MD1046Z - Method for predicting the risk of appearance of cardiovascular autonomic neuropathy in type 1 diabetes mellitus - Google Patents
Method for predicting the risk of appearance of cardiovascular autonomic neuropathy in type 1 diabetes mellitus Download PDFInfo
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- 230000002526 effect on cardiovascular system Effects 0.000 title claims abstract description 34
- 206010061666 Autonomic neuropathy Diseases 0.000 title claims abstract description 32
- 206010067584 Type 1 diabetes mellitus Diseases 0.000 title claims abstract description 18
- 238000000034 method Methods 0.000 title claims abstract description 18
- 206010012601 diabetes mellitus Diseases 0.000 claims abstract description 13
- 208000001380 Diabetic Ketoacidosis Diseases 0.000 claims abstract description 7
- 201000001119 neuropathy Diseases 0.000 claims abstract description 3
- 230000007823 neuropathy Effects 0.000 claims abstract description 3
- 208000033808 peripheral neuropathy Diseases 0.000 claims abstract description 3
- 208000007342 Diabetic Nephropathies Diseases 0.000 claims description 7
- 208000033679 diabetic kidney disease Diseases 0.000 claims description 7
- 239000003814 drug Substances 0.000 abstract description 2
- 208000017169 kidney disease Diseases 0.000 abstract 1
- 230000006870 function Effects 0.000 description 9
- 238000012360 testing method Methods 0.000 description 8
- 238000003745 diagnosis Methods 0.000 description 7
- 230000002349 favourable effect Effects 0.000 description 6
- 238000004393 prognosis Methods 0.000 description 6
- 206010023379 Ketoacidosis Diseases 0.000 description 3
- 208000007976 Ketosis Diseases 0.000 description 3
- 238000004458 analytical method Methods 0.000 description 3
- 238000001514 detection method Methods 0.000 description 3
- 206010066001 Cardiac autonomic neuropathy Diseases 0.000 description 2
- 230000000747 cardiac effect Effects 0.000 description 2
- 238000012937 correction Methods 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 230000002641 glycemic effect Effects 0.000 description 2
- LELAOEBVZLPXAZ-UHFFFAOYSA-N iberin Chemical compound CS(=O)CCCN=C=S LELAOEBVZLPXAZ-UHFFFAOYSA-N 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 230000001225 therapeutic effect Effects 0.000 description 2
- 208000002249 Diabetes Complications Diseases 0.000 description 1
- 208000032131 Diabetic Neuropathies Diseases 0.000 description 1
- 230000037424 autonomic function Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 238000007405 data analysis Methods 0.000 description 1
- 238000002405 diagnostic procedure Methods 0.000 description 1
- 230000002218 hypoglycaemic effect Effects 0.000 description 1
- 238000011835 investigation Methods 0.000 description 1
- 238000013178 mathematical model Methods 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
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- 208000024891 symptom Diseases 0.000 description 1
- 238000011282 treatment Methods 0.000 description 1
- 238000011269 treatment regimen Methods 0.000 description 1
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Abstract
Invenţia se referă la medicină, în special la endocrinologie şi poate fi utilizată pentru pronosticarea riscului apariţiei neuropatiei autonome cardiovasculare în diabetul zaharat de tip I.Metoda, conform invenţiei, include examenul clinic şi paraclinic, unde se stabilesc următorii parametri: gradul de severitate a nefropatiei diabetice (ND), frecvenţa apariţiei cetoacidozei diabetice (CAD), durata diabetului zaharat (DD), apoi se calculează funcţia discriminantă (F) conform formulei:F=-4,972+1,767·ND+1,530·CAD+0,078·DD,în cazul în care F > 0 se pronostichează riscul apariţiei neuropatiei autonome cardiovasculare în diabetul zaharat de tip I, iar când F < 0 - se pronostichează lipsa riscului apariţiei neuropatiei.The invention relates to medicine, in particular to endocrinology and can be used to predict the risk of cardiovascular autonomic neuropathy in type I diabetes. The method, according to the invention, includes the clinical and paraclinical examination, where the following parameters are set: the degree of severity of the nephropathy diabetic (ND), frequency of occurrence of diabetic ketoacidosis (CAD), duration of diabetes mellitus (DD), then the discriminant function (F) is calculated according to the formula: F = -4,972 + 1,767 · ND + 1,530 · CAD + 0.078 · DD, in the case in which F> 0 is predicted the risk of cardiovascular autonomic neuropathy in type I diabetes, and when F <0 - the risk of neuropathy is not predicted.
