CN116098958B - Traditional Chinese medicine composition for treating early diabetic nephropathy with symptoms of deficiency of both qi and yin and blood stasis and preparation method thereof - Google Patents
Traditional Chinese medicine composition for treating early diabetic nephropathy with symptoms of deficiency of both qi and yin and blood stasis and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a traditional Chinese medicine composition for treating early diabetic nephropathy with the symptoms of deficiency of both qi and yin and blood stasis and a preparation method thereof. The traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 10-60 parts of astragalus root, 5-30 parts of radix pseudostellariae, 5-30 parts of angelica sinensis, 5-30 parts of rehmannia, 5-30 parts of dogwood, 10-60 parts of Chinese yam, 5-45 parts of radix trichosanthis, 5-45 parts of medlar, 5-50 parts of radix salviae miltiorrhizae, 5-50 parts of poria cocos, 8-30 parts of rhizoma alismatis, 6-30 parts of peach kernel and 6-30 parts of liquorice. The traditional Chinese medicine composition can obviously reduce urine albumin of a diabetic mouse, reduce damage of foot cells and tubular epithelial cells of the diabetic mouse, improve kidney pathological changes of the diabetic mouse and improve renal vascular endothelial functions of the diabetic mouse according to standard dosage of adults and calculated dosage according to body surface areas of the mouse; can effectively improve early diabetic nephropathy caused by deficiency of both qi and yin and blood stasis in clinic, reduce urine albumin, reduce damage of podocyte and renal tubule epithelial cells, and improve traditional Chinese medicine symptoms of early diabetic nephropathy caused by deficiency of both qi and yin and blood stasis.
Description
Technical Field
The invention relates to the field of medicine, in particular to a traditional Chinese medicine composition for treating early diabetic nephropathy with qi-yin deficiency and blood stasis and a preparation method thereof.
Background
Diabetic nephropathy is one of the important causes of end-stage renal disease, the disease progresses rapidly, once the clinical stage renal disease stage is entered, the disease is always continuously progressed, the disease is extremely difficult to reverse, the disease is developed into end-stage renal disease, the life of a patient is endangered, and the social medical effect is great. Therefore, finding measures for preventing and treating early diabetic nephropathy has very important clinical and social significance. The pathogenesis of diabetic nephropathy is not elucidated at present; the Western medicine lacks effective medicines for treating diabetic nephropathy, has limited effects, and can not improve symptoms of fatigue, weakness, dry throat, dry mouth, dark urine, constipation and the like of diabetic nephropathy patients. The pathogenesis of diabetic nephropathy can be attributed to the deficiency with spleen and kidney deficiency as the main part and blood stasis, water dampness and turbid toxin as the main part. Early stage lesions usually occur due to impairment of both qi and yin, and obstruction of collaterals by blood stasis. Modern traditional Chinese medicine doctors achieve a certain curative effect by dialectical treatment of diabetic nephropathy, but no unified prescription is used at present, and the traditional Chinese patent medicines in clinic pay attention to deficiency and neglect excess. For early diabetic nephropathy with deficiency of both qi and yin and blood stasis, no effective mature standard prescription is available.
Disclosure of Invention
The invention aims to overcome the defects that the existing pharmaceutical preparation for treating diabetic nephropathy is poor in treatment effect and can only treat symptoms, and provides a traditional Chinese medicine composition for treating early diabetic nephropathy with deficiency of both qi and yin and blood stasis and a preparation method thereof. The composition is safe and effective, has low cost, and is easy to master.
The traditional Chinese medicine composition for treating diabetic nephropathy is prepared from the following raw materials in parts by mass:
10-60 parts of astragalus root, 5-30 parts of radix pseudostellariae, 5-30 parts of angelica sinensis, 5-30 parts of rehmannia, 5-30 parts of dogwood, 10-60 parts of Chinese yam, 5-45 parts of radix trichosanthis, 5-45 parts of medlar, 5-50 parts of radix salviae miltiorrhizae, 5-50 parts of poria cocos, 8-30 parts of rhizoma alismatis, 6-30 parts of peach kernel and 6-30 parts of liquorice.
More preferably, the Chinese medicinal composition is prepared from the following raw materials in parts by mass
15-45 Parts of astragalus membranaceus, 10-30 parts of radix pseudostellariae, 6-20 parts of angelica sinensis, 10-30 parts of rehmannia, 6-20 parts of dogwood, 10-30 parts of Chinese yam, 10-30 parts of radix trichosanthis, 10-30 parts of medlar, 10-30 parts of radix salviae miltiorrhizae, 10-30 parts of poria cocos, 8-30 parts of rhizoma alismatis, 6-30 parts of peach kernel and 6-20 parts of liquorice.
Further preferably, the traditional Chinese medicine composition is prepared from the following raw materials in parts by mass:
20 parts of astragalus membranaceus, 15 parts of radix pseudostellariae, 10 parts of angelica sinensis, 20 parts of rehmannia glutinosa, 10 parts of dogwood, 15 parts of Chinese yam, 15 parts of radix trichosanthis, 15 parts of medlar, 15 parts of radix salviae miltiorrhizae, 15 parts of poria cocos, 10 parts of rhizoma alismatis, 15 parts of peach kernel and 10 parts of liquorice.
