RU2501517C2 - Method of diagnosing stage of neuropathy in patients with type 2 diabetes mellitus - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention relates to field of medicine, namely to clinical-expert diagnostics of general pathological physiology. Diagnostics of state of neuropathy in patients with type 2 diabetes mellitus is carried out. Temperature sensitivity is tested, with carrying out temperature testing of foot by sensor method in successive way first, determining temperature of adaptation, then, supplying modified temperature stimulus, measuring threshold values in, at least, three zones. Results of measurements are registered and foot temperature coefficient is determined by formula: Tc=(Ts1-Cs1)×(Ts2-Cs2)×…×(Tsn-Csn), where (Tsh-Csh) (Tsh-Csh) (Tsh-Csh), where Tc is temperature coefficient of foot, Ts1, 2 is temperature sensitivity in selected zones (1, 2…) Cs1, 2 is cold sensitivity in selected zones (1,2…), Tsh is average value of heat sensitivity in healthy people without neuropathy, Csh is average value of cold sensitivity in healthy people without neuropathy. After that, value of foot temperature coefficient is used to assess neuropathy stage. Assessment of indices is performed in the following way: absence of neuropathy Tc≤2; subclinical neuropathy A - Tc from 2 to 50; B - Tc from 51 to 100; clinical neuropathy - Tc from 101 to 200; expressed (complicated) neuropathy - Tc higher than 200.

EFFECT: increased efficiency of diagnostics of neuropathy stage in patients with type 2 diabetes mellitus due to application of quantitative tests.

6 tbl, 3 ex

Description

The invention relates to medicine, namely to clinical expert diagnosis, general and pathological physiology.

Diabetic peripheral neuropathy is the presence of symptoms and / or signs of impaired peripheral nerve function in patients with diabetes mellitus (International Guide for Outpatient Management of Diabetic Peripheral Neuropathy, 1995).

Diabetic neuropathy significantly reduces the quality of life of patients and is one of the main risk factors for the development of foot ulcers in patients with diabetes mellitus.

The main function of the nerve fiber is to conduct an impulse. Thin myelinated and non-myelinated fibers are responsible for holding a feeling of pain, touch, temperature. The disease is based on the progressive loss of myelinated fibers and, as a result, a slowdown in the conduction of a nerve impulse.

The sooner a diagnosis of diabetic neuropathy is established, the earlier treatment can be carried out, the progression of neuropathy can be prevented, and the development of late complications can be prevented.

For the study of diabetic neuropathy, such diagnostic methods as clinical research using quantitative tests, morphological, biomechanical methods and electromyography are used.

In clinical practice, for the objective assessment of sensorimotor disorders, the following methods are used: the study of the threshold of sensitivity (tactile, pain, temperature and vibration, and the study of Achilles and knee reflexes).

Temperature sensitivity is assessed using objects with different temperatures (thermal conductivity), for example, using the metal and rubber parts of a neurological hammer (the surface area of the touch should be approximately the same) or a special device - a thermal tip (Tip-term). First, the metal (cold) and rubber (heat) parts of the malleus are touched in turn in the area of the skin of the forearm in order for the patient to feel the temperature difference. Then, in turn, the metal and rubber parts of the malleus are touched on the skin of the dorsum of the thumb, the rear of the foot, the inner ankle, the inner surface of the lower leg, and knee. In this case, the patient should not see when, where and with what part of the malleus the examiner touches. During the study, it is necessary to ask whether the patient feels the temperature difference at all the studied points. The threshold of temperature sensitivity is the level at which the patient begins to feel the difference in temperature. For example, the patient indicates that he feels cold and heat at the level of the knee, therefore, the temperature sensitivity is reduced to the level of the knee. Studies are carried out in a complex, namely the study of the threshold of sensitivity of tactile, pain, temperature and vibration and the study of Achilles and knee reflexes. Then a quantitative assessment of the degree of sensitivity is carried out with the assignment of points, while the sum of the values of each type of sensitivity and the sum of the values of the reflexes makes up a scale by which the stage of neuropathy is determined. (Center for INFORMATICS AND TRAINING IN THE FIELD OF DIABETES, CENTER “DIABETIC STOP” OF THE INTERNATIONAL PROGRAM “DIABETES”. Approved by the Academic Council of the Russian Academy of Medical Sciences Protocol No. 6 of June 22, Chairman Academician of the Russian Academy of Medical Sciences Professor L. L. Moshetova Scientific Uchen. . "Diabetic peripheral SENSOMOTOR NEUROPATHY. PATHOGENESIS, CLINIC AND DIAGNOSTICS." (See Guidelines for endocrinologists, therapists, surgeons, neuropathologists. Second edition revised and updated, Moscow 2004, Guidelines developed: IV Guryeva, E. Yu. Komelyagina, IV Kuzina, AS Ametov. This method requires a lot of time).

