Use of a traditional Chinese medicine composition in the preparation of a cardiovascular protective drug for myocardial infarction after PCI

Abstract

This invention provides the application of a traditional Chinese medicine composition in the preparation of cardiovascular protective drugs after percutaneous coronary intervention (PCI) for myocardial infarction, specifically acute ST-segment elevation myocardial infarction (STEMI), with a TCM syndrome of "heart yang deficiency." The composition comprises raw Cornus officinalis, dried ginger, ginseng, Astragalus membranaceus, Atractylodes macrocephala, Alisma plantago-aquatica, Poria cocos, and Aconitum carmichaelii. The cardiovascular protective effects of this composition include improving cardiac function, inhibiting postoperative oxidative stress, reducing NT-proBNP, and decreasing the risk of cardiovascular events within one year post-surgery. It can be prepared as a decoction, oral liquid, or other dosage forms, and can be used in combination with conventional Western medicine treatments for synergistic effects. The composition of this invention is scientifically formulated, targets multiple points of action, and effectively addresses the problem of limited cardiovascular protection methods after PCI in STEMI patients, significantly improving patient prognosis and demonstrating good clinical application value.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to the application of a traditional Chinese medicine composition in the preparation of cardiovascular protective drugs after PCI for myocardial infarction. Background Technology

[0002] Acute ST-segment elevation myocardial infarction (STEMI) is a common and critical cardiovascular emergency characterized by rapid onset and high mortality. Percutaneous coronary intervention (PCI) is currently the core clinical treatment for STEMI, rapidly opening occluded coronary arteries, restoring myocardial blood flow, and significantly reducing acute-phase mortality. However, myocardial reperfusion injury after PCI remains a pressing clinical challenge. The reperfusion process can trigger oxidative stress, myocardial cell damage, and decreased cardiac function, among other problems. Some patients still experience adverse cardiovascular events such as heart failure and arrhythmias post-PCI. Even with guideline-guided conventional medication, the risk of post-PCI cardiovascular events remains high, severely impacting patient prognosis.

[0003] Currently, clinical cardiovascular protection for STEMI patients after PCI is mainly based on Western medicine, including antiplatelet, anticoagulant, lipid-regulating, and myocardial remodeling drugs. However, these drugs mostly have single-target effects and are difficult to simultaneously improve postoperative cardiac function and inhibit oxidative stress. In addition, some drugs have problems such as tolerance and adverse reactions, and the overall protective effect is difficult to meet clinical needs. Traditional Chinese medicine has the advantages of holistic conditioning and multi-target effects in the treatment of cardiovascular diseases. STEMI patients after PCI often present with heart yang deficiency syndrome, with cold coagulation and blood stasis and internal retention of dampness as the main pathogenesis. However, there is a lack of TCM compositions specifically for heart yang deficiency syndrome after PCI in STEMI patients that can achieve multi-dimensional cardiovascular protection. There is also no TCM composition that can improve cardiac function, inhibit oxidative stress, reduce myocardial injury markers, and reduce the risk of long-term cardiovascular events.

[0004] Based on this, the present invention selects scientifically compatible Chinese herbal raw materials to form a drug composition with a specific ratio, and applies it to cardiovascular protection after PCI in STEMI patients, solving the technical problem that the existing postoperative cardiovascular protection methods are singular and have limited effects. Summary of the Invention

[0005] In view of this, the present invention proposes the application of a traditional Chinese medicine composition in the preparation of cardiovascular protective drugs after PCI for myocardial infarction, thereby solving the above-mentioned problems.

[0006] The technical solution of the present invention is implemented as follows: the application of a traditional Chinese medicine composition in the preparation of cardiovascular protective drugs after PCI for myocardial infarction, wherein the traditional Chinese medicine composition includes raw Cornus officinalis, dried ginger, ginseng, Astragalus membranaceus, Atractylodes macrocephala, Alisma plantago-aquatica, Poria cocos and Aconitum carmichaelii, wherein the myocardial infarction is acute ST segment elevation myocardial infarction.

[0007] Preferably, the TCM syndrome of acute ST-segment elevation myocardial infarction is heart yang deficiency syndrome, with symptoms such as chest tightness or chest pain, shortness of breath, palpitations, spontaneous sweating, fatigue and aversion to cold, pale complexion, cold or swollen limbs, pale and swollen tongue, white and greasy tongue coating, and deep, thready and slow pulse.

