A traditional Chinese medicine composition, preparation and application in preparing a medicine for treating cancer-related fatigue after thyroid cancer surgery

Abstract

This invention discloses a traditional Chinese medicine composition, preparation, and its application in the preparation of a drug for treating postoperative cancer-related fatigue in thyroid cancer patients. The traditional Chinese medicine composition comprises the following components in parts by weight: 30-50 parts raw Astragalus membranaceus, 5-20 parts stir-fried Atractylodes macrocephala, 5-20 parts Curculigo orchioides, 5-20 parts Epimedium brevicornu, 5-20 parts Prunella vulgaris, 5-20 parts Dendrobium nobile, and 5-20 parts Lycium barbarum. This invention combines raw Astragalus membranaceus, stir-fried Atractylodes macrocephala, Curculigo orchioides, Epimedium brevicornu, Prunella vulgaris, Dendrobium nobile, and Lycium barbarum. Through the rational combination of these raw materials, it can effectively improve immune function, relieve physical and mental fatigue, and improve the quality of life of postoperative thyroid cancer patients.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine, specifically to a traditional Chinese medicine composition, preparation, and its application in the preparation of a drug for treating postoperative cancer-related fatigue in thyroid cancer patients. Background Technology

[0002] Thyroid cancer is a common malignant tumor of the head and neck. The incidence of this disease has been gradually increasing in recent years. In 2018, the number of new cases of thyroid cancer worldwide reached 567,233. More than 95% of this disease is differentiated thyroid carcinoma (DTC), and the vast majority of cases have a good prognosis after surgical treatment.

[0003] However, surgery is not the end of treatment; postoperative management and treatment for these patients urgently need attention. The newly published group standard of the China Association of Traditional Chinese Medicine, "Guidelines for the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Thyroid Cancer," provides clinicians with a patient-centered, quality-of-life-oriented framework for postoperative rehabilitation management of thyroid cancer using integrated traditional Chinese and Western medicine. It clearly states that treatment should not stop at tumor resection and TSH suppression, but should actively utilize traditional Chinese medicine to comprehensively manage various physiological and psychological symptoms resulting from surgery and subsequent treatments, ultimately helping patients achieve holistic recovery of body, mind, society, and spirit.

[0004] Patients who have undergone thyroid cancer surgery still suffer from a variety of symptoms, including fatigue, hoarseness, choking when drinking, a feeling of a foreign body in the neck, numbness in the hands and feet, palpitations, and tremors, with fatigue being the most common. Literature studies show that thyroid cancer-related fatigue is characterized by a high incidence and long duration. Its incidence rate in the post-thyroid surgery population can reach 26-62%, far higher than the fatigue incidence rate in the general population (19-38%). Furthermore, the duration of thyroid cancer-related fatigue is long, ranging from one year to several decades. Currently, there is no unified treatment for this disease. The NCCN guidelines consider the use of corticosteroids such as prednisone to have some effectiveness. However, these drugs can cause adverse reactions such as excitation, edema, osteoporosis, femoral head necrosis, cataracts, glaucoma, and abnormal liver and kidney function, and their clinical acceptance is low.

[0005] Traditional Chinese medicine (TCM) believes that after thyroid cancer surgery, even with the removal of the tumor, the body's vital energy (qi) remains deficient, and essence and blood are insufficient, leading to fatigue and weakness, which falls under the category of asthenia. The treatment principle for asthenia is primarily to replenish deficiencies. The spleen and stomach are the foundation of acquired constitution and the source of qi and blood production; therefore, replenishing deficiencies should begin with strengthening the middle qi. Modern research has found that TCM's methods of invigorating qi and replenishing the middle qi can improve immune function and alleviate physical and mental fatigue. However, currently, there is no established TCM formula with evidence-based medicine support. Summary of the Invention

[0006] Purpose of the invention: The purpose of this invention is to provide a traditional Chinese medicine composition, preparation, and its application in the preparation of a drug for treating postoperative cancer-related fatigue in thyroid cancer patients.

