Method for prediction of clinical effectiveness of diabetic polyneuropathy in patients with type 2 diabetes mellitus and dyslipidemia

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely endocrinology, and concerns predicting the clinical effectiveness in diabetic polyneuropathy in the patients suffering type 2 diabetes and dyslipidemia. That is ensured by evaluating the intensity of diabetic polyneuropathy manifestations taking into account neuropathic dysfunctional score, evaluating triglycerides and glycolised blood hemoglobin before the treatment; the derived data are used to specify a therapeutic approach followed by further estimation of a probability of a successful correction of diabetic polyneuropathy by formula P = 1 1 1 + e ( 0 , 9 9 1 , 7 8 Z ) , wherein e is the basis of hyperbolic logarithm e=2.72; Z is a regression coefficient calculated by formula 7=4.56-0.05*"ДлСД"-0.02*IntDPN-0.05*TG-0.53*HbAlc+0.14TherApp; if the value P is 0.7 or more, the successful correction of DPN is predicted in the patients, and the value P less than 0.7 requires the therapeutic approach to be changed.

EFFECT: method provides the improved clinical effectiveness ensured by the individual therapeutic approach based on the lipid and carbohydrate metabolism of a specific patient.

2 ex

 

The invention relates to medicine, namely to endocrinology and diabetology and can be used to predict the effectiveness of treatment of diabetic polyneuropathy according to a study of source parameters of carbohydrate and lipid metabolism, the severity of polyneuropathy and application of different schemes hypoglycemic and hypolipidemic drugs.

Diabetic polyneuropathy (SFD) is one of the most frequent and serious complications of diabetes mellitus (DM). The duration of type 2 diabetes for more than 25 years of cash flow detected in more than 50% of patients (Kempler P. Diabetic neuropathy: clinical problems and possible approaches to treatment. // Complications of diabetes mellitus: pathophysiology and pathogenetic treatment options. Edited PG. Cornelli and Canlera. International working meeting of experts. Rome (Italy), 2008 - P.36-45). Recent evidence that the cash flow occurs in 13% of cases among patients with impaired glucose tolerance and 11.3% - elevated levels of fasting plasma glucose (Ziegler D, Rathmann W, et al. Prevalence of Polyneuropathy in Prediabetes and Diabetes is Associated with Abdominal Obesity and Macroangiopathy. The MONICA/KORA Augsburg Surveys S2 and S3 // Diabetes Care. - 2008. - Vol.31. - P.464-469) suggests that cash flow is not only one of the most common complications of type 2 diabetes, but may develop much earlier clinical manifestation of this disease. In this connection, only carbohydrate metabolism cannot explain how the development and progression of cash flow. In 2009, the study Wiggin T.D. et al. a correlation was found elevated levels of triglycerides with the progression of diabetic polyneuropathy (Wiggin T.D., Sullivan K.A, Pop-Busui R., A. Amato, A.A. Sima, E.L. Feldman Elevated Triglycerides Correlate with Progression of Diabetic Neuropathy. // Diabetes published online. May 1. - 2009. - as db08-1771). According to the authors, the correlation between triglycerides and progression of diabetic neuropathy suggests that hyperglycemia and impaired glucose metabolism are not the only factors contributing to nerve damage, it is necessary to take into account the nature of lipid metabolism.

There is a method of treatment of diabetic polyneuropathy (RF patent No. 2191011, publ. 20.10.2002), namely, that after reaching compensation of diabetes mellitus with insulin and/or glucose-lowering drugs for patients additionally prescribe thyroid hormones in the dose of from 12.5 to 50 μg. The use of thyroid hormones in the treatment method cash flow leads to an increase in the velocity of propagation of excitation in n. tibialis, n. peroneus, n. suralis determined by electroneuromyography, and hence to improvements in vibratory, tactile, temperature sensitivity as diabetic patients with thyroid disease, and the patient is in DM in the absence of thyroid disease. Presumably, this is achieved by activation of antioxidant protection, increase oxygen delivery to the periphery, reducing tissue hypoxia and improves the utilization of glucose, overcoming insulin resistance. The disadvantage of this method is that thyroid hormones are contentware problematic to use in the absence of a pathology of a thyroid gland, and this positive effect may be caused by weight loss and correction of atherogenic dyslipidemia. In this regard, pathogenetically more justified is the use of lipid-lowering drugs.

