Traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia and application of traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and provides a traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia and application thereof. The traditional Chinese medicine composition consists of the following traditional Chinese medicines: 25-35g of astragalus membranaceus, 6-12g of ginseng, 4-8g of cinnamon, 25-35g of maltose, 6-12g of cassia twig, 15-20g of white paeony root, 4-8g of honey-fried licorice root, 6-12g of ginger and 4-8 Chinese dates. The traditional Chinese medicine composition can obviously improve the left ventricular ejection fraction of a patient with chronic heart failure complicated with sarcopenia, improve the body weight of the patient, improve the muscle quantity index of skeletal muscles of limbs of the patient and improve the grip strength of the patient, and has a remarkable treatment effect on chronic heart failure complicated with sarcopenia. The traditional Chinese medicine composition has the advantages of low side effect, high compliance and the like, is suitable for treating chronic heart failure and sarcopenia, and has a better market application prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and relates to a traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia and its application. Background Technology

[0002] Chronic heart failure is the end stage of various heart diseases and a major cause of death in heart disease patients. Sarcopenia, also known as skeletal muscle loss or age-related skeletal muscle loss, is a degenerative syndrome characterized by a decline in skeletal muscle mass, strength, and function.

[0003] Sarcopenia is a common complication of chronic heart failure, and the reduction of peripheral skeletal muscle tissue can occur in the early stages of the disease in most patients. Studies have shown that chronic heart failure patients with sarcopenia often exhibit low grip strength, low quadriceps muscle strength, low 6-minute walk distance, low left ventricular ejection fraction, and low peak oxygen consumption during exercise.

[0004] For the treatment of patients with isolated chronic heart failure or sarcopenia, there is a relatively mature expert consensus both domestically and internationally. However, the treatment of chronic heart failure complicated with sarcopenia is still in the exploratory stage, and there is no definitive treatment plan yet. The main intervention is resistance exercise, either alone or in combination with nutritional support. In addition, testosterone has been proven to increase muscle strength and function; however, its adverse reactions should not be ignored. Other investigational drugs, including selective androgen receptor modulators, growth hormone, IGF-1, and compounds that transduce myostatin signaling, have also had adverse reactions.

[0005] Therefore, it is of great significance to develop a traditional Chinese medicine composition that can slow the progression of chronic heart failure complicated with sarcopenia, effectively treat chronic heart failure or sarcopenia, and thus improve the quality of life of patients. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia, with definite efficacy. This traditional Chinese medicine composition targets the characteristics of heart failure patients with sarcopenia, slowing disease progression and improving patients' quality of life.

[0007] The present invention also provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia.

[0008] The present invention also provides the application of the above-mentioned traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia in the preparation of a drug for treating chronic heart failure complicated with sarcopenia.

[0009] The technical solution adopted by the present invention to achieve the above objectives is as follows: In a first aspect, the present invention provides a traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia, comprising the following raw materials: Astragalus membranaceus 25-35g, Ginseng 6-12g, Cinnamomum cassia 4-8g, Maltose 25-35g, Cinnamomum cassia twig 6-12g, Paeonia lactiflora 15-20g, Glycyrrhiza uralensis (processed) 4-8g, Zingiber officinale 6-12g, and Jujube 4-8 pieces.

[0010] As a preferred technical solution of the present invention, the raw materials are composed of the following components: 30g of Astragalus membranaceus, 9g of ginseng, 6g of cinnamon, 30g of maltose, 9g of cassia twig, 18g of white peony root, 6g of prepared licorice root, 9g of ginger, and 6 jujubes.

[0011] As a preferred technical solution of the present invention, it is composed of the following raw materials: Astragalus membranaceus 25g, Ginseng 12g, Cinnamomum cassia 4g, Maltose 35g, Cinnamomum cassia twig 12g, Paeonia lactiflora 20g, Glycyrrhiza uralensis 8g, Zingiber officinale 12g, and Jujube 8 pieces.

[0012] As a preferred technical solution of the present invention, it is composed of the following raw materials: Astragalus membranaceus 35g, Ginseng 6g, Cinnamomum cassia 8g, Maltose 25g, Cinnamomum cassia twig 6g, Paeonia lactiflora 15g, Glycyrrhiza uralensis 4g, Zingiber officinale 6g, and Jujube 4 pieces.

[0013] In a second aspect, the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia, comprising the following steps: weighing the raw materials by weight, soaking them in warm water for 60 minutes, adding water to cover the raw materials by about 1-2 cm, decocting the raw materials twice, the first decoction being boiled for about 60 minutes after boiling, the second decoction being boiled for about 30 minutes after boiling, and combining the two decoctions to a total of 400 mL.

