CN113730520B

CN113730520B - Traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy

Info

Publication number: CN113730520B
Application number: CN202111157072.3A
Authority: CN
Inventors: 陈杰; 郑颖; 路建饶; 廖琳; 刘伟伟; 郭玥; 段连香
Original assignee: Shanghai Seventh Peoples Hospital
Current assignee: Shanghai Seventh Peoples Hospital
Priority date: 2021-09-30
Filing date: 2021-09-30
Publication date: 2022-06-10
Anticipated expiration: 2041-09-30
Also published as: CN113730520A

Abstract

The invention provides a traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy, which is prepared from the following raw materials in parts by weight: 15 to 60 portions of raw astragalus root, 10 to 30 portions of fried largehead atractylodes rhizome, 15 to 40 portions of winged euonymus twig, 5 to 15 portions of stiff silkworm, 15 to 40 portions of caragana sinica root, 15 to 40 portions of asiatic centella, 15 to 40 portions of elderberry, 3 to 15 portions of coptis root, 15 to 40 portions of glabrous greenbrier rhizome and 15 to 40 portions of spreading hedyotis herb. The invention can effectively reduce the proteinuria of diabetic nephropathy patients in the application of clinical cases, and has great clinical application and research values.

Description

Traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy

Technical Field

The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy.

Background

Diabetes mellitus is the main cause of chronic kidney diseases in China at present, and the prevalence rate of the diabetes mellitus is higher than that of chronic kidney diseases caused by glomerulonephritis. Diabetic Nephropathy (DN) has become an important cause of end-stage renal disease (ESRD). Once a diabetic nephropathy patient enters stage IV, the condition often progresses progressively, and if not actively controlled, the Glomerular Filtration Rate (GFR) will drop by 1ml/min per month on average, with the time to ESRD averaging 7-10 years. This stage is often the key point of progressive deterioration of renal function of diabetic nephropathy, and is also a difficult point in clinical treatment, if the treatment is appropriate, the condition of the disease can be controlled, otherwise, the condition of the disease is accelerated to end-stage renal disease. The occurrence mechanism of diabetic nephropathy is not clear, and recent research shows that diabetic nephropathy is an inflammation process, and immune cells may participate in the occurrence and progression process. Under the stress state of diabetes, kidney inherent cells recognize endogenous injury through DAMPs, can recruit inherent immune cells such as macrophages and mast cells, activate complement and recruit cytokines and adhesion molecules through pathways such as NF-kB, JNK, PKC and JAK/STAT, amplify inherent immune response, promote renal tissue infiltration of inflammatory cells and mast cells, and cause renal injury and renal function decline of diabetic nephropathy. In diabetic nephropathy, the complement system of the patient is activated, C3 is deposited on glomerulus, which causes glomerular sclerosis, inhibits complement C5, can reduce albuminuria and mesenteric dilatation, blocks complement C3a receptor, can reduce kidney inflammation and albuminuria, and delays fibrosis of kidney tissues and renal function loss of diabetic nephropathy. In addition, the dysfunction of the activation of T lymphocytes of patients with diabetic nephropathy affects the activation process of T cells, which is characterized by the reduction of CD8+ and the imbalance of the proportion of CD4+/CD8+, and the CD8+ inhibits the differentiation of target cells and the activity of cytotoxic T cells, thereby causing autoimmune dysfunction and exacerbating the development of diabetic nephropathy. Therefore, the activation of the immune system plays an important role in the occurrence and development process of the diabetic nephropathy, is closely related to clinical manifestation difference and prognosis, and provides a new target for the treatment of the diabetic nephropathy.

