Medicine for treating heart failure and subclinical hypothyroidism by combining traditional Chinese medicine and western medicine

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and discloses a medicine for treating heart failure and subclinical hypothyroidism through combination of traditional Chinese medicine and western medicine, and the in-hospital agreement prescription comprises 10 g of radix aconiti lateralis preparata, 15 g of bighead atractylodes rhizome, 10 g of honey-fried licorice root, 15 g of earthworm, 6 g of red ginseng, 30 g of astragalus membranaceus, 10 g of cassia twig, 20 g of salvia miltiorrhiza, 12 g of angelica sinensis, 15 g of fructus amomi, 15 g of radix paeoniae rubra, 10 g of almond, 15 g of pericarpium arecae, 30 g of semen plantaginis, 12 g of polyporus umbellatus, 15 g of poria cocos, 15 g of fried semen lepidii, 12 g of rhizoma alismatis and 10 g of jujube. The yang-strengthening and foundation-consolidating decoction is combined with western medicines to treat patients suffering from heart failure and subclinical hypothyroidism, the clinical signs of the patients are obviously improved, the heart function and the thyroid function are obviously improved after the patients are subjected to the traditional Chinese and western medicine combined therapy for a period of time, and compared with the patients only treated by the western medicines, the treatment effect of the traditional Chinese and western medicine combined therapy is better. At present, no adverse reaction is found temporarily, so that the medicine has no obvious toxic and side effects, is high in safety and moderate in price, and is worthy of clinical popularization and application.

Description

Technical Field

[0001] The present invention belongs to but is not limited to the technical field of traditional Chinese medicine, and in particular relates to a drug for treating heart failure combined with subclinical hypothyroidism by combining traditional Chinese and western medicine. Background Art

[0002] Heart failure is a clinical disease with the main symptoms of dyspnea on exertion, decreased exercise tolerance, edema, and congestion in the systemic or pulmonary circulation. Patients with a long course of heart failure are prone to other complications. Heart failure combined with subclinical hypothyroidism is a common clinical comorbidity. Subclinical hypothyroidism is an endocrine system disease. The laboratory test results of this disease only show a mild increase in TSH levels while the serum thyroid hormone (FT3, FT4) levels are normal.

[0003] (1) Studies have shown that cardiomyocytes are highly sensitive to thyroid hormones, which can affect cardiac output and the incidence of atherosclerosis.

[0004] (2) Other studies have shown that hypothyroidism tends to promote the progression of heart failure and that thyroid hormone drugs can affect the prognosis of patients with heart failure.

[0005] Existing drugs for the treatment of heart failure combined with subclinical hypothyroidism have the following key problems:

[0006] 1) Insufficient stability: Existing drugs are easily degraded in the in vivo environment, resulting in unstable efficacy.

[0007] 2) Limited efficacy: Due to the incompleteness of the drug components, the therapeutic effect is often not ideal, especially in terms of replenishing qi and activating blood circulation, promoting diuresis and reducing swelling.

[0008] 3) Serious side effects: Some drugs may cause serious side effects and affect patient compliance.

[0009] 4) Poor targeting: Traditional drugs lack specificity and are difficult to effectively target the symptoms of heart failure combined with subclinical hypothyroidism.

[0010] 5) Adverse reactions: Some drugs may cause more adverse reactions during long-term use. Summary of the invention

[0011] In view of the problems existing in the prior art, the present invention provides a drug for treating heart failure combined with subclinical hypothyroidism by combining traditional Chinese and western medicine.

[0012] The present invention is achieved by a medicine for treating heart failure combined with subclinical hypothyroidism by combining traditional Chinese and western medicine, wherein the in-hospital agreement formula comprises:

[0013] Processed aconite 8-10g, white atractylodes 10-15g, roasted licorice root 8-10g, earthworm 10-15g, red ginseng 3-6g, astragalus 25-30g, cinnamon twig 8-10g, salvia miltiorrhiza 15-20g, angelica 10-12g, amomum villosum 10-15g, red peony root 10-15g, apricot kernel 8-10g, tangerine peel 10-15g, plantain seed 25-30g, umbellate 8-12g, poria 10-15g, stir-fried scutellaria baicalensis seed 10-15g, oriental rhizome 8-12g, jujube 8-10g.

[0014] Furthermore, the parties to the intra-hospital agreement include:

[0015] Processed aconite 10g, white atractylodes 15g, roasted licorice 10g, earthworm 15g, red ginseng 6g, astragalus 30g, cinnamon twig 10g, salvia miltiorrhiza 20g, angelica 12g, amomum 15g, red peony root 15g, apricot 10g, tangerine peel 15g, plantain seed 30g, umbellate 12g, poria 15g, stir-fried scutellaria baicalensis seed 15g, oriental water plantain 12g, and jujube 10g.

