WO2022021636A1

WO2022021636A1 - Traditional chinese medicine composition for invigorating spleen and activating collaterals, and use thereof

Info

Publication number: WO2022021636A1
Application number: PCT/CN2020/124302
Authority: WO
Inventors: 陈超; 吴邦泰; 许旭昀; 陈秋铭; 王叙煌; 陈子睿; 吴典伟; 谢希; 林玺; 林俊和
Original assignee: 汕头市中医医院
Priority date: 2020-07-29
Filing date: 2020-10-28
Publication date: 2022-02-03
Also published as: CN111643586A

Abstract

Disclosed are a traditional Chinese medicine composition for invigorating the spleen and activating collaterals, and the use thereof. The composition is composed of the following ingredients in parts by weight: 15-25 parts of Puerariae lobatae radix, 12-18 parts of Salviae miltiorrhizae radix et rhizoma, 25-35 parts of Atractylodis macrocephalae rhizoma, 25-35 parts of Codonopsis radix, 8-12 parts of Phellodendri chinensis cortex, 8-12 parts of Acori tatarinowii rhizoma, 12-18 parts of Pheretima, 8-12 parts of Chuanxiong rhizoma, 25-35 parts of Astragali radix and 8-12 parts of Panax notoginseng. The traditional Chinese medicine composition has the effects of invigorating the spleen, tonifying qi, and promoting blood circulation for removing obstructions in collaterals, and is significantly effective in treating diabetes and diabetic peripheral neuropathy, diabetic vasculopathy, diabetic fundus lesion, diabetes complicated with coronary heart disease, diabetes complicated with cerebral infarction, etc. caused by spleen deficiency and blood stasis.

Description

A kind of traditional Chinese medicine composition for strengthening spleen and activating collaterals and application thereof

technical field

The invention relates to the field of traditional Chinese medicine formulations, in particular to a traditional Chinese medicine composition for strengthening the spleen and activating collaterals.

Background technique

Diabetes is a common and frequently-occurring disease in clinical practice. In 2010, Prof. Ning Guang's team surveyed the prevalence of diabetes and prediabetes among people over 18 years old in China, reaching 11.6% and 50.1%, respectively. The prevalence of diabetes in my country is increasing year by year, especially in recent years, the prevalence rate has risen sharply, the development trend is not optimistic, and the incidence has changed. Epidemiological data show that more than 80% of diabetics are obese in my country.

Diabetes, modern Chinese medicine mostly belongs to the category of "diabetes" in Chinese medicine. The related discussion of diabetes mellitus was first seen in the "Nei Jing", including "xiaoheng", "three eliminations", "diaphragm elimination", "xiaozhong" and other disease names. The explanation in "Shuowen Jiezi": "to disappear, to exhaust" means "to lose weight, dissipate, and consume". "Thirsty and desire" means "dry mouth and desire to drink". Literally, this disease name is a generalization of patients with similar symptoms. Ancient physicians formed various theories when discussing the pathogenesis of diabetes mellitus. Physicians of past dynasties have enriched and developed the pathogenesis of the disease, including the theory of yin deficiency and dryness, the theory of three eliminations, the theory of liver stagnation and qi stagnation, and the theory of blood stasis. Dispelling and other pathogenesis understanding.

At present, it is generally believed that the basic pathogenesis of the lung, stomach and kidney with multiple responsibilities of the diseased viscera is "Yin deficiency is the foundation, dryness and heat are the standard", and the treatment focuses on "nourishing yin and clearing heat".

However, today's clinical findings are different from those in ancient times in terms of etiology, pathogenesis and pathogenesis, clinical manifestations, and even treatment methods. In the long-term clinical practice, the applicant found that modern diabetics drink water again and again but do not quench their thirst. The water they drink cannot be transformed into body fluid and urinate frequently; Nourishing the limbs and the body is thin; modern diabetes patients are mostly obese, obese people have more phlegm, phlegm-dampness is full, dampness damages the spleen, the typical "Yin deficiency and dry-heat diabetes" patients are rare, and nourishing yin helps dampness. Spleen, clearing heat will damage spleen-yang and phlegm-dampness will be worse. Therefore, no matter "yin deficiency" or "dry heat", they are only the "marks" of diabetes, and only the symptoms of diabetes are seen, while the root of the disease is ignored.

The pathogenesis of modern diabetes has evolved from "dry heat due to yin deficiency" to "weak spleen and stomach, lack of clear yang, dampness and turbidity, and stagnation of fire." The qi, blood, and body fluids of qi, blood and body fluids are blocked, and "diabetes" is caused by not following the normal path. It should be treated by "invigorating the spleen and stomach, raising the yang, removing dampness and turbidity, and reducing yin fire".

Severe peripheral blood vessels, peripheral neuropathy, and fundus lesions are often seen in the middle and late stages of modern diabetic patients, manifesting as spleen deficiency and collateral stasis. Diabetic peripheral neuropathy is the most common chronic complication of diabetes and the main cause of disability. Modern medicine believes that it is mainly due to the disturbance of nerve microvascular energy supply, resulting in insufficient supply of neurotrophic nutrients, resulting in the death of neuronal cells Ken Schwann cells, resulting in neuronal death. damaged. Diabetic retinopathy (DR) is a common fundus complication caused by diabetes. It is the most serious microvascular disease of diabetes, which can seriously affect the optic nerve function of patients and cause peripheral nerve dysfunction. It is the main cause of blindness in patients, and the treatment is more difficult. The pathogenesis of modern medicine is mainly due to abnormal glucose metabolism. Long-term hyperglycemia causes protein glycosylation, causing damage to retinal fine arteries, increased vascular permeability, and thickening of vascular basement membranes, resulting in DR. Minimally invasive retinal surgery has a certain curative effect, mainly using retinal laser photocoagulation, hemostasis, dilation of blood vessels, improvement of microcirculation, etc., but it is invasive, has many complications, and the improvement effect on optic nerve function is not ideal, so drugs Treatment is still the main clinical treatment, especially for those with stage I, II, and III retinopathy. Strict control of blood sugar is the basis for preventing and delaying nerve and vascular disease, but ideal blood sugar control cannot completely prevent the occurrence of nerve and vascular disease. Therefore, controlling blood sugar alone cannot completely achieve the purpose of preventing nerve and vascular disease. Traditional Chinese medicine has unique advantages in preventing and improving diabetes and its complications. However, there are few proprietary Chinese medicines for the treatment of middle and late stage diabetes, especially those complicated with peripheral neuropathy and peripheral vascular disease. Clearing heat and promoting blood circulation, such as Yangyin Jiangtang tablets, some focus on nourishing yin and clearing heat, promoting blood circulation and removing blood stasis, nourishing qi and solidifying kidney, such as Tangmaikang granules, some focusing on nourishing qi and nourishing yin, promoting blood circulation and removing blood stasis, such as Qizhi Jiang For sugar capsules, etc., there is no relevant research on the effects of invigorating the spleen, invigorating qi, promoting blood circulation and dredging collaterals of the present invention, and there is no such variety available in the market.

SUMMARY OF THE INVENTION

In order to solve the problems of the prior art, the purpose of the present invention is to provide a traditional Chinese medicine composition for strengthening the spleen and activating collaterals, which harmonizes the spleen and stomach, strengthens the spleen and replenishes qi, promotes blood circulation and clears the collaterals, attacks and supplements simultaneously, is compatible, and has obvious characteristics in the treatment of diabetes. It is safe and effective in patients with diabetes and its complications caused by spleen deficiency and collateral stasis in the middle and late stages.

Another object of the present invention is to apply the above-mentioned Chinese medicinal composition for strengthening the spleen and activating collaterals in the preparation of medicines for the treatment of diabetes and its complications.

The object of the invention is achieved in this way: a kind of traditional Chinese medicine composition for strengthening the spleen and activating collaterals, is characterized in that: by weight, the formula is made up of the following components: 15-25 parts of Pueraria lobata, 12-18 parts of Salvia miltiorrhiza, 25-35 parts of Atractylodes Rhizoma Codonopsis, 25-35 copies of Codonopsis, 8-12 copies of Treats, 8-12 copies of Shichangpu, 12-18 copies of Dilong, 8-12 copies of Chuanxiong, 25-35 copies of Astragalus, and 8-12 copies of Tianqi.