The traditional Chinese medicine generally considers that the diabetic nephropathy is a syndrome of deficiency of the origin and marked excess, the deficiency of the origin is the deficiency of the spleen and kidney, and the marked excess is blood stasis and damp turbidity obstruction. The kidney is the innate root and the spleen is the acquired root. The kidney-essence depends on the nourishment of the food essence transformed and transported by the spleen and stomach, and once the spleen-qi is deficient and the food essence is micro-biochemical and passive, the kidney-qi is deficient and the kidney-essence is deficient. Diabetic nephropathy is caused by diabetes, as reported by Ling Shu & Ben zang: the spleen is brittle and good for pyretic consumption, and deficiency of spleen qi is one of the main causes of diabetes, so the diabetic nephropathy is based on deficiency of spleen qi. In the late stage of diabetes, kidney qi is damaged, deficiency of kidney deficiency, endogenous dryness heat, yin and fluid consumption, yin deficiency and yang impairment occur, and yin and yang are damaged. The protein belongs to the essence and tiny substance of the human body, is obtained by the biochemical process of spleen qi, and the storage and sealing of the protein depends on the ascending and clearing of spleen qi and the consolidation of kidney qi. After the spleen and kidney are deficient, the spleen does not ascend, the kidney fails to store, and the protein is lost from the urine. In the middle and late stages of diabetic nephropathy, the kidney fails to transform into qi, which may lead to generation of damp and turbid phlegm, or blockage of triple energizer, or general overflow, or transformation of fire into stagnation, which may lead to edema, fatigue, sticky stool or constipation. Food essence is subjected to micro-biochemical treatment without source, and the deficiency of qi and blood and malnutrition of viscera are caused, so that the symptoms of weakness and anorexia are caused; the fluids cannot be distributed, the water dampness stops accumulating, and edema is visible; water attacking the heart, manifesting as asthma and palpitation; the dampness-turbidity obstructing the middle energizer may cause the obstruction of qi movement, resulting in nausea and vomiting; kidney qi deficiency, inability to consolidate and essence outflow, which can be seen in a large amount of proteinuria within the scope of nephrotic syndrome; the deficiency of the kidney can lead to failure of qi transformation, urinary bladder anuresis, which is manifested as oliguria, edema, etc., and in short, the spleen and kidney fail to function normally. In addition, blood stasis is inserted throughout the development of diabetic nephropathy. In Sheng Ji Zong Lu, the prescription treats thirst for … …, and treats harmony and astringency. Diabetes due to yin deficiency with dryness-heat, consumption of body fluid and blood by decocting, long-term phlegm formation and blood stasis, obstruction of kidney collaterals, affecting the qi transformation function of kidney, failing to ascend the clear and descend the turbid, and retention of damp-turbidity in the body due to drowning-in-toxicity, which is manifested as diabetes and kidney syndrome. Combined with modern researches, hyperglycemia directly stimulates protein kinase C, the action of angiotensin is increased, the level of vasodilating substances is increased, so that the high pressure, high perfusion and high filtration of glomeruli are caused, in addition, the elevation of fibrinogen in plasma of diabetic nephropathy, hyperfunction of blood platelets, hypoproteinemia and the like cause blood hypercoagulation, the accumulation of glycosylation products and the release of inflammatory factors also cause the proliferation of endothelial cells and mesangial cells, so that the glomeruli are gradually hardened, and the actions are related to the blood stasis blockage in the traditional Chinese medicine.

The traditional view is that the development of diabetic nephropathy is related to heredity, hypertension, diabetes, hemodynamics, metabolism disorder of vasoactive substances and the like, and the treatment focuses on controlling blood pressure and blood sugar and the application of ACEI/ARB medicines. In recent years, oxidative stress and immune inflammatory injury play an important role in the occurrence and development of diabetic nephropathy, and a new direction is pointed out for the research of the diabetic nephropathy. Correspondingly, the theory and the medicine for treating the diabetic nephropathy of the traditional Chinese medicine are also newly developed in recent years. The traditional focus of traditional Chinese medicine treatment on diabetic nephropathy is to invigorate the spleen and tonify the kidney, activate blood and eliminate dampness, particularly, after the pathogenic theory of blood stasis of 'micro abdominal mass' of diabetic nephropathy kidney collaterals is provided by the Lu ren and professor and the like, the application of activating blood and dissolving stasis in the diabetic nephropathy is intensively researched by the traditional Chinese medicine field, and certain breakthrough is achieved. In recent years, the theory of pathogenic wind is proposed, the diabetic nephropathy is treated from the aspect of dispelling wind, the scientificity and effectiveness of the theory are proved on the mechanism of the immune inflammation injury of the diabetic nephropathy, and the theory and treatment means of treating the diabetic nephropathy through traditional Chinese medicine are enriched.

Disclosure of Invention

The technical problem to be solved by the invention is to provide a traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy, and the traditional Chinese medicine composition can effectively reduce proteinuria caused by diabetic nephropathy in clinical case application and has great clinical application and research values.

