A traditional Chinese medicine composition for treating subacute thyroiditis

Abstract

The application provides a traditional Chinese medicine composition for treating subacute thyroiditis, and relates to the technical field of subacute thyroiditis treatment. The traditional Chinese medicine composition comprises the following components in parts by weight: 3-12 parts of Banxia, 6-15 parts of Houpu, 6-15 parts of Lianqiao, 3-12 parts of Fangfeng, 5-15 parts of Baishaxiecao, 6-15 parts of Xiakucao, 3-18 parts of Yujin, 6-30 parts of vinegar tortoise plate, and 3-9 parts of Gancao. The traditional Chinese medicine composition has the effects of benefiting qi, resolving phlegm, removing blood stasis and resolving mass, and can relieve the manifestations of phlegm and qi obstruction, and blood stasis and stagnation of subacute thyroiditis.

Description

Technical Field

[0001] This invention relates to the field of subacute thyroiditis treatment technology, specifically to a traditional Chinese medicine composition for treating subacute thyroiditis. Background Technology

[0002] Thyroiditis is an autoimmune disease of the thyroid gland. The exact cause is not fully understood, but it is generally believed to be related to viral infection. Patients often have viral antibodies in their blood, most commonly Coxsackie virus antibodies, followed by adenovirus antibodies, influenza virus antibodies, and mumps virus antibodies. It is more common in young and middle-aged women. The onset is seasonal, with summer being the peak season. Patients often have a history of upper respiratory tract infection at the onset. Onset typically occurs 1-3 weeks after viral infection. The entire course of the disease can be divided into three phases: early stage (with hyperthyroidism), middle stage (subacute phase) (with hypothyroidism), and late stage (recovery phase).

[0003] 1. Early stage The onset is often sudden, with fever, accompanied by chills, shivering, fatigue, and loss of appetite. The most characteristic symptom is pain and tenderness in the thyroid area, which often radiates to the jaw, behind the ear, or neck. The pain worsens when chewing and swallowing. The extent of thyroid lesions varies; they may start in one lobe and then expand or spread to another lobe, or remain confined to one lobe.

[0004] The diseased thyroid gland is enlarged, hard, and significantly tender. At this time, a large amount of thyroid hormones and non-hormonal iodinated proteins are released into the bloodstream temporarily, so in addition to the general manifestations of infection, common manifestations of hyperthyroidism may also be present.

[0005] 2. Mid-stage (subacute phase) When thyroid hormones within the thyroid follicles are depleted due to infection, and before the thyroid parenchymal cells can repair themselves, serum thyroid hormone levels can drop to hypothyroid levels, clinically manifesting as hypothyroidism. With timely treatment, most patients can achieve a complete recovery, and only a very small number develop permanent hypothyroidism.

[0006] 3. Recovery period (late stage) Symptoms gradually improve, and the goiter or nodules gradually disappear. In many cases, small nodules remain and are slowly absorbed later.

[0007] In mild or atypical cases, the thyroid gland is only slightly enlarged, with mild pain and tenderness, no fever, and mild systemic symptoms. Clinically, there may not be signs of hyperthyroidism or hypothyroidism. The duration of the disease varies, ranging from several weeks to more than six months, but is generally about two to three months, so it is mostly self-limiting. Relapse is still possible after the condition has improved.

[0008] As can be seen from the above, this disease presents with complex clinical changes, is frequently misdiagnosed and missed, and is prone to recurrence, leading to long-term health consequences. Regarding treatment, for severe cases, such as those with significant pain and fever, short-term use of nonsteroidal anti-inflammatory drugs (NSAIDs) or glucocorticoids, such as prednisone, can rapidly alleviate clinical symptoms. However, continuous use of glucocorticoids can cause metabolic disorders.

[0009] Traditional Chinese medicine (TCM) has unique advantages in the prevention and treatment of subacute thyroiditis. TCM believes that insufficient vital energy (Qi) weakens the body's defensive Qi, allowing pathogenic factors to invade and cause phlegm and Qi stagnation in the throat, leading to further stagnation of Qi. Prolonged illness can also result in blood stasis. Furthermore, TCM has long recognized the potential of thyroid diseases and has proven effective in resolving phlegm, promoting Qi circulation, relieving stagnation, and dispersing stagnation. Therefore, using TCM to treat subacute thyroiditis and achieve satisfactory clinical results is of significant practical importance.