The well-known "Method for the diagnosis of endothelial dysfunction in patients with diabetes mellitus" (RF patent No. 2405418). To study microcirculation, a recording of skin blood flow oscillations is used using a LAKK-01 laser Doppler flowmeter, the microcirculation level (quantitative indicator), vascular tone, microcirculation efficiency, the level of neurogenic-humoral regulation of the microvasculature, the level of the effect of heart rate on the capillary bed, microcirculation index ( a qualitative indicator of the level of microcirculation), reserve capillary blood flow. With the help of a breathing or cold test, the adaptive reserve of blood flow is determined. Processing of the received signal is based on the mathematical method of wavelet analysis (Laser Doppler flowmetry of blood microcirculation / Ed. By A.I. Krupatkin, V.V. Sidorova: A Guide for Doctors, - M.: Publishing House “Medicine”, 2005. - 256 s.)

According to this method, skin temperature fluctuations associated with a change in vascular tone before and after a functional load are recorded and data is processed using mathematical analysis. The temperature of the nail phalanx of the palmar surface of the index finger of the patient is recorded for 10 minutes with a frequency of at least 1 Hz, then for 3 minutes during a cold test and another 10 minutes continuously using a temperature sensor, then calculate the average amplitude in the range from 0.0095-0.02 Hz for 10 minutes, then for 3 minutes of a cold test and from the 4th minute after a cold test. The coefficient B _{1 is} calculated by the formula: B ₁ = A ₂ / A ₁ and the coefficient B ₂ by the formula: B ₂ = A ₃ / A ₂ , where A ₁ is the average amplitude of the oscillations during 10 min of the study;

And ₂ - the average amplitude of the oscillations within 3 min of the cold test;

And ₃ is the average amplitude of oscillations from the 4th min after the cold test, and with a value of B ₁ greater than 1 and B ₂ less than 1, endothelial dysfunction is determined in patients with diabetes mellitus.

The disadvantages of the method include:

- the need for rare and expensive equipment,

- a large number of interference associated with the movement of the fiber relative to the probed surface. Such interference significantly reduces the accuracy of the analysis of low-frequency oscillations corresponding to the active mechanisms of regulation of vascular tone.

- the possibility of false positive and false negative results, which is eliminated as follows:

- before the start of the study, the patient is in a room with an air temperature of 24 ° C for 20-30 minutes in the supine position.

- the day before the study, the administration of vasoactive drugs is excluded, coffee and alcohol are excluded from the diet.

The known device "Thermodat" manufactured by NPP "Control Systems", Perm, Russia, certificate RU.C. 32.001.A N1832, which implements a method for detecting blood microcirculation by determining fluctuations in vascular tone before and after a functional load and processing data using mathematical wavelet analysis, characterized in that the temperature is recorded on the nail phalanx of the palm of the patient’s index finger with a measurement frequency of at least 1 Hz for 10 min, then for 3 min, during a breathing or cold test and for 10 min after it continuously using a temperature sensor.

The advantages of the proposed method are: the ability to register factors for the control of blood microcirculation (endothelial, neurogenic and myogenic mechanisms of regulation), increased sensitivity by eliminating interference with temperature recording, convenience and high speed of execution, reduction of artifacts due to the reliability of attaching the temperature sensor to the skin surface, low cost because eliminates the need for expensive equipment and the ability to simultaneously register signals from several skin areas when using multi-channel temperature measurement systems.

The disadvantages of the above methods:

In similar research methods, for the most part, the endothelial (vascular) component of the nerves is investigated, and TSA-II is the neurogenic (thin non-myelinated nerve fibers). Those. the above methods may be more complementary in the study of neuropathy than similar. Despite the fact that they are similar in execution technique.