Description
Invenţia se referă la medicină, în special la endocrinologie şi poate fi utilizată pentru pronosticarea riscului apariţiei neuropatiei autonome cardiovasculare în diabetul zaharat de tip I. The invention relates to medicine, in particular to endocrinology and can be used to predict the risk of cardiovascular autonomic neuropathy in type I diabetes.
Neuropatia autonomă cardiacă este una din complicaţiile diabetului zaharat adesea trecută cu vederea, dar care are un impact major asupra patologiei cardiovasculare, morbidităţii şi mortalităţii pacienţilor cu diabet zaharat. Dificultatea diagnosticării ei apare începând cu manifestările clinice, care pe de o parte mult timp rămâne asimptomatică, însă, pe de altă parte nu are simptome specifice, iar cele existente deseori pot fi confundate cu stările de hipoglicemie. Cardiac autonomic neuropathy is one of the complications of diabetes mellitus that is often overlooked, but which has a major impact on cardiovascular pathology, morbidity and mortality of patients with diabetes mellitus. The difficulty of diagnosing it begins with the clinical manifestations, which on the one hand remain asymptomatic for a long time, but on the other hand have no specific symptoms, and the existing ones can often be confused with hypoglycemic states.
Este cunoscut că diagnosticarea neuropatiei autonome cardiovasculare rămâne o problemă. A fost dovedit că factorul de risc major este durata diabetului şi controlul glicemic scăzut. După datele studiului Diabetes Control and Complications Trial (DCCT), un control glicemic intens a dus la scăderea incidenţei neuropatiei autonome cardiovasculare cu 50% după o perioadă de 6,5 ani de monitorizare, acest efect protectiv a persistat încă 14 ani după finalizarea studiului. Majoritatea studiilor au demonstrat corelaţiile dintre neuropatia autonomă cardiovasculară şi factorii de risc, cu toate acestea nu sunt studii care ar fi evaluat pronosticul apariţiei neuropatiei autonome cardiovasculare, care ar permite aplicarea testelor de screening la pacienţii cu risc de a face neuropatie autonomă cardiovasculară. În anii 1970 Ewing şi al. au propus cinci teste simple, neinvazive pentru aprecierea funcţiei autonome cardiovasculare, bazate pe răspunsul frecvenţei cardiace şi tensiunii arteriale la anumite manevre fiziologice. Aceste teste au o sensibilitate şi specificitate sporită în diagnosticarea neuropatiei autonome cardiovasculare [1]. It is known that the diagnosis of cardiovascular autonomic neuropathy remains a problem. It has been proven that the major risk factor is the duration of diabetes and poor glycemic control. According to the Diabetes Control and Complications Trial (DCCT), intensive glycemic control led to a 50% decrease in the incidence of cardiovascular autonomic neuropathy after a 6.5-year follow-up period, this protective effect persisted for another 14 years after the end of the study. Most studies have demonstrated correlations between cardiovascular autonomic neuropathy and risk factors, however, there are no studies that have evaluated the prognosis of cardiovascular autonomic neuropathy, which would allow the application of screening tests in patients at risk of developing cardiovascular autonomic neuropathy. In the 1970s, Ewing et al. proposed five simple, non-invasive tests for the assessment of cardiovascular autonomic function, based on the response of heart rate and blood pressure to certain physiological maneuvers. These tests have increased sensitivity and specificity in the diagnosis of cardiovascular autonomic neuropathy [1].
Dezavantajul acestor teste constă în faptul că ele necesită personal competent şi nu sunt disponibile în practica generală. The disadvantage of these tests is that they require competent personnel and are not available in general practice.