[0010] Therefore, there are areas for improvement. The present invention provides a traditional Chinese medicine composition for treating subacute thyroiditis. Summary of the Invention

[0011] To address the shortcomings of existing technologies, the present invention aims to provide a traditional Chinese medicine composition for treating subacute thyroiditis, the specific scheme of which is as follows: A traditional Chinese medicine composition for treating subacute thyroiditis, the composition comprising the following pharmaceutical ingredients in parts by weight: Pinellia ternata 3-12 parts Magnolia officinalis 6-15 parts Forsythia suspensa 6-15 parts 3-12 portions of windproof 5-15 parts of Hedyotis diffusa 6-15 parts of Prunella vulgaris 3-18 parts of turmeric 6-30 portions of vinegar-processed tortoise shell Licorice 3-9 parts.

[0012] Therefore, Pinellia ternata is commonly used to clear heat and resolve phlegm, soothe the liver and relieve depression. In subacute thyroiditis, it can help relieve symptoms such as sore throat and neck pain. Magnolia officinalis has the effects of regulating qi and stomach, and relieving depression. It can be used to relieve symptoms such as indigestion and chest tightness caused by subacute thyroiditis. Forsythia suspensa has the effects of clearing heat and detoxifying, and purging fire. In subacute thyroiditis, it can help relieve symptoms such as fever and sore throat. Saposhnikovia divaricata has the effects of dispelling wind and releasing the exterior, and dispelling cold and dampness. In subacute thyroiditis, it can be used to relieve symptoms such as joint pain and muscle pain caused by cold and dampness. Hedyotis diffusa has the effects of clearing heat and detoxifying, cooling blood and reducing swelling. It can help relieve symptoms such as fever and neck swelling caused by subacute thyroiditis. Prunella vulgaris is commonly used to clear heat and detoxify, cool blood and reduce swelling. In subacute thyroiditis, it can help relieve symptoms such as fever and sore throat. Curcuma longa has the effects of promoting blood circulation and removing blood stasis, regulating qi and relieving depression. It can be used in subacute thyroiditis to relieve symptoms such as chest and rib pain and blood stasis. Vinegar-processed tortoise shell has the effects of nourishing yin and blood, softening hard masses and dispersing nodules. In subacute thyroiditis, it can help regulate immune function and relieve pain. Licorice has the effects of harmonizing the properties of medicines, detoxifying, and moisturizing dryness. It can be used to regulate the overall properties of the prescription and increase the synergistic effect of the drugs.

[0013] Furthermore, the traditional Chinese medicine composition is in the form of granules.

[0014] Furthermore, the weight parts of the active ingredients of each drug component in the granules are as follows: Pinellia ternata 0.5-3 parts Magnolia officinalis 0.75-3 parts Forsythia suspensa 0.3-3 parts 1-5 parts windproof 0.5-2.5 parts of Hedyotis diffusa Prunella vulgaris 0.75-4 parts Turmeric 0.6-3 parts Vinegar-treated tortoise shell 0.75-3 parts Licorice 0.5-3 parts.

[0015] Furthermore, the preparation method of the traditional Chinese medicine composition includes the following steps: (1) Weigh out the raw materials of Pinellia ternata, Magnolia officinalis, Forsythia suspensa, Saposhnikovia divaricata, Hedyotis diffusa, Prunella vulgaris, Curcuma longa, vinegar-processed tortoise shell and Glycyrrhiza uralensis according to the corresponding weight proportions, and perform preliminary processing on the weighed raw materials to extract the effective components. (2) The effective components of each drug component are concentrated at low temperature, spray dried and then granulated by dry method to obtain granules of the effective components of each drug component. (3) Mix the active ingredient granules to make granules.

[0016] Furthermore, in step (1), the process for extracting the effective components from each raw material is as follows: coarse grinding → soaking → extraction with an extractor → filtration.

[0017] Furthermore, in step (2), the active ingredient particles of each drug component are passed through a 12-14 mesh sieve to grind the large particles, and the fine particles and powder that pass through the sieve can be packaged for testing.

[0018] Furthermore, in step (3), the weight of each granule is 8.64 grams.

