A method of treating diabetes mellitus in children and adolescents

 

The invention relates to medicine, endocrinology. After achieving normalization of metabolism determine the biologically active points of injection of the cell suspension. For use of the point address 4-6 damaged organs. The cell suspension organs of the mammal is administered in 0.3-0.5 ml per injection. Produce 2-5 injections every body. The way to reduce the dose of insulin prolongs the time reesii, stabilizes the terms of diabetes. table 1.

The invention relates to medicine, namely to endocrinology and Pediatrics.

Insulin-dependent diabetes mellitus occupies a significant place among the chronic diseases of children and adolescents, reduces life expectancy and increases morbidity of young people. Diabetes mellitus in children and adolescents, especially in pre - pubertal period is characterized by unstable during prone to ketoacidosis and hypoglycemic conditions, inability to achieve sustained metabolic compensation in most patients. This fact is explained by the increase kontribusinya hormones, which leads to morphological and clinical manifestations, progression with the help of diabetes by injection of insulin of prolonged and short steps before a meal. Each patient dose distribution of individual insulin (M. A. Zhukovsky, 1995., E. P. Kasatkina, 1996., M. I. Balabolkin, 1998).

However, this method cannot achieve stabilization of the disease, prevent complications, it is impossible to ensure adequate life situations insulin levels.

Closest to the present invention is a method of treating diabetes by the injection of a medicinal product on the basis of cell suspensions prepared from hematopoietic cells of the embryo liver or spleen tailored to the individual indicators of the patient (patent of Russia 2126260, 1999, M. class. And 61 To 31/28).

The use of this method is hampered by the problem of obtaining embryos and risk of infectious diseases. Furthermore, the method is not able to treat it diabetes and only affects the nature of immune responses. From the literature we have also not received information on the effectiveness of this method in diabetes mellitus in children.

The technical result of the proposed method is stable course of diabetes mellitus, lower doses of insulin, lengthening remission of the disease, ensuring regression complications of the underlying disease.

New in achieving technical the effective point of injection of the cell suspension, address 4-6 damaged organs.

New is also that the cell suspension is injected subcutaneously 0.3-0.5 ml and 2-5 injections on each organ.

The determination of the points of introduction of the cell suspension is conducted according to Voll using computer option (Reference representative points of electroacupuncture according to R. Voll. - Moscow: MC "System", 1991). When this mark the point of introduction, the address of the affected organs, allowing treatment to stabilize the function of this organ that. in turn, ensures the stability of the course of diabetes mellitus and regression complications.

The introduction of cell suspension mammal subcutaneously in biologically active points provides a large amount of exposure that increases the effectiveness of treatment due to the normalization of carbohydrate, lipid and protein metabolism, positive dynamics of physical and sexual development and normalizing emotional condition of the child and the teenager.

The amount of injected cell suspension and the number of injection on the body of the authors was determined by experiment.

Comparative analysis of the prototype shows that the inventive method is characterized by the fact that after achieving normalization currency is camping injected subcutaneously 0.3-0.5 ml per injection and 2-5 injections to the affected organ, that meets the criterion of "novelty."

A new set of features ensures the stability of the flow of diabetes, decreased insulin doses, lengthening remission of the disease, positive dynamics of physical and sexual development, normalization and emotional condition that meets the criterion of "industrial applicability".

The method is carried out as follows.