In order to solve the technical problems, the invention adopts the technical scheme that: a traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy comprises the following raw materials in parts by weight: 15 to 60 portions of raw astragalus root, 10 to 30 portions of fried largehead atractylodes rhizome, 15 to 40 portions of winged euonymus twig, 5 to 15 portions of stiff silkworm, 15 to 40 portions of caragana sinica root, 15 to 40 portions of asiatic centella, 15 to 40 portions of elderberry, 3 to 15 portions of coptis root, 15 to 40 portions of glabrous greenbrier rhizome and 15 to 40 portions of spreading hedyotis herb.

Preferably, the feed consists of the following raw materials in parts by weight: 20 to 40 portions of raw astragalus root, 12 to 18 portions of fried largehead atractylodes rhizome, 20 to 40 portions of winged euonymus twig, 8 to 12 portions of stiff silkworm, 20 to 35 portions of caragana sinica root, 20 to 35 portions of asiatic centella, 25 to 35 portions of elderberry, 5 to 12 portions of coptis root, 25 to 40 portions of glabrous greenbrier rhizome and 25 to 35 portions of spreading hedyotis herb.

Preferably, the feed consists of the following raw materials in parts by weight: 30 parts of raw astragalus membranaceus, 15 parts of fried bighead atractylodes rhizome, 30 parts of winged euonymus twig, 10 parts of stiff silkworm, 30 parts of caragana sinica root, 30 parts of centella asiatica, 30 parts of elderberry, 6 parts of coptis chinensis, 30 parts of rhizoma smilacis glabrae and 30 parts of oldenlandia diffusa.

Compared with the prior art, the invention has the following advantages:

1. according to the invention, raw astragalus and fried bighead atractylodes rhizome are used as monarch drugs, winged euonymus twig is used for dispelling wind and activating blood, stiff silkworm, elderberry, gorse root and glabrous greenbrier rhizome are used for dispelling wind, activating blood and removing dampness, coptis and spreading hedyotis herb are used for detoxifying and removing dampness, the whole formula mainly aims at tonifying qi, invigorating spleen and strengthening body resistance, and is supplemented with the effects of invigorating blood, dispelling wind and removing dampness, so that the pathogenesis of the diabetic nephropathy is satisfied, the use of the wind drugs is particularly emphasized, the gorse root, the elderberry and the glabrous greenbrier rhizome which have the effects of dispelling wind and activating blood or removing dampness and the worm-type drug stiff silkworm which has strong effects of dispelling wind and removing collaterals are selected, the effect of half the effort is doubled for long-term unremoved proteinuria, the method can effectively reduce the proteinuria of a diabetic nephropathy patient in clinical case application, and can effectively reduce trace proteinuria and 24-hour proteinuria of early and middle-term diabetic nephropathy (stage diabetic nephropathy II-III); can reduce the creatinine level of part of clinical diabetic nephropathy patients in stage IV, and has great clinical application and research values.

2. The invention is based on the theory of replenishing qi to invigorate the spleen, dispelling wind, promoting blood circulation and removing dampness, has strict formula, not only accords with the traditional viewpoints of spleen and kidney deficiency and dampness and stasis retardation of diabetic nephropathy, but also embodies the new progress of pathogenic wind, is a breakthrough on the theory and treatment principle, and is found to be capable of effectively reducing proteinuria of patients with early and middle diabetic nephropathy in the application of clinical cases, thereby having originality and the certainty of curative effect. The prescription is characterized in that the application of wind-evil medicines, such as caragana sinica root, elderberry and glabrous greenbrier rhizome which have the effects of dispelling wind and activating blood or removing dampness, and the stiff silkworm which has strong effects of dispelling wind, removing the wind and shaving collaterals, and has the effect of achieving half the effort for treating the long-term unremoved proteinuria.

The present invention will be described in further detail with reference to examples.

Detailed Description

Example 1

The traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy comprises the following raw materials in parts by weight: 30 parts of raw astragalus membranaceus, 15 parts of fried bighead atractylodes rhizome, 30 parts of winged euonymus twig, 10 parts of stiff silkworm, 30 parts of caragana sinica root, 30 parts of centella asiatica, 30 parts of elderberry, 6 parts of coptis chinensis, 30 parts of rhizoma smilacis glabrae and 30 parts of oldenlandia diffusa.