[0008] Preferably, the cardiovascular protection is a multi-dimensional protective effect, specifically including improving the patient's cardiac function, inhibiting postoperative oxidative stress, reducing the level of N-terminal pro-brain natriuretic peptide (NT-proBNP), and reducing the incidence of postoperative cardiovascular events.

[0009] Preferably, the improvement in cardiac function includes increasing left ventricular ejection fraction (LVEF) and improving non-invasive hemodynamic parameters.

[0010] Preferably, the non-invasive hemodynamic parameters include cardiac output (CO), cardiac index (CI), and peripheral vascular resistance (SVR).

[0011] Preferably, the inhibition of postoperative oxidative stress specifically includes reducing the level of reactive oxygen species (ROS) in the body, while increasing the expression levels of superoxide dismutase (SOD) and glutathione (GSH), thereby reducing myocardial reperfusion injury by regulating the body's antioxidant system.

[0012] Preferably, the reduction in the incidence of postoperative cardiovascular events refers to reducing the risk of cardiovascular events occurring within one year after PCI in patients, including cardiogenic shock, myocardial infarction, angina pectoris, arrhythmia, heart failure, stroke / transient ischemic attack, death due to revascularization, readmission, or emergency room treatment.

[0013] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 100-150 parts of raw Cornus officinalis, 50-80 parts of dried ginger, 20-40 parts of ginseng, 20-40 parts of Astragalus membranaceus, 20-40 parts of Atractylodes macrocephala, 50-80 parts of Alisma plantago-aquatica, 50-80 parts of Poria cocos, and 20-30 parts of Aconitum carmichaelii.

[0014] Preferably, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 120 parts of raw Cornus officinalis, 60 parts of dried ginger, 30 parts of ginseng, 30 parts of Astragalus membranaceus, 30 parts of Atractylodes macrocephala, 60 parts of Alisma plantago-aquatica, 60 parts of Poria cocos, and 25 parts of Aconitum carmichaelii.

[0015] Preferably, the pharmaceutical composition can be prepared in a pharmaceutically acceptable dosage form, including decoction, oral liquid, granules, capsules or tablets, each dosage form being suitable for clinical administration after PCI in STEMI patients.

[0016] Compared with the prior art, the beneficial effects of the present invention are:

[0017] The pharmaceutical composition of this invention is based on the traditional Chinese medicine theory of "warming yang and consolidating the body, tonifying qi and promoting diuresis." Targeting the core pathogenesis of cardiac yang deficiency after PCI in STEMI patients, the various raw materials work synergistically. The principal ingredient is raw Cornus officinalis, which is sour and warm, astringing the liver and consolidating the body's vital energy to prevent sudden collapse of cardiac qi after myocardial infarction. It is combined with large doses of Aconitum carmichaelii and dried ginger, which are pungent and hot, restoring yang and rescuing from collapse, warming and unblocking the yang of the heart and kidneys, to assist Cornus officinalis in consolidating the yang that is about to collapse. Ginseng, Astragalus membranaceus, and Atractylodes macrocephala are sweet and warm, tonifying qi and strengthening the spleen, replenishing acquired qi to nourish innate qi, serving as adjuvant herbs to invigorate qi and promote blood circulation and yang recovery. Furthermore, Alisma plantago-aquatica and Poria cocos are sweet and bland, promoting diuresis and eliminating turbidity to relieve the dampness affecting the heart after myocardial infarction, ensuring that tonification is not stagnant. This formula integrates warming yang, consolidating the body, replenishing qi, and promoting diuresis. Cornus officinalis has the power to astringe and consolidate the body to prevent sudden collapse of heart yang. Aconite, ginger, ginseng, astragalus, and atractylodes warm and replenish the yang qi of the heart, spleen, and kidneys to treat the root cause. Poria and purgative promote diuresis and eliminate dampness to treat the symptoms. The synergistic effect of these herbs aims to strongly replenish the original yang, astringe and consolidate the body, replenish qi and promote diuresis, and prevent heart failure caused by the decline of yang qi and the retention of water and fluids after myocardial infarction.