Prepare the patient for treatment in a period of 7-10 days, the training is evaluated and achieving normalization of metabolism by traditional methods. The survey includes registration of clinical symptoms, instrumental methods of investigation (ultrasound of the abdominal organs, kidneys, thyroid gland, EEG and M-echo, ECG, uzdg vessels of the brain and lower extremities, FLG, computer diagnostics by Voll, ophthalmoscopy). Laboratory tests include biochemical tests (sugar curve, daily glucosuria, glycated hemoglobin, C-peptide), indicators of lipid peroxidation and antioxidant protection of blood; immunological tests first level taking into account the absolute and relative content of immune cells (IR), receptor activity of the JV, NRT Jn), immunoglobulin a, M, G, according to Mancini. The compensation currents of diabetes includes the normalization of carbohydrate and lipid metabolism, treatment of complications of diabetes and related diseases with antibiotics, angioprotectors, hepatoprotectors, membrane-stabilizing therapy, vitamin therapy. The determination of the points of introduction of the cell suspension is done according to Voll using the PC version. This note biologically active points of introduction, address 4-6 damaged organs, depending on the results of the survey. The marked points are painted.

To resolve the question of introducing a cell suspension using the data of clinical, instrumental and laboratory investigations.

For cell suspensions using tissue pancreas, spleen, liver, adrenal glands, kidneys, myocardium, lung, brain of a mammal, for example a newborn Piglet. In the preparation of cell suspensions from the pancreas remove the capsule body, crushed it into fragments 2-3 ml, the cells fill in a solution of collagenase type 3 (NPP Paneco) at a concentration of 1 mg/1 ml for 15 minutes at 37oC and rubbed through a sieve. The cell mixture Rosado resuspension in Hanks solution. The tissue cells of other organs for xenotransplantation is prepared in the same way, by changing the exposure time of collagenase on the body, such as liver cells, kidney, spleen treated within 15 minutes, the cells of adrenal glands and infarction within 10 minutes, the cells of the lung treated with a solution of collagenase 25 minutes. The selected cells are stored on ice until use. The vital functions of the cell suspension control using a test with a 1% solution Trypanosoma blue. The percentage of living cells is 95-99%.

Introduction prepared cell suspension is carried out in the operating conditions. The dose of injected cell suspension picked individually from 0.3 to 0.5 ml per injection. The cell suspension is injected subcutaneously in marked biologically active point total introduction of cell suspension is 1.0-2.5 ml every body. In the treatment using cells from 4 to 6 bodies. After transplantation, given the condition of the patient, blood sugar define 4-5 times per day, determine the daily glycosuria. Strictly controlled diet. According to the observations of the authors hypoglycemia occurs on the first day in 100% of cases.

Already in the first days after transplantation blood sugar is reduced (M+m= 12,11.7 mmol is within 8-12 months after transplantation of cell suspensions. Accordingly decreased insulin requirements from 322.5 to 18of 1.8 UNITS per day. The dynamics of daily glycosuria was changed from 84,8 g before the introduction of cell suspension to 146 g 3-5 days after injection of the cell suspension. The level of C-peptide increases from 0.18of 0.06 to 0.520,12 DD/l one month after the introduction of cell suspension ( 0,8-4,0 DD/l). Stabilization of sugar at lower numbers than before treatment and at lower doses of insulin occurred within 30 to 45 days (table.1).

When receiving true labile diabetes in children and adolescents 100% of cases. Distal polyneuropathy were recorded in 62% of cases, manifested by convulsions, pain, paresthesiae in the legs and feet. All patients data subjective feelings disappeared or became less intense during the first days after the injection of cell suspensions. The effect lasted 8-12 months. Stabilization of flow of labile forms of diabetes in children and adolescents was observed within 30 to 45 days after the injection of cell suspensions. After the treatment approach in children and adolescents within 8-12 months of growth has increased. Sexual characteristics, rootpathname the following clinical examples.

Example 1. Kozlov Dima, 13 years. Duration of diabetes 4 months (for diabetes with frequent hypoglycemic States). Daily dose of insulin 20 IU/day. Glycosylated hemoglobin was 7.2%. Urine sugar 6 g/day. Blood sugar when entering 6,6-12,8-8,9-7.4 mmol/L. Growth 147 cm, weight of 35.5 kg of Sexual development Roach0F0V0L0. Was prepared cell suspension from the pancreas, liver, spleen, and adrenal glands of newborn piglets. In biologically active points, the address of the affected agencies, was introduced: the islets of Langerhans - 0.5 ml of 2 injections, liver 0.5 ml of 3 injections, spleen, 0.5 ml of 2 injections, adrenal 0.3 3 injections.