[0007] Technical Solution: This invention provides a traditional Chinese medicine composition, characterized by comprising the following components in parts by weight: 30-50 parts raw Astragalus membranaceus, 5-20 parts stir-fried Atractylodes macrocephala, 5-20 parts Curculigo orchioides, 5-20 parts Epimedium brevicornu, 5-20 parts Prunella vulgaris, 5-20 parts Dendrobium nobile, and 5-20 parts Lycium barbarum. The traditional Chinese medicine composition provided by this invention selects its components based on the theory of tonifying deficiency and strengthening the body's resistance in traditional Chinese medicine. Astragalus membranaceus is the principal ingredient, tonifying qi and strengthening the body's resistance; Atractylodes macrocephala invigorates the spleen and promotes digestion; Curculigo orchioides and Epimedium brevicornu tonify the kidneys and warm the yang; Prunella vulgaris resolves phlegm and dissipates nodules; and Dendrobium nobile and Lycium barbarum nourish the liver and kidneys. This formula can effectively improve immune function, relieve physical and mental fatigue, and improve the quality of life for patients after thyroid cancer surgery.

[0008] Preferably, the components include the following parts by weight: 35-45 parts of raw Astragalus membranaceus, 5-15 parts of stir-fried Atractylodes macrocephala, 5-15 parts of Curculigo orchioides, 5-15 parts of Epimedium brevicornu, 5-15 parts of Prunella vulgaris, 5-15 parts of Dendrobium nobile, and 10-20 parts of Lycium barbarum.

[0009] More preferably, the composition includes the following components in parts by weight: 40 parts raw Astragalus membranaceus, 15 parts stir-fried Atractylodes macrocephala, 15 parts Curculigo orchioides, 15 parts Epimedium brevicornu, 10 parts Prunella vulgaris, 15 parts Dendrobium nobile, and 20 parts Lycium barbarum.

[0010] The present invention also provides a traditional Chinese medicine preparation comprising the above-mentioned traditional Chinese medicine composition and pharmaceutical excipients.

[0011] Furthermore, the pharmaceutical excipient is one or a mixture of two or more of the following: filler, disintegrant, binder, or lubricant.

[0012] Furthermore, the traditional Chinese medicine composition accounts for 50-80% of the total weight of the preparation.

[0013] Furthermore, the dosage form of the preparation is any one of tablets, capsules, powders, or granules.

[0014] The present invention also provides a compound preparation comprising the above-mentioned traditional Chinese medicine composition and Western medicine.

[0015] Furthermore, the aforementioned Western medicine includes prednisone.

[0016] This invention provides the application of the above-mentioned traditional Chinese medicine composition in the preparation of a drug for treating postoperative cancer-related fatigue in thyroid cancer patients.

[0017] Beneficial effects: Compared with the prior art, the present invention has the following advantages: This invention combines raw Astragalus membranaceus, stir-fried Atractylodes macrocephala, Curculigo orchioides, Epimedium brevicornu, Prunella vulgaris, Dendrobium nobile, and Lycium barbarum. Through the rational combination of the above raw materials, it can effectively improve immune function, relieve physical and mental fatigue, and improve the quality of life of patients after thyroid cancer surgery.

[0018] The present invention relieves fatigue, has high clinical acceptance, is relatively safe, and has minimal impact on liver and kidney function. Attached Figure Description

