RU2240808C1 - Method for treating diabetic neuropathy - Google Patents

Abstract

FIELD: medicine, endocrinology.

SUBSTANCE: the present innovation deals with treating complicated diabetes mellitus - neuropathy. For this purpose, at the background of basic therapy of diabetic neuropathy one should intravenously inject ceruloplasmin at the dosage of 100 mg/d for 5 d at possible repeated courses. This provides decreased irritative-painful syndrome at the absence of side effects as allergic reactions.

EFFECT: higher efficiency of therapy.

1 cl, 2 ex

Description

The invention relates to medicine, in particular to endocrinology, and can be used to treat complications of diabetes.

Diabetic neuropathy is one of the most common complications of diabetes. So, with type II diabetes mellitus, by the time of diagnosis, the clinical manifestations of distal polyneuropathy are detected in 20-25% and with a disease duration of more than 10 years - in almost 50% of patients. Unlike other complications of diabetes mellitus, polyneuropathy can be accompanied by active clinical symptoms, for example, the development of pain, which determines a significant deterioration in the quality of life of patients. In this regard, the search for drugs that have both pathogenetic and symptomatic effects in the treatment of diabetic polyneuropathy is an urgent problem.

It has been established that oxidative stress caused by an increase in the formation of free radicals plays an important role in the development of diabetic complications, including neuropathy. In most pathological conditions, there is a marked inadequacy of the antioxidant defense of the body, which increases the vulnerability of cells to oxidative damage. In addition to the direct damaging effect of free radicals on cells, diabetes is characterized by a complex violation of the functions of endogenous protective systems, including the nitric oxide (NO) system, which plays an important role in the regulation of vascular tone.

A known method for the treatment of diabetic polyneuropathy using α-lipoic acid (Galstyan G.R., Antsiferov M.B. Treatment of distal diabetic polyneropathy. Russian Medical Journal, 2000, vol. 8, No. 4, p. 201-202).

Lipoic acid helps to reduce oxidative stress by preventing the modification of proteins caused by glucose, increasing decreased endoneural blood flow, compensating for glutathione deficiency in nerve cells, and reducing the concentration of lipid peroxidation products (Wagh SS, Natray CV, Menen KKG Mode of action of lipoic acid in diabetes J. Biosci., 1997, v. 11, p. 59-74).

The disadvantage of this method is the possibility of developing adverse reactions, expressed in skin allergic manifestations, in rare cases, systemic anaphylactic shock.

The closest to the proposed technical essence and the achieved result is a method of treating diabetic neuropathy, when the complex of basic therapy includes the use of the drug Actovegin, 10 ml per 200 ml of physiological saline intravenously, 1 time per day for 10 days (V. Yavorskaya , Egorkina OV, Mashkin ON, Grebenyuk AV Clinical experience of using Actovegin for diabetic polyneuropathy. Actovegin. New aspects of clinical use. Edited by S. A. Rumyantseva, Moscow, 2002, p.216 -219).

Actovegin activates cellular metabolism by increasing transport and accumulation of glucose and oxygen, enhancing intracellular utilization. These processes lead to an acceleration of ATP metabolism and an increase in cell energy resources. Under conditions that limit the normal functions of energy metabolism, Actovegin stimulates the energy processes of functional metabolism and anabolism.

The use of Actovegin in patients with diabetic neuropathy can reduce the severity of pain, improve sensitivity in the proximal limbs.

The disadvantage of this method of treatment is the possibility of developing allergic reactions, and with intravenous administration, anaphylaxis. Side effect is due to the fact that the drug is a blood derivative of animals and contains components foreign to the human body.

The problem solved by the invention is the expansion of the range of medicinal compounds used in the treatment of diabetic neuropathy.

The technical result from the use of the invention is to improve the quality of the course of diabetic neuropathy, expressed in a decrease in irritative-pain syndrome, as well as the exclusion of the development of allergic reactions due to the fact that the proposed drug is obtained from human blood and does not contain foreign components.

This result is achieved by the fact that against the background of basic therapy in the complex treatment of diabetic neuropathy, ceruloplasmin is administered at a dose of 100 mg / day for 5 days with possible repeated courses.