Wherein the radix astragali is dried root of Astragalus mongholicus Astragalus membranaceus (Fisch.) bge. Var. Mongholicus (bge.) Hsiao or Astragalus membranaceus Astragalus membranaceus (Fisch.) bge. Of Leguminosae; astragalus mongholicus has the effects of tonifying qi and yang, strengthening exterior and arresting sweating, inducing diuresis and removing edema, promoting fluid production and nourishing blood, promoting stagnancy and relieving arthralgia, expelling toxin and pus, healing sore and promoting granulation;
Radix Pseudostellariae is dried root tuber of radix Pseudostellariae Pseudostellaria heterophylla (Miq.) Pax ex Pax et Hoffm of Caryophyllaceae; radix pseudostellariae has effects of replenishing qi to invigorate spleen, promoting fluid production and moistening lung;
radix Angelicae sinensis is dry root of Angelica sinensis ANGELICA SINENSIS (Oliv.) Diels of Umbelliferae; the angelica has the effects of enriching and activating blood, regulating menstruation and relieving pain, and relaxing bowel;
rehmannia root is fresh or dried root tuber of rehmannia REHMANNIA GLUTINOSA Libosch of Scrophulariaceae; rehmannia has the effects of clearing heat and cooling blood, nourishing yin and promoting fluid production; in the invention, rehmannia is rehmannia;
the Corni fructus is dried ripe pulp of Corni fructus Cornus officinalis Sieb.et Zucc of Corni fructus of Cornaceae; fructus Corni has effects of invigorating liver and kidney, astringing, and relieving depletion;
Rhizoma Dioscoreae is dried rhizome of Dioscorea opposite Dioscorea opposita th uba of Dioscoreaceae; the Chinese yam has the effects of tonifying spleen and stomach, promoting fluid production and tonifying lung, and tonifying kidney and controlling seminal emission;
radix Trichosanthis is the dried root of Trichosanthes kirilowii Trichosanthes kirilowii maxim or Trichosanthes kirilowii Trichosanthes rosthornii Harms belonging to Cucurbitaceae; radix Trichosanthis has effects of clearing heat, purging pathogenic fire, promoting salivation, quenching thirst, relieving swelling, and expelling pus;
The fructus Lycii is dried mature fruit of Lycium barbarum L. Of Solanaceae; the medlar has the effects of nourishing liver and kidney, and tonifying essence and improving eyesight;
the Saviae Miltiorrhizae radix is dry root and rhizome of Saviae Miltiorrhizae radix Salvia miltiorrhiza bge of Labiatae; the red sage root has the effects of promoting blood circulation, removing blood stasis, dredging channels, relieving pain, clearing heart fire, relieving restlessness, cooling blood and eliminating carbuncles;
poria is dry sclerotium of Polyporaceae fungus Poria cocos (Schw.) Wolf; has effects in promoting diuresis, removing dampness, invigorating spleen, and calming heart;
The Alismatis rhizoma is dry tuber of Alismatis rhizoma Alisma orientale (Sam.) of Oriental family or Alismatis rhizoma Alisma plantago-aquatica Linn; has effects of promoting diuresis, removing dampness, clearing heat, eliminating turbid pathogen, and reducing blood lipid;
Semen Persicae is dried mature seed of Prunus persica (L.) Batsch or Prunus persica Prunus davidiana (Carr.) Franch; has effects of promoting blood circulation, removing blood stasis, loosening bowel to relieve constipation, relieving cough and asthma;
Glycyrrhrizae radix is dry root and rhizome of Glycyrrhrizae radix Glycyrrhiza uralensis Fisch. Glycyrrhiza uralensis Fisch. Glycyrrhiza inflata Bat. Or Glycyrrhiza glabra Glycyrrhiza glabra L. Of Leguminosae; has effects of invigorating spleen, replenishing qi, clearing heat, detoxicating, eliminating phlegm, relieving cough, relieving spasm, relieving pain, and harmonizing the medicines.
The diabetic nephropathy can be particularly early diabetic nephropathy with deficiency of both qi and yin and blood stasis.
The dosage form of the traditional Chinese medicine composition can be a conventional dosage form of a prescription, such as decoction or granules.
The traditional Chinese medicine composition can be prepared by adopting a conventional preparation method of traditional Chinese medicines. One of the preferred preparation methods for preparing the traditional Chinese medicine composition comprises the following steps: according to the mass parts, the raw materials for preparing the traditional Chinese medicine composition are mixed, soaked in water and decocted, and the decoction is collected to obtain the traditional Chinese medicine composition (water decoction).
In the above preferred preparation method, the water consumption per 185g of the raw materials by total mass can be more than 1/3 of the powder of the pharmaceutical mixture;
The soaking time can be 20-30 minutes;
The decoction time can be from 185g of raw materials to 150-300 ml, preferably 200ml, of residual liquid medicine;
The times of the decoction can be two times, and the decoction is combined after the decoction is finished.
The second preferred preparation method of the traditional Chinese medicine composition of the invention by preparing the traditional Chinese medicine raw materials can be a preparation method of a granule preparation conventional in the field, for example, the preparation method comprises the following steps: and uniformly mixing the granular preparation of each raw material for preparing the traditional Chinese medicine composition according to the mass parts to obtain the traditional Chinese medicine composition (granule). The granular formulation of each of the raw materials is commercially available.
When in use, the traditional Chinese medicine composition is taken after being dissolved by boiled water. The granule prepared from 185g of raw materials per total mass is dissolved with 300mL of boiled water, and then is divided into 150mL portions for standby.
The invention further provides a medicine for treating diabetic nephropathy, which consists of the traditional Chinese medicine composition and pharmaceutically acceptable auxiliary materials thereof. The diabetic nephropathy can be particularly early diabetic nephropathy with deficiency of both qi and yin and blood stasis.
The invention further provides a combined medicine composition for treating diabetic nephropathy, which comprises the traditional Chinese medicine composition and an angiotensin II receptor blocker.
The diabetic nephropathy can be particularly early diabetic nephropathy with deficiency of both qi and yin and blood stasis.
