WO2022021637A1 - 一种健脾益肾中药组合物及其应用 - Google Patents
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Definitions
- the invention relates to the field of traditional Chinese medicine formulations, in particular to a traditional Chinese medicine composition for strengthening the spleen and nourishing the kidney.
- Diabetes is a common and frequently-occurring disease in clinical practice.
- 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.
- “Thirsty and desire” means “dry mouth and desire to drink”.
- 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.
- Diabetic retinopathy is one of the more serious microvascular diseases of diabetes, and it is mainly manifested by different degrees of vision loss in clinical practice.
- 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, but it is invasive and has many complications. Therefore, drug therapy is still the main clinical treatment method, especially for patients with stage I, II, and III retinopathy.
- Diabetic retinopathy is mostly treated with western medicines such as improving microcirculation and lowering blood sugar, but the clinical efficacy is often unsatisfactory and there are many adverse reactions.
- the purpose of the present invention is to provide a traditional Chinese medicine composition for strengthening the spleen and nourishing the kidney, which has definite curative effect, has the functions of strengthening the spleen, nourishing the lung and nourishing the kidney, nourishing the yin and promoting the body fluid, and treating diabetes and diabetes mellitus caused by deficiency of both qi and yin.
- Retinopathy, diabetic nephropathy and other complications are safe and effective.
- Another object of the present invention is to apply the above-mentioned traditional Chinese medicine composition for strengthening the spleen and nourishing the kidney in the preparation of medicines for the treatment of diabetes, diabetic retinopathy, diabetic nephropathy and other complications.
- a kind of Chinese medicine composition for strengthening the spleen and nourishing the kidney is characterized in that: calculated in parts by weight, the formula is made up of the following components: 15-25 parts of pueraria, 12-18 parts of Salvia miltiorrhiza, 25- 35 parts, Taizishen 25-35 parts, Treats 12-18 parts, Astragalus 25-35 parts, Chinese yam 12-18 parts, Angelica 12-18 parts, Ligustrum lucidum 12-18 parts, Cornus 12-18 parts, Zhigancao 3-7 servings, 8-12 servings of dried tangerine peel.
- the formula is composed of the following components: 18-22 parts of Pueraria lobata, 14-16 parts of Salvia miltiorrhiza, 28-32 parts of Atractylodes Rhizoma, 28-32 parts of Taizishen, 14-16 parts of Treats, 28-16 parts of Astragalus 32 parts, 14-16 parts of Chinese yam, 14-16 parts of Angelica sinensis, 14-16 parts of Ligustrum lucidum, 14-16 parts of dogwood, 4-6 parts of licorice root, 9-11 parts of dried tangerine peel.
- 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 Taizishen, 15 parts of Treats, 30 parts of Astragalus, 15 parts of Chinese yam, 15 parts of Angelica sinensis, 15 parts of Ligustrum lucidum, 15 parts of dogwood, 5 parts of licorice root, and 10 parts of dried tangerine peel.
- the medicine is decoction, granule, tablet, capsule, oral liquid or pill.
- the medicine is a preparation prepared by taking the extracts of the components in the formula of the Chinese medicine composition for strengthening the spleen and nourishing the kidney as the active ingredient and adding medicinal excipients.
- the extract is a water extract.
- diabetes, diabetic retinopathy and diabetic nephropathy are diabetes, diabetic retinopathy and diabetic nephropathy of the deficiency of both qi and yin.
- the present invention is a formula for "treatment of diabetes from the spleen and stomach". , Overeating and weight loss, fatigue, sweating when moving, or seeing metrorrhagia, blood in the stool, subcutaneous hemorrhage, palpitations or upset, insomnia, forgetfulness, soreness of waist and knees, blurred vision, swelling of lower limbs, polyuria or foamy urine etc., the tongue is pale or red with little fluid, the coating is yellow and white or no coating, there are teeth marks on the side, and the pulse is thin and weak; diabetes, diabetic retinopathy, diabetic nephropathy and other complications have obvious curative effect after taking the medicine.
- the invention is a traditional Chinese medicine composition for strengthening the spleen and nourishing the kidney. 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 Taizishen, Treats 12-18 parts, Astragalus 25-35 parts, Chinese yam 12-18 parts, Angelica 12-18 parts, Ligustrum lucidum 12-18 parts, Cornus 12-18 parts, Zhigancao 3-7 parts, Chenpi 8-12 parts .
- the formula is composed of the following components: 18-22 parts of Pueraria lobata, 14-16 parts of Salvia miltiorrhiza, 28-32 parts of Atractylodes Rhizoma, 28-32 parts of Taizishen, 14-16 parts of Treats, 28-16 parts of Astragalus 32 parts, 14-16 parts of Chinese yam, 14-16 parts of Angelica sinensis, 14-16 parts of Ligustrum lucidum, 14-16 parts of dogwood, 4-6 parts of licorice root, 9-11 parts of dried tangerine peel.
- 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 Taizishen, 15 parts of Treats, 30 parts of Astragalus, 15 parts of Chinese yam, 15 parts of Angelica sinensis, 15 parts of Ligustrum lucidum, 15 parts of dogwood, 5 parts of licorice root, and 10 parts of dried tangerine peel.
- 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 nourishing the kidney as the active ingredient, and adding the pharmaceutical excipients of the corresponding dosage form according to the existing general process.
- 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.
- the number of patients with typical symptoms of "three more and one less” has been significantly reduced, mainly manifested as dry mouth, fatigue, shortness of breath, lazy speech, dry stool and blurred vision. Most common. Therefore, the present invention considers that qi and yin deficiency type diabetes is mostly manifested as deficiency of spleen, lung and kidney, and qi and yin of the three viscera.
- 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.
- 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.
- 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.
- 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.
- Deficiency syndrome is mainly qi deficiency and yin deficiency.
- Deficiency syndrome 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.
- the lung, spleen and kidney are mostly manifested as deficiency of the three viscera of the lung, spleen and kidney, which is mainly mainly due to deficiency of both qi and yin.
- the traditional Chinese medicine composition of the present invention is used for treatment. Astragalus is used to strengthen the power of invigorating the middle and replenishing qi, so that the central axis can be transported, and it is a ministerial medicine.
- Chinese yam enters the spleen, lung and kidney to invigorate the spleen and nourish the lung and kidney; Ligustrum lucidum and dogwood enter the liver and kidney to invigorate the yin of the liver and kidney; roast licorice to strengthen the power of invigorating the middle and invigorating qi; tangerine peel strengthens the spleen and regulates qi to make the spleen and stomach move; Dampness helps the spleen to purify and reduce Yin fire, and induces the fire to return to the Yuan as a medicine.
- the whole formula ascends and descends in harmony, together to strengthen the spleen, the lungs and the kidneys, and the powers of nourishing qi, nourishing yin, producing body fluid and quenching thirst.
- Atractylodes atractylodes in this recipe can promote the recovery of damaged autonomic nerve function, adjust the balance of human viscera function, regulate gastrointestinal motility, lower blood sugar, diuresis, and enhance resistance.
