Traditional Chinese medicine composition for diabetes mellitus complicated with chronic coronary syndrome as well as preparation method and application of traditional Chinese medicine composition

Abstract

The invention discloses a traditional Chinese medicine composition for diabetes mellitus complicated with chronic coronary syndrome as well as a preparation method and application thereof. The composition comprises 2-6 parts of codonopsis pilosula, 2-4 parts of radix ophiopogonis, 1-2 parts of schisandra chinensis, 2-4 parts of salvia miltiorrhiza, 1-2 parts of coptis chinensis, 2-6 parts of poria cocos and 1-2 parts of fructus amomi. Aiming at the characteristics of deficiency of both qi and yin and blood vessel stasis of the type 2 diabetes mellitus complicated with the chronic coronary syndrome, the composition has the effects of tonifying qi and yin and promoting blood circulation to remove blood stasis, makes up the defects of clinical comprehensive treatment of the diabetes mellitus complicated with the chronic coronary syndrome at present, and provides a new thought and method for comprehensive regulation and control of the diabetes mellitus complicated with the chronic coronary syndrome.

Description

Technical Field

[0001] The present application relates to the technical field of Chinese medicine compositions, and in particular to a Chinese medicine composition for treating diabetes combined with chronic coronary syndrome, and a preparation method and application thereof. Background Art

[0002] Diabetes is a major risk factor for multiple cardiovascular diseases. The elevated blood sugar levels caused by type 2 diabetes promote the progression of atherosclerotic cardiovascular disease (ASCVD) by damaging blood vessels. Consequently, cardiovascular events caused by endothelial damage are the leading cause of death in diabetic patients. Multiple retrospective studies of patients with diabetes and cardiovascular disease in China and abroad have demonstrated that enhanced blood sugar management is essential for the treatment of patients with cardiovascular disease. As of 2021, the global number of people with diabetes reached 529 million, and this number is projected to reach 1.31 billion by 2050. This means that the burden of managing and preventing diabetes and its complications, including cardiovascular disease, will continue to increase on healthcare systems.

[0003] The concept of chronic coronary syndrome (CCS) was proposed in the "Guidelines for the Diagnosis and Management of Chronic Coronary Syndromes" issued by the European Society of Cardiology (ESC) in 2019. It is the comprehensive clinical manifestation of coronary artery disease in the stable phase. Compared with the concept of stable coronary atherosclerotic disease (SCAD), it focuses more on the control of the patient's dynamic pathological process. Patients may face different risks at different stages and require continuous monitoring and management.

[0004] The "Guidelines for the Diagnosis and Management of Chronic Coronary Syndrome Patients in China," published in 2024, updated the management nomenclature for patients with this disease. The guidelines specifically mention that patients with coronary artery disease and diabetes have a significantly increased risk of major adverse cardiovascular events (MACE).

[0005] Compared with patients with isolated coronary artery disease, those with coronary artery disease and diabetes often have more complex symptoms and atypical features. Due to the widespread presence of autonomic neuropathy, their angina is often atypical and difficult to detect. Sympathetic nerve dysfunction also increases the risk of arrhythmias in diabetic patients, with resting tachycardia being more common. Once a myocardial infarction occurs in patients with diabetes and coronary artery disease, the infarct size is often larger and more severe than in patients with isolated coronary artery disease, making them more susceptible to complications such as arrhythmias and heart rupture. Patients with diabetes and coronary artery disease often have extensive coronary artery lesions, often involving multiple vessels, with a higher incidence of left main coronary artery lesions, double-vessel and triple-vessel lesions, and bifurcation lesions. Diffuse lesions, occlusive lesions, and collateral circulation are common, with severe bleeding, ulceration, and calcification. Atherosclerotic plaques are more widely distributed, and the lesion lumen is more narrowed, greatly increasing the risk of sudden death from a large-scale myocardial infarction. Furthermore, high glucose levels and insulin resistance trigger a series of metabolic disorders, such as hypertension and dyslipidemia, which are common in diabetic patients. These conditions further exacerbate vascular inflammation and endothelial changes, making the condition of patients with diabetes and coronary heart disease more complex and difficult to treat. Currently, there is a lack of drugs for diabetic patients with chronic coronary syndrome. Summary of the Invention

[0006] In order to solve the above-mentioned deficiencies in the art, the present application aims to provide a Chinese medicine composition for diabetes combined with chronic coronary syndrome, and its preparation method and application.