[0014] A third aspect of the present invention provides a traditional Chinese medicine preparation of a traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia, characterized in that the traditional Chinese medicine preparation is made from the above-mentioned traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia as raw material.

[0015] Furthermore, the traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients. The dosage form of the traditional Chinese medicine preparation is a decoction, pill, capsule, tablet, powder, or granule.

[0016] Furthermore, the dosage form of the traditional Chinese medicine preparation is a decoction.

[0017] A fourth aspect of the present invention provides the use of the traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia in the preparation of a medicament for the prevention or treatment of chronic heart failure complicated with sarcopenia.

[0018] In Traditional Chinese Medicine (TCM), heart failure and sarcopenia fall under the categories of "debilitation" and "atrophy syndrome," characterized by a deficiency of vital energy (yuanqi) and a decline in qi, blood, yin, and yang. The description in the *Huangdi Neijing Suwen* (Yellow Emperor's Inner Classic, Plain Questions), "The bones are withered, the flesh is sunken, the chest is full of qi, breathing is labored, and the qi moves the body," aligns with the symptoms of heart failure and sarcopenia. The *Jinkui Yaolue Bianzhu* (Essential Prescriptions of the Golden Chamber, Annotated) states, "If debilitation damages the acquired qi, the nutritive and defensive qi will not be sufficient for the five viscera, the viscera will become weak, essence and blood will gradually decline, and the viscera will become diseased on their own." Therefore, the TCM pathogenesis of heart failure and sarcopenia can be attributed to "insufficient vital energy, impaired visceral function; deficiency of the middle qi, and insufficient source for the generation of nutritive and defensive qi and blood." Thus, treatment should simultaneously address both "nourishing vital energy" and "strengthening the middle qi." Baoyuan Decoction first appeared in Wei Zhi's *Bo Ai Xin Jian* during the Ming Dynasty. Sun Zhihong recorded that it "treats weakness of vital energy, fatigue, muscle weakness, poor appetite, ... and various other symptoms, all of which are due to weakness, and is suitable for use." It is composed of ginseng, astragalus, cinnamon, and prepared licorice. *Zhang Shi Yi Tong* (Zhang's Medical Treatise) directly lists this formula as the first among qi-tonifying formulas, stating that it has the effect of tonifying qi, replenishing deficiency, nourishing the original qi, and simultaneously tonifying the lungs, spleen, and kidneys, summarizing the essentials of qi tonification in traditional Chinese medicine. Establishing the middle qi should be "regulated with sweet flavors," hence Zhang Zhongjing proposed Xiao Jianzhong Decoction as a representative formula for treating consumptive diseases in *Jin Gui Yao Lue* (Essential Prescriptions of the Golden Chamber). Therefore, the herbal composition of this invention is a combination of Baoyuan Decoction and Huangqi Jianzhong Decoction, which consists of astragalus, ginseng, cinnamon, cassia twig, white peony root, maltose, licorice, jujube, and ginger.

[0019] Formula analysis: Astragalus, according to *Mingyi Bielu*, "nourishes the deficiency of men, and treats weakness and emaciation caused by the five types of overwork." *Benjing Shuzheng* states, "Astragalus originates from one source and has three branches, dredging the root of the three jiaos and benefiting the qi of the nutritive and defensive qi." *Lixu Yuanjian* records, "For those suffering from fatigue and weakness, qi and blood are deficient, and the body is weakened. Astragalus, being a sweet and warm herb that tonifies qi, governs the central region. Once the central banner is raised, the troops in the five directions, which have lost their positions, will each take their place." Ginseng, according to *Yaoxing Lun*, "treats the deficiency of qi in the five internal organs, the five types of overwork and seven types of injury, and weakness and emaciation." It can greatly replenish primordial qi to nourish the innate constitution, and also strengthen the spleen and replenish qi to nourish the acquired constitution. Its sweet and warm nature enters the spleen, regulating the middle jiao and replenishing qi to generate qi and blood. *Leijing Tuyi* states, "The greatest treasure of man is this one breath of true yang." Yang qi is the most fundamental driving force for the circulation of qi and blood in the internal organs. Patients with cachexia suffer from deficiency of primordial qi and insufficient physiological fire, leading to a decline in organ function. Therefore, cinnamon is added to warm and tonify kidney yang, combined with astragalus and ginseng to tonify qi and assist yang. Cinnamon twig, ginger, and licorice, with their pungent and sweet properties, nourish yang and strengthen the body's defenses. White peony root, combined with licorice and jujube, astringes yin and harmonizes the nutritive qi. In this way, one can cultivate primordial qi, strengthen the middle qi, and transform the nutritive and defensive qi to nourish the internal organs and the body.