Therefore, we can say that the disadvantage of their methodology for studying the endothelial (vascular) components of the nerves (prototype) is that these research methods can be more complementary in the study of neuropathy.

The technical task of the proposed invention is to expand the arsenal of technical means for diagnosing the stages of neuropathy in patients with type 2 diabetes mellitus during a clinical neurological examination of patients using quantitative tests.

This problem is solved due to the fact that the method for diagnosing the stage of neuropathy in patients with type 2 diabetes mellitus is to study the temperature sensitivity, while the temperature of the foot is studied in a sensory way, sequentially, first determining the adaptation temperature, then applying a changed temperature stimulus, measure the threshold values in at least three zones, the measurement results are recorded and then the temperature coefficient of the foot is determined by the formula:

,

,

where Tk is the temperature coefficient of the foot

Тч1,2 ... - thermal sensitivity in the selected zones (1,2 ...)

Хч1,2 ... - cold sensitivity in selected zones (1,2 ...)

Tchz - the average value of thermal sensitivity in healthy people without neuropathy

Chchz - the average value of cold sensitivity in healthy people without neuropathy,

further, according to the value of the temperature coefficient of the foot, the stage of neuropathy is assessed.

Evaluation of the indicators is as follows:

lack of neuropathy - Tk≤2;

subclinical neuropathy: A - Tk from 2 to 50;

B - Tk from 51 to 100;

clinical neuropathy - Tk from 101 to 200;

severe (complicated) neuropathy - Tk more than 200.

According to the claimed method, the patient undergoes quantitative sensory testing on the TSA-II apparatus, with which the functional state of the A-delta and C-type fibers is assessed. Quantitative Sensory Testing (QST) is a method for the quantitative assessment of temperature pain sensitivity of A-delta fibers and low myelinated C-type fibers for dermatomes, as well as vibration sensitivity. Automation of functions allows research to mid-level personnel. Universal instrument software allows the use of TSA II for clinical diagnosis, allows automatic comparison of the results with regulatory data. The device is manufactured by Medical Systems LLC. To study temperature sensitivity, a device called Thermod is used that is applied to the patient’s skin area. The thermode has the ability to heat or cool a skin area. First, the adaptation temperature is determined between 30 and 32 ° C (after exposure for several seconds, the subject does not feel any heat or cold). To measure thresholds, a quantitatively measured temperature stimulus is supplied using the device. The patient’s response in the form of a simple button press is recorded on a computer and each phase of the study is completed. At the end, a printed report with test results is generated.

Using the TSA-II, it measures thresholds for the following four submodalities:

- Thermal sensitivity (CS), usually 1-2 ° C above the adaptation temperature. This type of sensitivity is carried out on C-type fibers.

- Cold sensitivity (HS) - a close value below the adaptation temperature, is carried out on fibers of the A-delta type.

- Heat pain (SR) - the threshold is higher than 45 ° C, is mostly carried out on C-type fibers and with some participation of A-delta type fibers.

- Cold pain (HP) is the most variable and difficult to determine indicator, about 10 ° C. It is carried out by a combination of fibers of type C and A-delta type.

The definition of sensory thresholds depends on the subjective acquisition of data. In order to minimize subjective variability and obtain as objective results as possible, threshold measurements are used, for example, the Limits method.

In the Limits method, the stimulation is increased in intensity until the patient has a sensation at which moment the subject stops the stimulation. The temperature of the Thermode immediately returns to the value of adaptation, preparing for the next stimulus. Then several stimuli are applied and the average threshold value is determined. To determine the threshold, as a rule, four stimuli are sufficient. This measurement takes into account the error of the reaction time, defined as the time interval between the moment of supplying enough energy to the stimulation point to cause sensation and the moment the brain reaches information, as well as the time for the signal sent by the brain to reach the patient’s hand pressing the stop button stimulus. This error is small when using a low frequency of temperature change. The Limits method is used most often, since it takes the shortest time and can be used to measure pain thresholds, in addition to studying non-pain temperature thresholds.

For the diagnosis of polyneuropathy, indicators are measured in at least three zones. The most reliable study in four symmetric zones (2 zones on each foot). The studies were performed in the lateral and medial zones of the feet, which correspond to the innervation zones of the calf nerve (dorsolateral zone) and the peroneal nerve (medial zone). The defeat of these nerves in the clinical stage is monitored by electroneuromyography. In diabetes mellitus, the lesion often begins with the innervation of the calf nerve (lateral zone), which is examined first. Then, the lesion spreads to the medial side, so it is for the study that these zones are chosen. A greater number of foot zones (maximum 6) can also be examined, but a long examination may cause patient fatigue. Therefore, the study is carried out in 4 zones.