[0007] According to one aspect of the present application, a traditional Chinese medicine composition for treating diabetes mellitus complicated with chronic coronary syndrome is provided, which comprises, by weight, 2-6 parts of Codonopsis pilosula, 2-4 parts of Ophiopogon japonicus, 1-2 parts of Schisandra chinensis, 2-4 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 2-6 parts of Poria cocos, and 1-2 parts of Amomum villosum.

[0008] According to some embodiments, the traditional Chinese medicine composition includes: 3-6 parts of Codonopsis pilosula, 3-4 parts of Ophiopogon japonicus, 1-2 parts of Schisandra chinensis, 3-4 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 3-6 parts of Poria cocos, and 1-2 parts of Amomum villosum.

[0009] According to some embodiments, the traditional Chinese medicine composition includes: 4-5 parts of Codonopsis pilosula, 2-4 parts of Ophiopogon japonicus, 1-2 parts of Schisandra chinensis, 2-3 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 2-5 parts of Poria cocos, and 1-2 parts of Amomum villosum.

[0010] On the other hand, the present application also provides a use of the above-mentioned traditional Chinese medicine composition in the preparation of medicines and health products for treating diabetes combined with chronic coronary syndrome.

[0011] The present application also includes a medicine, health product or food containing the above-mentioned traditional Chinese medicine composition for diabetes combined with chronic coronary syndrome.

[0012] According to some embodiments, the medicine, health product or food is taken orally.

[0013] According to some embodiments, the medicine, health product or food is in the form of tablets, granules, instant powder, tea or solid beverage.

[0014] According to one aspect of the present application, a method for preparing a drug for treating diabetes mellitus combined with chronic coronary syndrome is provided, comprising:

[0015] Weigh the following raw materials in parts by weight: 2-6 parts of Codonopsis pilosula, 2-4 parts of Ophiopogon japonicus, 1-2 parts of Schisandra chinensis, 2-4 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 2-6 parts of Poria cocos, and 1-2 parts of Amomum villosum;

[0016] Remove impurities from the raw materials, add 8-12 times of water to boil, and extract twice;

[0017] The extract is concentrated under reduced pressure and filtered to obtain a concentrate;

[0018] Add auxiliary materials to the concentrated solution, mix well, and spray dry in a spray dryer to obtain spray-dried powder;

[0019] Add appropriate amount of auxiliary materials to the spray-dried powder, mix well and then granulate.

[0020] According to some embodiments, the extract is concentrated under reduced pressure to a relative density of 1.05-1.07.

[0021] According to some embodiments, the temperature of the reduced pressure concentration is 70-75°C.

[0022] Compared with the prior art, this application has at least the following beneficial effects:

[0023] The present application provides a Chinese medicine composition for diabetes combined with chronic coronary syndrome, which is scientifically compatible with Codonopsis pilosula, Ophiopogon japonicus, Schisandra chinensis, Salvia miltiorrhiza, Coptis chinensis, Poria cocos, and Amomum villosum. Aiming at the characteristics of Qi and Yin deficiency and blood stasis in type 2 diabetes combined with chronic coronary syndrome, the composition takes into account both Qi and Yin nourishment and blood circulation and blood stasis removal, making up for the shortcomings of the current comprehensive clinical treatment of diabetes combined with chronic coronary syndrome, and provides new ideas and methods for the comprehensive regulation of diabetes combined with chronic coronary syndrome. At the same time, the composition has few medicinal flavors, a small dosage, and low cost. At the same time, it is safe and effective, with consistent and mature principles, methods, prescriptions and medicines, in line with traditional Chinese medicine theory. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 This is a comparison of the TCM syndrome scores of the two groups of patients before and after intervention in the experimental case of this application.

[0025] Figure 2 This is a comparison of fasting blood glucose levels in the two groups of patients before and after intervention in the experimental example of this application.

[0026] Figure 3This is a comparison of the SAQ mean scores of the two groups of patients before and after intervention in the experimental example of this application.

[0027] Figure 4 This is a comparison of the efficacy evaluation of the two groups of patients in the experimental example of this application. DETAILED DESCRIPTION

[0028] The following will clearly and completely describe the technical solutions of this application in conjunction with the embodiments of this application. Obviously, the embodiments described are part of the embodiments of this application, not all of them. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative work are within the scope of protection of this application.