[0019] Figure 1 The BPC (Base Peak Chromatogram) of the decoction of the traditional Chinese medicine composition of the present invention is a spectrum obtained by continuously depicting the intensity of the strongest ion in the mass spectrum at each time point. Figure 2 The TIC (Total Ion Chromatogram) of the decoction of the traditional Chinese medicine composition of the present invention is a graph of the sum of all ion intensities versus time or number of scans within a selected mass range. The graph is a chromatogram in positive and negative ion mode. Figure 3 This is a pie chart showing the top 10 components by content of the traditional Chinese medicine composition of the present invention; Figure 4 This is a pie chart showing the content distribution of the components of the traditional Chinese medicine composition of the present invention. Figure 5 This is a pie chart showing the distribution of the number of components in the traditional Chinese medicine composition of the present invention. Figure 6 This is a clinical grouping diagram in an embodiment of the present invention; Figure 7 This is the overall fatigue score chart in the embodiments of the present invention; Figure 8 This is a fatigue scoring body score diagram in an embodiment of the present invention; Figure 9 This is a fatigue and mental health rating chart in an embodiment of the present invention; Figure 10 This is a quality of life score chart in an embodiment of the present invention; Figure 11 This is a TCM syndrome integration graph in an embodiment of the present invention; Figure 12 This is a graph showing cortisol data in an embodiment of the present invention; Figure 13 This is a CD4 / CD8 data diagram from an embodiment of the present invention; Figure 14 The images show cortisol data, CD4, CD8, and CD4 / CD8 data in the embodiments of the present invention. Detailed Implementation

[0020] The technical solution of the present invention will be further described below with reference to the accompanying drawings and specific embodiments.

[0021] Example 1: The herbal formula consists of the following components by weight: 40 parts raw Astragalus membranaceus, 15 parts stir-fried Atractylodes macrocephala, 15 parts Curculigo orchioides, 15 parts Epimedium brevicornu, 10 parts Prunella vulgaris, 15 parts Dendrobium nobile, and 20 parts Lycium barbarum. Mix the above herbs (total weight 130g) together, place them in a container, add 600ml of water and soak for half an hour. Bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter to obtain the filtrate. Add 400ml of water to the residue and boil again, then filter to obtain the filtrate. Combine the two filtrates and concentrate to 240ml. Take 120ml twice daily, morning and evening.

[0022] Example 2: The herbal formula consists of the following ingredients by weight: 35 parts raw Astragalus membranaceus, 10 parts stir-fried Atractylodes macrocephala, 10 parts Curculigo orchioides, 10 parts Epimedium brevicornu, 15 parts Prunella vulgaris, 10 parts Dendrobium nobile, and 5 parts Lycium barbarum. Mix the above herbs (total weight 95g) together, place them in a container, add 600ml of water and soak for half an hour. Bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter to obtain the filtrate. Add 400ml of water to the residue and boil again, then filter to obtain the filtrate. Combine the two filtrates and concentrate to 240ml. Take 120ml twice daily, morning and evening.

[0023] Example 3: The herbal formula consists of the following ingredients by weight: 30 parts raw Astragalus membranaceus, 15 parts stir-fried Atractylodes macrocephala, 15 parts Curculigo orchioides, 15 parts Epimedium brevicornu, 10 parts Prunella vulgaris, 15 parts Dendrobium nobile, and 15 parts Lycium barbarum. Mix the above herbs (total weight 115g) together, place them in a container, add 600ml of water and soak for half an hour. Bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter to obtain the filtrate. Add 400ml of water to the residue and boil again, then filter to obtain the filtrate. Combine the two filtrates and concentrate to 240ml. Take 120ml twice daily, morning and evening.

[0024] Example 4: The herbal formula consists of the following components by weight: 50 parts raw Astragalus membranaceus, 20 parts stir-fried Atractylodes macrocephala, 20 parts Curculigo orchioides, 20 parts Epimedium brevicornu, 5 parts Prunella vulgaris, 5 parts Dendrobium nobile, and 10 parts Lycium barbarum. Mix the above herbs (total weight 130g) together, place them in a container, add 600ml of water and soak for half an hour. Bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter to obtain the filtrate. Add 400ml of water to the residue and boil again, then filter to obtain the filtrate. Combine the two filtrates and concentrate to 240ml. Take 120ml twice daily, morning and evening.