[0016] Another object of the present invention is to provide a method for preparing the medicine for treating heart failure combined with subclinical hypothyroidism by combining traditional Chinese and western medicine, comprising the following steps:

[0017] Step 1, clean the processed aconite root, white atractylodes, roasted licorice, earthworm, red ginseng, astragalus, cinnamon twig, salvia miltiorrhiza, angelica, amomum, red peony root, apricot kernel, dried tangerine peel, plantain seed, umbellate, poria, stir-fried scutellaria baicalensis, oriental water plantain and jujube respectively, dry them and chop or grind them into coarse powder;

[0018] Step 2, after mixing the above medicinal material coarse powders evenly according to the formula ratio, add appropriate amount of clean water for soaking, and the soaking time is 30-60 minutes;

[0019] Step 3, decocting the soaked medicinal materials for 2 times, 30 minutes each time, and adding 8-10 times the total weight of the medicinal materials each time;

[0020] Step 4, combining the two decoctions, filtering and removing the residue to obtain a medicinal solution, and concentrating the medicinal solution to an appropriate amount to prepare a medicinal soup or ointment;

[0021] Step 5, preparing the concentrated drug solution into granules or powder dosage form by spray drying or vacuum drying, and then making it into granules, capsules or tablets according to needs for easy administration and storage.

[0022] Another object of the present invention is to provide a method for taking the in-hospital agreed prescription for treating heart failure combined with subclinical hypothyroidism based on the combination of traditional Chinese and western medicine, the method comprising:

[0023] The above 19 ingredients are decocted in water and taken orally. Each dose is 400ml. One dose per day. Take 200ml in the morning and evening. 30 doses constitute a course of treatment.

[0024] In combination with the above technical solutions and the technical problems solved, the advantages and positive effects of the technical solutions to be protected by the present invention are as follows:

[0025] First, in the present invention, the processed aconite is used as the main drug, and its pungent, sweet and hot nature is used to warm the kidney and assist yang, and warm the spleen and soil. Cinnamon twig is used as the minister, and the merits of warming the heart and kidney, warming yang and promoting water circulation are played together. Red ginseng, astragalus, cinnamon twig and aconite are used to invigorate qi and strengthen the spleen, warm the kidney and consolidate the foundation. Lepidium and jujube are used to purge water without injuring the spleen, but it should be noted that patients with weak spleen and stomach should use this medicine group with caution to avoid excessive purgation and injuring the spleen and stomach during use. Atractylodes macrocephala, Polyporus umbellatus, Poria cocos, Rhizoma Alismatis, and Semen Plantaginis are combined to promote urination and eliminate dampness. Cortex dasyphyllae and Apricot kernel strengthen the merits of assisting yang and transforming qi, promoting diuresis and eliminating dampness, and purging the lung and relieving asthma. Salvia miltiorrhiza, red peony root, and Chinese angelica promote blood circulation and nourish blood, remove blood stasis and promote diuresis, Pheretima promotes blood circulation and unblocks meridians, and Fructus Amomi removes dampness and regulates qi and harmonizes the middle. Combined with roasted liquorice as adjuvant, it restricts the harsh nature of aconite, eliminates its toxicity, invigorates the spleen and invigorates qi, relieves cough and relieves asthma, and harmonizes various drugs.

[0026] Experimental data show that the Fuyang Guben Decoction combined with Western medicine is effective in treating patients with heart failure and subclinical hypothyroidism. After a period of combined Chinese and Western medicine treatment, the clinical signs of the patients were significantly improved, and the heart function and thyroid function were significantly improved. Compared with patients treated with Western medicine alone, the treatment effect of combined Chinese and Western medicine treatment is better. No adverse reactions have been found so far, indicating that the drug has no obvious toxic side effects, is highly safe, and is moderately priced, and is worthy of clinical promotion and use.

[0027] Second, the present invention provides a drug for treating heart failure combined with subclinical hypothyroidism by combining traditional Chinese and western medicine, which solves the above technical problems through the following technical solutions:

[0028] 1) Drug composition: processed aconite 10g, white atractylodes 15g, roasted liquorice 10g, earthworm 15g, red ginseng 6g, astragalus 30g, cinnamon twig 10g, salvia miltiorrhiza 20g, angelica 12g, amomum 15g, red peony root 15g, apricot kernel 10g, tangerine peel 15g, plantain seed 30g, umbellate 12g, poria 15g, stir-fried scutellaria baicalensis seed 15g, oriental rhizome 12g, jujube 10g.

[0029] 2) Combination of medicinal materials: Through precise combination of medicinal materials, the effects of Chinese medicine such as warming the yang, replenishing qi, activating blood circulation, and promoting diuresis are integrated to form an effective treatment system.

[0030] 3) Compatibility ratio: Adjust the compatibility ratio of medicinal materials according to different conditions and physical conditions to achieve the best therapeutic effect.

[0031] 4) Comprehensive effect: Utilize the treatment concept of combining traditional Chinese and Western medicine to give full play to the overall conditioning effect of traditional Chinese medicine and combine it with the precise treatment of Western medicine to ensure the efficacy.

[0032] 5) Personalized adjustment: Make personalized adjustments based on the patient’s specific condition and constitution to enhance the targeting and effectiveness of treatment.

[0033] Through the above technical solution, the present invention has achieved significant technical progress:

[0034] 1) Improve stability: By using processed aconite root, white atractylodes and other medicinal materials, the stability of the drug in the body is effectively enhanced to ensure long-lasting efficacy.

[0035] 2) Enhanced efficacy: Through reasonable compatibility and personalized adjustment, the present invention significantly improves the effects of invigorating qi and activating blood circulation, promoting diuresis and reducing swelling, and has a good therapeutic effect on heart failure combined with subclinical hypothyroidism.

[0036] 3) Reduce side effects: Through scientific combination and screening of medicinal materials, the side effects of drugs are reduced and the patient compliance is improved.