[0020] The beneficial effects of the traditional Chinese medicine composition of this invention are as follows: The herbal composition of this invention significantly improves left ventricular ejection fraction, improves patient weight, improves skeletal muscle mass index of the limbs, and improves grip strength in patients with chronic heart failure complicated with sarcopenia, and has a significant therapeutic effect on chronic heart failure complicated with sarcopenia.

[0021] The herbal composition of this invention has advantages such as low side effects and high compliance, and is suitable for the treatment of chronic heart failure complicated with sarcopenia, with good market application prospects. Attached Figure Description

[0022] Figure 1 To compare the grip strength of the limbs of rats in each group with that of the normal control group, & P < 0.05 && P < 0.01; compared with the model control group, * P < 0.05 ** P < 0.01; compared with experimental group 1, # P < 0.05 ## P < 0.01. Detailed Implementation

[0025] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0026] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0027] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0028] Example 1 Astragalus membranaceus 30g, ginseng 9g, cinnamon 6g, maltose 30g, cinnamon twig 9g, white peony root 18g, prepared licorice root 6g, fresh ginger 9g, jujube 6 pieces.

[0029] Weigh the raw materials according to their weight, soak them in warm water for 60 minutes, add water to cover the raw materials by about 1-2 cm, decoct the raw materials twice, boil for about 60 minutes after the first decoction boils, and boil for about 30 minutes after the second decoction boils, combine the two decoctions to a total of 400 mL.

[0030] Example 2 Astragalus membranaceus 25g, ginseng 12g, cinnamon 4g, maltose 35g, cinnamon twig 12g, white peony root 20g, prepared licorice root 8g, fresh ginger 12g, and jujubes 8 pieces.

[0031] The preparation method is the same as in Example 1.

[0032] Example 3 Astragalus membranaceus 35g, ginseng 6g, cinnamon 8g, maltose 25g, cinnamon twig 6g, white peony root 15g, prepared licorice root 4g, fresh ginger 6g, and 4 jujubes.

[0033] The preparation method is the same as in Example 1.

[0034] Example 4 Astragalus membranaceus 35g, ginseng 9g, cinnamon 8g, maltose 30g, cinnamon twig 6g, white peony root 18g, prepared licorice root 4g, fresh ginger 6g, jujube 4 pieces.

[0035] The preparation method is the same as in Example 1.

[0036] Example 5 Astragalus membranaceus 25g, ginseng 6g, cinnamon 6g, maltose 25g, cinnamon twig 9g, white peony root 15g, prepared licorice root 6g, fresh ginger 9g, jujube 8 pieces.

[0037] The preparation method is the same as in Example 1.

[0038] Example 6 Astragalus membranaceus 30g, ginseng 12g, cinnamon 4g, maltose 35g, cinnamon twig 12g, white peony root 20g, prepared licorice root 8g, fresh ginger 12g, jujube 6 pieces.

[0039] The preparation method is the same as in Example 1.

[0040] Comparative Example 1 Ginseng 9g, cinnamon 6g, maltose 30g, cinnamon twig 9g, white peony root 18g, prepared licorice root 6g, fresh ginger 9g, jujube 6 pieces.

[0041] Compared with Example 1, the difference is that it does not contain Astragalus membranaceus, while the other components and dosages remain the same.

[0042] The preparation method is the same as in Example 1.

[0043] Comparative Example 2 Astragalus membranaceus 30g, cinnamon 6g, maltose 30g, cinnamon twig 9g, white peony root 18g, prepared licorice root 6g, fresh ginger 9g, jujube 6 pieces.

[0044] Compared with Example 1, the difference is that it does not contain ginseng, while the other components and dosages remain the same.

[0045] The preparation method is the same as in Example 1.

[0046] Comparative Example 3 Astragalus membranaceus 30g, ginseng 9g, maltose 30g, white peony root 18g, prepared licorice root 6g, fresh ginger 9g, jujube 6 pieces.

[0047] Compared with Example 1, the difference is that it does not contain cinnamon or cassia twigs, while the other components and their amounts remain the same.

[0048] The preparation method is the same as in Example 1.

[0049] Comparative Example 4 Codonopsis pilosula 30g, ginseng 9g, cinnamon 6g, maltose 30g, cinnamon twig 9g, white peony root 18g, prepared licorice root 6g, fresh ginger 9g, jujube 6 pieces.