[0029] It is particularly important to note that similar substitutions and modifications made with respect to the present application are obvious to those skilled in the art and are considered to be included in the present application. Relevant persons can obviously modify or appropriately change and combine the methods and applications described herein without departing from the content, spirit, and scope of the present application to implement and apply the technology of the present application. Obviously, the embodiments described are only some of the embodiments of the present application, and not all of them.

[0030] If no specific conditions are specified in this application, the preparation shall be carried out in accordance with conventional conditions or the conditions recommended by the manufacturer. The raw materials or excipients used, as well as the reagents or instruments used, for which the manufacturers are not specified, are all conventional products that can be obtained commercially.

[0031] The present application is described in detail below with reference to specific embodiments.

[0032] Example Preparation of the Chinese medicine composition of this application

[0033] Weigh the following raw materials in parts by weight: 2-6 parts of Codonopsis pilosula, 2-4 parts of Ophiopogon japonicus, 1-2 parts of Schisandra chinensis, 2-4 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 2-6 parts of Poria cocos, and 1-2 parts of Amomum villosum;

[0034] Remove impurities from the raw materials, add 8-12 times of water to boil, and extract twice;

[0035] The extract was concentrated under reduced pressure at 70-75°C to a relative density of 1.05-1.07, and filtered to obtain a concentrated solution;

[0036] Add auxiliary materials to the concentrated solution, mix well, and spray dry in a spray dryer to obtain spray-dried powder;

[0037] Add appropriate amount of auxiliary materials to the spray-dried powder, mix well and then granulate.

[0038] Experimental example

[0039] The granules prepared in the examples were used to conduct a randomized, double-blind, placebo-controlled, parallel clinical trial for verification.

[0040] 1. Enrollment

[0041] Patients who visited the Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, between August 2024 and February 2025 were selected for this study. This study protocol was approved by the hospital's ethics committee (Ethics Approval No. 2024BL02-096-03). A randomized, double-blind study was conducted. Computer software generated a random sequence, and subjects were randomly assigned to the treatment group and the control group in a 1:1 ratio. Sequence-coded, sealed, opaque envelopes were used for randomization concealment.

[0042] 2. Inclusion criteria

[0043] All the patients met the diagnostic criteria for type 2 diabetes mellitus with qi and yin deficiency and blood stasis combined with chronic coronary syndrome.

[0044] (1) Aged 35-80 years (inclusive);

[0045] (2) patients who meet the diagnostic criteria for type 2 diabetes and chronic coronary syndrome and have angina symptoms;

[0046] (3) Those who meet the diagnostic criteria of diabetes mellitus and chest pain and heart pain in traditional Chinese medicine, and whose syndromes are qi and yin deficiency and blood stasis according to traditional Chinese medicine;

[0047] (4) Not taking any preparations containing Chinese medicine ingredients regularly in the month before enrollment;

[0048] (5) The subject or his / her legal representative voluntarily signs the informed consent form.

[0049] 3. Groups and intervention methods

[0050] A parallel group control was used, and patients who met the inclusion criteria were randomly divided into a treatment group and a control group at a ratio of 1:1. The subjects in the control group only received conventional Western medicine treatment.

[0051] (1) Treatment Group: In addition to conventional oral Western medication, the Chinese medicine composition prepared as described in the examples of this application was administered. The composition was prepared by the Department of Pharmacy of our hospital in the form of a mixture, 10 mL per bag. The composition should be taken 0.5 hours after the Western medication, one bag at a time, twice daily, for 4 consecutive weeks.

[0052] (2) Control group: only received conventional Western medicine standard treatment.

[0053] (3) Both the treatment group and the control group received lifestyle control and standardized Western medicine treatment. The specific Western medicine treatment plan was formulated by the cardiologists of our hospital based on the patient's condition, referring to the 2024 "Guidelines for the Prevention and Treatment of Diabetes in China" and the 2024 "Guidelines for the Diagnosis and Management of Chronic Coronary Syndrome Patients in China".

[0054] 4. Observation indicators

[0055] (1) Main observation indicators:

[0056] ① Traditional Chinese Medicine (TCM) syndrome score: A TCM syndrome score scale (Appendix 1) was developed based on the Guiding Principles for Clinical Research of New Chinese Medicines (2002 edition) and Traditional Chinese Medicine Internal Medicine (2021 edition). The TCM syndrome score was recorded 1 day before treatment and 4 weeks after treatment.

