CN111643586A

CN111643586A - Traditional Chinese medicine composition for invigorating spleen and activating collaterals and application thereof

Info

Publication number: CN111643586A
Application number: CN202010744301.0A
Authority: CN
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: Shantou Hospital Of Traditional Chinese Medicine
Current assignee: Shantou Hospital Of Traditional Chinese Medicine
Priority date: 2020-07-29
Filing date: 2020-07-29
Publication date: 2020-09-11
Also published as: WO2022021636A1

Abstract

The invention discloses a traditional Chinese medicine composition for invigorating spleen and activating collaterals and application thereof, wherein the formula comprises the following components in parts by weight: 15-25 parts of kudzuvine root, 12-18 parts of salvia miltiorrhiza, 25-35 parts of bighead atractylodes rhizome, 25-35 parts of codonopsis pilosula, 8-12 parts of golden cypress, 8-12 parts of grassleaf sweelflag rhizome, 12-18 parts of earthworm, 8-12 parts of szechuan lovage rhizome, 25-35 parts of astragalus mongholicus and 8-12 parts of pseudo-ginseng. The invention relates to a formula for treating diabetes from spleen and stomach, which has the functions of strengthening spleen and replenishing qi, and activating blood and dredging collaterals, and is used for treating diabetes arthralgia caused by spleen deficiency and collateral stasis, with symptoms of dry mouth, polydipsia, polyphagia, diuresis, listlessness, sallow or deep black complexion, abdominal fullness and distention, bad appetite, scaly skin and nail, limb paralysis and pain, which are mainly stabbing pain, aggravation at night, intermittent claudication, hemiplegia, facial distortion, pale tongue with petechia, white fur, deep, thready and unsmooth pulse and the like; the medicine has obvious curative effect on diabetes, diabetic peripheral neuropathy, diabetic angiopathy, diabetic fundus oculi lesion, diabetes complicated with coronary heart disease, diabetes complicated with cerebral infarction and other symptoms after being taken.

Description

Traditional Chinese medicine composition for invigorating spleen and activating collaterals and application thereof

Technical Field

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

Background

Diabetes is a common clinical disease and a frequently encountered disease, and the prevalence rates of diabetes and pre-diabetes in the population over 18 years old in China investigated by the 2010 Ningguang professor team reach 11.6% and 50.1% respectively. The prevalence rate of diabetes in China increases year by year, particularly, the prevalence rate rises sharply in recent years, the development trend is not optimistic, the morbidity situation is changed, and epidemiological data show that the prevalence rate of diabetes and obesity in China is more than 80%.

Diabetes mellitus, is mostly in the category of diabetes mellitus in traditional Chinese medicine. The related discussion of diabetes is first seen in the "interior classic" and has the names of "diabetes", "sanxiao", "diaphragmatic consumption" and "Xiaozhong". Explanation in "introduction to text and explanation of words": "Xiao, as far as possible" means "thin, disperse and consume". Thirst and desire for drinking are also defined as dry mouth and desire for drinking. From a conceptual point of view, the disease name is a summary of patients with similar symptoms. Ancient physicians have formed various theories when discussing the pathogenesis of diabetes, and ancient physicians have enriched and developed the pathogenesis of diabetes, including yin deficiency and dryness-heat theory, three-syndrome theory, liver depression and qi stagnation theory, blood stasis-induced syndrome theory and the like.

At present, it is considered that the pathogenesis of lung, stomach and kidney is "yin deficiency as the principal factor and dryness heat as the secondary factor", and the treatment focuses on "nourishing yin and clearing heat".

However, the clinical findings, whether the etiology and pathogenesis, the clinical manifestations, or the treatment methods, are different from the ancient times. The applicant finds in long-term clinical practice that modern diabetics drink water without quenching the thirst of the diabetics, and the water cannot generate body fluid so that frequent urination is caused; the patients with diabetes eat too much food and are easy to hunger, the skin is not good, and the food eaten by the patients does not nourish the limbs and is thin; modern diabetes patients are mostly obese, fat people are abundant in phlegm, phlegm dampness is abundant, and dampness damages spleen, typical patients suffering from yin deficiency and dryness heat type diabetes are rare, yin is nourished to help dampness to obstruct spleen, and heat is cleared to damage spleen yang to cause phlegm dampness to be worse. Therefore, whether the disease is caused by yin deficiency or dryness-heat, the disease is only the "sign" of diabetes, and only the symptoms of diabetes are seen, but the root cause of the disease is ignored.

Modern diabetes mellitus has evolved from yin deficiency and dryness-heat to spleen and stomach weakness, no rising of clear yang, downward flow of damp turbidity, stagnation of ministerial fire, insufficiency of primordial qi of the spleen and stomach, ascending of damp turbidity and yin fire from the lower energizer, consumption of qi, blood and body fluid of human body, impairment of qi, blood and body fluid distribution and no circulation to cause diabetes, and is treated by tonifying spleen and stomach, rising of clear yang, purging damp turbidity and lowering yin fire.

The middle and late stages of modern diabetes patients mostly have serious peripheral vascular and peripheral neuropathy and fundus oculi lesion, and the lesion is marked by spleen deficiency and collateral stasis. Diabetic peripheral neuropathy, the most common chronic complication and major disabling cause of diabetes, is believed by modern medicine to be mainly due to dysfunction of supply of neuro-microvasculature, resulting in insufficient supply of neurotrophic factors, leading to neuronal cell death and thus to nerve damage. Diabetic Retinopathy (DR), which is a common fundus complication caused by diabetes, is the most serious microvascular disease of diabetes, can seriously affect the optic nerve function of a patient, causes peripheral nerve dysfunction, is a main cause of blindness of the patient, and is relatively troublesome to treat. The pathogenesis of the modern medicine is mainly abnormal carbohydrate metabolism, protein glycosylation is caused by long-term hyperglycemia, retina arteriole damage is caused, the vascular permeability is increased, and the vascular basement membrane is thickened to cause DR. The minimally invasive retinal surgery has certain curative effect, mainly adopts retinal laser photocoagulation, hemostasis, blood vessel dilation, microcirculation improvement and the like, but has invasive property, more complications and not ideal effect of improving optic nerve function, so the drug therapy is still the main clinical treatment means, especially patients with I, II and III stage retinopathy. The strict control of blood sugar is the basis for preventing and delaying the pathological changes of nerves and blood vessels, but the ideal control of blood sugar cannot completely prevent the pathological changes of nerves and blood vessels, so the aim of preventing the pathological changes of nerves and blood vessels cannot be completely fulfilled by controlling blood sugar alone. The traditional Chinese medicine has unique advantages in preventing and improving diabetes and complications thereof. However, there are few Chinese patent medicines for treating middle and late stages of diabetes, especially complicated peripheral neuropathy and peripheral vasculopathy, and some have focused on tonifying qi, activating blood circulation, dredging collaterals and relieving pain, such as mu dan granules; some pay attention to nourishing yin, tonifying qi, clearing heat and activating blood, such as yin-nourishing and blood sugar-reducing tablets, some pay attention to nourishing yin, clearing heat, activating blood, dissolving stasis, tonifying qi and reinforcing kidney, such as Tangmaikang granules, some pay attention to tonifying qi, nourishing yin, activating blood, dissolving stasis, such as Qizhi blood sugar-reducing capsules and the like, and related researches similar to the effects of strengthening spleen, tonifying qi, activating blood and dredging collaterals of the invention are not available temporarily, and the market does not supply the variety.

Disclosure of Invention

In order to solve the problems of the prior art, the invention aims to provide a traditional Chinese medicine composition for strengthening spleen and activating collaterals, which has the effects of regulating spleen and stomach, strengthening spleen and replenishing qi, promoting blood circulation and removing meridian obstruction, performing purgation and tonification simultaneously, having precise and appropriate compatibility and obvious characteristics of a rational method, and is safe and effective for treating patients with diabetes and complications thereof caused by spleen deficiency and collateral stasis in the middle and later stages of diabetes.

The invention also aims to apply the traditional Chinese medicine composition for strengthening spleen and activating collaterals to prepare medicines for treating diabetes and complications thereof.

The purpose of the invention is realized by the following steps: a traditional Chinese medicine composition for invigorating spleen and activating collaterals is characterized in that: the formula comprises the following components in parts by weight: 15-25 parts of kudzuvine root, 12-18 parts of salvia miltiorrhiza, 25-35 parts of bighead atractylodes rhizome, 25-35 parts of codonopsis pilosula, 8-12 parts of golden cypress, 8-12 parts of grassleaf sweelflag rhizome, 12-18 parts of earthworm, 8-12 parts of szechuan lovage rhizome, 25-35 parts of astragalus mongholicus and 8-12 parts of pseudo-ginseng.

