Traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy and application

Abstract

The invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy and application. The traditional Chinese medicine composition comprises the following components: cassia twigs, honey-fried licorice roots, rhizoma polygonati, almonds, amomum kravanh, coix seeds, astragalus membranaceus, mangnolia officinalis, ginger processed pinellia, fermented soybeans, poria cocos and salvia miltiorrhiza. The traditional Chinese medicine composition follows the compatibility principle of monarch, minister, assistant and guide, the traditional Chinese medicine raw materials are scientifically compounded, the medicines are mutually assisted and compatible, and dialectical treatment is carried out from the perspective of yang deficiency and dampness obstruction, so that the prepared traditional Chinese medicine composition can obviously improve the clinical symptoms such as palpitation, chest distress, weakness and shortness of breath and the heart rate variability index of patients with diabetic cardiac autonomic neuropathy, and the curative effect is good. Moreover, the traditional Chinese medicine has small toxic and side effects after being taken for a long time, and is safe and reliable to take.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy and its application. Background Art

[0002] Diabetic cardiac autonomic neuropathy (DCAN) belongs to a type of autonomic neuropathy among diabetic microvascular complications. It refers to the damage of autonomic nerve fibers that innervate the heart and blood vessels, involving the imbalance of sympathetic and parasympathetic nerves, resulting in abnormal heart rate and hemodynamics. Clinically, it is characterized by resting tachycardia, intolerance to exercise, orthostatic hypotension, heart dysfunction and cardiomyopathy.

[0003] Currently, existing studies believe that the pathological factors of diabetic cardiac autonomic neuropathy include dryness, heat, dampness, phlegm, stasis, etc. Although excessive heat is commonly seen in diabetes mellitus in clinical practice, at the same time, patients often have improper diet, overeating fatty and sweet foods, resulting in the formation of damp-heat diabetes mellitus. Over time, heat scorches body fluids, essence dries up and blood becomes dry, which can lead to blood stasis and heat in the collaterals, forming stasis-heat. There are also reports summarizing the progress of traditional Chinese medicine in diabetic cardiac autonomic neuropathy, and it is found that the exploration history of traditional Chinese medicine for DCAN is long, and there are many discussions on its etiology and pathogenesis. Although the focuses of each school are different, it is generally believed that it is related to the deficiency of qi, blood, yin and yang of the heart. In terms of treatment, it mostly starts from supplementing qi and warming yang, nourishing yin and dredging meridians, promoting blood circulation to remove stasis, calming the heart and relieving palpitation, and regulating nutrient qi and defensive qi. Traditional Chinese medicine compounds or patent medicines such as Yishen Huayu Decoction, Wenxin Granules, and Shensong Yangxin Capsules have shown certain curative effects in the treatment of DCAN. In addition, there are also relevant studies on the effect of Shenxiong Injection on heart rate variability in patients with diabetic cardiac autonomic neuropathy and the regulatory effect of Guizhi Decoction on cardiac autonomic nerve remodeling.

[0004] However, there is currently no research report on the effect of Guiren Yangxin Decoction on patients with diabetic cardiac autonomic neuropathy. Therefore, filling this research gap and developing a similar product for the treatment of patients with yang deficiency and damp obstruction syndrome is of great significance. Summary of the Invention

[0005] The purpose of the present invention is to overcome the deficiencies of the prior art and provide a traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy and its application. The traditional Chinese medicine composition aims at warming yang and dispelling cold, strengthening the spleen and promoting diuresis, and promoting blood circulation to remove stasis, aiming to fundamentally improve the symptoms of diabetic autonomic neuropathy.

[0006] To achieve the above purpose, the technical solutions adopted by the present invention include:

[0007] In a first aspect, the present invention provides a traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy. The traditional Chinese medicine composition comprises the following components: cassia twig, roasted licorice root, polygonatum sibiricum, almond, cardamom, coix seed, astragalus membranaceus, magnolia officinalis, pinellia ternata processed with ginger, semen sojae praeparatum, poria cocos, and salvia miltiorrhiza.