The patient is yellow and female, and has age 48 years, has an initial diagnosis at 2020.11, and complains of foamy urine for 2 years, and edema of both lower limbs lasts for 1 week. The current medical history: there is a history of diabetes for 10 years and insulin therapy is currently used. The patients have foamy urine 2 years ago, the urine microalbumin is positive and unknown, the edema of the lower limbs appears 1 week ago, the patients are treated in our hospital, 2.13g of urine protein is checked for 24 hours, the urine microalbumin prompts are 959.1mg/l, 270.57mg/mmol of urine protein/urinary creatinine, 9mmol/l of fasting blood glucose and 7.9% of glycosylated hemoglobin, and the patients are admitted to the hospital for treatment of the diabetic nephropathy. The past hypertension history is more than 10 years, and at present, the blood pressure is controlled by taking irbesartan, and is about 140/90 mmhg. After the patient is admitted, the patient is treated by regulating insulin to control blood sugar, and the kidney health is treated by activating blood circulation to dissipate blood stasis, and the traditional Chinese medicine composition for treating the proteinuria caused by the diabetic nephropathy is used for treating the proteinuria, and is decocted with water for oral administration, twice a day and 150ml each time; two weeks in hospital, 24 hours before discharge, urine protein 1.93g, microalbumin indicator 765.2mg/l, urine protein/urinary creatinine 211.93mg/mmol were reviewed. After discharge, the patient is treated in outpatient service, and is retested at 3 months in 2021, the lower limbs are not swollen, and the urinary microalbumin indicates 496.2mg/l and the urinary protein/urinary creatinine 171.22 mg/mmol. The blood is normal and the liver and kidney function is normal during the treatment period.

Example 2

The traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy comprises the following raw materials in parts by weight: 40 parts of raw astragalus root, 12 parts of fried bighead atractylodes rhizome, 40 parts of winged euonymus twig, 8 parts of stiff silkworm, 35 parts of caragana sinica root, 20 parts of centella, 25 parts of elderberry, 12 parts of coptis root, 25 parts of glabrous greenbrier rhizome and 25 parts of spreading hedyotis herb.

In Zhongzhi, male, 75 years old, reported at 2021.6.1 and complained of repeated hematuria for 6 years, which aggravated 1 week with mild edema of both lower limbs. The current medical history: the patient has a diabetes history of 12 years, is diagnosed with hematuria in 2015, and has urine trace protein of 43.2mg/l, normal renal function and diagnosed with diabetic nephropathy, and is treated with Jinshuibao and Keyuanzhi, and the urine trace albumin is normal and is rechecked after 3 months, and then is automatically stopped, and after 1 year, the patient finds that the hematuria is increased again and has no diagnosis, and the patient takes Jinshuibao and Keyu automatically, stops taking the medicine after the spontaneous hematuria is reduced, and then stops taking the medicine after 6 years, and the patient is diagnosed with the hematuria increased with slight edema of two lower limbs before 1 week, and the urine trace albumin is diagnosed with a family, and has urine trace albumin prompting of 200.1mg/l, urinary protein/urinary creatinine of 54.05mg/mmol, urea nitrogen of 6.65umol/l and creatinine of 103.2 umol/l. The Chinese medicinal composition for treating the proteinuria caused by the diabetic nephropathy is decocted in water for oral administration, 150ml each time twice a day, and is continuously taken for 1 month. 2021.6.29 Recall the trace albumin before discharge, indicating 206.4mg/l, urinary protein/urinary creatinine 31.91mg/mmol, the original prescription is continued for 1 month. 2021.7.27 Recall the microalbumin suggested 151.2mg/l, uroprotein/urinary creatinine 29.88mg/mmol, urea nitrogen 7.86umol/l, creatinine 87.9 umol/l.

Example 3

The traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy comprises the following raw materials in parts by weight: 20 parts of raw astragalus membranaceus, 18 parts of fried bighead atractylodes rhizome, 20 parts of winged euonymus twig, 12 parts of stiff silkworm, 20 parts of caragana sinica root, 35 parts of centella asiatica, 35 parts of elderberry, 5 parts of coptis chinensis, 40 parts of rhizoma smilacis glabrae and 35 parts of oldenlandia diffusa.