Preferably, calculated in parts by weight, the formula is composed of the following components: 18-22 parts of Pueraria Root, 14-16 parts of Salvia miltiorrhiza, 28-32 parts of Atractylodes Rhizoma, 28-32 parts of Codonopsis Radix, 9-11 parts of Treats, 9-11 parts of Shichangpu 11 parts, Dilong 14-16 parts, Chuanxiong 9-11 parts, Astragalus 28-32 parts, Tian Qi 9-11 parts.

Most preferably, calculated in parts by weight, the formula is made up of the following components: 20 parts of Pueraria lobata, 15 parts of Salvia miltiorrhiza, 30 parts of Atractylodes Rhizoma, 30 parts of Codonopsis Radix, 10 parts of Treats, 10 parts of Shichangpu, 15 parts of Dilong, 10 parts of Chuanxiong , 30 parts of Astragalus, 10 parts of Tian Qi.

The application of the traditional Chinese medicine composition for strengthening the spleen and activating collaterals in the preparation of medicines for treating diabetes, diabetic peripheral neuropathy, diabetic peripheral vascular disease, diabetic ocular fundus disease, diabetes combined with coronary heart disease or diabetes combined with cerebral infarction.

The medicine is decoction, granule, tablet, capsule, oral liquid or pill.

The medicine is a preparation prepared by using the extracts of the components in the formula of the Chinese medicine composition for strengthening the spleen and activating collaterals as active ingredients and adding medicinal excipients.

The extract is a water extract.

Described diabetes, diabetic peripheral neuropathy, diabetic peripheral vascular disease, diabetic retinopathy, diabetes combined with coronary heart disease or diabetes combined with cerebral infarction are the late stage of diabetes mellitus, diabetic peripheral neuropathy, diabetic peripheral vascular disease, diabetic retinopathy of spleen deficiency and collateral stasis type. , Diabetes complicated with coronary heart disease or diabetes complicated with cerebral infarction.

The present invention is a formula for "treatment of diabetes from the spleen and stomach", which has the functions of strengthening the spleen and replenishing qi, promoting blood circulation and dredging collaterals, and is used for quenching thirst caused by spleen deficiency and collateral stasis, symptoms such as dry mouth and polydipsia, polyphagia and polyuria, Shenpi fatigue, pale or dark complexion, fullness in the abdomen and abdomen, poor appetite, wrong skin and nails, numbness and pain in limbs, mainly tingling, aggravated at night, intermittent limping, hemiplegia, crooked corners of the mouth, dull tongue with petechiae , white coating, deep and fine pulse, etc.; diabetes and diabetic peripheral neuropathy, diabetic vascular disease, diabetic ocular fundus disease, diabetes combined with coronary heart disease, diabetes combined with cerebral infarction and other symptoms have obvious curative effect after taking it.

detailed description

The invention is a traditional Chinese medicine composition for invigorating the spleen and activating collaterals. Calculated in parts by weight, the formula is composed of the following components: 15-25 parts of Pueraria, 12-18 parts of Salvia miltiorrhiza, 25-35 parts of Atractylodes Rhizoma, 25-35 parts of Codonopsis Radix, and 8 parts of Treats -12 copies, 8-12 copies of Shichangpu, 12-18 copies of Dilong, 8-12 copies of Chuanxiong, 25-35 copies of Astragalus, and 8-12 copies of Tianqi. Preferably, calculated in parts by weight, the formula is composed of the following components: 18-22 parts of Pueraria Root, 14-16 parts of Salvia miltiorrhiza, 28-32 parts of Atractylodes Rhizoma, 28-32 parts of Codonopsis Radix, 9-11 parts of Treats, 9-11 parts of Shichangpu 11 parts, Dilong 14-16 parts, Chuanxiong 9-11 parts, Astragalus 28-32 parts, Tian Qi 9-11 parts. Most preferably, calculated in parts by weight, the formula is made up of the following components: 20 parts of Pueraria lobata, 15 parts of Salvia miltiorrhiza, 30 parts of Atractylodes Rhizoma, 30 parts of Codonopsis Radix, 10 parts of Treats, 10 parts of Shichangpu, 15 parts of Dilong, 10 parts of Chuanxiong , 30 parts of Astragalus, 10 parts of Tian Qi.

The application of the traditional Chinese medicine composition for strengthening the spleen and activating collaterals in the preparation of medicines for treating diabetes, diabetic peripheral neuropathy, diabetic peripheral vascular disease, diabetic ocular fundus disease, diabetes combined with coronary heart disease or diabetes combined with cerebral infarction. Especially in the treatment of late-stage diabetes patients who are manifested by spleen deficiency and collateral stasis, diabetes complicated with coronary heart disease, diabetes complicated with cerebral infarction, diabetic peripheral neuropathy, diabetic peripheral vascular disease or diabetic eye disease.

The medicament can be in oral dosage forms such as decoction, granule, tablet, capsule, oral liquid or pill. The medicine is a corresponding preparation prepared by using the extracts of the components in the formula of the Chinese medicine composition for strengthening the spleen and activating the collaterals as active ingredients, and adding pharmaceutical excipients of corresponding dosage forms according to the existing general process. Preferably, the extract is a water extract.

The formula of the present invention comes from the theoretical system of the inventor's "Treatment of Diabetes from the Spleen and Stomach", and it is believed that the pathogenesis of diabetes is: "The spleen and stomach are out of balance, the things are not naturalized, the subtleties are not transported, and the organs are out of nourishment", so the treatment is to reconcile the spleen and stomach, attack and supplement both Shi is the core. Diabetes is mostly manifested as spleen deficiency, stagnation and heat in the early stage, blood stasis in the collaterals, in the middle stage of spleen and lung deficiency, heart and spleen deficiency, and spleen and kidney deficiency.

The symptoms of diabetes mellitus are mainly consumption of more food, dry mouth and more drinking. The metabolism, transportation and transformation of diet are most closely related to the spleen and stomach. So, how is water metabolized into the human body? "Plain Questions: The Differentiation of Meridians" says: "Drinking enters the stomach, escaping the essence and qi, and transporting it upward to the spleen, dispersing the spleen, returning to the lungs, regulating the water channels, and transporting the bladder downward. Under normal circumstances, food and water grains enter the human body, decompose through the stomach, metamorphose into the subtle substances, and transport and transform through the spleen to spread the subtle substances throughout the body to support the functional activities of the whole body. When the diet is disordered and the spleen and stomach are damaged, the disease will occur. It can be seen that as early as the "Neijing" period, it was clearly pointed out that the onset of diabetes is either due to overeating fat, sweet and thick, internal damage to the spleen and stomach, or due to accumulation of heat in the stomach, which is fundamentally in the "spleen and stomach".

(1) The spleen and stomach are out of balance, and things are not naturalized. Over time, heat, stagnation, dampness, phlegm, turbidity, and blood stasis are generated.

Fatty, sweet and thick-flavored diet damages the spleen and stomach, and cannot be transported and transformed. Thirst.

Diabetes the thirst for a long time, fat, sweet and thick taste, the change of the cream, the internal injury to the spleen and stomach, the spleen deficiency, the phlegm-dampness is endogenous, and the hair is diabetes.

Emotional depression, liver qi discomfort, stagnation of blood and heat for a long time will also lead to the pathogenesis of thirst.

(2) If the spleen fails to function properly, the subtleties are not transported, and the viscera fails to nourish, the qi and blood will be deficient, and both yin and yang will be deficient over time.

The spleen and stomach are located in the middle coke, which transports and transforms water and valleys. If the spleen fails to function properly, the spleen cannot disperse the essence, the upper essence cannot be transferred to the lungs, and the lower essence cannot be transported to the bladder, and the viscera cannot be nourished. Damage to the spleen and stomach of the middle burner, passive blood biochemistry, deficiency of qi and blood, and lack of righteousness, not only cause diabetes, but also various syndromes. Dystrophy of blood vessels, disharmony of meridians and collaterals, showing signs of paralysis of limbs; deficiency of liver and kidney yin, inability to nourish ears and eyes, showing signs of dim vision, sudden blindness, deafness, etc. And sores and boils, carbuncle.