[0008] In the formula, cassia twig is pungent, sweet and warm. It can not only warm and invigorate the heart yang, being the key medicine for warming the heart and dredging yang, but also warm and dredge the blood vessels to promote blood circulation, thus serving as the monarch drug. Roasted licorice root is used as the minister drug. On the one hand, it tonifies the heart qi and combines with the pungency and sweetness of cassia twig to transform yang, with warming and tonifying working simultaneously, which is the basic structure for warming and tonifying the heart yang. On the other hand, it strengthens the spleen qi, nourishes the middle energizer, enabling the qi and blood to be generated with a source. Semen sojae praeparatum and cardamom are used as adjuvant drugs to aromatically promote and ventilate the lung defense, disperse the exterior dampness, preventing yang from being stagnated internally. Polygonatum sibiricum is recorded in "Supplementary Records of Famous Physicians" as follows: "Sweet and flat in taste, non-toxic, mainly for tonifying the middle qi, dispelling wind-dampness and calming the five internal organs". Astragalus membranaceus replenishes qi and raises yang, promoting qi circulation and relieving pain due to stagnation; magnolia officinalis and pinellia ternata processed with ginger dry dampness and promote the transportation of the spleen, enabling the spleen to transport water and dampness without being trapped by damp pathogens. Almond disperses the lung qi upward, enabling the lung qi to disperse and descend, so that the body fluids can be regulated. Poria cocos and coix seed seep and promote diuresis downward, enabling the water channels to be unobstructed, so that dampness has a way out; poria cocos can also strengthen the spleen, promote appetite and calm the mind. Salvia miltiorrhiza is used as the guiding drug, leading the other drugs to enter the heart, and can also activate blood circulation to remove stasis, dredge the meridians and relieve pain.

[0009] The present invention follows the compatibility principle of "monarch, minister, adjuvant and guiding". Through the scientific compounding of the above traditional Chinese medicine raw materials, the various drugs assist and match with each other. Dialectically treating from the perspective of yang deficiency and dampness obstruction, they jointly achieve the effects of warming and dredging the heart meridian and seeping and promoting diuresis of dampness. The prepared traditional Chinese medicine composition can significantly improve the clinical symptoms such as palpitation, chest tightness, fatigue, shortness of breath and the heart rate variability index in patients with diabetic cardiac autonomic neuropathy. The curative effect on treating diabetic autonomic neuropathy is definite, and long-term administration has small toxic and side effects, with safe and reliable medication.

[0010] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 9 - 15 parts of cassia twig, 6 - 15 parts of roasted licorice root, 15 - 30 parts of polygonatum sibiricum, 9 - 12 parts of almond, 6 - 9 parts of cardamom, 12 - 30 parts of coix seed, 12 - 30 parts of astragalus membranaceus, 6 - 9 parts of magnolia officinalis, 6 - 9 parts of pinellia ternata processed with ginger, 3 - 6 parts of semen sojae praeparatum, 12 - 15 parts of poria cocos, and 9 - 15 parts of salvia miltiorrhiza.

[0011] Preferably, the traditional Chinese medicine composition comprises the following components in parts by weight: 15 parts of cassia twig, 12 parts of roasted licorice root, 15 parts of polygonatum sibiricum, 9 parts of almond, 9 parts of cardamom, 15 parts of coix seed, 15 parts of astragalus membranaceus, 9 parts of magnolia officinalis, 6 parts of pinellia ternata processed with ginger, 5 parts of semen sojae praeparatum, 12 parts of poria cocos, and 9 parts of salvia miltiorrhiza.

[0012] Through clinical trials, it is found that when the dosages of the components in the traditional Chinese medicine composition of the present invention are within the above preferred ranges, the various drugs complement each other, with excellent compatibility. While avoiding burdening the patient's spleen and stomach, the main drug and the auxiliary drugs play a synergistic role, significantly improving the overall treatment effect in patients with diabetic cardiac autonomic neuropathy.