[0018] The composition of this invention can effectively improve the left ventricular ejection fraction (LVEF) in STEMI patients after PCI, optimize non-invasive hemodynamic parameters such as cardiac output (CO), cardiac index (CI), and peripheral vascular resistance (SVR), improve cardiac pumping function, alleviate myocardial ischemia and hypoxia, and reduce the risk of postoperative heart failure. It can significantly reduce the level of reactive oxygen species (ROS) in patients after surgery, while increasing the expression levels of superoxide dismutase (SOD) and glutathione (GSH), enhancing the body's antioxidant capacity, reducing oxidative damage during myocardial reperfusion, and protecting the structural and functional integrity of cardiomyocytes. It can significantly reduce the level of N-terminal pro-brain natriuretic peptide (NT-proBNP) in patients' plasma, effectively improving myocardial remodeling, reducing poor repair after myocardial injury, and further reducing the risk of heart failure. It can significantly reduce the incidence of cardiovascular events within one year after STEMI PCI, and has a preventive effect on various adverse cardiovascular events such as cardiogenic shock, myocardial infarction, and angina pectoris, improving the long-term prognosis of patients.

[0019] This composition is designed for patients with cardiac yang deficiency after STEMI PCI. The active pharmaceutical ingredients have been clinically validated, demonstrating high safety. It can be prepared in various dosage forms, including decoctions, oral liquids, and granules, to meet diverse clinical administration needs and facilitate postoperative patient use. As an adjunct to PCI, this composition does not antagonize guideline-guided Western medicine treatments, achieving a synergistic protective effect combining traditional Chinese and Western medicine, further enhancing the overall efficacy of postoperative cardiovascular protection. Detailed Implementation

[0020] To better understand the technical content of this invention, specific embodiments are provided below to further illustrate the invention.

[0021] Unless otherwise specified, the experimental methods used in the embodiments of this invention are all conventional methods.

[0022] Unless otherwise specified, all materials and reagents used in the embodiments of this invention are commercially available.

[0023] Example 1

[0024] Weigh out 120g of raw Cornus officinalis, 60g of dried ginger, 30g of ginseng, 30g of Astragalus membranaceus, 30g of Atractylodes macrocephala, 60g of Alisma plantago-aquatica, 60g of Poria cocos, and 25g of Aconitum carmichaelii. Mix them together, add 10 times the amount of water, soak for 30 minutes, bring to a boil over high heat, simmer over low heat for 30 minutes, filter and collect the juice. Add 7 times the amount of purified water to the dregs, simmer over low heat for 20 minutes, filter and collect the juice. Combine the two decoctions and concentrate to a relative density of 1.20 (60℃) to obtain the decoction.

[0025] Example 2

[0026] Weigh out 100g of raw Cornus officinalis, 50g of dried ginger, 20g of ginseng, 20g of Astragalus membranaceus, 20g of Atractylodes macrocephala, 50g of Alisma plantago-aquatica, 50g of Poria cocos, and 20g of Aconitum carmichaelii. Prepare the oral liquid using the water decoction and alcohol precipitation method: decoct the raw materials twice with water. The first time, add 10 times the amount of water and decoct for 1 hour. The second time, add 8 times the amount of water and decoct for 40 minutes. Combine the decoctions, filter, and concentrate to a clear paste with a relative density of 1.12 (60℃). Add ethanol to make the alcohol content reach 60%. Let stand for 24 hours, take the supernatant, recover the ethanol, and concentrate to a thick paste with a relative density of 1.20 (60℃). Add an appropriate amount of sucrose, preservative, and purified water, stir to dissolve, make up to volume, fill and seal, and sterilize to obtain the oral liquid, each bottle containing 60mL.

[0027] Example 3

[0028] Weigh out 150g of raw Cornus officinalis, 80g of dried ginger, 40g of ginseng, 40g of Astragalus membranaceus, 40g of Atractylodes macrocephala, 80g of Alisma plantago-aquatica, 80g of Poria cocos, and 30g of Aconitum carmichaelii. Decocted twice with water, combined the decoctions, filtered, and concentrated to a thick paste with a relative density of 1.30 (60℃). Add dextrin and lactose, granulate, dry, and granulate to obtain granules. Each bag contains 15g (containing sucrose) / 5g (sugar-free).