[0025] Example 5: The herbal formula consists of the following components by weight: 45 parts raw Astragalus membranaceus, 5 parts stir-fried Atractylodes macrocephala, 5 parts Curculigo orchioides, 5 parts Epimedium brevicornu, 20 parts Prunella vulgaris, 20 parts Dendrobium nobile, and 20 parts Lycium barbarum. Mix the above herbs (total weight 120g) together, place them in a container, add 600ml of water and soak for half an hour. Bring to a boil over high heat, then simmer over low heat for 30 minutes. Filter to obtain the filtrate. Add 400ml of water to the residue and boil again, then filter to obtain the filtrate. Combine the two filtrates and concentrate to 240ml. Take 120ml twice daily, morning and evening.

[0026] Application Example 1 Ms. Zhang, female, 34 years old. Seven years post-thyroid cancer surgery, with fatigue for over five years. At the time of consultation: fatigue, shortness of breath, reluctance to speak, clear and copious urination, normal bowel movements, pale tongue with a thin white coating, and a deep pulse. After two weeks of oral administration of the drug described in Example 1 of this invention, her symptoms significantly improved. She subsequently discontinued medication due to travel, and the fatigue recurred. After continuing medication for over a month, her physical strength returned to normal.

[0027] Application Example 2 Ms. Chen, female, 35 years old. One month after thyroid cancer surgery, she experienced fatigue for two weeks. At the time of consultation: mental fatigue, general weakness, frequent and clear urination, normal bowel movements, pale tongue with a thin white coating, and a deep pulse. She was prescribed the medication from Example 2 of this invention orally for two weeks, which significantly relieved her symptoms. Later, due to busy work schedules, the symptoms recurred, so she continued the same prescription for another two weeks, after which all symptoms lessened. She was advised to avoid overexertion.

[0028] Application Example 3 Mr. Cheng, male, 48 years old. Two years after surgery for thyroid cancer, he had been experiencing fatigue for over a year, characterized by lethargy, reduced speech, weakness in the lower limbs, cold hands and feet, frequent urination at night, and loose stools 2-3 times per day. His tongue was pale with a thin white coating, and his pulse was deep and wiry. He was given the medication described in Example 3 of this invention orally for two weeks, after which his symptoms significantly improved. He continued the same medication for over a month, after which all symptoms lessened and his physical strength returned to normal.

[0029] Application Example 4 Ms. Jiang, 62 years old. Six years post-thyroidectomy, she had experienced fatigue for over four years. Upon consultation, she presented with dizziness, fatigue, cold extremities (especially the lower limbs), sweating easily, normal bowel movements, pale tongue with teeth marks, and a deep pulse. She was prescribed the medication described in Example 4 of this invention orally for two weeks, resulting in significant symptom relief. She continued the same prescription for another two weeks, further alleviating her symptoms and restoring her normal physical strength.

[0030] Application Example 5 Ms. Wang, female, 33 years old. Three months post-thyroid cancer surgery, experiencing fatigue for two months. At the time of consultation: fatigue, neck discomfort, thirst, dry eyes, slightly overweight, constipation, pale red tongue with a thin white coating, and a deep, thready pulse. She was prescribed the medication described in Example 5 of this invention orally for two weeks, after which her symptoms significantly improved. She continued the same prescription for another two weeks, and all symptoms lessened, with her strength returning to normal.

[0031] In the components of the inventive composition, wherein: Astragalus: Sweet in taste and warm in nature. It enters the lung and spleen meridians. It tonifies qi and strengthens the exterior, promotes diuresis and eliminates toxins, drains pus, and promotes tissue regeneration. It is used for palpitations, fatigue, spontaneous sweating, and night sweats.

[0032] Atractylodes macrocephala: Bitter and sweet in taste, warm in nature. It invigorates the spleen and replenishes qi, dries dampness and promotes diuresis, stops sweating, and calms the fetus. It is used for spleen deficiency with poor appetite, indigestion, diarrhea, edema, spontaneous sweating, and threatened abortion.

[0033] Curculigo orchioides: pungent and hot in nature. It warms the kidneys and strengthens yang, dispels cold and dampness. It is used for impotence and seminal emission caused by kidney yang deficiency and decline of the fire of the gate of life, as well as wind-cold in the waist and knees, and weakness and numbness of muscles and bones.