Quantitative sensory testing (QST) is carried out using the TSA-II neuro-sensory analyzer to diagnose the stage of neuropathy in patients with type 2 diabetes. It consists in the study of temperature, pain and vibration sensitivity; in this case, the temperature of the foot is studied in a sensory manner, first determining the adaptation temperature, then applying a changed temperature stimulus, threshold values are measured in at least three zones, the measurement results are recorded and then the temperature coefficient is determined feet according to the formula:

,

,

where Tk is the temperature coefficient of the foot

Тч1,2 ... - thermal sensitivity in the selected zones (1,2 ...)

Хч1,2 ... - cold sensitivity in selected zones (1,2 ...)

Tchz - the average value of thermal sensitivity in healthy people without neuropathy

Chchz - the average value of cold sensitivity in healthy people without neuropathy,

further, according to the value of the temperature coefficient of the foot, the stage of neuropathy is assessed.

At the same time, indicators are evaluated as follows:

lack of neuropathy - Tk≤2;

subclinical neuropathy: A - Tk from 2 to 50;

B - Tk from 51 to 100;

clinical neuropathy - Tk from 101 to 200;

severe (complicated) neuropathy - Tk more than 200.

The proposed method is an easy way to find out the stage of neuropathy. It defines:

- further tactics of examining the patient (referral to electroneuromyography, ultrasound of the vessels of the lower extremities - when revealing the clinical stage of neuropathy or severe (complicated) neuropathy).

- further treatment tactics of the patient, i.e. the choice of the appropriate groups of preparations for the pathogenetic and symptomatic therapy corresponding to the stage of neuropathy.

- in addition, if the temperature coefficient of the patient’s foot corresponds to subclinical neuropathy, prophylactic pathogenetic treatment can be started to prevent the development of the clinical stage of neuropathy and diabetic foot syndrome.

The resulting indicator is convenient for statistical data analysis.

The claimed method is confirmed by examples.

The examples show the identification of the preclinical stage of DPN and the evaluation of the effectiveness of therapy with the drug octolipene α-lipoic acid using the TSA-II neurosensor analyzer. The work was performed on the basis of CJSC Medical Center Philosophy of Beauty and Health. The object of the study was patients with type 2 diabetes, the average age of which was 56 ± 13 years, without clinical manifestations of diabetic neuropathy (n = 50). The comparison group consisted of 20 people without diabetes and neuropathy. By age, gender, body mass index groups were comparable. For the diagnosis of DPN, a standard procedure for detecting DPN was performed. An examination was also performed on the TSA-II apparatus before treatment with Oktolipen and after 3 months of therapy.

Laboratory studies included the glycemic triad (fasting blood glucose, postprandial glycemia, glycated hemoglobin), determination of the lipid spectrum, C-peptide, insulin, C-reactive protein. Patients with type 2 diabetes received metformin and sulfonylurea preparations. An alpha-lipoic acid preparation (Oktolipen, Pharmstandard) at a dose of 600 mg / day was used as pathogenetic therapy. on an empty stomach, for 3 months

Example 1. Patient H.,

Date of birth (years) - 06/02/1937 (73 g.)

The main diagnosis: type 2 diabetes of moderate severity. Retinopathy, Art. Subclinical distal neuropathy. GB 2 tbsp; II tbsp; risk 4.

Duration of diabetes - 2 years, GB - since 1983; diet No. 9 - observes, accepts Tab. Diabeton MB 30 mg - 2 tablets in the morning; Tab. Enalapril 20 mg - 1 tab. In the morning; Tab. Indapamide 1.5 mg - 1 tab. in the morning

The patient has a Thermod device installed that is applied to the patient’s skin area. A thermode has the ability to heat or cool a skin area. First, we determined the adaptation temperature between 30 and 32 ° C. To measure thresholds, a quantitatively measured temperature stimulus was applied using the device. The patient’s response in the form of a simple button press was recorded on a computer. At the end, a printed report was generated with the test results. The studies were performed in the lateral and medial zones of the feet, which correspond to the innervation zones of the calf nerve (dorsolateral zone) and the peroneal nerve (medial zone). We performed the calculation using the created formula. The study on the apparatus TSA-II was carried out at the first turnout and after 3 months.

