Diabetes mellitus express-diagnostic method

FIELD: medicine.

SUBSTANCE: invention refers to medicine and namely to medical diagnostics. There has been proposed express-diagnostic method of diabetes mellitus as per the content of acetone micro-impurities in the air breathed out by the patient, at that, evaluation of acetone content in the sample is performed with the instrument complex 'concentrating centrifuge - mass-spectrometre'.

EFFECT: possibility of observing the dynamics of acetone in real-time mode.

2 ex

 

The invention relates to medicine, namely to internal medicine, and can be used for early diagnosis not only obvious clinical feature types of diabetes, but also to identify secretive (current latent) form.

Currently, for the diagnosis of diabetes, besides taking into account the clinical manifestations, the necessary confirmation of the disease is by laboratory detection of the presence of sugar in the blood (hyperglycemia) and in urine (glucosuria). It is known that the characteristic increase of sugar in blood and urine is detected when expressed, clinical decorated stages of the disease, then how to identify hidden, latent current forms of diabetes (impaired glucose tolerance or potential violation of tolerance) requires the use of complex, special and time-consuming laboratory tests (functional tests with carbohydrate or carbohydrate double load) (internal diseases. Edited by F.I. Komarov. M.: Medicine, 1991, p 603).

A disadvantage of known methods is that the laboratory method to study the blood is invasive and time consuming, especially when conducting functional tests with carbohydrate loading.

Over the past years to study the lesions of blood vessels caused by diabetes, such as specific microangiopathy and macroangiopathies, apply metadataversion diagnostics, which allows you to comprehensively assess the state of the circulation in the lower limbs, to identify changes in the peripheral circulation.

For diabetes characterized by symmetrical (when microangiopathy) or unbalanced (in atherosclerotic macroangiopathies) hypothermia (reduction of infrared radiation) distal lower extremities (the Dissipation in medicine. Part II, Leningrad, 1981, p.55-64, "fundamentals of clinical distal thermodiagnostics. Lgerstel, Kiev, Health, 1988, pp.92).

The disadvantage of this method is the fact that for the detection of early, latent forms of pathology of vessels of lower extremities in persons younger than 40 years it is necessary to conduct functional tests with General or local cooling of the lower extremities (thermal Imaging in medicine. - L., 1984, Wenigerkind and other Opportunities thermography in the diagnosis of vascular diseases, s-285). This cooling procedure of the lower extremities with the aim of clarifying the diagnosis is time-consuming and unattractive for the patient.

The known method of reflexodiagnostics diabetes mellitus, is described in the article Aghbalou "Differential diagnosis of diabetes based on the standard autonomic test" ("Acupuncture and traditional methods of treatment", 1991, N 1). In this way investigate biological parameters preventable if the natural enemy evaluation: skin temperature, and skin conductivity at representative points of the acupuncture channels. The study was conducted in the prescribed manner by filing cards, it was found that the types of diabetes have their own variances vegetative character and their vegetative characteristics of the standard test. The principle of using the prototype method is based on the study of the dynamics of biophysical parameters TC and RPC patients with diagnosed diabetes mellitus type I, rarer type II in the treatment process. Primary diagnosis of diabetes in the method prototype is not provided. In addition, measurement of skin temperature and skin conductivity in the contact process is carried out by - hence the possible inaccuracies of the results, in no way indicate the possibility of discovering hidden forms of diabetes.

Known gas analysis method of medical diagnostics and device for its implementation in the form of the invention RU # 2000120996, G01N 33/52, G01N 33/497, 2000.07.26. The method consists in determining the qualitative and quantitative composition of the air taken from the surface of the skin, and the content of diagnostically important substances in the diagnostically relevant concentrations is carried out calorimetric method using adsorbents, so the study is subjected to the gas phase near or directly with the surface of the skin n the shelter.

The known method does not allow to follow the diagnostic parameters of a patient, the dynamics of the provision of gas components and difficult to implement.

A prototype of the selected known, published the article WITH DENG at al. Determination of aceton in human breath by gas chromatography-mass spectrometry and solid-phase microextraction with on-fiber derivatization (Journal of Chromatography B, Volume 810, Issue 2, 25 October 2004, Pages 269-275), a method for the diagnosis of diabetes by measuring concentration of acetone in the exhaled breath of the patient air. In this known method vidihnuly patient gas is collected in a plastic container. Then in the upper part of the tank is placed a sample of the fiber, pre-coated with oxime. The package is heated to a temperature of 40°C and incubated for 4 min Sample precipitated as a result of chemical reaction with the oxime acetone (acetone oxime on the fiber) is extracted from the package and analyze the extracted solid phase on the mass spectrometer.

Chemical redistribution complicates the process, limits its diagnostic capabilities and do not allow for diagnostics in real time.