[0034] Epimedium: pungent and warm in nature. It tonifies the kidneys and strengthens yang, dispels wind and dampness. It is used for kidney deficiency and impotence, seminal emission and premature ejaculation, weakness of the lower back and knees, cold limbs and aversion to cold, cold-dampness arthralgia, and contracture and numbness of the limbs.

[0035] Prunella vulgaris: Bitter and cold in nature. It clears heat and detoxifies, cools the blood and reduces swelling. It is used for sore throat, cough due to lung heat, and boils and carbuncles.

[0036] Dendrobium: Sweet in taste, slightly cold in nature. Nourishes Yin, strengthens the stomach, and promotes the production of body fluids. Used for Yin deficiency due to febrile diseases, dry mouth and thirst, or deficiency of body fluids and fever after illness, as well as symptoms such as insufficient stomach Yin, red tongue, and little saliva.

[0037] Goji berries: sweet in taste, neutral in nature. They nourish the kidneys and replenish essence, nourish the liver and improve eyesight. They are used for liver and kidney deficiency, seminal emission, lower back and knee pain, as well as dizziness and vertigo.

[0038] Pharmacological research The components of the decoction of traditional Chinese medicine were determined through pharmacological studies.

[0039] Preprocessing The traditional Chinese medicine composition of Example 1 was soaked for 30 min, then 600 mL of water was added and boiled. After that, it was simmered over low heat for 1-2 h to obtain 240 mL of the extract. The sample was taken out, homogenized, and 100 μL of the sample was placed in a 1.5 mL centrifuge tube. 900 μL of water (containing mixed internal standard, 4 μg / mL) was added, and the mixture was vortexed for 1 min. The mixture was then extracted by sonication in an ice-water bath for 60 min. The mixture was centrifuged for 10 min (12000 rpm, 4℃). 200 μL of the supernatant was placed in an LC-MS vial with an inner liner for analysis.

[0040] Liquid chromatography-mass spectrometry - chromatographic conditions The analytical instrument used in this experiment was a liquid chromatography-mass spectrometry (LC-MS) system consisting of an ACQUITY UPLC I-Class HF ultra-high performance liquid chromatography-tandem QE high-resolution mass spectrometer. Chromatographic conditions: Column: ACQUITY UPLC HSS T3 (100 mm × 2.1 mm, 1.8 μm); Column temperature: 45℃; Mobile phase: A-water (containing 0.1% formic acid), B-acetonitrile; Flow rate: 0.35 mL / min; Injection volume: 2 μL; PDA scan range: 210-400 nm. Mass spectrometry conditions: Ion source: HESI; Sample mass spectrometry signal acquisition used positive and negative ion scanning modes respectively; Data acquisition mode: DDA; Scan mode: Full MS / dd-MS2 (TOP 8).

[0041] Its chromatogram is as follows Figure 1 and Figure 2 As shown. BPC (Base Peak Chromatogram) is a spectrum obtained by continuously plotting the intensity of the strongest ion in the mass spectrum at each time point. TIC (Total Ion Chromatogram) is a graph of the sum of all ion intensities over time or number of scans within a selected mass range. The figure below shows a chromatogram in positive and negative ion modes.

[0042] Qualitative analysis Before pattern recognition, raw data underwent baseline filtering, peak identification, integration, retention time correction, peak alignment, and normalization using the metabolomics software XCMS v4.5.1. Compound identification was based on precise mass number, secondary fragmentation, and isotopic distribution, and qualitative analysis was performed using the TCM database.

[0043] Quantitative analysis For the substances qualitatively identified in the database, those with a total score of 40 or higher are retained. After merging and deduplicating substances in both positive and negative ion modes, the total content of the relative peak area of ​​the Chinese medicine components is set to 100% to obtain a qualitative and quantitative result data matrix. The matrix contains all the information that can be used for analysis extracted from the original data, and subsequent analyses are based on this matrix.

