Traditional Chinese medicine formula for treating chronic heart failure

Abstract

The invention discloses a traditional Chinese medicine formula for treating chronic heart failure. The traditional Chinese medicine composition provided by the invention comprises honeysuckle, radix scrophulariae, curcuma zedoary, astragalus membranaceus, radix pseudostellariae and radix ophiopogonis. Honeysuckle is used as a monarch drug, is honored as a good drug for clearing away heat and toxic materials, is sweet and cold, can clear away heat without hurting the stomach, is fragrant, can eliminate evil and is good for removing blood poison; the radix scrophulariae is used as a minister, is slightly cold in nature, is specially used for treating fever and straight blood circulation to remove stasis toxin, and is combined with the honeysuckle to achieve the effects of cooling blood, nourishing yin, clearing away heat and toxic materials. Radix astragali and radix pseudostellariae are mild in medicine property and sweet in taste, and enter heart, spleen and lung channels to reinforce vital energy and promote diuresis to relieve swelling; the curcuma zedoary is used for relieving blood in Qi and dispersing Yang Qi to reach Yin blood, and Qi is smooth if blood reaches; the three medicines are used as assistants, so that qi and blood are unobstructed, and toxic evil is relieved; the radix ophiopogonis is sweet in taste and cool in nature, enters the heart, lung and stomach meridians, and attacks pathogens and strengthens the body resistance without hurting yin. The six medicines are combined to achieve the effects of clearing away heat and toxic materials, strengthening the body resistance, promoting blood circulation, detoxifying, tonifying qi and nourishing yin.

Description

Technical Field

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

[0002] Chronic heart failure is a complex clinical syndrome caused by abnormal cardiac structure and / or function, often caused by a variety of heart diseases such as hypertension and coronary heart disease, with dyspnea, fluid retention and fatigue as the main clinical manifestations. The burden caused by chronic heart failure includes low quality of life, high hospitalization rate and low survival rate, and its prevention and treatment has become a difficult task.

[0003] According to the clinical characteristics of chronic heart failure, traditional Chinese medicine often classifies it as "heart water", "asthma" and "edema". For example, "Suwen•Tiaojinglun" says: "If a man cannot lie down and wheezes when lying down, it is because of the guest of water vapor". Traditional medicine believes that the pathogenesis of chronic heart failure is deficiency of the root and excess of the superficial. It can be caused by congenital deficiency or long-term illness leading to deficiency of vital energy, and combined with invasion of external evil, emotional stimulation or diet and fatigue, and then present with symptoms of phlegm or blood stasis.

[0004] Innovation in the understanding of pathogenesis is the premise and key to the breakthrough progress of TCM in treating chronic heart failure. The basic symptom characteristics of chronic heart failure can be summarized as qi deficiency and blood stasis. Although there are many existing heart failure treatment drugs, most of them are based on the treatment methods of invigorating qi, warming yang, and promoting blood circulation, and there is insufficient innovation in the theory of pathogenesis and treatment methods.

[0005] In view of this, the present invention is proposed. Summary of the invention

[0006] The purpose of the present invention is to provide a traditional Chinese medicine composition, which has a good effect on improving clinical symptoms such as shortness of breath, wheezing, fatigue, palpitations and the like caused by qi deficiency and blood stasis syndrome of chronic heart failure.

[0007] In order to achieve the above object, the present invention adopts the following technical solution: In a first aspect, the present invention provides a traditional Chinese medicine composition comprising the following components: 10 parts of honeysuckle, 6-8 parts of Scrophularia ningpoensis, 10-12 parts of Curcuma zedoaria, 25-30 parts of Astragalus membranaceus, 15-20 parts of Pseudostellaria baicalensis, and 10-12 parts of Ophiopogon japonicus.

[0008] Preferably, the Chinese medicine composition comprises the following components: 10g of honeysuckle, 6g of Scrophularia ningpoensis, 10g of Curcuma zedoaria, 30g of Astragalus membranaceus, 20g of Pseudostellaria baicalensis, and 10g of Ophiopogon japonicus.

[0009] The Golden Chamber states: "Toxins are the accumulation of evil qi that cannot be resolved." According to their nature, the toxic evils that cause chronic heart failure are mainly blood stasis and heat. Based on the macroscopic manifestations related to disease progression found in clinical practice and the efficacy characteristics of detoxifying Chinese medicines, the present invention combines the pharmacological research of detoxifying Chinese medicine systems and the theoretical tracing of classics, proposes that toxic evils are a new pathogenesis of heart failure, and creates an innovative Chinese medicine formula featuring detoxification.