Complaints and research data.

First After 3 months of treatment with Okolipen Complaints Periodic dry mouth, thirst, fatigue; periodic dizziness, headaches, insomnia, occasionally numbness of the big toes There are no complaints. HELL 150/100 124/75 diuresis / glucosuria Norm / Neg. Norm / Neg. fasting glycemia / after eating 6.7 / 8.0 5.4 / 7.2 weight height 58 kg / 158 cm 58 kg / 158 cm BMI kg / m ² 27 27 pulse 68 bpm 64 bpm liver enlargement (+) Neg. Neg. Urine protein / microalbumin Neg. / 0-20 Neg. / 0-20 CRP 6.04 mg / l 5.63 Нва1с 6.9% 6.3 XC 5.7 4.8 TG 2.2 1,1 HSLPVP 2.02 1a, 6 HSLPNP 3.79 2.73 HSLPONP 1,0 0.52 IA 1.82 2.0 Insulin 69.73 37.27 C peptide 1.09 0.762 Diabetes treatment Tab. Diabeton MB 30 mg - 2 tablets in the morning; Tab. Diabeton MB 30 mg - 2 tablets in the morning; Hypertension treatment Tab. Enalapril 20 mg - 1 tab. In the morning; Tab. Indapamide 1.5 mg - 1 tab. In the morning Tab. Enalapril 20 mg - 1 tab. In the morning; Tab. Indapamide 1.5 mg - 1 tab. In the morning other Caps. Oktolipen 300 mg - 2 caps. In the morning on an empty stomach Caps. Oktolipen 300 mg - 2 caps. In the morning on an empty stomach TSA and VSA - Examination

Zone Heat (C - fibers) Senses / pain (° C) Cold (Ad - fibers) Feelings / more (° C) Vibration (Ab - fibers) Ln-dorso-lateral 46.4 / 47.5 45.5 / 47.3 27.7 / 27 28.5 / 23.7 7.8 7.2 Mon - dorso-lateral 47.2 / 50 47.1 / 50 27.3 / 20 28.4 / 26.4 8.2 7.1 LN - medial 45.6 / 49.4 44.9 / 49.6 27.7 / 23.8 28.8 / 26.4 6.1 5.2 Mon - medial 48.5 / 50 44.4 / 49.3 27.2 / 23.2 30 / 28.6 6.1 5,4

Temperature coefficient of the foot:

Before treatment:

After treatment with Oktolipen (3 months):

.

.

Example 2: Patient R.,

Date of birth (years) - 09/30/1956 (52 g.)

The main diagnosis of type 2 diabetes is moderate. Clinical distal neuropathy. Non alcoholic steatohepatosis. Obesity 1 tbsp. WHO (BMI = 32) CHD. Angina pectoris 2 f. CHF-II. Stenting (10.17.2007) GB 2 tbsp; No, risk 4 HFR - CB class

Duration of diabetes - 3 years, diet No. 9 - does not comply, accepts Tab. Diabeton MB 30 mg - 2 tablets in the morning; Tab. Glucophage 500 mg - 1 tab. × 2 r / day - irregularly. Ischemic heart disease. Angina of exertion 2f.kl.CHSN-II. - since 2005, stenting (10/17/2007); AH year - since 2000 Treatment - Tab. Concor 2.5 mg in the morning; Tab. Amlodipine 10 mg / day.

The patient has a Thermod device installed that is applied to the patient’s skin area. The thermode has the ability to heat or cool a skin area. First, we determined the adaptation temperature between 30 and 32 ° C. To measure thresholds, a quantitatively measured temperature stimulus was applied using the device. The patient’s response in the form of a simple button press was recorded on a computer. At the end, a printed report was generated with the test results. The studies were performed in the lateral and medial zones of the feet, which correspond to the innervation zones of the calf nerve (dorsolateral zone) and the peroneal nerve (medial zone). We performed the calculation using the created formula. The study on the apparatus TSA-II was carried out at the first turnout and after 3 months.

The patient refused to participate in scientific research and therapy with Okolipen.

Complaints and survey data.