[0050] Compared with Example 1, the difference is that Codonopsis pilosula is used instead of Astragalus membranaceus, while the other components and dosages remain unchanged.

[0051] The preparation method is the same as in Example 1.

[0052] Comparative Example 5 Astragalus membranaceus 30g, ginseng 9g, cinnamon 6g, maltose 30g, cinnamon twig 9g, prepared licorice root 6g, fresh ginger 9g, jujube 6 pieces.

[0053] Compared with Example 1, the difference is that it does not contain white peony root, while the other components and dosages remain the same.

[0054] The preparation method is the same as in Example 1.

[0055] Animal model establishment and efficacy evaluation 1. Experimental Methods Forty-eight 6-week-old male DS salt-sensitive rats were used. Six rats were randomly selected as the normal control group and fed a diet containing 0.3% NaCl. The remaining rats were fed a diet containing 8% NaCl to induce a salt-sensitive sarcopenic heart failure model.

[0056] Rats were regularly measured weekly for body weight and muscle function (forelimb grip strength, suspension time, and time to exhaustion while running). After 6 weeks, echocardiography was performed to assess left ventricular (LV) and right ventricular (RV) function to evaluate the success of the heart failure model, and small animal MRI was used to analyze body composition and limb lean mass (AML).

[0057] The rat model of heart failure sarcopenia was considered successful when the rats in the model control group showed a significant decline in cardiac function and a marked decrease in muscle function and AML.

[0058] After modeling, rats were randomly divided into four groups: model control group, experimental group 1, control group 1, control group 2, control group 3, and control group 4, with six rats in each group. The model group and the blank control group were given an equal volume of physiological saline by gavage for a total of 6 weeks. The experimental groups and gavage protocols are shown in Table 1.

[0059] Table 1. Gavage regimens for each group of rats Rats were fasted for 8 hours before euthanasia, anesthetized with isoflurane gas, and blood was collected from the abdominal aorta. After standing at room temperature for 1 hour, the blood was centrifuged at 4000 r / min for 20 minutes at 4°C, and the supernatant was collected. Muscle tissue (tibialis anterior, gastrocnemius, and soleus) was cryoisolated.

[0060] 2. Detection indicators 2.1 Detection of left ventricular ejection fraction (LVEF) in rats Echocardiography was performed on rats under isoflurane gas anesthesia.

[0061] 2.2 Detection of serum NT-proBNP levels in rats The level of NT-proBNP in serum was quantified using an ELISA kit.

[0062] 2.3 Detection of rat muscle mass During the sampling process, the total mass of the tibialis anterior muscle, soleus muscle, and gastrocnemius muscle of both lower limbs was weighed.

[0063] 2.4 Grip strength test Before and after gavage, grip strength of the entire limb was assessed using a grip dynamometer. Rats were placed on a gripper with their limbs gripping a grid panel, their bodies perpendicular to the front edge of the panel. The rats' tails were grasped, parallel to the grid surface, and gently and evenly pulled backward until their limbs detached from the panel. The maximum force exerted by the rat before detachment was recorded as grams per force (gf). Each rat was tested three times, and the average value was used for statistical analysis.

[0064] 3. Statistical Methods Data processing was performed using GraphPad Prism 8.0 software, with the measurement data presented in... ±s indicates statistical significance. A t-test was used for univariate statistical analysis to determine statistical significance. P < 0.05 was considered statistically significant.

[0065] 4. Experimental Results 4.1 Effects on LVEF in rats As shown in Table 2, the LVEF of rats in the model control group was significantly reduced compared with that of the normal control group.

[0066] Compared with the model control group, the LVEF of rats in Experiment 1 was significantly increased.

[0067] Compared with control groups 1-5, experimental group 1 showed a significant difference in increasing LVEF.

[0068] Table 2 LVEF results for each group Note: Compared with the normal control group, & P < 0.05 &&P < 0.01; Compared with the model control group, * P < 0.05 ** P < 0.01; Compared with Example 1, # P < 0.05 ## P < 0.01.

[0069] 4.2 Effect on serum NT-proBNP levels in rats As shown in Table 3, the serum NT-proBNP content of rats in the model control group was significantly increased compared with that in the normal control group.

[0070] Compared with the model control group, the serum NT-proBNP level of rats in Experiment 1 was significantly reduced.

[0071] Compared with control groups 1-5, experimental group 1 showed a significant difference in reducing serum NT-proBNP levels.