[0010] In a second aspect, the present invention provides a traditional Chinese medicine composition, which is extracted from the following medicinal materials; the medicinal materials include: 10 parts of honeysuckle, 6-8 parts of Scrophularia ningpoensis, 10-12 parts of Curcuma zedoaria, 25-30 parts of Astragalus membranaceus, 15-20 parts of Pseudostellaria baicalensis, and 10-12 parts of Ophiopogon japonicus.

[0011] In the present invention, the medicinal materials include: 10g of honeysuckle, 6g of Scrophularia ningpoensis, 10g of Curcuma zedoaria, 30g of Astragalus membranaceus, 20g of Pseudostellaria baicalensis, and 10g of Ophiopogon japonicus.

[0012] In the present invention, the extraction method is: water decoction method.

[0013] In the present invention, the decoction is performed according to the following operation: after mixing the medicines, soak them in water for 0.5-1h, add 5-8 times the amount of water for decoction, boil for 15-20min, filter, add 5-8 times the amount of water to the residues for decoction, boil for 15-20min, filter, and combine the liquid medicines.

[0014] In a third aspect, the present invention provides a traditional Chinese medicine preparation, comprising the above-mentioned traditional Chinese medicine composition.

[0015] In the present invention, the dosage form of the Chinese medicine preparation is aqueous solution or granule.

[0016] In a fourth aspect, the present invention provides the use of the above-mentioned Chinese medicine composition or Chinese medicine preparation in the preparation of a drug for treating chronic heart failure or a drug for improving the prognosis of chronic heart failure.

[0017] In the present invention, the drug is used to treat chronic heart failure or improve the prognosis of chronic heart failure by reducing the NT-proBNP level and / or increasing the 6-minute walking test distance.

[0018] Compared with the prior art, the present invention has the following beneficial effects: This prescription is composed of six herbs: honeysuckle, Scrophularia, Curcuma, Astragalus, Radix Pseudostellariae, and Radix Ophiopogonis. Honeysuckle is the main herb, which is known as a good medicine for clearing heat and detoxifying. It is sweet and cold, clears heat without hurting the stomach, and has a penetrating fragrance that can dispel evil and clear blood toxins. Scrophularia is the minister, which is slightly cold in nature and specializes in treating fever. It goes straight to the blood and clears blood stasis and toxins. It works together with honeysuckle to cool blood, nourish yin, and clear heat and detoxify. Astragalus and Radix Pseudostellariae are mild in nature and sweet in taste. They enter the heart, spleen, and lung meridians, greatly replenish the vital energy, and also promote diuresis and reduce swelling. Curcuma is good at breaking up the blood in the qi, dredging the yang qi to reach the yin blood, and when the blood reaches the qi, the qi will flow smoothly. The three herbs are adjuvants, which make the qi and blood flow smoothly and help the evil to be resolved. Ophiopogon is the messenger, which is sweet and cool in nature. It enters the heart, lung, and stomach meridians, and attacks the evil and strengthens the body without hurting the yin. The six medicines are used together, with the characteristics of clearing away heat and detoxifying, while also taking into account strengthening the body, and together they have the effects of promoting blood circulation, detoxifying, invigorating Qi and nourishing Yin. DETAILED DESCRIPTION

[0019] The present invention will be further described below in conjunction with specific embodiments, but the present invention is not limited to the following embodiments.

[0020] Unless otherwise specified, the experimental methods used in the following examples are conventional methods.

[0021] Unless otherwise specified, the reagents, materials, instruments, etc. used in the following examples can be obtained from commercial sources.

[0022] Example The ingredients and contents of the prescription are as follows: 10g of honeysuckle, 6g of Scrophularia ningpoensis, 10g of Curcuma zedoaria, 30g of Astragalus membranaceus, 20g of Pseudostellaria baicalensis, and 10g of Ophiopogon japonicus.

[0023] Preparation steps: The medicinal solution is prepared by a simple decoction process; specifically: take a dose of Chinese herbal medicine, soak it in water for 0.5h, add 8 times the amount of water to decoct, boil it slightly for 20min, filter the medicinal solution with gauze, continue to add 8 times the amount of water to the residue and decoct it, boil it slightly for 20min, filter the medicinal solution with gauze, and combine the two medicinal solutions.

[0024] Test cases and clinical effect evaluation 1. Research subjects The clinical data of patients who were first diagnosed with chronic heart failure in the outpatient department of cardiology at Dongzhimen Hospital of Beijing University of Chinese Medicine from January to June 2024 were retrospectively collected and screened according to the diagnostic criteria, inclusion and exclusion criteria.

