Application of qi-tonifying and blood-nourishing preparation in preparation of medicine for treating thalassemia

Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to application of a qi-tonifying and blood-maintaining preparation in preparation of a medicine for treating thalassemia. Researches show that the preparation for tonifying qi and maintaining blood is used for treating thalassemia and can effectively improve the anemia state and iron metabolism disorder of patients. Specifically, the medicine can significantly improve the hemoglobin level, increase the red blood cell count and the red blood cell average volume, and improve the serum iron content, the ferritin content and the reticulocyte proportion. The results show that the qi-tonifying and blood-maintaining preparation has the effect of promoting the bone marrow hematopoiesis function and can regulate and optimize the iron metabolism process. The invention provides an economical, effective and convenient treatment scheme for the thalassemia patient.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of pharmaceutical preparations, and particularly relates to application of a qi-tonifying and blood-conserving preparation in preparation of a medicine for treating thalassemia. BACKGROUND

[0002] Thalassemia is a genetic and chronic hemolytic disease caused by decreased or complete absence of globin chain synthesis due to globin gene mutation or deletion, and belongs to the category of recessive genetic diseases.

[0003] Thalassemia is a rare recessive genetic blood disease with typical clinical symptoms of chronic anemia and hemolysis. Research has found that thalassemia patients often have clinical comorbidity with iron deficiency anemia, and this double anemia state can seriously damage the functions of the patient's body through the interaction of the iron metabolism-erythropoiesis axis, and lead to overall metabolic disorders. Thalassemia can cause immunodeficiency and severe infection, and even cerebral infarction risk. In view of the anemia state of many thalassemia patients, there is a need and necessity for treatment.

[0004] Therefore, it is necessary to explore an economical, effective and convenient medicine for the treatment of thalassemia. SUMMARY

[0005] Therefore, in order to solve the core technical problem that thalassemia lacks effective treatment drugs, the present application provides, on one aspect, application of a qi-tonifying and blood-conserving preparation in preparation of a medicine for treating thalassemia.

[0006] In some embodiments, the qi-tonifying and blood-conserving preparation increases the hemoglobin level, the number of red blood cells and the mean corpuscular volume of the subject when an effective dose is administered.

[0007] In some embodiments, the qi-tonifying and blood-conserving preparation increases the serum iron content of the subject when an effective dose is administered.

[0008] In some embodiments, the qi-tonifying and blood-conserving preparation increases the ferritin content of the subject when an effective dose is administered.

[0009] In some embodiments, the qi-tonifying and blood-conserving preparation increases the reticulocyte ratio of the subject when an effective dose is administered.

[0010] In some embodiments, the qi-tonifying and blood-conserving preparation includes qi-tonifying and blood-conserving tablets, qi-tonifying and blood-conserving granules and qi-tonifying and blood-conserving capsules.

[0011] In some embodiments, the qi-tonifying and blood-conserving preparation contains pig blood extract, astragalus and jujube.

[0012] In some embodiments, the subject of the Yiqi Weixue preparation is a mammal.

[0013] In some embodiments, the mammal is a primate.

[0014] In some embodiments, the primate is a human.

[0015] Currently, there is currently a lack of standard treatment drugs for thalassemia, and patients are long-term facing anemia-related symptoms and iron overload risks. Unlike simple iron deficiency anemia, thalassemia is a genetic hemolytic disease caused by globin synthesis disorder, and its pathological mechanism is complex, showing coexistence of ineffective erythropoiesis and iron metabolism disorder, and even a contradictory state of relative iron deficiency and tissue iron overload. The present application found that the Yiqi Weixue preparation for the treatment of thalassemia can not only significantly improve the hemoglobin level, increase the red blood cell count and mean volume, but also simultaneously increase the serum iron and ferritin content, and increase the reticulocyte ratio, indicating that the Yiqi Weixue preparation has the effect of promoting bone marrow hematopoiesis, and optimizing iron metabolism and utilization. This "double regulation" effect of improving hematopoietic indicators and iron metabolism indicators surpasses the known efficacy of the drug as an iron deficiency anemia treatment, and provides an effective treatment strategy for solving the clinical problem of coexistence of anemia and iron metabolism disorder in thalassemia patients. DETAILED DESCRIPTION

