RU2461386C1 - Use of uglanex as lipid, carbohydrate and protein normalising drug - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely therapy and endocrinology, and may be applicable as a lipid, carbohydrate and protein normalising drug in treating type II diabetes mellitus, atherosclerosis and metabolic syndrome. That is ensured by adding the integrating therapy with the drug Uglanex.

EFFECT: invention provides effective treatment of said pathological conditions ensured by reducing a cholesterol level, an atherogenicity index, blood sugar, insulin resistance and albuminuria.

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Description

The invention relates to medicine and can be used as a new means to normalize lipid metabolism in the treatment of type II diabetes mellitus, atherosclerosis and metabolic syndrome.

In patients with diabetes mellitus and metabolic syndrome, the state of lipid metabolism is one of the most significant risk factors for the development of cardiovascular complications and a criterion for the detection of metabolic syndrome. Diabetes mellitus is a consequence of relative or absolute insulin deficiency. In accordance with the WHO classification, two forms of the disease are distinguished: insulin-dependent (type I diabetes mellitus) and non-insulin-dependent (type II diabetes mellitus). Type I diabetes mellitus is characterized by absolute insulin deficiency and requires hormone replacement therapy with insulin preparations. Type II diabetes mellitus (non-insulin-dependent diabetes) is a metabolic disease characterized by chronic hyperglycemia that develops as a result of impaired insulin secretion or the mechanisms of its interaction with tissue cells. Type II diabetes patients need to be given oral antidiabetic drugs. Metabolic syndrome (MS), the prevalence of which according to the results of a large prospective study of ARIC reaches 24% in women and 23% in men, is an extremely relevant medical and social problem. All components of the metabolic syndrome, such as arterial hypertension, abdominal obesity, hypertriglyceridemia, and insulin resistance, are factors of cardiovascular risk. It has been shown that metabolic syndrome has a negative effect not only on the course of cardiovascular diseases, but also on kidney function. The risk of developing chronic kidney disease (CKD) increases as the number of components of the metabolic syndrome increases. In addition, the features of lipid metabolism disorders in the presence of metabolic syndrome can be the causes of impaired renal function in this category of patients. Filtered in glomeruli lipoproteins cause damage to the glomerular capillary endothelium and lipid deposition in mesangial cells, which stimulates the development of interstitial sclerosis. Therefore, the use of drugs that affect the lipid spectrum of the blood is relevant.

Known means of plant origin, which can be used as a means for the correction of disorders of carbohydrate metabolism for the prevention and treatment of type II diabetes mellitus. The product is an ecdysteroid-containing substance isolated from the aerial part of the plants of the serpent crowned Serratula coronata L. (Asteraceae), which is a mixture of 20-hydroxyecdysone in an amount of at least 75% and 25S-inocosterone in an amount of at least 10%. The proposed tool for the treatment of non-insulin-dependent diabetes (type II diabetes) has not only a hypoglycemic effect, but also lipid-lowering activity (Patent No. 2337698, publ. 10.11.2008).

It is known to use clinoptilolite zeolite of the Shivyrtuy field as a means for treating diabetes. The tool has a hypocholesterolemic effect, and also stimulates the regeneration of the endocrine part of the pancreas. Additionally, the drug enhances regenerative processes in the kidneys, liver, intestines; due to the binding and elimination of low molecular weight toxic substances, such as urea, uric acid, creatinine, etc., it reduces their toxic effect on the body, partially compensating for renal failure; stimulates reparative regeneration in the organs of hematopoiesis (Patent 2329813, publ. July 27, 2008).

Known plant fees for the prevention and treatment of diabetes. Suggested options. The first option for collecting medicinal plants for the treatment of diabetes mellitus contains herb galega officinalis, common blueberry leaf, dioica nettle grass, field horsetail grass, St. John's wort grass, bean fruit leaves, common fennel, common bearberry, rosehip, white birch leaf, flax seeds seed, walnut leaves. The second collection option for the treatment of diabetes mellitus contains medicinal galega grass, common blueberry leaf, dioica nettle grass, field horsetail grass, St. John's wort grass, bean fruit leaves, common fennel, common bearberry leaf, rosehip fruit, white birch leaf, seed flax seeds leaves of walnut and Aralia of Manchurian. The third collection option for the treatment of diabetes mellitus contains medicinal galega grass, common blueberry leaf, dioecious nettle grass, field horsetail grass, St. John's wort grass, bean fruit leaves, common fennel, common bearberry leaf, rose hips, white birch leaf, sowing flax seeds walnut leaves, eleutherococcus root. Variants of the collection of medicinal plants can improve therapeutic efficacy, they can be used both independently and as an additional tool along with other methods of treatment (Patent No. 2331431, publ. 20.08.2008).

Known means for the treatment of type II diabetes. For this, along with the commonly used drugs used to treat type 2 diabetes, drugs containing birch bark extract are also added. The method allows to increase the effectiveness of treatment due to the hypoglycemic, antioxidant and lipid-lowering properties of biologically active substances that are part of the birch bark extract (Patent No. 2304976, publ. 08.27.2007).