Preferably, the formula consists of the following components in parts by weight: 18-22 parts of kudzuvine root, 14-16 parts of salvia miltiorrhiza, 28-32 parts of largehead atractylodes rhizome, 28-32 parts of pilose asiabell root, 9-11 parts of amur corktree bark, 9-11 parts of grassleaf sweelflag rhizome, 14-16 parts of earthworm, 9-11 parts of szechuan lovage rhizome, 28-32 parts of astragalus root and 9-11 parts of pseudo-ginseng.

Most preferably, the formula consists of the following components in parts by weight: 20 parts of kudzuvine root, 15 parts of salvia miltiorrhiza, 30 parts of largehead atractylodes rhizome, 30 parts of pilose asiabell root, 10 parts of amur corktree bark, 10 parts of grassleaf sweelflag rhizome, 15 parts of earthworm, 10 parts of szechuan lovage rhizome, 30 parts of membranous milkvetch root and 10 parts of pseudo-ginseng.

The traditional Chinese medicine composition for invigorating spleen and activating collaterals is applied to preparation of medicines for treating diabetes, diabetic peripheral neuropathy, diabetic peripheral angiopathy, diabetic fundus oculi lesion, diabetes complicated with coronary heart disease or diabetes complicated with cerebral infarction.

The medicine is decoction, granules, tablets, capsules, oral liquid or pills.

The medicine is a preparation prepared by taking extracts of components in the formula of the traditional Chinese medicine composition for strengthening spleen and activating collaterals as effective components and adding pharmaceutic adjuvants.

The extract is water extract.

The diabetes, the diabetic peripheral neuropathy, the diabetic peripheral angiopathy, the diabetic fundus oculi lesion, the diabetic complicated coronary heart disease or the diabetic complicated cerebral infarction are the later stage of the diabetes with spleen deficiency and collateral stasis, the diabetic peripheral neuropathy, the diabetic peripheral angiopathy, the diabetic fundus oculi lesion, the diabetic complicated coronary heart disease or the diabetic complicated cerebral infarction.

The invention relates to a formula for treating diabetes from spleen and stomach, which has the functions of strengthening spleen and replenishing qi, and promoting blood circulation and removing obstruction in channels, and is used for treating diabetes caused by spleen deficiency and collateral stasis, with symptoms of dry mouth, polydipsia, polyphagia, diuresis, listlessness, sallow or sallow complexion, abdominal fullness and distention, bad appetite, scaly skin and nail, limb paralysis and pain, which are mainly stabbing pain, aggravation at night, intermittent claudication, hemiplegia, facial distortion, pale tongue with petechia, white fur, deep, thready and unsmooth pulse and the like; the medicine has obvious curative effect on diabetes, diabetic peripheral neuropathy, diabetic angiopathy, diabetic fundus oculi lesion, diabetes complicated with coronary heart disease, diabetes complicated with cerebral infarction and other symptoms after being taken.

Detailed Description

The invention relates to a traditional Chinese medicine composition for strengthening spleen and activating collaterals, which comprises the following components in parts by weight: 15-25 parts of kudzuvine root, 12-18 parts of salvia miltiorrhiza, 25-35 parts of bighead atractylodes rhizome, 25-35 parts of codonopsis pilosula, 8-12 parts of golden cypress, 8-12 parts of grassleaf sweelflag rhizome, 12-18 parts of earthworm, 8-12 parts of szechuan lovage rhizome, 25-35 parts of astragalus mongholicus and 8-12 parts of pseudo-ginseng. Preferably, the formula consists of the following components in parts by weight: 18-22 parts of kudzuvine root, 14-16 parts of salvia miltiorrhiza, 28-32 parts of largehead atractylodes rhizome, 28-32 parts of pilose asiabell root, 9-11 parts of amur corktree bark, 9-11 parts of grassleaf sweelflag rhizome, 14-16 parts of earthworm, 9-11 parts of szechuan lovage rhizome, 28-32 parts of astragalus root and 9-11 parts of pseudo-ginseng. Most preferably, the formula consists of the following components in parts by weight: 20 parts of kudzuvine root, 15 parts of salvia miltiorrhiza, 30 parts of largehead atractylodes rhizome, 30 parts of pilose asiabell root, 10 parts of amur corktree bark, 10 parts of grassleaf sweelflag rhizome, 15 parts of earthworm, 10 parts of szechuan lovage rhizome, 30 parts of membranous milkvetch root and 10 parts of pseudo-ginseng.

The traditional Chinese medicine composition for invigorating spleen and activating collaterals is applied to preparation of medicines for treating diabetes, diabetic peripheral neuropathy, diabetic peripheral angiopathy, diabetic fundus oculi lesion, diabetes complicated with coronary heart disease or diabetes complicated with cerebral infarction. Especially for treating patients with diabetes complicated with coronary heart disease, diabetes complicated with cerebral infarction, diabetic peripheral neuropathy, diabetic peripheral angiopathy or diabetic fundus oculi lesion caused by spleen deficiency and collateral stasis.

The medicine can be in the form of decoction, granules, tablets, capsules, oral liquid or pills and other oral preparations. The medicine is a corresponding preparation prepared by taking extracts of components in the formula of the traditional Chinese medicine composition for strengthening spleen and activating collaterals as active ingredients, adding pharmaceutic adjuvants of corresponding dosage forms and adopting the existing general process. Preferably, the extract is an aqueous extract.

The formula of the invention is from a theoretical system of 'treating diabetes from spleen and stomach' of the inventor, and the pathogenesis of the diabetes is considered as follows: the key to the treatment is the harmonization of the spleen and stomach with the combined action of tonification and purgation, because the spleen and stomach are disordered and the essence is not transported and the viscera are not nourished. Diabetes is often manifested as spleen deficiency with stagnated heat, channel stasis, middle-stage deficiency of spleen and lung, deficiency of heart and spleen, deficiency of spleen and kidney, and impairment of yin and yang in later stage, and develops into syndrome of deficiency of yin and yang or spleen deficiency with collateral stasis.

The symptoms of diabetes mainly include consumption of polyphagia, dry mouth and polydipsia, and the metabolism and transportation of diet are closely related to the spleen and stomach. Then, how do water drinks enter the human body? Su Wen, Jing Mai Bing Lun (plain questions, Jing Mai Bing Lun): it enters the stomach, and has the functions of transporting qi upwards to the spleen, dispersing essence from spleen qi, entering the lung, regulating water passage and transporting urinary bladder downwards. Refined water, four cloth, parallel five meridians. Under normal conditions, food enters the human body, and is decomposed by the stomach to generate the micro-substances of essence, which are then distributed to the whole body by the transportation and transformation of the spleen to support the functional activities of the whole body. When the spleen and stomach are damaged due to abnormal diet, the disease will occur. Therefore, early in the period of the "internal classic", it is clearly suggested that the onset of diabetes is either internal injury to the spleen and stomach due to overeating the fat, sweet and thick taste, or the heat accumulation in the stomach is primarily in the spleen and stomach.

The disorder of spleen and stomach, which is not classified into the nature, will cause heat, depression, dampness, phlegm, turbidity and stasis in the long term.

The food is fat, sweet and thick, and can damage spleen and stomach, and the food is not transported and dissolved, the dregs in the body can not be discharged through the actions of spleen and stomach ascending clear and descending turbid, the dregs accumulate in intestines to generate internal heat, and the body fluid is burned by decoction, so the dryness and heat are endogenous, and the diabetes is caused.

Long-term diabetes with a thick and fat taste can cause internal damage to the spleen and stomach due to changes of ointment and beam, and internal generation of phlegm-dampness due to spleen deficiency, resulting in diabetes.

Emotional depression, liver-qi discomfort, and heat resulting from prolonged stasis of blood can also lead to diabetes.

Secondly, when the spleen fails to transport and transport, the essence fails to transport and the viscera fail to nourish, the qi and blood will be deficient, and the yin and yang will be deficient for a long time.

The spleen and stomach are in the middle energizer and transport and transform food, which are the pivotal points of qi movement and the sources of qi and blood. If the spleen fails to transport and transform, the spleen fails to disperse essence, the essence fails to enter the lung from the upper part, and the essence fails to enter the bladder from the lower part, which results in malnutrition of the zang-fu organs. Impairment of spleen and stomach, biochemical and passive blood, deficiency of both qi and blood, and deficiency of healthy qi may cause not only diabetes but also various kinds of transformation syndromes. Malnutrition of the blood vessels and disharmony of the meridians can lead to paralysis of the limbs; liver and kidney yin deficiency failing to nourish the ears and eyes, manifested as blurred vision, sudden blindness, deafness, etc.; stagnant blood obstructing the collaterals and deficiency of the healthy qi may cause sores, furuncles, carbuncles and cellulitis due to heat-toxin.

