Traditional Chinese medicine composition for recovering and treating ejection fraction improved heart failure

Abstract

The traditional Chinese medicine composition is prepared from the following traditional Chinese medicinal materials in parts by weight: 3 to 9 parts of rhizoma chuanxiong, 3 to 9 parts of rhizoma cyperi, 3 to 9 parts of rhizoma atractylodis, 3 to 9 parts of fructus gardeniae praeparatus, 3 to 9 parts of medicated leaven, 3 to 9 parts of fructus crataegi cuneatae, 3 to 9 parts of radix rubiae, 3 to 9 parts of fructus trichosanthis, 3 to 9 parts of allium macrostemon, 3 to 9 parts of rhizoma pinellinae praeparata, 6 to 12 parts of fructus aurantii immaturus and 12 to 18 parts of rhizoma polygonati. And 3-9 parts of pseudo-ginseng. The traditional Chinese medicine composition can be used for treating ejection fraction improvement type chronic heart failure, and has the characteristics of sufficient medicinal material sources, low cost and relatively high safety; the traditional Chinese medicine composition is used for solving the technical problem that an existing traditional Chinese medicine for ejection fraction retention type heart failure or a traditional Chinese medicine composition for chronic heart failure is poor in targeted curative effect on ejection fraction improvement type heart failure.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and in particular is a traditional Chinese medicine composition for recovery treatment of heart failure with improved ejection fraction. Background Art

[0002] Heart failure with improved ejection fraction (HFimpEF) is defined as a baseline left ventricular ejection fraction (LVEF) ≤ 40%, a reexamination of LVEF> 40%, and an absolute improvement of ≥ 10%. Although the prognosis of HFimpEF is good, it does not mean that the myocardium has fully recovered or the left ventricular function has fully recovered to normal levels. The LVEF may also decrease, and the condition is very likely to recur.

[0003] At present, there is no effective Chinese medicine treatment scheme specifically for heart failure with improved ejection fraction. Most treatment schemes are only for heart failure with preserved ejection fraction. For example, patent application CN117838713A relates to the application of gardenia glycoside in the preparation of a medicine for improving heart failure with preserved ejection fraction. Gardenia glycoside is the main component of the Chinese medicine gardenia, which has a certain effect on heart failure with preserved ejection fraction. Patent application CN114588205A discloses the application of Tongxinluo in the preparation of a medicine for treating heart failure with preserved ejection fraction. The main components of Tongxinluo are ginseng, red peony root, spiny jujube seed, sandalwood extract, dalbergia odorifera, frankincense, borneol, scorpion, leech, earthworm, centipede and cicada shell. Among them, ginseng is expensive, and drugs such as borneol, centipede, scorpion and earthworm have certain toxicity and are not easy to obtain. Patent application CN116173121A relates to a Chinese medicine composition for treating heart failure with preserved ejection fraction, its preparation method and application, wherein the medicinal materials include Astragalus, Salvia miltiorrhiza, Paeonia lactiflora, Semen Amurense, Rhizoma Alismatis and Radix Puerariae. Semen Amurense has certain toxicity and the drug safety needs to be discussed. The above schemes are all Chinese medicine treatment schemes proposed for heart failure with preserved ejection fraction, and these treatment schemes are often not effective for heart failure with improved ejection fraction and can only be used as a certain reference. In addition, the prior art also reports Chinese medicine compositions for treating heart failure. Although they have certain efficacy for chronic heart failure, it is also not shown that these schemes have therapeutic efficacy for heart failure with improved ejection fraction. Summary of the invention

[0004] 1. Technical issues to be resolved In order to solve the problems existing in the prior art, the inventor hopes to propose a Chinese medicine composition for restorative treatment of heart failure with improved ejection fraction. The Chinese medicine composition is specifically for restorative treatment of improved heart failure that increases after a decrease in ejection fraction. It has the characteristics of sufficient source of medicinal materials, low cost and high safety. It is used to exert the therapeutic effect of traditional Chinese medicine in heart failure with improved ejection fraction and to make up for the problem that the existing Chinese medicine compositions have poor efficacy in treating heart failure with improved ejection fraction.

[0005] (II) Technical solution In a first aspect, the present invention provides a traditional Chinese medicine composition for recovery treatment of heart failure with improved ejection fraction, which is made of the following traditional Chinese medicines in parts by weight: 3-9 parts of Chuanxiong, 3-9 parts of Cyperus rotundus, 3-9 parts of Atractylodes macrocephala, 3-9 parts of Gardenia jasminoides, 3-9 parts of Shenqu, 3-9 parts of Crataegus pinnatifida, 3-9 parts of Rubia cordifolia, 3-9 parts of Trichosanthes kirilowii, 3-9 parts of Allium macrostemon, 3-9 parts of Pinellia ternata, 6-12 parts of Citrus aurantium, 12-18 parts of Polygonatum sibiricum, and 3-9 parts of Panax notoginseng.

[0006] Preferably, the Chinese medicine composition is made of the following Chinese medicinal materials in parts by weight: 7 parts of Chuanxiong, 5 parts of Cyperus rotundus, 8 parts of Atractylodes, 8 parts of Gardenia jasminoides, 8 parts of Shenqu, 6 parts of Crataegus pinnatifida, 3 parts of Rubia cordifolia, 3 parts of Trichosanthes, 9 parts of Xiebai, 9 parts of Pinellia ternata, 11 parts of Citrus aurantium, 12 parts of Polygonatum sibiricum, 3 parts of Panax notoginseng; or, 5 parts of Chuanxiong, 9 parts of Cyperus rotundus, 9 parts of Atractylodes, 9 parts of Gardenia jasminoides, 9 parts of Shenqu, 5 parts of Crataegus pinnatifida, 9 parts of Rubia cordifolia, 5 parts of Trichosanthes, 6 parts of Xiebai, 5 parts of Pinellia ternata, 12 parts of Citrus aurantium, 14 parts of Polygonatum sibiricum, 6 parts of Panax notoginseng; or, 6 parts of Chuanxiong, 6 parts of Cyperus rotundus, 6 parts of Atractylodes, 6 parts of Gardenia jasminoides, 6 parts of Shenqu, 6 parts of Crataegus pinnatifida, 6 parts of Rubia cordifolia, 6 parts of Trichosanthes, 6 parts of Xiebai, 6 parts of Pinellia ternata, 9 parts of Citrus aurantium, 16 parts of Polygonatum sibiricum, 8 parts of Panax notoginseng; or, 9 parts of Chuanxiong, 9 parts of Cyperus rotundus, 3 parts of Atractylodes, 5 parts of Gardenia jasminoides, 5 parts of Shenqu, 7 parts of Crataegus pinnatifida, 8 parts of Rubia cordifolia, 8 parts of Trichosanthes, 9 parts of Xiebai, 8 parts of Pinellia ternata, 9 parts of Citrus aurantium, 18 parts of Polygonatum sibiricum, 9 parts of Panax notoginseng; or, 8 parts of Chuanxiong, 8 parts of Cyperus rotundus, 5 parts of Atractylodes, 5 parts of Gardenia jasminoides, 3 parts of Shenqu, 8 parts of Crataegus pinnatifida, 9 parts of Rubia cordifolia, 9 parts of Trichosanthes, 4 parts of Xiebai, 7 parts of Pinellia ternata, 10 parts of Citrus aurantium, 15 parts of Polygonatum sibiricum, 4 parts of Panax notoginseng; or, 4 parts of Rhizoma Chuanxiong, 7 parts of Rhizoma Cyperi, 6 parts of Rhizoma Atractylodis Macrocephalae, 4 parts of Rhizoma Gardeniae, 3 parts of Radix Angelicae Pubescentis, 9 parts of Crataegus Pinelliae, 9 parts of Rubia cordifolia, 3 parts of Fructus Trichosanthis, 3 parts of Radix Allii Macrostemonis, 9 parts of Rhizoma Pinelliae, 6 parts of Fructus Aurantii Immaturus, 13 parts of Rhizoma Polygonati, and 5 parts of Radix Notoginseng.

[0007] Preferably, the Chinese medicine composition is a capsule, Chinese medicine granules, Chinese medicine ointment, Chinese medicine pills or decoction.