[0072] Table 3. Results of NT-proBNP content in each group Note: Compared with the normal control group, & P < 0.05 && P < 0.01; Compared with the model control group, * P < 0.05 ** P < 0.01; Compared with Example 1, # P < 0.05 ## P < 0.01.

[0073] 4.3 Effects on rat muscle mass As shown in Table 4, the muscle mass of rats in the model control group was significantly reduced compared with that in the normal control group.

[0074] Compared with the model control group, the muscle mass of rats in Experiment 1 was significantly increased.

[0075] Compared with control groups 1-5, experimental group 1 showed a significant difference in increasing rat muscle mass.

[0076] Table 4. Muscle mass results for each group Note: Compared with the normal control group, & P < 0.05 && P < 0.01; Compared with the model control group, * P < 0.05 ** P < 0.01; Compared with Example 1, # P < 0.05 ## P < 0.01.

[0077] 4.4 Effects on grip strength of rat limbs Depend on Figure 1 It can be seen that, compared with the normal control group, the grip strength of the rats in the model control group was significantly reduced.

[0078] Compared with the model control group, the grip strength of rats in Experiment 1 was significantly increased.

[0079] Compared with control groups 1-5, experimental group 1 showed a significant difference in increasing grip strength in the limbs.

[0080] Comparative Example 1 does not contain Astragalus membranaceus, Comparative Example 2 does not contain ginseng, Comparative Example 3 does not contain cinnamon or cassia twig, Comparative Example 4 uses Codonopsis pilosula instead of Astragalus membranaceus, and Comparative Example 5 does not contain Paeonia lactiflora. Compared with the control groups 1-5, the experimental group 1 showed a more significant improvement in the relevant indicators of heart failure complicated with sarcopenia, proving that the components of the traditional Chinese medicine composition of the present invention are indispensable in the treatment of heart failure complicated with sarcopenia and have a synergistic effect.

[0081] The following clinical trials demonstrate the beneficial effects of this invention.

[0082] Fifty patients with chronic heart failure complicated with sarcopenia were selected and divided into a control group and an experimental group. The control group received conventional Western medicine treatment, while the experimental group received the same treatment as the control group, plus the traditional Chinese medicine composition of Example 1 of this invention. The treatment effects were clinically tracked and observed, and the results were compared.

[0083] I. Diagnostic Criteria (a) Diagnostic criteria for chronic heart failure Refer to the diagnostic criteria in the "Chinese Guidelines for the Diagnosis and Treatment of Heart Failure 2018". A diagnosis can be made if two major criteria or one major criterion plus two minor criteria are met.

[0084] Table 5 Diagnostic criteria for heart failure (II) Cardiac Function Classification Standards Refer to the New York Heart Association (NYHA) functional classification.

[0085] Table 6 NYHA Classification of Cardiac Function (III) Diagnostic criteria for sarcopenia Refer to the "Chinese Guidelines for the Diagnosis and Treatment of Sarcopenia (2024 Edition)".

[0086] 1. Diagnosis of low muscle mass: The skeletal muscle mass index (ASMI) of the extremities is recommended. When measured by dual-energy X-ray ablation (DXA), a value of <7.0 kg / m² for men and <5.4 kg / m² for women can be diagnosed as low muscle mass. When measured by multi-frequency bioelectrical impedance analysis (BIA), a value of <7.0 kg / m² for men and <5.7 kg / m² for women can be diagnosed as low muscle mass.

[0087] 2. Diagnosis of low muscle strength: Grip strength is recommended as an indicator of muscle strength. A grip strength of <28.0 kg for men and <18.0 kg for women can be diagnosed as low grip strength.

[0088] 3. Diagnosis of physical dysfunction: Daily walking speed, 5-times chair-to-stand test and Mini-Physical Fitness Test (SPPB) are recommended. Walking speed <1 m / s, 5-times chair-to-stand test ≥12 s, and SPPB score ≤9 points can be diagnosed as physical dysfunction.

[0089] Table 7. Short Physical Performance Battery (SPPB) II. Case Selection Criteria (a) Case inclusion criteria 1. Patients diagnosed with chronic heart failure.

[0090] 2. Age ≥ 50 years old.

[0091] 3. NYHA functional classification: Class II-IV.

[0092] 4. Those who meet the diagnostic criteria for sarcopenia.

[0093] 5. No acute heart failure, serious infection or other acute illness in the past month.

[0094] 6. The patient or their legal representative voluntarily participates in the trial and signs an informed consent form.

[0095] (II) Exclusion criteria for cases 1. Those who do not meet the above inclusion criteria or whose information is incomplete.