Also known is a method for predicting diabetic peripheral neuropathy in children and adolescents (RF patent No. 2273028, publ. 27.03.2006). The method includes defining in the peripheral blood serologic method of brain-derived neurotrophic factor. When the value of subjects neurotrophin more than 9000 PG/ml diagnose subclinical stage of cash flow. The method allows to predict the complication in diabetes mellitus type 1 in children and adolescents and early preventive treatment. However, the implementation of the method does not take into account characteristics of the underlying disease, the degree of metabolic changes in the patient, which reduces the objectivity of the prediction method, acetylaminophenol formation of cash flow.

The task of the invention is to provide a method for predicting the effectiveness of treatment of diabetic polyneuropathy with the help of various schemes combination of antidiabetic and gipolipidemicheskih drugs with the original parameters of carbohydrate and lipid metabolism, the severity of neuropathy and anamnestic data.

This task is achieved by the fact that patients define duration of T2DM (Dlcd) in years, appreciate the severity of the manifestations of diabetic polyneuropathy (Virden) on the scores of the questionnaire neuropathic dysfunctional account, determine the content of triglycerides (TG) and glycated hemoglobin (HbAlc) in the blood before treatment. Choose the treatment strategy (Ctrl), ranging as follows: 1 point - standard glucose-lowering therapy: Metformin + diabeton MB; 2 points - glucose-lowering therapy with a combination of drugs that reduce insulin resistance, and entretenimiento (Metformin + ecstatic); 3 points - glucose-lowering and lipid-lowering therapy (Metformin, ecstatic, statins); 4 points - glucose-lowering and lipid-lowering therapy, including the fibrates (Metformin, ecstatic, statins, fibrates). Determine the probability of successful correction of the cash flow formulaP=1-11+e- (0,99-1,78Z),where e is the base of natural logarithm, e=2,72; Z - regression coefficient, calculated according to the formula Z=4,56-0,05·Dlsd-0,02·Virden-0,05·TG-0,53·HbAlc+0,14·Strl, if the P value is 0.7 or more, patients predict successful correction of cash flow, and if the P value has a value less than 0.7, it is necessary to change the treatment strategy.

The novelty of the invention lies in the fact that simultaneous assessment of anamnestic data, parameters of carbohydrate and lipid metabolism, points on a scale VAT, the use of multiple regression analysis, which is the main in multivariate statistics allow to increase the sensitivity of the predictive determine the effectiveness of treatment are still at the planning stage of its use.

The invention involves an inventive step, because the endocrinologist is not obvious from the level of medicine in the field of diabetology.

In the available sources of Russia and foreign't found similar to the proposed method of predicting the effectiveness of treatment of cash flow.

The claimed invention is industrially applicable as there may be many times repeated and used on ence treatment effectiveness cash flow and reproduced in various medical and scientific medical institutions, especially endocrinology and therapeutic profile.

A method for predicting the effectiveness of treatment of diabetic polyneuropathy in patients with diabetes mellitus type 2 and dyslipidemia, as follows.

In a patient with type 2 diabetes clarify, when he was first diagnosed and determine the duration of disease in years - Dlsd.

On a scale of neuropathic dysfunctional account (VAT) specify in points the severity of peripheral polyneuropathie - Virden (Young M.J., Zhou Y.Q., E. Rodrigues et al. Variable relationship between peripheral somatic and autonomic neuropathy in patients with different syndromes of diabetic polyneuropathy // Diabetes. - 1986. - Vol.35. - P.192-197; Chernyshev, IE, I.V. Guryev, Altynbaev R.A. with Soave. Diabetic neuropathy (pathogenesis, diagnosis, treatment). - M.: publishing house MEDPRAKTIKA - M, 2006. - P.39-40), and rank scores for the scale of VAT in the following way: 1 point - the initial cash flow (the number of points in the questionnaire VAT initial cash flow (the number of points in the questionnaire VAT 0-4 points), 2 points - moderate cash flow (the number of points in the questionnaire VAT 5-13 points)3 points - severe cash flow (the number of points on the scale of VAT 14 points or more).