[0057] ② Blood glucose level: Detect the patient's fasting blood glucose level 1 day before treatment and 29 days after treatment.

[0058] ③Seattle Angina Questionnaire (SAQ, Appendix 2) score: The patient's SAQ score was recorded 1 day before treatment and 4 weeks after treatment. The SAQ score was mainly evaluated from five dimensions: physical limitation (PL), anginal frequency (AF), anginal stability (AS), disease specific (DS) and treatment satisfaction (TS). The average of the five scores was calculated as the overall quality of life score of chronic coronary syndrome.

[0059] (2) Secondary observation indicators:

[0060] ① Glycated hemoglobin level: Detect the patient's plasma HbA1c level 1 day before treatment and 29 days after treatment.

[0061] ② Blood glucose fluctuation level: Patients were asked to wear a continuous glucose monitoring (CGM) system 1 week before treatment and 5 weeks after treatment. The changes in the relevant parameters of CGM were observed 1 week before treatment and 1 week after treatment (calibrated with fingertip blood glucose levels), including the percentage of time in the target glucose range (3.9-10.0 mmol / L) (time in range, TIR), the percentage of time with glucose below the target range (<3.9 mmol / L) (time below range, TBR), the percentage of time with glucose above the target range (>10.0 mmol / L) (time above range, TAR), standard deviation (SD) of blood glucose levels, coefficient of variation (CV), mean blood glucose level (MBG), and glucose management indicator (GMI).

[0062] (3) Safety indicators and adverse event follow-up

[0063] Safety indicators were measured one day before treatment and four weeks after treatment. These included routine laboratory tests such as blood and urine tests, liver function tests (ALT, AST), and kidney function tests (Cr, Urea), as well as adverse reactions experienced by patients in each group during treatment, such as allergies, gastrointestinal symptoms, and severe liver and kidney damage. Patients were followed up in the outpatient clinic for four weeks after treatment, and symptoms and adverse events were recorded.

[0064] Efficacy evaluation:

[0065] (1) TCM syndrome efficacy: The TCM syndrome efficacy of each group of patients was recorded on the 28th day of treatment. The TCM syndrome efficacy evaluation criteria refer to the "Guiding Principles for Clinical Research of New Chinese Medicines". The specific criteria are as follows:

[0066] Markedly effective: Clinical symptoms and signs were significantly improved, with syndrome scores reduced by ≥70%.

[0067] Effective: Clinical symptoms and signs improved, and the syndrome score decreased by ≥30%.

[0068] Ineffective: There is no significant improvement in clinical symptoms and signs, or they may even worsen, and the symptom score decreases by less than 30%.

[0069] (2) Diabetes efficacy: The diabetes efficacy of each group of patients was recorded on the 28th day of treatment. The criteria for determining the efficacy of diabetes were based on the "Guiding Principles for Clinical Research of New Chinese Medicines". The specific criteria are as follows:

[0070] Markedly effective: Fasting blood sugar and blood sugar 2 hours after meal dropped to normal range, or dropped by more than 40% of the pre-treatment range. Glycated hemoglobin dropped to normal range, or dropped by more than 30% of the pre-treatment range.

[0071] Effective: Fasting blood sugar and 2-hour postprandial blood sugar levels decreased by more than 20% of pre-treatment levels, but did not reach the marked effect standard. Glycated hemoglobin decreased by more than 10% of pre-treatment levels, or did not reach the marked effect standard.

[0072] Ineffective: Fasting blood sugar and 2-hour postprandial blood sugar levels did not decrease, or the decrease did not reach the effective standard. Glycated hemoglobin did not decrease, or the decrease did not reach the effective standard.