[0013] Preferably, the traditional Chinese medicine composition is prepared by decoction. The specific method is as follows: take the above components, add water for decoction. The amount of added water is 3 - 5 times the total weight of the components. Decoct for 1 - 1.5 hours, filter to obtain the decoction, and thus the traditional Chinese medicine composition is prepared.

[0014] Preferably, the dosage form of the traditional Chinese medicine composition includes one of aqueous solution, ointment, pill, tablet, and granule.

[0015] In the second aspect, the present invention provides the application of the described traditional Chinese medicine composition in the preparation of a drug for treating diabetic cardiac autonomic neuropathy.

[0016] In the third aspect, the present invention provides a traditional Chinese medicine preparation for treating diabetic cardiac autonomic neuropathy. The traditional Chinese medicine preparation includes the described traditional Chinese medicine composition and pharmaceutically acceptable excipients.

[0017] In order to achieve a better therapeutic effect, syndrome differentiation and treatment can be carried out according to the patient's constitution and different etiologies. If the heart yang deficiency is severe, based on the above formula, the dosage of cinnamon twig can be increased to 18 - 20 parts, and 6 - 12 parts of prepared aconite root can be added. If the edema is obvious, based on the above formula, the dosages of poria cocos and coix seed are increased, and 9 - 15 parts of polyporus umbellatus are added. If the chest tightness and chest pain are severe, based on the above formula, the dosage of salvia miltiorrhiza is increased to 18 - 20 parts, and 6 - 12 parts of ligusticum wallichii are added. If there is much cough and phlegm, based on the above formula, 9 - 12 parts of perilla seed and 9 - 15 parts of radish seed are added. If there is loss of appetite and severe abdominal distension, based on the above formula, 9 - 15 parts of each of stir-fried medicated leaven, stir-fried malt, and stir-fried hawthorn can be added. If there are insomnia and many dreams, based on the above formula, 15 - 30 parts of wild jujube seed and 9 - 15 parts of semen platycladi are added.

[0018] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0019] The present invention follows the compatibility principle of "sovereign, ministerial, adjuvant, and courier", and through scientific compounding of the above traditional Chinese medicine raw materials, various herbs assist and match with each other, and dialectically treat from the perspective of yang deficiency and damp obstruction, jointly achieving the effects of warming and dredging the heart meridian and promoting diuresis and removing dampness. The prepared traditional Chinese medicine composition can significantly improve the clinical symptoms such as palpitation, chest tightness, fatigue, and shortness of breath and the heart rate variability index in patients with diabetic cardiac autonomic neuropathy. The curative effect on treating diabetic autonomic neuropathy is definite, and long-term administration has small toxic and side effects, and the medication is safe and reliable. Description of the Drawings

[0020] Figure 1 The ambulatory electrocardiogram of the patient before and after treatment with the traditional Chinese medicine composition described in Example 1 is given. Detailed Embodiments

[0021] To better illustrate the purpose, technical solution and advantages of the present invention, the present invention will be further described below in conjunction with specific embodiments. Those skilled in the art should understand that the specific embodiments described herein are only used to explain the present invention and are not used to limit the present invention.

[0022] Example 1

[0023] This example provides a traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy. The traditional Chinese medicine composition includes the following components in parts by weight: 15 parts of Cinnamon Twig, 12 parts of Prepared Licorice Root, 15 parts of Polygonatum Sibiricum, 9 parts of Apricot Kernel, 9 parts of Nutmeg, 15 parts of Coix Seed, 15 parts of Astragalus Root, 9 parts of Magnolia Bark, 6 parts of Pinellia Tuber Prepared with Ginger, 5 parts of Sojae Semen Praeparatum, 12 parts of Poria Cocos, and 9 parts of Salvia Miltiorrhiza.

[0024] The traditional Chinese medicine composition is prepared by the decoction method. The specific method is: add water to the medicinal materials for decoction. The amount of added water is 4 times the total weight of the medicinal materials. Decoct for 1 hour, filter to obtain the decoction, and thus the traditional Chinese medicine composition is prepared. Take 1 dose per day, divided into morning and evening doses. One course of treatment is 30 days.