First After 3 months Complaints Periodic dry mouth, thirst, cramps in the calf muscles, fatigue, headaches, drops in blood pressure. Periodic dry mouth, thirst, cramps in the calf muscles fatigue, headaches, drops in blood pressure, aching leg pain, cramps, the appearance of pigmentation on the back of the feet HELL 120/80 130/80 diuresis / glucosuria Norm / Neg. Norm / Neg. fasting glycemia / after eating 9.2 / 13 10.2 / 15 weight height 86 kg / 161 cm 86 kg / 161 cm BMI kg / m ² 32 32 pulse 65 bpm 63 bpm liver enlargement (+) +1 cm +1 cm Urine protein / microalbumin Neg. / 50 mg / L Neg. / 20 mg / L CRP 3.51 mg / l 6.32 mg / l Nva1 s 7.3% 8.8% XC 4.9 5.5 TG 4.16 4.6 HSLPVP 1.22 1.17 HSLPNP 3.2 2.7 HSLPONP 4.0 2.22 IA 3.02 3,7 Insulin (pmol, l) 104.9 152.0 C peptide (nmol / L) 1.18 1.47 Diabetes treatment Tab. Diabeton MB 30 mg - 2 tablets in the morning; Tab. Diabeton MB 30 mg - 2 tablets in the morning; Tab. Glucophage 500 mg - 1 tab. × 2r / day Hypertension treatment Tab. Concor 2.5 mg in the morning; Tab. Amlodipine 10 mg / day Tab. Concor 2.5 mg in the morning; Tab. Amlodipine 10 mg / day TSA and VSA - Examination

Zone Heat (C-fiber) Feelings / pain (° C) Cold (Ad fiber) Feelings / more (° C) Vibration (Ab-fibers) LN - dorso-lateral 49.1 / 50 49.9 / 50 16.6 / 0 18.2 / 5.7 8.4 7.1 Mon dorso-lateral 45.2 / 50 48.5 / 50 23 / 24.2 9.9 / 1.2 12.1 7.4 Ln-medial 50/50 50/50 11.7 / 1.8 14.8 / 7.7 6.6 6.3 Mon-medial 46.3 / 50 47.5 / 50 20.5 / 13.1 15.3 / 0 2,8 7.2

Temperature coefficient of the foot:

Before treatment:

After 3 months without Octolipen treatment:

Example 3: Patient I.

Date of birth (years) - 01/07/1957 (52 g.)

The main diagnosis is type 2 diabetes mellitus of moderate severity Subclinical distal neuropathy of coronary artery disease. CHF-II. GB 2 tbsp; II tbsp; risk 4 HFP - CB class

Duration of diabetes - 4 years, diet No. 9 - abides, accepts Tab. Diabeton MB 30 mg - 2 tablets in the morning; IBS.NRS according to the type of frequent ZhES.SSSU. CHF-II. - since 2001; AG year - since 2001

The patient has a Thermod device installed that is applied to the patient’s skin area. The thermode has the ability to heat or cool a skin area. First, we determined the adaptation temperature between 30 and 32 ° C. To measure thresholds, a quantitatively measured temperature stimulus was applied using the device. The patient's response in the form of a simple button press was recorded on a computer. At the end, a printed report was generated with the test results. The studies were performed in the lateral and medial zones of the feet, which correspond to the innervation zones of the calf nerve (dorsolateral zone) and the peroneal nerve (medial zone). We performed the calculation using the created formula. The study on the apparatus TSA-II was carried out at the first turnout and after 3 months.

Complaints and survey data.

First After 3 months of treatment with Okolipen Complaints Periodic attacks of tachycardia, cardiac arrhythmias, such as somersaults in the chest, pain in the heart, fatigue No complaints HELL 120/70 115/70 diuresis / glucosuria Norm / Neg. Norm / Neg. fasting glycemia / after eating 5.0 / 6.5 4.9 / 6.5 weight height 64 kg / 166 cm 64 kg / 166 cm BMI kg / m ² 24 24 pulse 76 bpm 72 bpm liver enlargement (+) Neg. Neg. Urine protein / microalbumin Neg. / 0-20 Neg. / 0-20 CRP 0.49 mg / l 0.24 mg / l Нва1с 6.6% 6.2% XC 4.7 4.3 TG 2.1 2.06 HSLPVP 0.92 1,08 HSLPNP 2,8 2.7 HSLPONP 0.95 0.94 IA 4.1 3.0 Insulin (pmol, l) 73.63 73.33 C peptide (nmol / L) 1,0 0.954 Diabetes treatment Tab. Diabeton MB 30 mg - 2 tablets in the morning; Tab. Diabeton MB 30 mg - 2 tablets in the morning; Hypertension treatment Tab. Concor 1.25 mg in the morning Tab. Concor 1.25 mg in the morning Other Caps. Oktolipen 300 mg - 2 caps. In the morning on an empty stomach Caps. Oktolipen 300 mg - 2 caps. In the morning on an empty stomach TSA and VSA - Examination