- Polysaccharide of Taizishen can reduce the blood sugar of alloxan-induced diabetic mice, and at the same time can improve insulin resistance to a certain extent, and improve the sensitivity of the body to insulin;
- Astragalus has the functions of resisting free radical damage and enhancing immunity;
- Pueraria lobata has the effect of lowering blood sugar.
- the preparations of puerariae and its extracts have been widely used in the treatment of diabetes and its complications.
- Salvia miltiorrhiza contains a large number of diterpene quinone pigments, tanshinones, danshensu, diyl aldehydes and other substances, which have the functions of promoting blood circulation and removing blood stasis, It can reduce blood viscosity and improve the blood viscosity of diabetic patients.
- Angelica has analgesic, anti-inflammatory, and immune function enhancement.
- Chinese yam has antioxidant, anti-aging, immune-regulating, anti-tumor, and hypoglycemic effects.
- Sadako has antioxidant, anti-inflammatory, hypoglycemic, lipid-lowering, immune-regulating, anti-osteoporosis effects; Cornus has obvious immune-regulating, hypoglycemic, anti-tumor, and anti-aging effects; licorice has analgesic and antitussive properties.
- Anti-asthmatic, anti-arrhythmic, anti-inflammatory, and immune-regulating effects, tangerine peel has anti-oxidative and anti-inflammatory effects, and can achieve the effects of regulating blood lipids, anti-thrombosis, and anti-atherosclerosis.
- the three viscera of the spleen, lung and kidney of the present invention are in synchrony, attack and supplement simultaneously, and are well-matched and have obvious characteristics of principles and methods.
- this recipe treats the middle stage of diabetes mellitus, the deficiency of the three viscera of the lung, spleen and kidney, and always uses qi and yin.
- the patients with two-deficiency mainly have definite curative effect, safe and effective.
- the formula consists of the following components: 20g of Pueraria lobata, 15g of Salvia miltiorrhiza, 30g of Atractylodes Rhizoma, 30g of Taizishen, 15g of Treats, 30g of Astragalus, 15g of Chinese yam, 15g of Angelica, 15g of Ligustrum lucidum, 15g of Cornus root, 5g of Zhigancao, and 10g of dried tangerine peel. Add water and cook to a bowl.
- Embodiment 2 (decoction)
- the formula consists of the following components: 18g Pueraria lobata, 14g Salvia miltiorrhiza, 28g Atractylodes Rhizoma, 28g Taizishen, 14g Phellodendri, 28g Astragalus, 14g Chinese yam, 14g Angelica, 14g Ligustrum lucidum, 14g Cornel, 4g licorice, and 9g dried tangerine peel. Add water and cook to a bowl.
- Embodiment 3 (decoction)
- Each dose of the formula consists of the following components: 22g of Pueraria lobata, 16g of Salvia miltiorrhiza, 32g of Atractylodes Rhizoma, 32g of Taizishen, 16g of Treats, 32g of Astragalus, 16g of Chinese yam, 16g of Angelica, 16g of Ligustrum lucidum, 16g of Dogwood, 6g of Zhigancao, and 11g of dried tangerine peel. Add water and cook to a bowl.
- the formula consists of the following components: Pueraria 20g, Salvia miltiorrhiza 16g, Atractylodes Rhizoma 32g, Taizishen 28g, Phellodendron 14g, Astragalus 32g, Chinese yam 16g, Angelica 16g, Ligustrum lucidum 14g, Cornel 14g, Zhigancao 5g, and dried tangerine peel 11g. Add water and cook to a bowl.
- 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 Taizishen, 18 parts of Treats, 35 parts of Astragalus, 18 parts of Chinese yam, 18 parts of Angelica sinensis, 18 parts of Ligustrum lucidum , 18 parts of dogwood, 7 parts of Zhigancao, and 12 parts of dried tangerine peel. 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.
- Example 5 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.
- TCM syndrome differentiation criteria dry mouth and polydipsia, weight loss, retching and hiccups, poor appetite, loose stools or constipation; dry throat and dry cough, palpitations or upset, insomnia and dreaminess, forgetfulness, fatigue, soreness and weakness of waist and knees, sweating or constipation when moving Metrorrhagia, hematochezia, subcutaneous hemorrhage, pale tongue or reddish fluid, yellow or white coating or no coating, tooth marks on the side, thin and weak pulse.
- Exclusion criteria (1) Exclude hospitalized patients with myocarditis, pericardial disease, other organic heart disease, electrolyte imbalance and other heart diseases; (2) Patients with severe cardiovascular and cerebrovascular, liver and kidney dysfunction, or patients with recent diabetes mellitus Symptoms, hyperosmolar coma, and severe interference; (3) Pregnancy, allergies, etc. are not suitable for receiving this treatment plan; (4) Those older than 70 years old; (5) The lifestyle changes during the data collection period may Patients who influence the analysis of the study results; (6) non-cooperators.
- Treatment method Control group diabetes health education, strict diet control, emotional stability, appropriate exercise, oral hypoglycemic drugs or routine insulin therapy, so that blood sugar is controlled at fasting ⁇ 7.0mmol/L, 2h postprandial blood sugar ⁇ 11.0mmol/L L.
- Example 1 of the present invention 20g of Radix Puerariae, 15g of Salvia miltiorrhiza, 30g of Taizishen, 30g of Cortex Phellodendri, 15g of Astragalus, 30g of Chinese yam, 15g of Angelica sinensis, 15g of Ligustrum lucidum, 15g of Dogwood, 15g of Zhigancao, 5g of dried tangerine peel, 10g of tangerine peel), water Decoction, 1 dose per day, decocted into 400mL, 200mL each time, warmed twice in the morning and evening, and the treatment results were counted after 1 month of treatment.
- Radix Puerariae 15g of Salvia miltiorrhiza, 30g of Taizishen, 30g of Cortex Phellodendri, 15g of Astragalus, 30g of Chinese yam, 15g of Angelica sinensis, 15g of Ligustrum lucidum, 15g of Dogwood, 15g
- TCM efficacy Evaluate TCM efficacy by TCM symptom score scale: 1Significantly effective: TCM symptoms and signs have improved significantly, and the symptom score has been reduced by more than or equal to 70%; 2Effective: TCM symptoms and signs have improved, and the symptom score has been reduced more than or equal to 30%; 3 Ineffective: TCM symptoms and signs did not improve significantly, or even worsened, and the symptom score was reduced by less than 30%.
- HbAlc glycosylated hemoglobin
- FBG fasting blood glucose
- 2hPG 2h postprandial blood glucose
- 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”.
- ancient traditional Chinese medicine mostly treats it from “dryness and heat due to yin deficiency”.
- the current clinical findings have changed in terms of etiology, pathogenesis and pathogenesis, clinical manifestations, and even treatment methods.
- Clinical practice has shown that Jianpi Yishen prescription in the treatment of qi and yin deficiency type diabetes not only has an accurate hypoglycemic effect and is safe to use, but also has advantages over simple western medicine in improving the quality of life of patients and alleviating symptoms caused by diabetes.
