A traditional Chinese medicine formula for treating chronic heart failure

Abstract

The application discloses a traditional Chinese medicine composition for treating chronic heart failure. The traditional Chinese medicine composition provided by the application comprises honeysuckle, radix scrophulariae, curcuma zedoaria, astragalus, radix pseudostellariae and radix ophiopogonis. The honeysuckle is the monarch in the composition, and is praised as a good medicine for clearing heat and detoxifying. The honeysuckle is sweet and cold, and can clear heat without damaging the stomach, and can expel evil with fragrance and permeability, and is good at clearing blood toxin. The radix scrophulariae is the minister, and is cold in nature, and is good at treating heat diseases, and can directly reach blood and remove blood stasis, and is used with the honeysuckle, and can cool blood, nourish yin, clear heat and detoxify. The astragalus and the radix pseudostellariae are sweet in flavor and are in the heart, spleen and lung channels, and can tonify primordial qi, and can also benefit water and remove edema. The curcuma zedoaria is good at breaking blood in qi, and can make yang qi reach yin blood, and blood reaching yin blood can make qi unobstructed. The three drugs are the adjuvants, and can make qi and blood unobstructed, and help evil to be removed along with the trend. The radix ophiopogonis is the guide, and is sweet and cold, and is in the heart, lung and stomach channels, and can attack evil and support the healthy without damaging yin. The six drugs are used together, and are characterized by clearing heat and detoxifying, and can also support the healthy, and can cool blood, detoxify, tonify qi and nourish yin.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine formula for treating chronic heart failure. BACKGROUND

[0002] Chronic heart failure is a complex clinical syndrome caused by abnormal structure and / or function of the heart, which is often caused by hypertension and coronary heart disease and the like, and is mainly manifested by dyspnea, fluid retention and fatigue in clinic. The burden caused by chronic heart failure includes low quality of life, high hospitalization rate and low survival rate, and the prevention and treatment thereof has become a difficult task.

[0003] According to the clinical characteristics of chronic heart failure, the traditional Chinese medicine often classifies it into the categories of 'heart water', 'asthma syndrome' and 'edema' and the like. It is stated in 'Discussion on Regulating Channels' of 'Plain Questions' that 'a person cannot sleep and feels short of breath when lying down, which is caused by water-qi'. The traditional medicine believes that the pathogenesis of chronic heart failure belongs to deficiency in origin and excess in symptoms, and the deficiency in origin is caused by congenital deficiency or consumption due to long-term illness, and the excess in symptoms is caused by invasion of exogenous pathogenic factors, emotional stimulation or diet and overstrain, and is accompanied by phlegm-dampness or blood stasis and the like.

[0004] The innovation of pathogenesis cognition is the premise and key for making breakthrough progress in the treatment of chronic heart failure by traditional Chinese medicine. The basic syndrome characteristics of chronic heart failure can be summarized as deficiency of qi and blood stasis. Although there are many existing heart failure treatment drugs, they are mostly formulated based on the methods of tonifying qi, warming yang and promoting blood circulation, and the innovation of pathogenesis and treatment method theory is insufficient.

[0005] Therefore, the application is proposed. SUMMARY

[0006] The purpose of the application is to provide a traditional Chinese medicine composition which has a good improvement effect on the clinical symptoms of shortness of breath, wheezing, fatigue and palpitation caused by deficiency of qi and blood stasis in chronic heart failure.

[0007] In order to achieve the above purpose, the technical scheme of the application is as follows.

[0008] In the first aspect, the application provides a traditional Chinese medicine composition, which comprises the following components: 10 parts of honeysuckle, 6-8 parts of xuan-shen, 10-12 parts of curcuma zedoaria, 25-30 parts of astragalus, 15-20 parts of radix pseudostellariae and 10-12 parts of radix ophiopogonis.

[0009] Preferably, the traditional Chinese medicine composition comprises the following components: 10g of honeysuckle, 6g of xuan-shen, 10g of curcuma zedoaria, 30g of astragalus, 20g of radix pseudostellariae and 10g of radix ophiopogonis.

[0010] Synopsis of Golden Chamber has said: "toxic, evil, accumulation of non-solution is called". The toxic evil causing chronic heart failure, according to its nature, mainly to blood stasis, heat toxicity. The present application is based on the macroscopic manifestations related to the disease progression and the efficacy characteristics of detoxification traditional Chinese medicine found in clinical practice, combined with the pharmacological research of detoxification traditional Chinese medicine system, the theory of tracing back to the classics, it is proposed that the toxic evil is the new pathogenesis of heart failure, and the innovative traditional Chinese medicine composition with detoxification characteristics is created.