[0008] Preferably, the preparation method of the capsule is as follows: after cleaning and drying each medicinal material, chopping it into pieces, putting it into a casserole for decoction, filtering, harvesting the filtrate, concentrating the filtrate into a paste, drying, sterilizing, grinding it into a powder, passing it through a 100-200 mesh sieve, and then putting it into capsules; Preferably, the preparation method of the Chinese medicine granules is: after cleaning and drying the medicinal materials, chopping them into pieces, putting them into a casserole for decoction, filtering, harvesting the filtrate, concentrating the filtrate into an extract, mixing the extract with a flavoring agent and an excipient, and then granulating; the excipient is dextrin or starch; Preferably, the preparation method of the Chinese medicine pills is: after cleaning and drying the medicinal materials, chopping them into pieces, putting them into a casserole for decoction, filtering, harvesting the filtrate, concentrating the filtrate to a fluid extract with a relative density of 1.1-1.2, mixing the auxiliary materials, stirring evenly and making the pills; the auxiliary materials are water, honey, wine or vinegar; Preferably, the preparation method of the Chinese medicine ointment is: after cleaning and drying the medicinal materials, pounding them into powder, putting them into a casserole for decoction, filtering, harvesting the filtrate, adding 10% of auxiliary materials to the filtrate, mixing, and then concentrating it into a thick paste with a relative density of 1.5-1.6 to obtain the ointment; the auxiliary materials are donkey-hide gelatin, sucrose or honey; Preferably, the preparation method of the decoction is: after cleaning, drying and chopping each medicinal material, soaking the treated raw materials in water for 30-60 minutes, boiling over high heat, decocting for the first time at 80-100°C for 10-15 minutes, pouring out 1 / 3-1 / 2 of the medicinal liquid; then adding water to the original volume, decocting for the second time for 10-15 minutes, the decoction temperature range is 60-80°C, and then pouring out 1 / 3-1 / 2 of the medicinal liquid, mixing the two medicinal liquids to obtain the decoction.

[0009] Preferably, in the preparation process of the above dosage forms of the Chinese medicine composition, the medicinal materials are first fully absorbed with water and then placed in a casserole, and water is added until all the Chinese medicinal materials are submerged by 3-5 cm. During decoction, the amount of water is maintained to submerge all the Chinese medicinal materials by 3-5 cm.

[0010] In the present invention, the pretreatment and processing methods of various medicinal materials are detailed in the "Chinese Pharmacopoeia 2010 Edition".

[0011] The medicinal materials that need to be pre-processed or pre-processed are as follows: French Pinellia: French Pinellia is processed through licorice and lime using a special process. After processing, the toxicity of the Pinellia is reduced and its dryness is milder. It also has the effect of harmonizing the spleen and stomach, helping to improve the absorption efficiency of each medicinal ingredient, enhance appetite and nutritional supplements, relieve stomach discomfort caused by heart failure, and then help the positive energy and improve the patient's own immunity.

[0012] Scorched Gardenia: Scorched Gardenia is a kind of gardenia that has been processed using a special craft. After processing, the effect of detoxification and purging fire is reduced, and the effect of clearing heat and dampness is increased. It is beneficial for resolving phlegm, removing dampness and clearing away heat, and also helps to dredge the Qi of the middle Jiao spleen and stomach, enhance appetite, and improve the body's positive energy.

[0013] Southern hawthorn: refers to the wild hawthorn distributed in Henan, Shanxi, Jiangsu, Zhejiang, Jiangxi, Hubei, Hunan, Shaanxi and other places, which is dried and the impurities are removed. It is good at breaking up qi and dispersing blood stasis. At the same time, pharmacology shows that it also has the effects of lowering blood pressure, increasing coronary blood flow and other effects on the cardiovascular system. Ordinary hawthorn is good at digestion and has no effect on the cardiovascular system.

[0014] (III) Beneficial effects Compared with the prior art, the main technical effect of the present invention is: based on the problem of "the stagnation of phlegm and stagnation of chest yang, which enters the blood for a long time and blocks the heart meridian" in patients with improved heart failure, the present invention uses Chuanxiong and Cyperus rotundus as the main medicine, uses Trichosanthes, Xiebai, and Pinellia ternata as the ministerial medicine, uses Atractylodes lancea, Gardenia jasminoides, Shenqu, Crataegus pinnatifida, Zhishi, and Polygonatum sibiricum as the adjuvant medicine, and uses Rubia cordifolia and Panax notoginseng as the guiding medicine to obtain the Chinese medicine composition. Among them, the main medicine Chuanxiong is a blood-qi medicine, and Cyperus rotundus is a qi-blood medicine. The two regulate qi and relieve depression, activate blood circulation and dredge the meridians, and the internal qi flows and the blood flows. The ministerial medicine is matched with Trichosanthes, Xiebai, and Pinellia ternata, which can regulate qi and relieve chest tightness, resolve phlegm and relieve turbidity, and promote yang and disperse stagnation; the main and ministerial medicines are matched, qi and blood are coordinated, and phlegm and blood stasis are eliminated. The adjuvant Atractylodes lancea dries dampness and invigorates the spleen, treating the source of phlegm. Scorched Gardenia jasminoides clears heat and removes dampness, treating phlegm-dampness and accumulated heat. Heart failure patients have obstructed lung qi in the upper burner, and obstructed spleen and stomach qi in the middle burner, and the disease lasts for a long time and the patient is often weak. Therefore, among the adjuvants, Shenqu, Crataegus pinnatifida and Citrus aurantium work together to digest food and lower qi. When qi is smooth, phlegm will disappear. They are used with Polygonatum sibiricum to replenish essence and blood, and are further used with Rubia cordifolia and Panax notoginseng as guiding drugs to resolve blood stasis and dredge meridians, and guide meridians into blood. The above-mentioned formula achieves the effects of regulating qi and activating blood circulation, resolving blood stasis and dredging meridians, promoting yang and dispersing stagnation, and removing phlegm and relieving chest tightness. DETAILED DESCRIPTION

[0015] In order to better explain the present invention and facilitate understanding, the present invention is described in detail below in conjunction with specific implementation methods.

[0016] The invention provides a traditional Chinese medicine composition for recovery treatment of heart failure with improved ejection fraction. The traditional Chinese medicine composition is prepared from the following traditional Chinese medicines in parts by weight: 3-9 parts of chuanxiong, 3-9 parts of cyperus rotundus, 3-9 parts of atractylodes, 3-9 parts of scorched gardenia, 3-9 parts of shenqu, 3-9 parts of south hawthorn, 3-9 parts of madder, 3-9 parts of trichosanthes, 3-9 parts of allium macrostemon, 3-9 parts of pinellia, 6-12 parts of immature bitter orange, 12-18 parts of polygonatum and 3-9 parts of panax notoginseng.

[0017] The prescription of the Chinese medicine composition of the present invention is explained as follows: Chuanxiong and Cyperus rotundus are the main drugs, Trichosanthes kirilowii, Xiebai and Pinellia ternata are the ministerial drugs, Atractylodes lancea, Gardenia jasminoides, Shenqu, Crataegus pinnatifida, Citrus aurantium and Polygonatum sibiricum are the adjuvant drugs, and Rubia cordifolia and Panax notoginseng are the guiding drugs.

[0018] The prescription of the present invention is derived from the classic Chinese medicine works "Golden Chamber Synopsis" and "Danxi's Heart Method", and is modified according to the characteristics of the disease by using the classic prescriptions of Gualou Xiebai Banxia Decoction and Yueju Pills (composed of five herbs: Cyperus rotundus, Ligusticum chuanxiong, Atractylodes macrocephala, Shenqu, and Gardenia jasminoides). Yueju Pills promote qi circulation and relieve depression, relieve fullness and eliminate fullness, while Gualou Xiebai Banxia Decoction promotes yang and disperses stagnation, relieves chest tightness and eliminates numbness.