Angiotensin ii receptor blockers include, but are not limited to, irbesartan, valsartan, losartan, and the like.
The invention also provides application of the traditional Chinese medicine composition, the medicine or the combined medicine composition in the following A1) or A2):
a1 The application of the composition in preparing medicines for treating or assisting in treating diabetic nephropathy;
a2 For improving diabetic nephropathy.
The diabetic nephropathy can be particularly early diabetic nephropathy with deficiency of both qi and yin and blood stasis.
The invention also provides application of the traditional Chinese medicine composition, the medicine or the combined medicine composition in preparing medicines for reducing the urinary albumin/creatinine ratio (urinary albumin-to-CREATININE RATIO, UACR).
The invention also provides application of the traditional Chinese medicine composition, the medicine or the combined medicine composition in preparation of the following B1) or B2):
b1 Preparing a medicament for reducing urinary podocalyxin (Podocalyxin);
B2 Preparation of a medicament for protecting glomerular podocytes or reducing glomerular podocyte damage.
The invention also provides application of the traditional Chinese medicine composition, the medicine or the combined medicine composition in the following C1) or C2):
C1 Preparing a medicament for reducing urine N-Acetyl-beta-D glucosaminidase (N-Acetyl-b-D-glucosaminidase, NAG);
c2 Preparation of a medicament for protecting or reducing damage to tubular epithelial cells.
The invention also provides application of the traditional Chinese medicine composition, the medicine or the combined medicine composition in the following D1) or D2):
D1 The application of the composition in preparing medicines for improving pathological changes of diabetes kidneys;
D2 The application of the composition in preparing medicines for improving the renal vascular endothelial function of diabetes.
The research results of the traditional Chinese medicine composition and the combined medicine composition show that the traditional Chinese medicine composition has the following advantages:
The traditional Chinese medicine composition can reduce UACR, urine Podocalyxin and urine NAG of a diabetic mouse (UACR (db/db group VS db/db+traditional Chinese medicine dose group) under the condition of a dose calculated according to the body surface area of the mouse according to the standard dose of an adult: 31.75+ -4.17 vs.14.91+ -3.64 μg/ml, P < 0.001; urine Podocalyxin (VSdb/db group in VSdb/db+Chinese medicine dosage group) 30.12+ -4.74 vs.18.85+ -4.07 ng/ml, P < 0.001; NAG urine (db/db group VSdb/db+Chinese medicine dosage group) 409.99 + -63.82 vs.129.88+ -51.52 ng/ml, P < 0.001], the Chinese medicinal composition can reduce urine albumin of diabetic mice and reduce damage to foot cells and tubular epithelial cells of diabetic mice; the traditional Chinese medicine composition obviously improves kidney pathological changes of the diabetic mice and improves renal vascular endothelial functions of the diabetic mice under the dosage calculated according to the body surface area of the mice according to the standard dosage of adults; the traditional Chinese medicine composition can effectively improve kidney injury of diabetic mice.
The traditional Chinese medicine composition can reduce UACR [136.41 (95.21, 194.88) vs.53.53 (27.83, 77.52) mg/g, z= -12.968, P < 0.001] of early diabetic nephropathy patients when being singly used; the total effective rate of the traditional Chinese medicine composition for treating early diabetic nephropathy with both qi and yin deficiency and blood stasis is 90.75%; the traditional Chinese medicine composition can effectively improve early diabetic nephropathy with deficiency of both qi and yin and blood stasis.
Compared with the single use of the angiotensin II receptor blocker (irbesartan), the traditional Chinese medicine composition combined with the angiotensin II receptor blocker (irbesartan) can further reduce UACR, urine Podocalyxin and urine NAG [ UACR ] of patients with early diabetic nephropathy: 36.04 (33.45, 38.62) vs.68.49 (33.11, 132.84) mg/g, z= -4.175, p < 0.001; urine Podocalyxin: 8.16+ -3.13vs.14.63+ -6.77 μg/L, t= -6.947, P < 0.001; urine NAG: 16.65+ -3.12vs.23.93+ -6.53U/L, t= -8.043, P < 0.001]; the traditional Chinese medicine composition is combined with an angiotensin II receptor blocker to treat early diabetic nephropathy patients with deficiency of both qi and yin and blood stasis, and the improvement of traditional Chinese medicine symptoms is obviously better than that of the single use of the angiotensin II receptor blocker (z= -3.993, P < 0.001); the traditional Chinese medicine composition can effectively improve early diabetic nephropathy with deficiency of both qi and yin and blood stasis, reduce urine albumin and reduce damage to podocytes and tubular epithelial cells.
The traditional Chinese medicine composition is prepared by adding and subtracting a ginseng, astragalus and rehmannia decoction as a basic prescription according to the differentiation and treatment thought of tonifying qi and nourishing yin, promoting blood circulation and removing obstruction in channels; the astragalus root in the traditional Chinese medicine composition has slight temperature, and has the effects of tonifying qi, raising yang, inducing diuresis and relieving swelling; radix Pseudostellariae is a product for tonifying qi and regulating the balance, and can tonify both qi and yin; rehmannia root, radix rehmanniae has the effects of nourishing yin and clearing heat, and replenishing essence and marrow; fructus Corni has effects of tonifying liver and kidney, astringing essence, and relieving diarrhea; dioscorea opposita can smooth and tonify qi and yin of lung, spleen and kidney; radix trichosanthis has effects of clearing heat and purging pathogenic fire, and promoting salivation to quench thirst; the medlar nourishes liver and kidney, benefits essence and improves eyesight; the red sage root and the peach kernel can promote blood circulation to remove blood stasis; poria and Alismatis rhizoma can invigorate spleen and promote diuresis; the liquorice can tonify qi and invigorate spleen, and can harmonize various medicines; the traditional Chinese medicine composition has the effects of tonifying qi and nourishing yin, activating blood and dissolving stasis, and improves symptoms such as lassitude, hypodynamia, dry throat and mouth, dark urine, constipation and the like of patients with early diabetic nephropathy due to deficiency of both qi and yin and blood stasis. The traditional Chinese medicine composition takes astragalus and radix pseudostellariae as monarch drugs, rehmannia root, dogwood, yam, red sage root and peach seed as ministerial drugs, medlar, radix trichosanthis, poria cocos and rhizoma alismatis as adjuvant drugs and liquorice as conductant drugs.