The basis of the proposed method the task: expand diagnostic capabilities of the method of rapid diagnosis through the detection of early latent, latent forms of diabetes; the simplification and acceleration of the method by investigation of a single physical parameter, increasing the giving of the reliability of the method through the use of non-contact distance and at the same time visual way of visualizing the analyzed parameter.

The task in the way of rapid diagnosis of diabetes on the measurement in the air diagnostically important substances in the diagnostically relevant concentrations, namely acetone, is achieved by the fact that diabetes is diagnosed on the content of the concentration of acetone in the exhaled breath of the patient air, and the determination of acetone in the exhaled breath of the patient, the instrument air is a complex concentrating centrifuge - mass spectrometer (CE-MS).

While deciding on the content of acetone in the exhaled breath of the patient air exercise before eating and after 0.5-2 hours after a meal and change the content of acetone in the exhaled breath of the patient, the air and the speed of this change or save the content of acetone in the exhaled breath of the patient air establish the presence of disease in a patient, and its shape or absence of disease.

Additionally, the analyzed gas phase is taken forcibly. In addition, the analyzed gas phase to analysis incubated in plastic containers.

Additionally, the analyzed gas phase before analysis is passed through the layer of adsorbent water vapor.

The proposed method is as follows. The patient before eating exhales about 5 liters of air in a plastic bag. The bag is connected to the instrument complex CC-MS and determine the content of n is m acetone. The patient is given to take carbohydrate-containing foods: sample carbohydrate load (standard Breakfast): sugar on an empty stomach. After 0.5-2 hours the patient after eating exhales about 5 liters of air in a plastic bag. The bag is connected to the instrument complex CC-MS to determine the content of acetone. To improve the stability of the results of the analyzed gas phase before analysis can be skipped at the entrance to the instrument complex CC-MS through the layer of adsorbent water vapor. The feature of the instrument complex CC-MS is (Patent RU №2064205 "Mass spectrometer for analysis of trace impurities in gases and vapours (and its variants)", H01J 49/26, 1992,08 .20)that the combination in one instrument complex gas centrifuges and mass spectrometer allows to increase sensitivity in the last 103-106time and measure micromeria in the content of acetone in the breath of the patient over time. Compare the content of acetone in vydohnula patient air before and after a meal and see the growth, preservation or reduction of the content of acetone in exhaled air. In the case of increasing concentrations of acetone establish the presence of the disease, and when you save or fall in the concentration of acetone is the absence of disease.

The average examination time per patient in two dimensions does not exceed 10 minutes, without accounting for 0.5 to 2 hours time periyamadu measurements.

Diabetes mellitus is an endocrine disease due to abnormal metabolic disorders caused or impaired insulin secretion, or a violation of the mechanism of action of this hormone on the tissues. Diabetes mellitus is the most common disease, a significant number of people have latent diabetes or genetically predisposed to it. The basis for classification of diabetes mellitus, adopted in 1979, who lay perceptions of mnogopartiinosti this disease.

In practical medicine uses classification:

Insulin-dependent type I

Non-insulin-dependent type II

Impaired carbohydrate tolerance

Significant classes of risk

The most common type II diabetes usually develops in people over 50 years old, often on the background of obesity.

Impaired carbohydrate tolerance is referred to by most clinicians as "latent diabetes", therefore, timely detection of this form of diabetes, and conduct of remedial measures can prevent the development of clinically decorated the stage of the disease.

The selection of reliable risk classes is of great importance, because it is determined contingents in need of special attention.

In the significant classes of risk are persons with normal glucose tolerance, but significantly increased risk of developing diabetes (preceded by the s violations glucose tolerance), in the absence of clinical manifestations of the disease.

However, with the development of those people infectious diseases, pregnancy, test, glucose tolerance revealed deviations (indicators of sugar in the blood is higher than in healthy, but lower than in patients with impaired glucose tolerance).

The development of diabetes is accompanied by various complications. Especially dangerous lesions of lower extremities vessels, retinal fundus, coronary vessels, which are the main cause of disability in this disease. Vascular lesions of the lower extremities clearly detected with a thermal imaging study, but do not forget that the identification of vascular lesions of any form, even earlier, is not pronounced, it is still a diagnosis only complications, not the disease diabetes. The results of clinical studies using complex CC-MS, we identified concentrations of acetone and modify the content of acetone in the analyzed sample, exhaled breath of the patient before and after eating, the combination of which indicates the presence of signs of diabetes not only in persons with established clinical diagnosis, but also in persons with asymptomatic disease.

The positive effect of the invention is that the use of neenu the exclusive method of rapid diagnosis of latent forms of diabetes can significantly improve the reliability of detection of hidden forms of diabetes and can be recommended for use in General diagnostic process, and for mass screening examinations of the population.

The invention is illustrated by the following examples.