Combined with a large number of clinical practice, the present invention believes that the syndrome of deficiency and excess is common in the clinical diagnosis of diabetes, and the combination of deficiency and excess runs through the entire course of diabetes. Deficiency syndrome is mainly qi deficiency and yin deficiency. Generally speaking, in the early stage, it is mostly manifested as spleen deficiency and lung heat, spleen deficiency and stomach deficiency, spleen deficiency and liver stagnation. , and develop into a syndrome of yin and yang deficiency or spleen deficiency and collateral obstruction. Concurrent syndromes are mostly evidence, mainly stagnation, heat, dampness, phlegm, turbidity, and blood stasis, often caused by multiple evil qi intermingled with each other, or appearing in the entire course of diabetes, or more prominent at a certain stage. Therefore, reconciling the spleen and stomach, attacking and nourishing as the core treatment method, and nourishing the spleen and strengthening the core are the core. In the process of strengthening the righteousness, attention must be paid to exorcising evil spirits.

Severe peripheral vascular and peripheral neuropathy in the middle and late stages of modern diabetics is often manifested as spleen deficiency and collateral stasis. In view of such disease characteristics, the treatment with the spleen-invigorating and activating collaterals formula of the present invention has a certain and exact curative effect on diabetes and complications. In the prescription, Atractylodes atractylodes invigorates the spleen and replenishes qi and dries dampness, while Codonopsis pilosula invigorates the middle and replenishes qi, so that the central axis can be transported. It is a king medicine. Compatible with Astragalus, salvia, chuanxiong, and Tianqi can promote blood circulation, remove blood stasis and clear spleen and collaterals, and replenish qi. To help activating blood circulation, it is a ministerial medicine in total; it is combined with Pueraria lobata to promote Qingyang to clear spleen and collaterals, relieve heat to promote fluid and quench thirst, Chuanchangpu dispels dampness and appetizers, regulates qi and removes phlegm and removes turbidity, and Dilong promotes blood circulation and clears collaterals. Help the spleen to purify and reduce Yin fire, and induce the fire to return to the Yuan as the medicine. The whole side ascends and descends and harmonizes together, together to invigorate the spleen and replenish qi, and promote blood circulation and dredging collaterals.

According to modern research, Atractylodes macrocephala in this recipe can promote the recovery of damaged autonomic nerve function, adjust the balance of human viscera functions, regulate gastrointestinal motility, lower blood sugar, diuresis, and enhance resistance. Codonopsis polysaccharide can reduce alloxan-induced diabetes. At the same time, it can improve insulin resistance to a certain extent and improve the body's insulin sensitivity; Astragalus has the functions of resisting free radical damage and enhancing immunity; Salvia contains a large amount of diterpene quinone pigment, tanshinone, danshensu, two It has the functions of promoting blood circulation and removing blood stasis, reducing blood viscosity, etc., and can well improve the blood viscosity of diabetic patients. Chuanxiong has sedative and analgesic, inhibiting the release of oxygen free radicals, etc., and Tianqi can dilate blood vessels, Improve microcirculation disorders, lower blood lipids, scavenge free radicals, anti-inflammatory, anti-oxidation, etc., improve fundus microcirculation and retinal ischemia and hypoxia; Pueraria lobata has hypoglycemic effects, and the preparations of Pueraria lobata and its extracts have been Widely used in the treatment of diabetes and its complications, calamus can improve immunity, anti-tumor, lipid-lowering, anti-inflammatory, and earthworm can improve microcirculation, regulate blood pressure, improve atherosclerosis and hemangioma, and improve blood flow, etc. Cortex Phellodendri has various pharmacological effects, mainly including hypoglycemic, antibacterial, antifungal, antitussive, antihypertensive, anti-trichomoniasis, anti-hepatitis, anti-ulcer and immunosuppressive effects.

Therefore, the clinical treatment of diabetes in the present invention is generally based on reconciling the spleen and stomach, attacking and supplementing and applying it as the core, and creating a prescription for strengthening the spleen and activating collaterals. Through the data of the following clinical studies, the data proves that this prescription is good for strengthening the spleen and replenishing qi, promoting blood circulation and dredging collaterals, and is especially suitable for The treatment of diabetic peripheral neuropathy and diabetic peripheral vascular disease caused by spleen deficiency and collateral stasis in the late stage of diabetes is effective, safe and reliable.

Example 1 (decoction)

The formula consists of the following components: 20g of Pueraria lobata, 15g of Salvia miltiorrhiza, 30g of Atractylodes Rhizoma, 30g of Codonopsis Radix, 10g of Treats, 10g of Shichangpu, 15g of Dilong, 10g of Chuanxiong, 30g of Astragalus, and 10g of Tianqi. Add water and cook to a bowl.

Embodiment 2 (decoction)

The formula consists of the following components: 18g of pueraria, 14g of Salvia miltiorrhiza, 28g of Atractylodes, 28g of Codonopsis, 9g of Treats, 9g of Shichangpu, 14g of Dilong, 0g of Chuanxiong, 28g of Astragalus, and 9g of Tianqi. Add water and cook to a bowl.

Embodiment 3 (decoction)

Each dose of the formula is composed of the following components: 22g of Pueraria lobata, 16g of Salvia miltiorrhiza, 32g of Atractylodes Rhizoma, 32g of Codonopsis Radix, 11g of Treats, 11g of Shichangpu, 16g of Dilong, 10g of Chuanxiong, 32g of Astragalus, and 11g of Tianqi. Add water and cook to a bowl.

Example 4 (decoction)

The formula consists of the following components: 20g of Pueraria lobata, 14g of Salvia miltiorrhiza, 30g of Atractylodes Rhizoma, 32g of Codonopsis Radix, 9g of Treats, 11g of Shichangpu, 16g of Dilong, 11g of Chuanxiong, 28g of Astragalus, and 11g of Tianqi. Add water and cook to a bowl.

Example 5 (tablet)

Calculated by weight, the formula is composed of the following components: 25 parts of Pueraria lobata, 18 parts of Salvia miltiorrhiza, 35 parts of Atractylodes Rhizoma, 35 parts of Codonopsis Radix, 12 parts of Treats, 12 parts of Shichangpu, 18 parts of Dilong, 12 parts of Chuanxiong, 35 parts of Astragalus, Tianqi 12 copies. Extract with water twice, add 8-10 times of water each time, decoct for 1-1.5 hours, combine the water extracts, concentrate and dry to obtain dry extract.

Take 20g of dry extract and grind it into fine powder, according to the tablet manufacturing process, add medicinal starch and micropowder silica gel, mix, granulate, dry and granulate, then add magnesium stearate, mix well, and press into 100 tablets, namely Get tablets. Each tablet weighs 0.3g.

Example 6 (capsule)

Take 20 g of the dry extract obtained in Example 5 and grind it into fine powder, according to the capsule manufacturing process, add medicinal starch and micropowder silica gel, mix, sieve, and put into capsules to make 100 capsules to obtain capsules. The content of each capsule weighs 0.2g.

Clinical comparative experiment

In order to objectively evaluate the clinical effectiveness and safety of the traditional Chinese medicine composition of the present invention, according to the requirements of the clinical research guidelines for new traditional Chinese medicines, clinical research is carried out on the medicine. The following studies were approved by the Ethics Committee of Shantou Hospital of Traditional Chinese Medicine, and all patients gave informed consent to this study.

1. Clinical research on the treatment of diabetes

1 Materials and methods

1.1 General information 64 patients with diabetic peripheral neuropathy who were treated in the outpatient and inpatient departments of the Diabetes Department of Shantou Hospital of Traditional Chinese Medicine from January 2016 to January 2018 were randomly divided into two groups: Jianpi Huoluo Fang treatment group and control group . There were 32 cases in the observation group, including 17 males and 15 females, the average age was (58.2±6.8) years, the course of diabetes was (10.5±3.1) years, the course of diabetic peripheral neuropathy was (6.8±4.6) years, and the fasting blood glucose was (7.1±2.0) years. mmol/L; control group of 32 cases, 20 males and 12 females, age (57.9±5.3) years, duration of diabetes (11.8±4.2) years, duration of diabetic peripheral neuropathy (7.1±2.2) years, fasting blood glucose (7.4 ±1.8) mmol/L. There was no significant difference in the general data of appeal between the two groups (P>0.05), which was comparable.