[0016] The present application will be further described below in conjunction with the embodiments and examples. It should be understood that these embodiments and examples are only used to illustrate the present application and not to limit the scope of the present application, and the purpose of providing these embodiments and examples is to make the understanding of the disclosed content of the present application more thorough and comprehensive. It should also be understood that the present application can be realized in many different forms and is not limited to the embodiments and examples described herein, and those skilled in the art can make various modifications or changes without departing from the spirit of the present application, and the equivalent forms obtained thereby also fall within the protection scope of the present application. In addition, in the following description, a large number of specific details are given in order to provide a more complete understanding of the present application, and it should be understood that the present application can be implemented without one or more of these details.

[0017] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs.

[0018] Unless otherwise indicated or contradictory, the terms or phrases used herein have the following meanings:

[0019] The selection range of the terms "and / or", "or / and", "and / or" used in the present application includes any one of two or more relevant listed items, and also includes any and all combinations of the relevant listed items, which includes any two relevant listed items, any more relevant listed items, or all relevant listed items. It should be noted that when at least two conjunctions selected from "and / or", "or / and", "and / or" are combined to connect at least three items, it should be understood that in the present application, the technical solution undoubtedly includes the technical solution connected by "logical and", and also undoubtedly includes the technical solution connected by "logical or". For example, "A and / or B" includes three parallel solutions of A, B and A+B. For another example, the technical solution of "A, and / or, B, and / or, C, and / or, D" includes any one of A, B, C and D (i.e. the technical solution connected by "logical or"), and also includes any and all combinations of A, B, C and D, i.e. includes the combination of any two or any three of A, B, C and D, and also includes the four-item combination of A, B, C and D (i.e. the technical solution connected by "logical and").

[0020] In the present application, "multiple", "various", "multiple times", "multiple" and the like are used without specific limitation, which means greater than or equal to 2 in quantity. For example, "one or more" means one or greater than or equal to two.

[0021] As used herein, "combinations thereof", "any combination thereof", "any combination manner thereof" and the like include all suitable combination manners of any two or more listed items.

[0022] In the present application, "suitable", "suitable", "any suitable manner" and the like are described in the context of being able to implement the technical solutions of the present application, solve the technical problems of the present application, and achieve the intended technical effects of the present application.

[0023] In the present application, "further", "more further", "particularly" and the like are used for description purposes to indicate differences in content, but should not be understood as limiting the scope of protection of the present application.

[0024] In the present application, "optionally", "optional", "optional" means optional, i.e. selected from two parallel solutions of "yes" or "no". If there are multiple "optional" in a technical solution, and there is no specific description, and no contradictory relationship or mutual restriction, each "optional" is independent.

[0025] In the present application, the technical features described in an open manner include both the closed technical solution consisting of the listed features and the open technical solution of the listed features.

[0026] In the present application, when referring to a numerical interval (i.e. a numerical range), unless otherwise specified, the optional numerical distribution within the numerical interval is considered to be continuous, and includes both numerical end points (i.e. the minimum and maximum values) of the numerical range, and every numerical value between the two numerical end points. When a numerical interval refers to integers within the numerical interval, unless otherwise specified, including both end point integers of the numerical range, and every integer between the two end point integers, in the present application, it is equivalent to directly listing every integer, for example, t is an integer selected from 1-10, means that t is any one integer selected from the group consisting of 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10. In addition, when multiple ranges are provided to describe a feature or characteristic, these ranges can be combined. In other words, unless otherwise specified, the ranges disclosed herein should be understood to include any and all sub-ranges therein.

[0027] In the present application, unless otherwise specified, the temperature parameter allows both constant temperature treatment and variation within a certain temperature interval. It should be understood that the constant temperature treatment allows the temperature to fluctuate within the accuracy range controlled by the instrument. Fluctuation within a range such as ±5°C, ±4°C, ±3°C, ±2°C, ±1°C is allowed.

[0028] In the present application, (w / w) and wt% both represent weight percentage, (v / v) refers to volume percentage, and (w / v) refers to mass volume percentage.