Example No. 1. B-Aya, 29 years. Disease diabetes first diagnosed 5 years ago during pregnancy. Amid the diet and receive Mannila a long time managed to maintain blood sugar stable on figures 4.5 to 5.5 mmol/L.

Unwell the last 1.5 months. Complaints of weakness, dizziness, irritability.

Objectively: height 162 cm, weight 63 kg the Correct shape. Skin and visible mucous net. Language and wet clean. Light - vesicular breathing. Heart tones are clean, rhythmic. The pulse is 70/min, BP-120/80.

The abdomen is soft, painless, liver and spleen not palpable. Symptom of Pasternack negative, dysuric disorders no.

CZ-MS study.

In the analysis of the samples showed signs of increase of the content of acetone before and after eating. The slew rate of 0.5%/hour.

Conclusion: the pattern of signs of diabetes.

Laboratory investigations. A General analysis of urine and blood - without a pathology. Basal hyperglycemia was 8.8 mmol/l, during the day from 8.6-16.0 mmol/L.

Daily glucosuria is from 1.6 to 2.0, the Reaction for acetone - negative. Sample carbohydrate load (standard Breakfast): sugar on an empty stomach 8,8, after 30 min - 10,, after 60 min - 10,0, after 120 min of 8.8 mmol/L. the Level of antibodies and insulin - 3,9% (N up to 5%).

On the basis of full clinical examination established the final diagnosis of NIDDM (non-insulin-dependent diabetes mellitus).

Example No. 2. B-th K., 56, years.

Suffers from chronic cholecysto-pancreatitis in a long time (over 7 years), for the last 4 years growing obesity, signs of hypertension.

Complaints about persistent pain in the epigastrium, in the right and left hypochondrium, nausea from fatty and rich food, weakness, heart pain, headaches.

Repeatedly treated in city hospitals, outpatient constant surveillance. Twice recorded basal glycemia within about 6.5-6.8 mmol/l After a carbohydrate load increase to 8.6 mmol/L. When diet blood sugar stabilized quickly in figures 4.5 to 5.0 mmol/L.

Objective: growth 151, weight 92 kg Skin clean, slimy pink. Light - vesicular breathing, heart - pure tones, rhythmic. Pulse 78/min, BP 170/100. The stomach is increased due to the subcutaneous fat layer, slightly swollen, painful to palpation in the right and left hypochondrium. The lymph nodes are not enlarged, peripheral edema no.

CZ-MS study.

In the analysis of the samples showed signs of increasing content of acetone before and after eating. The slew rate of 1.5%/hour.

Enclosed is e: thermal imaging picture of the signs of diabetes.

A General analysis of urine and blood - no change. Glycemia (blood sugar - 6.6 mmol/l Sample carbohydrate load - sugar after 120 min - 8.25 mmol/l (N - up to 7.7). Double oral load of glucose (Staub-Traugott) - 90 min sugar - 11 mmol/L. This is more than normal in healthy, but less than in patients with clinical diabetes.

Bilirubin total - 2, line 3, indirect - 9. Cholesterol - 6.8 mmol/l, triglycerides - 2.8 mmol/l Prothrombin index - 0,97.

X-ray: lung fields clear, heart expanded to the left aorta is expanded, condensed. From stomach made signs of chronic gastritis. FGS: signs of chronic gastritis.

Ultrasound: acalculous cholecystitis, chronic pancreatitis.

CH. bottom: plethora, irregular tortuous veins, isolated microaneurysms.

ECG: signs of changes in the myocardium is not revealed, sinus rhythm, 76/min

AKOKO: moderate left ventricular hypertrophy with some increase in the cavity.

On the basis of full clinical examination established the final diagnosis: chronic cholecysto-pancreatitis, chronic gastritis. General atherosclerosis, hypertension II A. Obesity, latent diabetes with impaired glucose tolerance.

1. The method of rapid diagnosis of diabetes on the measurement in the air diagnostically testing imih substances in diagnostically relevant concentrations is characterized in that what diabetes is diagnosed on the content of the concentration of acetone in the exhaled breath of the patient air, and the determination of acetone in exhaled breath of the patient air exercise instrument complex concentrating centrifuge - mass spectrometer.

2. The method according to claim 1, characterized in that the determination of acetone in exhaled breath of the patient air exercise before eating and after 0.5-2 hours after eating, and change the content of acetone in the exhaled breath of the patient, the air and the speed of this change or save the content of acetone in the exhaled breath of the patient air establish the presence of disease in a patient, and its shape or absence of disease.

3. The method according to any one of claims 1 or 2, characterized in that the analyzed gas phase is taken away forcibly.

4. The method according to any one of claims 1 or 2, characterized in that the analyzed gas phase to analysis incubated in plastic containers.

5. The method according to any one of claims 1 or 2, characterized in that the analyzed gas phase before analysis is passed through the layer of adsorbent water vapor.



 

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