[0044] For each identified Chinese herbal medicine component, an EIC plot and an MS2 mirror image with annotations of secondary fragment structures were plotted. (The fragment structures in the secondary mass spectrometry mirror images were calculated using MetFrag software and are topological fragments generated by simulated bond breaking of the parent compound. The fragment structures do not contain adduct ions. These fragments are the parent substructures used to explain the measured m / z of the secondary fragments. Therefore, there will be differences in the number of protons (H atoms) and the mass of adduct ions between the fragment m / z and the measured m / z.)

[0045] For all identified Chinese herbal medicine components, pie charts were created based on their quantity and content under each chemical classification category. For example... Figure 3-5 As shown.

[0046] In terms of quantity distribution, the most abundant components in traditional Chinese medicine formulas are flavonoids, sugars and glycosides, amino acids and polypeptides; in terms of content distribution, the most abundant components are sugars and glycosides, amino acids and polypeptides, carboxylic acids and their derivatives; the top 10 components with the highest content are betaine, citric acid, malic acid, α-lactose, L-arginine, etc.

[0047] Sugars and glycosides, including alpha-lactose, provide energy, support immune regulation, and gut health. Amino acids and peptides, particularly L-arginine, promote repair and regulate immunity. Amino acids and peptides are the foundation for protein synthesis and may be used to improve physical strength, repair tissues, and enhance immunity. Citric acid participates in the body's energy metabolism (tricarboxylic acid cycle), helping to reduce physiological stress and alleviate fatigue. Flavonoids are widely available antioxidants and anti-inflammatory components. L-arginine supplementation improves endurance and relieves fatigue by enhancing energy metabolism, protecting glycogen, reducing muscle damage, and mitigating oxidative stress.

[0048] Clinical research This study validated the clinical efficacy of this formula in improving cancer-related fatigue in patients after surgery for differentiated thyroid cancer. The study included 120 patients who were pathologically diagnosed with malignant thyroid tumors and who visited the Scrofula Department of Nanjing Integrated Traditional Chinese and Western Medicine Hospital between January 2023 and December 2024. These patients had a moderate or higher overall fatigue level (score of 41 or higher) as assessed by the Fatigue Self-Assessment Scale (FSAS). They were randomly divided into a psychological support group, a traditional Chinese medicine group, and a combined treatment group using a simple random sampling method.

[0049] Figure 6As shown, the three groups received different interventions: the psychological support group received psychological support in addition to the basic Western medicine treatment prescribed by the doctor; the traditional Chinese medicine group received this formula in addition to the Western medicine treatment; and the combined treatment group received psychological support and oral administration of this formula in addition to the basic Western medicine treatment. Basic Western medicine treatment: All postoperative patients took levothyroxine sodium tablets as prescribed by the doctor. Depending on the condition, 131I treatment, radiotherapy, chemotherapy, targeted therapy, etc., may be administered. Psychological support: Nursing staff introduced the occurrence, development, prognosis, and influencing factors of thyroid cancer to patients and their families, explained the treatment plan and its necessity, explained possible adverse reactions during treatment, answered patients' questions in detail, built patients' confidence in treatment, and improved their cooperation with treatment. Multiple methods, including psychological guidance, motivation, peer support, positive reinforcement, and suggestion, were employed to change the patient's negative behavioral patterns, encourage them to face the illness, and strengthen their confidence in treatment. Traditional Chinese medicine was administered orally: the herbs mentioned in the treatment plan were soaked for 30 minutes, then boiled in 600mL of water, followed by simmering over low heat for 1-2 hours, yielding 240mL of decoction. The dregs were removed, and the patient was taken twice daily, morning and evening. The treatment period was one month. Informed consent was obtained from the patient, and relevant data were collected, including comparisons of general information, laboratory indicators, and scale evaluations.

[0050] The study included 141 patients, with 23 dropping out, leaving 118 patients who completed the study. These were divided into three groups: a psychological support group (n=40), a traditional Chinese medicine group (n=39), and a combined treatment group (n=39). General information is compared below: Table 1: Comparison of General Information ; There were no statistically significant differences among the three groups in terms of gender, age, and lesion size (P > 0.05), indicating they were comparable.