Drawings
FIG. 1 is a photograph of HE staining of kidney tissue (FIG. 1A), PAS staining (FIG. 1B) and Masson staining of mice in group db/m, group db/db, group db/db+valsartan, group db/db+low dose of traditional Chinese medicine, group db/db+medium dose of traditional Chinese medicine, group db/db+high dose of traditional Chinese medicine in example 2 of the present invention.
FIG. 2 shows the renal endothelial function of mice in the db/m, db/db and db/db+ dosing groups of the traditional Chinese medicine according to example 2, wherein FIG. 2 (A) shows the comparison of the expression of nitric oxide synthase (endothelial nitric oxide synthase, eNOS) in the renal endothelium of mice in each group, FIG. 2 (B) shows the comparison of the level of nitric oxide (nitric oxide, NO) in the renal endothelium of mice in each group, and FIGS. 2 (C) and (D) show the comparison of the level of ROS production in the renal kidney of mice (#, P < 0.017 to db/m; and P < 0.017 to db/db).
Detailed Description
The following detailed description of the invention is provided in connection with the accompanying drawings that are presented to illustrate the invention and not to limit the scope thereof. The examples provided below are intended as guidelines for further modifications by one of ordinary skill in the art and are not to be construed as limiting the invention in any way.
The experimental methods used in the following examples are conventional methods unless otherwise specified. Materials, reagents and the like used in the examples described below are commercially available unless otherwise specified.
The Chinese medicinal materials used in the following examples all meet the relevant regulations under the text of one part of Chinese pharmacopoeia (2020 edition). Before feeding, the identification shows that the physical objects of the medicinal materials conform to the names and the quality conforms to the standard.
Example 1 preparation of a Chinese medicinal composition (decoction) for the treatment of early diabetic nephropathy due to deficiency of both qi and yin and blood stasis
1. Raw material formula
The traditional Chinese medicine composition for treating early diabetic nephropathy with both qi and yin deficiency and blood stasis in the embodiment is prepared from the following raw materials in parts by weight:
20 parts of astragalus membranaceus, 15 parts of radix pseudostellariae, 10 parts of angelica sinensis, 20 parts of rehmannia glutinosa, 10 parts of dogwood, 15 parts of Chinese yam, 15 parts of radix trichosanthis, 15 parts of medlar, 15 parts of radix salviae miltiorrhizae, 15 parts of poria cocos, 10 parts of rhizoma alismatis, 15 parts of peach kernel and 10 parts of liquorice.
2. Preparation method
The preparation method of the traditional Chinese medicine composition for treating early diabetic nephropathy with qi and yin deficiency and blood stasis comprises the following specific steps:
According to the formula, 20g of astragalus root, 15g of radix pseudostellariae, 10g of angelica, 20g of rehmannia root, 10g of dogwood, 15g of Chinese yam, 15g of radix trichosanthis, 15g of medlar, 15g of red sage root, 15g of poria cocos, 10g of rhizoma alismatis, 15g of peach kernel and 10g of liquorice are taken, all the weighed medicines are mixed, water is added until the medicines are submerged and exceed 1/3 of the medicine surface, the medicines are soaked for 20 minutes, then the medicines are boiled by strong fire, then the medicines are boiled by slow fire until the residual medicine liquid is 200ml, the boiling process is repeated for two times, the obtained medicine liquid is divided into two parts after being mixed, and each part is about 200ml, thus obtaining the traditional Chinese medicine composition (water decoction).
Example 2 animal Studies of Chinese medicinal composition for treating diabetic nephropathy
1. Research method
1.1. Grouping and treatment of laboratory animals
30 Male db/db mice (leptin receptor deficient spontaneous type 2 diabetic mice) at 4 weeks of age and 6 male heterozygote mice db/m mice (purchased from Nanjing university model animal institute) at the same litter. Feeding into standardized clean animal house, feeding with common feed, and drinking water. db/db mice were randomly divided into db/db group, db/db+valsartan group, db/db+low-dose group of traditional Chinese medicine, db/db+medium-dose group of traditional Chinese medicine and db/db+high-dose group of traditional Chinese medicine at 8 weeks, 6 each, and distilled water, valsartan 10mg/kg/d (according to adult standard dose, according to mouse body surface area conversion, dissolved in distilled water), the low-dose of traditional Chinese medicine of the present invention (1/2 according to adult standard dose, according to mouse body surface area conversion dose: 12g/kg/d, in example 1, water decoction concentration to 2 g/mL), the medium-dose of the present invention (according to adult standard dose, according to mouse body surface area conversion dose: 24g/kg/d, in example 1, water decoction concentration to 2 g/mL) and the high-dose of traditional Chinese medicine of the present invention (according to adult standard dose, according to mouse body surface area conversion dose: 48g/kg/d, in example 1, water decoction concentration to 2 g/mL) were administered separately. Mice were placed in metabolic cages to give urine specimens at 20 weeks, after which time the mice were sacrificed to give blood specimens and kidney tissue.