- control group was given calcium dobesilate capsules (Beijing Jingfeng Pharmaceutical Group Co., Ltd., H20010795) 0.5g, orally three times a day.
- the treatment group added traditional Chinese medicine treatment on the basis of the control group, and the decoction of the embodiment of the present invention 1 (hereinafter referred to as Jianpi Yishen prescription) was taken orally, 1 dose a day, decocted into 400mL, 200mL each time, 2 times in the morning and evening Warm clothes.
- Jianpi Yishen prescription the decoction of the embodiment of the present invention 1
- an automatic blood flow analyzer 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).
- VEGF vascular endothelial growth factor
- Ang-1 angiopoietin 1
- SOD superoxide dismutase
- 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 inability of qi and yin to transport blood, the stagnant blood flow and the obstruction of blood stasis in the eyes and collaterals. 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.
- DR is based on deficiency of both qi and yin, and the lesions are in the spleen, liver, and kidney.
- 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.
- 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.
- DR is mostly formed due to the deficiency of spleen, lung and kidney, qi and yin.
- the spleen and kidney formula of the present invention strengthens the spleen, nourishes the lungs and nourishes the kidney, nourishes the yin and invigorates the body, and can significantly improve the blood rheology and retinal of DR patients.
- the formation of microcirculation blood vessels, the improvement of visual acuity, the treatment of both the symptoms and the symptoms, and the high safety are worthy of clinical application.
- the diagnosed diabetic nephropathy patients 60 selected patients were randomly divided into 2 groups according to the ratio of 1:1, namely the traditional Chinese medicine group and the control group. The gender, age and other general data of the two groups were compared, and SPSS software was used to determine whether they were comparable (no significant difference P>0.05).
- Type 2 diabetes determined by WHO diagnostic classification criteria (1999).
- Tongue pulse The tongue is pale and fat with white or greasy coating, and the pulse is deep and thin.
- the traditional Chinese medicine group and the control group were given conventional western medicine treatment without difference at the same time, including diabetes health education, diet control, oral hypoglycemic drugs or conventional treatment with insulin, so that blood sugar was controlled at ⁇ 7.0mmol/L on an empty stomach, 2 hours after meals Blood sugar ⁇ 10.0mmol/L.
- the Chinese medicine group additionally took the invigorating spleen and nourishing kidney formula of Example 1, decocted in water, 1 dose per day, decocted into 400 mL, 200 mL each time, warmed twice in the morning and evening, 4 weeks was a course of treatment, and after 2 courses of treatment Statistical treatment results.