[0019] In the Chinese medicine composition of the present invention, the rhizome of Chuanxiong in the monarch drug is a blood-qi drug, and the angelica in the monarch drug is a blood-qi drug. The two regulate qi and relieve depression, activate blood circulation and dredge meridians, and the inner qi circulates when the blood circulates. The minister drugs are matched with trichosanthes, white allium and pinellia, and the functions of regulating qi and relieving chest tightness, resolving phlegm and relieving turbidity, and promoting yang and dispersing stagnation are achieved together. The monarch and minister drugs are matched, qi and blood are regulated in unison, and phlegm and blood stasis are eliminated at the same time. The adjuvant drug Atractylodes lancea dries dampness and moves the spleen, and treats the source of phlegm. The scorched gardenia clears heat and removes dampness, and treats phlegm dampness and stagnation of heat. If the upper-jiao lung qi of patients with heart failure is not smooth, the qi of the middle-jiao spleen and stomach is also not smooth, and long-term illness is mostly weak. Among the adjuvant drugs, Shenqu, southern hawthorn and immature bitter orange can digest food and descend qi, and phlegm will disappear when qi is smooth. They can replenish essence and blood with polygonatum, and are further matched with madder and notoginseng as guiding drugs to remove blood stasis and dredge meridians, guide the meridians into the blood, and improve the absorption speed and utilization rate of the active ingredients. The above-mentioned prescription achieves the effects of regulating qi and activating blood circulation, removing blood stasis and unblocking meridians, promoting yang and dispersing nodules, and removing phlegm and relieving chest tightness.

[0020] The functions of the above components in the Chinese medicine composition of the present invention are as follows: Ligusticum chuanxiong: "Shennong's Herbal Classic" records that it "tastes spicy and is warm. It is mainly used to treat headaches caused by stroke, cold arthralgia, and muscle spasms." "Yao Xing Fu" records that it "has two uses: it goes up to the head and horns to help clear the yang qi and relieve pain; it goes down to the blood sea to nourish new blood and regulate menstruation." This medicine tastes spicy and is warm in nature; it enters the liver, gallbladder, and pericardium meridians; it has the effects of promoting blood circulation and qi, dispelling wind and relieving pain; its water extract and alkaloids have the effects of dilating coronary arteries, increasing coronary blood flow, and improving myocardial hypoxia.

[0021] Cyperus rotundus: "Yaojian" records that it "has a heavy aroma and a light taste. It is a blood-qi medicine and is a must-have in all blood-qi prescriptions. It can relieve qi and depression, remove blood stasis and regulate menstruation." This medicine tastes pungent, slightly bitter, and slightly sweet, and is neutral in nature. It enters the liver, spleen, and triple burner meridians. It has the effects of soothing the liver, regulating qi, relieving depression, regulating menstruation and relieving pain. Its ethanol extract and the triterpenoid compounds in Cyperus rotundus have analgesic effects, and the alcohol extract has sedative and antipyretic effects.

[0022] Atractylodes: "Shennong's Herbal Classic" records that it "tastes bitter and is warm. It is mainly used to treat wind-cold and dampness arthralgia." "Yao Xing Jie" records that it "soothes the stomach and strengthens the spleen, relieves fullness and disperses stagnation." This medicine tastes pungent and bitter, and is warm in nature; it enters the spleen, stomach, and liver meridians; it has the effects of drying dampness and strengthening the spleen, dispelling wind and cold; pharmacological studies have shown that it has diuretic, anti-hypoxia, and vasodilator effects.

[0023] Scorched Gardenia: "Ming Yi Bie Lu" records that it is "very cold and non-toxic. It is mainly used to treat hot and painful eyes, severe heat in the chest and large and small intestines, irritability, and heat in the stomach." "Ben Jing Feng Yuan" records that "Gardenia kernel is light in nature and is specifically used to remove heat from the heart and lungs." This medicine tastes bitter and is cold in nature; it enters the heart, liver, lung, stomach, and triple burner meridians; it has the effects of purging fire and relieving irritability, clearing away heat and promoting diuresis, cooling blood and stopping bleeding; pharmacological studies have shown that its extract can reduce myocardial contractility, and its decoction has the effects of slowing down the heart rate and dilating blood vessels.

[0024] Shenqu: "Explanation of Medicinal Properties" records that it "mainly regulates the middle-Jia and stops diarrhea, stimulates appetite and helps digestion, breaks up symptoms and knots, removes accumulated phlegm, and relieves bloating." This medicine tastes sweet and spicy and is warm in nature; it enters the spleen and stomach meridians; it has the effects of helping digestion and strengthening the spleen, regulating qi and harmonizing the stomach; pharmacological research has shown that it can promote the body's digestion, absorption and utilization of protein in food.

[0025] Southern hawthorn: "Compendium of Materia Medica" records that it "relieves stagnant qi, eliminates accumulation, disperses blood stasis, and resolves phlegm." "Medical Records of Chinese and Western Medicine" records that it "is good at entering the blood and is an important medicine for resolving blood stasis, and also enters the qi to relieve qi stagnation and phlegm, and treat heart and abdominal pain." It is slightly warm in nature, sour and sweet in taste; it enters the spleen, stomach, and liver meridians; it has the effects of digesting food, strengthening the stomach, promoting blood circulation and removing blood stasis; pharmacological research has the effects of lowering blood lipids, strengthening the heart, and increasing coronary artery flow.

[0026] Rubia cordifolia: Compendium of Materia Medica states that "its sour taste enters the liver while its salty taste moves to the blood. It is a medicine for the hand and foot Jueyin blood system, and is specialized in promoting blood circulation." It tastes bitter, is cold in nature, and enters the liver meridian; it has the effects of cooling blood and stopping bleeding, promoting blood circulation and removing blood stasis, and relieving pain; pharmacological studies have shown that its extract has the effect of lowering the ST segment and reducing the scope of myocardial infarction in an artificial myocardial infarction model.

[0027] Trichosanthes: "Compendium of Materia Medica" records that it "treats chest pain that extends to the heart and back, coughing, spitting, wheezing, and chest fullness and pain." It tastes sweet, slightly bitter, and is cold in nature; it enters the lung, stomach, and large intestine meridians; it has the effects of clearing away heat and phlegm, and relieving chest congestion and dispersing congestion; pharmacological studies have shown that it can significantly reduce hematocrit and blood viscosity.

[0028] Xiebai: Depei Materia Medica states that "when used with Trichosanthes kirilowii, it can treat chest pain; adding white wine is even better." Bencao Sibianlu states: "Among the pungent, warm and lubricating medicines, Xiebai is the only one. It is the best at clearing the yang in the chest and dispersing the knots in the large intestine." It tastes pungent and bitter, and is warm in nature. It enters the lung, stomach and large intestine meridians; it has the effects of clearing yang and dispersing knots, promoting qi and removing stagnation; pharmacological studies have shown that it has anti-atherosclerotic and anti-platelet aggregation effects.

[0029] French Pinellia: "Shennong's Herbal Classic" records that it "treats cold and fever caused by typhoid fever, hardness under the heart, relieves gas, sore throat and pharynx, dizziness, chest distension, cough, intestinal rumbling, and stops sweating." "Yao Xing Jie" records that it "relieves gas and stops vomiting, relieves depression and disperses external evil, removes dampness and resolves phlegm, and harmonizes the spleen and stomach." This medicine is pungent in taste, warm in nature, and toxic; it enters the spleen, stomach, and lung meridians; it has the effects of drying dampness and resolving phlegm, relieving adverse reactions and stopping vomiting, and eliminating lumps and resolving knots; pharmacological studies have shown that it has the effects of inhibiting cardiac function, lowering blood pressure, and resisting arrhythmias.

[0030] Zhishi: "Ming Yi Bie Lu" records that it "is mainly used to eliminate chest and rib pain, expel stagnant water, break up lumps, relieve bloating, heart urgency, pain in the middle, reverse qi, and rib pain." This medicine tastes bitter, pungent, and sour, and is slightly cold in nature; it enters the spleen, stomach, and large intestine meridians; its effects are to break up qi and eliminate accumulation, resolve phlegm and relieve lumps; pharmacological studies have shown that it has the effects of strengthening the heart, increasing cardiac output, constricting blood vessels, and increasing peripheral resistance.

[0031] Panax notoginseng: Depei Materia Medica records that it is "sweet, slightly bitter, and warm. It enters the blood division of the foot Jueyin meridian. It can stop bleeding, disperse blood, relieve pain, and treat all blood diseases." Bencao Beiyao records that its main function is to "disperse blood stasis and relieve pain." It tastes sweet, slightly bitter, and is warm in nature; it enters the liver and stomach meridians; it has the effects of dispersing blood stasis, stopping bleeding, reducing swelling and relieving pain; pharmacological studies have shown that it has a protective effect on myocardial ischemia-reperfusion injury, reduces myocardial oxygen consumption and has anti-arrhythmic effects.