In whole blood of the patient determine the level of glycosylated hemoglobin in %, for example, using the fast ion-exchange method using reagents "HUMAN"firm, Germany (Ostapenko V.A., Firstova, L.P., Eliseeva I.P. with Soave. Optim is within the definition of a stable fraction of glycosylated hemoglobin HbAlc method of indexing the total fraction of glycosylated hemoglobin HbAl // Fundamental research. - 2008. No. 6 - P.116-117).

Serum determine the level of triglycerides in mmol/l, for example, by using a set of reagents "Cleanitest-Cholesterol", produced by SPC Eco-Service" (Kiskun A.A. guidelines on laboratory methods of diagnosis. - M.: GEOTAR - Media, 2007. - S).

Analyzing carbohydrate and lipid metabolism, determine the treatment regimen of the four below, ranging its relevant points: 1 point - standard glucose-lowering therapy: Metformin + diabeton MB; 2 points - glucose-lowering therapy with a combination of drugs that reduce insulin resistance, and entretenimiento (Metformin + ecstatic); 3 points - glucose-lowering and lipid-lowering therapy (Metformin, ecstatic, statins); 4 points - glucose-lowering and lipid-lowering therapy, including the fibrates (Metformin, ecstatic, statins, fibrates).

Further calculates the regression coefficient Z by the formula:

Z=4,56-0,05·Dlsd-0,02·Virden-0,05·TG-0,53·HbAlc+0,14·Strl,

where Dlsd - duration type 2 diabetes, defined in years;

Virden - cash flow severity: 1 point - the initial cash flow (the number of points in the questionnaire VAT 0-4 points), 2 points - moderate cash flow (the number of points in the questionnaire VAT 5-13 points)3 points - severe cash flow (the number of points on the scale of VAT 14 points or more);

TG - triglycerides blood before treatment in mmol/l;

HbAlc - glycosylated is p hemoglobin before treatment in%;

Ctrl strategy proposed treatment: 1 point - standard glucose-lowering therapy: Metformin + diabeton MB; 2 points - glucose-lowering therapy with a combination of drugs that reduce insulin resistance, and entretenimiento (Metformin + ecstatic); 3 points - glucose-lowering and lipid-lowering therapy (Metformin, ecstatic, statins); 4 points - glucose-lowering and lipid-lowering therapy, including the fibrates (Metformin, ecstatic, statins, fibrates).

The calculated Z value substituted into the formula to determine the probability of successful correction cash flow in patients with type 2 diabetes and dyslipidemia (in percentage units), which has the following form:

P=1-11+e-(0,99-1,78Z)

where e is the base of natural logarithm, e=2,72;

Z - factor regression.

If the P value is 0.7 or more, the patient is predicted successful correction of the cash flow. When P has a value less than 0.7, it is necessary to change the treatment strategy and re-calculate R when a different number of points to select a more successful method of combination of drugs in individual sieve is tion.

The proposed method eliminates the presence of subjectivity. The method will allow the doctor to assess the possibility of successful adjustment cash flow, to predict its course, promptly appoint an adequate therapy. This will reduce the risk of late vascular complications of diabetes and improve the health and quality of life of patients.

The operability of the invention the following examples.

For example, the patient D., 58 years, type 2 diabetes was diagnosed at the age of 55, lasted 3 years, the questionnaire VAT number of points was 11, therefore, the severity of cash flow was moderate (2 points), before treatment triglycerides blood was 2.1 mmol/l) glycated hemoglobin was 7.1%. The patient was assigned to a combination of glucose-lowering and lipid-lowering therapy with Metformin, ecstatic, simvastatin, fenofibrate (4 points).