- microalbuminuria is currently the preferred early diagnostic indicator, and UAER20-200ug/min is defined as microalbumin.
- the short-term efficacy evaluation criteria for renal disease are as follows:
- TCM efficacy Evaluate TCM efficacy by TCM symptom score scale: 1 Markedly effective: TCM symptoms and signs have improved significantly, and symptom scores have been reduced by more than or equal to 70%; UAER has returned to normal or decreased by more than 50% compared with before treatment; blood sugar, blood lipids, etc. Metrics improved by 30% or returned to normal. 2Effective: TCM symptoms and signs improved, symptom scores decreased by more than or equal to 30%; UAER decreased by 20%-49%; blood glucose, blood lipids and other indicators improved by 15%-29%. 3 Invalid: TCM symptoms and signs did not improve significantly, or even worsened, and the symptom score decreased by less than 30%; various laboratory indicators did not meet the above standards or increased.
- diabetes mellitus There is no such thing as "diabetic nephropathy" in traditional Chinese medicine.
- the treatment of this disease lies in the treatment of diabetes mellitus.
- diabetic nephropathy most researchers believe that its pathogenesis is a dynamic evolution process. Deficiency of the spleen and kidney, internal resistance of turbid toxins leads to deficiency of yin and yang of the five viscera, qi and blood.
- the three organs of spleen, lung and kidney are deficient in Qi and Yin. effect.
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Abstract
发明公开了一种健脾益肾中药组合物及其应用，按重量份数计，由以下组分组成：葛根15-25份、丹参12-18份、白术25-35份、太子参25-35份、黄柏12-18份、黄芪25-35份、山药12-18份、当归12-18份、女贞子12-18份、山茱萸12-18份、炙甘草3-7份、陈皮8-12份。本发明是"从脾胃论治糖尿病"的组方，具有健脾益肺补肾、养阴生津之功，用于气阴两虚所致的消渴病，症见口干多饮、咽燥干咳等；糖尿病及糖尿病视网膜病变、糖尿病肾病等并发症见上述证候者服用后均有明显疗效。
Description
本发明涉及中药组方领域，特别是一种健脾益肾中药组合物。
糖尿病是临床常见病、多发病，2010年宁光教授团队在中国18岁以上的人群中调查的糖尿病和糖尿病前期的患病率分别达到11.6％和50.1％。我国糖尿病患病率逐年增加，尤其是近几年患病率骤升，发展趋势不容乐观，且发病情况有所变化，有流行病学资料显示我国糖尿病肥胖者占80％以上。
糖尿病，现代中医多归属于中医学“消渴”范畴。消渴病相关的论述最早见于《内经》，有“消瘅”，“三消”，“膈消”“消中”等病名。《说文解字》中的解释：“消，尽也”，为“消瘦、消散、消耗”的意思。“渴，欲也”，为“口干欲饮”的意思。从字面上的概念看，此病名是对存在类似症状病人的归纳。古代医家论述消渴病的病机时形成了多种学说，历代医家对该病病机都有丰富和发展，形成了包括阴虚燥热说、三消说、肝郁气滞说、瘀血致消说等病机认识。
目前多认为，病变脏腑多责之肺胃肾，基本病机为“阴虚为本，燥热为标”，治疗则重在“养阴清热”。
然而,现今临床发现不论是病因病机与发病，还是临床表现，乃至治疗方法，都与古代不同。申请人在长期临床实践中发现，现代糖尿病人饮水连连却不解其渴，所饮之水不能化生津液而小便频频；消渴病人多食而易饥，且肌肤不荣，所食水谷不养四肢而形体消瘦；现代之消渴病人肥胖者居多，肥人多痰，痰湿素盛，湿盛伤脾，典型“阴虚燥热型消渴”的病人已经少见，养阴则助湿碍脾，清热则伤脾阳而痰湿更甚。所以，不管“阴虚”还是“燥热”，都只是消渴病的“标”，只看到消渴的症状，而忽视疾病的根本。
现代糖尿病病机已从“阴虚燥热”，演变为“脾胃虚弱、清阳不升、湿浊下注、相火郁闭”，脾胃元气不足,来自下焦之湿浊阴火乘机上乘，消耗人体的气血津液,气血津液施布障碍，不循常道而致“消渴”，应以“补脾胃、升清阳、泻湿浊、降阴火”治之。
而关于治疗糖尿病中期的中成药，有的着重于益气健脾，滋阴清热，生津止渴，如糖适康；有的着重于滋阴补肾，益气润肺，和胃生津，如糖尿乐胶囊；有的着重于益气养阴，健脾运津，如津力达颗粒；有的着重于益气养阴，滋脾补肾，如参芪降糖胶囊等等，暂无与本验方健脾益肺补肾，益气养阴生津止渴功效相近的相关研究，市场暂无此类品种供应。
糖尿病视网膜病变(diabetic retinopathy，DR)是糖尿病较为严重的微血管病变之一，临床上 主要表现为不同程度的视力减退，病情严重者可引起失明，严重影响患者生活质量。其现代医学发病机制主要为糖代谢异常，长期的高血糖引起蛋白质糖基化，引起视网膜细微动脉损害，血管通透性增加，血管基底膜增厚而出现DR。视网膜微创手术治疗具有一定疗效，但其为有创性，并发症较多，因此药物治疗仍是临床主要治疗手段，尤其是Ⅰ、Ⅱ、Ⅲ期视网膜病变者。糖尿病视网膜病变多以改善微循环、降血糖等西药治疗为主，但临床疗效常不理想，不良反应较多。
发明内容
为解决现有技术的问题，本发明的目的是提供一种健脾益肾中药组合物，其疗效确切，具有健脾益肺补肾、养阴生津，治疗气阴两虚所致的糖尿病及糖尿病视网膜病变、糖尿病肾病等并发症安全有效。