[0037] 4) Targeted therapy: The combination of Chinese and Western medicine enhances the targeting of drugs, making the treatment more accurate and effective.

[0038] 5) Reduce adverse reactions: Through personalized adjustments and comprehensive effects, the long-term adverse reactions of drugs are significantly reduced, ensuring the safety and efficacy of patients.

[0039] In summary, the present invention significantly improves the drug level for treating heart failure combined with subclinical hypothyroidism by solving the problems of stability, efficacy, side effects, targeting and adverse reactions in the prior art, and has broader application prospects and higher practical value. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 The present invention provides a flow chart of a method for preparing a drug for treating heart failure combined with subclinical hypothyroidism by combining traditional Chinese and western medicine. DETAILED DESCRIPTION

[0041] In order to make the purpose, technical solution and advantages of the present invention more clearly understood, the present invention is further described in detail below in conjunction with the embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0042] The present invention aims to explore an effective treatment for heart failure combined with subclinical hypothyroidism through the combination of traditional Chinese and western medicine, which has practical social significance.

[0043] Zhenwu Decoction is an important prescription for treating Yang deficiency syndrome (heart and kidney Yang deficiency syndrome, Yang deficiency and water retention syndrome). When the heart Yang and kidney Yang are weak, it is difficult to transport and transform water and dampness, and cold water is retained in the body, which leads to symptoms such as cough and asthma, urination difficulties, palpitations, limb edema, etc. Zhenwu Decoction is used to warm and nourish the heart and kidney, warm Yang and promote water excretion to treat the above symptoms. The author has summarized the experience in many years of clinical work, and combined with classics and relevant literature, with the treatment principles of warming the kidney and consolidating the foundation, supporting yang and promoting diuresis, and developed this Fuyang Guben Decoction by adding and subtracting on the basis of Zhenwu Decoction: processed Aconitum 10g, Atractylodes 15g, Poria 12g, Poria 15g, Plantago seed 30g, Alisma 12g, stir-fried Trichosanthes seed 15g, Amomum villosum 15g, Cibotium bark 15g, Apricot 10g, roasted Licorice root 10g, Pheretima lumbarum 15g, Red ginseng 6g, Astragalus 30g, Cassia twig 10g, Salvia miltiorrhiza 20g, Angelica 12g, Red Peony Root 158g, and Jujube 10g.

[0044] In this prescription, processed aconite is the main drug, and its pungent, sweet and hot nature is used to warm the kidney and assist yang, and warm the spleen and earth. Cinnamon twig is the minister, and together they play the role of warming and nourishing the heart and kidney, warming yang and promoting water circulation. Red ginseng, astragalus, cinnamon twig and aconite are combined to invigorate qi and strengthen the spleen, warm the kidney and consolidate the foundation. Lepi and jujube are used to purge water without hurting the spleen, but when using them, it should be noted that patients with weak spleen and stomach should use this medicine group with caution to avoid excessive purgation and hurting the spleen and stomach. Atractylodes macrocephala, Polyporus umbellatus, Poria cocos, Alisma orientalis, and Plantago seed are combined to promote urination and eliminate dampness. Dictamni peel and apricot kernel strengthen the role of invigorating yang and transforming qi, promoting water and eliminating dampness, and purging the lungs and relieving asthma. Salvia miltiorrhiza, red peony root, and Chinese angelica promote blood circulation and nourish blood, remove blood stasis and promote water circulation, earthworm promotes blood circulation and unblocks meridians, and Amomum villosum removes dampness, regulates qi and harmonizes the middle. Combined with roasted licorice as an adjuvant, it restrains the harsh nature of aconite, eliminates its toxicity, tonifies the spleen and replenishes qi, relieves cough and relieves asthma, and harmonizes various drugs.

[0045] Experimental data show that the Fuyang Guben Decoction combined with Western medicine is effective in treating patients with heart failure and subclinical hypothyroidism. After a period of combined Chinese and Western medicine treatment, the clinical signs of the patients were significantly improved, and the heart function and thyroid function were significantly improved. Compared with patients treated with Western medicine alone, the treatment effect of combined Chinese and Western medicine treatment is better. No adverse reactions have been found so far, indicating that the drug has no obvious toxic side effects, is highly safe, and is moderately priced, and is worthy of clinical promotion and use.

[0046] The following is an analysis of the components of the agreement and their possible pharmacological effects:

[0047] 1) Processed Aconite: It has the effects of warming the yang and dispelling cold, restoring the yang and rescuing adverse conditions. In the treatment of heart failure, Aconite can enhance myocardial contractility and improve cardiac function.

[0048] 2) Atractylodes macrocephala: Strengthens the spleen and replenishes Qi, expels dampness and promotes diuresis. For patients with heart failure and edema, Atractylodes macrocephala helps eliminate excess water in the body and reduce the burden on the heart.

[0049] 3) Roasted Licorice: tonifies the middle qi and harmonizes various medicines. The glycyrrhizic acid and other ingredients in roasted licorice have multiple pharmacological effects such as anti-inflammatory, antioxidant, and anti-arrhythmic.

[0050] 4) Earthworm: Clears away heat and calms wind, dredges meridians and promotes diuresis. Earthworm contains a variety of active ingredients, such as lumbrokinase, which has anticoagulant, thrombolytic, and antihypertensive effects and is beneficial for cardiovascular diseases.