1.2. Observation index
Blood glucose (Johnson & Johnson company, usa), blood urinary creatinine (Olympus AU480, japan), urine albumin (R & D company, usa), urine Podocalyxin (Exocell company, usa), urine NAG (Elabscience company, usa), kidney pathology stain, dihydroethidium (DHE) stain, kidney eNOS (BD transmission, usa) expression and kidney NO (Sigma-Aldrich, china).
1.3. Statistical method
Statistical analysis was performed using SPSS 22.0 software. The measurement data adopts mean ± standard deviation. The difference between groups is compared by adopting an ANOVA test, and the difference is statistically significant by adopting a double-side test and taking P < 0.05 as the difference; the multiple comparisons among the groups are tested by LSD, the double-side test is adopted, the 6 groups of comparisons have statistical significance with P < 0.003 as difference, and the 3 groups of comparisons have statistical significance with P < 0.017 as difference.
2. Results
2.1. Comparison of mouse basic data
The body weight, kidney mass and blood glucose of each group of db/db mice were elevated compared to db/m mice, but the differences were not statistically significant in comparison with the body weight, kidney mass and blood glucose of each group of db/db mice (Table 1).
2.2. Comparison of renal injury index in mice
The difference is not statistically significant in the comparison of creatinine in blood of each group of mice. UACR, urine Podocalyxin, and urine NAG were elevated in each group of db/db mice compared to db/m mice; the levels of UACR, urine Podocalyxin and urine NAG in the db/db + traditional Chinese medicine and db/db + traditional Chinese medicine high-dose mice were significantly lower than in the db/db group, and the comparison difference was not statistically significant in the two groups, and the comparison difference was not statistically significant in the db/db + valsartan group (Table 2). The above results suggest that the traditional Chinese medicine composition of the invention can reduce urine albumin of diabetic mice and reduce injury of glomerular podocytes and tubular epithelial cells at a dose calculated according to the body surface area of the mice according to the standard dose of adults.
2.3. Kidney pathology staining of mice
As shown in fig. 1, the db/m group of mice kidney tissue HE staining (fig. 1A) showed clear glomerular structure, normal size, regular and ordered arrangement of tubular epithelial cells, no apparent purplish red glycogen deposition was seen in PAS staining (fig. 1B), and less fibrosis area was shown by Masson staining (fig. 1C); the db/db group of mice kidney tissue HE staining (fig. 1A) showed expansion of glomerular mesangial matrix, thickening of basement membrane, K-W nodules in part of glomeruli, vacuolation degeneration of part of tubular epithelial cells, PAS staining (fig. 1B) showed visible purplish red glycogen apparent deposition in glomeruli, masson staining (fig. 1C) showed a significant increase in fibrosis; after 12 weeks of administration, the renal tissue HE staining (fig. 1A) of mice in the db/db+valsartan group and db/db+traditional Chinese medicine groups showed improved expansion of glomerular mesangial matrix and thickening of basement membrane, reduced glomerular K-W nodules and reduced degree of vacuolation of the tubular, PAS staining (fig. 1B) showed reduced levels of glomerular mauve glycogen deposition, and Masson staining (fig. 1C) showed reduced areas of fibrosis, compared to the db/db mice. Moreover, the db/db+valsartan group is similar to the kidney pathology of the db/db+traditional Chinese medicine medium dose group and the db/db+traditional Chinese medicine high dose group mice. The results indicate that the traditional Chinese medicine composition can improve kidney pathological damage of a diabetic mouse under the dosage calculated according to the body surface area of the mouse according to the standard dosage of an adult.
2.4. Renal endothelial function in mice
As shown in fig. 2, kidney endothelial function of mice in db/m group, db/db group and db/db+ group of the traditional Chinese medicine were compared, kidney eNOS expression of db/db group mice was decreased (fig. 2A) compared with db/m group mice, NO generation was decreased (fig. 2B), reactive oxygen species (reactive oxygen species, ROS generation was increased (fig. 2C and D); the mice in the db/db+ traditional Chinese medicine dose group had increased renal eNOS expression (FIG. 2A) and increased NO production (FIG. 2B) and decreased ROS production (FIGS. 2C and D) compared to the mice in the db/db group. The results indicate that the traditional Chinese medicine composition can improve the renal endothelial cell function of the diabetic mice at a dosage calculated according to the body surface area of the mice according to the standard dosage of adults.
Therefore, the traditional Chinese medicine composition can reduce UACR, urine Podocalyxin and urine NAG of a diabetic mouse (UACR (db/db group VS db/db+traditional Chinese medicine dosage group) at a dosage calculated according to the body surface area of the mouse according to the standard dosage of an adult: 31.75+ -4.17 vs.14.91+ -3.64 μg/ml, P < 0.001; urine Podocalyxin (VSdb/db group in VSdb/db+Chinese medicine dosage group) 30.12+ -4.74 vs.18.85+ -4.07 ng/ml, P < 0.001; NAG urine (db/db group VSdb/db+Chinese medicine dosage group): 409.99 + -63.82 vs.129.88+ -51.52 ng/ml, P < 0.001], the Chinese medicinal composition can reduce urine albumin of diabetic mice, and reduce injury of glomerular podocyte and tubular epithelial cells; the traditional Chinese medicine composition obviously improves kidney pathological changes of the diabetic mice and improves renal vascular endothelial functions of the diabetic mice under the dosage calculated according to the body surface area of the mice according to the standard dosage of adults; the traditional Chinese medicine composition can effectively improve kidney injury of diabetic mice.