[0029] Example 4

[0030] Weigh out 120g of raw Cornus officinalis, 60g of dried ginger, 30g of ginseng, 30g of Astragalus membranaceus, 30g of Atractylodes macrocephala, 60g of Alisma plantago-aquatica, 60g of Poria cocos, and 25g of Aconitum carmichaelii. Decoction twice with water, combine the decoctions, filter, concentrate to a thick paste, vacuum dry to obtain dry extract, pulverize into fine powder, add appropriate amount of microcrystalline cellulose and magnesium stearate, mix well, fill into empty capsules to obtain capsules, each containing 0.5g.

[0031] Example 5

[0032] Weigh out 120g of raw Cornus officinalis, 60g of dried ginger, 30g of ginseng, 30g of Astragalus membranaceus, 30g of Atractylodes macrocephala, 60g of Alisma plantago-aquatica, 60g of Poria cocos, and 25g of Aconitum carmichaelii. Decoction twice with water, combine the decoctions, filter, concentrate to a thick paste, spray dry to obtain dry extract powder, add appropriate amount of starch, sodium carboxymethyl starch, and magnesium stearate, mix well, granulate, dry, compress into tablets, and coat to obtain tablets, each weighing 0.8g.

[0033] Clinical application efficacy verification

[0034] To verify the cardiovascular protective effect of the pharmaceutical composition of the present invention, a clinical controlled trial was conducted, as follows:

[0035] 1. Research Subjects and Methods

[0036] 1.1 Research Subjects

[0037] We collected data on STEMI patients who visited the Chest Pain Center of Hainan Provincial Hospital of Traditional Chinese Medicine between January 2018 and March 2021.

[0038] 1) Western medicine diagnostic criteria: Meets the STEMI diagnostic criteria in the "Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction 2019";

[0039] 2) Diagnostic criteria for TCM syndromes: Refer to the diagnostic criteria for chest pain and heart yang deficiency syndrome in the fifth edition of TCM internal medicine. Symptoms include chest tightness or heart pain, shortness of breath, palpitations, spontaneous sweating, fatigue and aversion to cold, pale complexion, cold or swollen limbs, pale and swollen tongue, white and greasy tongue coating, and deep, thready and slow pulse.

[0040] 3) Inclusion criteria: (1) Age 18-80 years; (2) Willing to participate in this study and sign informed consent form; (3) Opening of diseased blood vessels within the treatment time window; 4) Exclusion criteria: (1) Hemodynamic or vital signs are still unstable after opening of blood vessels; (2) Circulatory support device is installed; (3) History of myocardial infarction; (4) Killip grade II or above of acute myocardial infarction; (5) Accompanied by severe infection; (6) Malignant tumor within 3 years; (7) Severe liver and kidney dysfunction.

[0041] 4) This study was reviewed by the hospital's ethics committee.

[0042] 1.2 Collection of general clinical data

[0043] Establish a clinical database to record the gender, age, comorbidities, smoking history, alcohol consumption history, body mass index, blood pressure, and pulse of the study subjects. Record the following day after PCI: white blood cell count, neutrophil count, hemoglobin, albumin, fasting blood glucose, uric acid, creatinine, blood urea nitrogen, troponin I, creatine kinase isoenzyme, and N-terminal pro-brain natriuretic peptide.

[0044] 1.3 Intervention methods

[0045] All patients included in the study were treated according to the guidelines for the diagnosis and treatment of acute ST-segment elevation myocardial infarction (2019), including pre-PCI antiplatelet and anticoagulant therapy, and post-PCI secondary prevention of coronary artery disease. The experimental group received the medication described in Example 1 in addition to these treatments. One dose daily. Dosage: Decoction in water, 60 mL each time, four times daily, every 6 hours.

[0046] Patients in the control group were treated strictly according to the standard protocol recommended in the "Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction 2019", which included antiplatelet and anticoagulant therapy before PCI and routine Western medicine drug therapy such as secondary prevention of coronary heart disease after the procedure. The drug of this invention was not added, and the treatment duration was the same as that of the experimental group, which was one week of continuous treatment.