The invention combines a large amount of clinical practice, and considers that clinically common deficiency-excess mixed symptoms of diabetes are seen, and the deficiency-excess mixed symptoms run through the whole course of the diabetes. The deficiency syndrome mainly refers to qi deficiency and yin deficiency, generally speaking, it is manifested as spleen deficiency with lung heat, spleen deficiency with excess stomach, spleen deficiency with liver depression, middle stage spleen-lung deficiency, heart-spleen deficiency, spleen-kidney deficiency, and later stage impairment of yin and yang, and it develops into yin-yang deficiency or spleen deficiency with collateral obstruction. The concurrent syndrome is mostly excess syndrome, mainly manifested as depression, heat, dampness, phlegm, turbidity and stasis, usually caused by the intermingled pathogenic qi, or in the whole course of diabetes, or in some stage. Therefore, harmonizing the spleen and stomach, and performing both reinforcement and elimination are the core treatment methods, and reinforcing the spleen and strengthening the body resistance are the core, and in the process of strengthening the body resistance, the elimination of pathogenic factors must be considered.

The middle and later stages of modern diabetes patients mostly have serious peripheral vascular and peripheral neuropathy, which is manifested by spleen deficiency and collateral stasis, and aiming at the characteristics of the disease, the spleen-tonifying and collateral-activating formula is used for treating the diabetes and the complications, and the curative effect is definite and exact. In the formula, the bighead atractylodes rhizome, rhizoma atractylodis macrocephalae, as a monarch drug, strengthens the spleen, replenishes qi and eliminates dampness, and the codonopsis pilosula, as a monarch drug, strengthens the middle warmer and supplements qi to ensure that the middle warmer is transported; radix astragali is matched to supplement the qi of the whole body, and the salvia miltiorrhiza, the ligusticum wallichii and the panax notoginseng are used for promoting blood circulation, removing blood stasis, dredging spleen and collaterals, supplementing qi to promote blood circulation and are used as ministerial drugs; radix Puerariae has effects of invigorating clear yang to dredge spleen collaterals, relieving fever to promote fluid production to quench thirst, rhizoma Acori Calami has effects of eliminating dampness and promoting appetite, regulating qi-flowing, eliminating phlegm and removing turbid pathogen, Lumbricus has effects of promoting blood circulation and dredging collaterals, and cortex Phellodendri has effects of clearing heat, eliminating dampness and invigorating spleen to reduce yin fire, and guiding fire to origin. The whole formula is lifted and combined, and the effects of tonifying spleen and qi, and promoting blood circulation and removing obstruction in channels are achieved together.

According to modern researches, the bighead atractylodes rhizome in the formula has the effects of promoting recovery of damaged vegetative nerve functions, adjusting functional balance of human viscera, regulating gastrointestinal motility, reducing blood sugar, promoting urination, enhancing resistance and the like, and the codonopsis pilosula polysaccharide can reduce blood sugar of mice with diabetes caused by alloxan, improve insulin resistance to a certain extent and improve insulin sensitivity of organisms; radix astragali has effects in resisting free radical injury and enhancing immunity; the salvia miltiorrhiza contains a large amount of diterpene quinone pigment, tanshinone, tanshinol, diyl aldehyde and other substances, has the effects of promoting blood circulation, removing blood stasis, reducing blood viscosity and the like, can well improve the blood viscosity condition of a diabetic patient, has the effects of calming, easing pain, inhibiting release of oxygen free radicals and the like, can dilate blood vessels, improve microcirculation disturbance, reduce blood fat, remove free radicals, resist inflammation, resist oxidation and the like, and can improve the microcirculation of eyeground and the ischemia and anoxia state of retina; kudzu root has the function of reducing blood sugar, the preparation of the kudzu root formula and the extract thereof is widely used for treating diabetes and complications thereof, calamus can improve immunity, resist tumor, reduce lipid and resist inflammation, and earthworm has the functions of improving microcirculation, regulating blood pressure, improving atherosclerosis and hemangioma, improving blood rheology and the like; cortex Phellodendri has various pharmacological effects, including blood sugar lowering, antibacterial, antifungal, antitussive, blood pressure lowering, trichomonal resisting, hepatitis resisting, antiulcer, and immunosuppressive effects.

Therefore, the clinical treatment of diabetes generally takes the functions of regulating spleen and stomach and performing both reinforcement and purgation as the core, and creates the formula for tonifying spleen and activating collaterals.

Example 1 (decoction)

The formula consists of the following components: 20g of kudzuvine root, 15g of salvia miltiorrhiza, 30g of largehead atractylodes rhizome, 30g of pilose asiabell root, 10g of amur corktree bark, 10g of grassleaf sweelflag rhizome, 15g of earthworm, 10g of szechuan lovage rhizome, 30g of membranous milkvetch root and 10g of pseudo-ginseng. Decocting in water until a bowl is taken.

Example 2 (decoction)

The formula consists of the following components: 18g of kudzuvine root, 14g of salvia miltiorrhiza, 28g of largehead atractylodes rhizome, 28g of pilose asiabell root, 9g of amur corktree bark, 9g of grassleaf sweelflag rhizome, 14g of earthworm, 0g of szechuan lovage rhizome, 28g of membranous milkvetch root and 9g of pseudo-ginseng. Decocting in water until a bowl is taken.

Example 3 (decoction)

Each agent of the formula consists of the following components: 22g of kudzuvine root, 16g of salvia miltiorrhiza, 32g of largehead atractylodes rhizome, 32g of pilose asiabell root, 11g of amur corktree bark, 11g of grassleaf sweelflag rhizome, 16g of earthworm, 10g of szechuan lovage rhizome, 32g of membranous milkvetch root and 11g of pseudo-ginseng. Decocting in water until a bowl is taken.

Example 4 (decoction)

The formula consists of the following components: 20g of kudzuvine root, 14g of salvia miltiorrhiza, 30g of largehead atractylodes rhizome, 32g of pilose asiabell root, 9g of amur corktree bark, 11g of grassleaf sweelflag rhizome, 16g of earthworm, 11g of szechuan lovage rhizome, 28g of membranous milkvetch root and 11g of pseudo-ginseng. Decocting in water until a bowl is taken.

Example 5 (tablet)

The formula comprises the following components in parts by weight: 25 parts of kudzuvine root, 18 parts of salvia miltiorrhiza, 35 parts of largehead atractylodes rhizome, 35 parts of pilose asiabell root, 12 parts of amur corktree bark, 12 parts of grassleaf sweelflag rhizome, 18 parts of earthworm, 12 parts of szechuan lovage rhizome, 35 parts of membranous milkvetch root and 12 parts of pseudo-ginseng. Extracting with water twice, each time adding 8-10 times of water, decocting for 1-1.5 hr, mixing water extractive solutions, concentrating, and drying to obtain dry extract.

Grinding 20g of the dry extract into fine powder, adding medicinal starch and aerosil according to a tablet manufacturing process, mixing, granulating, drying, granulating, adding magnesium stearate, mixing uniformly, and pressing into 100 tablets to obtain the tablets. Each tablet weighs 0.3 g.

Example 6 (Capsule)

Grinding 20g of the dry extract prepared in the embodiment 5 into fine powder, adding medicinal starch and superfine silica gel powder according to a capsule manufacturing process, mixing, sieving, and encapsulating to prepare 100 capsules to obtain the capsules. The weight of each content is 0.2 g.

Clinical comparative experiment

In order to objectively evaluate the clinical effectiveness and safety of the traditional Chinese medicine composition, the clinical research is carried out on the medicine according to the requirements of clinical research guidelines of new traditional Chinese medicines. The following studies were approved by the ethical committee of the Shantou province of TCM, and patients gave their consent to the study.

Clinical research on diabetes treatment

1 data and method

1.1 general data about 64 patients with peripheral neuropathy of diabetes mellitus who were diagnosed in outpatient service of diabetes department and department of residence in Shantou City in 2016 (1 month-2018) month were randomly divided into two groups: spleen invigorating and collateral activating formula for treatment group and control group. The observation group comprises 32 cases, 17 cases for men and 15 cases for women, the average age (58.2 +/-6.8) year, the diabetic course (10.5 +/-3.1) year, the diabetic peripheral neuropathy course (6.8 +/-4.6) year and the fasting blood sugar (7.1 +/-2.0) mmol/L; the control group comprises 32 cases, 20 cases for men and 12 cases for women, the age (57.9 +/-5.3) years, the diabetic course (11.8 +/-4.2) years, the diabetic peripheral neuropathy course (7.1 +/-2.2) years and fasting blood glucose (7.4 +/-1.8) mmol/L. The difference between the two groups of cases in terms of general data is not statistically significant, (P >0.05), and the cases are comparable.