TABLE 1 comparison of the essential data for mice of each group
( And (3) injection: * P <0.003 compared to db/m group; p <0.003 compared to db/db group; and (c) P <0.003 compared with db/db+valsartan group )
TABLE 2 comparison of renal injury index for mice of each group
( And (3) injection: * P <0.003 compared to db/m group; p <0.003 compared to db/db group; and (c) P <0.003 compared with db/db+valsartan group )
Example 3 clinical study of the Chinese medicinal composition for treating early diabetic nephropathy due to deficiency of both qi and yin and blood stasis
1. Data and method
The study retrospectively analyzes the effect of treating 227 early diabetic nephropathy patients with deficiency of both qi and yin and blood stasis for 3 months by using the traditional Chinese medicine composition in 1 month-2015 12 months in 2010.
1.1. Inclusion criteria:
the age of the selected patient is 18-80 years, and the sex and the ethnicity are not limited.
Western diagnosis of diabetes is based on the world health organization diagnostic criteria. The western medicine diagnosis standard of early diabetic nephropathy is based on the consensus of the specialist for prevention and treatment of diabetic nephropathy in China in 2014: there is a history of diabetes, between 30-300mg/g UACR 2 times a day over 3 months, except for other causes of kidney disease.
The traditional Chinese medicine diagnosis standard for the deficiency of both qi and yin and blood stasis syndrome is according to the guidelines for preventing and treating diabetic nephropathy, the guidelines for diagnosing and treating common diseases in traditional Chinese medicine, western medicine disease and the guidelines for clinical research of new traditional Chinese medicine. The main symptoms of deficiency of both qi and yin are dry throat, lassitude and debilitation; the secondary symptoms are excessive eating and hunger, thirst and drink preference, shortness of breath and no desire to speak, dysphoria with feverish sensation in the chest, palpitation and insomnia, and dark urine and constipation; the tongue pulse is red, less fluid, stripped or stripped tongue fur, and thready, rapid and weak or wiry and thready pulse. The main symptoms of the stasis syndrome are lumbago, backache, fixed parts, numbness of limbs and severe pain at night; the secondary symptoms are skin and skin malformation, purple and dark lips, facial ecchymosis, vexation and insomnia; the tongue pulse is dark, with ecchymosis, dark purple and tortuosity of the sublingual vessels, and wiry or deep and astringent pulse. The Chinese medicinal composition is suitable for the principal symptoms of deficiency of both qi and yin 2 items and the principal symptoms of blood stasis 3 items or the principal symptoms of deficiency of both qi and yin 2 items and the secondary symptoms of principal symptoms 2 items, and can be distinguished as the symptoms of both deficiency of both qi and yin and blood stasis by combining tongue pulse.
1.2. Exclusion criteria:
The traditional Chinese medicine composition is treated by using an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker before and during treatment or other medicines for treating diabetic nephropathy; history of primary kidney disease or history of secondary kidney disease other than diabetic nephropathy; history of urinary infections or other severe infectious diseases, history of urine Lu Jiedan, history of vaginitis or prostatitis; acute complications associated with diabetes, such as diabetic ketoacidosis, hyperglycemia hypertonic state, lactic acidosis, etc.; pregnant or lactating women; and severe diseases such as heart, lung, cerebral vessels, liver and hematopoietic system are complicated.
1.3. Treatment:
All patients were required to follow the diabetic diet strictly, with high quality protein intake and limited to (0.8-1.0 g/d). All patients were given the traditional Chinese medicine composition of example 1. One dose is taken twice a day before breakfast and supper, 200mL each time, and the treatment period is more than 12 weeks.
1.4. Observation index
Clinical observations included fasting blood glucose, transaminase, creatinine, UACR.
The curative effect judgment refers to the principles of the clinical study guidelines for new Chinese medicine, and is carried out on the study subjects. The obvious effect is that clinical symptoms and physical signs are obviously improved, and the reduction rate of UACR is more than or equal to 70%; the effective improvement of clinical symptoms and physical signs is achieved, and the reduction rate of UACR is more than or equal to 30 percent but less than 70 percent; the failure is that clinical symptoms and physical signs are not obviously improved, and the reduction rate of UACR is less than 30 percent.
1.5. Statistical method
Statistical analysis was performed using SPSS 22.0 software. After the baseline characteristic equalization comparison, normal distribution metering data is represented by mean ± standard deviation, and the difference comparison before and after treatment is performed by paired sample t test; the non-normal distribution metering data is represented by a median quartile distribution, and the comparison of the differences before and after treatment is carried out by Wilcoxon rank sum test. The two-side test is adopted, and the difference of P <0.05 is statistically significant.
2. Results
2.1. Comparison of two sets of basic data
227 Cases were included in compliance with the diabetic nephropathy inclusion standard, 139 cases for men and 88 cases for women; average age 56.08±8.14 years.
2.2. Post-treatment clinical index comparison
After treatment, there was no statistical significance (P > 0.05) for both patient blood glucose and transaminase compared to pre-treatment (Table 3). Patient creatinine and UACR decreased prior to treatment, with differences statistically significant (P < 0.05) (table 3).
From the results, the traditional Chinese medicine composition can reduce UACR of patients with early diabetic nephropathy due to deficiency of both qi and yin and blood stasis, and improve early diabetic nephropathy due to deficiency of both qi and yin and blood stasis.
2.3. Evaluation of efficacy
The traditional Chinese medicine composition has the obvious effect of 76 cases, 130 cases, 21 cases and 90.75% of total effective rate in treating early diabetic nephropathy caused by deficiency of both qi and yin and blood stasis.