[0047] 1.4 Observation Indicators and Methods

[0048] 1.4.1 Observation Indicators

[0049] 1) Traditional Chinese Medicine (TCM) syndrome score: The main symptoms (chest tightness or heart pain, shortness of breath, palpitations) and secondary symptoms (spontaneous sweating, fatigue and aversion to cold, pale complexion, cold or swollen limbs) are scored as 0, 2, 4, 6 and 0, 1, 2, 3 respectively, according to the scale of none, mild, moderate, and severe. The sum of the scores of each symptom is the TCM syndrome score (tongue and pulse are for reference only and are not included in the score).

[0050] 2) Non-invasive hemodynamic monitoring: Non-invasive hemodynamic parameters such as cardiac output, cardiac output index (CI), peripheral vascular resistance (SVR), and peripheral vascular resistance index (SVRI) were measured using a non-invasive cardiac output monitor manufactured by Cardiodynamics, USA. Monitoring was performed once, at the end of the treatment course. All examinations were conducted by the same physician.

[0051] 3) Cardiac function test: The HP5500 Doppler color ultrasound diagnostic instrument was used with a probe frequency of 2.5MHz. The left ventricular ejection fraction (LVEF) was measured using a two-dimensional modified method. The values ​​of 3 cardiac cycles were taken as the measurement values ​​and the test was performed after the course of treatment.

[0052] 4) Detection of N-terminal pro-brain natriuretic peptide (NTP) and oxidative stress indicators: Fasting venous blood was collected from patients before and after treatment. After centrifugation, plasma N-terminal NTP was detected using a Hitachi fully automated biochemical analyzer. Reactive oxygen species (ROS), superoxide dismutase (SOD), and glutathione (r-glutamyl cysteinyl glycine, GSH) were detected using enzyme-linked reaction (ELISA).

[0053] 1.4.2 Efficacy Evaluation Criteria

[0054] (1) The TCM syndrome efficacy evaluation criteria refer to the "Guiding Principles for Clinical Research of New Chinese Medicines" Efficacy Index (EI) = (Pre-treatment score - Post-treatment score) / Pre-treatment score × 100%.

[0055] Significant effect: EI > 70%; Effective: 30% ≤ EI < 70%; Ineffective: 0 < EI < 30%.

[0056] 1.4.3 Prognosis

[0057] Patients were followed up in outpatient or by telephone at 3, 6, and 12 months after the end of treatment to record the occurrence of major adverse events. Endpoint events included cardiovascular events, all-cause mortality, readmissions or emergency room treatment for any cause, and composite endpoint events including all of the above. Cardiovascular events were defined as death due to cardiogenic shock, myocardial infarction, angina pectoris, arrhythmia, heart failure, stroke / transient ischemic attack (TIA), revascularization, readmissions, or emergency room treatment. The start time of an endpoint event was defined as the time when the patient completed the screening visit, met the inclusion and exclusion criteria, and signed the informed consent form; the end time was defined as the time when any endpoint event first occurred.

[0058] 1.5 Statistical Methods

[0059] The collected data were processed using SPSS 25.0 statistical software. The Shapiro-Wilk test was first used to check if the data conformed to a normal distribution. Normally distributed quantitative data were expressed as mean plus or minus standard deviation (x±s). For comparisons of means between two groups, an independent samples t-test was used, followed by an F-test for homogeneity of variance. If the variances were homogeneous, a t-test was used; otherwise, a t′-test was used. Within-group comparisons of control means were performed using paired t-tests. Non-normally distributed quantitative data were expressed as mean rank (R) and quartiles (Q1, Q3). For comparisons of non-normally distributed quantitative data, small sample proportions, and medians of ordinal data between two groups, the data were expressed as frequency (ƒ), proportion or percentage (P), and mean rank (R), and the Mann-Whitney nonparametric test was used. For data from four-fold tables, the Fisher exact test (χ²) was used. α=0.05.

[0060] 2. Results

[0061] 2.1 Comparison of General Data and Laboratory Indicators

[0062] A total of 89 cases were included in this study, with 46 cases in the control group and 43 cases in the experimental group. Among them, 23 were female and 18 were female, with an average age of 59.89±12.15 years and 57.83±11.32 years, respectively. There were no significant differences in the above data, as well as other general information such as body mass index, vital signs, comorbidities, history of smoking and alcohol consumption, Killip classification, PCI procedure, postoperative reflow, and time from onset to PCI (P>0.05). Regarding laboratory tests, there were no significant differences in white blood cell count, neutrophil count, hemoglobin, albumin, fasting blood glucose, glycated hemoglobin, uric acid, creatinine, urea nitrogen, creatine kinase isoenzyme, troponin I, and N-terminal pro-brain natriuretic peptide (P>0.05) among all cases before inclusion in the study.