[0025] Example 2

[0026] This example provides a traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy. The traditional Chinese medicine composition includes the following components in parts by weight: 9 parts of Cinnamon Twig, 6 parts of Prepared Licorice Root, 15 parts of Polygonatum Sibiricum, 9 parts of Apricot Kernel, 6 parts of Nutmeg, 12 parts of Coix Seed, 12 parts of Astragalus Root, 6 parts of Magnolia Bark, 6 parts of Pinellia Tuber Prepared with Ginger, 3 parts of Sojae Semen Praeparatum, 12 parts of Poria Cocos, and 9 parts of Salvia Miltiorrhiza.

[0027] The decoction method and administration method of the traditional Chinese medicine composition are the same as those in Example 1.

[0028] Example 3

[0029] This example provides a traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy. The traditional Chinese medicine composition includes the following components in parts by weight: 15 parts of Cinnamon Twig, 15 parts of Prepared Licorice Root, 30 parts of Polygonatum Sibiricum, 12 parts of Apricot Kernel, 9 parts of Nutmeg, 30 parts of Coix Seed, 30 parts of Astragalus Root, 9 parts of Magnolia Bark, 9 parts of Pinellia Tuber Prepared with Ginger, 6 parts of Sojae Semen Praeparatum, 15 parts of Poria Cocos, and 15 parts of Salvia Miltiorrhiza.

[0030] The decoction method and administration method of the traditional Chinese medicine composition are the same as those in Example 1.

[0031] Comparative Example 1

[0032] This comparative example provides a traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy. The difference from Example 1 is that: the traditional Chinese medicine composition does not contain Cinnamon Twig and Apricot Kernel, and the remaining components and dosages are the same as those in Example 1.

[0033] Comparative Example 2

[0034] This comparative example provides a traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy, which is different from Example 1 in that: the traditional Chinese medicine composition does not contain roasted licorice and coix seed, and the remaining components and dosages are the same as those in Example 1.

[0035] Comparative Example 3

[0036] This comparative example provides a traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy, which is different from Example 1 in that: the traditional Chinese medicine composition uses equal amounts of atractylodes macrocephala and tangerine peel to replace astragalus membranaceus and amomum kravanh respectively, and the remaining components and dosages are the same as those in Example 1.

[0037] Effect Example

[0038] This effect example illustrates the therapeutic effect of the traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy described in the present invention through clinical trials.

[0039] 1. Clinical Data

[0040] (1) Western medicine diagnostic criteria: The western medicine diagnostic criteria for clinical research cases refer to the diagnostic criteria of "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)", as shown in Table 1 specifically;

[0041] Table 1

[0042] Diagnostic criteria Venous plasma glucose or HbA1C Typical diabetic symptoms (polydipsia, polyuria, polyphagia, unexplained weight loss Plus random blood glucose ≥11.1 mmol / L Or plus fasting blood glucose ≥7.0 mmol / L Or plus 2-hour plasma glucose during OGTT ≥11.1 mmol / L Or plus HbA1C ≥6.5％ For those without typical diabetic symptoms, reexamination is required on the same day for confirmation Diagnostic criteria Venous plasma glucose or HbA1C

[0043] Note: Random blood glucose refers to the blood glucose at any time of the day without considering the last meal time, and cannot be used to diagnose impaired fasting glucose or impaired glucose tolerance; fasting state refers to at least 8 hours without calorie intake.

[0044] The western medicine diagnostic criteria for cardiac autonomic neuropathy adopt the standard cardiovascular reflex test (CARTs) recommended by the International Consensus Group on Diabetic Neuropathy in Toronto, that is, the Ewing test as the diagnostic method. Since the grip strength test has poor specificity and it is known from the literature that many tests no longer include it as a diagnostic standard, this test will not be performed this time. The results are judged according to the reference value standard of the cardiovascular reflex test results:

[0045] ① Heart rate difference during deep breathing (E / I ratio): The subject lies in the supine position and takes deep breaths at a frequency of about 6 times per minute. The changes in the shortest and longest R-R intervals during a single maximal deep inspiration and deep expiration are recorded using lead II electrocardiogram, and the difference is calculated by converting them into heart rates. (Normal: ≥15 beats / min, Critical: 11 - 14 beats / min, Abnormal: ≤10 beats / min).