2.4 Adverse reactions
All patients treated by the traditional Chinese medicine composition have no serious adverse reaction.
Therefore, the traditional Chinese medicine composition can reduce UACR [136.41 (95.21, 194.88) vs.53.53 (27.83, 77,52) mg/g, z= -12.968, P < 0.001] of early diabetic nephropathy patients; and the total effective rate for treating early diabetic nephropathy caused by deficiency of both qi and yin and blood stasis is 90.75%; the traditional Chinese medicine composition can effectively improve early diabetic nephropathy with deficiency of both qi and yin and blood stasis.
TABLE 3 variation of indices before and after 3 months of treatment
Example 4 clinical study of the treatment of early diabetic nephropathy with the combination of the Chinese medicinal composition of the present invention and the angiotensin II receptor blocker
1. Data and method
The clinical study is put into a group from 2018, 1 month and 2019, 6 months, 128 cases of patients with early diabetic nephropathy due to deficiency of both qi and yin and blood stasis based on traditional Chinese medicine differentiation. Each enrollee voluntarily participated in the study and signed an informed consent form prior to the study.
1.1. Inclusion criteria:
The age of the selected patient is 18-80 years, and the sex and the ethnicity are not limited. Western diagnosis of diabetes is based on the world health organization diagnostic criteria. The western medicine diagnosis standard of early diabetic nephropathy is based on the consensus of the specialist for prevention and treatment of diabetic nephropathy in China in 2014: there is a history of diabetes, with UACR between 30-300mg/g 2 times a day over 3 months, except for other causes of kidney disease. In addition, the fasting blood glucose is less than or equal to 9mmol/L, and the glycosylated hemoglobin is less than or equal to 8 percent. The blood pressure is more than or equal to 130/80mmHg.
The traditional Chinese medicine diagnosis standard for the deficiency of both qi and yin and blood stasis syndrome is according to the guidelines for preventing and treating diabetic nephropathy, the guidelines for diagnosing and treating common diseases in traditional Chinese medicine, western medicine disease and the guidelines for clinical research of new traditional Chinese medicine. The main symptoms of deficiency of both qi and yin are dry throat, lassitude and debilitation; the secondary symptoms are excessive eating and hunger, thirst and drink preference, shortness of breath and no desire to speak, dysphoria with feverish sensation in the chest, palpitation and insomnia, and dark urine and constipation; the tongue pulse is red, less fluid, stripped or stripped tongue fur, and thready, rapid and weak or wiry and thready pulse. The main symptoms of the stasis syndrome are lumbago, backache, fixed parts, numbness of limbs and severe pain at night; the secondary symptoms are skin and skin malformation, purple and dark lips, facial ecchymosis, vexation and insomnia; the tongue pulse is dark, with ecchymosis, dark purple and tortuosity of the sublingual vessels, and wiry or deep and astringent pulse. The Chinese medicinal composition is suitable for the principal symptoms of deficiency of both qi and yin 2 items and the principal symptoms of blood stasis 3 items or the principal symptoms of deficiency of both qi and yin 2 items and the secondary symptoms of principal symptoms 2 items, and can be distinguished as the symptoms of both deficiency of both qi and yin and blood stasis by combining tongue pulse.
1.2. Exclusion criteria:
History of primary kidney disease and history of secondary kidney disease other than diabetic nephropathy; the use of angiotensin converting enzyme inhibitors or angiotensin ii receptor blockers, or other drugs for the treatment of diabetic nephropathy, in the last 3 months; a history of urinary infections or other severe infectious diseases, history of urine Lu Jiedan, history of vaginitis or prostatitis in the last 3 months; acute complications of diabetes occur within about 1 month, such as diabetic ketoacidosis, hyperglycemic state, lactic acidosis, etc.; pregnant or lactating women; patients with serious diseases such as heart, lung, cerebral vessels, liver and hematopoietic system; cannot co-workers with mental diseases.
1.3 Grouping and treatment:
The randomized numbers were generated in silico and subjects were randomized into the traditional Chinese medicine combination angiotensin ii receptor blocker (angiotensin receptor blockers, ARB) group (64 persons) and the ARB group (64 persons), and the traditional Chinese medicine combination ARB group was given the traditional Chinese medicine composition of example 1 once daily, twice daily, 200mL each time before breakfast and evening, while 150mg of irbesartan was combined once daily. Irb group alone was administered with 150mg of irbesartan once daily. All panelists observed a total of 3 courses of treatment with a course of 4 weeks.
All subjects were prescribed strict compliance with the diabetic diet, intake of high quality protein and limited to (0.8-1.0 g/d), and continued all currently available glycemic control medications. If the blood sugar is less than or equal to 3.9mmol/L, the current blood sugar reducing medicament dosage can be reduced under the guidance of doctors, and no new medicament is added except the research medicament.
1.4. Observation index
Western medicine observation indexes comprise blood pressure, fasting blood glucose, glycosylated hemoglobin, creatinine, UACR, urine Podocalyxin, urine NAG, etc.
The observation index of traditional Chinese medicine is based on the principles of the clinical study guidelines of new traditional Chinese medicines, and the curative effect judgment of the traditional Chinese medicine symptoms is carried out on the researched subjects by adopting the nimodipine method (table 4). The obvious effect is that the clinical symptoms and signs of the traditional Chinese medicine are obviously improved, and the symptom integral reduction rate is more than or equal to 70%; the Chinese medicine has the effective improvement of clinical symptoms and physical signs, and the symptom integral reduction rate is more than or equal to 30 percent but less than 70 percent; the ineffectiveness is that the clinical symptoms and physical signs of the traditional Chinese medicine are not obviously improved, and the symptom integral reduction rate is less than 30 percent.