The patient is Zhang, female, 67 years old, and 2021.3.9 for a doctor. The chief complaint is repeated foaming urine for 3 years with edema of both lower limbs for 1 year and aggravation for 2 weeks. The patient has 8 years of diabetes history and 3 years of cerebral infarction history, and the left upper limb is kept moving unfavorably. Foam urine and urine protein + appear 3 years ago, the edema of the lower limbs is not treated 1 year ago, and the edema can be resolved after the quick urination. Before 2 weeks, the patient is diagnosed with edema of both lower limbs, the trace albumin is checked to indicate 893.4mg/l, urine protein/urine creatinine 173.73mg/mmol, urea nitrogen 16.53umol/l and creatinine 269.5umol/l, the quick-acting diaper is orally taken 1 granule per day, and simultaneously the traditional Chinese medicine combination therapy for treating proteinuria caused by diabetic nephropathy is taken by decocting with water twice a day, 150ml each time and continuously taken for 1 month. 2021.4.6 for repeated diagnosis, edema of both lower limbs subsides, checking the trace albumin to indicate 738.5mg/l, uroalbumin/urinary creatinine 131.93mg/mmol, urea nitrogen 18.43umol/l, creatinine 311.1umol/l, stopping quick urination, and taking the medicine again. 2021.6.25 when the doctor is retested, the microalbumin is checked to indicate 569.1mg/l, urinary protein/urinary creatinine is 192.96mg/mmol, urea nitrogen is 13.11umol/l and creatinine is 206.7umol/l, and the original prescription is continuously taken. 2021.8.12 for repeated diagnosis, no obvious discomfort caused by self-complaints, better control of blood pressure and blood sugar, trace albumin search, 311.3mg/l, 156.33mg/mmol of urine protein/urine creatinine, 10.87umol/l of urea nitrogen, 187.7umol/l of creatinine.

Example 4

The traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy comprises the following raw materials in parts by weight: 15 parts of raw astragalus membranaceus, 10 parts of fried bighead atractylodes rhizome, 15 parts of winged euonymus twig, 5 parts of stiff silkworm, 15 parts of caragana sinica root, 40 parts of centella asiatica, 40 parts of elderberry, 15 parts of coptis chinensis, 15 parts of rhizoma smilacis glabrae and 40 parts of oldenlandia diffusa.

The patient is high in male age 71 and is treated at 2021.7.29. The chief complaint found that edema of both lower limbs increased for 1 month and 3 days. The patient has a diabetes history of 7 years, and is found to have proteinuria for 1 year, and takes the abelmoschus manihot capsules with the proteinuria between plus and minus plus. When the patient is in a treatment, the patient has slight edema of the lower limbs, which is slight twitch and heavy, the trace amount of albumin is checked to indicate 57.1mg/l and the urine protein/urine creatinine is 10.76mg/mmol, the traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy is used for treatment, and the traditional Chinese medicine composition is decocted in water twice a day, and 150ml is taken each time. 2021.8.19 the doctor consults the doctor, checks the trace albumin to show 5.4mg/l, the urine protein/urine creatinine is 3.72mg/mmol, and continues the administration of the original prescription.

Example 5

The traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy consists of the following raw materials in parts by weight: 60 parts of raw astragalus, 30 parts of fried bighead atractylodes rhizome, 40 parts of winged euonymus twig, 15 parts of stiff silkworm, 40 parts of caragana sinica root, 15 parts of centella, 15 parts of elderberry, 3 parts of coptis chinensis, 40 parts of glabrous greenbrier rhizome and 15 parts of spreading hedyotis herb.