[0051] 5) Red ginseng: It greatly replenishes vital energy, restores the pulse and strengthens the body. The ginsenosides and other ingredients in red ginseng have the effects of enhancing myocardial contractility, dilating coronary arteries, and improving myocardial ischemia.

[0052] 6) Astragalus: replenishes qi and raises yang, promotes diuresis and reduces swelling. Astragalus is a commonly used qi-replenishing medicine, which has a positive effect on improving cardiac function and reducing edema in patients with heart failure.

[0053] 7) Cinnamon twig: warms and dredges the meridians, helps to invigorate yang and transform qi. Cinnamaldehyde and other ingredients in cinnamon twig can dilate blood vessels, increase coronary blood flow, and help improve blood supply to the heart.

[0054] 8) Salvia miltiorrhiza, Chinese Angelica sinensis, and Paeonia lactiflora: These three herbs are all blood-activating and blood-stasis-removing drugs, which can improve microcirculation, alleviate myocardial ischemia and hypoxia, and are beneficial to patients with heart failure.

[0055] 9) Amomum villosum: It can eliminate dampness, stimulate appetite, warm the spleen and stop diarrhea. The volatile oil and other ingredients in Amomum villosum can promote gastrointestinal motility and improve digestive function, which is helpful for the absorption of nutrients by patients with heart failure.

[0056] 10) Almond, dried tangerine peel, plantain seed, Poria cocos, Poria cocos, stir-fried scutellaria baicalensis seed, and Alisma orientalis: These medicines all have the effect of promoting diuresis and reducing swelling, which can help patients with heart failure to excrete excess water in the body and reduce the burden on the heart.

[0057] 11) Jujube: replenishes qi, nourishes blood and calms the mind. The various nutrients in jujube help to strengthen the patient's physique and improve disease resistance.

[0058] Comprehensive analysis shows that this prescription treats the pathophysiological characteristics of heart failure combined with subclinical hypothyroidism through multiple pathways such as warming yang and replenishing qi, promoting blood circulation and removing blood stasis, and promoting diuresis and reducing swelling. Among them, the cardiotonic effects of drugs such as aconite, red ginseng, and astragalus, the blood circulation and blood stasis effects of drugs such as earthworm and salvia miltiorrhiza, and the combined use of multiple diuretic and detumescent drugs together constitute the therapeutic characteristics of this prescription.

[0059] However, it should be noted that the pharmacological effects of traditional Chinese medicine are complex and diverse, and there may be interactions between different drugs. Therefore, in practical applications, personalized adjustments should be made according to the patient's specific condition and physical characteristics to ensure the therapeutic effect and safety. At the same time, the combination of Chinese and Western medicine should give full play to the respective advantages of Chinese and Western medicine to form a complementary effect to achieve the best therapeutic effect.

[0060] The embodiment of the present invention provides a drug for treating heart failure combined with subclinical hypothyroidism by combining traditional Chinese and western medicine. The in-hospital agreement includes:

[0061] Processed aconite 10g, white atractylodes 15g, roasted licorice 10g, earthworm 15g, red ginseng 6g, astragalus 30g, cinnamon twig 10g, salvia miltiorrhiza 20g, angelica 12g, amomum 15g, red peony root 15g, apricot 10g, tangerine peel 15g, plantain seed 30g, umbellate 12g, poria 15g, stir-fried scutellaria baicalensis seed 15g, oriental water plantain 12g, and jujube 10g.

[0062] Interval formula: processed aconite 8-10g, white atractylodes 10-15g, roasted licorice 8-10g, earthworm 10-15g, red ginseng 3-6g, astragalus 25-30g, cinnamon twig 8-10g, salvia miltiorrhiza 15-20g, angelica 10-12g, amomum villosum 10-15g, red peony root 10-15g, apricot kernel 8-10g, tangerine peel 10-15g, plantain seed 25-30g, umbellate 8-12g, poria 10-15g, stir-fried scutellaria baicalensis seed 10-15g, oriental water plantain 8-12g, and jujube 8-10g.

[0063] like Figure 1 As shown, the embodiment of the present invention provides a method for preparing a drug for treating heart failure combined with subclinical hypothyroidism by combining traditional Chinese and western medicine, comprising the following steps:

[0064] S101, clean the processed aconite root, white atractylodes, roasted liquorice root, earthworm, red ginseng, astragalus, cinnamon twig, salvia miltiorrhiza, angelica, amomum, red peony root, apricot kernel, dried tangerine peel, plantain seed, umbellate, poria, stir-fried scutellaria baicalensis, oriental water plantain and jujube respectively, and chop or grind into coarse powder after drying;

[0065] S102, after the above-mentioned medicinal material coarse powder is evenly mixed according to the formula ratio, an appropriate amount of clean water is added for soaking, and the soaking time is 30-60 minutes;

[0066] S103, decocting the soaked medicinal materials for 2 times, each time for 30 minutes, and adding water each time for 8-10 times the total weight of the medicinal materials;

[0067] S104, combining the two decoctions, filtering and removing the residue to obtain a medicinal solution, and concentrating the medicinal solution to an appropriate amount to prepare a medicinal soup or ointment;

[0068] S105, preparing the concentrated drug solution into granules or powder dosage form by spray drying or vacuum drying, and then preparing into granules, capsules or tablets according to demand for easy administration and storage.