[0019] Furthermore, the preferred pharmaceutical components of the traditional Chinese medicine composition are: 9 portions of Pinellia ternata Magnolia officinalis 9 parts 12 portions of Forsythia 10 portions of windproof 15 portions of Hedyotis diffusa 9 parts of Prunella vulgaris 15 portions of turmeric 15 portions of vinegar-processed tortoise shell Licorice, 3 parts.

[0020] Compared with the prior art, the beneficial effects of the present invention are as follows: (1) Through the synergistic effect of Pinellia ternata, Magnolia officinalis, Forsythia suspensa, Saposhnikovia divaricata, Hedyotis diffusa, Prunella vulgaris, Curcuma longa, vinegar-processed tortoise shell and Glycyrrhiza uralensis, the traditional Chinese medicine composition of the present invention has the effects of invigorating qi and resolving phlegm, eliminating blood stasis and dispersing nodules, which can relieve the symptoms of phlegm and qi stagnation and blood stasis in subacute thyroiditis.

[0021] (2) The present invention adopts the form of granules, each medicine is processed separately, and can be freely combined before taking the medicine. The dosage is adjustable, which avoids the disadvantage of the traditional granules having no adjustable dosage. Because it adopts the form of granules, it is convenient to carry and is not restricted. Detailed Implementation

[0022] The present invention will be further described in detail below with reference to the embodiments and accompanying drawings, but the embodiments of the present invention are not limited thereto.

[0023] A traditional Chinese medicine composition for treating subacute thyroiditis, the composition comprising the following pharmaceutical ingredients in parts by weight: Pinellia ternata 3-12 parts Magnolia officinalis 6-15 parts Forsythia suspensa 6-15 parts 3-12 portions of windproof 5-15 parts of Hedyotis diffusa 6-15 parts of Prunella vulgaris 3-18 parts of turmeric 6-30 portions of vinegar-processed tortoise shell Licorice 3-9 parts.

[0024] It should be noted that Pinellia ternata is commonly used to clear heat and resolve phlegm, and soothe the liver and relieve depression. In subacute thyroiditis, it can help relieve symptoms such as sore throat and neck pain. Magnolia officinalis has the effects of regulating qi and stomach, and relieving depression. It can be used to relieve symptoms such as indigestion and chest tightness caused by subacute thyroiditis. Forsythia suspensa has the effects of clearing heat and detoxifying, and purging fire. In subacute thyroiditis, it can help relieve symptoms such as fever and sore throat. Saposhnikovia divaricata has the effects of dispelling wind and releasing the exterior, and dispelling cold and dampness. In subacute thyroiditis, it can be used to relieve symptoms such as joint pain and muscle pain caused by cold and dampness. Hedyotis diffusa has the effects of clearing heat and detoxifying, cooling blood and reducing swelling. It can help relieve symptoms such as fever and neck swelling caused by subacute thyroiditis. Prunella vulgaris is commonly used to clear heat and detoxify, cool blood and reduce swelling. In subacute thyroiditis, it can help relieve symptoms such as fever and sore throat. Curcuma longa has the effects of promoting blood circulation and removing blood stasis, and regulating qi and relieving depression. It can be used in subacute thyroiditis to relieve symptoms such as chest and rib pain and blood stasis. Vinegar-processed tortoise shell has the effects of nourishing yin and blood, softening hard masses and dispersing nodules. In subacute thyroiditis, it can help regulate immune function and relieve pain. Licorice has the effects of harmonizing the properties of medicines, detoxifying, and moisturizing dryness. It can be used to regulate the overall properties of the prescription and increase the synergistic effect of the drugs.

[0025] The preparation method of the above-mentioned traditional Chinese medicine composition includes the following steps: (1) Weigh out the raw materials of Pinellia ternata, Magnolia officinalis, Forsythia suspensa, Saposhnikovia divaricata, Hedyotis diffusa, Prunella vulgaris, Curcuma longa, vinegar-processed tortoise shell and Glycyrrhiza uralensis according to the corresponding weight proportions, and perform preliminary processing on the weighed raw materials to extract the effective components. (2) The effective components of each drug component are concentrated at low temperature, spray dried and then granulated by dry method to obtain granules of the effective components of each drug component. (3) Mix the active ingredient granules to make granules.