[0073] (3) Efficacy of angina pectoris symptoms: The frequency of angina attacks, duration of each attack, severity of pain, and dosage of nitroglycerin or other drugs (such as Suxiao Jiuxin Pills) used to control acute attacks of angina pectoris symptoms were recorded 1 day before treatment and on the 28th day of treatment. The criteria for judging the efficacy of angina pectoris symptoms were based on the "Guiding Principles for Clinical Research of New Chinese Medicines". The specific criteria are as follows:

[0074] Markedly effective: After treatment, exertional angina symptoms are reduced by two levels or disappear. For patients with previously graded angina I or II, angina essentially disappears (i.e., angina is essentially non-recurring even during strenuous physical activity exceeding daily activities), with no need for nitroglycerin or other medications to control acute attacks of angina. For non-exertional angina, symptoms disappear or essentially disappear, with angina attacks occurring no more than twice a week, and no need for nitroglycerin or other medications to control acute attacks of angina.

[0075] Improvement: After treatment of exertional angina, the symptoms of angina pectoris were reduced by one level, and the use of nitroglycerin was reduced by more than half. For those who were originally in grade A, the angina pectoris basically disappeared and nitroglycerin was no longer needed. For non-exertional angina pectoris, the number of angina pectoris and the amount of nitroglycerin used were reduced by more than half after treatment.

[0076] Ineffective: Symptoms and nitroglycerin dosage remain unchanged, or are reduced but not to the extent of improvement.

[0077] Aggravation: The frequency, severity and duration of pain attacks increase, or angina pectoris escalates, and the dosage of nitroglycerin increases.

[0078] Effective rate = (markedly effective + effective) / total number of cases × 100%.

[0079] 5. Data collection, data management and statistical analysis

[0080] After enrollment, the investigators collected general information, Traditional Chinese Medicine (TCM) syndrome scores, Seattle Angina Questionnaire (SAQ) scores, and adverse reactions. Fasting plasma glucose (FPG), glycosylated hemoglobin (HbA1c), blood and urine routine, liver function tests (ALT, AST), and renal function tests (Cr, UREA) were measured by our hospital's laboratory. Blood glucose fluctuations were measured using a continuous glucose monitoring system (model: GX-03S) before and after the intervention, and were monitored for one week.

[0081] During the trial, senior research physicians will regularly oversee the study to ensure strict adherence to all study protocols and accurate recording of clinical data. Researchers should objectively and truthfully record and retain all data, protocol implementation, and protocol modifications during the trial. During patient recruitment, inclusion and exclusion criteria should be maintained as consistently as possible.

[0082] 6. Research Results

[0083] (1) Baseline comparison of general conditions between the treatment group and the control group

[0084] A total of 60 patients were enrolled, 57 of whom completed the study and 3 dropped out. Of these, 28 completed the study and 2 dropped out in the treatment group, while 29 completed the study and 1 dropped out in the control group. Among the dropouts, one subject in the treatment group withdrew from the study for personal reasons within 1 week of the start of the intervention. One subject in each of the treatment and control groups was lost to follow-up 4 weeks after the start of the study. No subjects withdrew from the study due to adverse events. The treatment group consisted of 17 male and 11 female subjects, with an age distribution of (67.36 ± 10.37) years. Nineteen subjects had hypertension and 20 had hyperlipidemia. The control group consisted of 21 male and 8 female subjects, with an age distribution of (64.90 ± 10.06) years. Twenty-two subjects had hypertension and 19 had hyperlipidemia. Baseline data comparing the general characteristics of the two groups are shown in Table 1. There was no statistically significant difference in age, gender, T2DM, duration of CCS history, combined hypertension, hyperlipidemia and proportion of combined treatment between the treatment group and the control group (P>0.05).

[0085] Table 1 Comparison of general conditions of the two groups of patients

[0086]

[0087]

[0088] Note: n represents the number of people in the group.

[0089] Patients who met the inclusion criteria were randomly divided into a treatment group and a control group. A standardized Western medicine treatment plan was developed based on the patient's condition. For patients with stable conditions, the original treatment plan was maintained as much as possible. The baseline parameters measured before the intervention were compared between the two groups. The results are shown in Table 2. There were no statistically significant differences in the observed parameters between the treatment and control groups (P>0.05), indicating that the baseline data between the two groups were not significantly different and comparable.

[0090] Table 2 Comparison of observation indicators before intervention between the two groups of patients

[0091]

[0092] Note: n represents the number of people in the group.

[0093] As shown in Tables 1 and 2, there were no statistically significant differences between the treatment group and the control group in terms of age, gender, BMI, T2DM, duration of CCS history, proportion of hypertension and hyperlipidemia, combined insulin therapy, revascularization therapy, and baseline observation indicators (P>0.05). Therefore, the baselines of the treatment group and the control group were consistent, and the two groups were comparable.