The patient was in a female, age 46, at 2021.3.2. Complaining of foam urine for 1 year. The patient discovers that the diabetes is more than 3 years, the diabetic nephropathy is diagnosed by seeing a large amount of foam urine before 1 year, the patient takes the Kogya and the Tripterygium wilfordii protein for reducing urine, the foam urine appears repeatedly after 1 year, and the urine protein is between + and +++. When in use, patients feel hypodynamia and mild edema of both lower limbs, 70.1u/l of glutamic-pyruvic transaminase is detected, 941.7mg/l of trace albumin is prompted, 97.34mg/mmol of urine protein/urine creatinine is considered, tripterygium wilfordii is taken for taking, and the composition of the traditional Chinese medicine for treating the proteinuria caused by the diabetic nephropathy is taken, wherein the composition is decocted with water twice a day and 150ml of the composition is taken each time. 2021.3.18 when the liver function is normal, the normal urination indicates that the recipe is continued to be taken and the sub-dose of the codopein is unchanged. 2021.6.4 when the liver function is normal, the trace albumin indicates 532.1mg/l, urine protein/urine creatinine 60.32mg/mmol, and the original prescription is taken continuously. 2021.7.2 for a double-check, trace albumin is found to indicate 509.3mg/l, and urine protein/urine creatinine is 55.2 mg/mmol.

Example 6

This example is a clinical trial using the traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy of the present invention:

1. study object

(1) Selected cases were: 120 diabetic nephropathy (diabetic nephropathy) patients are treated in outpatient service and ward of the seventh national hospital in Shanghai city in 2018 and 2020.

(2) Clinical diagnosis standard of diabetic nephropathy: referring to the 2007 KDOQI guidelines for diabetic nephropathy diagnostic criteria, there is profuse albuminuria or minimal albuminuria in the following cases: there is diabetic retinopathy, which lasts for more than 10 years.

(3) The diagnosis standards of spleen deficiency, blood stasis and damp turbidity are as follows: according to the national guide principle of new drug clinical research of 2002 edition of the administration of traditional Chinese medicine. The main symptoms of spleen deficiency: lassitude, dry mouth, soreness and weakness of the loins and legs or pale complexion, spontaneous perspiration and aversion to wind. Secondary symptoms of spleen deficiency: laziness in speaking, palpitation, shortness of breath, pale tongue with thin and white coating, and thready pulse. The syndrome differentiation is spleen deficiency with 2 main symptoms and 1 secondary symptom. The main symptoms of blood stasis: numbness of hands and feet, chest pain, lumbago, especially at night. The secondary symptoms are as follows: facial ecchymosis, dark mouth and lip, insomnia, amnesia, dark tongue and even ecchymosis, purplish and circuitous veins under the tongue, and deep and unsmooth pulse. The syndrome differentiation can be made into blood stasis syndrome by 2 main symptoms and 1 secondary symptom. The main symptoms of damp turbidity: nausea, vomiting, heaviness of the limbs, poor appetite, dry mouth and bitter taste. The secondary symptoms are as follows: abdominal distention, sticky and greasy mouth, edema, thick and greasy tongue coating; the pulse is slippery. The syndrome can be distinguished as damp turbidity syndrome by 2 items of main symptoms and 1 item of secondary symptoms. The composition has spleen deficiency syndrome, blood stasis syndrome and damp turbidity syndrome, and the standard diagnosis is spleen deficiency blood stasis damp turbidity syndrome.

(4) And (3) inclusion standard: the inpatient and outpatient of the hospital meet the diagnosis standards of the diabetic nephropathy and the traditional Chinese medicine spleen qi deficiency and damp stasis, the urine microalbumin is 30-3500mg/d (clinical diabetic nephropathy II-III stage), the eGFR is more than 60ml/min/1.73m2 (chronic nephropathy II-III stage), and the age is 18-75 years.

(5) Exclusion criteria: 1-type diabetes mellitus; ② hyperglycemia patients caused by other diseases such as gestational diabetes and hyperthyroidism; those with psychosis and senile dementia; ③ serious complications of heart, brain, liver, etc.; malignant tumors, severe cardiac insufficiency, pregnancy, immune system diseases or other complications, and patients with acute and chronic infections; patients known to be allergic to the drugs used; is participating in other clinical trial participants or has participated in other clinical trial participants within 3 months. eGFR is less than 60ml/min/1.73m 2; sixthly, the age is less than 18 years old or more than 75 years old.

(6) Shedding/rejection criteria: those not meeting the selection standard; secondly, the judgment of curative effect and safety is not influenced by the incomplete data; thirdly, the compliance of the patient has problems in observation; (4) patients who are treated by other medicines because of serious complications in the midway; fourthly, the treatment is stopped midway or the adverse reaction occurs and the medicine is stopped midway.