[0032] Polygonatum: "Famous Doctors' Records" records that it "tonifies the middle and replenishes qi, eliminates rheumatism, and calms the five internal organs." It tastes sweet and is neutral in nature; it enters the spleen, lung, and kidney meridians; it has the effects of tonifying qi and nourishing yin, strengthening the spleen and moistening the lungs, and benefiting the kidneys; its pharmacological effects include lowering blood lipids, resisting atherosclerosis, and lowering blood pressure, dilating coronary arteries, resisting myocardial ischemia, and improving microcirculation.

[0033] The Chinese medicine composition of the present application, from the analysis of nature and taste, is mainly warm, supplemented by cold, and all medicines are matched, and qi and blood are in harmony. The whole prescription is rigorously and orderly in its combination of monarch, minister, assistant and envoy, and is intended to promote qi and blood circulation. Qi is the leader of blood, and blood circulates when qi moves. Together, they can promote qi and relieve depression, promote blood circulation and remove blood stasis, promote yang and disperse knots, and remove phlegm and widen the chest, which is consistent with the formation mechanism of heart failure with improved ejection fraction. Experiments have shown that the Chinese medicine composition can enhance cardiac function, improve cardiac blood supply, promote reversal of myocardial remodeling, promote myocardial or left ventricular function to return to normal levels, stabilize LVEF values ​​(prevent LVEF from falling again), and prevent recurrence of the disease during the treatment of heart failure with improved ejection fraction.

[0034] The following is a description of the preferred embodiments and technical effects of the present invention.

[0035] Example 1 This embodiment provides a Chinese medicinal decoction for recovery treatment of heart failure with improved ejection fraction, and the preparation method thereof is as follows: (1) Weigh the following medicinal materials: Rhizoma Chuanxiong 6g, Rhizoma Cyperi 6g, Rhizoma Atractylodis Macrocephalae 6g, Rhizoma Gardeniae 6g, Rhizoma Shenqu 6g, Rhizoma Crataegus 6g, Rhizoma Rubiae 6g, Rhizoma Trichosanthis 6g, Rhizoma Allii Macrostemonis 6g, Rhizoma Pinelliae 6g, Rhizoma Citrus Aurantii Immaturus 9g, Rhizoma Polygonati 16g, Rhizoma Panax Notoginseng 8g.

[0036] (2) Preparation of decoction: After cleaning, drying and chopping the herbs, soak them in cold water for 60 minutes to allow them to absorb water. Then put them into a casserole and add water to cover all the herbs by 5 cm. After boiling over high heat, boil them at 90℃ for 15 minutes for the first time, and pour out 1 / 2 of the liquid. Then add water to the original volume and boil them for the second time at 80℃ for 15 minutes. Pour out 1 / 2 of the liquid again, mix the two liquids, filter the liquid with two layers of gauze, remove the small residues, and obtain a clear and transparent decoction.

[0037] Example 2 This embodiment provides a Chinese medicine pill for recovery treatment of heart failure with improved ejection fraction, and the preparation method thereof is as follows: (1) Weigh the following medicinal materials: Rhizoma Chuanxiong 5g, Rhizoma Cyperi 9g, Rhizoma Atractylodis Macrocephalae 9g, Rhizoma Gardeniae 9g, Rhizoma Shenqu 9g, Rhizoma Crataegus 5g, Rhizoma Rubiae 9g, Rhizoma Trichosanthis 5g, Rhizoma Allii Macrostemonis 6g, Rhizoma Pinelliae 5g, Rhizoma Citrus Aurantii Immaturus 12g, Rhizoma Polygonati 14g, Rhizoma Panax Notoginseng 6g.

[0038] (2) Pill preparation: Prepare 103g of honey (1:1 with the material mass). After cleaning and chopping the above medicinal materials, soak them in cold water for 60 minutes to make all the medicinal materials absorb water, then put them into a casserole and add water to cover all the Chinese medicinal materials by 5cm. After boiling over high heat, first boil at 90℃ for 30 minutes and pour out all the liquid medicine; then add water to the original volume, boil at 70℃ for 30 minutes, and then pour out all the liquid medicine. Mix the two poured liquid medicines, filter with two layers of gauze, harvest the filtrate, boil the filtrate and concentrate it into a fluid extract with a relative density of 1.2, mix it with honey, stir evenly, and make Chinese medicine pills.

[0039] Example 3 This embodiment provides a Chinese medicine granule for recovery treatment of heart failure with improved ejection fraction, and the preparation method thereof is as follows: (1) Weigh the following medicinal materials: Rhizoma Chuanxiong 9g, Rhizoma Cyperi 9g, Rhizoma Atractylodis Macrocephalae 3g, Rhizoma Gardeniae 5g, Rhizoma Shenqu 5g, Rhizoma Crataegus 7g, Rhizoma Rubiae 8g, Rhizoma Trichosanthis 8g, Rhizoma Allii Macrostemonis 9g, Rhizoma Pinelliae 8g, Rhizoma Citrus Aurantii Immaturus 9g, Rhizoma Polygonati 18g, Rhizoma Panax Notoginseng 9g.

[0040] (2) Preparation of granules: After cleaning and chopping the above medicinal materials, soak them in cold water for 60 minutes to allow all the medicinal materials to absorb water, then put them into a casserole and add water to cover all the Chinese medicinal materials by 5 cm. After boiling over high heat, first boil at 90℃ for 30 minutes and pour out all the medicinal liquid; then add water to the original volume, boil at 70℃ for 30 minutes, and then pour out all the medicinal liquid. Mix the two poured medicinal liquids, filter with two layers of gauze, and harvest the filtrate. Concentrate the filtrate into an extract with a relative density of 1.3 (20℃), mix the extract with white sugar and dextrin in a mass ratio of 100:6:27, and then granulate.

[0041] Comparative Example 1 In this comparative example, a Chinese medicine decoction is prepared. The preparation method is as described in Example 1, but the composition of the ministerial drug and the adjuvant drug is adjusted. Specifically, in this comparative example, only Trichosanthes kirilowii is retained as the ministerial drug, while "Xiebai and French Pinellia" are removed; "Scorched Gardenia" is removed as the adjuvant drug, and ordinary hawthorn is used as the adjuvant drug instead of the southern hawthorn in Example 1. A Chinese medicine decoction is also prepared according to the method of Example 1.

[0042] Clinical trials 1. Case source Case source: 180 patients with heart failure with improved ejection fraction who visited the Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine and the Second Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine from January 1, 2022 to December 31, 2023 were collected.

[0043] 2. Diagnostic criteria: (1) Western medicine diagnostic criteria: According to the National Heart Failure Guidelines 2018, the diagnostic criteria for heart failure with improved ejection fraction are: 1) Previous cardiac ultrasound or cardiac MRI examination showed that LVEF was ≤40%, and after treatment, LVEF was greater than 40% and increased by 10% compared with baseline.

[0044] 2) echocardiography showed cardiac structure (such as left atrial enlargement, left ventricular hypertrophy) or impaired left ventricular filling; 3) Having typical symptoms and / or signs of heart failure: The diagnosis can be made if at least two of the following major criteria are met at the same time, or at least one major criterion and two minor criteria are met.

[0045] Main criteria: paroxysmal nocturnal dyspnea or orthopnea; distended jugular veins; pulmonary rales; cardiomegaly; acute pulmonary edema; third heart sound (gallop rhythm); increased venous pressure >1.57 kPa; circulation time >25 seconds; positive hepatojugular reflux sign.

[0046] Minor criteria: ankle edema; nighttime cough; dyspnea after activity; hepatomegaly; pleural effusion; vital capacity reduced to 1 / 3 of maximum vital capacity; tachycardia (more than 120 beats / min); weight loss of more than 4.5 kg within 5 days after treatment; presence of risk factors such as hypertension, diabetes, and dyslipidemia.

[0047] (2) TCM diagnostic criteria: According to the "Guidelines for Clinical Research of New Chinese Medicines (2002)" and "Expert Consensus on Diagnosis and Treatment of Chronic Heart Failure in Traditional Chinese Medicine (2014)", the TCM diagnostic criteria for heart failure with reduced ejection fraction are determined as follows: Main symptoms: chest tightness; chest pain; fatigue; palpitations.

[0048] Secondary symptoms: spontaneous sweating; fear of cold; shortness of breath; purple lips; abdominal distension; difficulty urinating.