[0094] (2) Comparison of TCM syndrome scores between the two groups before and after intervention

[0095] Table 3 Comparison of TCM syndrome scores between the two groups of patients before and after intervention

[0096]

[0097] Note: △ indicates P < 0.05 compared with the control group, ※ indicates P < 0.05 compared with the control group, n indicates the number of people in the group.

[0098] According to the results in Table 3, the comparison of the TCM syndrome scores of the patients in the treatment group before and after the intervention showed that the TCM syndrome scores of the patients in the treatment group were significantly improved after the intervention, with intra-group comparison P < 0.001, and the difference was statistically significant; the intra-group comparison of the TCM syndrome scores of the control group before and after the intervention P = 0.057 > 0.05, and the difference was not statistically significant; the inter-group comparison of the two groups after the intervention P = 0.003 < 0.05, and the difference was statistically significant.

[0099] (3) Comparison of blood glucose levels between the two groups before and after intervention

[0100] Table 4 Comparison of blood glucose levels in the two groups before and after intervention

[0101]

[0102] Note: △ indicates P < 0.05 compared with the control group, ※ indicates P < 0.05 compared with the control group, n indicates the number of people in the group.

[0103] As shown in Table 4, the overall FPG levels of the treatment group decreased before and after the intervention, while those of the control group increased after the intervention. The intragroup comparison of FPG levels in the treatment group before and after the intervention was statistically significant (P = 0.022 < 0.05); the intragroup comparison of FPG levels in the control group before and after the intervention was statistically significant (P = 0.027 < 0.05); the intergroup comparison between the two groups after the intervention was not statistically significant (P = 0.402 > 0.05). However, the decrease in FPG levels from baseline in the treatment group (difference: 0.26 ± 1.05 mmol / L) was greater than that in the control group (difference: -0.60 ± 1.29 mmol / L), P = 0.024 < 0.05, so the difference remained statistically significant.

[0104] (4) Comparison of SAQ scores between the two groups before and after intervention

[0105] Table 5 Comparison of SAQ scores between the two groups before and after intervention

[0106]

[0107]

[0108] Note: △ indicates P < 0.05 compared with the control group, ※ indicates P < 0.05 compared with the control group, n indicates the number of people in the group.

[0109] Table 5 shows that before and after the intervention, patients in the treatment group showed increases in AS, AF, TS, DS, and SAQ mean scores. The intragroup comparison of PL scores before and after the intervention in the treatment group (P = 0.106 > 0.05) and the intragroup comparison of PL scores in the control group (P = 0.952 > 0.05) before the intervention were not statistically significant. The intergroup comparison of AS scores before and after the intervention in the treatment group (P = 0.002 < 0.05) was statistically significant. The intragroup comparison of AS scores before and after the intervention in the control group (P = 0.248 > 0.05) was not statistically significant. The intergroup comparison of PL scores after the intervention was statistically significant (P = 0.001 < 0.05). In terms of AF, the intra-group comparison of AF scores before and after intervention in the treatment group was P = 0.001 < 0.05, indicating a statistically significant difference; the intra-group comparison of AF scores before and after intervention in the control group was P = 0.589 > 0.05, indicating no statistically significant difference; the inter-group comparison after intervention was P = 0.029 < 0.05, indicating a statistically significant difference. In terms of TS, the intra-group comparison of TS scores before and after intervention in the treatment group was P < 0.001, indicating a statistically significant difference; the intra-group comparison of TS scores before and after intervention in the control group was P = 0.401 > 0.05, indicating no statistically significant difference; the inter-group comparison after intervention was P < 0.001, indicating a statistically significant difference. In terms of DS, the intra-group comparison of DS scores before and after intervention in the treatment group was P = 0.004 < 0.05, indicating a statistically significant difference; the intra-group comparison of DS scores before and after intervention in the control group was P = 0.004 < 0.05, indicating a statistically significant difference; the inter-group comparison after intervention was P < 0.001, indicating a statistically significant difference. In terms of SAQ mean scores, the intra-group comparison of SAQ before and after intervention in the treatment group was P < 0.001, and the difference was statistically significant; the intra-group comparison of SAQ mean scores before and after intervention in the control group was P = 0.984 > 0.05, and the difference was not statistically significant; the inter-group comparison between the two groups after intervention was P < 0.001, and the difference was statistically significant.