2. Grouping tests: 120 patients are selected according to the standard, a random digital table is generated by adopting statistical software, and the subjects are randomly divided into a spleen-tonifying blood-activating wind-dispelling prescription combined losartan potassium treatment group and a losartan potassium treatment group singly according to a ratio of 1:1, wherein each group comprises 60 patients. Clinical trials were started after signing the informed consent.

3. The treatment scheme and the treatment course are as follows:

both groups of patients received diabetes education, diabetes diet, internal medicine oral hypoglycemic drugs or subcutaneous insulin injection treatment, on the basis of which: (1) combined traditional and western medicine treatment group: the traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy is used for treating the proteinuria in combination with losartan potassium (Coltsia), and the traditional Chinese medicine composition is decocted in water for taking, twice a day and 150ml each time; the losartan potassium (Colonina) dose is once a day, 100mg each time is orally taken. (2) Western medicine (losartan potassium) treatment group: losartan potassium (Colorania) is administered once daily, 100mg each time orally. The total treatment course of the two groups is 6 months.

4. The clinical observation indexes are as follows: 24 hours urine protein quantification, urine microalbumin quantification and urine albumin/creatinine ratio (ACR)

5. Test results

TABLE 1 comparison of proteinuria quantification at 24h, microalbumin quantification and urine albumin/creatinine ratio before and after treatment in two groups

Note: before treatment, the treatment group and the control group are compared, P is greater than 0.05, and the statistical significance is avoided; after treatment, the treatment group and the control group are compared, and the # P is less than 0.01, which has statistical significance.

At present, the acknowledged western medicines with definite curative effect for treating the proteinuria caused by the diabetic nephropathy are ACEI/ARB medicines, while the traditional Chinese medicine decoction is used as a traditional preparation form, and due to the diversity, the convenience and the syndrome differentiation and treatment completeness of the formula, the clinical medicine composition for treating the diabetic nephropathy can be screened out. The test adopts the spleen-invigorating, blood-activating and wind-dispelling formula combined with the biotin subunit to treat the proteinuria caused by the diabetic nephropathy, and results after 6 months show that compared with the single treatment of the biotin subunit, the two groups can reduce the ratio of urine protein, urine microalbumin and urine albumin/creatinine in 24 hours, but the obvious reduction degree of the ratio of the spleen-invigorating, blood-activating and wind-dispelling formula combined with the biotin subunit to the urine protein, urine microalbumin and urine albumin/creatinine in 24 hours is superior to that of the biotin subunit, and the statistical significance is achieved.

The above description is only for the preferred embodiment of the present invention, and is not intended to limit the present invention in any way. Any simple modifications, alterations and equivalent changes of the above embodiments according to the technical essence of the invention are still within the protection scope of the technical solution of the invention.

Claims

1. The traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy is characterized by comprising the following raw materials in parts by weight: 15-60 parts of raw astragalus membranaceus, 10-30 parts of fried bighead atractylodes rhizome, 15-40 parts of winged euonymus twig, 5-15 parts of stiff silkworm, 15-40 parts of caragana sinica root, 15-40 parts of centella asiatica, 15-40 parts of elderberry, 3-15 parts of coptis chinensis, 15-40 parts of glabrous greenbrier rhizome and 15-40 parts of spreading hedyotis herb.

2. The traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy according to claim 1, which is prepared from the following raw materials in parts by weight: 20-40 parts of raw astragalus membranaceus, 12-18 parts of fried bighead atractylodes rhizome, 20-40 parts of winged euonymus twig, 8-12 parts of stiff silkworm, 20-35 parts of caragana sinica root, 20-35 parts of centella asiatica, 25-35 parts of elderberry, 5-12 parts of coptis chinensis, 25-40 parts of glabrous greenbrier rhizome and 25-35 parts of spreading hedyotis herb.

3. The traditional Chinese medicine composition for treating proteinuria caused by diabetic nephropathy according to claim 2, which is prepared from the following raw materials in parts by weight: 30 parts of raw astragalus membranaceus, 15 parts of fried bighead atractylodes rhizome, 30 parts of winged euonymus twig, 10 parts of stiff silkworm, 30 parts of caragana sinica root, 30 parts of centella asiatica, 30 parts of elderberry, 6 parts of coptis chinensis, 30 parts of rhizoma smilacis glabrae and 30 parts of oldenlandia diffusa.