[0026] It is understood that in this invention, the traditional Chinese medicine composition is in the form of granules. It should be noted that in step (1), the process for extracting the active ingredients from each raw material is as follows: coarse grinding → soaking → extraction with an extractor → filtration. In step (2), the active ingredient particles of each drug component are passed through a 12-14 mesh sieve to grind the large particles, and the fine particles and powder that pass through the sieve can be packaged for testing. In step (3), the weight of each granule is 8.64 grams.

[0027] It should be noted that after step (1), the weight fractions of the active ingredients in each drug component of the granules are as follows: Pinellia ternata 0.5-3 parts Magnolia officinalis 0.75-3 parts Forsythia suspensa 0.3-3 parts 1-5 parts windproof 0.5-2.5 parts of Hedyotis diffusa Prunella vulgaris 0.75-4 parts Turmeric 0.6-3 parts Vinegar-treated tortoise shell 0.75-3 parts Licorice 0.5-3 parts.

[0028] In view of the above, the present invention proposes the following embodiment 1.

[0029] In Example 1, the preferred pharmaceutical components of the traditional Chinese medicine composition are: 9 portions of Pinellia ternata Magnolia officinalis 9 parts 12 portions of Forsythia 10 portions of windproof 15 portions of Hedyotis diffusa 9 parts of Prunella vulgaris 15 portions of turmeric 15 portions of vinegar-processed tortoise shell Licorice, 3 parts.

[0030] In this invention, the concept of a p-value is used. The p-value represents the probability of the observed statistical result, or a more extreme result, occurring if the null hypothesis is true. The p-value is a statistical indicator used to measure the degree of difference between the observed result and the control result. The smaller the p-value, the more significant the difference. Generally, a p-value less than 0.05 is considered the threshold for a significant difference. This indicates a p-value less than 0.05. This indicates a p-value less than 0.01. This indicates a p-value less than 0.001. P<0.05 indicates a significant difference. P < 0.01 indicates that the difference is highly significant. P < 0.001 indicates that the difference is extremely significant. P<0.05 P<0.01 P<0.001 are commonly used statistical symbols to indicate significant differences between data. Similarly, in this embodiment, there are also #P<0.05, ##P<0.01, and ###P<0.001.

[0031] Clinical data 418 patients with SAT were randomly divided into two groups: a treatment group of 216 patients (aged 25–57 years, mean age 38.2 ± 5.2 years) and a control group of 202 patients (aged 26–58 years, mean age 37.6 ± 5.9 years). There was no significant difference between the two groups (P > 0.05).

[0032] Western medicine diagnostic criteria: The diagnosis of subacute thyroiditis can be determined based on medical history, symptoms, signs, and laboratory test results.

[0033] Subacute thyroiditis is mainly caused by viral infection that damages the thyroid gland. Along with fever and neck pain, it can also present with clinical manifestations of hyperthyroidism, such as palpitations, sweating, and weight loss. Thyroid function tests will show characteristics similar to hyperthyroidism, such as elevated T3 and T4 levels and decreased TSH levels, which can easily lead to misdiagnosis as hyperthyroidism.

[0034] As time goes on, peripheral thyroid hormones are metabolized, but the thyroid gland's own synthesis function has not recovered, so subacute thyroiditis symptoms appear. In the second stage, clinical manifestations of hypothyroidism may appear, and the laboratory report will show signs of hypothyroidism, namely decreased levels of T3, T4, and FT3, FT4, and increased levels of TSH.

[0035] Low iodine uptake is a criterion for differentiating between subacute thyroiditis and true hyperthyroidism.

[0036] Traditional Chinese Medicine diagnostic criteria: Refer to the diagnostic criteria for goiter in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine".

[0037] There is no specific disease name for subacute thyroiditis in Traditional Chinese Medicine. It is usually referred to as goiter, goiter disease, or depression. Its etiology is mostly caused by a combination of internal and external factors. External factors include exposure to wind-heat or heat-toxin, while internal factors include constitution factors such as phlegm-dampness, qi stagnation, or blood stasis. The combination of internal and external factors leads to this disease.