[0063] 2.2 Comparison of TCM syndromes after treatment

[0064]

[0065] Note: 1) The main symptoms of TCM syndrome (chest tightness or heart pain, shortness of breath, palpitations) are scored as 0, 2, 4, and 6 points respectively, depending on whether they are absent, mild, moderate, or severe; the secondary symptoms (spontaneous sweating, fatigue and aversion to cold, pale complexion, cold or swollen limbs) are scored as 0, 1, 2, and 3 points respectively.

[0066]

[0067] 2.3 Comparison of LVEF% and non-invasive cardiac function indicators between the two groups after treatment

[0068]

[0069] As shown in Table 3, the LVEF% of the experimental group was higher than that of the control group after treatment (P<0.05). Regarding non-invasive cardiac function indicators, the cardiac output, CI, and SVR of the experimental group were higher than those of the control group after treatment (P<0.01 or P<0.05).

[0070] 2.4 Comparison of N-terminal pro-brain natriuretic peptide (BNP) levels before and after treatment in the two groups of patients

[0071]

[0072] Note: Compared with before treatment △△ P < 0.01, compared with the control group *P < 0.05.

[0073] As shown in Table 4, there was no significant difference in N-terminal pro-brain natriuretic peptide (BNP) levels between the two groups before treatment (P > 0.05). After treatment, the levels of BNP in both groups decreased compared to before treatment (P < 0.01), and the decrease in the experimental group was greater than that in the control group (P < 0.05).

[0074] 2.5 Comparison of oxidative stress indicators before and after treatment in the two groups of patients

[0075]

[0076] Note: Compared with before treatment △△ P < 0.01, and **P < 0.05 compared with the control group. The same applies below.

[0077]

[0078]

[0079] As shown in Tables 5, 6, and 7, there were no significant differences in ROS, SOD, and GSH levels between the two groups before treatment (P > 0.05). After treatment, ROS levels in both groups decreased significantly compared to before treatment (P < 0.01), and the decrease in the experimental group was significantly greater than that in the control group (P < 0.01). Regarding SOD and GSH levels, both groups showed increases after treatment (P < 0.01), but the increase in the experimental group was significantly greater than that in the control group (P < 0.01).

[0080] 2.6 Prognosis and Outcome

[0081] This study followed all cases for 365 days via outpatient and telephone follow-up. During the follow-up period, the all-cause mortality rate was 10% in the control group and 5% in the experimental group. The readmission rate was 34% in the control group and 15% in the experimental group. The emergency treatment rate was 21% in the control group and 15% in the experimental group. The incidence of cardiovascular events was 28% in the control group and 10% in the experimental group, with the experimental group showing better results than the control group (P < 0.05).

[0082] in conclusion

[0083] The pharmaceutical composition described in this invention was applied to cardiovascular protection in patients with acute ST-segment elevation myocardial infarction (STEMI) after percutaneous coronary intervention (PCI). After one week of clinical intervention, significant therapeutic effects were achieved, and its mechanism of action is clear, demonstrating outstanding clinical application value. Specific conclusions are as follows:

[0084] 3.1 The pharmaceutical composition of the present invention can significantly improve cardiac function-related indicators after PCI in STEMI patients. The N-terminal natriuretic peptide level of the experimental group after intervention with this composition was significantly lower than that of the control group that only received guideline-guided conventional Western medicine treatment (P<0.05). The improvement in left ventricular ejection fraction and non-invasive cardiac function indicators was also significantly better than that of the control group (P<0.05 or 0.01), which confirms that the composition has a clear improving effect on cardiac function after PCI in STEMI patients.

[0085] 3.2 The pharmaceutical composition of the present invention can effectively regulate the body's oxidative stress system and significantly reduce myocardial reperfusion injury after PCI in STEMI patients. Clinical data show that the levels of reactive oxygen species (ROS) in both the experimental and control groups were significantly lower than before treatment, while the levels of superoxide dismutase (SOD) and glutathione (GSH) were significantly higher than before treatment (P < 0.01). However, the reduction in ROS and the increase in SOD and GSH in the experimental group were significantly better than those in the control group (P < 0.01). This indicates that the composition can effectively protect myocardial cells by reducing the ROS level during myocardial reperfusion after PCI, increasing the expression levels of endogenous antioxidants SOD and GSH, and blocking ROS-mediated damage pathways such as mitochondrial damage, autophagy induction, and inflammasome activation in cardiomyocytes.