Table 4. Chinese medicine syndrome questionnaire
1.5. Statistical method
Statistical analysis was performed using SPSS 22.0 software. After the baseline characteristic equality comparison, the metrology data is represented by mean ± standard deviation (normal distribution) or median quartile distribution (bias distribution). The group comparisons used either two independent samples t-test (normal distribution) or Mann-Whitney U rank sum test (bias distribution). Pre-treatment and post-treatment differential comparisons employed paired sample t-test (normal distribution) or Wilcoxon rank sum test (bias distribution). The counting data are described by frequency numbers, and the differences are compared by using chi-square test. Both sides are used for inspection, and the difference of P < 0.05 is statistically significant.
2. Results
2.1. Comparison of two sets of basic data
The age and sex of the subjects in the combination of the traditional Chinese medicine ARB group and ARB group were compared, and the difference was not statistically significant (P > 0.05) (see Table 5).
TABLE 5 basic clinical data
2.2. Comparison of two Western medicine indices before treatment
The differences were statistically significant (P > 0.05) compared with the traditional Chinese medicine combination ARB and ARB pre-treatment systolic pressure, diastolic pressure (Table 6), blood glucose, glycosylated hemoglobin (Table 7), creatinine, UACR (Table 8), urine Podocalyxin and urine NAG (Table 9).
2.3. Western medicine index comparison after treatment
After treatment, the differences were statistically significant (P > 0.05) in the blood glucose, glycosylated hemoglobin (Table 7) and creatinine (Table 8) of the traditional Chinese medicine combination ARB and ARB groups compared to those before treatment, and were also statistically significant (P > 0.05) in the two groups. After treatment, the systolic and diastolic pressures of the ARB and ARB groups were both reduced compared to that before treatment, the difference was statistically significant (P < 0.05), but the difference was not statistically significant (P > 0.05) compared with the systolic and diastolic pressures of the two groups after treatment (Table 6).
After treatment, the UACR, urine Podocalyxin and NAG of the traditional Chinese medicine combined ARB group and ARB group were reduced compared with those before treatment, and the difference was statistically significant (P < 0.05). And the UACR (Table 8), urine Podocalyxin and urine NAG of the post-treatment traditional Chinese medicine combination ARB group showed a further decrease in the level (Table 9) compared with the post-treatment ARB group, the difference was statistically significant (P < 0.05).
From the results, the use of the traditional Chinese medicine composition in combination with the angiotensin II receptor blocker can further reduce UACR, urine Podocalyxin and urine NAG of patients with early diabetic nephropathy with deficiency of both qi and yin and blood stasis compared with the use of the angiotensin II receptor blocker alone, which suggests that the traditional Chinese medicine composition can improve early diabetic nephropathy with deficiency of both qi and yin and blood stasis by protecting glomerular podocyte and renal tubular epithelial cells.
Table 6 blood pressure comparison
TABLE 7 comparison of sugar metabolism
TABLE 8 comparison of blood creatinine to urine albumin/creatinine ratio
TABLE 9 urine Podocalyxin comparison with urine N-acetyl-beta-D-aminoglucosidase (NAG)
2.4. Evaluation of therapeutic efficacy of traditional Chinese medicine
The traditional Chinese medicine is combined with the ARB to improve the traditional Chinese medicine symptoms, the effective rate is 30 cases, the effective rate is 26 cases, the ineffective rate is 8 cases, the ARB has the effective rate of 14 cases, the effective rate is 22 cases, and the ineffective rate is 28 cases. The data are analyzed and compared, the two groups of differences have statistical significance, and the traditional Chinese medicine composition combined with the angiotensin II receptor blocker has better improvement on the traditional Chinese medicine symptoms than the single use of the angiotensin II receptor blocker (z= -3.993 and P < 0.001).
Therefore, compared with the single use of the angiotensin II receptor blocker, the treatment of the traditional Chinese medicine composition combined with the angiotensin II receptor blocker further reduces UACR, urine Podocalyxin and urine NAG of patients with early diabetic nephropathy due to deficiency of both qi and yin and blood stasis [ UACR:36.04 (33.45, 38.62) vs.68.49 (33.11, 132.84) mg/g, z= -4.175, p < 0.001; urine Podocalyxin: 8.16+ -3.13vs.14.63+ -6.77 μg/L, t= -6.947, P < 0.001; urine NAG: 16.65+ -3.12vs.23.93+ -6.53U/L, t= -8.043, P < 0.001]; the traditional Chinese medicine syndrome improvement of the traditional Chinese medicine combined ARB group is obviously better than that of the ARB group (z= -3.993, P is less than 0.001); the traditional Chinese medicine composition can effectively improve early diabetic nephropathy with deficiency of both qi and yin and blood stasis, reduce urine albumin and reduce damage to podocytes and tubular epithelial cells.
Claims (1)
1. Use of a combination composition in the following A1):
a1 Preparing a medicament for treating early diabetic nephropathy with the symptoms of deficiency of both qi and yin and blood stasis;
The combined medicine composition consists of a traditional Chinese medicine composition and irbesartan;
The traditional Chinese medicine composition is prepared from the following raw materials in parts by mass: 20 parts of astragalus membranaceus, 15 parts of radix pseudostellariae, 10 parts of angelica sinensis, 20 parts of rehmannia glutinosa, 10 parts of dogwood, 15 parts of Chinese yam, 15 parts of radix trichosanthis, 15 parts of medlar, 15 parts of radix salviae miltiorrhizae, 15 parts of poria cocos, 10 parts of rhizoma alismatis, 15 parts of peach kernel and 10 parts of liquorice.
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