Zone Heat (C-fiber) Feelings / pain (° C) Cold (Ad Fiber) Feelings / More (° C) Vibration (Ab-fibers) LN - dorso-lateral 41 / 49.5 36.7 / 49.5 23.3 / 23.9 23.6 / 21.9 3.0 1,1 Mon - dorso-lateral 45.2 / 50 41.1 / 50 23 / 24.2 26.8 / 22.6 3.2 0.8 LN - medial 43.4 / 49.9 40.8 / 49.9 26/27 26.4 / 23.7 2,5 1.9 Mon - medial 44 / 48.4 41.2 / 50 25.6 / 24.8 25.4 / 23.8 4.8 1,1

Temperature coefficient of the foot:

Before treatment:

After treatment with Oktolipen (3 months):

Conclusions on the achievement of the technical result.

The technical result of the alleged invention is the expansion of the arsenal of technical means for diagnosing the stages of neuropathy in patients with type 2 diabetes mellitus during a clinical neurological examination of patients using quantitative tests.

The proposed method is an easy way to find out the stage of neuropathy. It defines:

1. - further tactics of examining the patient (referral to electroneuromyography, ultrasound of the vessels of the lower extremities - if the clinical stage of neuropathy or severe (complicated) neuropathy is detected).

2. - further treatment tactics for the patient, i.e. the choice of the appropriate groups of preparations for the pathogenetic and symptomatic therapy corresponding to the stage of neuropathy.

3. - in addition, if the temperature coefficient of the patient’s foot corresponds to subclinical neuropathy, prophylactic pathogenetic treatment can be started to prevent the development of the clinical stage of neuropathy and diabetic foot syndrome.

4. The resulting indicator is convenient for statistical data analysis.

5. In similar research methods, for the most part, the endothelial (vascular) component of the nerves is examined, and TSA-II is the neurogenic (thin non-myelinated nerve fibers). Those.

6. The previously listed methods may be more complementary in the study of neuropathy than similar. Despite the fact that they are similar in execution technique.

The inventive method - neurogenic - is basic in contrast to the prototype. The inventive method is used to study non-myelinated nerve fibers using the TEA-Shchprichom device, the device is only an instrument in our method). The method itself consists in the sequence of measurements in the selected neurological zones and in the calculations according to the formula that we created. The results of the method are used to assess the degree of disease.

Thus, the task posed by this invention, namely, expanding the arsenal of technical means for diagnosing the stages of neuropathy in patients with type 2 diabetes mellitus during a clinical neurological examination of patients using quantitative tests, has been completed.

Claims (1)

A method for diagnosing the stage of neuropathy in patients with type 2 diabetes mellitus, which consists in the study of temperature sensitivity,
characterized in that the temperature study of the foot is carried out in a sensory manner sequentially, first determining the adaptation temperature, then applying a changed temperature stimulus, threshold values are measured in at least three zones, the measurement results are recorded and then the temperature coefficient of the foot is determined by the formula:

where Tk is the temperature coefficient of the foot;
Тч1,2 ... - thermal sensitivity in the selected zones (1,2 ...);
Хч1,2 ... - cold sensitivity in selected zones (1,2 ...);
Tchz - the average value of thermal sensitivity in healthy people without neuropathy;
Chchz - the average value of cold sensitivity in healthy people without neuropathy, then, according to the value of the temperature coefficient of the foot, the stage of neuropathy is assessed, and indicators are evaluated as follows: lack of neuropathy Tk≤2;
subclinical neuropathy A Tk from 2 to 50;
B - Tk from 51 to 100;
clinical neuropathy Tk from 101 to 200;
severe complicated neuropathy Tk more than 200.