[0038] Treatment generally requires different medications depending on the cause. Wind-heat pathogens can usually be treated with formulas like Yinqiao Powder; heat-toxin pathogens can be treated with Wuwei Xiaodu Decoction. Phlegm stagnation pathogens can be treated by adding blood-activating, phlegm-resolving, and stasis-removing herbs, such as Panax notoginseng and Angelica sinensis, to the Haizao Yuhu Decoction.

[0039] Subacute thyroiditis caused by qi stagnation and blood stasis can be treated with medications such as Xuefu Zhuyu Decoction and Danzhi Xiaoyao Powder.

[0040] Treatment (1) Treatment group Treatment plan: The patient takes the traditional Chinese medicine composition in granule form of Example 1 of this invention orally, once a day, one sachet each time, for a course of eight weeks.

[0041] (2) Control group Treatment plan: The patient takes levothyroxine tablets orally once a day, 12.5-25 ug each time, for a course of eight weeks.

[0042] Observation indicators Clinical syndrome scoring: The main clinical syndromes are scored based on clinical symptoms and signs, and the results are compared before and after treatment.

[0043] Efficacy assessment: The efficacy is judged by the score reduction rate after the course of treatment.

[0044] Reduction rate = (Pre-treatment score - Post-treatment score) / Pre-treatment score 100% Judgment criteria Clinical cure: The disappearance or near-disappearance of TCM clinical symptoms and signs, and a syndrome score rate of ≥90% are considered a cure; Significant effect: Significant improvement in TCM clinical symptoms and signs, with a syndrome reduction rate of ≥70% is considered significant effect; Effective: Improvement in TCM clinical symptoms and signs, with a syndrome reduction rate of ≥30% is considered effective; Ineffective: If there is no improvement in clinical symptoms and signs in traditional Chinese medicine and the syndrome reduction rate is <30%, it is considered ineffective.

[0045] Evaluation methods See the quantitative scoring table of the main clinical symptoms of this disease, namely Table 1 and Table 2.

[0046] (1) In Table 1, the following symptoms / signs are scored differently according to their severity (0 / 2 / 4 / 6 points). Table 1 (2) In Table 2, the following symptoms / signs are scored differently according to their presence or absence.

[0047] Table 2 Treatment effect The results of comparing the number of cases with the therapeutic effect before and after treatment in the treatment group and the control group are shown in Table 3 below.

[0048] Table 3: Comparison of Treatment Efficacy Grading Before and After Treatment As shown in Table 3, after treatment with the two methods, the treatment effects of both groups of patients showed significant improvement. It should be noted that the number of cured cases and the number of effective cases in the treatment group were greater than those in the control group, while the number of cases with significant effects was slightly less in the treatment group, but the number of ineffective cases in the treatment group was far less than that in the control group.

[0049] The results of comparing the effectiveness rates of the treatment group and the control group before and after treatment are shown in Table 4 below.

[0050] Wherein, the effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases 100% Table 4: Comparison of Effectiveness Rates Before and After Treatment in the Treatment Group and the Control Group Table 4 shows that there is a difference in the effectiveness rate between the treatment group and the control group, and the degree of difference is... P<0.01, P<0.01 indicates a highly significant difference. Therefore, after treatment with both methods, the effective rates of patients in both groups were significantly improved, and the treatment group was superior to the control group.

[0051] The results of comparing the syndrome scores before and after treatment in the treatment group and the control group are shown in Table 5 below.

[0052] Table 5: Comparison of syndrome scores before and after treatment in the treatment group and the control group. As shown in Table 5, after treatment with the above two methods, the syndrome scores of patients in both the treatment group and the control group were significantly reduced, and the treatment group was superior to the control group.

[0053] The changes in thyroid hormone-related indicators before and after treatment in the treatment group and the control group are shown in Table 6 below.

[0054] Table 6 Note 1: Compared with before treatment, P<0.05 P<0.01; compared with the control group, # P<0.05.

[0055] Note 2: Thyroid-stimulating hormone (TSH), normal range: 0.35-5.10 uIU / ml Total triiodothyronine (TT3), normal range: 0.89-2.49 nmol / L Total thyroxine (TT4), normal range: 64.4-186.60 pmol / L Free triiodothyronine (FT3), normal range: 2.76-6.45 pmol / L Free thyroxine (FT4), normal range: 11.2-23.81 pmol / L As can be seen from the index data and P-values ​​in Table 6, the thyroid function-related indicators of the cases treated by both methods were significantly improved compared with those before treatment, proving that both methods are effective. However, in the intergroup comparison, the three indicators of the treatment group, namely TT4, FT3, and FT4, were better than those of the control group.