1.2 standard of diagnosis and syndrome differentiation Western diagnosis: diabetes diagnosis and typing was performed according to the 1999 WHO diagnosis and classification criteria. The traditional Chinese medicine syndrome differentiation standard is as follows: dry mouth with polydipsia, mental fatigue, sallow complexion, abdominal fullness and distention, bad appetite, pain due to paralysis of limbs, pain due to stabbing pain, aggravation at night, intermittent claudication, hemiplegia, pale and dark tongue with petechia, white coating, deep, thready and unsmooth pulse.

1.3 inclusion criteria (1) compliance with type 2 diabetes diagnostic criteria; (2) the syndrome differentiation of the traditional Chinese medicine belongs to a patient who can be treated by using the spleen-tonifying and collateral-activating formula due to spleen deficiency and collateral stasis.

1.4 exclusion criteria (1) people under 35 years of age or over 75 years of age; (2) cognitive impairment, those without complete expression ability, those who cannot be co-treated. (3) Those with serious liver, kidney, heart and brain diseases or those with diabetes ketosis. (4) Combined with other neuropathy such as multiple sclerosis, erythromelalgia, lumbar intervertebral disc prolapse, cervical spondylotic radiculopathy, etc. (5) Poor compliance, no prescribed medication, affecting clinical efficacy.

2 method

2.1 methods of treatment both groups are given diabetes complex treatment, i.e. health education, diet management, exercise management, blood sugar monitoring and management, etc., oral hypoglycemic drugs or conventional treatment with insulin. The control group orally administered Mikebao tablets, 0.5mg each time, 3 times/day. The spleen-tonifying and collateral-activating formula in example 1 is added to the observation group for treatment, the decoction is taken with water, 1 dose is taken every day, the decoction is 400mL, 200mL is taken every time, the warm decoction is taken 2 times in the morning and evening, and the treatment result is counted after 4 weeks of treatment.

2.2 Observation index

2.2.1 safety assessment criteria general physical examination: blood pressure, respiration, pulse, body temperature. ② routine examination of hematuria and defecation.

2.2.2 curative Effect observations fasting and 2h post-prandial blood glucose, glycated hemoglobin, TCSS score.

2.3 statistical treatment of relevant data in the study statistical treatment was performed by selecting statistical software SPSS 18.0, the measured data was expressed as mean plus or minus standard deviation, and the comparison difference of the counting data among groups was significant and was statistically significant when P <0.05 by t-test.

3 results

3.1 comparison of blood glucose and glycated hemoglobin in 2 groups of patients before and after treatment 2 groups of patients had no statistical difference in comparison of fasting blood glucose, postprandial 2h blood glucose and glycated hemoglobin before treatment (P >0.05), and was comparable. The fasting blood sugar of the patients in the group 2 is reduced after treatment, the contrast difference before and after treatment has statistical significance (P <0.05), the blood sugar level, the fasting blood sugar level and the glycosylated hemoglobin level of the patients in the group with the spleen-tonifying and collateral-activating formulas after treatment for 2 hours after meal are obviously superior to those of the patients in the control group (P <0.05), and the statistical significance exists, and is shown in table 1.

TABLE 1 comparison of fasting plasma glucose, postprandial 2h blood glucose and glycated hemoglobin before and after treatment (n ═ 32)

Note: major axis of kidney meridian, major axis of kidney meridian is P < 0.05; ● compared to the control group, P < 0.05.

3.2 results of TCSS scores (Toronto clinical neuropathy scores) of 2 groups of patients before and after treatment, the TCSS scores of two groups of patients after treatment are obviously reduced compared with the TCSS scores of the patients before treatment, the difference has statistical significance (P is less than 0.05), the two groups of patients are shown to be improved through treatment symptoms, compared among the groups, the TCSS scores of the observation group are reduced more obviously (P is less than 0.05), and the treatment effect of the observation group is better than that of the control group. See table 2.

TABLE 2 comparison of TCSS scores before and after treatment in two groups

Note: major axis of kidney meridian, major axis of kidney meridian is P < 0.05; ● P <0.05 compared to control

3.3 before and after treatment, adverse reactions of 2 groups of patients do not have acute complications such as liver and kidney dysfunction, diabetic ketoacidosis, hypoglycemia coma and the like.

3. Conclusion

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

Clinical practice shows that the spleen-tonifying and collateral-activating formula disclosed by the invention is used for treating spleen deficiency and collateral stasis in the middle and later stages of diabetes, shows that patients with limb paralysis and stabbing pain as main symptoms are accurate in blood sugar reducing effect and safe to use, and has more advantages than western medicine treatment in terms of improving the life quality of the patients and relieving symptoms caused by diabetes.

Second, clinical research for treating diabetic retinopathy

1. Data and method

1.1 general data of all 68 cases are inpatients in traditional Chinese medicine of Shantou city of 1 month-2019 month in 2017, and are divided into two groups according to a random digital table method. Treatment groups 34, 20 men and 14 women; the age is 45-78 years, and the average (56.67 +/-6.53) years; the disease course is 2-14 years, and the average (8.46 +/-0.67) year; staging of retinopathy: 16 cases in I phase, 12 cases in II phase and 6 cases in III phase. Control group 34, 19 men and 15 women; age 46-76 years, mean (56.65 ± 6.57) years; the disease course is 1-16 years, and the average (8.48 +/-0.69) years; staging of retinopathy: 18 cases in I phase, 11 cases in II phase and 5 cases in III phase. The comparison difference between two groups of general data has no statistical significance (P is more than 0.05), and the data is comparable.

1.2 case selection

1.2.1 reference is made to the diagnostic standard of DR in modern diabetes diagnostic and therapeutic science; ② the syndrome differentiation of the traditional Chinese medicine belongs to the patients who can be treated by the spleen-tonifying collateral-activating prescription of the invention.

1.2.2 is brought into the standard that anticoagulation and microcirculation improvement medicines are not used in nearly 4 weeks; no organ dysfunction; ③ no drug allergy.

1.2.3 exclusion criteria (first there is a history of retinal surgery); ② gestation; ③ not signing treatment informed consent; fourthly, patients with incomplete clinical data or lost visits; patients with other primary or secondary retinopathy are combined; sixthly, merging the blood system diseases; and patients with serious cardiovascular and cerebrovascular and liver and kidney function damage, or patients with diabetic ketosis, hyperosmolar coma and serious disturbance.

1.3 methods of treatment two groups are both used for treating hypoglycemic drugs and controlling exercise and diet, and the blood sugar is controlled stably.

1.3.1 the control group was orally administered with 0.5g of calcium dobesilate capsule (Beijing Jingfeng pharmaceutical group, Ltd., national drug Standard H20010795) 3 times a day.

1.3.2 treatment groups are added with traditional Chinese medicine treatment on the basis of control groups, and the decoction of the spleen-tonifying and collateral-activating formula in the embodiment 1 is orally taken for 1 day.

1.3.3 treatment course two groups each have 4 weeks as 1 treatment course, and 2 treatment courses are continued.

1.4 observation indexes and methods, namely, 3-5 mL of fasting elbow venous blood of a patient is extracted in the morning, the blood is centrifuged conventionally, supernatant is taken, the levels of VEGF and Ang-1 are detected by adopting an enzyme-linked immunosorbent assay (ELISA), and the level of SOD is detected by adopting a colorimetric method. The kit is provided by Shanghai enzyme-linked biotechnology, Inc., and the operation is carried out according to the kit instruction. Secondly, a full-automatic hemorheology analyzer (Tangyu medical instrument science and technology development Co., Ltd. of Tianjin) is used for detecting hemorheology indexes such as plasma viscosity, whole blood viscosity (high cut), whole blood viscosity (medium cut), whole blood viscosity (low cut), erythrocyte aggregation index, erythrocyte rigidity index and Fibrinogen (FIB).

1.5 curative effect standard is significant: after the treatment, the vision of the patient is improved by 4 rows, and microangioma and hemorrhage basically disappear; the method has the following advantages: after the treatment, the vision of the patient is improved by 2 lines, and microangioma and bleeding part disappear; and (4) invalidation: after the treatment, the vision and the above-mentioned pathological changes of the eyeground of the patient have no obvious change or aggravation.

1.6 statistical method SPSS 21.0 statistical software is used for statistical analysis of data, and the average value plus or minus standard deviation is used for measuring data

Representing, adopting t test; the comparison of the count data rate adopts χ²And (6) checking. P <0.05 is statistically significant.