The objective is to expand the arsenal of herbal remedies that normalize the metabolism in the treatment of type II diabetes mellitus, atherosclerosis and metabolic syndrome, which are non-toxic and do not cause side effects.

The technical result from the use of a herbal drug is the normalization of the state of lipid, carbohydrate and protein metabolism in complex therapy in the treatment of type II diabetes mellitus, atherosclerosis and metabolic syndrome, does not cause side effects and is non-toxic.

The technical result is achieved by the use of the drug Yuglaneks in complex therapy as a means of normalizing lipid, carbohydrate and protein metabolism in the treatment of type II diabetes mellitus, atherosclerosis and metabolic syndrome

An open, randomized, comparative, 12-week, prospective study was conducted to study the effectiveness of Yuglanex therapy, which included 100 patients with diabetes mellitus, atherosclerosis, and metabolic syndrome, confirmed by outpatient and / or inpatient examination. Patients were randomized according to the “1-2” principle to 2 groups: the main group (50 people) received, in addition to basic therapy (drugs for controlling blood pressure and treating coronary heart disease and, if necessary, hypoglycemic agents) - Yuglaneks. Control group (50 person) received only basic therapy. Yuglaneks was used in a dose of 5 ml (1 teaspoon), dissolved in 1/2 cup of boiled water, 3 times a day after meals. The characteristics of the groups of patients participating in the study are shown in table 1.

Table 1. Parameter main group control group Number of patients fifty fifty Age 57.17 + 1.56 60.4 + 2.58 Men / women 17/33 23/27 Diabetes mellitus, type II, m / f 4/5 4/5 Metabolic syndrome, m / f 6/14 7/14 Obesity 12/24 13/23 Body mass index, kg / m ² 30.28 ± 4.06 31.76 ± 4.42 Glucose of capillary blood, mmol / l 7.03 ± 1.03 6.25 ± 0.89 Glycated hemoglobin, HbAl _c 5.79 ± 1.13 5.26 ± 0.89 Arterial hypertension 38 39 GARDEN, mmHg 141.3 ± 11.03 142.5 ± 15.9 DBP, mmHg 84.25 ± 5.39 87.7 ± 9.57 Coronary heart disease twenty twenty Stable angina pectoris 8/4 9/3 Heart rhythm disorders 4/1 3/2 Postinfarction cardiosclerosis 2/1 2/1 Diabetic Microangiopathies 9 9 Diabetic peripheral neuropathy 5 5

We studied the effect of combined treatment with Yuglaneks on the state of lipid metabolism in patients with diabetes mellitus, atherosclerosis and metabolic syndrome. In patients with diabetes mellitus and metabolic syndrome, the state of lipid metabolism is one of the most significant modifiable risk factors for the development of cardiovascular complications and a criterion for identifying the metabolic syndrome. In addition, the features of lipid metabolism disorders in the presence of MS can be the causes of impaired renal function in this category of patients. Filtered in glomeruli lipoproteins lead to damage to the endothelium of the glomerular capillaries and the deposition of lipids in mesangial cells.

In the main group of patients taking Yuglaneks, a positive effect of the drug on almost all indicators of the blood lipid spectrum was noted: total cholesterol (OX), high lipid cholesterol (ChsLVP), very low (ChsLONP) and low density (ChsLNP), triglycerides (TG), atherogenic index (IA). In the main group of patients, a significant decrease in the content of OH was noted by 10.19% of the initial (p <0.05), in the control group - by 0.85% (p> 0.05) (the difference between the groups was significant, p = 0.019 ) There was also a significant decrease in the content of LDL-C by 18.04% (p <0.05) in the main group and 1.99% (p> 0.05) in the control group, the difference between the groups was significant (p = 0.003). The content of TG did not significantly change in both the main and control groups.

The atherogenicity index (IA) significantly decreased by 16.62% in the main group of patients, while in the control group it remained practically unchanged (Δ,% 0.75).

Thus, in the main group, a significant beneficial effect of the drug Yuglaneks on the lipid profile of the examined patients with type II diabetes mellitus, atherosclerosis and metabolic syndrome was noted.

The effect of Yuglaneks treatment on fasting glycemia, glycated hemoglobin level in patients with diabetes mellitus, atherosclerosis and metabolic syndrome was studied.

Disorders of carbohydrate metabolism characteristic of diabetes mellitus and metabolic syndrome also lead to an increased risk of mortality from cardiovascular disease. Even in patients without diabetes mellitus, who are morbidly obese and with impaired glucose tolerance, the likelihood of developing myocardial infarction and cerebral stroke is 1.9-2.1 times higher, and mortality is two times higher than in patients without metabolic disorders.

We studied the effect of Yuglaneks on HbAlc, fasting glycemia in patients with diabetes mellitus, atherosclerosis and metabolic syndrome. Fasting glycemia decreased by 4.93% in the main group, and in the control group increased by 10.23% (p> 0.05).