[0056] The changes in thyroiditis-related indicators before and after treatment in the treatment group and the control group are shown in Table 7 below.

[0057] Table 7 Note 1: Compared with before treatment, P<0.05 P<0.01 Compared with the control group, after treatment, # P<0.05 ## P<0.01 Note 2: Thyroglobulin (ThG), normal range: 1.28-50 ng / ml Thyroglobulin antibody (TG-Ab), normal range: 0-4 IU / ml Anti-thyroid peroxidase antibody (TPOAb), normal range: 0-9 IU / ml Thyroid-stimulating hormone receptor antibody (TRABb), normal range: 0-1.5 IU / L Erythrocyte sedimentation rate (ESR), normal value: <15 mm / h After treatment using the two methods described above, the inflammatory markers of both groups of patients showed significant improvement, with the treatment group showing superior results compared to the control group. The treatment group exhibited better performance in four indicators compared to the control group: ThG, TG-Ab, TPOAb, and ESR. This indicates that the traditional Chinese medicine composition of the present invention has a better anti-inflammatory effect and exerts its mechanism for reversing thyroid function.

[0058] The above description is merely a preferred embodiment of the present invention. The scope of protection of the present invention is not limited to the above embodiments. All technical solutions falling within the scope of the present invention's concept are within the scope of protection of the present invention. It should be noted that for those skilled in the art, any improvements and modifications made without departing from the principles of the present invention should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating subacute thyroiditis, characterized in that, The raw materials of the traditional Chinese medicine composition are as follows, by weight: 3-12 portions of Pinellia ternata Magnolia officinalis 6-15 parts Forsythia suspensa 6-15 parts 3-12 portions of windproof 5-15 parts of Oldenlandia diffusa 6-15 parts of Prunella vulgaris 3-18 parts of turmeric 6-30 portions of vinegar-processed tortoise shell Licorice 3-9 parts.

2. The traditional Chinese medicine composition for treating subacute thyroiditis according to claim 1, characterized in that, The traditional Chinese medicine composition is in the form of granules.

3. The traditional Chinese medicine composition for treating subacute thyroiditis according to claim 2, characterized in that, The preparation method of the traditional Chinese medicine composition includes the following steps: (1) Weigh out the raw materials of Pinellia ternata, Magnolia officinalis, Forsythia suspensa, Saposhnikovia divaricata, Hedyotis diffusa, Prunella vulgaris, Curcuma longa, vinegar-processed tortoise shell and Glycyrrhiza uralensis according to the corresponding weight proportions, and perform preliminary processing on the weighed raw materials to extract the effective components. (2) The effective components of each drug component are concentrated at low temperature, spray dried and then granulated by dry method to obtain granules of the effective components of each drug component. (3) Mix the active ingredient granules to make granules.

4. The traditional Chinese medicine composition for treating subacute thyroiditis according to claim 3, characterized in that, In step (1), the process for extracting the effective components from each raw material is as follows: coarse grinding → soaking → extraction with an extractor → filtration.

5. The traditional Chinese medicine composition for treating subacute thyroiditis according to claim 3, characterized in that, In step (2), the active ingredient particles of each drug component are passed through a 12-14 mesh sieve to grind the large particles, and the fine particles and powder that pass through the sieve can be packaged for testing.

6. The traditional Chinese medicine composition for treating subacute thyroiditis according to claim 3, characterized in that, In step (3), the weight of each granule is 8.64 grams.

7. The traditional Chinese medicine composition for treating subacute thyroiditis according to any one of claims 1-6, characterized in that, The raw materials of the traditional Chinese medicine composition are as follows, by weight: 9 portions of Pinellia ternata Magnolia officinalis 9 parts 12 portions of Forsythia 10 portions of windproof 15 portions of Hedyotis diffusa 9 parts of Prunella vulgaris 15 portions of turmeric 15 portions of vinegar-processed tortoise shell Licorice, 3 parts.

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