O altă metodă de diagnosticare a neuropatiei autonome cardiovasculare este aplicarea Holter-ECG în decurs de 24 ore, pentru aprecierea variabilităţii ritmului cardiac. Însă, metoda dată este costisitoare şi necesită utilaj special, din care cauză diagnosticul este stabilit tardiv. Astfel, devine oportun aprecierea grupelor de risc pentru apariţia neuropatiei autonome cardiace şi aplicarea metodelor de diagnostic la stadiile incipiente cu preîntâmpinarea agravării neuropatiei autonome cardiovasculare. Another method of diagnosing cardiovascular autonomic neuropathy is the application of Holter-ECG within 24 hours, to assess heart rate variability. However, this method is expensive and requires special equipment, which is why the diagnosis is established late. Thus, it becomes appropriate to assess the risk groups for the occurrence of cardiac autonomic neuropathy and apply diagnostic methods at the early stages to prevent the worsening of cardiovascular autonomic neuropathy.
Matematic problema fiind formalizată se reduce la deducerea unei reguli, unui criteriu de discriminare, în baza analizei datelor a două selecţii (pacienţi fără neuropatie autonomă cardiovasculară şi pacienţi cu neuropatie autonomă cardiovasculară confirmată în baza testelor funcţiei vegetative cardiace), care permite a atribui un nou element (pacient cu diabet zaharat şi neuropatie autonomă cardiovasculară nediagnosticată) la una din cele două mulţimi cu o exactitate destul de bună. Folosirea analizei discriminante în analiza datelor statistice ne-a permis să deducem funcţia discriminantă propusă mai jos, care este pusă în esenţa metodei de pronosticare. Mathematically, the problem being formalized, is reduced to deducing a rule, a discrimination criterion, based on the data analysis of two selections (patients without cardiovascular autonomic neuropathy and patients with cardiovascular autonomic neuropathy confirmed based on cardiac vegetative function tests), which allows to attribute a new element (patient with diabetes mellitus and undiagnosed cardiovascular autonomic neuropathy) to one of the two sets with quite good accuracy. The use of discriminant analysis in the analysis of statistical data allowed us to deduce the discriminant function proposed below, which is put at the heart of the prediction method.
Problema pe care o rezolvă invenţia propusă este elaborarea unei metode noi pentru creşterea exactităţii pronosticării apariţiei neuropatiei autonome cardiovasculare în diabetul zaharat tip 1. The problem solved by the proposed invention is the development of a new method for increasing the accuracy of predicting the occurrence of cardiovascular autonomic neuropathy in type 1 diabetes.
Metoda de pronosticare a riscului apariţiei neuropatiei autonome cardiovasculare în diabetul zaharat de tip I include examenul clinic şi paraclinic, unde se stabilesc următorii parametri: gradul de severitate a nefropatiei diabetice (ND), frecvenţa apariţiei cetoacidozei diabetice (CAD), durata diabetului zaharat (DD), apoi se calculează funcţia discriminantă (F) conform formulei: The method for predicting the risk of cardiovascular autonomic neuropathy in type I diabetes mellitus includes clinical and paraclinical examination, where the following parameters are established: the severity of diabetic nephropathy (ND), the frequency of diabetic ketoacidosis (DKA), the duration of diabetes mellitus (DD), then the discriminant function (F) is calculated according to the formula:
F=-4,972+1,767·ND+1,530·CAD+0,078·DD, F=-4.972+1.767·ND+1.530·CAD+0.078·DD,
unde parametrii menţionaţi primesc următoarele valori: where the mentioned parameters receive the following values:
ND - 0 - absent; 1 - stadiul I; 2 - stadiul II; 3 - stadiul III; 4 - stadiul IV-V; ND - 0 - absent; 1 - stage I; 2 - stage II; 3 - stage III; 4 - stage IV-V;
CAD - 1 - rar; 2 - o dată pe an; 3 - mai mult de 2 ori pe an; DD - valori în ani, CAD - 1 - rarely; 2 - once a year; 3 - more than 2 times a year; DD - values in years,
în cazul în care F > 0 se pronostichează riscul apariţiei neuropatiei autonome cardiovasculare în diabetul zaharat de tip I, iar când F < 0 se pronostichează lipsa riscului apariţiei neuropatiei. if F > 0, the risk of cardiovascular autonomic neuropathy in type I diabetes is predicted, and when F < 0, the lack of risk of neuropathy is predicted.