[0011] In a second aspect, the present application provides a traditional Chinese medicine composition, which is extracted from the following medicinal materials; the medicinal materials comprise: honeysuckle 10 parts, xuan Shen 6-8 parts, zedoary 10-12 parts, radix astragali 25-30 parts, radix pseudostellariae 15-20 parts, radix ophiopogonis 10-12 parts.

[0012] In the present application, the medicinal materials comprise: honeysuckle 10g, xuan Shen 6g, zedoary 10g, radix astragali 30g, radix pseudostellariae 20g, radix ophiopogonis 10g.

[0013] In the present application, the extraction method is water decoction method.

[0014] In the present application, the decoction is carried out according to the following operation: after mixing each medicine, water is added for soaking for 0.5-1h, 5-8 times amount of water is added for decoction, boiling for 15-20min, filtering, the dregs are continuously added with 5-8 times amount of water for decoction, boiling for 15-20min, filtering, and combining the medicinal liquid.

[0015] In a third aspect, the present application provides a traditional Chinese medicine preparation, comprising the above-mentioned traditional Chinese medicine composition.

[0016] In the present application, the dosage form of the traditional Chinese medicine preparation is water agent, granules.

[0017] In a fourth aspect, the present application provides the use of the above-mentioned traditional Chinese medicine composition or traditional Chinese medicine preparation in the preparation of a medicine for treating chronic heart failure or a medicine for improving the prognosis of chronic heart failure.

[0018] In the present application, the medicine is used for treating chronic heart failure or improving the prognosis of chronic heart failure by reducing the level of NT-proBNP and / or increasing the distance of 6 minute walk test.

[0019] Compared with the prior art, the present application has the following beneficial effects:

[0020] The present prescription is composed of six ingredients: honeysuckle, radix scrophulariae, curcuma zedoaria, astragalus, radix pseudostellariae and radix ophiopogonis. Honeysuckle is the monarch drug, which is praised as a good drug for clearing heat and resolving toxins. It is sweet and cold in nature, and can clear blood toxins. Radix scrophulariae is the minister drug, which is cold in nature and is good for treating heat disease. It can remove blood stasis and toxins, and is used with honeysuckle to cool blood, nourish yin and clear heat and resolve toxins. Astragalus and radix pseudostellariae are sweet in flavor and are used to tonify the primordial qi and drain water to reduce swelling. Curcuma zedoaria is used to break blood in the qi and make the yang qi reach the yin blood, so that the blood reaches the qi. Radix ophiopogonis is used to make the pathogenic factors and the healthy qi not hurt the yin. The six drugs are used together to clear heat and resolve toxins, and to tonify the healthy qi and nourish the yin. DETAILED DESCRIPTION

[0021] The application will be further described below in combination with specific examples, but the application is not limited to the following examples.

[0022] The experimental methods used in the following examples are conventional methods unless otherwise specified.

[0023] The reagents, materials and instruments used in the following examples can be obtained from commercial channels unless otherwise specified.

[0024] EXAMPLE

[0025] The prescription ingredients and contents are as follows: honeysuckle 10g, radix scrophulariae 6g, curcuma zedoaria 10g, astragalus 30g, radix pseudostellariae 20g and radix ophiopogonis 10g.

[0026] Preparation steps: The medicinal liquid is prepared by simple decoction process. Specifically, one dose of traditional Chinese medicine prescription decoction pieces is soaked in water for 0.5h, 8 times the amount of water is added for decoction, and after micro-boiling for 20min, the medicinal liquid is filtered with gauze. The medicinal dregs are continuously added with 8 times the amount of water for decoction, and after micro-boiling for 20min, the medicinal liquid is filtered with gauze. The two times of medicinal liquid are combined.

[0027] TEST EXAMPLE, CLINICAL EFFECT EVALUATION

[0028] 1. Research object

[0029] The clinical data of patients who were first diagnosed with chronic heart failure in the outpatient department of the Department of Cardiology of Beijing University of Chinese Medicine Dongzhimen Hospital from January 2024 to June 2024 were retrospectively collected, and were screened according to the diagnostic criteria, inclusion and exclusion criteria.

[0030] 2. Diagnostic criteria

[0031] The diagnostic criteria for chronic heart failure refer to the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018": For patients suspected of having chronic heart failure, the possibility of heart failure should be determined based on medical history, physical examination, electrocardiogram, and chest imaging; then, the presence of heart failure should be confirmed by plasma natriuretic peptide testing (NT-proBNP ≥125pg / mL or BNP ≥35pg / mL) and echocardiography (cardiac structural and / or functional abnormalities).