[0049] Tongue and pulse: The tongue is dark purple, the tongue is enlarged or has teeth marks, and the pulse is thin, slow and weak.

[0050] Note: The patient must have at least 2 of the main symptoms and at least 1 of the secondary symptoms, and the diagnosis can be made based on the tongue and pulse.

[0051] TCM syndrome scoring table: Each of the above symptoms is divided into four levels: asymptomatic, mild, moderate, and severe. The degree grading method is used to assign 0, 2, 4, and 6 points to the main symptoms and 0, 1, 2, and 3 points to the secondary symptoms. If the tongue and pulse are consistent, each item will be recorded as 1 point.

[0052] 3. Inclusion criteria: (1) Meet the above-mentioned Western medical diagnostic criteria; (2) Meet the above-mentioned TCM diagnostic criteria; (3) New York Heart Association (NYHA) heart function class II-IV; (4) Aged 18-75, regardless of gender; (5) Having complete clinical treatment data; (6) The patient still has discomfort symptoms despite taking standardized Western medicine and the auxiliary examination is positive; (7) Voluntarily participate in this clinical trial, understand and sign the informed consent form.

[0053] 4. Exclusion criteria: (1) Patients with acute coronary syndrome within 30 days before enrollment; (2) Patients who have received or are expected to receive implantable devices (such as ICD, CRT) during the trial period, or undergo revascularization (such as PCI, CABG) within 3 months, or other cardiac / cardiovascular surgery; (3) Patients with severe primary diseases of the liver, kidney, hematopoietic system, tumors, mental illness, or other uncontrolled systemic diseases; (4) The presence of restrictive cardiomyopathy, hypertrophic (obstructive) cardiomyopathy, uncontrollable arrhythmias, active myocarditis, constrictive pericarditis, immune- and inflammatory-mediated myocardial damage, etc.; (5) Patients with heart failure caused by other systemic diseases, such as heart failure caused by endocrine diseases, kidney disease, lung disease, liver disease, etc., heart failure caused by factors such as drugs and poisoning, or heart failure caused by valvular heart disease and congenital heart disease; (6) ALT and AST ≥ 1.5 times the upper limit of normal values, Scr > 1.2 times the upper limit of normal values, and abnormal blood potassium that is difficult to correct; (7) Patients with hypertension that is difficult to control with medication (systolic blood pressure ≥ 180 mmHg and / or diastolic blood pressure ≥ 110 mmHg); (8) Women who are pregnant, preparing to become pregnant or breastfeeding; (9) People with allergic constitution or known allergy to the ingredients of the therapeutic drugs; (10) Participating in clinical research of other drugs within 3 months.

[0054] 5. Elimination, falling off and termination standards: (1) Those who were lost to follow-up or did not come to the hospital for follow-up on time; (2) During treatment, heart failure is not well controlled and additional medication is required: 1) Pleural effusion, ascites, or pericardial effusion occurs; 2) Heart function grade increases by more than 2 levels; 3) Minnesota Heart Failure Quality of Life Questionnaire score increases by 50% compared to the previous score.

[0055] (3) Those who received other drug treatment during the trial; (4) Patients who develop serious complications during the trial: 1) Patients with malignant tumors in any part of the body.

[0056] (5) Serious safety issues occur during the trial; (6) During the trial, serious deviations occur from the research plan.

[0057] 6. Test methods (1) Grouping method: According to the random principle, the patients were divided into a control group (60 cases), an experimental group (60 cases), and a comparison group (60 cases).

[0058] (2) Treatment methods: 1) General treatment: Basic treatment is given, including disease-related education, low-salt and low-fat diet, smoking cessation and alcohol restriction, moderate exercise, avoidance of wind and cold, emotional regulation, and careful daily life.

[0059] 2) Drug treatment: Treatment regimen for the control group: ① Bisoprolol fumarate tablets, manufacturer: Beijing Huasu Pharmaceutical Co., Ltd., specifications: 5 mg × 10 tablets, dosage: maintenance dose is 10 mg, once a day; medication time: around 7:00 in the morning.

[0060] ②Sacubitril / valsartan sodium tablets, manufacturer: Beijing Novartis Pharmaceuticals Co., Ltd., specifications: 100 mg × 14 tablets, dosage: 1 tablet each time, once a day; time of taking medicine: around 7:00 in the morning.

[0061] ③ Spironolactone tablets, manufacturer: Hangzhou Minsheng Pharmaceutical Co., Ltd., specifications: 20 mg × 100 tablets, dosage: 20 mg each time, twice a day; medication time: around 7:00 in the morning and around 19:00 in the evening.

[0062] ④Empagliflozin tablets, manufacturer: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., specifications: 10 mg × 30 tablets, dosage: one tablet each time, once a day, time of taking medicine: around 7:00 in the morning.

[0063] The experimental group was given the Chinese medicine decoction of Example 1 on the basis of the control group. Usage: one dose per day, taken twice, 300 ml each time, taken warm in the morning and evening.

[0064] The control group was given the Chinese medicine decoction of comparative example 1 on the basis of the control group. Usage: one dose per day, taken twice, 300 ml each time, taken warm in the morning and evening.

[0065] Treatment course: One treatment cycle is 4 weeks. Clinical data are collected at the beginning of treatment and on the 28th day of treatment to observe the changes before and after taking the medicine.

[0066] (3) Observation indicators 1) Safety indicators: Blood routine, liver and kidney function, electrolytes, blood lipids, urine and stool routine tests (once before and after treatment).

[0067] 2) Efficacy indicators: ① Echocardiography; ② Serum amino-terminal pro-brain natriuretic peptide (NT-proBNP); ③ TCM syndrome score: ④ NYHA grade; ⑤ Follow-up: 6 months after the end of treatment, the three groups of patients were followed up by telephone to find out whether they were readmitted to the hospital due to acute heart failure within 6 months.

[0068] 3) Criteria for determining efficacy: ① Criteria for judging the efficacy of TCM syndromes: According to the nimodipine efficacy evaluation criteria: efficacy index = [(total score of symptoms before treatment - total score of symptoms after treatment) / total score of symptoms before treatment] × 100% Markedly effective: clinical symptoms and signs are significantly improved, and the therapeutic index is reduced by ≥70%; Effective: clinical symptoms and signs improved, and the therapeutic index decreased by ≥30%; Ineffective: Clinical symptoms and signs did not improve, or even worsened, and the therapeutic index decreased by <30%.

[0069] ② Cardiac function efficacy evaluation criteria (according to NYHA classification standards) Markedly effective: The patient's heart failure symptoms are basically relieved and / or the heart function improves by ≥2 levels; Effective: The patient's cardiac function improved by more than 1 grade but less than 2 grades; Ineffective: The patient's cardiac function improved by less than 1 grade; Aggravation: The patient's heart function deteriorates by ≥1 grade.

[0070] 7. Statistical analysis: SPSS 25.0 statistical software was used for analysis and processing, and the quantitative data were t Test, expressed as mean ± standard deviation, rank sum test for unequal variance, rank sum test for ranked data, and chi-square test for count data. P <0.05 was considered to be significantly different.

[0071] 8. Test results ① Comparison of general information of patients in the control group, experimental group and comparison group is shown in Table 1.

[0072] Table 1: Comparison of general information of patients in the control group and the experimental group .

[0073] A total of 180 patients with heart failure with improved ejection fraction were collected, including 60 cases in the experimental group, 60 cases in the control group, and 60 cases in the comparative group. There was no statistically significant difference in gender, age, and course of heart failure among the control group, experimental group, and comparative group (P>0.05), and they were comparable.

[0074] ② Comparison of the main TCM symptom scores of patients before and after treatment, see Table 2.

[0075] Table 2: Comparison of the main TCM symptom scores of the three groups of patients before and after treatment: control group, experimental group and comparison group ( ±s) .

[0076] Note: a: The main TCM symptom scores after treatment were compared with those in the control group, P < 0.05; b: The main TCM symptom scores after treatment were compared with those in the control group, P < 0.05; c: The main TCM symptom scores of each group were compared before and after treatment, P < 0.05.