1.2 Diagnosis and differentiation criteria Western medicine diagnostic criteria: Diagnosis and classification of diabetes according to the 1999 WHO diagnostic and classification criteria. TCM syndrome differentiation criteria: dry mouth and excessive drinking, mental fatigue, pale complexion, fullness in the abdomen and abdomen, poor appetite, numbness and pain in limbs, mainly tingling, aggravating at night, intermittent claudication, hemiplegia, dull tongue with petechiae , white fur, pulse is fine and astringent.

1.3 Inclusion criteria (1) Meet the diagnostic criteria for type 2 diabetes; (2) The main syndrome of TCM syndrome differentiation belongs to patients with spleen deficiency and collateral stasis who can be treated with Jianpi Huoluo Formula.

1.4 Exclusion Criteria (1) Those under 35 years old or over 75 years old; (2) Those with cognitive impairment, lack of complete expression ability, and those who cannot cooperate with treatment. (3) Patients with severe liver, kidney, heart, and brain diseases, or patients with acute or severe complications such as diabetic ketosis. (4) Combined with other neuropathy such as (multiple sclerosis, erythematous extremity pain, lumbar disc herniation, cervical radiculopathy, etc.). (5) Those who have poor compliance and fail to take medication as prescribed, which affects the clinical efficacy.

2 methods

2.1 Treatment methods Both groups were given comprehensive diabetes treatment, including health education, diet management, exercise management, blood glucose monitoring and management, etc., oral hypoglycemic drugs or routine treatment with insulin. The control group was orally administered Micobao tablets, 0.5 mg each time, 3 times/d. The observation group was additionally treated with the Jianpi Huoluo Decoction of Example 1, decocted in water, 1 dose per day, 1 dose per day, decocted into 400 mL, 200 mL each time, warmed twice in the morning and evening, and the treatment results were counted after 4 weeks of treatment.

2.2 Observation indicators

2.2.1 Safety evaluation criteria General physical examination: blood pressure, respiration, pulse, body temperature. ② Routine examination of hematuria and stool.

2.2.2 Efficacy observation Fasting and postprandial 2h blood glucose, glycosylated hemoglobin, TCSS score.

2.3 Statistical processing The statistical software SPSS 18.0 was used for statistical processing of the relevant data in this study, and the measurement data were expressed as the mean ± standard deviation, and the t test was used. There is statistical significance.

3 results

3.1 Comparison of blood glucose and glycated hemoglobin between the two groups before and after treatment There was no significant difference in fasting blood glucose, 2h postprandial blood glucose and glycated hemoglobin between the two groups before treatment (P>0.05), which was comparable. The fasting blood glucose of both groups decreased after treatment, and the difference between before and after treatment was statistically significant (P<0.05). Compared with the control group patients (P<0.05), there was statistical significance, see Table 1.

Table 1 Comparison of fasting blood glucose, 2h postprandial blood glucose and glycosylated hemoglobin between the two groups before and after treatment (n=32)

Note: ★Compared with before treatment, P<0.05; ●Compared with control group, P<0.05.

3.2 Comparison of TCSS scores (Toronto Clinical Neuropathy Score) between the two groups before and after treatment After treatment, the TCSS scores of the two groups of patients were significantly lower than before, and the difference was statistically significant (P<0.05), indicating that the two groups of patients had better symptoms after treatment. Compared with the control group, the TCSS score of the observation group decreased more significantly (P<0.05), indicating that the treatment effect of the observation group was better than that of the control group. See Table 2.

Table 2 Comparison of TCSS scores between the two groups before and after treatment

Note: ★Compared with before treatment, P<0.05; ●Compared with control group, P<0.05

3.3 Comparison of adverse reactions between the two groups before and after treatment There were no acute complications such as abnormal liver and kidney function, diabetic ketoacidosis, hypoglycemia and coma in the two groups.

3. Conclusion

Diabetes belongs to the category of "diabetes" in traditional Chinese medicine, and ancient traditional Chinese medicine mostly treats it from "dryness and heat due to yin deficiency". However, the current clinical findings have changed in terms of etiology, pathogenesis and pathogenesis, clinical manifestations, and even treatment methods.

Clinical practice shows that the Jianpi Huoluo Decoction of the present invention treats patients with spleen deficiency and collateral stasis in the middle and late stages of diabetes, and the main symptom is limb paralysis and tingling. Symptoms are more advantageous than western medicine treatment.

2. Clinical research on the treatment of diabetic fundus lesions

1. Materials and methods

1.1 General information All 68 patients were inpatients in Shantou Hospital of Traditional Chinese Medicine from January 2017 to May 2019, and were divided into two groups according to the random number table method. There were 34 cases in the treatment group, including 20 males and 14 females; the age ranged from 45 to 78 years, with an average of (56.67±6.53) years; the course of disease was 2 to 14 years, with an average of (8.46±0.67) years; the stage of retinopathy: 16 cases of stage I, 12 cases were in stage II and 6 cases were in stage III. There were 34 cases in the control group, 19 males and 15 females; aged 46-76 years, mean (56.65±6.57) years; disease duration 1-16 years, mean (8.48±0.69) years; stage of retinopathy: 18 cases of stage I, 11 cases were in stage II and 5 cases were in stage III. There was no significant difference in general data between the two groups (P > 0.05), which was comparable.

1.2 Case selection

1.2.1 Diagnostic criteria ① Referring to the diagnostic criteria of DR in "Modern Diagnosis and Treatment of Diabetes"; ② the main syndrome of TCM syndrome differentiation belongs to the patients with spleen deficiency and collateral stasis that can be treated with the spleen invigorating and activating collateral formula of the present invention.

1.2.2 Inclusion criteria ① No anticoagulation or microcirculation-improving drugs in the past 4 weeks; ② No organ dysfunction; ③ No drug allergy.

1.2.3 Exclusion criteria ①Have a history of retinal surgery; ②Pregnancy; ③Not signed the informed consent for treatment; ④Incomplete clinical data or lost to follow-up; ⑤Combined with other primary or secondary retinopathy; ⑥Combined with blood Systemic diseases; ⑦ Patients with severe cardiovascular and cerebrovascular and liver and kidney damage, or those who have recently developed diabetic ketosis, hyperosmolar coma and severe interference.

1.3 Treatment methods Both groups were treated with hypoglycemic drugs, exercise, diet control, etc., and the blood sugar control was stable.

1.3.1 The control group was given calcium dobesilate capsules (Beijing Jingfeng Pharmaceutical Group Co., Ltd., H20010795) 0.5g, orally three times a day.

1.3.2 Treatment group The treatment group was added traditional Chinese medicine treatment on the basis of the control group, and the decoction of Jianpi Huoluofang of Example 1 was orally administered, 1 dose per day.

1.3.3 Course of treatment The two groups were treated for 4 weeks as a course of treatment, and two courses of continuous treatment were given.

1.4 Observation indicators and methods ①The fasting cubital venous blood of 3-5mL was drawn from the patients in the morning, and the supernatant was collected by routine centrifugation. The levels of VEGF and Ang-1 were detected by enzyme-linked immunosorbent assay (ELISA) method, and the level of SOD was detected by colorimetric method. . The kit was provided by Shanghai Enzyme Link Biotechnology Co., Ltd., and the operation was carried out according to the kit instructions. ②Apply an automatic blood flow analyzer (Tianjin Tangyu Medical Device Technology Development Co., Ltd.) to detect blood rheological indicators: plasma viscosity, whole blood viscosity (high shear), whole blood viscosity (middle shear), whole blood viscosity (low shear) cut), erythrocyte aggregation index, erythrocyte stiffness index and fibrinogen (FIB).

1.5 Efficacy criteria Markedly effective: the patient's vision improved by 4 lines after treatment, and the microvascular tumor and hemorrhage basically disappeared; effective: the patient's vision improved by 2 lines after treatment, and the microvascular tumor and bleeding partially disappeared; Ineffective: the patient's visual acuity and fundus above lesions did not change significantly after treatment or aggravated.

1.6 Statistical methods SPSS 21.0 statistical software was used for statistical analysis of data, and measurement data were used as mean ± standard deviation

The t test was used; the comparison of count data rates was performed by the χ ² test. P<0.05 was considered statistically significant.

