MD1411Z - Method for diagnosing exocrine pancreatic insufficiency in patients with type 1 diabetes mellitus - Google Patents
Method for diagnosing exocrine pancreatic insufficiency in patients with type 1 diabetes mellitus Download PDFInfo
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- 206010067584 Type 1 diabetes mellitus Diseases 0.000 title claims abstract description 17
- 238000000034 method Methods 0.000 title claims description 11
- 201000007089 exocrine pancreatic insufficiency Diseases 0.000 title abstract description 7
- 108010088751 Albumins Proteins 0.000 claims abstract description 11
- 102000009027 Albumins Human genes 0.000 claims abstract description 11
- 108010074051 C-Reactive Protein Proteins 0.000 claims abstract description 10
- 102100032752 C-reactive protein Human genes 0.000 claims abstract description 10
- 206010012601 diabetes mellitus Diseases 0.000 claims abstract description 9
- 108090001060 Lipase Proteins 0.000 claims abstract description 8
- 102000004882 Lipase Human genes 0.000 claims abstract description 8
- 239000004367 Lipase Substances 0.000 claims abstract description 8
- 235000019421 lipase Nutrition 0.000 claims abstract description 8
- 210000002966 serum Anatomy 0.000 claims abstract description 6
- 108010071390 Serum Albumin Proteins 0.000 claims abstract description 5
- 102000007562 Serum Albumin Human genes 0.000 claims abstract description 5
- 210000004369 blood Anatomy 0.000 claims abstract description 3
- 239000008280 blood Substances 0.000 claims abstract description 3
- 208000035467 Pancreatic insufficiency Diseases 0.000 claims description 20
- 239000003814 drug Substances 0.000 abstract description 3
- 238000003745 diagnosis Methods 0.000 description 8
- 230000006870 function Effects 0.000 description 8
- 102000016387 Pancreatic elastase Human genes 0.000 description 4
- 108010067372 Pancreatic elastase Proteins 0.000 description 4
- 238000011160 research Methods 0.000 description 4
- 238000001514 detection method Methods 0.000 description 3
- 230000002349 favourable effect Effects 0.000 description 3
- 210000003608 fece Anatomy 0.000 description 3
- 230000004064 dysfunction Effects 0.000 description 2
- 230000000977 initiatory effect Effects 0.000 description 2
- 238000011835 investigation Methods 0.000 description 2
- 230000001575 pathological effect Effects 0.000 description 2
- 238000004393 prognosis Methods 0.000 description 2
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 238000002405 diagnostic procedure Methods 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 238000002641 enzyme replacement therapy Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 230000004204 exocrine pancreatic function Effects 0.000 description 1
- 239000003550 marker Substances 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
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- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
- Investigating Or Analysing Biological Materials (AREA)
Abstract
Description
Invenţia se referă la medicină, în special la gastroenterologie şi endocrinologie. The invention relates to medicine, in particular to gastroenterology and endocrinology.
Insuficienţa pancreatică exocrină este o stare patologică frecvent întâlnită la pacienţii cu diabet zaharat tip 1, prevalenţa acesteia fiind, conform mai multor autori, de 40...73%. Mecanismele etiopatogenetice de apariţie a insuficienţei exocrine pancreatice la persoanele cu diabet zaharat tip 1 sunt complexe, la aceşti pacienţi existând mai mulţi factori predispozanţi pentru această condiţie patologică. Pe parcursul ultimilor ani, mai mulţi autori au pus în evidenţă asocierea insuficienţei exocrine pancreatice la pacienţii cu diabet zaharat tip 1 cu anumiţi parametri clinici şi paraclinici. Exocrine pancreatic insufficiency is a pathological condition frequently encountered in patients with type 1 diabetes mellitus, its prevalence being, according to several authors, 40...73%. The etiopathogenetic mechanisms of the occurrence of exocrine pancreatic insufficiency in people with type 1 diabetes mellitus are complex, in these patients there are several predisposing factors for this pathological condition. Over the past few years, several authors have highlighted the association of exocrine pancreatic insufficiency in patients with type 1 diabetes mellitus with certain clinical and paraclinical parameters.