[0069] The embodiment of the present invention provides a method for taking the in-hospital agreed prescription for treating heart failure combined with subclinical hypothyroidism based on the combination of traditional Chinese and western medicine, the method comprising:

[0070] The above 19 ingredients are decocted in water and taken orally. Each dose is 400ml. One dose per day. Take 200ml in the morning and evening. 30 doses constitute a course of treatment.

[0071] 1. In order to prove the creativity and technical value of the technical solution of the present invention, this section is an application example of the application of the claimed technical solution on a specific product or related technology.

[0072] Example 1

[0073] Drug composition: 10g of processed aconite, 15g of white atractylodes, 10g of roasted licorice, 15g of earthworm, 6g of red ginseng, 30g of astragalus, 10g of cinnamon twig, 20g of salvia miltiorrhiza, 12g of angelica, 15g of amomum, 15g of red peony root, 10g of apricot kernel, 15g of dried tangerine peel, 30g of plantain seed, 12g of umbellate, 15g of poria, 15g of stir-fried scutellaria seed, 12g of oriental rhizome, 10g of jujube. This prescription achieves the effects of replenishing qi, activating blood circulation, promoting diuresis, and warming yang by combining the characteristics of various medicinal materials.

[0074] Example 2

[0075] Drug composition: 8g of processed aconite, 20g of white atractylodes, 8g of roasted licorice, 18g of earthworm, 5g of red ginseng, 25g of astragalus, 12g of cinnamon twig, 22g of salvia miltiorrhiza, 14g of angelica, 12g of amomum, 18g of red peony root, 8g of apricot kernel, 18g of dried tangerine peel, 28g of plantain seed, 14g of umbellate, 12g of poria, 18g of stir-fried scutellaria seed, 14g of oriental rhizome, 12g of jujube. This prescription further enhances the effects of replenishing qi and activating blood circulation, and at the same time increases the effects of clearing heat and removing dampness by adjusting the dosage of each medicinal material.

[0076] Example 3

[0077] Drug composition: 12g of processed aconite, 12g of white atractylodes, 12g of roasted licorice, 12g of earthworm, 8g of red ginseng, 28g of astragalus, 8g of cinnamon twig, 18g of salvia miltiorrhiza, 10g of angelica, 10g of amomum, 12g of red peony root, 12g of apricot kernel, 12g of dried tangerine peel, 32g of plantain seed, 10g of umbellate, 18g of poria, stir-fried scutellaria seed, 10g of oriental water rhizome, 8g of jujube. While enhancing qi-tonifying and yang-warming effects, this prescription further emphasizes the effects of diuresis and swelling reduction, and is suitable for patients with qi-deficiency edema.

[0078] Example 4

[0079] Drug composition: 15g of processed aconite, 18g of white atractylodes, 15g of roasted licorice, 10g of earthworm, 10g of red ginseng, 35g of astragalus, 15g of cinnamon twig, 25g of salvia miltiorrhiza, 15g of angelica, 20g of amomum, 20g of red peony root, 15g of apricot, 20g of dried tangerine peel, 35g of plantain seed, 15g of umbellate, 20g of poria, 20g of fried scutellaria seed, 15g of oriental rhizome, 15g of jujube. This prescription greatly enhances the effect of warming yang and replenishing qi by increasing the dosage of aconite, astragalus and cinnamon twig, and is suitable for patients with severe yang deficiency.

[0080] Example 5

[0081] Drug composition: 7g of processed aconite, 10g of white atractylodes, 7g of roasted licorice, 9g of earthworm, 4g of red ginseng, 20g of astragalus, 9g of cinnamon twig, 15g of salvia miltiorrhiza, 8g of angelica, 9g of amomum, 10g of red peony root, 7g of apricot kernel, 10g of dried tangerine peel, 25g of plantain seed, 9g of umbellate, 10g of poria, 10g of stir-fried scutellaria seed, 9g of oriental rhizome, 7g of jujube. This prescription mainly strengthens the effect of diuresis and detumescence on the basis of adjusting the dosage, and is suitable for patients with more obvious edema.

[0082] Example 6

[0083] Drug composition: processed aconite 9g, white atractylodes 13g, roasted licorice 9g, earthworm 14g, red ginseng 7g, astragalus 27g, cinnamon twig 13g, salvia miltiorrhiza 23g, angelica 13g, amomum 13g, red peony root 13g, apricot kernel 9g, tangerine peel 13g, plantain seed 29g, umbellate 11g, poria 13g, stir-fried scutellaria baicalensis 13g, oriental rhizome 11g, jujube 9g. This prescription increases the dosage of astragalus, salvia miltiorrhiza and angelica on the premise of ensuring the basic compatibility, further enhancing the effect of replenishing qi and activating blood circulation.

[0084] 2. Relevant evidence of the technical effects obtained by the embodiments of the present invention.

[0085] A total of 42 patients with heart failure (NYHA heart function grade II-IV) and subclinical hypothyroidism who were hospitalized in the Department of Cardiology of Minxian Traditional Chinese Medicine Hospital from January 2022 to March 2024 were randomly divided into a study group and a control group. The control group (n=21) received conventional Western medicine treatment, and the study group (n=21) received integrated Chinese and Western medicine treatment (i.e., taking the author's self-prescribed Fuyang Guben Decoction on the basis of Western medicine treatment in the control group). The clinical efficacy of the two groups before and after treatment was compared, and the changes in heart failure Lee's score, LVEF score, and TSH level were recorded and analyzed and compared.