2. Results

2.1 Comparison of curative effect between the two groups There were statistically significant differences in the markedly effective rate and total effective rate between the two groups (P<0.05), and the curative effect of the treatment group was better than that of the control group. See Table 3.

Table 3 Comparison of curative effect of two groups of patients [n(%)]

Note: Compared with the control group, *P<0.05.

2.2 Comparison of VEGF, Ang-1 and SOD between the two groups before and after treatment After 4 and 8 weeks of treatment in the two groups, VEGF decreased (P < 0.05), while Ang-1 and SOD increased (P < 0.05). VEGF in the group was lower than that in the control group during the same period of treatment (P<0.05), while Ang-1 and SOD were higher than those in the control group during the same period of treatment (P<0.05). See Table 4.

Table 4 Comparison of VEGF, Ang-1, SOD before and after treatment in the two groups of patients (

n=68)

Note: Compared with the group before treatment, ^* P<0.05; compared with the control group in the same period of treatment, ^# P<0.05.

2.3 Comparison of blood rheology indexes before and after treatment , erythrocyte rigidity index and FIB were lower than those before treatment in this group (P<0.05), and were lower than those in the control group during the same period of treatment (P<0.05). There was no significant difference in hemorheology indexes before and after treatment in the control group (P<0.05). See Table 5.

Table 5 Comparison of blood rheology indexes before and after treatment in the two groups of patients (

n=68)

3 Discussion

Chinese medicine believes that DR is mainly developed on the basis of quenching thirst and spleen deficiency. Diabetes the thirst for a long time, the deficiency of both qi and yin, the deficiency of qi and yin, the inability to transport blood, the blood stasis due to qi deficiency, and the stasis of blood in the eyes and collaterals; in addition, most of the patients are old and weak, the kidney essence is deficient, the liver blood is insufficient, and the essence and blood are difficult to flourish. In the eyes, the eyes and collaterals are out of nourishment, and the vision is blurred; qi deficiency has no right to absorb blood, which can cause blood to overflow the veins, causing bleeding, and finally causing blood stasis to persist for a long time, further blocking the eye collaterals and causing blindness. As stated in "Confucianism and Family Affairs", "Those who suffer from thirst often become blind and deaf", and "The Essentials of Syndrome and Treatment" says that "the three eliminations take a long time, and the essence and blood will be depleted, or the eyes will not see." Therefore, DR is mostly a syndrome of deficiency and deficiency. It is based on deficiency of qi or both qi and yin, and blood stasis and phlegm obstruct collaterals. The lesions are in the spleen, liver and kidney. Removing blood stasis is the rule of thumb. Calcium dobesilate is a capillary regulating drug developed and marketed in recent years, mainly for the treatment of microvascular disease and varicose vein syndrome. It has a good effect on microvascular disease.

Microvascular disease is the basic link in the pathogenesis of DR. It is manifested as the expansion of capillary non-perfusion area, the atresia of large retinal vessels, severe ischemia and hypoxia, and finally the formation of new blood vessels. This process involves a variety of cytokines. VEGF is a vascular endothelial growth factor, and its high expression can promote the formation of new blood vessels in DR, enhance vascular permeability, induce endothelial cell growth, and also promote retinal oxidative stress state, induce inflammatory response, and aggravate retinal damage. Ang-1 can regulate angiogenesis, inhibit the expression of VEGF and vascular proliferation, and improve the stability of endothelial cells. SOD can indirectly reflect the antioxidant capacity in the body. With the aggravation of the disease, the retinal tissue may appear telangiectasia, resulting in traction retinal detachment, resulting in blindness of the patient. Hyperglycemia causes fundus microcirculation disorder, activates protein kinase C, catalyzes the activation of endothelial nitric oxide synthase, and promotes angiogenesis. In addition, low blood perfusion produces more free radicals, activates some genes that induce apoptosis, and increases the attention to nerve damage.

The results of this study showed that the levels of VEGF in the treatment group decreased after 4 and 8 weeks of treatment, while the levels of Ang-1 and SOD increased (P<0.05), and the levels of VEGF were lower than those in the control group during the same period of treatment (P<0.05). It was higher than the control group in the same period of treatment (P<0.05), suggesting that Jianpi Yihuoluo Fang could interfere with retinal microvascular formation and inhibit disease progression by regulating the expression of VEGF and Ang-1 in blood. Abnormal hemorheology index is also one of the important factors of DR. Due to the small retinal blood vessels, once the plasma viscosity, whole blood viscosity, erythrocyte aggregation index and FIB increase, it is easy to form microvascular emboli, reduce the oxygen tolerance of the retina, and promote the generation of blood vessels. Compensatory expansion, resulting in the formation of hemangioma, causing or aggravating the patient's condition. The results of this study showed that the plasma viscosity, whole blood viscosity, erythrocyte aggregation index, erythrocyte rigidity index and FIB in the treatment group were lower than those in the control group (P < 0.05), indicating that Jianpi Huoluo Fang could reduce the levels of hemorheological indexes, Thereby, the local microcirculation of the retina can be improved, and the vision level of patients can be improved.

To sum up, DR is mostly caused by deficiency of the spleen spleen and blood stasis, and the formation of eye collaterals. , improve vision level, treat both the symptoms and root causes, high safety, worthy of clinical application.

3. Clinical research on the treatment of diabetic peripheral neuropathy

1Clinical data

1.1 Test objects

A total of 80 patients with diabetic peripheral neuropathy (DSPN) admitted to Shantou Hospital of Traditional Chinese Medicine from July 2018 to June 2019 were selected. According to the random number table method, they were divided into a treatment group and a control group, with 40 cases in each group. In the treatment group, there were 26 males and 14 females; the age ranged from 45 to 76 years, with an average of (54.1±2.2) years; the course of disease was 3 to 20 years, with an average of (10.5±3.2) years. In the control group, there were 21 males and 19 females; the age ranged from 43 to 77 years, with an average of (53.3±3.1) years; the course of disease was 2 to 19 years, with an average of (10.1±1.3) years. There was no significant difference in gender, age, course of disease and other general data between the two groups (P>0.05), which was comparable.

1.2 Diagnostic criteria

1.2.1 The diagnostic criteria of western medicine refer to the "Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2017 Edition)" to formulate the criteria. (1) A clear history of diabetes; (2) Neuropathy at or after the diagnosis of diabetes; (3) The clinical symptoms and signs are consistent with the manifestations of DSPN; (4) Those with clinical symptoms (pain, numbness, paresthesia, etc.) , any one of the five tests (ankle reflex, acupuncture pain, temperature, vibration, and pressure) is abnormal; for those without clinical symptoms, any two of the five tests are abnormal, and the clinical diagnosis is DSPN; (5) excluded The following conditions: Neuropathy caused by other causes, such as cervical and lumbar spondylosis (nerve root compression, spinal stenosis, cervical and lumbar degenerative changes), cerebral infarction, Guillain-Barré syndrome; severe arteriovenous vascular disease (venous embolism, Lymphangitis), etc.; neurotoxic effects caused by drugs, especially chemotherapy drugs, and damage to nerves caused by metabolic poisons caused by renal insufficiency.

1.2.2 Diagnostic criteria for spleen deficiency and collateral stasis type: (1) Shenpi and fatigue, (2) pale or dark complexion, (3) abdominal fullness, (4) poor appetite, (5) wrong skin and nails, (6) Limb paralysis and pain, mainly tingling, (7) worsening at night, (8) intermittent claudication, (9) hemiplegia, (10) skewed corners of the mouth, (11) pale tongue with petechiae, white coating, (12) The pulse is thin and astringent. Those who meet more than 7 of the above symptoms can be judged as spleen deficiency and collateral stasis type.

1.3 Inclusion criteria

(1) Age: 18-80 years old; (2) Meet the diagnostic criteria for diabetes; (3) Meet the diagnostic criteria for diabetes DSPN; (4) Based on the above criteria, TCM syndrome differentiation of spleen deficiency and collateral stasis.

1.4 Exclusion criteria

(1) Pregnant or breastfeeding women; (2) Those with cognitive or communication impairments; (3) Those with severe impairment of liver and kidney function; (4) Those with severe impairment of other systems or organs; (5) In the past 1 month, have Diabetic ketoacidosis, or severe infection; (6) some allergic constitution, or allergic to any drug in the treatment.