Rezultatele cercetării realizate de Kangrga (2016) demonstrează asocierea insuficienţei exocrine pancreatice cu valoarea lipazei serice, proteinei C reactive, fără a demonstra o asociere a funcţiei exocrine cu durata diabetului zaharat [1]. The results of the research conducted by Kangrga (2016) demonstrate the association of pancreatic exocrine insufficiency with the value of serum lipase and C-reactive protein, without demonstrating an association of exocrine function with the duration of diabetes mellitus [1].
Dezavantajul metodei constă în aceea că nu este demonstrată asocierea funcţiei exocrine cu durata diabetului zaharat. The disadvantage of the method is that the association of exocrine function with the duration of diabetes mellitus has not been demonstrated.
Au fost realizate mai multe cercetări pentru a evalua asocierea insuficienţei exocrine pancreatice cu alţi factori, dar rezultatele nu au permis evidenţierea unor factori de risc şi efectuarea unui diagnostic al insuficienţei exocrine pancreatice la pacienţii cu diabet zaharat tip 1. Au existat contraverse ale rezultatelor cercetărilor din cauza anumitor limitări: inexactitatea criteriilor de includere în cercetare, neexcluderea unor factori de risc cunoscuţi pentru insuficienţa exocrină pancreatică. Several studies have been conducted to evaluate the association of pancreatic exocrine insufficiency with other factors, but the results did not allow for the identification of risk factors and the diagnosis of pancreatic exocrine insufficiency in patients with type 1 diabetes. There have been controversies in the research results due to certain limitations: inaccuracy of the inclusion criteria in the research, failure to exclude known risk factors for pancreatic exocrine insufficiency.
Problema pe care o rezolvă invenţia constă în elaborarea metodei de diagnostic al insuficienţei pancreatice exocrine la pacienţii cu diabet zaharat tip 1, utilizând factorii de risc conturaţi conform rezultatelor cercetării. The problem solved by the invention consists in developing a method for diagnosing exocrine pancreatic insufficiency in patients with type 1 diabetes, using the risk factors outlined according to the research results.
Matematic fiind formalizată, problema se reduce la deducerea unei reguli, criteriu de discriminare, în baza analizei datelor a două selecţii (pacienţi cu diabet zaharat tip 1, care au dezvoltat insuficienţă exocrină pancreatică şi pacienţi, care nu au insuficienţă exocrină pancreatică), care permite a atribui un nou element la una din cele două mulţimi cu o exactitate bună. Folosirea analizei discriminante în analiza datelor statistice despre pacienţii cercetaţi ne-a permis să deducem funcţia discriminantă propusă mai jos, care este inclusă în esenţa metodei de diagnosticare. Mathematically formalized, the problem is reduced to deducing a rule, a discrimination criterion, based on the analysis of data from two selections (patients with type 1 diabetes mellitus, who developed pancreatic exocrine insufficiency and patients, who do not have pancreatic exocrine insufficiency), which allows to attribute a new element to one of the two sets with good accuracy. The use of discriminant analysis in the analysis of statistical data about the patients studied allowed us to deduce the discriminant function proposed below, which is included in the essence of the diagnostic method.