[0086] 1. The 42 patients participating in the study were all patients with heart failure and subclinical hypothyroidism who were admitted to Minxian Hospital of Traditional Chinese Medicine from January 2022 to March 2024. They were randomly divided into two groups: control group (n=21, 9 / 12 males / females, age range 43-76 years, average age 65±6.3 years); study group (n=21, 8 / 13 males / females, age range 48-77 years, average age 67±7.4 years).

[0087] 2. Diagnostic criteria

[0088] Diagnostic criteria for heart failure

[0089] Western medicine diagnosis: ① The patient experiences symptoms such as dyspnea (worsened when tired or at night), decreased exercise tolerance, and lower limb edema; ② Cardiac ultrasound confirms that the patient has organic heart changes; ③ Left ventricular ejection fraction ≤49%.

[0090] TCM diagnosis: It meets the category of TCM heart failure, and the patients are diagnosed with yang deficiency (heart and kidney yang deficiency syndrome, yang deficiency and water flooding syndrome): occasional palpitations, wheezing and inability to lie down, oliguria and limb swelling, fatigue, chills and cold limbs, abdominal distension, loose stools, cyanotic lips, pale and fat tongue with teeth marks, or petechiae and ecchymosis, deep and thin pulse or knotted, intermittent and rapid pulse.

[0091] 3. Diagnostic criteria for subclinical hypothyroidism

[0092] After literature review, there is no relevant record about subclinical hypothyroidism in traditional Chinese medicine. In this study, the diagnosis of patients with subclinical hypothyroidism was based on the Western medical diagnostic criteria: ① patients felt that their physical strength decreased, they were afraid of cold and liked warmth, and their reactions were slow; ② laboratory examinations showed that the patients' FT3 and FT4 levels were normal, and their TSH levels were elevated.

[0093] 4. Inclusion and Exclusion Criteria

[0094] 1) Inclusion criteria: The age meets the above-mentioned Chinese and Western medicine diagnostic criteria, NYHA heart function grade II-IV, serum thyroid stimulating hormone level slightly higher than the upper limit of the normal range, and serum thyroid hormone (FT3, FT4) levels are within the normal range, the patient has no or only mild clinical hypothyroidism symptoms, and is aware of the trial and signs the informed consent.

[0095] 2) Exclusion criteria: patients with other serious diseases; patients with heart failure due to renal failure, pericarditis, severe valvular stenosis, systemic lupus erythematosus or other causes, malignant tumors of the respiratory system, mental illness, poor compliance and inability to cooperate; incomplete information.

[0096] Inclusion criteria: ① The patient's laboratory tests and imaging examinations met the diagnostic criteria for heart failure[10-11] and subclinical hypothyroidism[12-13]; ② The patient had not received other treatments recently.

[0097] Exclusion criteria: ① Patients with major cardiovascular disease in the past six months; ② Patients with communication disorders; ③ Patients with allergies to related drugs in this study; ④ Patients who have taken drugs that can affect thyroid function in the past 3 months.

[0098] 5. Treatment Methods

[0099] The conventional western medicine group mainly gave diuretics (aldosterone receptor antagonists, thiazides or loop diuretics), beta-blockers (metoprolol succinate sustained-release tablets or bisoprolol tablets), ACEI or ARB, sodium-glucose co-transporter 2 (SGLT-2) inhibitors (dapagliflozin). In addition to the above conventional western medicine regimen, the Chinese medicine combined with western medicine group gave patients our hospital's in-hospital agreement prescription Fuyang Guben Decoction orally, and insisted on taking it orally for 14 to 28 days. When patients were admitted to the hospital, the Chinese medicine symptom score was evaluated, NT-proBNP, cardiac ultrasound, and thyroid function were checked, and the EF value was recorded. The above indicators were rechecked after seven days of treatment to observe the dynamic evolution. Follow-up was conducted one week and one month after discharge; follow-up was conducted for half a year and one year, and the re-admission situation was counted.

[0100] The study group received the same drug treatment as the control group, and in addition, took a dose of Fuyang Guben Decoction every day. Prescription: 10g of processed aconite, 15g of white atractylodes, 10g of roasted licorice, 15g of earthworm, 6g of red ginseng, 30g of astragalus, 10g of cinnamon twig, 20g of salvia miltiorrhiza, 12g of angelica, 15g of amomum, 15g of red peony root, 10g of apricot kernel, 15g of big belly peel, 30g of plantain seed, 12g of umbellate, 15g of poria, 15g of stir-fried scutellaria, 12g of oriental rhizome, 10g of jujube. The above 19 ingredients were decocted in water, 400ml per dose, one dose per day, and 200ml was taken in the morning and evening. 30 doses constituted a course of treatment. In order to ensure the concentration and efficacy of the decoction, the decoctions used in this treatment were all uniformly decocted by the pharmacy of Minxian Hospital of Traditional Chinese Medicine.

[0101] 6. Observation indicators

[0102] According to the 2002 edition of the "Guidelines for Clinical Research of New Chinese Medicines", the TCM symptom score of this study was formulated, and the TCM symptom scores of the two groups of patients before and after treatment were compared to determine the clinical efficacy. If the TCM symptom score after treatment is 0 or decreases by more than 70% compared with before treatment, it is judged as markedly effective; if the TCM symptom score after treatment is 30% to 70% less than before, it is judged as effective; if the TCM symptom score after treatment is less than 30% or higher than before treatment, it is judged as ineffective.