[0032] The TCM diagnostic criteria refer to the "Guidelines for the Diagnosis and Treatment of Chronic Heart Failure in Traditional Chinese Medicine (2022)": Primary symptoms: Shortness of breath / wheezing, fatigue, palpitations. Secondary symptoms: ① Lethargy and reluctance to speak, easily fatigued; ② Involuntary sweating during the day without obvious cause, worsening after activity; ③ Weak voice; ④ Dark purple complexion or lips. Tongue and pulse: Dark purple tongue (or with ecchymosis, petechiae, or tortuous bluish-purple sublingual veins), neither too thick nor too thin, white coating, deep, thready, or weak pulse. When ≥2 primary symptoms and ≥2 secondary symptoms are present, combined with tongue and pulse diagnosis, it can be diagnosed as Qi deficiency and blood stasis syndrome.

[0033] 3. Inclusion and Exclusion Criteria

[0034] Inclusion criteria: ① Age 18-85 years; ② First-time diagnosis of chronic heart failure; ③ Meets the diagnostic criteria for Qi deficiency and blood stasis syndrome; ④ Regular outpatient follow-up for no less than 3 months with complete clinical data; ⑤ Patients in the traditional Chinese medicine treatment group took the formula of this group for no less than 2 months during the follow-up period.

[0035] Exclusion criteria: ① Acute exacerbation of chronic heart failure; ② Comorbid acute myocardial infarction, drug-resistant arrhythmias, hypertensive crisis, or other serious cardiovascular diseases; ③ Impaired liver function: persistently elevated transaminases (more than 3 times the upper limit of normal); ④ Renal insufficiency: eGFR < 60 mL / min / 1.73 m2; ⑤ History of severe mental illness; ⑥ Pregnancy and lactation; ⑦ Regular use of other traditional Chinese medicines or proprietary Chinese medicines during the follow-up period; ⑧ Unable to complete the 6-minute walk test for various reasons.

[0036] 4. Treatment plan and grouping

[0037] Patients were divided into a control group and a traditional Chinese medicine group based on their actual treatment plan.

[0038] Control group: Only Western medicine treatment was used, including standard medication regimens such as diuretics, renin-angiotensin system inhibitors, beta-blockers, sodium-glucose cotransporter 2 inhibitors, and mineralocorticoid receptor antagonists.

[0039] Traditional Chinese Medicine Group: This group of prescriptions (i.e., the example) is taken in addition to Western medicine treatment. The prepared herbal pieces or decoction substitutes are provided by the Pharmacy Department of Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine. Usage: Decocted in water and taken orally, one dose daily, divided into two administrations, morning and evening.

[0040] 5. Collection of clinical data and observation indexes

[0041] The general demographic data, NYHA classification, personal history, comorbidities, and NT-proBNP, 6-minute walk test, and left ventricular ejection fraction at baseline and after 3 months of follow-up were collected from the outpatient case system.

[0042] The NT-proBNP level after 3 months of follow-up was the primary outcome measure; the 6-minute walk test and left ventricular ejection fraction were the secondary outcome measures. Safety indicators included drug-related adverse reactions (fatigue, dizziness, headache, nausea, vomiting, diarrhea, abdominal distension, electrolyte imbalance, liver and kidney function damage) and adverse events (acute myocardial infarction, acute stroke, acute exacerbation of chronic heart failure, cardiovascular death).

[0043] 6. Statistical methods

[0044] SPSS 27.0 statistical software was used for data analysis. Normally distributed measurement data were expressed as (x ̅±S), and independent sample t-test was used for comparison between the two groups. Non-normally distributed measurement data were expressed as [M (P25, P75)], and Mann-Whitney U test was used for comparison between the two groups. Count data were expressed as relative numbers, and χ2 test or Fisher's exact probability method was used for comparison between groups. P<0.05 was considered statistically significant.

[0045] 7. Results

[0046] 7.1 Comparison of baseline data between the two groups of patients

[0047] A total of 52 patients with chronic heart failure and qi deficiency and blood stasis syndrome who met the criteria were included, including 24 cases in the control group and 28 cases in the Chinese medicine group. As shown in Table 1, there were no statistically significant differences in gender, age, heart function classification, smoking history, drinking history, coronary heart disease, hypertension, diabetes, NT-proBNP, 6-minute walk test, and left ventricular ejection fraction between the two groups (P>0.05), and they were comparable.

[0048] Table 1 Baseline data of patients in the two groups

[0049]

[0050] 7.2 NT-proBNP

[0051] After 3 months of follow-up, the NT-proBNP levels in both groups were significantly decreased compared with baseline (P<0.05), and the improvement in NT-proBNP in the Chinese medicine group was significantly better than that in the control group (P<0.05), as shown in Table 2.