Esenţa invenţiei constă în stabilirea duratei diabetului zaharat (DDZ) şi efectuarea examenului paraclinic, unde se determină valoarea albuminei plasmatice (ALB), lipazei serice (LPZ) şi proteinei C reactive (PCR) în sânge şi se calculează funcţia discriminantă (F) conform formulei: The essence of the invention consists in establishing the duration of diabetes mellitus (DDZ) and performing a paraclinical examination, where the value of plasma albumin (ALB), serum lipase (LPZ) and C-reactive protein (CRP) in the blood is determined and the discriminant function (F) is calculated according to the formula:
F = -6,422 + 0,146·ALB + 0,070·LPZ - 0,102·DDZ - 0,234·PCR, F = -6.422 + 0.146·ALB + 0.070·LPZ - 0.102·DDZ - 0.234·PCR,
unde: where:
ALB - valoarea albuminei plasmatice; ALB - plasma albumin value;
LPZ - valoarea lipazei serice; LPZ - serum lipase value;
DDZ - durata diabetului zaharat; DDD - duration of diabetes mellitus;
PCR - valoarea proteinei C reactive, PCR - C-reactive protein value,
şi dacă F<0 se diagnosticheză prezenţa insuficienţei exocrine pancreatice, iar dacă F>0 se diagnosticheză lipsa insuficienţei exocrine pancreatice la pacienţii cu diabet zaharat tip 1. and if F<0 the presence of pancreatic exocrine insufficiency is diagnosed, and if F>0 the absence of pancreatic exocrine insufficiency is diagnosed in patients with type 1 diabetes.
Rezultatul constă în diagnosticarea insuficienţei exocrine pancreatice la pacienţii cu diabet zaharat tip 1, cu utilizarea parametrilor biochimici simpli şi duratei diabetului zaharat. The result is the diagnosis of pancreatic exocrine insufficiency in patients with type 1 diabetes mellitus, using simple biochemical parameters and the duration of diabetes mellitus.
Metoda propusă permite depistarea categoriei de pacienţi, care au risc mare să dezvolte insuficienţă exocrină pancreatică şi selectarea pacienţilor, care ar necesita efectuarea testării specifice pentru diagnosticul insuficienţei exocrine pancreatice. Diagnosticul acestei disfuncţii ar permite iniţierea tratamentului de substituţie enzimatică la necesitate. The proposed method allows the detection of the category of patients who are at high risk of developing pancreatic exocrine insufficiency and the selection of patients who would require specific testing for the diagnosis of pancreatic exocrine insufficiency. The diagnosis of this dysfunction would allow the initiation of enzyme replacement treatment if necessary.
Verificarea funcţiei discriminante s-a efectuat pe un lot de 128 de pacienţi cu diagnosticul de diabet zaharat tip 1. Rezultatul favorabil a fost considerat în cazul în care F>0 şi nefavorabil dacă rezultatul este F<0. The discriminant function was verified on a group of 128 patients diagnosed with type 1 diabetes. The favorable result was considered if F>0 and unfavorable if the result was F<0.
Rezultatul real Rezultatul asteptat Favorabil Nefavorabil Total Favorabil, persoane (%) 33 (84,62%) 6 (8,16%) 39 (100%) Nefavorabil, persoane (%) 17 (20,24%) 67 (79,76%) 84 (100%) Total, persoane (%) 50 (40,65%) 73 (59,35%) 123 (100%)Actual result Expected result Favorable Unfavorable Total Favorable, people (%) 33 (84.62%) 6 (8.16%) 39 (100%) Unfavorable, people (%) 17 (20.24%) 67 (79.76%) 84 (100%) Total, people (%) 50 (40.65%) 73 (59.35%) 123 (100%)
Drept indicaţie pentru utilizarea acestei metode constituie depistarea pacienţilor cu insuficienţă exocrină pancreatice în scopul iniţierii terapiei de substituţie enzimatică. An indication for using this method is the detection of patients with pancreatic exocrine insufficiency for the purpose of initiating enzyme replacement therapy.
Contraindicaţii pentru utilizarea acestei metode nu sunt. There are no contraindications to using this method.
Exemple concrete de realizare. Concrete examples of achievement.