本发明的另一个目的是将上述健脾益肾中药组合物应用于制备治疗糖尿病及糖尿病视网膜病变、糖尿病肾病等并发症的药物上。
发明的目的是这样实现的：一种健脾益肾中药组合物，其特征在于：按重量份数计算，配方由以下组分组成：葛根15-25份、丹参12-18份、白术25-35份、太子参25-35份、黄柏12-18份、黄芪25-35份、山药12-18份、当归12-18份、女贞子12-18份、山茱萸12-18份、炙甘草3-7份、陈皮8-12份。
优选的，按重量份数计算，配方由以下组分组成：葛根18-22份、丹参14-16份、白术28-32份、太子参28-32份、黄柏14-16份、黄芪28-32份、山药14-16份、当归14-16份、女贞子14-16份、山茱萸14-16份、炙甘草4-6份、陈皮9-11份。
最优选的，按重量份数计算，配方由以下组分组成：葛根20份、丹参15份、白术30份、太子参30份、黄柏15份、黄芪30份、山药15份、当归15份、女贞子15份、山茱萸15份、炙甘草5份、陈皮10份。
所述健脾益肾中药组合物在制备治疗糖尿病、糖尿病视网膜病变、糖尿病肾病的药物的应用。
所述的药物为汤剂、颗粒剂、片剂、胶囊剂、口服液或丸剂。
所述的药物为以所述健脾益肾中药组合物配方中组分的提取物为有效成分，添加药用辅料制得的制剂。
所述的提取物为水提取物。
所述的糖尿病、糖尿病视网膜病变、糖尿病肾病是气阴两虚型的糖尿病、糖尿病视网膜病变、糖尿病肾病。
本发明是“从脾胃论治糖尿病”的组方，具有健脾益肺补肾、养阴生津之功，用于气阴两虚所致的消渴病，症见口干多饮、咽燥干咳、多食消瘦、体倦乏力、动则汗出、或见崩漏、便血、皮下出血心悸怔忡或心烦、失眠多梦、健忘、腰膝酸软、视物模糊、下肢浮肿、多尿或泡沫尿等，舌淡或红少 津，苔黄白或无苔，边有齿印，脉细弱；糖尿病及糖尿病视网膜病变、糖尿病肾病等并发症见上述证候者服用后均有明显疗效。
发明是一种健脾益肾中药组合物，按重量份数计算，配方由以下组分组成：葛根15-25份、丹参12-18份、白术25-35份、太子参25-35份、黄柏12-18份、黄芪25-35份、山药12-18份、当归12-18份、女贞子12-18份、山茱萸12-18份、炙甘草3-7份、陈皮8-12份。优选的，按重量份数计算，配方由以下组分组成：葛根18-22份、丹参14-16份、白术28-32份、太子参28-32份、黄柏14-16份、黄芪28-32份、山药14-16份、当归14-16份、女贞子14-16份、山茱萸14-16份、炙甘草4-6份、陈皮9-11份。最优选的，按重量份数计算，配方由以下组分组成：葛根20份、丹参15份、白术30份、太子参30份、黄柏15份、黄芪30份、山药15份、当归15份、女贞子15份、山茱萸15份、炙甘草5份、陈皮10份。
所述健脾益肾中药组合物在制备治疗糖尿病的药物的应用，尤其是气阴两虚型的糖尿病、糖尿病视网膜病变或糖尿病肾病等。所述的药物可以为汤剂、颗粒剂、片剂、胶囊剂、口服液或丸剂等口服剂型。所述的药物为以所述健脾益肾中药组合物配方中组分的提取物为有效成分，添加相应剂型的药用辅料按已有通用工艺制得的相应制剂。优选的，所述的提取物为水提取物。
本发明组方来自发明人“从脾胃论治糖尿病”理论体系，认为糖尿病病机为：“脾胃失调，物不归化，精微不运，脏腑失养”，故治疗以调和脾胃，攻补兼施为核心。据大量糖尿病临床分析研究发现，典型“三多一少”症状患者已显著减少，主要表现为口干、乏力、气短懒言、大便干结及视物模糊等，中医辨证也以气阴两虚证最为常见。因此本发明认为气阴两虚型糖尿病，多表现为脾肺肾三脏气阴均虚损，以脾为本而重于肾，故立健脾益肾方治之。
消渴病症状以消耗多食，口干多饮为主，饮食的代谢与运化，与脾胃关系最为密切。那么，水饮进入人体如何代谢的呢？《素问·经脉别论》云：“饮入于胃，游溢精气，上输于脾，脾气散精，上归于肺，通调水道，下输膀胱。水精四布，五经并行”。正常情况下，饮食水谷进入人体，经胃之腐熟，化生精微物质，经脾之运化，将精微物质散布全身，支持全身功能活动。当饮食失常，脾胃受损时，就要发病。可见，早在《内经》时期就明确提出了消渴发病或因过食肥甘厚味，内伤脾胃，或因胃中积热，根本在于“脾胃”。
(一)脾胃失调，物不归化，日久则内生热、郁、湿、痰、浊、瘀。
饮食肥甘厚味，损伤脾胃，运化不及，体内的糟粕无法通过脾胃升清降浊作用排出，蕴积肠腑而生内热，煎灼津液，则燥邪、热邪内生，发为消渴病。
消渴日久，肥甘厚味，膏粱之变，内伤脾胃，脾虚则痰湿内生，发为消渴。
情志抑郁、肝气不舒，瘀血郁久化热也会导致消渴的病机。
(二)脾失健运，精微不运，脏腑失养，则气血亏虚，日久阴阳俱虚。
脾胃居中焦，运化水谷，为气机升降之枢纽，气血生化之来源。若脾失健运，则脾不能散精，精微上不能归于肺，下不能输于膀胱，则脏腑失养。中焦脾胃受损，血液生化无源，气血亏虚，正气不足，不只发为消渴，又可出现多种变证。血脉失养，经络不和，可见肢体麻痹之证；肝肾阴亏，不能上养耳目，可见视瞻昏渺、暴盲、耳聋等证；瘀阻络脉，正气亏虚，易感热毒而发疮疖、痈疽。
本发明结合大量临床实际，认为消渴临床常见虚实夹杂之证，且虚实夹杂贯穿消渴病整个病程。虚证以气虚、阴虚为主，一般而言，早期多表现为脾虚肺热、脾虚胃实、脾虚肝郁，中期脾肺两虚、心脾两虚、脾肾两虚，后期损及阴阳，而发展为阴阳两虚或脾虚络阻之证。兼证多为实证，以郁、热、湿、痰、浊、瘀为主，往往由多个邪气互相夹杂为病，或出现于消渴的整个病程，或在某个阶段较为突出。因此，调和脾胃，攻补兼施为核心治疗方法，补脾扶正是核心，在扶正的过程中，必需重视驱邪。
现代糖尿病人中期多表现为肺脾肾三脏虚损，总以气阴两虚为主，以本发明中药组合物治疗，方中白术健脾益气燥湿，为君药；配伍太子参、黄芪以加强补中益气之功，使中轴得运，共为臣药；佐以葛根升清阳以通脾络，解热以生津止渴，丹参、当归以活血化瘀通脾络，山药入脾肺肾而健脾益肺补肾，女贞子、山茱萸入肝肾而补肝肾之阴，炙甘草加强补中益气之功，陈皮健脾理气使脾胃得运；并用黄柏清热燥湿助脾以泻降阴火，引火归元以为使药。全方升降和合，共凑健脾益肺补肾，益气养阴生津止渴之功。
同时，根据现代研究，此方中白术，具有促进受损植物神经功能的恢复，调整人体脏腑功能平衡和调节胃肠运动、降糖、利尿、增强抵抗力等作用。太子参多糖能够降低四氧嘧啶致糖尿病小鼠的血糖,同时能在一定程度上改善胰岛素抵抗,提高机体胰岛素的敏感性；黄芪具有抗自由基损伤、增强免疫力等功能；葛根有降血糖作用，以葛根组方及其提取物的制剂已广泛用于糖尿病及其并发症的治疗，丹参含有大量的二萜醌色素、丹参酮、丹参素、二基醛等多种物质,具有活血化瘀、降低血液粘度等作用,能很好的改善糖尿病患者的血黏度状况，当归具有镇痛抗炎、提升机体免疫功能，山药具有抗氧化、抗衰老、调节免疫、抗肿瘤、降血糖等作用，女贞子具有抗氧化、抗炎、降糖、降脂、调节免疫、抗骨质疏松功效，山茱萸具有明显的免疫调节、降血糖、抗肿瘤、抗衰老等作用，炙甘草有镇痛、镇咳平喘、抗心律失常、抗炎、调节免疫作用，陈皮抗氧化和抗炎作用，能达到调血脂、抗血栓、抗动脉粥样硬化等功效；黄柏具有多方面药理作用，主要包括降糖、抗菌、抗真菌、镇咳、降压、抗滴虫、抗肝炎、抗溃疡以及免疫抑制作用等。