2. Results

2.1 the comparison of the two groups of curative effects and the comparison and difference of the two groups of significant efficiency and total effective rate have statistical significance (P is less than 0.05), and the curative effect of the treatment group is better than that of the control group. See table 3.

TABLE 3 comparison of therapeutic efficacy of two groups of patients [ n (%) ]

Note: p <0.05 compared to control.

2.2 comparison of VEGF, Ang-1 and SOD before and after two groups of treatment, VEGF is reduced (P is less than 0.05) and Ang-1 and SOD is increased (P is less than 0.05) after two groups of treatment are carried out for 4 and 8 weeks, VEGF in the treatment group is lower than that in the control group (P is less than 0.05), and Ang-1 and SOD are higher than that in the control group (P is less than 0.05). See table 4.

TABLE 4 comparison of VEGF, Ang-1, and SOD before and after treatment in two groups of patients (

n＝68)

Note: compared with the group before treatment,^＊p is less than 0.05; compared with the control group which is treated at the same period,^#P＜0.05。

2.3 comparison of hemorheology indexes before and after treatment of two groups, after 4 and 8 weeks of treatment of the treatment group, the plasma viscosity, the whole blood viscosity (high cut), the whole blood viscosity (middle cut), the whole blood viscosity (low cut), the erythrocyte aggregation index, the erythrocyte rigidity index and the FIB are all reduced (P is less than 0.05) compared with those before treatment of the group and are lower than the treatment period (P is less than 0.05) of the control group. The comparative difference of the hemorheology indexes before and after treatment of the control group has no statistical significance (P is less than 0.05). See table 5.

TABLE 5 comparison of rheological indices of blood flow before and after treatment in two groups of patients: (

n＝68)

3. discussion of the related Art

The traditional Chinese medicine holds that DR is developed mainly on the basis of diabetes and spleen deficiency. Long-term diabetes, deficiency of both qi and yin, weakness of blood circulation due to qi deficiency, blood stasis in the eyes and collaterals; in addition, most of the patients have senile asthenia, deficiency of kidney essence, deficiency of liver blood, difficulty in supplying essence and blood to eyes, and malnutrition of eye collaterals, so the vision is blurred; qi deficiency failing to control blood may cause blood to overflow the vessels, causing bleeding, and finally causing blood stasis which may not be removed for a long time, further obstructing the eye collaterals and causing blindness. Just as the book "changeable deafness of thirsty patients" recorded in "Ru Men Shi Qin", the book "essential formula for syndrome treatment" could be recorded in the cloud "the three kinds of diseases are chronic, the essence and blood are deficient, or not seen at all". Therefore, DR is mostly indicated for deficiency of origin and excess of origin, with qi deficiency or deficiency of both qi and yin as the origin, blood stasis and phlegm as the secondary symptoms, and the pathological changes in spleen, liver and kidney should be treated with the therapeutic principles of invigorating spleen and replenishing qi, tonifying liver and kidney, and promoting blood circulation to remove blood stasis. Calcium dobesilate is a capillary vessel regulating medicament which is developed and marketed in recent years and mainly treats microangiopathy and varicose vein syndrome. Has good effect on microangiopathy.

The microvascular disease becomes the basic link of DR onset, which is characterized in that a capillary non-perfusion area is enlarged, a large retinal blood vessel is blocked, severe ischemia and hypoxia occur, and a new blood vessel is finally formed, and a plurality of cytokines participate in the process. VEGF is a vascular endothelial growth factor, and its high expression promotes the formation of DR neovasculature, enhances vascular permeability, induces endothelial cell growth, and in addition, promotes retinal oxidative stress, induces inflammatory responses, and exacerbates retinal injury. Ang-1 can regulate blood vessel formation, inhibit VEGF expression and blood vessel proliferation, and improve stability of endothelial cell. SOD indirectly reflects the antioxidant ability in vivo. As the disease condition worsens, the retinal tissue may develop a hyperemia and dilation of the capillaries, resulting in a tractional retinal detachment, which may lead to blindness in the patient. The hyperglycemia causes fundus microcirculation disturbance, activates protein kinase C, catalyzes and activates endothelial cell nitric oxide synthase, and promotes angiogenesis. In addition, low blood flow perfusion generates more free radicals, activates certain genes inducing apoptosis, and aggravates optic nerve damage.

The research result shows that the VEGF level is reduced, Ang-1 and SOD are increased (P is less than 0.05) after the treatment group is treated for 4 to 8 weeks, the VEGF level is lower than the control group treatment period (P is less than 0.05), and Ang-1 and SOD are higher than the control group treatment period (P is less than 0.05), which indicates that the expression of blood VEGF and Ang-1 is regulated to strengthen the spleen and benefit the collaterals, so that the retina microvascular formation is intervened, and the disease progression is inhibited. Abnormal indexes of hemorheology are also one of important factors of DR, and as retinal blood vessels are fine, blood plasma viscosity, whole blood viscosity, erythrocyte aggregation index and FIB are increased once, microvascular emboli are easily formed, the retinal oxygen resistance is reduced, and compensatory expansion of blood vessels is promoted, so that hemangioma is formed, and the disease condition of a patient is caused or aggravated. The research result shows that the blood plasma viscosity, the whole blood viscosity, the erythrocyte aggregation index, the erythrocyte rigidity index and the FIB of the treated group are all lower than those of a control group (P is less than 0.05), which indicates that the spleen-tonifying and collateral-activating formula can reduce the level of the hemorheology index, thereby improving the local microcirculation of retina and the vision level of a patient, and the research result is probably related to the strong blood circulation and blood stasis-removing effects of the spleen-tonifying and collateral-activating formula.

In conclusion, DR is mostly formed due to spleen qi deficiency and blood stasis blocking the eye collaterals, the spleen-tonifying and collateral-activating formula of the invention has the effects of tonifying spleen and replenishing qi, activating blood and dissolving stasis, can obviously improve hemorheology and retinal microcirculation blood vessel formation of DR patients, improves vision level, treats both principal and secondary aspect of disease, has high safety, and is worthy of clinical popularization and application.

Clinical research on treatment of diabetic peripheral neuropathy

1 clinical data

1.1 test subjects

80 patients with diabetic peripheral neuropathy (DSPN) who were collected by traditional Chinese medicine hospitals in Shantou City between 7 months and 2019 months in 2018 are selected. Treatment groups and control groups were divided according to the random number table method, 40 each. In the treatment group, 26 men and 14 women; the age is 45-76 years, and the average (54.1 +/-2.2) years; the disease course is 3-20 years, and the average (10.5 +/-3.2) years. In the control group, 21 men and 19 women; age 43-77 years, mean (53.3 ± 3.1) years; the disease course is 2-19 years, and the average (10.1 +/-1.3) years. The general data of sex, age, course of disease, etc. of 2 groups were compared, and the difference was not statistically significant (P >0.05), and was comparable.

1.2 diagnostic criteria

1.2.1 the standard of Western medicine diagnosis is formulated with reference to the Chinese guideline for prevention and treatment of type 2 diabetes (2017). (1) A definite history of diabetes; (2) diagnosing neuropathy occurring at or after diabetes; (3) clinical symptoms and signs are consistent with the manifestations of DSPN; (4) for patients with clinical symptoms (pain, numbness, paresthesia, etc.), 1 of the 5 tests (ankle reflex, acupuncturing pain sensation, temperature sensation, vibration sensation, pressure sensation) is abnormal; the patient without clinical symptoms, 2 abnormal patients in 5 tests, and the clinical diagnosis is DSPN; (5) the following are excluded: neuropathy caused by other causes, such as cervical and lumbar spondylosis (nerve root compression, spinal stenosis, cervical and lumbar degeneration), cerebral infarction, Guillain-Barre syndrome; severe arteriovenous vascular lesions (venous embolism, lymphangitis), etc.; neurotoxic effects of drugs, especially chemotherapeutic drugs, and damage to nerves by metabolic poisons caused by renal insufficiency.

1.2.2 spleen deficiency and collateral blood stasis type diagnosis standard: (1) mental fatigue, (2) sallow or sallow complexion, (3) abdominal fullness and distention, (4) bad appetite, (5) scaly complexion, (6) pain of limbs paralysis, mainly tingling pain, (7) aggravation at night, (8) intermittent claudication, (9) hemiplegia, (10) facial distortion, (11) pale and dark tongue with petechia and white fur, and (12) deep, thready and unsmooth pulse. Those who meet the above symptoms of more than 7 items are considered to be diabetes with spleen deficiency and collateral stasis.

1.3 inclusion criteria

(1) Age: 18-80 years old; (2) the diabetes diagnosis standard is met; (3) the diagnostic standard of diabetes DSPN is met; (4) based on the above standards, the traditional Chinese medicine distinguishes the pattern of spleen deficiency and collaterals stasis.