[0029] All documents mentioned in the present application are incorporated by reference in the present application as if each document was individually incorporated by reference. Unless and to the extent that the cited documents conflict with the purpose and / or technical solutions of the present application, the cited documents are incorporated by reference in their entirety. When the present application refers to the cited documents, the definitions of the relevant technical features, terms, nouns, phrases, etc. in the cited documents are also incorporated by reference. When the present application refers to the cited documents, the examples and preferred modes of the relevant technical features cited are also incorporated by reference into the present application, but are limited to the implementation of the present application. It should be understood that when the cited content conflicts with the description in the present application, the present application is given priority or is modified according to the description in the present application.

[0030] The function of the Yiqi Weixue preparation is to tonify blood and replenish qi, and it is used for the treatment of blood deficiency syndrome, qi and blood deficiency syndrome, and the treatment of patients with iron deficiency anemia. The heme iron contained in the raw materials of the preparation is a biological organic iron, which can be directly absorbed by intestinal mucosal epithelial cells, and is converted into iron ions in intestinal cells to enter the blood, and the bioavailability can be up to 35%, and the stimulation to the gastrointestinal tract is low. The root cause of iron deficiency anemia is insufficient iron intake, excessive loss or absorption disorder, resulting in iron deficiency in the body. It is an acquired disease. The root cause of thalassemia is globin gene defect and hemoglobin synthesis disorder, and the iron metabolism in the body is disorder, which is a genetic disease. The treatment methods of the two are opposite, iron supplement treatment is needed for patients with iron deficiency anemia, while iron removal treatment or hematopoietic stem cell transplantation is needed for patients with thalassemia. Although both are anemic diseases, the treatment methods are completely opposite. If thalassemia is misdiagnosed as iron deficiency anemia, the patient will take a large amount of iron supplements for a long time. This will aggravate the iron load in the body of the thalassemia patient, accelerate the deposition of iron in organs such as heart, liver and pancreas, and cause fatal complications such as heart failure, cirrhosis and diabetes. If iron deficiency anemia is misdiagnosed as thalassemia, the patient will not receive the correct iron supplement treatment, the anemia cannot be corrected, the quality of life and work ability are affected, and the underlying serious cause (such as chronic blood loss caused by gastrointestinal tumors) may be ignored.

[0031] Due to the high risk, the treatment of the above two types of anemia is carried out in a predetermined manner to avoid medical accidents.

[0032] As a drug for treating iron deficiency anemia, the Yiqi Weixue preparation has an unexpected positive therapeutic effect in the exploratory clinical study of thalassemia, in addition to promoting hematopoiesis, it also optimizes iron metabolism and utilization, which provides effective support for the Yiqi Weixue preparation to increase the therapeutic effect.

[0033] Based on this, the application provides the use of the Yiqi Weixue preparation in the preparation of a drug for treating thalassemia.

[0034] The application provides the use of the Yiqi Weixue preparation in the preparation of a drug for treating thalassemia, and the application finds that the Yiqi Weixue preparation applied to the treatment of thalassemia can effectively improve the anemic state and iron metabolism disorder of the patient, has the effect of tonifying qi and nourishing blood, can significantly improve the hemoglobin level of the patient, increase the red blood cell count and mean corpuscular volume, increase the serum iron content and ferritin content, and can also significantly increase the reticulocyte ratio, indicating that the Yiqi Weixue preparation has the effect of promoting bone marrow hematopoiesis, and also has the mechanism of optimizing iron metabolism. That is, the application provides an economical, effective and convenient treatment option for patients with thalassemia.

[0035] In some embodiments, the treatment refers to increasing the subject's hemoglobin level, red blood cell count, and mean corpuscular volume by administering an effective dose.

[0036] In some embodiments, the treatment refers to increasing the serum iron content, ferritin content, and reticulocyte ratio of a subject by administering an effective dose.

[0037] The treatment refers to increasing the subject's hemoglobin level, red blood cell count, and mean corpuscular volume at an effective dose. Specifically, the dosage of the Qi-nourishing and Blood-nourishing preparation (Yi Qi Wei Xue tablets) can be selected from 4 tablets each time, 3 times daily, and the course of treatment can be selected from any time period of 1 month, 2 months, or 3 months. The Yi Qi Wei Xue tablets (National Drug Approval Number Z20050186) are a product manufactured by Guangdong Red Coral Pharmaceutical Co., Ltd.