[0051] The fatigue score comparison results are as follows: Table 2: Comparison Table of Fatigue Scores ; Figures 7-9 The rating bar chart is displayed, by Figures 7-9 And Table 2: The overall pre-treatment scores, physical scores, and mental scores of the three groups were compared (P > 0.05).

[0052] In the psychological support group, there were no significant differences in overall scores, physical scores, or mental health scores before and after treatment (P < 0.05); in the traditional Chinese medicine group, there were no significant differences in overall scores, physical scores, or mental health scores before and after treatment (P < 0.001); and in the combined treatment group, there were no significant differences in overall scores, physical scores, or mental health scores before and after treatment (P < 0.001).

[0053] The overall, physical, and mental scores of the three groups after treatment were compared (P < 0.001). Specifically, the psychological support group and the traditional Chinese medicine group had a P < 0.001 comparison, the psychological support group and the combined treatment group had a P < 0.001 comparison, and the traditional Chinese medicine group and the combined treatment group had a P > 0.05 comparison.

[0054] Studies show that the psychological support group, the traditional Chinese medicine group, and the combined treatment group can all alleviate fatigue in multiple dimensions, including physical, mental, and overall. However, the score reduction was more significant with the intervention of traditional Chinese medicine.

[0055] Their quality of life score data can be found Figure 10 And Table 3: Table 3: Quality of Life Rating Table ; The comparison of the pre-treatment quality of life scores among the three groups was P>0.05.

[0056] The quality of life scores before and after treatment were significantly different in the psychological support group (P>0.05); in the traditional Chinese medicine group (P<0.001); and in the combined treatment group (P<0.001).

[0057] The quality of life scores of the three groups after treatment were compared (P < 0.001). Specifically, the psychological support group and the traditional Chinese medicine group had a P < 0.001 comparison, the psychological support group and the combined treatment group had a P < 0.001 comparison, and the traditional Chinese medicine group and the combined treatment group had a P < 0.05 comparison.

[0058] Studies have shown that both the traditional Chinese medicine group and the combined treatment group can improve the postoperative quality of life of thyroid cancer patients.

[0059] Traditional Chinese Medicine syndrome score data can be found Figure 11 And Table 4: Table 4: Comparison of Traditional Chinese Medicine Syndrome Scores ; Before treatment, there were no significant differences (P>0.05) among the three groups. In the psychological support group, there were no significant differences (P<0.05) in TCM syndrome scores before and after treatment; in the traditional Chinese medicine group, there were no significant differences (P<0.001); and in the combined treatment group, there were no significant differences (P<0.001). After treatment, there were no significant differences (P<0.001) between the psychological support group and the traditional Chinese medicine group, between the psychological support group and the combined treatment ...

[0060] Studies show that all three groups can improve the TCM syndrome after surgery in patients with thyroid cancer, with the TCM group and the combined treatment group showing more significant efficacy.

[0061] The comparison chart of cortisol data before and after treatment is shown below. Figure 12 CD4 / CD8, etc. Figure 13 The specific data can be found here. Figure 14.

[0062] The study showed that there was no significant difference in cortisol levels before, during, and after treatment in the psychological support group (P>0.05). Cortisol levels in the traditional Chinese medicine group and the combined treatment group significantly increased after treatment (P<0.05) (P<0.001 in the combined treatment group). Traditional Chinese medicine may achieve its anti-fatigue effect by increasing cortisol levels. Furthermore, the CD4 / CD8 ratio significantly decreased after traditional Chinese medicine intervention (P<0.05) (P<0.001 in the combined treatment group), suggesting that the body's immune system reached a more balanced homeostasis after treatment. This study preliminarily elucidates that this formula may improve the immune-related mechanisms of fatigue by regulating serum cortisol levels and T lymphocyte subsets (such as CD4+ / CD8+).