[0086] 3.3 The pharmaceutical composition of the present invention can effectively compensate for the shortcomings of conventional Western medicine treatment in the prevention and control of myocardial reperfusion injury after PCI in STEMI patients. It provides an efficient and targeted treatment plan for cardiovascular protection after PCI in STEMI patients. The plan has a clear target and fits the pathophysiological characteristics of STEMI patients after PCI. It has important clinical promotion value in the field of cardiovascular disease postoperative rehabilitation and also provides reliable clinical evidence for the application of traditional Chinese medicine in the field of myocardial infarction postoperative protection.

[0087] Furthermore, this study followed up on the prognosis of the two groups of patients within one year after discharge. The follow-up results showed that although there were no significant differences between the two groups in terms of all-cause mortality, emergency treatment rate, and readmission rate (P>0.05), the experimental group was superior to the control group in terms of readmission and cardiovascular event incidence (P<0.05), indicating that treatment with the drug composition of this invention can reduce the occurrence of cardiovascular events, thereby improving the prognosis of patients.

[0088] In summary, this study demonstrates to some extent that timely treatment with the drug composition of this invention after PCI in STEMI patients can effectively improve cardiac function and reduce the incidence of cardiovascular events within one year.

[0089] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. The application of a traditional Chinese medicine composition in the preparation of cardiovascular protective drugs after PCI for myocardial infarction, characterized in that, The traditional Chinese medicine composition includes raw Cornus officinalis, dried ginger, ginseng, astragalus, atractylodes macrocephala, alisma plantago-aquatica, poria cocos, and aconite, and the myocardial infarction is acute ST-segment elevation myocardial infarction.

2. The application as described in claim 1, characterized in that, The TCM syndrome pattern for acute ST-segment elevation myocardial infarction is heart yang deficiency syndrome.

3. The application as described in claim 1, characterized in that, The cardiovascular protection includes improving cardiac function, inhibiting postoperative oxidative stress, reducing N-terminal pro-brain natriuretic peptide levels, and reducing the incidence of postoperative cardiovascular events.

4. The application as described in claim 3, characterized in that, The improvement in cardiac function includes increasing left ventricular ejection fraction and improving noninvasive hemodynamic parameters.

5. The application as described in claim 4, characterized in that, The non-invasive hemodynamic parameters include cardiac output, cardiac index, and peripheral vascular resistance.

6. The application as described in claim 3, characterized in that, The inhibition of postoperative oxidative stress specifically includes reducing the level of reactive oxygen species in the body, while increasing the expression levels of superoxide dismutase and glutathione.

7. The application as described in claim 3, characterized in that, The reduction in the incidence of postoperative cardiovascular events refers to reducing the risk of cardiovascular events occurring within one year after PCI in patients. These cardiovascular events include cardiogenic shock, myocardial infarction, angina pectoris, arrhythmia, heart failure, stroke / transient ischemic attack, death due to revascularization, readmission, or emergency room treatment.

8. The application as described in any one of claims 1-7, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 100-150 parts of raw Cornus officinalis, 50-80 parts of dried ginger, 20-40 parts of ginseng, 20-40 parts of Astragalus membranaceus, 20-40 parts of Atractylodes macrocephala, 50-80 parts of Alisma plantago-aquatica, 50-80 parts of Poria cocos, and 20-30 parts of Aconitum carmichaelii.

9. The application as described in claim 8, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: 120 parts of raw Cornus officinalis, 60 parts of dried ginger, 30 parts of ginseng, 30 parts of Astragalus membranaceus, 30 parts of Atractylodes macrocephala, 60 parts of Alisma plantago-aquatica, 60 parts of Poria cocos, and 25 parts of Aconitum carmichaelii.

10. The application as described in claim 8, characterized in that, The pharmaceutical dosage form of the pharmaceutical composition is a decoction, oral liquid, granules, capsules, or tablets.

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