[0038] Specifically, the serum iron content can be increased to 35-45 μmol / L, the ferritin content can be increased to 130-150 ng / L, and the reticulocyte ratio can be increased to 2.5-3.5%.

[0039] In some embodiments, the drug is a tablet. Specifically, the tablet has a strength of 0.57g / tablet.

[0040] In some embodiments, the Qi-boosting and blood-nourishing preparation includes Qi-boosting and blood-nourishing tablets, Qi-boosting and blood-nourishing granules, and Qi-boosting and blood-nourishing capsules.

[0041] In some embodiments, the formula of the Qi-tonifying and blood-nourishing preparation includes pig blood extract, astragalus, and jujube.

[0042] In some embodiments, the subject of the drug is a mammal.

[0043] In some embodiments, the mammal is a primate.

[0044] In some embodiments, the primate is a human.

[0045] Based on the above application, this application also provides a treatment method for thalassemia, comprising administering a therapeutically effective amount of the pharmaceutical composition to the desired patient. That is, administering a therapeutically effective amount of the pharmaceutical composition to the patient. In this document, "patient" refers to an animal, preferably a mammal, and more preferably a human. The term "mammal" primarily refers to warm-blooded vertebrate mammals, including but not limited to: cats, dogs, rabbits, bears, foxes, wolves, monkeys, deer, rats, pigs, cattle, sheep, horses, humans, etc., preferably primates, and more preferably humans.

[0046] This application utilizes a qi-tonifying and blood-nourishing preparation to treat thalassemia, which can significantly improve patients' hemoglobin levels, red blood cell count, and mean corpuscular volume, effectively improving anemia. It can also optimize patients' iron metabolism, increase serum iron content, ferritin content, and reticulocyte ratio, and promote bone marrow hematopoietic function.

[0047] In summary, the Qi-boosting and blood-nourishing preparation of this application provides an economical, effective, and convenient treatment option for patients with thalassemia, filling a gap in the field of therapeutic drugs.

[0048] The embodiments of this application will be described in detail below with reference to examples. It should be understood that these embodiments are for illustrative purposes only and are not intended to limit the scope of this application. For experimental methods in the following embodiments where specific conditions are not specified, please refer to the guidelines given in this application, or follow experimental manuals or conventional conditions in the art, or follow the conditions recommended by the manufacturer, or refer to experimental methods known in the art.

[0049] In the specific embodiments described below, the measurement parameters involving raw material components may have slight deviations within the weighing accuracy range unless otherwise specified. Temperature and time parameters are subject to acceptable deviations due to instrument testing accuracy or operational precision.

[0050] It should be understood that in the various embodiments of this application, the order of the above-mentioned processes does not imply the order of execution. The execution order of each process should be determined by its function and internal logic, and should not constitute any limitation on the implementation process of the embodiments of this application.

[0051] Example 1

[0052] 1. Case criteria

[0053] 1.1 Diagnostic Criteria

[0054] The diagnostic criteria for Western medicine shall be based on the "Standards for Diagnosis and Efficacy of Hematological Diseases"; the diagnostic criteria for deficiency of both Qi and Blood shall be based on the "Guiding Principles for Clinical Research of New Chinese Medicines", Shen Ziyin et al. "Reference Standards for Differentiation of Deficiency Syndromes in Traditional Chinese Medicine" and "Diagnostics of Traditional Chinese Medicine".

[0055] 1.2. Efficacy Criteria

[0056] The treatment efficacy criteria for thalassemia are based on those in *Diagnostic and Efficacy Standards for Hematological Diseases*, edited by Zhang Zhinan and Shen Ti. The criteria are as follows: Markedly effective: Hb increases ≥30 g / L after treatment, accompanied by varying degrees of HbF elevation; Effective: Hb increases ≤5 g / L after treatment but <30 g / L, accompanied by elevations in Hb, RBC, and Ret; Ineffective: Hb increases <5 g / L after treatment. The overall effective rate is calculated as: (Number of markedly effective cases + Number of effective cases) / Total number of cases × 100%.