[0046] ②Heart rate change from lying to standing position (30 / 15 ratio): The subject quickly stands up from a quiet supine position within 5 seconds, and at the same time, 30 consecutive waveforms on lead II of the electrocardiogram are recorded. Calculate the ratio of the R-R interval of the 30th heartbeat to the 15th heartbeat after standing. (Normal: ≥1.04, Critical: 1.00 - 1.04, Abnormal: ≤1.00).

[0047] ③Valsalva maneuver index (Valsalva ratio): The subject takes a deep breath, covers the nose and closes the mouth, and forcefully exhales for 15 seconds, then relaxes and exhales naturally for 10 seconds while recording the electrocardiogram. Measure the ratio of the longest R-R interval after the Valsalva maneuver to the shortest R-R interval after the Valsalva maneuver. (Normal ≥1.21, Critical: 1.10 - 1.21, Abnormal: ≤1.10).

[0048] ④Blood pressure difference from lying to standing position: First, measure the blood pressure of the patient in the supine position, then instruct the patient to quickly change from the supine position to the standing position, and measure the blood pressure again within 3 minutes. Calculate the systolic blood pressure difference between the standing and supine positions. (Normal ≤10 mmHg, Critical value: 11 - 29 mmHg, Abnormal: ≥30 mmHg).

[0049] (2) Traditional Chinese medicine diagnostic criteria: Currently, there is no traditional Chinese medicine diagnosis and treatment guideline related to diabetes mellitus combined with constipation. This research project refers to the "Guiding Principles for Clinical Research of New Chinese Medicines" issued in 2002 and the textbook "Internal Medicine of Traditional Chinese Medicine" for national higher traditional Chinese medicine colleges and universities in 2017 to formulate the criteria.

[0050] ①Traditional Chinese medicine diagnosis of diabetes mellitus with palpitation: Simultaneously meet the diagnoses of "diabetes mellitus" and "palpitation".

[0051] Diabetes mellitus: Excessive thirst with polydipsia, polyphagia with easy hunger, frequent urination with large urine volume, emaciation; accompanied by syndromes such as dizziness, chest impediment, pulmonary consumption, stroke, night blindness, and sores and carbuncles after a long illness; Clinically, improving fasting blood glucose, random blood glucose, OGTT, glycosylated hemoglobin, urine routine, etc. is helpful for diagnosis.

[0052] Palpitation: Conscious of palpitations and uneasiness in the heart, abnormal heart beats, either rapid or slow, paroxysmal or continuous, mental tension, flustered and uneasy, accompanied by chest discomfort, irritability, restlessness, poor sleep, tremors, weakness, dizziness and other symptoms. Clinically, improving electrocardiogram examination, 24-hour ambulatory electrocardiogram, echocardiogram, etc. is more helpful for diagnosis.

[0053] ②Phlegm-dampness type diabetes mellitus with palpitation

[0054] Main symptoms: Chest and epigastric distension and fullness, fullness after eating, heaviness of the head and body, palpitation, chest tightness, shortness of breath.

[0055] Subsidiary symptoms: Obesity, restlessness in the heart and chest, heaviness of the limbs, dizziness and vertigo, poor appetite with nausea and vomiting, palpitations and dyspnea. Scanty urine, loose stools.

[0056] Tongue manifestation: The tongue body is red, with yellow or white greasy coating.

[0057] Pulse condition: The pulse is soft and slow, or soft and slippery, or thready and weak.

[0058] The diagnosis can be made by referring to the main symptoms, tongue manifestation and pulse condition.