[0110] (5) Comparison of HbA1c levels and CGM parameters between the two groups before and after intervention

[0111] Table 6 Comparison of HbA1c levels in the two groups before and after intervention

[0112]

[0113] Note: △ indicates P < 0.05 compared with the control group before intervention, n indicates the number of people in the group.

[0114] As shown in Table 6, the overall HbA1c levels of the two groups decreased before and after the intervention. The intragroup comparison of HbA1c levels in the treatment group before and after the intervention (P = 0.048 < 0.05) was statistically significant. The intragroup comparison of HbA1c levels in the control group before and after the intervention (P = 0.839 > 0.05) was not statistically significant. The intergroup comparison after the intervention (P = 0.774 > 0.05) was not statistically significant.

[0115] Table 7 Comparison of CGM parameters between the two groups of patients before and after intervention

[0116]

[0117] Note: △ indicates P < 0.05 compared with the control group before intervention, n indicates the number of people in the group.

[0118] As shown in Table 7, before and after the intervention, the intra-group comparison of the TBR treatment group before and after the intervention was P = 0.026 < 0.05, and the difference was statistically significant; the intra-group comparison of the TBR control group before and after the intervention was P = 0.313 > 0.05, and the inter-group comparison after the intervention was P = 0.222 > 0.05, and the difference was not statistically significant. The intra-group comparison before and after the intervention in the MBG treatment group was P = 0.799 > 0.05, the intra-group comparison before and after the intervention in the control group was P = 0.895 > 0.05, and the inter-group comparison after the intervention was P = 0.180 > 0.05; the intra-group comparison before and after the intervention in the GMI treatment group was P = 0.597 > 0.05, the intra-group comparison before and after the intervention in the control group was P = 0.058 > 0.05, and the inter-group comparison after the intervention was P = 0.063 > 0.05; the intra-group comparison before and after the intervention in the TIR treatment group was P = 0.524 > 0.05, and the intra-group comparison before and after the intervention in the control group was P = 0.589 > 0.05. After the intervention, the inter-group comparison between the two groups was P=0.170>0.05; the intra-group comparison of TAR in the treatment group before and after the intervention was P=446>0.05, the intra-group comparison in the control group before and after the intervention was P=0.909>0.05, and the inter-group comparison between the two groups after the intervention was P=0.067>0.05. Although the TAR data of the two groups showed different trends of change after the intervention, the overall difference in TAR levels between the two groups before and after the intervention [treatment group 1.4 (-3.4, 9.75) control group 0.2 (-7.45, 7.95)] P=0.443>0.05, the difference was still not statistically significant. The intra-group comparison before and after the intervention in the SD treatment group was P=0.227>0.05, the intra-group comparison before and after the intervention in the control group was P=0.864>0.05, and the inter-group comparison after the intervention was P=0.621>0.05; the intra-group comparison before and after the intervention in the CV treatment group was P=0.245>0.05, the intra-group comparison before and after the intervention in the control group was P=0.891>0.05, and the inter-group comparison after the intervention was P=0.737>0.05. The differences were not statistically significant.

[0119] (6) Efficacy evaluation

[0120] Table 7 Comparison of TCM syndrome efficacy between the two groups of patients

[0121]

[0122] Note: ※ indicates P < 0.05 compared with the control group, n indicates the number of people in the group.

[0123] As shown in Table 7, after treatment, 1 patient in the treatment group had a markedly effective TCM syndrome, 12 patients were effective, 15 patients were ineffective, and the total effective rate was 46.43%; 0 patient in the control group had a markedly effective syndrome, 5 patients were effective, 24 patients were ineffective, and the total effective rate was 17.24%; the comparison of the effective rates between the two groups was P = 0.018 < 0.05, and the difference was statistically significant.

[0124] Table 8 Comparison of the efficacy of diabetes mellitus in the two groups

[0125]

[0126] Note: n represents the number of people in the group.

[0127] As shown in Table 8, in the treatment group, 3 cases of diabetes were significantly effective, 11 cases were effective, 14 cases were ineffective, and the total effective rate was 50.00%; in the control group, 0 cases of diabetes were significantly effective, 11 cases were effective, 18 cases were ineffective, and the total effective rate was 37.93%; the comparison of the effective rates between the two groups was P=0.359>0.05, and the difference was not statistically significant.