Rezultatul constă în elaborarea unei metode ce permite pronosticarea ieftină, obiectivă şi eficace a apariţiei neuropatiei autonome cardiovasculare în diabetul zaharat tip I. The result consists in the development of a method that allows for the cheap, objective and effective prediction of the occurrence of cardiovascular autonomic neuropathy in type I diabetes.
Avantajul constă în sporirea exactităţii şi a obiectivizării pronosticării apariţiei neuropatiei autonome cardiovasculare în diabetul zaharat tip 1. Metoda propusă este una ieftină, uşor aplicabilă şi nu necesită utilaj medical. Ea permite depistarea precoce a bolnavilor cu risc crescut de apariţie a neuropatiei autonome cardiovasculare, fapt ce impune o atenţie sporită pentru această categorie de pacienţi cu corijare la timp a programului terapeutic şi evidenţă în dinamică. The advantage lies in increasing the accuracy and objectivity of the prognosis of the occurrence of cardiovascular autonomic neuropathy in type 1 diabetes. The proposed method is inexpensive, easily applicable and does not require medical equipment. It allows for the early detection of patients with an increased risk of cardiovascular autonomic neuropathy, which requires increased attention for this category of patients with timely correction of the therapeutic program and evidence in dynamics.
Metoda se efectuează în felul următor: analiza datelor anamnezei şi testarea prin modelul matematic, cu aprecierea următoarelor date: gradul de severitate a nefropatiei diabetice (ND), frecvenţa cetoacidozei (CAD), durata diabetului zaharat (DD) şi în baza rezultatelor acestor parametri se calculează funcţia discriminantă (F) care serveşte pentru stabilirea pronosticului favorabil sau nefavorabil de apariţie a neuropatiei autonome cardiovasculare în diabetul zaharat tip I conform formulei: F = -4,972 +1,767×ND+1,530×CAD+0,078×DD unde ND - gradul nefropatiei diabetice: 0 - ND absent; 1 - ND stadiul I; 2 - ND stadiul II; 3 - ND stadiul III; 4 - ND stadiul IV-V; CAD - frecvenţa cetoacidozei diabetice: 1 - rar; 2 - o dată/an; 3 - mai mult de 2 ori/an şi DD - durata diabetului zaharat măsurat în ani. The method is performed as follows: analysis of anamnesis data and testing through the mathematical model, with the assessment of the following data: severity of diabetic nephropathy (ND), frequency of ketoacidosis (CAD), duration of diabetes mellitus (DD) and based on the results of these parameters, the discriminant function (F) is calculated which serves to establish the favorable or unfavorable prognosis of the occurrence of cardiovascular autonomic neuropathy in type I diabetes mellitus according to the formula: F = -4.972 +1.767×ND+1.530×CAD+0.078×DD where ND - degree of diabetic nephropathy: 0 - ND absent; 1 - ND stage I; 2 - ND stage II; 3 - ND stage III; 4 - ND stage IV-V; CAD - frequency of diabetic ketoacidosis: 1 - rare; 2 - once/year; 3 - more than 2 times/year and DD - duration of diabetes mellitus measured in years.
La etapa iniţială au fost selectaţi pacienţi cu diabet zaharat tip I, de la care s-au colectat datele anamnezei în ceea ce priveşte durata diabetului zaharat, frecvenţa cetoacidozei, severitatea nefropatiei diabetice, apoi în baza testelor funcţiei vegetative cardiace a fost apreciată prezenţa neuropatiei autonome cardiovasculare. At the initial stage, patients with type I diabetes were selected, from whom medical history data were collected regarding the duration of diabetes, the frequency of ketoacidosis, the severity of diabetic nephropathy, then based on cardiac vegetative function tests, the presence of cardiovascular autonomic neuropathy was assessed.
Verificarea funcţiei discriminante s-a efectuat pe un lot de 83 pacienţi cu diagnosticul - diabet zaharat tip I, apreciindu-se prezenţa neuropatiei autonome cardiovasculare. Rezultatul favorabil a fost considerat în cazul în care F < 0 şi nefavorabil dacă F > 0. The discriminant function was tested on a group of 83 patients diagnosed with type I diabetes mellitus, assessing the presence of cardiovascular autonomic neuropathy. The favorable result was considered if F < 0 and unfavorable if F > 0.