First calculate the Z-factor=4,56-0,05·3-0,02·2-0,05·2,1-0,53·7,1+0,14·4=1,04,

Then we substitute it into the formula

P=1-11+e-(0,99-1,781,04)

R=0,7.

Therefore, the probability of successful correction cash flow in Tomlinson case is equal to 0.7 or 70%.

Another clinical example. Patient A., 64 years, experience of diabetes was 12 years and questionnaire VAT scores corresponded to 15, therefore cash flow was severe (3 points), the original content of triglycerides blood was 2.6 mmol/l) glycated hemoglobin was 7.4%. The patient was assigned only antidiabetic therapy Metformin and ecstatic (2 points).

First calculate the Z-factor=4,56-0,05·12-0,02·3-0,05·2,6-0,53·7,4+0,14·2=0,06

Then we substitute it into the formula

P=1-11+e-(0,99-1,780,06)

P=0.29.

Therefore, the probability of successful correction of the cash flow that the patient had a low - to 0.29 or 29% and was determined not feasible to use this method of treatment.

Determination of the significance of all of the studied parameters for predicting the likelihood of effective treatment cash flow was high, because the determination coefficient was R2=0,82. Therefore, created a regression model in 82% was explained by the effectiveness of the treatment. The Fisher's F amounted to 27.3 (p<0,001), indicating a high statistical significance regr ssional model. The coefficient of multiple correlation, reflecting the relationship between the original variables and the probability of good results, had a value of 0.91, indicating their strong interaction. The coefficient of determination of residues (that is unaccounted for variables in the model) was a minor R2=0,12, testified that the risk of uncontrolled flow was due mainly it is accounted for in the regression model parameters and did not depend on factors not considered.

To check the quality of the model was performed ROC analysis with the construction of curves of sensitivity and specificity. ROC curve reflects the dependence of the number of correctly classified positive examples from the number of incorrectly classied negative examples. The calculated area under the ROC curve was 0.71, which corresponds to "good" as a model.

Technical and economic efficiency of the proposed method is that the method allows to choose an effective way to ensure cash flow and prevent the development of ulcers of the feet, diabetic foot syndrome, which reduces the risk of disability of the patient and they lose their social and labour potential.

A method for predicting the effectiveness of treatment of diabetic polyneuropathy (SFD) is diabetes mellitus (DM) type 2 and dyslipidemia, namely, that patients with diabetes mellitus type 2 and dyslipidemia determine the duration of type 2 diabetes (Dlcd) in years, appreciate the severity of the manifestations of diabetic polyneuropathy (Virden) taking into account the points of neuropathic dysfunctional account (VAT): 1 point severity cash flow corresponds 0-4 scores on questionnaire VAT, 2 points severity of cash flow - 5-13 scores on questionnaire VAT, 3 credits severity of cash flow is 14 or more points on questionnaire VAT; determine the content of triglycerides (TG) and glycated hemoglobin (HbAlc) in the blood before treatment and choose the treatment strategy (Ctrl): 1 point - standard glucose-lowering therapy Metformin + diabeton MB; 2 points - glucose-lowering therapy with a combination of drugs that reduce insulin resistance and entretenimiento - Metformin + ecstatic; 3 points - glucose-lowering and lipid-lowering therapy Metformin + ecstatic + statins; 4 points-glucose-lowering and lipid-lowering therapy, including fibrates - Metformin + ecstatic + statins + fibrates; then determine the probability of successful correction cash flow in fractions of a unit by the formula
P=1-11+e-(0,99-1,78Z),
where e is the base of natural logarithm e=2,72; Z - regression coefficient, calculated according to the formula Z=4,56-0,05·Dlsd-0,02·Virden-0,05·TG-0,53·HbAlc+0,TL, if the P value is 0.7 or more, patients predict successful correction of cash flow, and if the P value has a value less than 0.7, it is necessary to change the treatment strategy.



 

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