[0059] 2. Inclusion criteria:

[0060] ① Those who meet the above diagnostic criteria can be used as test cases; ② Aged between 18 and 80 years old; ③ Informed consent is obtained and the informed consent form is signed.

[0061] 3. Exclusion criteria:

[0062] ① Aged < 18 years old or ≥ 80 years old; ② Pregnant women; ③ Diabetic proliferative retinopathy that has not been stabilized under treatment; including increased intraocular pressure caused by various reasons such as glaucoma (intraocular pressure of either eye > 21 mmHg); ④ Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg before the test); ⑤ Presence of acute coronary syndrome, heart failure NYHA class III or IV, aortic dissection, acute cerebral infarction, cerebral hemorrhage, severe acute kidney injury (eGFR < 15 ml / min / 1.73 m2), decompensated liver failure, acute exacerbation of chronic obstructive pulmonary disease, diabetic ketoacidosis, hyperglycemic hyperosmolar syndrome, shock and other critical conditions that clinicians judge need urgent treatment. ⑥ Any other cases that the researcher deems unsuitable for this test or unable to cooperate with the examination.

[0063] 4. Withdrawal and dropout criteria:

[0064] ① The patient shows discomfort symptoms including but not limited to amaurosis, syncope, unsteady walking, etc.; ② Abnormal signs such as significant increase in blood pressure (systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg); ③ The subject is unwilling to continue the test; ④ Adverse events or serious adverse events occur, resulting in the inability to continue the test; ⑤ Unable to continue the test due to other reasons.

[0065] 120 clinical cases that meet the diagnostic criteria for diabetic autonomic neuropathy were randomly divided into treatment groups 1 - 3 (administered the traditional Chinese medicine compositions described in Examples 1 - 3) and control groups 1 - 3 (administered the traditional Chinese medicine compositions described in Comparative Examples 1 - 3), with 20 cases in each group. Each group was given basic diet, exercise and blood glucose control, and the treatment period was 2 months.

[0066] 5. Observation indicators and clinical efficacy evaluation criteria

[0067] (1) Traditional Chinese medicine syndrome indicators: Through the subjective descriptions of patients and the evaluations of doctors, observe the changes in the main symptoms (palpitation, excessive sweating, chest tightness, shortness of breath) and secondary symptoms (fatigue, dizziness, dyspnea and stuffiness, abdominal distension) before and after treatment in each group. The main symptoms are scored 2, 4, and 6 points respectively for mild, moderate, and severe, and the secondary symptoms are scored 1, 2, and 3 points respectively for mild, moderate, and severe. The tongue and pulse are scored 0 and 1 point respectively according to absence and presence.

[0068] Criteria for judging the curative effect of traditional Chinese medicine syndromes: Drawn up with reference to the "Guiding Principles for Clinical Research of New Chinese Medicines (Trial)", markedly effective: Clinical symptoms and signs are significantly improved, and the syndrome integral is reduced by ≥70%. Effective: Clinical symptoms and signs are all improved, and 30% ≤ the reduction of the syndrome integral < 70%. Ineffective: Clinical symptoms and signs are not significantly improved, or even worsened, and the reduction of the syndrome integral < 30%; Syndrome integral = (integral before treatment - integral after treatment) / integral before treatment × 100%.

[0069] (2) Heart rate variability measurement: Use 24-hour ambulatory electrocardiogram to conduct tests on patients before and after treatment, and the HRV results are analyzed by the staff of the electrocardiogram room of our hospital. HRV includes time domain indexes and frequency domain indexes. The time domain indexes are SDNN, RMSSD, and PNN50, and the frequency domain indexes are ULF, LF, HF, and LF / HF.