2. Research methods

2.1 Basic treatment: conventional western medicine treatment. Including diabetic diet, moderate exercise, health education, oral appropriate hypoglycemic drugs or insulin injection. The blood glucose control level was 5.0-8.0 mmol/L fasting blood glucose and 5.0-10.0 mmol/L before bedtime.

2.2 Control group: On the basis of basic treatment, each patient was given 500 μg of mecobalamin tablets orally three times a day.

2.3 Treatment group: On the basis of the treatment of the control group, each patient was added with the prescription of Example 1, decocted into 400 mL, 200 mL each time, and warmed twice in the morning and evening.

2.4 Statistical treatment results after 8 weeks of treatment.

3. Observation indicators

3.1 The TCSS score includes neurological symptoms, reflexes and sensory scores: (1) Symptoms: numbness or no sensation in the lower limbs, pain (burning pain or electric shock-like pain), fatigue, needle-like sensation, unsteady walking, and ask whether there are similarities in the upper limbs symptom. 0 points for no abnormality, 1 point for one symptom, 6 points in total; (2) Reflex: ankle and knee reflex, 8 points in total, 0 points for no abnormality, 1 point for one side weakening, 2 points for disappearance; (3) ) Feeling: Check 5 items of pain, vibration, position, touch and temperature of the right thumb. No abnormality is scored as 0, one symptom is scored as 1, a total of 5 points. The total score of 3 inspections is 19 points.

3.2 Vibration Perception Threshold (VPT) Examination - Foot Sensory Nerve: Let the patient lie supine, connect the vibration sensory meter to the base of the patient's first toe and the dorsum of the foot, as the current increases, the vibration amplitude of the vibration meter will increase accordingly , the volts of the vibration that the patient perceives, as the inspection result, 3 measurements, and the average value is taken. Reference range: 10-15V for critical lesions, 16-24V for mild-moderate lesions, and >25V for severe lesions.

3.3 Refer to "Classification and Analysis of Clinical Efficacy Evaluation Criteria for Diabetic Peripheral Neuropathy" to judge the curative effect of 3 groups of patients after treatment: (1) Significantly effective: no symptoms, knee tendon reflex is basically normal, and VPT test results are normal; (2) ) Effective: subjective symptoms, knee tendon reflexes improved significantly, and VPT test results improved; (3) Ineffective: subjective symptoms, knee tendon reflexes and VPT test results did not change. The total effective rate is the sum of markedly effective and effective cases/total cases multiplied by 100%.

3.4 Quality of life assessment: The assessment scale refers to the simple scale of quality of life SF-36, which is approved by the World Health Organization (WHO) and has reliable reliability. The scale contains 8 dimensions, covering life functions and functions, physical pain, energy, general health, emotional and mental health, etc. Each dimension is scored separately and then accumulated. This is the original score, which is then converted into a total average score through a standard formula. The score ranges from 0 to 100. The higher the score, the better the quality of life.

3.5. Statistical analysis

Data were analyzed by SPSS 20.0. Enumeration data were analyzed by χ2 test, and rank data were analyzed by rank sum test. measurement data to

Indicates that the comparison within the group before and after treatment, if it conforms to the normal distribution, the paired t test is used, and if it does not conform, the rank sum test is used; for the comparison between the two groups, when the normal distribution and the variance are homogeneous, the t test is used, and the rank sum test is used when the variance is not consistent. test. P<0.05 was regarded as a statistically significant difference.

4 results

4.1 Comparison of TCSS scores between the two groups Before treatment, the baseline TCSS scores of the two groups were balanced (P>0.05); after treatment, the TCSS scores of the two groups were significantly lower than those before treatment (P<0.05), and there was a statistical difference between the two groups (P<0.05). <0.05), see Table 6.

Table 6 Comparison of TCSS scores of two groups of patients

Note: Compared with before treatment, ^a P<0.05; compared with control group, ^b P<0.05.

4.2 Comparison of VPT test results between the two groups Before treatment, there was no significant difference in VPT test results between the two groups (P>0.05). (P<0.05), see Table 7.

Table 7 compares the results of VPT examination in the two groups of patients[

n=40]

4.3 Comparison of curative effect between the two groups After treatment, the total effective rate of the observation group was 87.50%, and that of the control group was 62.50%, and the difference between the two groups was significant (P<0.05), as shown in Table 8.

Table 8 compares the efficacy of the three groups of patients [n (%)]

Note: Compared with the control group, ^a P<0.05.

4.4 Comparison of quality of life of patients in the two groups Before treatment, there was no significant difference in the total mean scores of each dimension of SF-36 in the two groups (P>0.05); after treatment, the total mean scores of each dimension of quality of life in the two groups were significantly improved (P<0.05), there was a significant difference between the two groups (P<0.05), see Table 9.

Table 9 compares the quality of life between the two groups [

n=40]

4.5 Comparison of adverse reactions between the two groups There was no abnormal liver and kidney function, and acute complications such as diabetic ketoacidosis and hypoglycemia coma in the two groups. Among the 40 patients in the control group, 1 patient had mild dizziness, and the symptoms relieved spontaneously without stopping the treatment.

5 Discussion

Vibration sensory threshold (VPT) examination-foot sensory nerve is a specific indicator for the diagnosis of diabetic peripheral neuropathy, and it is a commonly used clinical standard for evaluating diabetic peripheral neuropathy and its treatment effect. The results of this study show that after the comparison before and after treatment and the comparison between groups, Jianpi Huoluo Fang can significantly improve the clinical symptoms of patients with diabetic peripheral neuropathy, improve clinical efficacy, improve the quality of life of patients, and enhance patients' confidence in treatment. It has no obvious adverse reactions, is simple and easy to operate, and has strong operability, which is worthy of clinical application.

4. Clinical study on the treatment of diabetic peripheral vascular disease with spleen deficiency and collateral stasis type

1Clinical data

1.1 Test objects

A total of 90 patients with diabetic peripheral vascular disease admitted to Shantou Hospital of Traditional Chinese Medicine from July 2018 to June 2019 were selected. According to the random number table method, they were divided into a treatment group and a control group, with 45 cases in each group. In the treatment group, there were 31 males and 19 females; the age ranged from 45 to 77 years, with an average of (54.1±2.1) years; the course of disease was 3 to 19 years, with an average of (10.4±3.2) years. In the control group, there were 26 males and 24 females; the age ranged from 42 to 75 years, with an average of (53.2±3.0) years; the disease duration was 2 to 21 years, with an average of (10.1±1.4) years. There was no significant difference in gender, age, course of disease and other general data between the two groups (P>0.05), which was comparable.

1.2 Diagnostic criteria

1.2.1 Western Medicine Diagnostic Criteria The 2017 "China Guidelines for the Prevention and Treatment of Type 2 Diabetes" was drafted. (1) Patients with clinically diagnosed diabetes. (2) Clinical manifestations of lower extremity arteriosclerosis occlusion ischemia. (3) ABI examination: ABI≤0.90 can be diagnosed as lower extremity ischemia. (4) Color Doppler ultrasound of carotid artery: prompts arteriosclerosis, plaque, lumen stenosis, etc. (5) CTA, MRA or DSA of peripheral blood vessels: prompts lumen stenosis, etc.

1.2.2 Diagnostic criteria for spleen deficiency and collateral stasis type: (1) Shenpi and fatigue, (2) pale or dark complexion, (3) abdominal fullness, (4) poor appetite, (5) wrong skin and nails, (6) Limb paralysis and pain, mainly tingling, (7) worsening at night, (8) intermittent claudication, (9) hemiplegia, (10) skewed corners of the mouth, (11) pale tongue with petechiae, white coating, (12) The pulse is thin and astringent. Those who meet more than 7 of the above symptoms can be judged as spleen deficiency and collateral stasis type of Xiaoke Bi syndrome.

1.3 Inclusion criteria

(1) Age: 18 to 80 years old; (2) Meet the diagnostic criteria for diabetes; (3) Meet the diagnostic criteria for diabetic peripheral vascular disease; (4) Based on the above criteria, TCM syndrome differentiation of spleen deficiency and collateral stasis.