1.4 exclusion criteria

(1) Pregnant or lactating women; (2) those with cognitive or communication disorders; (3) severe impairment of liver and kidney function; (4) other serious system or organ disorders; (5) in the last one month, people with diabetic ketoacidosis or serious infection; (6) certain allergic conditions, or those who are allergic to any medication used in the treatment.

2. Research method

2.1 basic treatment: adopts conventional western medicine treatment. Comprises diabetic diet, proper exercise, health education, oral administration of proper hypoglycemic agent or insulin injection. The blood sugar control level is 5.0-8.0 mmol/L of fasting blood sugar and 5.0-10.0 mmol/L of blood sugar before sleep.

2.2 control group: on the basis of the basic treatment, each patient is orally administered with mecobalamin tablets of 500 μ g 3 times a day.

2.3 treatment groups: on the basis of the treatment of the control group, each patient added the formulation of example 1 and decocted to 400mL, 200mL each time, and taken 2 times in the morning and evening.

2.4 statistics of treatment results 8 weeks after treatment.

3. Observation index

3.1TCSS scores included neurological symptom, reflex and sensory scores: (1) symptoms are: numbness or unconsciousness of the lower limbs, pain (burning pain or electric shock-like pain), weakness, needle-prick-like sensation, unstable walking, and inquiry as to whether the upper limbs have similar symptoms. No abnormality counts 0 point, one symptom counts 1 point, and 6 points in total; (2) reflection: ankle and knee reflex, 8 points in total, no abnormality is counted as 0 point, one side is weakened to 1 point, and disappearance is 2 points; (3) feeling: the right thumb was examined for 5 items of pain sensation, vibration sensation, position sensation, tactile sensation and temperature sensation, with no abnormal score of 0, and one symptom of 1 score, for a total of 5 scores. The total score of 3 examinations was 19.

3.2 shock sensation threshold (VPT) check-sensory nerve of foot: the patient is allowed to lie on the back, the vibration sensation tester is connected to the first toe base and the instep of the patient, the amplitude of the vibration tester is increased along with the increase of the current, the number of volts of the vibration is sensed by the patient and is an examination result, the measurement is carried out for 3 times, and the average value is obtained. Reference ranges: the lesion critical area is 10-15V, mild-moderate lesion is 16-24V, and severe lesion is > 25V.

3.3 refer to "Classification and analysis of clinical efficacy assessment criteria for diabetic peripheral neuropathy" to determine the efficacy of 3 groups of patients after treatment: (1) the effect is shown: no subjective symptom, basically normal knee tendon reflex and normal VPT inspection result; (2) the method has the following advantages: subjective symptoms and knee tendon reflex are improved obviously, and VPT examination results are improved; (3) and (4) invalidation: subjective symptoms, knee tendon reflexes and VPT examination were unchanged. The total effective rate is the sum of the effective and effective cases/the total cases multiplied by 100%.

3.4 quality of life assessment: the assessment scale refers to a quality of life simple scale SF-36, which is approved by the World Health Organization (WHO) and has reliable credibility. The scale comprises 8 dimensions and covers aspects of living functions and functions, physical pain, energy, general health status, emotional and mental health status, and the like. And respectively scoring and accumulating all dimensions, wherein the scores are original scores, and then converting the original scores into total average scores through a standard formula, wherein the scores are 0 to 100, and the higher the score is, the better the life quality is.

3.5. Statistical analysis

Data were statistically analyzed by SPSS 20.0. The counting data is tested by adopting X2, and the grading data is tested by adopting rank sum. Measure data to

Showing that the results are compared before and after treatment in the group, if the results accord with normal distribution, the matching t test is adopted, and if the results do not accord with normal distribution, the rank sum test is adopted; and 2, comparing the groups, and performing t test when the groups accord with normal distribution and the variances are uniform, and performing rank sum test when the groups do not accord with the variances. The difference is statistically significant when P is less than 0.05.

4 results

Baseline balance of TCSS score in group 4.12 patients versus TCSS score in pre-treatment group 2 patients (P > 0.05); after treatment, TCSS scores were significantly lower in all 2 groups than before treatment (P <0.05), with statistical differences between groups (P <0.05), as shown in table 6.

TABLE 6 TCSS score for comparative 2 groups of patients

Note that compared with the treatment before,^aP<0.05; in comparison with the control group,^bP<0.05。

4.22 patients' VPT test results are not significantly different from the VPT test results of 2 patients before treatment (P > 0.05); after treatment, the VPT test results were significantly reduced in 2 groups (P <0.05) and the contrast difference between 2 groups (P <0.05) as shown in Table 7.

TABLE 7 results of VPT examination of patients of comparative group 2

n＝40]

the curative effect of 4.32 patients is compared with the total effective rate of 87.50% in an observation group after treatment, 62.50% in a control group, and the comparison difference of 2 groups is obvious (P is less than 0.05), which is shown in a table 8.

TABLE 8 curative effect [ n (%) ] on 3 groups of patients

Note that, in comparison with the control group,^aP<0.05。

before 4.42 groups of patients are treated by comparing the quality of life, the difference of the total average score of each dimension of the quality of life SF-36 of 2 groups is not obvious (P is more than 0.05); after treatment, the overall average of each dimension of the life quality SF-36 of the 2 groups is obviously improved (P is less than 0.05), and the contrast difference between the 2 groups is obvious (P is less than 0.05), which is shown in the table 9.

TABLE 9 quality of life [ 2 ] group

n＝40]

4.52 groups of patients do not have adverse reactions compared with two groups of patients who do not have liver and kidney function abnormality and acute complications such as diabetic ketoacidosis, hypoglycemia coma and the like. In 40 patients in the control group, 1 patient shows slight dizziness and has no withdrawal treatment, and the symptoms are relieved automatically.

Discussion of 5

Vibration sensation threshold (VPT) examination-the sensory nerve of the foot is a specific index for diagnosing diabetic peripheral neuropathy and is a standard for clinically and frequently evaluating diabetic peripheral neuropathy and treatment effect. The research result shows that through comparison before and after treatment and comparison among groups, the spleen-strengthening and collateral-activating formula can obviously improve the clinical symptoms of patients with diabetic peripheral neuropathy, improve the clinical curative effect, improve the life quality of the patients, enhance the treatment confidence of the patients, has no obvious adverse reaction, is simple and easy to implement, has strong operability, and is worthy of clinical popularization and application.

Clinical research on treating spleen deficiency and collateral stasis type diabetic peripheral vascular disease

1 clinical data

1.1 test subjects

90 patients with peripheral vascular diseases of diabetes mellitus who are treated by Shantou Chinese medical hospital in the period of 7 months to 2019 months in 2018 are selected. Treatment groups and control groups were divided according to the random number table method, and each group had 45 cases. In the treatment group, 31 men and 19 women; age 45-77 years, mean (54.1 ± 2.1) years; the disease course is 3-19 years, and the average (10.4 +/-3.2) years. In the control group, 26 men and 24 women; age 42-75 years, mean (53.2 ± 3.0) years; the disease course is 2-21 years, and the average (10.1 +/-1.4) years. The general data of sex, age, course of disease, etc. of 2 groups were compared, and the difference was not statistically significant (P >0.05), and was comparable.

1.2 diagnostic criteria

1.2.1 Western medicine diagnostic standard No. 2017 & lt guidance for prevention and treatment of type 2 diabetes mellitus & gt. (1) Clinically, patients with diabetes are diagnosed. (2) Has clinical manifestations of arteriosclerosis obliteration ischemia of lower limb. (3) ABI examination: ABI is less than or equal to 0.90, and the lower limb ischemia can be diagnosed. (4) Carotid artery color ultrasound: suggesting arteriosclerosis, plaque, luminal stenosis, etc. (5) Peripheral vessel CTA, MRA or DSA: indicating stenosis of the lumen, etc.

1.2.2 spleen deficiency and collateral blood stasis type diagnosis standard: (1) mental fatigue, (2) sallow or sallow complexion, (3) abdominal fullness and distention, (4) bad appetite, (5) scaly complexion, (6) pain of limbs paralysis, mainly tingling pain, (7) aggravation at night, (8) intermittent claudication, (9) hemiplegia, (10) facial distortion, (11) pale and dark tongue with petechia and white fur, and (12) deep, thready and unsmooth pulse. Those who meet the above symptoms of more than 7 items can be judged to be diabetes arthralgia syndrome due to spleen deficiency and collateral stasis.