[0077] Before treatment (control group, experimental group, comparison group), there was no statistically significant difference in the scores of the main TCM symptoms (chest tightness, chest pain, fatigue, palpitations) of the three groups of patients (the severity of symptoms before treatment was similar in the three groups), and they were comparable (P>0.05). After treatment (control group, experimental group, comparison group), the scores of the main TCM symptoms (chest tightness, chest pain, fatigue, palpitations) of the three groups of patients were all lower than before treatment, and the TCM syndrome scores of the experimental group and the comparison group were significantly lower than those of the control group, and the TCM syndrome scores of the experimental group were significantly lower than those of the comparison group. The degree of reduction in the TCM syndrome scores of the experimental group was significantly greater than that of the comparison group and the control group, and the difference was statistically significant (P<0.05). In summary, the Chinese medicine composition of the present invention can better improve the main TCM clinical symptoms (chest tightness, chest pain, fatigue, palpitations) of patients with heart failure with improved ejection fraction.

[0078] ③ Comparison of the minor TCM symptom scores of patients before and after treatment, see Table 3.

[0079] Table 3: Comparison of minor TCM symptom scores before and after treatment in the control group, experimental group and comparison group ( ±s) .

[0080] Note: a: After treatment, the minor TCM symptom scores were compared with those of the control group, P < 0.05; b: After treatment, the minor TCM symptom scores were compared with those of the control group, P < 0.05; c: The minor TCM symptom scores of each group were compared before and after treatment, P < 0.05.

[0081] Before treatment (control group, experimental group, comparison group), there was no significant difference in the scores of the minor TCM symptoms (spontaneous sweating, fear of cold, shortness of breath, purple lips, fullness of the stomach, and difficulty urinating) among the three groups of patients (the minor TCM symptoms of the three groups of patients were similar), and they were comparable (P>0.05). After treatment (control group, experimental group, comparison group), the scores of the minor TCM symptoms (spontaneous sweating, fear of cold, shortness of breath, purple lips, fullness of the stomach, and difficulty urinating) of the three groups of patients were all lower than before treatment. The minor TCM syndrome scores of the experimental group and the comparison group were significantly lower than those of the control group, and the minor TCM syndrome scores of the experimental group were significantly lower than those of the comparison group. The degree of reduction in the TCM syndrome scores of the experimental group was significantly greater than that of the comparison group and the control group, and the difference was statistically significant (P<0.05). In summary, the Chinese medicine composition of the present invention can better improve the minor TCM clinical symptoms (spontaneous sweating, fear of cold, shortness of breath, purple lips, fullness of the stomach, and difficulty urinating) of patients with heart failure with improved ejection fraction.

[0082] ④ Comparison of TCM syndrome scores and effective rates of the three groups (control group, experimental group and comparison group) before and after treatment, see Tables 4 and 5.

[0083] Table 4: Comparison of TCM syndrome scores among the three groups of patients before and after treatment ( ±S) .

[0084] Note: a: After treatment, the TCM symptom score was compared with that of the control group, P < 0.05; b: After treatment, the TCM symptom score was compared with that of the control group, P < 0.05; c: The TCM symptom score of each group was compared before and after treatment, P < 0.05. The TCM syndrome scores of the three groups of patients before and after treatment were the sum of the main TCM symptom scores (Table 2) and the secondary TCM symptom scores (Table 3) relative to the average of the total number of patients in the group.

[0085] Table 5: Comparison of the efficacy of TCM syndromes in three groups (control group, experimental group and comparison group) before and after treatment Before treatment (control group, experimental group, comparison group), there was no statistically significant difference in the TCM symptom scores of the three groups of patients, which were comparable (P>0.05). After treatment (control group, experimental group, comparison group), the TCM symptom scores of the three groups of patients were all lower than before treatment, and the TCM symptom scores of the experimental group and the comparison group were significantly lower than those of the control group, and the TCM symptom scores of the patients in the experimental group were significantly lower than those of the comparison group, and the degree of reduction of the TCM symptom scores of the patients in the experimental group was significantly higher than that of the comparison group, and the difference was statistically significant (P<0.05). In summary, the Chinese medicine composition of the present invention can better improve the clinical symptoms of patients with heart failure with improved ejection fraction, effectively improve the quality of life of patients, and prevent recurrence of the disease.

[0086] Table 5: Comparison of the efficacy of TCM syndromes in the three groups of patients before and after treatment .

[0087] Note: a: The efficacy of TCM syndrome after treatment was compared with that of the control group, P < 0.05; b: The efficacy of TCM syndrome after treatment was compared with that of the control group, P < 0.05.

[0088] As can be seen from the above table, after 4 weeks of treatment, the total effective rate of TCM syndrome efficacy in the experimental group was 80.00% (48 / 60), which was higher than 73.33% (44 / 60) in the comparison group and even higher than 60.00% (36 / 60) in the control group. The difference was statistically significant (P<0.05).

[0089] ⑤ Comparison of NYHA cardiac function efficacy among three groups (control group, experimental group and comparison group), see Table 6.

[0090] Table 6: Comparison of NYHA cardiac function efficacy among the three groups of patients before and after treatment .

[0091] Note: a: NYHA cardiac function efficacy after treatment compared with the control group, P < 0.05; b: NYHA cardiac function efficacy after treatment compared with the control group, P < 0.05. NYHA cardiac function classification is a standard classification system used to assess the cardiac function and symptom severity of patients with heart disease.

[0092] As can be seen from the above table, after 4 weeks of treatment, the total effective rate of NYHA cardiac function in the experimental group was 90.00% (54 / 60), which was higher than 81.67% (49 / 60) in the comparison group and even higher than 70% (42 / 60) in the control group. The difference was statistically significant (P<0.05).

[0093] ⑥ Comparison of NT-proBNP levels in the three groups (control group, experimental group and comparison group) of patients before and after treatment, see Table 7.

[0094] Table 7: Comparison of NT-proBNP among three groups of patients (`X ±S) .

[0095] Note: a: NT-proBNP after treatment was compared with the control group, P < 0.05; b: NT-proBNP after treatment was compared with the control group, P < 0.05; c: Comparison of NT-proBNP before and after treatment in each group, P < 0.05. NT-proBNP (N-terminal pro-brain natriuretic peptide) is a biomarker. The level of NT-proBNP can reflect the burden of the heart and usually increases when the heart is stressed or damaged.

[0096] Before treatment, there was no significant difference in the NT-proBNP levels among the three groups of patients (control group, experimental group, and comparison group), and they were comparable (P>0.05). After treatment, the NT-proBNP levels in the three groups of patients (control group, experimental group, and comparison group) were all lower than before treatment, and the NT-proBNP levels in the experimental group and the comparison group were significantly lower than those in the control group, and the NT-proBNP levels in the experimental group were significantly lower than those in the comparison group. The degree of reduction in the NT-proBNP levels in the experimental group was significantly greater than that in the comparison group, and the difference was statistically significant (P<0.05). In summary, the Chinese medicine composition of the present invention can effectively reduce the NT-proBNP level in patients with heart failure with improved ejection fraction.

[0097] ⑦ Comparison of left ventricular ejection fraction (LVEF) among the three groups (control group, experimental group and comparison group) is shown in Table 8.

[0098] Table 8: Comparison of LVEF levels among the three groups of patients ( ±S) .

[0099] Note: a: LVEF after treatment was compared with that in the control group, P < 0.05; b: LVEF after treatment was compared with that in the control group, P < 0.05; c: LVEF before and after treatment in each group was compared, P < 0.05.

[0100] Before treatment, there was no significant difference in LVEF levels among the three groups (control group, experimental group, and comparison group), and they were comparable (P>0.05). After treatment, the LVEF levels of the three groups (control group, experimental group, and comparison group) were all higher than before treatment, and the LVEF levels of the experimental group and the comparison group were significantly higher than those of the control group, and the LVEF level of the experimental group was significantly higher than that of the comparison group, and the degree of increase in the LVEF level of the experimental group was also higher than that of the comparison group, and the difference was statistically significant (P<0.05).

[0101] In summary, the Chinese medicine composition of the present invention can effectively improve the cardiac function of patients with heart failure with improved ejection fraction, increase the LVEF level of patients, prevent it from decreasing again, and has a good restorative effect on heart failure with improved ejection fraction.

[0102] ⑧ Comparison of the rate and number of readmissions within 6 months after one treatment cycle among the three groups (control group, experimental group and comparison group), see Tables 9 and 10 for reference.