The method is as follows. Ceruloplasmin before administration is dissolved in 200 ml of saline and administered intravenously at a rate of 30 drops per minute according to the instructions for use of the drug. Ceruloplasmin is used at a dose of 100 mg per day for 5 days with possible repeated courses.

The ceruloplasmin used is a protein secreted from human blood. This is the main plasma antioxidant that binds superoxide radicals and prevents lipid peroxidation of cell membranes (Mashkovsky M.D. Medicines, Moscow: Medicine, 1993, v. 2, pp. 182-183).

The advantage of this method is that ceruloplasmin is a human blood product and does not contain foreign components that can provoke the development of allergic reactions. Ceruloplasmin, unlike other drugs used, is the main antioxidant factor in blood plasma (A. Yaropolov. Mechanisms of the antioxidant action of ceruloplasmin. Reports of the USSR Academy of Sciences, 1986, vol. 291, No. 1, pp. 237-241). Attention to ceruloplasmin has been attracted in the last decade due to the establishment of its role in iron metabolism and regulation of neutrophil myeloperoxidase functions (Segelmark M., Persson B., Hellmark T., Wieslander J. Binding and inhibition of myeloperoxidase (MPO): a major function of ceruloplasmin ? // Clin. Exp. Immunol., 1997, vl 08, No. 1, p. 167-174) and NO vascular endothelial synthase (Bianchini A., Musci G., Calabrese L. Inhibition of Endothelial Nitric-oxide Synthase by Ceruloplasmin / J. Biol. Chem., 1999, v. 274, No. 29, p.20265-20270). Its necessity for the normal functioning of the pancreas has been proved - hereditary ceruloplasmin deficiency is accompanied by the development of diabetes mellitus (Miyajima H., Takahashi Y., Kono S. Aceruloplasminemia, an inherited disorder of iron metabolism // Biometals, 2003, v.l6, No. 1, p .205-213). Evidence has been obtained of the neuroprotective effect of ceruloplasmin (Mateescu M.-A., Paquin J., De Grandpre E. Ceruloplasmin and an antioxidant composition comprising the same and their uses as neuroprotective agent, patent CA2373058, published November 16, 2000). The above advantages make it possible to use the drug in the treatment of patients with diabetes mellitus complicated by polyneuropathy.

Example 1. Extract from the medical history. Patient M., 56 years old, was undergoing treatment at the Nizhny Novgorod Regional Hospital. Semashko from 04/09/03 with a diagnosis of type 2 diabetes mellitus, decompensated, complicated by degree I retinopathy, distal sensorimotor polyneuroneuropathy, diabetic foot syndrome. On admission, complaints of malaise, dry mouth, severe signs of irritative pain syndrome (pain, numbness, burning, paresthesia in the lower extremities - 8.65 points on the TSS scale), abrasions and corns on the feet, superficial ulcers with hyperkeratosis (~ 0.3 cm) on the inner surface of the toes of both feet. 7 days after the start of treatment (diet, insulin therapy 20 IU / day, ceruloplasmin 100 mg iv IV No. 5), there was an improvement in well-being, a decrease in the symptoms of polyneuropathy, the severity of irritative pain syndrome (6.66 points on the TSS scale), and epithelization of superficial foot ulcers.

Example 2. Extract from the medical history. Patient B., 54 years old, was undergoing treatment at the Nizhny Novgorod Regional Hospital. Semashko from 03/27/03 with a diagnosis of type 2 diabetes mellitus, decompensated, complicated by retinopathy of the first degree, distal sensorimotor polyneuropathy. Upon admission - complaints of malaise, dry mouth, pain, numbness, burning, paresthesia in the lower extremities (5.99 points on the TSS scale). 7 days after the start of treatment (diet, insulin therapy 20 units / day) - complaints of pain, paresthesia, numbness in the legs are the same (5.99 points on the TSS scale).

Claims (2)

1. A method of treating diabetic neuropathy, including basic therapy, characterized in that against the background of the basic therapy in the complex treatment of diabetic neuropathy, ceruloplasmin is administered for 5 days, with possible repeated courses. 2. The method according to claim 1, characterized in that ceruloplasmin is administered at a dose of 100 mg / day.