[0103] Lee's score for heart failure

[0104] Each patient's cardiac function was scored according to the Lee's score table for the efficacy of heart failure treatment. The Lee's score of each patient before and after treatment was recorded and statistically analyzed.

[0105] Left ventricular ejection fraction

[0106] The LVEF score is obtained through cardiac ultrasound examination and is an important indicator for diagnosing heart failure in patients and determining the extent of heart failure. The EF values ​​of patients before and after treatment are recorded to understand the extent of heart failure in patients and perform statistical analysis.

[0107] Serum thyroid stimulating hormone index

[0108] 5 ml of cubital venous blood was drawn from the patient before and after treatment to measure the patient's TSH level before and after treatment to evaluate the improvement of the patient's subclinical hypothyroidism symptoms.

[0109] 7. Statistical methods

[0110] SPSS 26.0 software was used for statistical analysis. The mean ± standard deviation (x ± s) was used to represent quantitative data, (%) was used to represent counting data, and t, χ 2 The data were compared by test, and the difference was statistically significant if P < 0.05.

[0111] 8. Results

[0112] Comparison of clinical efficacy

[0113] The effective rates of the two groups after treatment were calculated as follows: total effective rate = (effective number of patients + markedly effective number of patients) * 100% / total number of cases. After treatment, the total effective rate of the control group was 76.19%, and the total effective rate of the research group was 92.86%. The treatment of the research group was more effective than that of the control group (P<0.05). See Table 1.

[0114] Table 1 Comparison of clinical efficacy between the two groups of patients [n (%)]

[0115]

[0116] Comparison of Lee's score in heart failure

[0117] Lee's score after treatment: the control group was 13.11±2.75, and the study group was 10.95±2.86, which was lower than the control group. See Table 2.

[0118] Table 2 Comparison of Lee's scores between the two groups before and after treatment (x±s)

[0119]

[0120] Comparison of LVEF scores

[0121] The LVEF scores of the patients before and after treatment were recorded and analyzed. After treatment, the LVEF score of the control group was 52.49±8.46(%), and the LVEF score of the study group was 56.84±9.24(%), see Table 3.

[0122] Table 3 Comparison of LVEF scores (%)

[0123]

[0124] Comparison of thyroid function

[0125] Venous blood was drawn from patients to measure TSH levels of the two groups of patients before and after treatment. The TSH value of the control group after treatment was 6.23±1.28, and the TSH value of the study group was 5.64±1.37, see Table 4.

[0126] Table 4 Comparison of TSH indicators (μIU / mL)

[0127]

[0128] Adverse Reactions

[0129] No adverse complications occurred in the 42 patients during treatment.

[0130] After treatment, the effective rate of the control group was 76.19%, which was significantly lower than 92.86% of the study group (P<0.05); the Lee's scores of heart failure in both groups decreased, the Lee's score of the control group was 13.11±2.75, and the Lee's score of the study group was 10.95±2.86, which was significantly lower than that of the control group (P<0.05); the left ventricular ejection fraction of both groups increased to varying degrees, the LVEF score of the control group was 52.49±8.46(%), and the LVEF score of the study group was 56.84±9.24(%), which was significantly better than that of the control group (P<0.05); the TSH value of the control group after treatment was 6.23±1.28, which was significantly higher than 5.64±1.37 of the study group (P<0.05).

[0131] The cases are as follows:

[0132] Patient 1

[0133] TCM symptom scoring, NT-proBNp, EF value (ejection fraction), three thyroid function tests, and Lee's heart failure score were performed upon admission and on the 7th and 14th days of treatment. Patients were followed up for 1 month and TCM symptom scores and cardiac function assessment were performed again.

[0134]

[0135] Patient 2

[0136] TCM symptom scoring, NT-proBNp, EF value (ejection fraction), three thyroid function tests, and Lee's heart failure score were performed upon admission and on the 7th and 14th days of treatment. Patients were followed up for 1 month and TCM symptom scores and cardiac function assessment were performed again.

[0137]

[0138] Patient 3

[0139] TCM symptom scoring, NT-proBNp, EF value (ejection fraction), three thyroid function tests, and Lee's heart failure score were performed upon admission and on the 7th and 14th days of treatment. Patients were followed up for 1 month and TCM symptom scores and cardiac function assessment were performed again.

[0140]

[0141] Patient 4

[0142] TCM symptom scoring, NT-proBNp, EF value (ejection fraction), three thyroid function tests, and Lee's heart failure score were performed upon admission and on the 7th and 14th days of treatment. Patients were followed up for 1 month and TCM symptom scores and cardiac function assessment were performed again.

[0143]

[0144] Patient 5

[0145] TCM symptom scoring, NT-proBNp, EF value (ejection fraction), three thyroid function tests, and Lee's heart failure score were performed upon admission and on the 7th and 14th days of treatment. Patients were followed up for 1 month and TCM symptom scores and cardiac function assessment were performed again.

[0146]

[0147] Patient 6

[0148] TCM symptom scoring, NT-proBNp, EF value (ejection fraction), three thyroid function tests, and Lee's heart failure score were performed upon admission and on the 7th and 14th days of treatment. Patients were followed up for 1 month and TCM symptom scores and cardiac function assessment were performed again.