[0057] 1.3 Inclusion Criteria

[0058] Inclusion criteria: ① Meets the diagnostic criteria for thalassemia. ② Age 18-50 years. ③ Hemoglobin level < 60 g / L < normal value (male: 120 g / L, female: 110 g / L) and no history of blood transfusion in the past six months. ④ Has not taken any anti-anemia drugs in the past six months. ⑤ Willing to accept this traditional Chinese medicine treatment. ⑥ The syndrome is diagnosed as Qi and Blood Deficiency, with pale complexion, joint pain, fatigue and weakness as the main symptoms, and palpitations, shortness of breath, pale nails, poor appetite, dizziness as secondary symptoms. The tongue and pulse are pale, with a thin coating, and a weak or deep and thready pulse.

[0059] 1.4 Exclusion Criteria

[0060] Exclusion criteria: ① Individuals with immunodeficiency, or other primary diseases of the liver, kidneys, or hematologic system. ② Individuals with malignant tumors, autoimmune diseases, or rheumatic connective tissue diseases. ③ Pregnant or lactating women. ④ Individuals who refuse traditional Chinese medicine treatment. ⑤ Individuals allergic to the experimental drug.

[0061] 2. Treatment Plan

[0062] 2.1 Treatment Drug: Yiqi Weixue Tablets, specification: 0.57 g / tablet, National Drug Approval Number Z20050186, Guangdong Hongshanhu Pharmaceutical Co., Ltd., batch number: 20230228. Placebo Tablets: Starch preparation tablets, specifications, color, size, and taste are consistent with Yiqi Weixue Tablets, provided by Guangdong Hongshanhu Pharmaceutical Co., Ltd.

[0063] 2.2 Treatment methods

[0064] In this study, the treatment group received oral administration of Yiqi Weixue tablets (drug approval number: Z20050186, manufacturer: Guangdong Hongshanhu Pharmaceutical Co., Ltd.), specifically 4 tablets each time, 3 times a day; the control group received oral placebo tablets, with the same dosage and frequency as the treatment group. The entire treatment course was set at 1 month. During the treatment period, both groups were prohibited from using any traditional Chinese medicine with proven effects in treating anemia, including decoctions and prepared Chinese medicines; symptomatic and supportive treatments were provided to each group as needed, including liver and stomach protection treatments, and blood transfusions when necessary.

[0065] 2.3 Observation Indicators

[0066] Changes in hemoglobin (HB), red blood cell count (RBC), mean corpuscular volume (MCV), reticulocyte percentage, serum iron, and ferritin levels were measured before and after treatment.

[0067] 2.4 Statistical Analysis

[0068] All data were analyzed using SPSS 27.0 software. Quantitative data were expressed as mean ± standard deviation. Count data are expressed as (%). Paired t-tests were used for within-group comparisons, and nonparametric tests were used for between-group comparisons. Nonparametric tests were used for continuous data that did not conform to a normal distribution. The rank-sum test was used to analyze ordinal data. Chi-square tests or Fisher's exact tests were used for count data. A p-value < 0.05 was considered statistically significant.

[0069] 3. Research Results

[0070] 3.1 Source of Cases

[0071] According to the inclusion and exclusion criteria, a total of 70 patients with thalassemia admitted to four tertiary hospitals—the Third Affiliated Hospital of Guangzhou University of Chinese Medicine, Shunde Hospital of Guangzhou University of Chinese Medicine, Jiangmen Traditional Chinese Medicine Hospital of Guangdong Province, and Guangzhou Integrated Traditional and Western Medicine Hospital—between 2022 and March 2025 were collected. Due to reasons such as patients refusing examination, 66 patients were actually enrolled, including 33 patients in the treatment group and 33 patients in the control group.

[0072] 3.2 Demographic Data

[0073] The mean age of the treatment group was 34.06±7.52 years, the mean weight was 54.50±5.68 kg, and the mean height was 163.73±5.59 cm. The mean age of the control group was 33.45±8.66 years, the mean weight was 55.21±5.75 kg, and the mean height was 163.91±8.62 cm. There were no statistically significant differences in demographic data between the two groups (P>0.05), indicating they were comparable.

[0074] 3.3 Clinical efficacy analysis

[0075] The results of the efficacy analysis of the two groups of cases are shown in Table 1.