1.4 Exclusion criteria

(1) Pregnant or breastfeeding women; (2) Those with cognitive or communication impairments; (3) Those with severe impairment of liver and kidney function; (4) Those with severe impairment of other systems or organs; (5) In the past 1 month, have Diabetic ketoacidosis, or severe infection; (6) some allergic constitution, or allergic to any drug in the treatment. All patients gave informed consent and signed the agreement.

2. Research methods

2.2 Control group: On the basis of basic treatment, each patient was given aspirin enteric-coated tablet 100mg qn and atorvastatin calcium 20mg qn orally.

2.4 Statistical treatment results after 8 weeks of treatment.

3. Observation indicators

3.1 Carotid intima-media thickness (CIMT): Color Doppler ultrasound diagnostic instrument was used to detect the IMT of the carotid artery before and after treatment.

3.2 ABI evaluation method Refer to "Guidelines for Diagnosis and Treatment of Arteriosclerosis Obliterans of Lower Limbs" (2015). (1) ABI calculation method: the ratio of the systolic blood pressure of the ankle artery (posterior tibial artery or dorsal foot artery) to the systolic blood pressure of the upper arm (take the higher side of the left and right arms). (2) ABI evaluation method: normal range: 1.00-1.40; critical range: 0.91-0.99; lower extremity ischemia: ≦0.9.

3.3 Judgment of curative effect (1) Clinical recovery: clinical symptoms and signs disappeared or basically disappeared, symptom curative effect index ≥ 90%; or ABI returned to the normal range. (2) Significantly effective: the clinical symptoms and signs are significantly improved, and the symptom efficacy index is ≥70% and <90%; or the ABI returns to the critical value. (3) Effective: the clinical symptoms and signs have improved, and the symptom efficacy index is ≥30% and <70%; or the ABI is improved compared with before treatment. (4) Ineffective: no significant improvement in clinical symptoms and signs, or even aggravation, symptom efficacy index <30%; or no improvement in ABI compared with before treatment.

Note: symptom efficacy index=(integration before treatment-integration after treatment)/integration before treatment×100%. If the efficacy of symptoms is inconsistent with the efficacy of ABI, the one with better efficacy shall prevail.

3.4. Statistical analysis

4 results

4.1 Comparison of CIMT in the two groups Before treatment, the baseline CIMT of the two groups was balanced (P>0.05); after treatment, the CIMT in the observation group was significantly lower than that before treatment (P<0.05), and there was a statistical difference between the two groups (P<0.05) , see Table 10.

Table 10 Comparison of CIMT (mm) in two groups of patients[

n=40]

4.2 Comparison of ABI test results between the two groups Before treatment, there was no significant difference in ABI test results between the two groups (P>0.05); after treatment, the VPT test results of the two groups were significantly decreased (P<0.05), and the difference between the two groups was significant. (P<0.05), see Table 11.

Table 11 compares the ABI examination results of the two groups of patients [

n=40]

4.3 Comparison of curative effect between the two groups After treatment, the total effective rate of the observation group was 87.50%, and that of the control group was 62.50%. The difference between the two groups was significant (P<0.05), see Table 12.

Table 12 Comparison of the efficacy of the two groups of patients [n (%)]

Note: Compared with the control group, ^a P<0.05.

4.5 Comparison of adverse reactions between the two groups There was no abnormal liver and kidney function, and acute complications such as diabetic ketoacidosis and hypoglycemia coma in the two groups.

5 Discussion

The results of this study show that after the comparison before and after treatment and the comparison between groups, the Jianpi Huoluo prescription of the present invention can significantly improve the clinical symptoms of patients with diabetic peripheral vascular disease, improve clinical efficacy, improve the quality of life of patients, and enhance patients' confidence in treatment , and no obvious adverse reactions, simple and easy to operate, strong operability, worthy of clinical application.

V. Clinical research on the treatment of diabetes mellitus complicated with coronary heart disease

Diabetic patients are mainly characterized by abnormally high blood sugar, which leads to blood viscosity and slow blood flow, which can lead to serious complications such as cardiovascular disease. Coronary heart disease (CHD) is a common cardiovascular complication of diabetes, characterized by myocardial ischemia and hypoxia caused by coronary atherosclerosis and lumen stenosis. In recent years, my country's aging trend has accelerated, coupled with changes in dietary structure, the incidence of diabetes mellitus with coronary heart disease has increased year by year, and timely treatment is needed to improve the prognosis of patients. The inventors applied Jianpi Huoluo Fang to treat diabetes mellitus with coronary heart disease, and obtained good curative effect, which is summarized as follows:

1 Materials and methods

1.1 General information

The subjects included in this study were randomly selected from 83 patients with diabetes and coronary heart disease admitted to Shantou Hospital of Traditional Chinese Medicine from December 2018 to December 2019. All patients met the diagnostic criteria for coronary heart disease and diabetes, and informed consent to this study. The above 83 patients with diabetes and coronary heart disease were randomly divided into control group of 41 cases and treatment group of 42 cases. There were 27 males and 15 females in the treatment group; the age ranged from 37 to 80 years old, with an average age of (49.34±11.13) years old. The course of disease ranged from 5 months to 5 years, with an average course of (2.51±0.21) years; the body weight was 42kg to 78kg, with an average body weight of (57.31±8.25)kg. The control group consisted of 27 males and 14 females, aged 37-79 years, with an average age of (49.10±11.53) years. The disease course ranged from 5 months to 5 years, with an average course of (2.56±0.25) years; the body weight was 42kg to 78kg, and the average weight was (57.92±8.45)kg. The general data of the two groups of patients, the difference was statistically significant P>0.05, comparable.

1.2 Diagnosis and differentiation criteria Western medicine diagnostic criteria: diabetes is diagnosed and classified according to the 1999 WHO diagnostic and classification criteria; coronary heart disease is diagnosed according to the diagnostic criteria of the 2007 Guidelines for the Diagnosis and Treatment of Chronic Stable Angina Pectoris.

TCM syndrome differentiation criteria: dry mouth and polydipsia, chest tightness or chest pain, mental fatigue, sallow complexion, fullness of the abdomen and abdomen, poor appetite, paralysis and pain of limbs, mainly tingling, worsening at night, intermittent claudication, hemiplegia, pale tongue Dark with petechiae, white fur, and thin and astringent pulse.

1.3 Inclusion criteria (1) Meet the diagnostic criteria for type 2 diabetes mellitus and coronary heart disease; (2) The main syndrome of TCM syndrome differentiation belongs to patients with spleen deficiency and collateral stasis who can be treated with Jianpihuoluo prescription.

1.4 Exclusion Criteria (1) Those under 35 years old or over 80 years old; (2) Those with cognitive impairment, lack of complete expression ability, and those who cannot cooperate with treatment. (3) Patients with diabetic ketosis, diabetic ketoacidosis, severe hypertension, severe arrhythmia, severe cardiopulmonary insufficiency, tumors, or serious primary diseases such as liver, kidney, brain, and hematopoietic system. (4) Chest tightness and pain caused by acute myocardial infarction or other heart disease, cervical spondylosis, hyperthyroidism, gastric and esophageal reflux, biliary heart disease, severe neurosis, menopausal syndrome, etc. (5) Those with poor compliance and failure to take medication as prescribed, affecting clinical efficacy.

1.5 Methods

The control group was given conventional western medicine treatment, oral hypoglycemic drugs or insulin injection to control the blood sugar level to 3.9-7.8 mmol/L, and given simvastatin to regulate lipids and stabilize plaques, combined with routine dietary guidance and exercise guidance.

On the basis of the control group, Chinese medicine treatment was added to the treatment group, and the decoction of Example 1 of the present invention (hereinafter referred to as the spleen-invigorating and activating-loose formula) was taken orally, one dose per day.

Both groups were treated for 1 month.

1.6 Observation indicators and standards

The two groups were compared (1) the total effective rate of diabetes complicated with coronary heart disease treatment; (2) the differences of fasting blood glucose, E/A, plasma viscosity and erythrocyte aggregation index between patients before and after intervention.