[0103] Table 9: Comparison of readmission rates within 6 months after treatment among the three groups of patients .

[0104] Note: a: The readmission rate of patients within 6 months after treatment was compared with that of the control group, P < 0.05; b: The readmission rate of patients within 6 months after treatment was compared with that of the control group, P < 0.05.

[0105] As can be seen from the table above, within 6 months after a treatment cycle, the readmission rate of the patients in the experimental group was 3.33% (2 / 60), which was lower than 10.00% (6 / 60) of the comparison group, and much lower than 16.67% (10 / 60) of the control group, and the difference was statistically significant (P<0.05). It can be seen that the Chinese medicine composition of the present invention can indeed effectively stabilize the condition of patients with heart failure with improved ejection fraction, prevent the recurrence of the condition, and has a promoting effect on the recovery of patients with heart failure with improved ejection fraction.

[0106] Table 10: Comparison of the number of readmissions within 6 months after one treatment cycle among the three groups of patients ( ±S) .

[0107] Note: a: The number of readmissions within 6 months after treatment was compared with that in the control group, P < 0.05; b: The number of readmissions within 6 months after treatment was compared with that in the control group, P < 0.05. ±S represents the mean number of readmissions relative to the total number of patients examined in this group (60).

[0108] The number of readmissions within 6 months after treatment (one treatment cycle) in the experimental group and the control group was significantly lower than that in the control group, and the number of readmissions in the experimental group was significantly lower than that in the control group, and the difference was statistically significant (P < 0.05). In summary, the Chinese medicine composition of the present invention can well improve the cardiac function of patients with heart failure with improved ejection fraction, reduce the number of readmissions and the readmission rate of patients, and has reliable efficacy.

[0109] ⑨Safety evaluation: During the four-week treatment period, the biochemical examination indicators, liver function, kidney function, blood routine, urine routine, blood lipids, blood creatinine and other routine examination indicators of the three groups of patients were compared within the group. There was no situation where the normal results before treatment were abnormal after treatment, and the patients did not experience allergic reactions and other adverse reactions.

[0110] Typical treatment cases Case 1: Mr. Du, male, 58 years old, was diagnosed with "chest tightness and shortness of breath for 2 years, aggravated with lower limbs for 1 week". Symptoms: The patient was conscious, weak, chest tightness and shortness of breath, severe shortness of breath when moving, unable to lie flat, panic, palpitations, edema of both lower limbs, sputum of white foam, fear of cold, cold limbs, no nausea and vomiting, no chest pain or abdominal pain, purple lips, poor appetite, tasteless mouth, restless sleep, difficulty falling asleep, loose stools, undigested food, 2-3 times / day, clear and long urine, pale purple tongue, greasy white fur, deep and smooth pulse. Three months ago, cardiac ultrasound showed: left ventricular ejection fraction: 30.4%, reduced left ventricular function; bilateral atrium enlargement; second and third reversals (both small and medium), main reversals (small). The current cardiac ultrasound showed: left ventricular ejection fraction: 41.9%, reduced left ventricular function; second and third reversals (small); bilateral atrium and left ventricular enlargement. Diagnosed as heart failure with improved ejection fraction, the Chinese medicine decoction of Example 1 was used, twice a day, 300 mL each time, taken in the morning and evening, and followed up after 1 month of treatment. The patient's symptoms improved, with occasional chest tightness and shortness of breath, no lower limb edema, and stable condition. Reexamination of cardiac color Doppler ultrasound showed: left ventricular ejection fraction: 69.7%, large biatrial, full left ventricle; two anti-(small amount), three anti-(small to medium amount); ventricular wall motion was acceptable at rest.

[0111] Case 2: Huang, female, 56 years old, was diagnosed with "repeated chest tightness and shortness of breath for more than 3 years, aggravated with edema of both lower limbs for 7 days". Symptoms: The patient was clear-headed, weak in spirit, general fatigue, chest tightness, palpitation and shortness of breath with edema of both lower limbs, symptoms aggravated after activities and weather changes, dizziness, drowsiness, no fever, back aversion to cold, cough and sputum, white sputum, no nausea and vomiting, no chest pain or abdominal pain, good appetite, poor sleep at night, dry stool 2-3 times / day, frequent urination at night, dark tongue, white and greasy tongue coating, moist texture, and smooth pulse. One year ago, the color Doppler ultrasound of the heart showed left ventricular ejection fraction: 27%, reduced left ventricular function; enlarged biatrial valve; a small amount of mitral and tricuspid valve regurgitation. The color Doppler ultrasound of the heart now shows: left ventricular ejection fraction: 42.5%, reduced left ventricular function; a small amount of mitral and tricuspid valve regurgitation; enlarged biatrial valve. The patient was diagnosed with heart failure with improved ejection fraction. The Chinese medicine granules of Example 3 were taken twice a day, one small grid (30g) each time with warm water. After 2 months of treatment, the patient's chest tightness and shortness of breath improved, there was no obvious edema of both lower limbs, and the condition was stable. The reexamination of cardiac ultrasound showed: left ventricular ejection fraction: 69.2%, a small amount of mitral and tricuspid valve regurgitation; bilateral atria were enlarged, and aortic valve degeneration was accompanied by a small amount of regurgitation.

[0112] Case 3: Xu, male, 57 years old, was diagnosed with "repeated chest tightness and shortness of breath for 1 year, and then aggravated for half a month". Symptoms: The patient was clear-headed, with poor spirits, pale complexion, general fatigue, chest tightness, shortness of breath, dizziness, no obvious chest pain and headache, cough and sputum, white sputum and large amount, less during the day, obvious at night, no aversion to cold and fever, no nausea and vomiting, no abdominal distension and pain, poor appetite, constipation, relieved every four to five days, flat urine, poor sleep at night, pale tongue, thick and greasy white fur, and stringy and slippery pulse. Nine months ago, the color Doppler ultrasound of the heart showed left ventricular ejection fraction: 34%, left atrial enlargement, a small amount of mitral valve regurgitation; left ventricular diastolic function decreased. The color Doppler ultrasound of the heart now showed: left ventricular ejection fraction: 45.8%, left atrial enlargement, a small amount of mitral valve regurgitation; left ventricular diastolic function decreased, aortic valve degeneration with a small amount of regurgitation. The patient was diagnosed with heart failure with improved ejection fraction. The Chinese medicine pills of Example 2 were used twice a day, 1 pill each time (15 g / pill). After 1 month of treatment, the patient's chest tightness and shortness of breath were relieved, and there was no dizziness or headache, and the condition was stable. The reexamination of cardiac color Doppler ultrasound showed: left ventricular ejection fraction: 63%, left atrial enlargement, a small amount of mitral and tricuspid valve regurgitation; left ventricular diastolic function decreased, and the aortic valve was mildly calcified with a small amount of regurgitation.

[0113] Case 4: Deng, female, 53 years old, came to the hospital for "chest tightness and shortness of breath after activities for more than 1 year, aggravated for 1 month". Symptoms: The patient is clear-minded, in poor spirits, with chest tightness and palpitations, wheezing and shortness of breath, aggravated after activities, decreased endurance, accompanied by general fatigue, cough and sputum, a small amount of white sticky sputum in the throat, no dizziness and headache, no chest pain and abdominal pain, no aversion to cold and fever, poor appetite, normal sleep, normal bowel movements, pale and fat tongue, greasy tongue coating, and slippery pulse. One year ago, the color Doppler ultrasound of the heart showed left ventricular ejection fraction: 31.8%, enlarged left atrium, changes in the posterior mitral valve, a small amount of mitral regurgitation; decreased left ventricular diastolic function. The color Doppler ultrasound of the heart now shows: left ventricular ejection fraction: 43.5%, enlarged left atrium, a small amount of mitral regurgitation; decreased left ventricular diastolic function, and decreased aortic elasticity. The patient was diagnosed with heart failure with improved ejection fraction. The Chinese medicine pills of Example 2 were used, twice a day, 1 pill each time (15 g / pill). After 2 months of treatment, the patient's chest tightness and shortness of breath improved, and there was no cough or sputum. The patient's appetite was good and his condition was stable. The reexamination of cardiac ultrasound showed: left ventricular ejection fraction: 57%, left atrial enlargement, posterior mitral valve changes, and a small amount of mitral regurgitation; left ventricular diastolic function decreased, and the aorta was mildly calcified with a small amount of regurgitation.