因此，本发明脾肺肾三脏同调，攻补兼施，配伍精当，理法特色明显，通过下述临床研究的数据， 证明本方治疗糖尿病中期，肺脾肾三脏虚损，总以气阴两虚为主的患者疗效确切、安全有效。
实施例1(汤剂)
配方由以下组分组成：葛根20g、丹参15g、白术30g、太子参30g、黄柏15g、黄芪30g、山药15g、当归15g、女贞子15g、山茱萸15g、炙甘草5g、陈皮10g。加水煎煮至一碗服用。
实施例2(汤剂)
配方由以下组分组成：葛根18g、丹参14g、白术28g、太子参28g、黄柏14g、黄芪28g、山药14g、当归14g、女贞子14g、山茱萸14g、炙甘草4g、陈皮9g。加水煎煮至一碗服用。
实施例3(汤剂)
配方每剂由以下组分组成：葛根22g、丹参16g、白术32g、太子参32g、黄柏16g、黄芪32g、山药16g、当归16g、女贞子16g、山茱萸16g、炙甘草6g、陈皮11g。加水煎煮至一碗服用。
实施例4(汤剂)
配方由以下组分组成：葛根20g、丹参16g、白术32g、太子参28g、黄柏14g、黄芪32g、山药16g、当归16g、女贞子14g、山茱萸14g、炙甘草5g、陈皮11g。加水煎煮至一碗服用。
实施例5(片剂)
按重量份计算，配方由以下组分组成：葛根25份、丹参18份、白术35份、太子参35份、黄柏18份、黄芪35份、山药18份、当归18份、女贞子18份、山茱萸18份、炙甘草7份、陈皮12份。水提两次，每次加8-10倍的水，煎煮1-1.5小时，合并水提液，浓缩干燥，得到干浸膏。
取干浸膏20g研磨成细粉，按片剂制造工艺，加入药用淀粉和微粉硅胶，混合、制粒、干燥、整粒，然后加入硬脂酸镁，混匀，压制成100片，即得片剂。每片重0.3g。
实施例6(胶囊剂)
取实施例5制得的干浸膏20g研磨成细粉，按胶囊剂制造工艺，加入药用淀粉和微粉硅胶，混合、过筛、装入胶囊中，制成100粒，即得胶囊。每粒内容物重重0.2g。
临床对比实验
为了客观评价本发明中药组合物的临床有效性与安全性，按照中药新药临床研究指南的要求，对该药进行临床研究。以下研究均经汕头市中医院伦理委员会批准，患者均对本研究知情同意。
一、治疗糖尿病的临床研究
1临床资料
1.1一般资料 选取2016年1月至2018年2月汕头市中医医院糖尿病科门诊及住院治疗的64例气阴两虚型2型糖尿病患者，随机将其分为对照组和观察组，每组32例。对照组男12例，女20例；年龄41～69(55.77±8.85)岁；糖尿病病程5～10年，平均(7±3.9)年。对照组32例，男15例，女 17例；年龄43～68岁，平均(54.61±9.05)岁；糖尿病病程6～11，平均(8±2.8)年。2组一般资料比较差异无统计学意义(P＞0.05)，具有可比性。
1.2诊断与辨证标准 西医诊断标准：采用1999年世界卫生组织(WHO)：具有糖尿病症状(多饮、多尿、不能解释的体质量下降)，并符合随机血糖≥11.1mmol·L
-1或FBG≥7.0mmol·L
-1。中医辨证标准：口干多饮，消瘦，干呕呃逆，纳呆便溏或便秘；咽燥干咳，心悸怔忡或心烦，失眠多梦，健忘，倦怠乏力，腰膝酸软，动则汗出或见崩漏、便血、皮下出血，舌淡或红少津，苔黄白或无苔，边有齿印，脉细弱。
1.3纳入标准 (1)符合2型糖尿病诊断标准；(2)中医辨证主证属于气阴两虚可以使用健脾益肾方治疗的患者。
1.4排除标准 (1)排除住院诊断合并心肌炎、心包病及其他器质性心脏病、电解质失调等心脏疾病者；(2)合并有严重心脑血管及肝肾功能损害患者，或者近期出现糖尿病酮症、高渗性昏迷及严重干扰者；(3)妊娠、过敏等不适合于接受本治疗方案者；(4)年龄大于70岁者；(5)资料采集期间生活方式发生较大变化，可能影响研究结果的分析的患者；(6)不合作者。
2方法
2.1治疗方法 对照组：糖尿病健康教育，严格的饮食控制、情绪稳定、适当运动，口服降糖药物或应用胰岛素常规治疗，使血糖控制在空腹＜7.0mmol/L，餐后2h血糖＜11.0mmol/L。在此基础上治疗组给予本发明实施例1的健脾益肾方(葛根20g丹参15g白术30g太子参30g黄柏15g黄芪30g山药15g当归15g女贞子15g山茱萸15g炙甘草5g陈皮10g)，水煎服，每日1剂，煎煮成400mL，每次200mL，早晚2次温服，治疗1月后统计治疗结果。
2.2观察指标
2.2.1安全评价标准 一般体格检查：血压、呼吸、脉搏、体温。②血尿便常规检查。
2.2.2疗效性观察 空腹及餐后2h血糖、糖化血红蛋白，中医临床症状与体征，治疗前后各评估1次。
2.3疗效评定标准
中医疗效评定标准：通过中医症状评分量表评估中医疗效：①显效：中医症状、体征有明显好转，症状积分减少大于等于70％；②有效：中医症状、体征均有好转，症状积分减少大于等于30％；③无效：中医症状、体征无明显好转，甚至加重，症状积分减少小于30％。
参照《中药新药临床研究指导原则》，观察患者糖化血红蛋白(HbAlc)、空腹血糖(FBG)、餐后2h血糖(2hPG)及中医疗效评估等相关指标实际变化，临床症状改善及不良反应等情况。
2.4统计学处理 本研究中的相关数据选择统计学软件SPSS 18.0展开统计学处理，以均数±标准差表示计量资料，采用t检验；采用卡方检验，P<0.05则表示组间计数资料对比差异性较为显著，存在统计学意义。
3结果
3.1治疗前后2组患者血糖比较 治疗前2组患者的餐后2h血糖和空腹血糖比较差异没有统计学意义(P>0.05)，具有可比性。治疗后2组患者的空腹血糖均有所下降，治疗前后对比差异性有统计学意义(P<0.05)，治疗后健脾益肾方组患者后餐后2h血糖与空腹血糖、糖化血红蛋白水平明显优于对照组患者(P<0.05)，存在统计学意义，见表1。
表1两组治疗前后空腹血糖、餐后2h血糖及糖基化血红蛋白比较(n＝32)
注：★与治疗前相比，P<0.05；●与二甲双胍组相比，P<0.05
3.2治疗前后2组患者中医症状评分比较 治疗后健脾益肾方组患者的中医症状疗效评估善明显优于对照组，差异有统计学意义(P<0.05)，见表2。
表2治疗后中医疗效评估比较
注：★与二甲双胍组比较，P＜0.05
3.3 2组患者不良反应比较 两组均未出现肝肾功能异常，糖尿病酮症酸中毒、低血糖昏迷等急性并发症。
4.结论
糖尿病属于中医学“消渴”范畴，古代中医学多从“阴虚燥热”论治。然而,现今临床发现不论是病因病机与发病，还是临床表现，乃至治疗方法，都已发生变化。临床实践表明，健脾益肾方治疗气阴两虚型糖尿病，不仅降糖效果确切，使用安全，而且在改善患者生活质量，减轻糖尿病引起的症状上较之单纯西药治疗更有优势。
二、治疗糖尿病视网膜病变的临床研究
1.资料与方法
1.1一般资料 全部136例均为汕头市中医院住院患者，按照随机数字表法分为两组。治疗组68例，男43例，女25例；年龄45～78岁，平均(56.67±6.53)岁；病程2～14年，平均(8.46±0.67)年；视网膜病变分期：Ⅰ期32例，Ⅱ期23例，Ⅲ期13例。对照组68例，男41例，女27例；年龄46～76岁，平均(56.65±6.57)岁；病程1～16年，平均(8.48±0.69)年；视网膜病变分期：Ⅰ期30例，Ⅱ期24例，Ⅲ期14例。两组一般资料比较差异无统计学意义(P＞0.05)，具有可比性。