[0076] Table 1: Treatment efficacy in the two groups of cases (cases, %)

[0077]

[0078] As shown in Table 1, the total effective rate was 81.9% in the treatment group (27 cases were effective, 6 cases were ineffective) and 15.2% in the control group (5 cases were effective, 28 cases were ineffective). Fisher's exact test analysis showed a statistically significant difference in efficacy between the treatment group and the control group (P < 0.01), indicating that the treatment group was superior to the control group.

[0079] 3.4 Laboratory Testing Indicators

[0080] Table 2 shows the results of hemoglobin, red blood cell count, mean corpuscular volume, mean corpuscular hemoglobin content, reticulocyte percentage, serum iron, and ferritin levels before and after treatment in both groups of cases.

[0081] Table 2: Changes in laboratory test indicators before and after treatment in the two groups of cases ( )

[0082]

[0083] Compared with before treatment, p < 0.01; compared with the control group, # p < 0.05.

[0084] Table 2 shows the following results: ① Hemoglobin: Before treatment, there was no statistically significant difference between the two groups (p>0.05), indicating comparability. After treatment, the Hb level in the treatment group increased significantly compared to before treatment (p<0.01). The difference between the two groups after treatment was statistically significant (p<0.01), with the treatment group showing better results than the control group. ② Red blood cell count: Before treatment, there was no statistically significant difference between the two groups (p>0.05), indicating comparability. After treatment, the red blood cell count in the treatment group increased significantly compared to before treatment (p<0.05). The difference between the two groups after treatment was statistically significant (p<0.05), with the increase in red blood cell count in the treatment group being greater than that in the control group. ③ Red blood cell volume: Before treatment, there was no statistically significant difference between the two groups (p>0.05), indicating comparability. After treatment, compared with before treatment, the red blood cell volume in the treatment group increased significantly (p<0.01). The increase in red blood cell volume in the treatment group was significantly greater than that in the control group (p<0.05). ④ Reticulocyte ratio: Before treatment, there was no statistically significant difference between the two groups (p>0.05), indicating comparability. After treatment, compared with before treatment, the reticulocyte ratio in the treatment group increased significantly (p<0.01). The increase in reticulocyte ratio in the treatment group was significantly greater than that in the control group (p<0.05). ⑤ Serum iron content: Before treatment, there was no statistically significant difference between the two groups (p>0.05), indicating comparability. After treatment, serum iron levels in the treatment group significantly increased compared to before treatment (p<0.05). The difference between the two groups after treatment was statistically significant (p<0.05), with the treatment group showing a greater increase in serum iron content than the control group. ⑥ Ferritin: Before treatment, there was no statistically significant difference between the two groups (p>0.05), indicating comparability. After treatment, ferritin levels in the treatment group significantly increased compared to before treatment (p<0.05). The difference between the two groups after treatment was statistically significant (p<0.05), with the treatment group showing a greater increase in serum iron content than the control group.

[0085] 3.5 Drug Safety Evaluation

[0086] Yiqi Weixue Tablets are a traditional Chinese medicine made from Astragalus membranaceus, jujube, and pig blood extract. Astragalus membranaceus and jujube are both food and medicine, with good safety profiles. Pig blood is a common human food, and the pig blood extract is derived from fresh pig blood. The heme iron in this extract is converted into iron ions in the intestines, achieving a bioavailability of up to 35% after entering the bloodstream, with low gastrointestinal irritation. The formula of Yiqi Weixue Tablets is simple, with each ingredient being a commonly used traditional Chinese medicine and food with good safety profiles. As of 2023, the estimated incidence of adverse reactions to Yiqi Weixue Tablets is approximately 0.337‰ (about 0.03%), which is considered rare according to the recommended adverse reaction rate by the Committee on International Organizations of Medical Sciences (CIOMS). In summary, Yiqi Weixue Tablets are safe and reliable, with low clinical risk. Adverse reactions are mainly gastrointestinal, such as nausea, diarrhea, vomiting, constipation, abdominal discomfort, and bloating, followed by skin reactions such as rash and itching. All of the above adverse reactions will disappear on their own after discontinuation of the medication.