[0063] The above-mentioned components are scientifically and rationally combined, supporting each other and possessing the effects of invigorating qi and warming yang, and strengthening the body's resistance. They are effectively used to treat postoperative fatigue due to cancer in thyroid cancer patients, demonstrating good efficacy and safety, as fully proven by clinical data. Studies show that the psychological support group, the traditional Chinese medicine group, and the combined treatment group all alleviated fatigue in multiple dimensions, including physical, mental, and overall health, but the reduction in scores was more significant with the traditional Chinese medicine intervention. All three groups improved the postoperative TCM syndromes in thyroid cancer patients, but the efficacy was more significant in the traditional Chinese medicine group and the combined treatment group. Furthermore, both the traditional Chinese medicine group and the combined treatment group improved the postoperative quality of life in thyroid cancer patients. In terms of overall efficacy assessment, the traditional Chinese medicine group and the combined treatment group were significantly more effective than the psychological support group.

[0064] This formula provides an effective TCM intervention for postoperative cancer-related fatigue in thyroid cancer patients. Clinical efficacy evaluation shows that this formula (including the herbal medicine group and the combined treatment group) is significantly superior to simple psychological support in relieving fatigue (especially physical fatigue), improving TCM symptoms, and enhancing quality of life. This offers a safe, effective, and TCM-specific treatment option for this challenging disease, for which there are few effective Western medicines, and has significant clinical value. The potential mechanism of action has been preliminarily elucidated: the mechanism exploration section found that the efficacy of this formula may be related to regulating the hypothalamic-pituitary-adrenal axis (increasing cortisol levels) and improving immune balance (regulating the CD4+ / CD8+ T cell ratio). This provides modern biological evidence for the traditional TCM theory of "strengthening the body's resistance and consolidating its foundation, harmonizing Yin and Yang" in treating cancer-related fatigue.

Claims

1. A traditional Chinese medicine composition, characterized in that: The formula includes the following components by weight: 30-50 parts raw Astragalus membranaceus, 5-20 parts stir-fried Atractylodes macrocephala, 5-20 parts Curculigo orchioides, 5-20 parts Epimedium brevicornu, 5-20 parts Prunella vulgaris, 5-20 parts Dendrobium nobile, and 5-20 parts Lycium barbarum.

2. The traditional Chinese medicine composition according to claim 1, characterized in that: The formula includes the following components by weight: 35-45 parts raw Astragalus membranaceus, 5-15 parts stir-fried Atractylodes macrocephala, 5-15 parts Curculigo orchioides, 5-15 parts Epimedium brevicornu, 5-15 parts Prunella vulgaris, 5-15 parts Dendrobium nobile, and 10-20 parts Lycium barbarum.

3. The traditional Chinese medicine composition according to claim 2, characterized in that: The ingredients include the following components by weight: 40 parts raw Astragalus membranaceus, 15 parts stir-fried Atractylodes macrocephala, 15 parts Curculigo orchioides, 15 parts Epimedium brevicornu, 10 parts Prunella vulgaris, 15 parts Dendrobium nobile, and 20 parts Lycium barbarum.

4. A traditional Chinese medicine preparation, characterized in that: Includes the traditional Chinese medicine composition and pharmaceutical excipients as described in any one of claims 1-3.

5. A traditional Chinese medicine preparation according to claim 4, characterized in that: The pharmaceutical excipient is one or a mixture of two or more of the following: filler, disintegrant, binder or lubricant.

6. A traditional Chinese medicine preparation according to claim 5, characterized in that: The traditional Chinese medicine composition accounts for 50-80% of the total weight of the preparation.

7. The traditional Chinese medicine preparation according to any one of claims 4-6, characterized in that: The dosage form of the preparation is any one of tablets, capsules, powders or granules.

8. A compound preparation, characterized in that: Includes the traditional Chinese medicine composition and Western medicine as described in any one of claims 1-3.

9. A compound preparation according to claim 8, characterized in that: The Western medicine mentioned includes prednisone.

10. The use of the traditional Chinese medicine composition according to any one of claims 1-3 in the preparation of a drug for treating postoperative cancer-related fatigue in thyroid cancer patients.

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