1.3 inclusion criteria

(1) Age: 18-80 years old; (2) the diabetes diagnosis standard is met; (3) the diagnosis standard of diabetic peripheral vascular lesion is met; (4) based on the above standards, the traditional Chinese medicine distinguishes the pattern of spleen deficiency and collaterals stasis.

1.4 exclusion criteria

(1) Pregnant or lactating women; (2) those with cognitive or communication disorders; (3) severe impairment of liver and kidney function; (4) other serious system or organ disorders; (5) in the last one month, people with diabetic ketoacidosis or serious infection; (6) certain allergic conditions, or those who are allergic to any medication used in the treatment. The patients all informed consent and signed an agreement.

2. Research method

2.2 control group: on the basis of basic treatment, 100mg qn of aspirin enteric-coated tablets and 20mg qn of atorvastatin calcium are added to each patient for oral administration.

2.4 statistics of treatment results 8 weeks after treatment.

3. Observation index

And 3.1 carotid intimal-media thickness (CIMT) detecting the IMT of the carotid artery before and after treatment of the patient by using a color Doppler ultrasonic diagnostic apparatus.

3.2ABI evaluation methods refer to the guidelines for diagnosis and treatment of arteriosclerosis obliterans of lower limbs (2015). (1) ABI calculation method: the ratio of the systolic pressure of the ankle artery (posterior tibial artery or dorsal foot artery) to the systolic pressure of the upper arm (the side with the higher numerical value of the left and right arms). (2) ABI evaluation method: normal range: 1.00 to 1.40; critical range: 0.91 to 0.99; ischemia of lower limbs: 0.9% or less.

3.3 the curative effect is judged (1) the clinical cure is: clinical symptoms and physical signs disappear or basically disappear, and the index of the curative effect of the symptoms is more than or equal to 90 percent; or ABI returned to the normal range. (2) The effect is shown: the clinical symptoms and physical signs are obviously improved, and the symptom curative effect index is more than or equal to 70 percent and less than 90 percent; or ABI returns to a critical value. (3) The method has the following advantages: the clinical symptoms and physical signs are improved, and the curative effect index of the symptoms is more than or equal to 30 percent and less than 70 percent; or the ABI is improved over before treatment. (4) And (4) invalidation: clinical symptoms and physical signs are not obviously improved or even aggravated, and the index of curative effect of symptoms is less than 30%; or no improvement in ABI compared to pre-treatment.

Note: the index of the symptom efficacy is (pre-treatment integral-post-treatment integral)/pre-treatment integral x 100%. If the therapeutic effect of the syndrome is inconsistent with that of ABI, the therapeutic effect is better.

3.4. Statistical analysis

4 results

Baseline balance of CIMT in group 4.12 patients versus 2 patients before treatment (P > 0.05); after treatment, the observed group showed a significant decrease in CIMT compared to pre-treatment (P <0.05), with statistical differences between the group comparisons (P <0.05), as shown in table 10.

TABLE 10 comparison of 2 groups of patients CIMT (mm), (+)

n＝40]

4.22 patients had no significant difference in ABI test results compared to the ABI test results of the 2 patients before treatment (P > 0.05); after treatment, the VPT test results were significantly reduced in 2 groups (P <0.05) and the contrast difference between 2 groups (P <0.05) as shown in Table 11.

TABLE 11 ABI examination result of comparative group 2 patients

n＝40]

the curative effect of 4.32 patients is compared with the total effective rate of 87.50% in an observation group after treatment, 62.50% in a control group, and the comparison difference of 2 groups is obvious (P is less than 0.05), which is shown in Table 12.

TABLE 12 curative effect [ n (%) ]for comparative 2 groups of patients

Note that, in comparison with the control group,^aP<0.05。

4.52 groups of patients do not have adverse reactions compared with two groups of patients who do not have liver and kidney function abnormality and acute complications such as diabetic ketoacidosis, hypoglycemia coma and the like.

Discussion of 5

The research result shows that through comparison before and after treatment and comparison among groups, the spleen-tonifying and collateral-activating formula can obviously improve the clinical symptoms of patients with diabetic peripheral vasculopathy, improve the clinical curative effect, improve the life quality of the patients, enhance the treatment confidence of the patients, has no obvious adverse reaction, is simple and easy to operate, has strong operability, and is worthy of clinical popularization and application.

Clinical research on treating diabetes complicated with coronary heart disease

The diabetic is mainly characterized by blood viscosity and blood flow speed reduction caused by abnormal rise of blood sugar, and can cause serious complications such as cardiovascular diseases and the like. Coronary heart disease is a common cardiovascular complication of diabetes, and is mainly characterized by myocardial ischemia and hypoxia caused by myocardial coronary atherosclerosis and luminal stenosis. In recent years, the aging trend of China is accelerated, and the incidence of diabetes and coronary heart disease is increased year by year due to the change of dietary structure, so that the diabetes and coronary heart disease are treated in time, and the prognosis of patients is improved. The inventor applies the spleen-strengthening and collateral-activating formula to treat diabetes complicated with coronary heart disease, and obtains better curative effect, which is summarized as follows:

1 data and method

1.1 general data

The subjects included in the study are 83 randomly drawn in patients receiving and treating diabetes mellitus combined with coronary heart disease in 12-month Shantou city Chinese medical hospitals in 2018. All patients met the diagnosis standard of coronary heart disease and diabetes, and were informed to agree with the study. The 83 patients with diabetes complicated with coronary heart disease were randomly divided into 41 control groups and 42 treatment groups. The treatment group had 27 men and 15 women; the age is 37-80 years, and the average age is 49.34 +/-11.13 years. The disease course is 5 months to 5 years, and the average disease course (2.51 +/-0.21) years; the weight is 42 kg-78 kg, and the average weight is 57.31 +/-8.25 kg. 27 men and 14 women in the control group; the age is 37-79 years, and the average age is 49.10 +/-11.53 years. The disease course is 5 months to 5 years, and the average disease course (2.56 +/-0.25) years; the weight is 42 kg-78 kg, and the average weight is (57.92 + -8.45) kg. The general data of two groups of patients, the difference has statistical significance P >0.05, and is comparable.

1.2 standard of diagnosis and syndrome differentiation Western diagnosis: diabetes diagnosis and typing are carried out according to the 1999 WHO diagnosis and classification standard; coronary heart disease was diagnosed according to 2007 'guidelines for diagnosis and treatment of chronic stable angina pectoris'.

The traditional Chinese medicine syndrome differentiation standard is as follows: dry mouth with polydipsia, chest distress or chest pain, mental fatigue and hypodynamia, sallow complexion, abdominal fullness and distention, bad appetite, limb paralysis and pain, stabbing pain as the main part, aggravation at night, intermittent claudication, hemiplegia, pale and dark tongue with petechia, white fur and deep, thready and unsmooth pulse.

1.3 inclusion criteria (1) meets the diagnosis criteria of type 2 diabetes and coronary heart disease; (2) the syndrome differentiation of the traditional Chinese medicine belongs to a patient who can be treated by using the spleen-tonifying and collateral-activating formula due to spleen deficiency and collateral stasis.

1.4 exclusion criteria (1) under 35 years of age or over 80 years of age; (2) cognitive impairment, those without complete expression ability, those who cannot be co-treated. (3) Patients with diabetic ketosis, diabetic ketoacidosis, severe hypertension, severe arrhythmia, severe cardiopulmonary insufficiency, tumor, or serious primary diseases of liver, kidney, brain, hematopoietic system, etc. (4) The chest distress and pain caused by acute myocardial infarction or other heart diseases, cervical spondylosis, hyperthyroidism, reflux of stomach and esophagus, gallbladder heart disease, severe neurosis, climacteric syndrome and the like are proved after perfect examination. (5) Poor compliance, no prescribed medication, affecting clinical efficacy.

1.5 methods

And (3) performing conventional treatment on the control group by western medicine, performing oral administration or insulin injection on a hypoglycemic drug, controlling the blood sugar level to be 3.9-7.8 mmol/L, and performing lipid regulation and plaque stabilization by simvastatin, wherein the conventional diet guidance and exercise guidance are combined.

The treatment group is added with traditional Chinese medicine treatment on the basis of a control group, and the decoction (hereinafter called as the spleen-tonifying and collateral-activating formula) in the embodiment 1 of the invention is orally taken for 1 day.

Both groups were treated for 1 month.

1.6 Observation indicators and standards

Comparing the total effective rate of the two groups of patients (1) for treating diabetes and coronary heart disease; (2) differences in fasting plasma glucose, E/A, plasma viscosity, and erythrocyte aggregation index in patients before and after intervention.