[0052] Table 2 Comparison of NT-proBNP levels between two groups of patients

[0053]

[0054] 7.3 6-minute walk test

[0055] After 3 months of follow-up, the 6-minute walk test distance of both groups was significantly increased compared with baseline (P<0.05); and the 6-minute walk test distance of the traditional Chinese medicine group was significantly greater than that of the control group (P>0.05), as shown in Table 3.

[0056] Table 3 Comparison of 6-minute walk test distance between two groups of patients

[0057]

[0058] 7.4 Left ventricular ejection fraction

[0059] After 3 months of follow-up, the left ventricular ejection fraction of both groups was significantly increased compared with baseline (P<0.05); the improvement of left ventricular ejection fraction in the traditional Chinese medicine group was slightly better than that in the control group, but the difference was not statistically significant (P>0.05), as shown in Table 4.

[0060] Table 4 Comparison of left ventricular ejection fraction between two groups of patients

[0061]

[0062] 7.5 Safety

[0063] During the 3-month follow-up period, no adverse events occurred in all patients; 2 cases of abdominal distension occurred in the traditional Chinese medicine group, and 1 case of abdominal distension and 2 cases of hyperkalemia occurred in the control group, with no statistically significant difference in adverse reactions between the two groups (P>0.05).

[0064] 7.6 Summary

[0065] This traditional Chinese medicine formula is characterized by clearing heat and detoxifying, and also considers supporting the body, so as to achieve the effects of promoting blood circulation and detoxification, and tonifying qi and nourishing yin. Clinically, most patients with heart failure are mainly of qi deficiency and blood stasis, accompanied by stasis or heat toxicity, so this traditional Chinese medicine formula has a solid theoretical basis in the treatment of chronic heart failure.

[0066] Through further clinical research, it is confirmed that this traditional Chinese medicine formula can effectively reduce the level of NT-proBNP and improve the 6-minute walk test distance, thereby improving the symptoms and prognosis of patients with heart failure. In terms of improving left ventricular ejection fraction, this traditional Chinese medicine formula shows certain potential. In addition, this traditional Chinese medicine formula has good safety, with no significant adverse reactions or adverse events.

[0067] While the application has been described in detail and with reference to specific embodiments thereof, it will be apparent to one skilled in the art that various modifications or changes can be made therein without departing from the spirit and scope thereof. Accordingly, it is intended that all such modifications and changes be included within the scope of the application as claimed.

Claims

1. A traditional Chinese medicine composition for treating chronic heart failure, comprising the following medicinal materials: 10 parts honeysuckle, 6-8 parts scrophularia, 10-12 parts curcuma, 25-30 parts astragalus, 15-20 parts codonopsis, and 10-12 parts ophiopogon.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, It is composed of the following medicinal materials: honeysuckle 10g, scrophularia 6g, turmeric 10g, astragalus 30g, codonopsis 20g, and ophiopogon 10g.

3. A traditional Chinese medicine composition for treating chronic heart failure, obtained by extraction from the following medicinal materials; the medicinal materials consist of the following: 10 parts honeysuckle, 6-8 parts scrophularia, 10-12 parts turmeric, 25-30 parts astragalus, 15-20 parts codonopsis, and 10-12 parts ophiopogon. The extraction method is: water decoction.

4. The traditional Chinese medicine composition according to claim 3, characterized in that, The medicinal materials consist of the following: 10g honeysuckle, 6g scrophularia, 10g turmeric, 30g astragalus, 20g codonopsis, and 10g ophiopogon.

5. The traditional Chinese medicine composition according to claim 3, characterized in that, The decoction is carried out as follows: after mixing the various drugs, soak them in water for 0.5-1 hour, add 5-8 times the amount of water and decoct, simmer for 15-20 minutes, filter, add 5-8 times the amount of water to the dregs and decoct, simmer for 15-20 minutes, filter, and combine the decoctions.

6. A traditional Chinese medicine preparation for treating chronic heart failure, comprising the traditional Chinese medicine composition according to claim 1 or 2, or the traditional Chinese medicine composition according to any one of claims 3-5.

7. The traditional Chinese medicine preparation according to claim 6, characterized in that, The dosage forms of the traditional Chinese medicine preparations are aqueous solutions and granules.

8. The use of the traditional Chinese medicine composition according to claim 1 or 2, the traditional Chinese medicine composition according to any one of claims 3-5, or the traditional Chinese medicine preparation according to claim 6 or 7 in the preparation of a drug for treating chronic heart failure.

9. The application according to claim 8, characterized in that, The drug treats chronic heart failure by lowering NT-proBNP levels and / or increasing the distance of a 6-minute walk test.

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