[0070] 6. Treatment results

[0071] (1) Comparison of curative effects of traditional Chinese medicine syndromes

[0072] Table 2 Comparison of curative effects of traditional Chinese medicine syndrome integrals

[0073] Group Number of cases Marked effect Effective Ineffective Total effective rate Treatment group 1 20 6(30％) 13(65％) 1(5％) 95％ Treatment group 2 20 3(15％) 15(75％) 2(10％) 90％ Treatment group 3 20 4(20％) 14(70％) 2(10％) 90％ Control group 1 20 0(0％) 11(55％) 9(45％) 55％ Control group 2 20 0(0％) 14(70％) 6(30％) 70％ Control group 3 20 0(0％) 15(75％) 5(25％) 75％

[0074] As shown in Table 2, when using the traditional Chinese medicine composition described in the present invention to treat diabetic cardiac autonomic neuropathy, the total effective rate of the traditional Chinese medicine syndrome integral can reach more than 90%. Among them, the treatment effect of the traditional Chinese medicine composition prepared in Example 1 is the best, and the total effective rate of the traditional Chinese medicine syndrome integral reaches 95%. In Comparative Examples 1-2, due to the absence of specific components in the formula, the total effective rate of the traditional Chinese medicine syndrome integral is significantly lower compared with the treatment group. When Atractylodes macrocephala and Tangerine peel with the same properties as Astragalus membranaceus and Amomum kravanh are used for replacement in Comparative Example 3, the total effective rate of the traditional Chinese medicine syndrome integral also decreases, indicating that the various herbs in the traditional Chinese medicine composition described in the present invention assist and match with each other, and can synergistically and significantly improve the clinical symptoms such as palpitation, chest tightness, fatigue, and shortness of breath in patients with diabetic cardiac autonomic neuropathy, and its curative effect is not a simple superposition of known active components.

[0075] (2) Comparison of time domain indexes of heart rate variability

[0076] Table 3 Comparison of time domain indexes of heart rate variability (x±s)

[0077]

[0078]

[0079] (3) Comparison of frequency domain indexes of heart rate variability

[0080] Table 4 Comparison of frequency domain indexes of heart rate variability (x±s)

[0081]

[0082] In this study, time domain indexes (SDNN, rMSDD, PNN50) and frequency domain indexes (LF, HF, LF / HF) of HRV were observed. Among them, SDNN can reflect the overall regulation ability of the autonomic nervous system, rMSSD reflects vagal nerve tone, LF is affected by both sympathetic and vagal nerves, but mainly reflects sympathetic nerve tone, HF reflects the function of the vagus nerve, LF / HF reflects the balance state of sympathetic and parasympathetic nerve functions, and the normal range of LF / HF is 1.5 - 2.0.

[0083] As shown in Table 3, SDNN, rMSSD, and PNN50 after treatment with the traditional Chinese medicine composition described in the present invention (i.e., treatment groups 1 - 3) were significantly higher than those before treatment. In particular, the traditional Chinese medicine composition prepared in Example 1 (treatment group 1) had the best effect. Although SDNN and rMSSD after treatment with the traditional Chinese medicine compositions described in Comparative Examples 1 - 3 (i.e., control groups 1 - 3) were also higher than those before treatment, SDNN, rMSSD, and PNN50 in the treatment group were significantly higher than those in the control group after treatment, that is, the curative effect on diabetic cardiac autonomic neuropathy was better. As shown in Table 4, LF and HF after treatment with the traditional Chinese medicine compositions in treatment groups 1 - 3 and control groups 1 - 3 were significantly increased compared with those before treatment in the same group. LF / HF in treatment groups 1 - 3 was significantly decreased after treatment compared with that before treatment, and LF and HF in the treatment group after treatment were significantly higher than those in the control group, and LF / HF was significantly lower than that in the control group. The above results can fully prove that the traditional Chinese medicine composition described in the present invention can repair the function of the cardiac autonomic nervous system and further regulate the imbalance state of the autonomic nervous system.

