), pulsatility index (PI), and the occurrence of adverse reactions.

9. The use according to claim 4, characterized in that, The efficacy evaluation criteria for the drug were formulated with reference to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine": Clinical cure is defined as the disappearance of symptoms and an efficacy index ≥ 90%; effective is defined as significant improvement of symptoms and 60% ≤ efficacy index < 90%; improved is defined as some relief of symptoms and 30% ≤ efficacy index < 60%; ineffective is defined as not meeting the above standards or aggravation; where efficacy index = (pre-treatment score - post-treatment score) / pre-treatment score × 100%.

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