We studied the effect of Yuglaneks treatment on the severity of albuminuria (AU) in patients with diabetes mellitus, atherosclerosis, and metabolic syndrome.

The relationship between microalbuminuria (UIA) and obesity was shown in a GUBBIO study: with an increase in body mass index (BMI) of 4 kg / m ^{2, the} probability of an increase in urinary albumin excretion increased by 1.83 times in men and 1.33 times in men and women.

The presence of MAU indicates a significant renal dysfunction in patients with diabetes mellitus and MS and is associated with an unfavorable cardiovascular prognosis in this category of patients. The dynamics of the level of albuminuria in patients with diabetes mellitus, atherosclerosis and metabolic syndrome are shown in table 2

table 2 Indicator main group control group initially after 12 weeks Δ,% p initially after 12 weeks Δ,% p AU mg / l 390 ± 33.41 297.79 ± 26.81 * # -23.64 <0.05 335.35 ± 21.21 334.4 ± 21.36 -0.4 > 0.05 Note. Significance of differences with indicators before treatment: * p <0.05. Significance of differences between groups # - p <0.05

A positive effect of Yuglaneks on the severity of albuminuria was noted. In patients of the main group, while taking the drug, AU decreased by 23.64% (p <0.05), while in the control group the severity of AU did not change (Δ,% -0.4, p> 0.05). The difference between the groups is significant (p = 0.001).

Thus, a positive effect of the drug Yuglaneks on the functional state of the kidneys was noted, which can be mediated by a high content of antioxidants in the drug.

We studied the effect of Yuglaneks therapy on insulin resistance in patients with diabetes mellitus, atherosclerosis, and metabolic syndrome.

Insulin resistance, which determines the development of diabetes and MS, is currently considered as the primary etiological factor in the development of heart failure of non-ischemic origin. It is shown that the pathogenesis of the development of "insulin-resistant cardiomyopathy" is based on a violation of myocardial energy metabolism, mediated by the formation of lipotoxicity syndrome, sympathetic dysregulation, oxidative and inflammation, which is manifested by the predominance of b-oxidation of fatty acids in it and a sharp suppression of glucose oxidation in the myocardium and metabolic disturbance in him. Therefore, the use of drugs with a high content of antioxidants is promising in patients of this category.

The results obtained by evaluating the effect of the drug Yuglaneks on insulin levels (IRI) and insulin resistance (HOMA index) are presented in table 3.

Table 3 Indicator main group control group initially after 12 weeks Δ,% p initially after 12 weeks Δ,% p IRI 16.25 + 1.62 13.02 + 0.88 -19.88 > 0.05 10.7 ± 0.76 11.09 ± 0.75 3.64 > 0.05 NOMA Index 4.04 + 0.55 2.87 + 0.19 * -28.96 # 0.05 3.27 + 0.33 2.85 + 0.29 -12.8 > 0.05 Note: p - * significance of differences between initial and final parameters, significance of differences between groups # - p <0.05

A significant decrease in the severity of insulin resistance was noted in the main group of patients (while taking YUGLANEXA) - Δ,% - 28.96 (p <0.05). In the control group, no significant changes in the NOMA index were obtained.

Thus, the obtained results indicate the possibility of correcting the severity of insulin resistance in patients with diabetes mellitus and metabolic syndrome using Yuglaneks.

We studied the effect of Yuglaneks therapy on the activity of serum alanine and aspartic aminotransferases in patients with diabetes mellitus, atherosclerosis, and metabolic syndrome.

The safety issue of treatment is an essential aspect of the use of any medicine. It acquires special importance when introducing into clinical practice a drug intended for groups of patients with different age and degree of weakened health. The positive effect of many drugs that affect lipid metabolism is associated with inhibition of cholesterol (cholesterol) synthesis in hepatocytes, which may be accompanied by a decrease in the cholesterol content in the hepatocyte membrane and a decrease in their microviscosity, and an increase in the permeability of the plasma membrane of cells. This forms a cytolysis syndrome - the outflow into the intercellular medium and blood of the contents of the cytosol, in particular alanine aminotransferase and aspartate aminotransferase.

In this regard, transaminases are indicator enzymes, and the content of alanine (ALT) and aspartic (ACT) aminotransferase are the most widely used markers of damage to the liver parenchyma and hepatocellular necrosis.

In our study, both in the main and in the control group, there were no undesirable side effects and clinically significant increases in transaminases.

Thus, the claimed invention for the use of the drug Yuglaneks in complex therapy normalizes lipid, carbohydrate and protein metabolism in the treatment of type II diabetes mellitus, atherosclerosis and metabolic syndrome, does not cause side effects and is non-toxic.

Claims (1)

The use of the drug Yuglaneks in complex therapy as a means of normalizing lipid, carbohydrate and protein metabolism in the treatment of type II diabetes mellitus, atherosclerosis and metabolic syndrome.