[0084] 4. Related cases

[0085] (1) Case 1: Wang, male, 45 years old, a newly diagnosed diabetic patient, with palpitations and fatigue, no obvious chest tightness or chest pain, drowsiness, and the symptoms aggravated after activities. After hospitalization and treatment in our hospital, the blood sugar was well controlled, but there were still discomforts such as palpitations and drowsy fatigue. On March 21, 2024, a Holter electrocardiogram was examined: sinus tachycardia, decreased heart rate variability (SDNN: 79.59). After treatment with the traditional Chinese medicine composition described in Example 1 of the present invention, the above symptoms were relieved. On August 2, 2024, a Holter electrocardiogram was reexamined: sinus rhythm, very occasional supraventricular premature beats (SDNN: 140.35), and the CART test was negative. Figure 1It is the ambulatory electrocardiogram before and after the treatment of the patient.

[0086] (2) Case 2: Chen, male, 48 years old. Diabetes was found during the hospitalization examination for hypertension. The ambulatory electrocardiogram showed a decrease in heart rate variability (SDNN: 76.05). After two courses of treatment with the traditional Chinese medicine composition described in Example 1 of the present invention, the content of glycosylated hemoglobin in the patient's venous blood was effectively relieved, decreasing from the high value of 7.5 mmol / L before treatment to the normal level of 6.0 mmol / L, and the CART test was negative.

[0087] 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 the protection scope of the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that the technical solutions of the present invention can be modified or equivalently replaced without departing from the essence and scope of the technical solutions of the present invention.

Claims

1. A traditional Chinese medicine composition for treating diabetic cardiac autonomic neuropathy, characterized in that, The traditional Chinese medicine composition comprises the following components: Ramulus Cinnamomi, Radix Glycyrrhizae Preparata, Polygonatum sibiricum, Semen Armeniacae Amarum, Fructus Amomi Rotundus, Semen Coicis, Radix Astragali, Cortex Magnoliae Officinalis, Rhizoma Pinelliae Praeparatum, Semen Sojae Praeparatum, Poria cocos, and Radix Salviae Miltiorrhizae.

2. The traditional Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition comprises the following components in parts by weight: 9-15 parts of Ramulus Cinnamomi, 6-15 parts of Radix Glycyrrhizae Preparata, 15-30 parts of Polygonatum sibiricum, 9-12 parts of Semen Armeniacae Amarum, 6-9 parts of Fructus Amomi Rotundus, 12-30 parts of Semen Coicis, 12-30 parts of Radix Astragali, 6-9 parts of Cortex Magnoliae Officinalis, 6-9 parts of Rhizoma Pinelliae Praeparatum, 3-6 parts of Semen Sojae Praeparatum, 12-15 parts of Poria cocos, and 9-15 parts of Radix Salviae Miltiorrhizae.

3. The traditional Chinese medicine composition according to claim 2, characterized in that, The traditional Chinese medicine composition comprises the following components in parts by weight: 15 parts of Ramulus Cinnamomi, 12 parts of Radix Glycyrrhizae Preparata, 15 parts of Polygonatum sibiricum, 9 parts of Semen Armeniacae Amarum, 9 parts of Fructus Amomi Rotundus, 15 parts of Semen Coicis, 15 parts of Radix Astragali, 9 parts of Cortex Magnoliae Officinalis, 6 parts of Rhizoma Pinelliae Praeparatum, 5 parts of Semen Sojae Praeparatum, 12 parts of Poria cocos, and 9 parts of Radix Salviae Miltiorrhizae.

4. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that, The traditional Chinese medicine composition is prepared by a decocting method. The specific method is as follows: taking the above components, adding water for decocting, the amount of added water being 3-5 times the total weight of the components, decocting for 1-1.5 h, filtering to obtain the decoction, and thus preparing the traditional Chinese medicine composition.

5. The traditional Chinese medicine composition according to any one of claims 1-3, characterized in that The dosage form of the traditional Chinese medicine composition includes one of aqueous solution, ointment, pill, tablet, and granule.

6. Use of the traditional Chinese medicine composition according to any one of claims 1-5 in the preparation of a drug for treating diabetic cardiac autonomic neuropathy.

7. A traditional Chinese medicine preparation for treating diabetic cardiac autonomic neuropathy, characterized in that, The traditional Chinese medicine preparation comprises the traditional Chinese medicine composition according to any one of claims 1-3 and pharmaceutically acceptable excipients.

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