[0025] 2. Diagnostic criteria The diagnostic criteria for chronic heart failure refer to the "Guidelines for the Diagnosis and Treatment of Heart Failure in China 2018": For patients suspected of chronic heart failure, the possibility of heart failure is determined based on medical history, physical examination, electrocardiogram, and chest imaging examinations; then, plasma natriuretic peptide testing (NT-proBNP ≥ 125pg / mL or BNP ≥ 35pg / mL) and echocardiography (abnormal cardiac structure and / or function) are used to determine whether heart failure exists.

[0026] The TCM syndrome differentiation standard refers to the "Guidelines for TCM Diagnosis and Treatment of Chronic Heart Failure (2022)": Main symptoms: shortness of breath / wheezing, fatigue, palpitations. Secondary symptoms: ① fatigue and laziness, easy fatigue during activities; ② involuntary sweating during the day for no obvious reason, aggravated after activities; ③ low voice; ④ dark purple complexion or lips. Tongue and pulse: dark purple tongue (or with ecchymosis, petechiae or tortuous purple veins under the tongue), the tongue is neither fat nor thin, the tongue coating is white, and the pulse is deep, thin or weak. When there are ≥2 main symptoms and ≥2 secondary symptoms, combined with the tongue and pulse, it can be identified as Qi deficiency and blood stasis syndrome.

[0027] 3. Inclusion and Exclusion Criteria Inclusion criteria: ① Age 18-85 years old; ② First diagnosis of chronic heart failure; ③ Meet the syndrome differentiation criteria of Qi deficiency and blood stasis; ④ Regular outpatient follow-up for no less than 3 months and complete clinical data; ⑤ The total time of taking this prescription for patients in the Chinese medicine treatment group during the follow-up period is no less than 2 months.

[0028] Exclusion criteria: ① Acute exacerbation of chronic heart failure; ② Combined with severe cardiovascular diseases such as acute myocardial infarction, drug-resistant arrhythmias and hypertensive crisis; ③ Impaired liver function: persistent elevation of transaminase (higher 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 Chinese medicines or Chinese patent medicines during the follow-up period; ⑧ Unable to complete the 6-minute walk test due to various reasons.

[0029] 4. Treatment plan and grouping The patients were divided into a control group and a Chinese medicine group according to their actual treatment plan.

[0030] Control group: only western medicine was used for treatment, including diuretics, renin-angiotensin system inhibitors, β-blockers, sodium-glucose co-transporter 2 inhibitors, mineralocorticoid receptor antagonists and other standardized medication regimens.

[0031] Chinese medicine group: Take this prescription (ie, the embodiment) on the basis of western medicine treatment. Chinese medicine pieces or decoctions are provided by the Pharmacy Department of Dongzhimen Hospital of Beijing University of Chinese Medicine. Usage: Decoction in water, 1 dose per day, twice a day, morning and evening.

[0032] 5. Clinical data collection and observation indicators The patients' general demographic data, NYHA functional class, 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 medical record system.

[0033] The primary outcome was the level of NT-proBNP after 3 months of follow-up; the secondary outcome was the 6-minute walk test and left ventricular ejection fraction. Safety indicators included drug-related adverse reactions (fatigue, dizziness, headache, nausea, vomiting, diarrhea, abdominal distension, electrolyte imbalance, liver and kidney damage) and adverse events (acute myocardial infarction, acute stroke, acute exacerbation of chronic heart failure, cardiovascular death).

[0034] 6. Statistical methods SPSS 27.0 statistical software was used for data analysis. Normally distributed measurement data were expressed as (x ̅±S), and the two groups were compared using the independent sample t test. Non-normally distributed measurement data were expressed as [M (P25, P75)], and the two groups were compared using the Mann-Whitney U test. Count data were expressed as relative numbers, and the inter-group comparisons were performed using the χ2 test or Fisher's exact probability method. P < 0.05 was considered statistically significant.

[0035] 7. Results 7.1 Comparison of baseline data between the two groups of patients A total of 52 patients with chronic heart failure and qi deficiency and blood stasis syndrome who met the criteria were included, including 24 in the control group and 28 in the Chinese medicine group. As shown in Table 1, there was no significant difference in gender, age, cardiac 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.

[0036] Table 1 Baseline data of the two groups of patients

[0037] NT-proBNP After 3 months of follow-up, the NT-proBNP levels of both groups were significantly decreased compared with the baseline (P < 0.05), and the improvement of NT-proBNP in the Chinese medicine group was significantly better than that in the control group (P < 0.05), as shown in Table 2 for details.

[0038] Table 2 Comparison of NT-proBNP levels between the two groups

[0039] 7.3 6-Minute Walk Test After 3 months of follow-up, the 6-minute walk test distances of both groups were significantly increased compared with the baseline (P < 0.05); and the 6-minute walk test distance of the Chinese medicine group was significantly greater than that of the control group (P > 0.05), as shown in Table 3 for details.