Exemplul 1 Example 1
Pacientul I., 29 ani, cu diagnosticul de diabet zaharat tip 1 stabilit de 5 ani. A fost investigat paraclinic. S-au obţinut următoarele rezultate: ALB=50 g/1; LPZ=38 U/1; PCR=1,1 mg/di, DDZ= 5 ani. Valoarea calculată a funcţiei discriminante este de F=2,77; adica F>0, ceea ce permite de a presupune lipsa insuficienţei exocrine pancreatice la acest pacient. Metoda aplicată a demonstrat coincidenţa pronosticării cu rezultatul real, pacientul având valoarea elastazei pancreatice în limitele valorilor de referinţă. Patient I., 29 years old, with a diagnosis of type 1 diabetes mellitus established for 5 years. He was investigated paraclinically. The following results were obtained: ALB=50 g/1; LPZ=38 U/1; PCR=1.1 mg/di, DDZ= 5 years. The calculated value of the discriminant function is F=2.77; i.e. F>0, which allows us to assume the absence of pancreatic exocrine insufficiency in this patient. The applied method demonstrated the coincidence of the prognosis with the real result, the patient having the value of pancreatic elastase within the limits of the reference values.
Exemplul 2 Example 2
Pacienta B., 23 ani, cu diagnosticul de diabet zaharat tip 1 stabilit de 13 ani. S-au obţinut următoarele rezultate: ALB=32 g/1; LPZ=34 U/1; PCR=2,3 mg/di, DDZ=13 ani. Valoarea calculată a funcţiei discriminante este de F=-1,234, adica F<0, ceea ce permite de a presupune prezenţa insuficienţei exocrine pancreatice la acest pacient. Metoda aplicată a demonstrat coincidenţa pronosticării cu rezultatul real. Patient B., 23 years old, with a diagnosis of type 1 diabetes mellitus established for 13 years. The following results were obtained: ALB=32 g/1; LPZ=34 U/1; PCR=2.3 mg/di, DDZ=13 years. The calculated value of the discriminant function is F=-1.234, i.e. F<0, which allows us to assume the presence of pancreatic exocrine insufficiency in this patient. The applied method demonstrated the coincidence of the prognosis with the actual result.
Exemplul 3 Example 3
Pacienta T., 21 ani, cu diagnosticul de diabet zaharat tip 1 stabilit de 16 ani. În urma investigaţiilor efectuate s-au obţinut următoarele rezultate: ALB=40 g/1; LPZ=23 U/1; PCR=1,55 mg/di, DDZ=16 ani. Valoarea calculată a funcţiei discriminante este de F=-0,96; adica F<0, ceea ce permite de a presupune prezenţa insuficienţei exocrine pancreatice. În realitate însă, valoarea elastazei pancreatice în materiile fecale a fost normală, fiind exclusă insuficenţa exocrină pancreatică. Patient T., 21 years old, with a diagnosis of type 1 diabetes mellitus established for 16 years. Following the investigations performed, the following results were obtained: ALB=40 g/1; LPZ=23 U/1; PCR=1.55 mg/di, DDZ=16 years. The calculated value of the discriminant function is F=-0.96; i.e. F<0, which allows us to assume the presence of pancreatic exocrine insufficiency. In reality, however, the value of pancreatic elastase in feces was normal, excluding pancreatic exocrine insufficiency.
Având la bază datele obţinute în rezultatul evaluării elastazei pancreatice în materiile fecale la pacienţii examinaţi, metoda de diagnosticare a insuficienţei exocrine pancreatice propusă permite depistarea categoriei de persoane cu diabet zahrat tip 1, la care ar trebui aplicate metode specifice de investigaţie, care ar permite stabilirea diagnosticului acestei disfuncţii pentru o conduită terapeutică optimă. Based on the data obtained as a result of the evaluation of pancreatic elastase in feces in the examined patients, the proposed method of diagnosing pancreatic exocrine insufficiency allows the detection of the category of people with type 1 diabetes mellitus, to whom specific investigation methods should be applied, which would allow the diagnosis of this dysfunction to be established for optimal therapeutic conduct.
1. Kangrga R.N. et al. Pancreatic Elastase Levels in Feces As A Marker of Exocrine Pancreatic Function in Patients With Diabetes Mellitus. Laboratory Medicine, 2016, vol. 47, supl. 2, p. 140-148 1. Kangrga R.N. et al. Pancreatic Elastase Levels in Feces as a Marker of Exocrine Pancreatic Function in Patients With Diabetes Mellitus. Laboratory Medicine, 2016, vol. 47, suppl. 2, p. 140-148
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