[0096] 2. Heart failure caused by the failure of vital organs such as the liver and kidneys.

[0097] 3. Uncontrolled severe hypertension, severe arrhythmia, or acute myocardial infarction.

[0098] 4. Use of medications within the past month that may affect the treatment of heart failure or sarcopenia.

[0099] 5. Patients with mental disorders who are unable to cooperate with treatment or follow-up.

[0100] 6. Individuals allergic to any component of the traditional Chinese medicine composition.

[0101] (III) Criteria for Case Dropout, Exclusion, and Termination of Observation 1. Patients who experience serious adverse reactions or complications during the trial.

[0102] 2. Patients who voluntarily withdraw from the trial or fail to take medication as required during the trial.

[0103] 3. Patients who cannot follow the study protocol and have poor compliance.

[0104] III. Research Content and Methods (a) Grouping method Fifty patients who met the inclusion criteria were randomly divided into a control group and an experimental group, with 25 patients in each group.

[0105] (II) Treatment methods Refer to the methods, protocols and principles recommended in the Chinese Guidelines for the Diagnosis and Treatment of Heart Failure (2024) and the Chinese Guidelines for the Diagnosis and Treatment of Sarcopenia (2024 Edition).

[0106] (1) General treatment ① Treat the underlying cause and take targeted measures for the identified cause, such as actively controlling hypertension and improving myocardial ischemia; ② Actively control infection, especially respiratory infection; ③ Correct anemia and electrolyte imbalance; ④ Control physical activity and avoid mental stress; ⑤ Allow appropriate exercise for those who are bedridden for a long time; ⑥ Control sodium intake.

[0107] (2) Drug treatment New quadruple therapy for heart failure: ① Angiotensin receptor neprilysin inhibitor: Sacubitril / valsartan sodium tablets (Imported drug registration standard JX20160017, Novartis Singapore Pharmaceutical Manufacturing Private Ltd), the dosage is 100mg / time, twice a day. If the patient tolerates it, the dosage should be gradually increased to the target dose.

[0108] ②β-receptor blockers: Metoprolol succinate extended-release tablets (National Drug Approval Number J20150044, AstraZeneca Co., Ltd.), starting dose 23.75mg / time, once a day, starting with a low dose. If the patient tolerates it, the dose can be doubled in 2-4 weeks, gradually increasing to the target dose.

[0109] ③ Aldosterone receptor antagonist: Spironolactone (National Drug Approval Number H31021273, Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd.), dosage is 20mg / time, once a day.

[0110] ④ Sodium-glucose cotransporter 2 inhibitor: Dapagliflozin (National Drug Approval Number HJ20170119, AstraZeneca Pharmaceutical Co., Ltd.), dosage is 5mg / time, once a day.

[0111] Nutritional supplements such as protein, essential amino acids, and vitamin D are used to treat sarcopenia.

[0112] Control group: treated with the above-mentioned conventional Western medicines.

[0113] Experimental group: In addition to conventional Western medicine treatment, the traditional Chinese medicine composition of this invention was taken.

[0114] The herbal composition of this invention is as follows: Astragalus membranaceus 30g, Ginseng 9g, Cinnamomum cassia 6g, Maltose 30g, Cinnamomum cassia twig 9g, Paeonia lactiflora 18g, Glycyrrhiza uralensis (processed) 6g, Zingiber officinale 9g, and Jujube 6 pieces.

[0115] All the above Chinese medicines are from the pharmacy of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine.

[0116] Preparation and administration method: Decoction in water. Weigh the raw materials according to their weight for each dose, soak them in warm water for 60 minutes, add water to cover the raw materials by about 1-2 cm, and decoct the raw materials twice. Boil for about 60 minutes after the first decoction and about 30 minutes after the second decoction. Combine the two decoctions to a total of 400 ml, and take 200 ml warm, 2 hours after breakfast and dinner, one dose per day.

[0117] Treatment duration: Both groups received medication continuously for 8 weeks.

[0118] (III) Observation Indicators (1) Echocardiography: to detect changes in left ventricular ejection fraction (LVEF) before and after treatment.

[0119] (2) Detect changes in serum N-terminal pro-brain natriuretic peptide (NT-proBNP) before and after treatment to assess the condition of heart failure.

[0120] (3) Weight.

[0121] (4) Muscle mass index: skeletal muscle mass index of the limbs.

[0122] (5) Muscle strength index: grip strength is used as the muscle strength measurement index.

[0123] (6) Physical function indicators: Minimum Physical Fitness Test (SPPB) score.