Rezultatul aşteptat Rezultatul real Favorabil, persoane (%) Nefavorabil, persoane (%) Favorabil, persoane (%) 28 (100%) 26 (92,86%) 2 (7,14%) Nefavorabil, persoane (%) 55 (100%) 8 (14,55%) 47 (85,45%) Total, persoane (%) 83 (100%) 34 (40,96%) 49 (59,04%)Expected result Actual result Favorable, people (%) Unfavorable, people (%) Favorable, people (%) 28 (100%) 26 (92.86%) 2 (7.14%) Unfavorable, people (%) 55 (100%) 8 (14.55%) 47 (85.45%) Total, people (%) 83 (100%) 34 (40.96%) 49 (59.04%)
Drept indicaţie pentru utilizarea acestei metode constituie depistarea pacienţilor cu risc sporit de apariţie a neuropatiei autonome cardiovasculare în scopul întocmirii unei precoce tactici de tratament. An indication for using this method is the detection of patients at increased risk of developing cardiovascular autonomic neuropathy in order to develop an early treatment strategy.
Contraindicaţii pentru utilizarea acestei metode nu sunt. There are no contraindications for using this method.
Exemplul 1 Example 1
Pacienta F., în vârstă de 34 ani, s-a internat în Secţia Endocrinologie a IMSP SCR în stare gravă cu diagnosticul - diabet zaharat tip I, decompensat. A fost aplicată metoda propusă conform invenţiei. S-au obţinut următoarele rezultate: ND = 3 (cu nefropatie diabetică confirmată de medicul nefrolog); CAD = 1 (cetoacidoze - rar în anamneză) şi DD = 11 ani. Patient F., 34 years old, was admitted to the Endocrinology Department of IMSP SCR in serious condition with the diagnosis of type I diabetes mellitus, decompensated. The proposed method according to the invention was applied. The following results were obtained: ND = 3 (with diabetic nephropathy confirmed by the nephrologist); CAD = 1 (ketoacidosis - rare in the anamnesis) and DD = 11 years.
Valoarea calculată a funcţiei discriminante F = 2,717, ceea ce permite pronosticarea riscului de apariţie a neuropatiei autonome cardiovasculare. Metoda aplicată a demonstrat coincidenţa pronosticării cu rezultatul real la 1 an de supraveghere. The calculated value of the discriminant function F = 2.717, which allows predicting the risk of cardiovascular autonomic neuropathy. The applied method demonstrated the coincidence of the prediction with the actual result at 1 year of surveillance.
Exemplul 2 Example 2
Pacientul V., 18 ani, la internare - stare de gravitate medie, diagnosticul diabet zaharat tip I, compensat. S-au înregistrat următoarele rezultate: ND = 0 (fără nefropatie diabetică); CAD = 1 şi DD = 8 ani. Valoarea calculată a funcţiei discriminante F = -2,818, fapt care permite pronosticarea riscului apariţiei neuropatiei autonome cardiovasculare, ceea ce demonstrează coincidenţa pronosticului cu rezultatul clinic favorabil. Patient V., 18 years old, at admission - moderate severity, diagnosis of type I diabetes mellitus, compensated. The following results were recorded: ND = 0 (no diabetic nephropathy); CAD = 1 and DD = 8 years. The calculated value of the discriminant function F = -2.818, which allows predicting the risk of cardiovascular autonomic neuropathy, which demonstrates the coincidence of the prognosis with a favorable clinical outcome.