3 months after treatment: Height 152 cm, weight 39 kg, blood sugar and 4.4 to 6.0-5.2 to 8.2 mmol/L. Glycosylated hemoglobin of 6.2%. In urine glycosuria, daily dose of insulin 8 UNITS.

After 1 year, at 14, the second transplantation of cell suspensions. When receiving the dose of insulin 20 IU/day. Blood sugar 14,2-24,0-8.0 to 12.2 mmol/L. Glycosylated hemoglobin of 7.9%, height 155 cm, weight of 47.5 kg of Sexual development complies with Rho1Oh0F0V1L1age. Was prepared cell suspension from PAGEL the address of the affected organs, was introduced: the islets of Langerhans in 0.5 ml of 2 injections, liver at 0.5 to 5 ml injection, spleen 0.5 ml of 2 injections, adrenal 0.5 ml of 2 injections, kidney 0.5 ml of 2 injections.

7 months after treatment blood sugar of 4.7 to 6.2 to 5.0-7.2 mmol/l, the dose of insulin 12 UNITS/day in urine glycosuria, glycosylated hemoglobin of 5.9%. C-peptide to treat 0.2 PD/l, one month after treatment 0,7 (norm 0,8-4,0 DD/l). Height 161 cm, weight 54 kg, Sexual development, P2Ax1F0V2L2.

Example 2. Vakulenko Alexander, 7 years. Diagnosis: insulin-dependent diabetes severe with frequent hypoglycemic States. Disease duration of approximately 2 years. Admission glycemia- 6,9-7,3-10,2-5,2-13,2 mmol/l Dose of insulin - 18 IU/day. Glycosylated hemoglobin was 9.3%. The growth of 119 cm, body weight 20,5 kg After normalization of metabolism and determine the points of introduction, the address of the affected organs, was prepared cell suspension from the pancreas, liver, adrenal glands, spleen of newborn piglets. The cell suspension is introduced subcutaneously in number: the islets of Langerhans in 0.5 ml of 2 injections, liver 0.5 ml of 3 injections, the adrenal glands - 0.3 ml of 2 injection, spleen - 0.5 ml of 2 injections. On the third day after introduction is 22 cm, weight 21 kg in 3 months after treatment, sugar in the urine is negative. The dose of insulin to 0. Glycosylated hemoglobin was 5.3%. After 6 months, the growth of 127 cm, weight 22 kg Underwent ARI t 38oC. Insulin 8 UNITS/day, urine sugar 12 g/day. After 12 months, the growth of 130 cm, weight 22 kg Daily dose of insulin 14 UNITS. Glycosylated hemoglobin was 7.3%.

In total 52 cell transplantation for children and adolescents ranging in age from 4.5 to 18 years with disease duration from 4 months to 13 years.

Clinical indications for treatment with the use of xenotransplantation: - labile diabetes; - delayed physical and sexual development; - the formation and progression of diabetic angiopathies; - depletion effect of a previous transplant.

Thus, the proposed method for the treatment of diabetes provides: - stabilization of the course of diabetes mellitus from 8 months to 1 year or more; - improvements in physical and sexual development; - normalization of neuropsychological function; - possibility to achieve a more stable course of the disease on the background of lower doses of insulin;
- prevention, regression of microangiopathy (nephropathy, retinopathy, encephalopathy, Aneta and adolescents by introducing into the organism of the patient cell suspension organs of a mammal, characterized in that after achieving normalization of metabolism determine the biologically active points of injection of cell suspensions, address 4-6 damaged organs, while the cell suspension is injected subcutaneously 0.3-0.5 ml per injection and 2-5 injections every body.

 

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