[0128] Table 9 Comparison of efficacy of angina pectoris symptoms in two groups of patients

[0129]

[0130] Note: ※ indicates P < 0.05 compared with the control group, n indicates the number of people in the group.

[0131] As shown in Table 9, in the treatment group, 3 cases of angina pectoris symptoms were significantly effective, 12 cases were effective, 13 cases were ineffective, and the total effective rate was 50.00%; in the control group, 0 cases of angina pectoris symptoms were significantly effective, 4 cases were effective, 25 cases were ineffective, and the total effective rate was 37.93%; the comparison of the effective rates between the two groups was P=0.001<0.05, and the difference was statistically significant.

[0132] 7. Safety indicators, adverse reactions, and other occurrences

[0133] During the clinical observation period, neither group experienced nausea, vomiting, hematuria, hematochezia, rash, or other drug allergic reactions. No patients in either group experienced acute hypoglycemia or diabetic ketoacidosis during the trial. No adverse cardiovascular events, such as ACS, occurred in either group. Both groups showed no significant abnormalities in blood routine, liver, or kidney function before and after treatment.

[0134] The above embodiments are only intended to help understand the method and core concept of the present application. It should be noted that, for those skilled in the art, without departing from the principles of the present application, several improvements and modifications may be made to the present application, and such improvements and modifications also fall within the scope of protection of the claims of the present application.

Claims

1. A Chinese medicine composition for diabetes combined with chronic coronary syndrome, characterized in that: The composition comprises, by weight, 2-6 parts of Codonopsis pilosula, 2-4 parts of Radix Ophiopogonis, 1-2 parts of Schisandrae Chinensis, 2-4 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 2-6 parts of Poria cocos, and 1-2 parts of Amomum villosum.

2. The Chinese medicine composition for treating diabetes mellitus complicated with chronic coronary syndrome according to claim 1, wherein The Chinese medicine composition comprises: 3-6 parts of Codonopsis pilosula, 3-4 parts of Ophiopogon japonicus, 1-2 parts of Schisandra chinensis, 3-4 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 3-6 parts of Poria cocos, and 1-2 parts of Amomum villosum.

3. The Chinese medicine composition for treating diabetes mellitus complicated with chronic coronary syndrome according to claim 1, wherein The Chinese medicine composition comprises: 4-5 parts of Codonopsis pilosula, 2-4 parts of Ophiopogon japonicus, 1-2 parts of Schisandra chinensis, 2-3 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 2-5 parts of Poria cocos, and 1-2 parts of Amomum villosum.

4. Use of the traditional Chinese medicine composition according to any one of claims 1 to 3 in the preparation of medicines and health products for treating diabetes mellitus complicated with chronic coronary syndrome.

5. A medicine, health product or food, characterized in that: A traditional Chinese medicine composition for treating diabetes mellitus complicated with chronic coronary syndrome comprising the composition according to any one of claims 1 to 3.

6. The medicine, health product or food according to claim 5, characterized in that: The medicine, health product or food is for oral administration.

7. The medicine, health product or food according to claim 5, characterized in that: The medicine, health product or food is in the form of tablets, granules, instant powder, tea or solid beverage.

8. A method for preparing a drug for treating diabetes mellitus combined with chronic coronary syndrome, characterized in that: include: Weigh the following raw materials in parts by weight: 2-6 parts of Codonopsis pilosula, 2-4 parts of Ophiopogon japonicus, 1-2 parts of Schisandra chinensis, 2-4 parts of Salvia miltiorrhiza, 1-2 parts of Coptis chinensis, 2-6 parts of Poria cocos, and 1-2 parts of Amomum villosum; Remove impurities from the raw materials, add 8-12 times of water to boil, and extract twice; The extract is concentrated under reduced pressure and filtered to obtain a concentrate; Add auxiliary materials to the concentrated solution, mix well, and spray dry in a spray dryer to obtain spray-dried powder; Add appropriate amount of auxiliary materials to the spray-dried powder, mix well and then granulate.

9. The preparation method according to claim 8, characterized in that The extract is concentrated under reduced pressure to a relative density of 1.05-1.

07.

10. The preparation method according to claim 9, characterized in that The temperature of the reduced pressure concentration is 70-75°C.

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