1.2病例选择
1.2.1诊断标准 ①参照《现代糖尿病诊断治疗学》中DR的诊断标准；②中医辨证主证属于气阴两虚夹瘀可以使用本发明健脾益肾方治疗的患者。
1.2.2纳入标准 ①近4周未使用抗凝、改善微循环药物；②无脏器功能障碍；③无药物过敏。
1.2.3排除标准 ①有视网膜手术史；②妊娠期；③未签署治疗知情同意书；④临床资料不完整或失访者；⑤合并其他原发性或继发性视网膜病变者；⑥合并血液系统疾病者；⑦合并有严重心脑血管及肝肾功能损害患者，或者近期出现糖尿病酮症、高渗性昏迷及严重干扰者。
1.3治疗方法 两组均予降血糖药物治疗及运动、饮食控制等，血糖控制平稳。
1.3.1对照组 予羟苯磺酸钙胶囊(北京京丰制药集团有限公司，国药准字H20010795)0.5g，每日3次口服。
1.3.2治疗组 疗组在对照组基础上增加中医治疗，口服本发明实施例1汤剂(以下称健脾益肾方)，日1剂，煎煮成400mL，每次200mL，早晚2次温服。
1.3.3疗程 两组均4周为1个疗程，连续治疗2个疗程。
1.4观察指标及方法 ①清晨抽取患者空腹肘静脉血3～5mL，常规离心，取上清液，采用酶联免疫吸附测定(ELISA)法检测VEGF、Ang-1水平，采用比色法检测SOD水平。试剂盒由上海酶联生物科技有限公司提供，操作按试剂盒说明书进行。②应用全自动血流变分析仪(天津市唐宇医疗器械科技发展有限公司)检测血液流变学指标血浆黏度、全血黏度(高切)、全血黏度(中切)、全血黏度(低切)、红细胞聚集指数、红细胞刚性指数及纤维蛋白原(FIB)。
1.5疗效标准 显效：患者治疗后视力改善4行，微血管瘤、出血基本消失；有效：患者治疗后视力改善2行，微血管瘤、出血部分消失；无效：患者治疗后视力、眼底上述病变无明显变化或加重。
1.6统计学方法 采用SPSS 21.0统计软件进行数据统计分析，计量资料用均数±标准差
表示，采用t检验；计数资料率的比较采用χ
2检验。P＜0.05为差异有统计学意义。
2.结果
2.1两组疗效比较 见表3。
表3两组患者疗效比较[n(％)]
注：与对照组比较，*P＜0.05。
由表3可见，两组显效率、总有效率比较差异均有统计学意义(P＜0.05)，治疗组疗效优于对照组。
2.2两组治疗前后血管内皮生长因子(VEGF)、血管生成素1(Ang-1)及超氧化物歧化酶(SOD)比较见表4。
表4两组患者治疗前后VEGF、Ang-1、SOD比较(
n＝68)
注：与本组治疗前比较，
＊P＜0.05；与对照组治疗同期比较，
#P＜0.05。
由表4可见，两组治疗4、8周后VEGF均较本组治疗前降低(P＜0.05)，Ang-1、SOD升高(P＜0.05)，且治疗组VEGF低于对照组治疗同期(P＜0.05)，Ang-1、SOD高于对照组治疗同期(P＜0.05)。
2.3两组治疗前后血液流变学指标比较 见表5。
表5两组患者治疗前后血流流变学指标比较(
n＝68)
注：与本组治疗前比较，
＊P＜0.05；与对照组治疗同期比较，
#P＜0.05。
由表5可见，治疗组治疗4、8周后，血浆黏度、全血黏度(高切)、全血黏度(中切)、全血黏度 (低切)、红细胞聚集指数、红细胞刚性指数及FIB均较本组治疗前降低(P＜0.05)，且低于对照组治疗同期(P＜0.05)。对照组治疗前后血液流变学指标比较差异无统计学意义(P＜0.05)。
3.讨论
中医学认为，DR主要是在消渴脾虚的基础上发展而成。消渴日久，气阴两虚，气虚运血无力，阴虚则血行滞涩，瘀血阻于目络；加上年老体衰，肾精亏虚，肝血不足，精血难以上荣于目，目络失养，则视物昏渺；气虚摄血无权，均可致血溢脉外，引发出血，最终致瘀血日久不去，进一步阻滞目络而失明。正如《儒门事亲》所载“夫消渴者多变盲聋”，《证治要诀》云“三消日久，精血既亏，或目无所见”。因此，DR以气阴两虚为本，病变在脾、肝、肾，应以健脾益肺补肾、养阴生津为治则。
微血管病变为DR发病的基本环节，表现为毛细血管无灌注区扩大，视网膜大片血管闭锁，严重缺血缺氧，最终形成新生血管，此过程有多种细胞因子参与。VEGF是一种血管内皮生长因子，其高表达可促进DR新生血管的形成，增强血管通透性，诱导内皮细胞生长，此外还促进视网膜氧化应激状态，诱导炎性反应，加重视网膜损伤。Ang-1可调节血管形成，抑制VEGF的表达及血管增殖，改善内皮细胞的稳定性。SOD可间接反映体内的抗氧化能力。本研究结果表明，治疗组治疗4、8周后VEGF水平降低，Ang-1、SOD升高(P＜0.05)，且VEGF水平低于对照组治疗同期(P＜0.05)，Ang-1、SOD高于对照组治疗同期(P＜0.05)，提示健脾益肾方通过调节血液VEGF、Ang-1表达，从而干预视网膜微血管形成，抑制疾病进展。
血液流变学指标异常也是DR的重要因素之一，由于视网膜血管细小，血浆黏度、全血黏度、红细胞聚集指数及FIB一旦增加，极易形成微血管栓子，降低视网膜耐氧能力，促进血管代偿性扩张，从而形成血管瘤，引起或加重患者病情。本研究结果表明，治疗组治疗后血浆黏度、全血黏度、红细胞聚集指数、红细胞刚性指数及FIB均低于对照组(P＜0.05)，说明补健脾益肾方可降低血液流变学指标水平，从而改善视网膜局部微循环，改善患者视力水平，这可能与健脾益肾方具有较强的健脾益肺补肾、养阴生津作用有关。
综上所述，DR多因脾肺肾三脏气阴均虚损而形成，本发明的健脾益肾方健脾益肺补肾、养阴生津，能显著改善DR患者血液流变学及视网膜微循环血管形成，提高视力水平，标本兼治，安全性高，值得临床推广应用。
三、治疗糖尿病肾病的临床研究
1.一般资料与方法
1.1病例来源
随机选取2016年1月到2018年1月在汕头市中医院糖尿病科门诊就诊及住院病房收治的符合条件的糖尿病肾病患者60例。
1.2病例分组
在确诊的糖尿病肾病患者中，将入选的60例患者按1：1比例随机分为2组，即中药组，对照组。将两组性别、年龄等一般资料进行比较，应用SPSS软件，经卡方检验比较后，确定是否具有可比性(无显著性差异P＞0.05)。
1.3病例诊断标准
1.3.1西医诊断标准：
(1)WHO诊断分类标准(1999)确定的2型糖尿病。
(2)2007NKF-KDOQI《糖尿病肾脏疾病诊疗指南》推荐的糖尿病肾脏疾病诊断建议：
①有糖尿病视网膜病变者
②有临床蛋白尿者
③并排除原发性高血压病、心力衰竭、泌尿系感染、酮症酸中毒等引起尿白蛋白增加的因素。
1.3.2中医诊断标准
中医诊断标准参照2002年中华人民共和国卫生部出版的《中药新药临床研究指导原则》及《中医内科学》(普通高等教育中医药类规划教材)。
主症:神疲乏力、口干、畏寒肢冷、尿多而甜，形体渐见消瘦；
兼证:视物模糊、胸闷脘痞、便溏、水肿等；
舌脉:舌淡胖苔白或白腻,脉沉细。
1.4.病例的纳入及排除标准
1.4.1纳入标准：凡符合以上西医糖尿病诊断标准，病程较短，临床表现为口干多饮、多尿、多食消瘦、体倦乏力、动则汗出、心悸失眠、腰酸等中医辨证为气阴两虚的患者为纳入对象。