Exemplul 3 Example 3
Pacientul O., 28 ani, s-a internat în Secţia Endocrinologie a IMSP SCR în stare de gravitate medie, fiind stabilit diagnosticul - diabet zaharat tip I, subcompensat, în urma investigaţiilor efectuate s-au obţinut următoarele rezultate: ND = 0; CAD = 3 (cetoacidoze diabetice mai mul de 2 ori/an); DD = 7. Valoarea calculată a funcţiei discriminante F = 0,164, ceea ce permite pronosticarea unei evoluţii nefavorabile a apariţiei neuropatiei autonome cardiovasculare. În realitate însă, şcolarizarea pacientului şi modificarea tratamentului au adus o ameliorare evidentă a stării pacientului. După 12 luni de supraveghere fiind atestată o ameliorare clinică evidentă. Fapt ce demonstrează necoincidenta pronosticului cu rezultatul clinic favorabil. Patient O., 28 years old, was admitted to the Endocrinology Department of IMSP SCR in a moderately severe condition, the diagnosis being established - type I diabetes mellitus, subcompensated, following the investigations performed, the following results were obtained: ND = 0; CAD = 3 (diabetic ketoacidosis more than 2 times/year); DD = 7. The calculated value of the discriminant function F = 0.164, which allows the prognosis of an unfavorable evolution of the occurrence of cardiovascular autonomic neuropathy. In reality, however, the patient's education and the modification of the treatment brought a clear improvement in the patient's condition. After 12 months of surveillance, a clear clinical improvement was attested. This fact demonstrates the non-coincidence of the prognosis with a favorable clinical outcome.
Având la bază datele obţinute la pacienţii cu diabet zaharat tip I, metoda de pronosticare a apariţiei neuropatiei autonome cardiovasculare permite depistarea precoce a bolnavilor cu risc crescut de dezvoltare a complicaţiei date, fapt ce impune o atenţie sporită pentru această categorie de pacienţi cu corijarea la timp a tacticii terapeutice, şcolarizarea lor şi aplicarea testelor de screening. Based on data obtained in patients with type I diabetes, the method of predicting the occurrence of cardiovascular autonomic neuropathy allows for the early detection of patients at high risk of developing this complication, which requires increased attention for this category of patients with timely correction of therapeutic tactics, their education and the application of screening tests.
Cercetările şi utilizarea metodei au fost efectuate pe un lot de 83 pacienţi în cadrul laboratorului şi catedrelor Universităţii. Metoda propusă este precisă şi uşor de aplicat atât în staţionar, cât şi în centrele medicilor de familie. The research and use of the method were conducted on a group of 83 patients within the University's laboratory and departments. The proposed method is precise and easy to apply both in inpatient and family doctor centers.
1. Spallone V., Ziegler D., Freeman R., et. al. on behalf of the Toronto Consensus Panel on Diabetic neuropaty, Cardiovascular autonomic neuropathy in diabetes: clinical impact, assessment, diagnosis, and management. Diabetes Metabolism Research and Reviews, 2011, 27, p. 639-653 1. Spallone V., Ziegler D., Freeman R., et al. al. on behalf of the Toronto Consensus Panel on Diabetic neuropathy, Cardiovascular autonomic neuropathy in diabetes: clinical impact, assessment, diagnosis, and management. Diabetes Metabolism Research and Reviews, 2011, 27, p. 639-653
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| UA7348U (en) * | 2004-12-03 | 2005-06-15 | Andrii Semenovych Yefimov | Method for assessing stage of diabetic cardiovascular autonomic neuropathy |
| MD833Y (en) * | 2014-05-15 | 2014-11-30 | Константин ЖУКОВСКИЙ | Method for early prediction of the evolution of acute myocardial infarction in patients with pancreatic diabetes |
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| UA7348U (en) * | 2004-12-03 | 2005-06-15 | Andrii Semenovych Yefimov | Method for assessing stage of diabetic cardiovascular autonomic neuropathy |
| MD833Y (en) * | 2014-05-15 | 2014-11-30 | Константин ЖУКОВСКИЙ | Method for early prediction of the evolution of acute myocardial infarction in patients with pancreatic diabetes |
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| Title |
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| Spallone V., Ziegler D., Freeman R., et. al. on behalf of the Toronto Consensus Panel on Diabetic neuropaty, Cardiovascular autonomic neuropathy in diabetes: clinical impact, assessment, diagnosis, and management. Diabetes Metabolism Research and Reviews, 2011, 27, p. 639-653 * |
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|---|---|---|---|
| FG9Y | Short term patent issued | ||
| KA4Y | Short-term patent lapsed due to non-payment of fees (with right of restoration) |