[0124] (iv) Statistical methods SPSS was used for analysis and processing. t-tests were used for continuous data, and the mean ± standard deviation was used. ±SD) indicates variance. A rank-sum test was performed for unequal variances; the rank-sum test was used for ordinal data, and the χ² test was used for categorical data. P < 0.05 was considered statistically significant.

[0125] IV. Therapeutic Effect Analysis (a) General Information After the trial, complete data were available for 50 cases, including 25 cases in the experimental group and 25 cases in the control group. There were no significant differences in gender and age distribution between the two groups (see Tables 8 and 9).

[0126] Table 8. Gender distribution of the two groups of patients As shown in Table 8, there was no statistically significant difference in gender distribution between the control group and the experimental group (P > 0.05), and their baselines were comparable.

[0127] Table 9. Age distribution of the two groups of patients As shown in Table 9, there was no statistically significant difference in age distribution between the control group and the experimental group (P > 0.05), and their baselines were comparable.

[0128] (II) Therapeutic effect analysis 1. Comparison of left ventricular ejection fraction (LVEF) between the two groups of patients As shown in Table 10, there was no statistically significant difference in LVEF between the experimental group and the control group before treatment (P>0.05), indicating comparability; there was a statistically significant difference in LVEF between the experimental group and the control group before and after treatment (P<0.05); there was a statistically significant difference in LVEF between the experimental group and the control group after treatment (P<0.05).

[0129] This indicates that the improvement in LVEF in the experimental group was better than that in the control group.

[0130] Table 10 Comparison of LVEF before and after treatment in the two groups of patients (%) Comparison between the two groups before treatment: # P > 0.05; Comparison before and after treatment in each group: * P < 0.05 ** P < 0.01; Comparison between the two groups after treatment: △ P < 0.05.

[0131] 2. Comparison of NT-proBNP levels between the two groups of patients As shown in Table 11, there was no statistically significant difference in NT-proBNP levels between the experimental group and the control group before treatment (P > 0.05), indicating comparability. However, there was a statistically significant difference in NT-proBNP levels before and after treatment between the two groups (P < 0.01). Furthermore, there was a statistically significant difference in NT-proBNP levels after treatment between the two groups (P < 0.01). This suggests that the improvement in NT-proBNP levels in the experimental group was superior to that in the control group.

[0132] Table 11 Comparison of NT-proBNP levels before and after treatment in the two groups (pg / mL) Comparison between the two groups before treatment: # P > 0.05; Comparison before and after treatment in each group: ** P < 0.01; Comparison between the two groups after treatment: △△ P < 0.01.

[0133] 3. Comparison of weight between the two groups of patients As shown in Table 12, there was no statistically significant difference in weight between males and females before treatment in the experimental group and the control group (P>0.05), indicating comparability. However, there was a statistically significant difference in weight between males in the control group and the experimental group before and after treatment (P<0.05), and a statistically significant difference in weight between females in the experimental group before and after treatment (P<0.01). After treatment, there was a statistically significant difference in weight between males and females in the experimental group and the control group (P<0.05).

[0134] This indicates that the experimental group showed a greater degree of improvement in body weight than the control group.

[0135] Table 12 Comparison of body weight (kg) before and after treatment in the two groups of patients. Comparison between the two groups before treatment: # P > 0.05; Comparison before and after treatment in each group: * P < 0.05 ** P < 0.01; Comparison between the two groups after treatment: △ P < 0.05 △△ P < 0.01.

[0136] 4. Comparison of skeletal muscle mass index (ASMI) of the extremities between the two groups of patients. Table 13 shows that there was no statistically significant difference in ASMI between males and females in the experimental group and the control group before treatment (P > 0.05), indicating comparability. However, there was a statistically significant difference in ASMI before and after treatment between the male control group and the experimental group (P < 0.05), and a statistically significant difference in ASMI before and after treatment between females in the experimental group (P < 0.01). Furthermore, there were statistically significant differences in ASMI after treatment between males and females in both the experimental group and the control group (P < 0.05). This indicates that the degree of ASMI improvement in the experimental group was superior to that in the control group.

[0137] Table 13 Comparison of ASMI before and after treatment in the two groups of patients Comparison between the two groups before treatment: # P > 0.05; Comparison before and after treatment in each group: * P < 0.05 ** P < 0.01; Comparison between the two groups after treatment: △ P < 0.05 △△ P < 0.01.