[0087] Clinically, thalassemia patients often exhibit decreased serum iron and increased ferritin levels due to ineffective hematopoiesis and the inability to effectively utilize iron. Yiqi Weixue tablets break this vicious cycle, promoting efficient iron utilization and stimulating the production of healthier red blood cells. This application proposes the following possible explanations: 1. Promoting efficient utilization and redistribution of iron to red blood cells: Yiqi Weixue tablets may upregulate the expression of transferrin receptor 1 (TfR1) on the erythroid precursor cell membrane or enhance the cell's ability to take up iron, thus more efficiently mobilizing stored iron (in the form of ferritin) and circulating iron to the bone marrow hematopoietic site. This iron is then used to synthesize more hemoglobin, thereby improving anemia. 2. Regulating the hepcidin-membrane transporter axis: Hepcidin is a core hormone regulating iron absorption and release. Yiqi Weixue tablets indirectly or directly positively regulate hepcidin levels to a more physiological state, which may be related to Astragalus polysaccharides. Studies have shown that astragalus polysaccharides have a bidirectional regulatory effect on the body's iron content. In mice with iron overload models, it can regulate intestinal iron absorption, thereby alleviating iron overload. However, in mice with iron deficiency anemia, it can increase serum iron and ferritin levels. Furthermore, it may be related to astragaloside A. For example, a team using an iron overload mouse model found that astragaloside A intervention could reduce serum and liver iron levels to varying degrees, and also reduce brain iron levels in Alzheimer's disease model mice, suggesting that astragaloside A has a mechanism for optimizing iron metabolism.

[0088] In summary, the results of this study indicate that Yiqi Weixue tablets are significantly effective in treating thalassemia, with a total effective rate of 81.9% in the treatment group. It significantly increases patients' hemoglobin levels, red blood cell count, and mean corpuscular volume. It also increases serum iron and ferritin levels, and significantly increases the proportion of reticulocytes, suggesting that Yiqi Weixue tablets promote bone marrow hematopoiesis and have a mechanism for optimizing iron metabolism. This application demonstrates that Yiqi Weixue tablets have good clinical efficacy in treating thalassemia, primarily showing that they can increase peripheral blood hemoglobin levels in thalassemia patients, improve red blood cell-related parameters, promote hematopoiesis, and optimize iron metabolism and utilization. This provides important evidence for further research on Yiqi Weixue tablets in the treatment of thalassemia.

[0089] The embodiments described above are merely illustrative of several implementation methods of this application, intended to facilitate a detailed understanding of the technical solutions of this application, but should not be construed as limiting the scope of protection of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the scope of protection of this application. Furthermore, it should be understood that after reading the above teachings of this application, those skilled in the art can make various alterations or modifications to this application, and the equivalent forms obtained also fall within the scope of protection of this application. It should also be understood that technical solutions obtained by those skilled in the art based on the technical solutions provided in this application through logical analysis, reasoning, or limited experimentation are all within the scope of protection of the appended claims. Therefore, the scope of protection of this patent application should be determined by the content of the appended claims, and the specification can be used to interpret the content of the claims.

Claims

1. Use of a Yiqi Weixue preparation in the preparation of a medicament for treating thalassemia.

2. Use according to claim 1, characterized in that, The Yiqi Weixue preparation, when administered in an effective amount, increases the hemoglobin level, red blood cell count, and mean corpuscular volume of a subject.

3. Use according to claim 1, characterized in that, The Yiqi Weixue preparation refers to a preparation that, when administered in an effective amount, increases the serum iron content of a subject.

4. Use according to claim 1, characterized in that, The Yiqi Weixue preparation refers to a preparation that, when administered in an effective amount, increases the ferritin content of a subject.

5. The use according to claim 1, characterized in that, The Yiqi Weixue preparation refers to a preparation that, when administered in an effective amount, increases the reticulocyte ratio of a subject.

6. Use according to claim 1, characterized in that, The Yiqi Weixue preparation includes Yiqi Weixue tablets, Yiqi Weixue granules, and Yiqi Weixue capsules.

7. Use according to claim 6, characterized in that, The Yiqi Weixue preparation comprises pig blood extract, Astragalus membranaceus, and Chinese jujube.

8. Use according to any one of claims 2 to 5, characterized in that, The subject of the Yiqi Weixue preparation is a mammal.

9. Use according to claim 8, characterized in that, The mammal is a primate.

10. Use according to claim 9, characterized in that, The primate is a human.

Images