1.4.2排除标准：①6个月内有心肌梗死、脑血管意外、糖尿病酮症酸中毒等危急重症病史者；②其它原因引起的肾脏损伤；③合并有肿瘤者,妊娠或哺乳期妇女；④对治疗方案中相关药物过敏者；⑤年龄小于18岁或大于75岁
1.4.3剔除及脱落标准：符合入选标准，并且已经分组，但因各种原因未实施任何治疗的患者，或因各种原因未按规定完成治疗与对照观察者，疗效观察记录不完整者。
1.5研究方法：中药组和对照组同时无差异的给予西医常规治疗,包括糖尿病健康教育，控制饮食、口服降糖药物或应用胰岛素常规治疗，使血糖控制在空腹＜7.0mmol/L，餐后2h血糖＜10.0mmol/L。同时中药组加服用实施例1的健脾益肾方，水煎服，每日1剂，煎煮成400mL，每次200mL，早晚2次温服，4周为1个疗程，2个疗程后统计治疗结果。
1.6.观察方法
1.6.1观察指标
1.6.1.1安全评价标准
①一般体格检查：血压、呼吸、脉搏、体温。②血常规、尿常规、肝肾功能、血钾。
1.6.1.2疗效性观察
①空腹血糖、餐后2小时血糖、糖化血红蛋白、尿微量白蛋白(UAER)、24小时尿蛋白定量、胱氨酸蛋白酶抑制剂(CysC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、甘油三脂(TG)、总胆固醇(CHOL)等。
②中医临床症状与体征，治疗前、治疗2月后各评估1次。
1.7疗效评定标准
参照《中药新药临床研究指导原则》和《糖尿病肾脏疾病诊疗指南》的有关内容,结合临床,微量 白蛋白尿是目前优选的早期诊断指标,UAER20-200ug/min定义为微量白蛋白,拟定早期糖尿病肾病近期疗效评定标准如下:
中医疗效评定标准：通过中医症状评分量表评估中医疗效：①显效：中医症状、体征有明显好转，症状积分减少大于等于70％；UAER恢复正常或比治疗前减少50％以上；血糖、血脂等指标改善30％或恢复正常。②有效：中医症状、体征均有好转，症状积分减少大于等于30％；UAER减少20％-49％；血糖、血脂等指标改善15％-29％。③无效：中医症状、体征无明显好转，甚至加重，症状积分减少小于30％；各项实验室指标未达到以上标准或升高。
观察患者尿微量白蛋白(UAER)、24小时尿蛋白定量、糖化血红蛋白(HbAlc)、空腹血糖(FBG)、餐后2h血糖(2hPG)及中医疗效评估等相关指标实际变化，临床症状改善及不良反应等情况。统计后判断治疗后两组临床症状较治疗前差异是否具有统计学意义。
1.8统计学处理本研究中的相关数据选择统计学软件SPSS 18.0展开统计学处理，以均数±标准差表示计量资料，采用t检验；采用卡方检验，P<0.05则表示组间计数资料对比差异性较为显著，存在统计学意义。
2结果
2.1治疗前后2组患者血糖比较 2组患者治疗前的餐后2h血糖和空腹血糖比较差异没有统计学意义(P>0.05)。2组患者在治疗后的空腹血糖均有所下降，治疗前后对比差异性有统计学意义(P<0.05)，治疗后健脾益肾方组患餐后2h血糖与空腹血糖水平明显优于对照组患者(P<0.05)，存在统计学意义，见表6。
表6两组治疗前后空腹血糖、餐后2h血糖及糖基化血红蛋白比较(n＝30)
注：★与治疗前相比，P<0.05；●与对照组相比，P<0.05
2.2治疗前后2组患者尿白蛋白、24小时尿蛋白定量比较 2组患者治疗前的餐后尿白蛋白、24小时尿蛋白定量比较差异没有统计学意义(P>0.05)。2组患者在治疗后的尿白蛋白、24小时尿蛋白定量均有所下降，治疗前后对比差异性有统计学意义(P<0.05)，治疗后健脾益肾方组患尿白蛋白、24小时尿蛋白定量水平明显优于对照组患者(P<0.05)，存在统计学意义，见表7。
表7两组治疗前后尿白蛋白、24小时尿蛋白定量比较(n＝30)
注：★与治疗前相比，P<0.05；●与对照组相比，P<0.05
2.3 2组患者中医症状评分比较 治疗后健脾益肾方组患者的中医症状疗效评估善明显优于对照 组，差异有统计学意义(P<0.05)，见表8。
表8治疗后中医疗效评估比较
注：★与对照组比较，P＜0.05
2.4 2组患者不良反应比较 健脾益肾方组有3例服中药后出现嗳气反酸，咽喉疼痛，2例出现腹痛腹泻；对照组有4例出现腹胀腹泻，持续时间5天到10天，均经对症处理后可以完成治疗。两组未出现肝肾功能异常，糖尿病酮症酸中毒、低血糖昏迷等急性并发症。
3.结论
传统中医没有“糖尿病性肾病”之说，其对本病的治疗寓于消渴病的治疗之中,对于糖尿病肾病,多数学者认为其病机是一个动态的演变过程,肾病至最后阴阳俱损,脾肾亏虚,浊毒内阻而致五脏气血阴阳亏虚。中医强调“不治已病治未病”，根据早期糖尿病肾病的脾肺肾三脏气阴均虚损的临床特点，近年来,许多医家从理论上强调健脾益肾在治疗糖尿病肾病中的重要作用。
临床实践表明，本发明的健脾益肾方治疗糖尿病肾病早期气阴两虚，表现以口干多饮、多尿、多食消瘦、体倦乏力、动则汗出、心悸失眠、水肿、腰酸、便溏为主症的患者，不仅可以有效改善症状，使用安全，而且在延缓慢性肾脏疾病进展方面较之单纯西药治疗更有优势。
Claims (8)
- 一种健脾益肾中药组合物，其特征在于：按重量份数计算，配方由以下组分组成：葛根15-25份、丹参12-18份、白术25-35份、太子参25-35份、黄柏12-18份、黄芪25-35份、山药12-18份、当归12-18份、女贞子12-18份、山茱萸12-18份、炙甘草3-7份、陈皮8-12份。
- 根据权利要求1所述的健脾益肾中药组合物，其特征在于：按重量份数计算，配方由以下组分组成：葛根18-22份、丹参14-16份、白术28-32份、太子参28-32份、黄柏14-16份、黄芪28-32份、山药14-16份、当归14-16份、女贞子14-16份、山茱萸14-16份、炙甘草4-6份、陈皮9-11份。
- 根据权利要求1所述的健脾益肾中药组合物，其特征在于：按重量份数计算，配方由以下组分组成：葛根20份、丹参15份、白术30份、太子参30份、黄柏15份、黄芪30份、山药15份、当归15份、女贞子15份、山茱萸15份、炙甘草5份、陈皮10份。
- 权利要求1-3任一权利要求所述健脾益肾中药组合物在制备治疗糖尿病、糖尿病视网膜病变、糖尿病肾病的药物的应用。
- 根据权利要求4所述的应用，其特征在于：所述的药物为汤剂、颗粒剂、片剂、胶囊剂、口服液或丸剂。
- 根据权利要求4所述的应用，其特征在于：所述的药物为以所述健脾益肾中药组合物配方中组分的提取物为有效成分，添加药用辅料制得的制剂。
- 根据权利要求6所述的应用，其特征在于：所述的提取物为水提取物。
- 根据权利要求4所述的应用，其特征在于：所述的糖尿病、糖尿病视网膜病变、糖尿病肾病是气阴两虚型的糖尿病、糖尿病视网膜病变、糖尿病肾病。
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| CN114982717B (zh) * | 2022-06-09 | 2023-07-21 | 辽宁中医药大学 | 粪菌移植法建立2型糖尿病阴虚证和/或2型糖尿病非阴虚证动物模型建立、评价及应用 |
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