[0138] 5. Comparison of grip strength between the two groups of patients Table 14 shows that there was no statistically significant difference in grip strength between the experimental group and the control group before treatment for both males and females (P>0.05), indicating comparability. However, there were statistically significant differences in grip strength between the experimental and control groups before and after treatment for both males and females (P<0.05). Furthermore, there were statistically significant differences in grip strength between the experimental and control groups after treatment for both males and females (P<0.01). This indicates that the experimental group showed a greater degree of improvement in grip strength than the control group.

[0139] Table 14 Comparison of grip strength before and after treatment in the two groups of patients Comparison between the two groups before treatment: # P > 0.05; Comparison before and after treatment in each group: * P < 0.05 ** P < 0.01; Comparison between the two groups after treatment: △△ P < 0.01.

[0140] 6. Comparison of SPPB scores between the two groups of patients As shown in Table 15, there was no statistically significant difference in SPPB scores between the experimental group and the control group before treatment (P>0.05), indicating comparability. However, there was a statistically significant difference in SPPB scores between the experimental group and the control group before and after treatment (P<0.01). Furthermore, there was a statistically significant difference in SPPB scores between the experimental group and the control group after treatment (P<0.01).

[0141] This indicates that the experimental group showed better improvement in physical dysfunction than the control group.

[0142] Table 15 Comparison of SPPB scores before and after treatment in the two groups of patients Comparison between the two groups before treatment: # P > 0.05; Comparison before and after treatment in each group: ** P < 0.01; Comparison between the two groups after treatment: △△ P < 0.01.

[0143] The embodiments described above are merely preferred embodiments of the present invention and are not intended to limit the scope of the present invention. Various modifications and improvements made by those skilled in the art to the technical solutions of the present invention without departing from the spirit of the present invention should fall within the protection scope defined by the claims of the present invention.

Claims

1. A traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia, characterized in that, The traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia consists of the following herbs: Astragalus membranaceus 25-35g, Ginseng 6-12g, Cinnamomum cassia 4-8g, Maltose 25-35g, Cinnamomum cassia twig 6-12g, Paeonia lactiflora 15-20g, Glycyrrhiza uralensis (processed) 4-8g, Zingiber officinale 6-12g, and Jujube 4-8 pieces.

2. The traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia according to claim 1, characterized in that, The traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia consists of the following herbs: Astragalus membranaceus 30g, Ginseng 9g, Cinnamomum cassia 6g, Maltose 30g, Cinnamomum cassia twig 9g, Paeonia lactiflora 18g, Glycyrrhiza uralensis 6g, Zingiber officinale 9g, and Jujube 6 pieces.

3. The traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia according to claim 1, characterized in that, The traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia consists of the following herbs: Astragalus membranaceus 25g, Ginseng 12g, Cinnamomum cassia 4g, Maltose 35g, Cinnamomum cassia twig 12g, Paeonia lactiflora 20g, Glycyrrhiza uralensis (processed) 8g, Zingiber officinale 12g, and Jujube 8 pieces.

4. The traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia according to claim 1, characterized in that, The traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia consists of the following herbs: Astragalus membranaceus 35g, Ginseng 6g, Cinnamomum cassia 8g, Maltose 25g, Cinnamomum cassia twig 6g, Paeonia lactiflora 15g, Glycyrrhiza uralensis (processed) 4g, Zingiber officinale 6g, and Jujube 4 pieces.

5. The method for preparing the traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia according to any one of claims 1-4, characterized in that, The preparation method includes the following steps: weigh the raw materials by weight, soak them in warm water for 60 minutes, add water to cover the raw materials by about 1-2 cm, decoct the raw materials twice, boil for about 60 minutes after the first decoction, boil for about 30 minutes after the second decoction, and combine the two decoctions to a total of 400 mL.

6. A traditional Chinese medicine preparation comprising a traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia, characterized in that, The traditional Chinese medicine preparation is made from the traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia as described in any one of claims 1-4.

7. The traditional Chinese medicine preparation according to claim 6, characterized in that, The traditional Chinese medicine preparation also includes pharmaceutically acceptable excipients.

8. The traditional Chinese medicine preparation according to claim 7, characterized in that, The dosage forms of the traditional Chinese medicine preparations are decoctions, pills, capsules, tablets, powders, or granules.

9. The traditional Chinese medicine preparation according to claim 8, characterized in that, The dosage form of the traditional Chinese medicine preparation is a decoction.

10. The use of the traditional Chinese medicine composition for treating chronic heart failure complicated with sarcopenia according to any one of claims 1-4 in the preparation of a drug for the prevention or treatment of chronic heart failure complicated with sarcopenia.

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