The effect is shown: through treatment, the attack frequency of angina pectoris of a patient is reduced by more than 80 percent, the attack duration is obviously shortened, the pain is obviously relieved, and the electrocardiogram and the blood sugar level are normal; the method has the following advantages: through treatment, the frequency of angina attack of a patient is reduced by more than 50%, the attack duration is shortened, the pain is relieved, and the electrocardiogram and the blood sugar level are improved; and (4) invalidation: the above standard is not achieved. The total effective rate of the treatment of diabetes combined with coronary heart disease is marked as obvious efficiency and effective rate.

1.4 statistical processing methods

SPSS 21.0 software statistics of data of patients with diabetes and coronary heart disease, and data collection of the count²And (5) checking, namely, t-checking the metering data. The difference is statistically significant when P is less than 0.05.

2 results

2.1 the total effective rate of the two groups of patients for treating diabetes complicated with coronary heart disease

The total effective rate of the treatment group is higher than that of the control group for treating diabetes complicated with coronary heart disease, and the difference has statistical significance (P is less than 0.05), which is shown in Table 13.

TABLE 13 comparison of the total effective rate of diabetes and coronary heart disease treatment for two groups of patients [ n (%) ]

Note: p is less than 0.05 compared with the control group.

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

Before intervention, the fasting blood sugar, E/A, blood plasma viscosity and erythrocyte aggregation index of the two groups are similar, and the difference has no statistical significance (P is more than 0.05); compared with a control group, the treatment group has more obvious improvement on fasting blood glucose, E/A, plasma viscosity and erythrocyte aggregation index after intervention, and the difference has statistical significance (P is less than 0.05). See table 14.

TABLE 14 comparison of fasting plasma glucose, E/A, plasma viscosity, erythrocyte aggregation index before and after intervention

Note: compared with before intervention, # denotes P < 0.05; p <0.05 compared to control group after intervention.

Discussion of 3

The research shows that the total effective rate of the treatment group is higher than that of the control group for treating the diabetes complicated with the coronary heart disease, and the improvement of the fasting blood sugar, the E/A, the blood plasma viscosity and the erythrocyte aggregation index is more obvious.

Sixth, clinical research for treating diabetes complicated with cerebral infarction

Diabetes mellitus is easy to have large vascular lesion, wherein combined cerebral infarction is a more serious complication, and the diabetes mellitus is mainly characterized by interstitial infarction, small artery infarction and middle artery infarction and has higher morbidity and recurrence rate. The inventor applies the spleen-strengthening and collateral-activating formula to treat diabetes complicated with coronary heart disease, and obtains better curative effect, which is summarized as follows:

1 materials and methods

1.1 general data Shantou Chinese medicine Hospital, No. 8 patients who received treatment in 1 month-2019 12 months in 2018 and had type 2 diabetes combined cerebral infarction were divided into two groups at random. The control group comprises 17 men and 13 women, the ages of the two groups are 40-75 years, the average age is (59.7 +/-12.3) years, the diabetes course is 2-31 years, the average course is (15.6 +/-5.8) years, and the cerebral infarction positions are as follows: 8 cases are apical leaf infarction, 13 cases are basal segment infarction, 2 cases are multiple cerebral infarction, 7 cases are frontal lobe infarction; the observation group includes 18 men and 12 women, the ages of the men are 42-77 years, the average age is (60.6 +/-12.9) years, the course of disease is 1-30 years, the average course of disease is (16.1 +/-5.9), the cerebral infarction positions: 6 cases are apical lobe infarction, 15 cases are basal segment infarction, 3 cases are multiple cerebral infarction, and 6 cases are frontal lobe infarction. The two groups of patients have no significant difference in the general data of age, sex and course of disease.

1.2 methods clinically, the conventional treatment of patients in a control group, namely symptomatic treatment for reducing intracranial pressure, reducing blood fat, controlling blood sugar and the like, and closely monitors the blood sugar of the patients. The observation group was administered the decoction of example 1 based on the treatment of the control group, and the decoction was decocted in water and taken 1 dose daily, 2 times in the morning and evening with warm water. 1 course of treatment is 1 month.

1.3 therapeutic efficacy assessment criteria application of the National Institute of Health Stroke Scale (NIHSS) score for neurological function to score, (1) basic recovery: clinical symptoms completely disappear, the neurological impairment score is reduced by 91-100% compared with that before treatment, and the disability degree is 0 grade; (2) the effect is shown: the clinical symptoms are obviously improved, the neurological impairment degree is reduced by 46-90% compared with that before treatment, and the disability degree is grade 1-3; (3) the method has the following advantages: the clinical symptoms are relieved, and the neurological impairment score is reduced by 18 to 45 percent compared with that before treatment; (4) and (4) invalidation: no change in clinical symptoms occurred, the neurological deficit score decreased by < 18% compared to before treatment, and the disease condition progressed further.

2 results

2.1 comparison of the clinical treatment effects of the two groups, after 1 course of treatment, no 1 patient died and successfully completed the treatment, see Table 15

TABLE 15 comparison of two groups of clinical treatment effects [ n (%) ]

P <0.05 for both groups.

2.2 during the period of two groups of adverse reactions contrast treatment, 1 patient in the observation group is observed to have nausea and vomiting; 1 patient had diarrhea with 6.7% of adverse reactions, while 3 patients in the control group had nausea and vomiting, and 2 patients had diarrhea with 16.7% of adverse reactions (P < 0.05). No 1 patient of the two patients has serious adverse reactions such as liver and kidney damage, drug allergy and the like, and all the patients are relieved after symptomatic treatment without influencing the treatment effect.

Discussion of 3

The research result shows that the total effective rate of the observation group is 90%, the total effective rate of the control group is 70%, the effect of strengthening spleen and activating collaterals on improving nerve function is obvious, and compared with the control group, the observation group has low incidence rate of adverse reaction, so the method is worthy of further clinical research and popularization.

Claims

1. A traditional Chinese medicine composition for invigorating spleen and activating collaterals is characterized in that: the formula comprises the following components in parts by weight: 15-25 parts of kudzuvine root, 12-18 parts of salvia miltiorrhiza, 25-35 parts of bighead atractylodes rhizome, 25-35 parts of codonopsis pilosula, 8-12 parts of golden cypress, 8-12 parts of grassleaf sweelflag rhizome, 12-18 parts of earthworm, 8-12 parts of szechuan lovage rhizome, 25-35 parts of astragalus mongholicus and 8-12 parts of pseudo-ginseng.

2. The spleen-invigorating and collateral-activating traditional Chinese medicine composition according to claim 1, which is characterized in that: the formula comprises the following components in parts by weight: 18-22 parts of kudzuvine root, 14-16 parts of salvia miltiorrhiza, 28-32 parts of largehead atractylodes rhizome, 28-32 parts of pilose asiabell root, 9-11 parts of amur corktree bark, 9-11 parts of grassleaf sweelflag rhizome, 14-16 parts of earthworm, 9-11 parts of szechuan lovage rhizome, 28-32 parts of astragalus root and 9-11 parts of pseudo-ginseng.

3. The spleen-invigorating and collateral-activating traditional Chinese medicine composition according to claim 1, which is characterized in that: the formula comprises the following components in parts by weight: 20 parts of kudzuvine root, 15 parts of salvia miltiorrhiza, 30 parts of largehead atractylodes rhizome, 30 parts of pilose asiabell root, 10 parts of amur corktree bark, 10 parts of grassleaf sweelflag rhizome, 15 parts of earthworm, 10 parts of szechuan lovage rhizome, 30 parts of membranous milkvetch root and 10 parts of pseudo-ginseng.

4. The use of the spleen-invigorating and collateral-activating Chinese medicinal composition of any one of claims 1-3 for the preparation of a medicament for treating diabetes, diabetic peripheral neuropathy, diabetic peripheral angiopathy, diabetic retinopathy, diabetes complicated with coronary heart disease or diabetes complicated with cerebral infarction.

5. Use according to claim 4, characterized in that: the medicine is decoction, granules, tablets, capsules, oral liquid or pills.

6. Use according to claim 4, characterized in that: the medicine is a preparation prepared by taking extracts of components in the formula of the traditional Chinese medicine composition for strengthening spleen and activating collaterals as effective components and adding pharmaceutic adjuvants.

7. Use according to claim 6, characterized in that: the extract is water extract.

8. Use according to claim 4, characterized in that: the diabetes, the diabetic peripheral neuropathy, the diabetic peripheral angiopathy, the diabetic fundus oculi lesion, the diabetic complicated coronary heart disease or the diabetic complicated cerebral infarction are the later stage of the diabetes with spleen deficiency and collateral stasis, the diabetic peripheral neuropathy, the diabetic peripheral angiopathy, the diabetic fundus oculi lesion, the diabetic complicated coronary heart disease or the diabetic complicated cerebral infarction.