[0114] Case 5: Wang, female, 59 years old, came to the hospital for "chest tightness and shortness of breath for 2 years, aggravated with bilateral lower limb edema for 3 months". Symptoms: The patient is clear-headed and in good spirits, with chest tightness, palpitations and shortness of breath, which worsens after activities, and can lie completely flat, with weakness in the limbs, edema in the bilateral lower limbs, dry mouth and bitter mouth, medium-quality stool, once a day, clear and long urine, poor appetite, poor sleep, and easy awakening. Pale and fat tongue, white and greasy fur, and stringy and slippery pulse. Nine months ago, the color Doppler ultrasound of the heart showed left ventricular ejection fraction: 32.2%, left ventricular dysfunction, reduced aortic elasticity, and enlarged bilateral atria. The color Doppler ultrasound of the heart now shows: left ventricular ejection fraction: 44.8%, left ventricular dysfunction, reduced aortic elasticity; enlarged bilateral atria, and a small amount of mitral valve regurgitation. Diagnosed as heart failure with improved ejection fraction, the Chinese medicine decoction of Example 1 was used, twice a day, 300 mL each time, warm in the morning and evening, and the patient was followed up after 2 months of treatment. The patient's chest tightness and shortness of breath improved, there was no edema of both lower limbs, the appetite was good, the bowel movements were normal, and the condition was stable. Reexamination of the heart color Doppler ultrasound showed: left ventricular ejection fraction: 62.5%, bilateral atrium enlargement, a small amount of mitral valve regurgitation, left ventricular dysfunction, aortic valve calcification and trace regurgitation.

[0115] It can be seen from the above typical cases that the Chinese medicine composition of the present invention has a significant improvement effect on heart failure with improved ejection fraction after treatment, and cardiac color ultrasound shows that the left ventricular ejection fraction is significantly increased after treatment.

[0116] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or replace some or all of the technical features therein with equivalents. However, these modifications or replacements do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A Chinese medicine composition for recovery treatment of heart failure with improved ejection fraction, characterized in that: The invention is prepared from the following Chinese medicinal materials in parts by weight: 3-9 parts of chuanxiong, 3-9 parts of cyperus rotundus, 3-9 parts of atractylodes, 3-9 parts of scorched gardenia, 3-9 parts of shenqu, 3-9 parts of south hawthorn, 3-9 parts of madder, 3-9 parts of trichosanthes, 3-9 parts of allium macrostemon, 3-9 parts of pinellia, 6-12 parts of immature bitter orange, 12-18 parts of polygonatum and 3-9 parts of panax notoginseng.

2. The Chinese medicine composition according to claim 1, characterized in that: The Chinese medicine composition is made of the following Chinese medicinal materials in parts by weight: 7 parts of Chuanxiong, 5 parts of Cyperus rotundus, 8 parts of Atractylodes, 8 parts of Gardenia jasminoides, 8 parts of Shenqu, 6 parts of Crataegus pinnatifida, 3 parts of Rubia cordifolia, 3 parts of Trichosanthes, 9 parts of Xiebai, 9 parts of Pinellia ternata, 11 parts of Citrus aurantium, 12 parts of Polygonatum sibiricum, 3 parts of Panax notoginseng; or, 5 parts of Chuanxiong, 9 parts of Cyperus rotundus, 9 parts of Atractylodes, 9 parts of Gardenia jasminoides, 9 parts of Shenqu, 5 parts of Crataegus pinnatifida, 9 parts of Rubia cordifolia, 5 parts of Trichosanthes, 6 parts of Xiebai, 5 parts of Pinellia ternata, 12 parts of Citrus aurantium, 14 parts of Polygonatum sibiricum, 6 parts of Panax notoginseng; or, 6 parts of Chuanxiong, 6 parts of Cyperus rotundus, 6 parts of Atractylodes, 6 parts of Gardenia jasminoides, 6 parts of Shenqu, 6 parts of Crataegus pinnatifida, 6 parts of Rubia cordifolia, 6 parts of Trichosanthes, 6 parts of Xiebai, 6 parts of Pinellia ternata, 9 parts of Citrus aurantium, 16 parts of Polygonatum sibiricum, 8 parts of Panax notoginseng; or, 9 parts of Chuanxiong, 9 parts of Cyperus rotundus, 3 parts of Atractylodes, 5 parts of Gardenia jasminoides, 5 parts of Shenqu, 7 parts of Crataegus pinnatifida, 8 parts of Rubia cordifolia, 8 parts of Trichosanthes, 9 parts of Xiebai, 8 parts of Pinellia ternata, 9 parts of Citrus aurantium, 18 parts of Polygonatum sibiricum, 9 parts of Panax notoginseng; or, 8 parts of Chuanxiong, 8 parts of Cyperus rotundus, 5 parts of Atractylodes, 5 parts of Gardenia jasminoides, 3 parts of Shenqu, 8 parts of Crataegus pinnatifida, 9 parts of Rubia cordifolia, 9 parts of Trichosanthes, 4 parts of Xiebai, 7 parts of Pinellia ternata, 10 parts of Citrus aurantium, 15 parts of Polygonatum sibiricum, 4 parts of Panax notoginseng; or, 4 parts of Rhizoma Chuanxiong, 7 parts of Rhizoma Cyperi, 6 parts of Rhizoma Atractylodis Macrocephalae, 4 parts of Rhizoma Gardeniae, 3 parts of Radix Angelicae Pubescentis, 9 parts of Crataegus Pinelliae, 9 parts of Rubia cordifolia, 3 parts of Fructus Trichosanthis, 3 parts of Radix Allii Macrostemonis, 9 parts of Rhizoma Pinelliae, 6 parts of Fructus Aurantii Immaturus, 13 parts of Rhizoma Polygonati, and 5 parts of Radix Notoginseng.

3. The Chinese medicine composition according to claim 1 or 2, characterized in that: The Chinese medicine composition is a capsule, Chinese medicine granules, Chinese medicine ointment, Chinese medicine pill or decoction.

4. The Chinese medicine composition according to claim 3, characterized in that: The preparation method of the capsule is as follows: after cleaning and drying the medicinal materials, chopping them into pieces, putting them into a casserole for decoction, filtering, collecting the filtrate, concentrating the filtrate into a paste, drying, sterilizing, grinding into powder, passing through a 100-200 mesh sieve, and then putting them into capsules; The preparation method of the Chinese medicine granules is as follows: after cleaning and drying each medicinal material, chopping it into pieces, putting it into a casserole for decoction, filtering, collecting the filtrate, concentrating the filtrate into an extract, mixing the extract with a flavoring agent and an excipient, and then granulating; The excipient is dextrin or starch; The preparation method of the Chinese medicine pills is as follows: after cleaning and drying the medicinal materials, the medicinal materials are chopped, put into a casserole for decoction, filtered, and the filtrate is harvested, and the filtrate is concentrated to a fluid extract with a relative density of 1.1-1.2, mixed with auxiliary materials, and stirred evenly to form pills; the auxiliary materials are water, honey, wine or vinegar; The preparation method of the Chinese medicine ointment is as follows: after cleaning and drying the medicinal materials, the medicinal materials are pounded into powder, put into a casserole for decoction, filtered, and the filtrate is harvested, and the filtrate is mixed with 10% auxiliary materials and then concentrated into a thick paste with a relative density of 1.5-1.6 to obtain the ointment; the auxiliary materials are donkey-hide gelatin, sucrose or honey; The preparation method of the decoction is as follows: after cleaning, drying and chopping the medicinal materials, soaking the processed raw materials in water for 30-60 minutes, boiling them with high fire, decocting them for the first time at 80-100° C. for 10-15 minutes, pouring out 1 / 3-1 / 2 of the medicinal liquid; adding water to the original volume, decocting them for the second time for 10-15 minutes, the decoction temperature range is 60-80° C., pouring out 1 / 3-1 / 2 of the medicinal liquid, mixing the two medicinal liquids to obtain the decoction.

5. The Chinese medicine composition according to claim 4, characterized in that: In the preparation process of the above-mentioned Chinese medicine compositions, the medicinal materials are first fully absorbed with water and then placed in a casserole, and water is added until all the Chinese medicinal materials are submerged by 3-5 cm. During decoction, the amount of water is maintained to submerge all the Chinese medicinal materials by 3-5 cm.