[0040] Table 3 Comparison of 6-minute walk test distance between the two groups of patients

[0041] 7.4 Left ventricular ejection fraction After 3 months of follow-up, the left ventricular ejection fraction of both groups was significantly increased compared with the baseline (P < 0.05). The improvement of left ventricular ejection fraction in the Chinese medicine group was slightly better than that in the control group, but the difference was not statistically significant (P > 0.05). See Table 4 for details.

[0042] Table 4 Comparison of left ventricular ejection fraction between the two groups

[0043] 7.5 Security During the 3-month follow-up period, no adverse events occurred in all patients; 2 cases of abdominal distension occurred in the Chinese medicine group, and 1 case of abdominal distension and 2 cases of hyperkalemia occurred in the control group. There was no statistical difference in adverse reactions between the two groups (P>0.05).

[0044] 7.6 Summary This Chinese medicine formula is characterized by clearing away heat and detoxifying, while also taking into account strengthening the body, thereby achieving the effects of promoting blood circulation and detoxifying, invigorating qi and nourishing yin. Clinically, patients with heart failure are mostly characterized by qi deficiency and blood stasis, with stasis or heat toxicity. Therefore, this Chinese medicine formula has a solid theoretical basis for the treatment of chronic heart failure.

[0045] Further clinical studies have confirmed that this Chinese medicine formula can effectively reduce NT-proBNP levels and increase the distance of the 6-minute walk test, thereby improving the symptoms and prognosis of patients with heart failure. In terms of improving left ventricular ejection fraction, this Chinese medicine formula has shown certain potential. In addition, this Chinese medicine formula has good safety, and no obvious adverse reactions or adverse events occur.

[0046] Although the present invention has been described in detail above with general descriptions and specific embodiments, it is obvious to those skilled in the art that some modifications or improvements may be made thereto based on the present invention. Therefore, these modifications or improvements made without departing from the spirit of the present invention all fall within the scope of protection claimed by the present invention.

Claims

1. A Chinese medicine composition comprising the following components: 10 parts of honeysuckle, 6-8 parts of Scrophularia ningpoensis, 10-12 parts of Curcuma zedoaria, 25-30 parts of Astragalus membranaceus, 15-20 parts of Pseudostellaria baicalensis, and 10-12 parts of Ophiopogon japonicus.

2. The Chinese medicine composition according to claim 1, characterized in that: It includes the following ingredients: 10g of honeysuckle, 6g of Scrophularia ningpoensis, 10g of Curcuma zedoaria, 30g of Astragalus membranaceus, 20g of Pseudostellaria baicalensis, and 10g of Ophiopogon japonicus.

3. A Chinese medicine composition, obtained by extracting the following medicinal materials; the medicinal materials include: 10 parts of honeysuckle, 6-8 parts of Scrophularia, 10-12 parts of Curcuma, 25-30 parts of Astragalus, 15-20 parts of Pseudostellariae, and 10-12 parts of Ophiopogon japonicus.

4. The Chinese medicine composition according to claim 3, characterized in that: The medicinal materials include: 10g of honeysuckle, 6g of Scrophularia ningpoensis, 10g of Curcuma zedoaria, 30g of Astragalus membranaceus, 20g of Pseudostellaria baicalensis, and 10g of Ophiopogon japonicus.

5. The Chinese medicine composition according to claim 3 or 4, characterized in that: The extraction method is water decoction.

6. The Chinese medicine composition according to claim 5, characterized in that: The decoction is performed according to the following operation: after mixing the medicines, soak them in water for 0.5-1h, add 5-8 times the amount of water for decoction, slightly boil for 15-20min, filter, continue to add 5-8 times the amount of water to the residues for decoction, slightly boil for 15-20min, filter, and combine the liquid medicines.

7. A Chinese medicine preparation, comprising the Chinese medicine composition according to claim 1 or 2, or the Chinese medicine composition according to any one of claims 3 to 6.

8. The Chinese medicine preparation according to claim 7, characterized in that: The dosage form of the traditional Chinese medicine preparation is aqueous solution or granule.

9. Use of the Chinese medicine composition according to claim 1 or 2, the Chinese medicine composition according to any one of claims 3 to 6, or the Chinese medicine preparation according to claim 7 or 8 in the preparation of a drug for treating chronic heart failure or a drug for improving the prognosis of chronic heart failure.

10. The use according to claim 9, characterized in that: The drug is used to treat chronic heart failure or improve the prognosis of chronic heart failure by reducing the NT-proBNP level and / or increasing the distance of a 6-minute walking test.

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