Significantly effective: After treatment, the number of angina pectoris attacks of the patient was reduced by >80%, the duration of the attack was significantly shortened, the pain was significantly reduced, and the ECG and blood sugar levels were normal; , pain relief, ECG and blood sugar levels improved; ineffective: the above criteria were not met. The total effective rate of diabetes combined with coronary heart disease treatment = markedly effective rate + effective rate.

1.4 Statistical processing methods

SPSS 21.0 software was used to count the data of patients with diabetes mellitus complicated with coronary heart disease. The enumeration data was tested by χ ² , and the measurement data was by t test. P<0.05 was considered to be statistically significant.

2 results

2.1 Comparison of the total effective rate of the two groups of patients with diabetes and coronary heart disease

Compared with the control group, the treatment group had a higher total effective rate in the treatment of diabetes complicated with coronary heart disease, and the difference was statistically significant (P<0.05), as shown in Table 13.

Table 13 Comparison of the total effective rate of diabetes complicated with coronary heart disease in the two groups of patients [n(%)]

Note: Compared with the control group, P<0.05.

2.2 Comparison of fasting blood glucose, E/A, plasma viscosity, and erythrocyte aggregation index before and after intervention

Before the intervention, the fasting blood glucose, E/A, plasma viscosity, and erythrocyte aggregation index of the two groups were similar, and the difference was not statistically significant (P>0.05). The index improvement was more significant, and the difference was statistically significant (P<0.05). See Table 14.

Table 14 Comparison of fasting blood glucose, E/A, plasma viscosity, and erythrocyte aggregation index before and after intervention

Note: Compared with before intervention, # means P<0.05; compared with control group after intervention, * means P<0.05.

3 Discussion

Through research, the results show that compared with the control group, the treatment group has a higher total effective rate in the treatment of diabetes combined with coronary heart disease, and the improvement of fasting blood glucose, E/A, plasma viscosity, and red blood cell aggregation index is more significant. Coronary heart disease has an exact curative effect, can effectively improve blood glucose and cardiac function, and improve hemodynamics, which is beneficial to the prognosis of patients, and is worthy of promotion.

6. Clinical research on the treatment of diabetes complicated with cerebral infarction

Diabetes is more prone to macrovascular disease, and cerebral infarction is a serious complication. The disease is mainly characterized by lacunar infarction, small artery infarction, and middle artery infarction, and has a high incidence and recurrence rate. The inventors applied Jianpi Huoluo Fang to treat diabetes mellitus with coronary heart disease, and obtained good curative effect, which is summarized as follows:

1 Materials and methods

1.1 General information 60 patients with type 2 diabetes mellitus complicated with cerebral infarction admitted to Shantou Hospital of Traditional Chinese Medicine from January 2018 to December 2019 were randomly divided into two groups. The control group consisted of 17 males and 13 females, aged 40-75 years, with an average age of (59.7±12.3) years, diabetes duration of 2-31 years, and an average duration of (15.6±5.8) years, cerebral infarction site: 8 There were parietal lobe infarction in 13 cases, basal ganglia infarction in 13 cases, multiple cerebral infarction in 2 cases, and frontal lobe infarction in 7 cases. In the observation group, 18 cases were male and 12 were female, and the average age was ( 60.6±12.9) years old, the course of disease was 1 to 30 years, the average course of disease was (16.1±5.9) years, the location of cerebral infarction: 6 cases were parietal lobe infarction, 15 cases were basal ganglia infarction, 3 cases were multiple cerebral infarction, 6 cases were Frontal lobe infarction. There was no significant difference in general data such as age, gender and course of disease between the two groups.

1.2 Methods Clinically, the patients in the control group received routine treatment, namely, symptomatic treatment such as lowering intracranial pressure, lowering lipids and controlling blood sugar, and closely monitored the blood sugar of the patients. The observation group was given the decoction of Example 1 on the basis of the treatment of the control group, decoction in water, 1 dose per day, and twice in the morning and evening. 1 course of treatment is 1 month.

1.3 Efficacy evaluation criteria The National Institutes of Health Stroke Scale (NIHSS) score, which reflects neurological function, is used for scoring. (1) Basic recovery: the clinical symptoms completely disappear, and the neurological deficit score is reduced by 91% to 100% compared with that before treatment. The disability level is grade 0; (2) markedly effective: clinical symptoms are significantly improved, the degree of neurological deficit is reduced by 46% to 90% compared with before treatment, and the degree of disability is grade 1 to 3; (3) effective: clinical symptoms are alleviated, neurological function Defect score decreased by 18% to 45% compared with before treatment; (4) Ineffective: no change in clinical symptoms, neurological deficit score decreased by <18% compared with before treatment, and even the disease further developed and deteriorated.

2 results

2.1 Comparison of clinical treatment effects between the two groups

Table 15 Comparison of clinical treatment effects between the two groups [n(%)]

*P<0.05 compared between two groups.

2.2 Comparison of adverse reactions between the two groups During the treatment, 1 patient in the observation group had nausea and vomiting; 1 patient had diarrhea, and the incidence of adverse reactions was 6.7%, while in the control group, 3 patients had nausea and vomiting, 2 patients had diarrhea, and adverse reactions The incidence was 16.7% (P<0.05). None of the two patients had serious adverse reactions such as liver and kidney damage, drug allergy, etc., and all patients were relieved after symptomatic treatment, which did not affect the therapeutic effect.

3 Discussion

The results of this study showed that the total effective rate of treatment in the observation group was 90%, while that in the control group was 70%. It can be seen that Jianpi Huoluo Decoction has a significant effect on improving neurological function. The incidence of adverse reactions is low, so it is worthy of further clinical research and promotion.

Claims

A traditional Chinese medicine composition for strengthening the spleen and activating collaterals, characterized in that: calculated in parts by weight, the formula is composed of the following components: 15-25 parts of Pueraria lobata, 12-18 parts of Salvia miltiorrhiza, 25-35 parts of Atractylodes Rhizoma, 25-35 parts of Codonopsis Radix, Treats 8-12 parts, Shichangpu 8-12 parts, Dilong 12-18 parts, Chuanxiong 8-12 parts, Astragalus 25-35 parts, Tian Qi 8-12 parts.
The traditional Chinese medicine composition for strengthening the spleen and activating collaterals according to claim 1, is characterized in that: by weight, the formula is made up of the following components: 18-22 parts of Pueraria lobata, 14-16 parts of Salvia miltiorrhiza, 28-32 parts of Atractylodes Rhizoma, Codonopsis pilosula 28-32 parts, Cork 9-11 parts, Shichangpu 9-11 parts, Dilong 14-16 parts, Chuanxiong 9-11 parts, Astragalus 28-32 parts, Tianqi 9-11 parts.
The traditional Chinese medicine composition for strengthening the spleen and activating collaterals according to claim 1, is characterized in that: by weight, the formula is made up of the following components: 20 parts of Pueraria lobata, 15 parts of Salvia miltiorrhiza, 30 parts of Atractylodes Rhizoma, 30 parts of Codonopsis pilosula, 10 parts of Treats , 10 copies of Shichangpu, 15 copies of Dilong, 10 copies of Chuanxiong, 30 copies of Astragalus, and 10 copies of Tianqi.
The application of the Chinese medicine composition for strengthening the spleen and activating collaterals according to any one of claims 1 to 3 in the preparation of medicines for the treatment of diabetes, diabetic peripheral neuropathy, diabetic peripheral vascular disease, diabetic fundus disease, diabetes complicated with coronary heart disease or diabetes complicated with cerebral infarction.
Application according to claim 4, is characterized in that: described medicine is decoction, granule, tablet, capsule, oral liquid or pill.
The application according to claim 4, characterized in that: the medicine is a preparation prepared by adding medicinal excipients with extracts of components in the Chinese medicine composition for strengthening the spleen and activating collaterals as active ingredients.
The application according to claim 6, wherein the extract is a water extract.
Application according to claim 4, is characterized in that: described diabetes, diabetic peripheral neuropathy, diabetic peripheral vascular disease, diabetic ocular fundus disease, diabetes with coronary heart disease or diabetes with cerebral infarction are the late stage of diabetes of spleen deficiency and collateral stasis type, Diabetic peripheral neuropathy, diabetic peripheral vascular disease, diabetic retinopathy, diabetes with coronary heart disease or diabetes with cerebral infarction.