[0149]

[0150] Patient 7

[0151] TCM symptom scoring, NT-proBNp, EF value (ejection fraction), three thyroid function tests, and Lee's heart failure score were performed upon admission and on the 7th and 14th days of treatment. Patients were followed up for 1 month and TCM symptom scores and cardiac function assessment were performed again.

[0152]

[0153]

[0154] In addition, the prescription can also be made into granules by different methods to increase the utilization rate of precious medicinal materials such as red ginseng and salvia miltiorrhiza, improve the taste, and facilitate carrying and medication. The details are as follows:

[0155] 1. Decoction method: Cut the above Chinese medicine into slices or powder, then put it into a suitable container, add water to cover the medicinal materials, soak for a period of time and then decoct with fire, then centrifuge or filter the separated medicinal liquid, and finally obtain the remaining ointment, divide it into appropriate amounts and package it, and take it with warm water when using.

[0156] 2. Immersion method: First crush the herbs, cut them into slices, and then put them in a bottle with a lid, then add a certain solvent and seal it. After three to five days, the medicinal effect will generally be fully leached out, and then filter and precipitate the ointment; the method of taking is the same as above.

[0157] 3. Drying method: Drying method is to extract the ingredients from traditional Chinese medicine into powder form before making them into granules, and then use membrane concentration technology, reverse osmosis technology, spray drying and other drying technologies to remove moisture from the extracted traditional Chinese medicine. The method of taking is the same as above.

[0158] You can also add maltose or honey to the prescription without causing conflict or incompatibility with the other medicines in the prescription, and make the prescription into honey pills, which can be divided into appropriate doses for easy storage, improve the taste of the prescription, and at the same time improve the stability of the medicine, further improving the patient's compliance with the medication.

[0159] In addition, regular follow-up is conducted during the patient's medication process, and the patient is asked to go to the hospital for regular follow-up visits, so that the medication can be added or subtracted at any time according to the patient's response and the effect of the medication, so as to achieve better therapeutic effects and improve the targetedness and effectiveness of the treatment.

[0160] The above description is only a specific implementation mode of the present invention, but the protection scope of the present invention is not limited thereto. Any modifications, equivalent substitutions and improvements made by any technician familiar with the technical field within the technical scope disclosed by the present invention and within the spirit and principle of the present invention should be covered by the protection scope of the present invention.

Claims

1. A drug for treating heart failure combined with subclinical hypothyroidism by combining traditional Chinese and western medicine, characterized in that: According to the quality score, it includes: Processed aconite 8-10g, white atractylodes 10-15g, roasted licorice root 8-10g, earthworm 10-15g, red ginseng 3-6g, astragalus 25-30g, cinnamon twig 8-10g, salvia miltiorrhiza 15-20g, angelica 10-12g, amomum villosum 10-15g, red peony root 10-15g, apricot kernel 8-10g, tangerine peel 10-15g, plantain seed 25-30g, umbellate 8-12g, poria 10-15g, stir-fried scutellaria baicalensis seed 10-15g, oriental rhizome 8-12g, jujube 8-10g.

2. The drug for treating heart failure combined with subclinical hypothyroidism by combining traditional Chinese and western medicine as claimed in claim 1, characterized in that: The parties to the intra-hospital agreement include: Processed aconite 10g, white atractylodes 15g, roasted licorice 10g, earthworm 15g, red ginseng 6g, astragalus 30g, cinnamon twig 10g, salvia miltiorrhiza 20g, angelica 12g, amomum 15g, red peony root 15g, apricot 10g, tangerine peel 15g, plantain seed 30g, umbellate 12g, poria 15g, stir-fried scutellaria baicalensis seed 15g, oriental water plantain 12g, and jujube 10g.

3. A method for preparing the drug for treating heart failure combined with subclinical hypothyroidism by combining traditional Chinese and western medicine as claimed in claim 2, characterized in that: The method comprises the following steps: Step 1, clean the processed aconite root, white atractylodes, roasted licorice, earthworm, red ginseng, astragalus, cinnamon twig, salvia miltiorrhiza, angelica, amomum, red peony root, apricot kernel, dried tangerine peel, plantain seed, umbellate, poria, stir-fried scutellaria baicalensis, oriental water plantain and jujube respectively, dry them and chop or grind them into coarse powder; Step 2, after mixing the above medicinal material coarse powders evenly according to the formula ratio, add appropriate amount of clean water for soaking, and the soaking time is 30-60 minutes; Step 3, decocting the soaked medicinal materials for 2 times, 30 minutes each time, and adding 8-10 times the total weight of the medicinal materials each time; Step 4, combining the two decoctions, filtering and removing the residue to obtain a medicinal solution, and concentrating the medicinal solution to an appropriate amount to prepare a medicinal soup or ointment; Step 5, preparing the concentrated drug solution into granules or powder dosage form by spray drying or vacuum drying, and then making it into granules, capsules or tablets according to needs for easy administration and storage.

4. A method of taking the in-hospital agreed prescription for treating heart failure combined with subclinical hypothyroidism by combining traditional Chinese and western medicine as claimed in claim 3, characterized in that: The method includes: The above 19 ingredients are decocted in water and taken orally. Each dose is 400ml. One dose per day. Take 200ml in the morning and evening. 30 doses constitute a course of treatment.

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