MD1419Z - Method for predicting pancreatic exocrine insufficiency in patients with type 1 diabetes - Google Patents

Method for predicting pancreatic exocrine insufficiency in patients with type 1 diabetes Download PDF

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MD1419Z
MD1419Z MDS20190076A MDS20190076A MD1419Z MD 1419 Z MD1419 Z MD 1419Z MD S20190076 A MDS20190076 A MD S20190076A MD S20190076 A MDS20190076 A MD S20190076A MD 1419 Z MD1419 Z MD 1419Z
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pancreatic exocrine
score
insufficiency
patients
diabetes mellitus
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Наталия ПОРЧЕРЯНУ
Константин ЖУКОВСКИЙ
Еуджениу ТКАЧУК
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Государственный Медицинский И Фармацевтический Университет "Nicolae Testemitanu" Республики Молдова
Институт Кардиологии Республики Молдова
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Abstract

The invention relates to medicine, in particular to gastroenterology and endocrinology.Summary of the invention consists in that are recorded the anamnestic data, namely the duration of diabetes mellitus (DDM) and the frequency of glycemic monitoring (FGM), is conducted the clinical examination with the scoring of peripheral diabetic neuropathy according to the Toronto (PDN) score and cardiovascular autonomic neuropathy established using the Ewing's tests battery (CAN) and is calculated the discriminant function (F) by the formula:F = 3.532 - 0.157·PDN - 0.876·FGM - 0.104·CAN - 0.079·DDM,and if F<0, the presence of pancreatic exocrine insufficiency is predicted, and if F>0, the absence of pancreatic exocrine insufficiency is predicted.

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 reprezintă 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 patologie. Pe parcursul ultimilor ani, a fost pusă 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 pathology. Over the past few years, the association of exocrine pancreatic insufficiency in patients with type 1 diabetes mellitus with certain clinical and paraclinical parameters has been highlighted.

A fost demonstrată asocierea insuficienţei exocrine pancreatice la pacienţii cu diabet zaharat tip 1 cu neuropatia diabetică vegetativă. Există mai multe studii care demonstrează asocierea insuficienţei exocrine pancreatice cu controlul glicemic precar şi severitatea diabetului zaharat. Una dintre cercetări care a inclus pacienţi cu diabet zaharat tip 1, efectuată de Larger (2012) nu a demonstrat asocierea dintre insuficienţa exocrină pancreatică şi HbA1c [1]. The association of pancreatic exocrine insufficiency in patients with type 1 diabetes mellitus with diabetic autonomic neuropathy has been demonstrated. There are several studies that demonstrate the association of pancreatic exocrine insufficiency with poor glycemic control and diabetes severity. One of the studies that included patients with type 1 diabetes mellitus, conducted by Larger (2012), did not demonstrate the association between pancreatic exocrine insufficiency and HbA1c [1].

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 pronostic al apariţiei insuficienţei exocrine pancreatice la pacienţii cu diabet zaharat tip 1. Au existat contraverse ale rezultatelor cercetărilor din cauza anumitor limitări ale cercetărilor: 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 prediction of the occurrence of pancreatic exocrine insufficiency in patients with type 1 diabetes. There have been controversies in the results of the studies due to certain limitations of the studies: inaccuracy of the inclusion criteria in the study, failure to exclude known risk factors for pancreatic exocrine insufficiency.

Problema pe care o rezolvă invenţia este crearea metodei de pronosticare a apariţiei insuficienţei pancreatice exocrine la pacienţii cu diabet zaharat tip 1, utilizând factorii de risc conturaţi conform rezultatelor cercetării. The problem solved by the invention is the creation of a method for predicting the occurrence of exocrine pancreatic insufficiency in patients with type 1 diabetes, using risk factors outlined according to research results.

Matematic problema find formalizată, 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 destul de bună. Folosirea analizei discriminante în analiza datelor statistice despre pacienţii cercetaţi ne-a permis să deducem funcţia discriminantă propusă mai jos şi 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 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 quite 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 and which is at the heart of the prognostic method.

Esenţa invenţiei constă în aceea că se înregistrează datele anamnestice şi anume durata diabetului zaharat (DDZ) şi intensitatea monitorizării glicemice (IMG), se efectuează examenul clinic cu stabilirea punctajului neuropatiei diabetice periferice conform scorului Toronto (NDP) şi neuropatiei autonome cardiovasculare stabilite cu ajutorul bateriei de teste Ewing (NAC) şi se calculează funcţia discriminantă (F) conform formulei: The essence of the invention consists in recording the anamnestic data, namely the duration of diabetes mellitus (DDZ) and the intensity of glycemic monitoring (IMG), performing the clinical examination with the establishment of the score of diabetic peripheral neuropathy according to the Toronto score (NDP) and cardiovascular autonomic neuropathy established using the Ewing test battery (NAC), and calculating the discriminant function (F) according to the formula:

F = 3,532 - 0,157·NDP - 0,876·IMG - 0,104·NAC - 0,079·DDZ, F = 3.532 - 0.157·NDP - 0.876·IMG - 0.104·NAC - 0.079·DDZ,

unde: where:

NDP - punctajul neuropatiei diabetice periferice conform scorului Toronto; NDP - diabetic peripheral neuropathy score according to the Toronto score;

IMG - intensitatea monitorizării glicemice (0 - mai mult de 2 ori/zi, 1 - 1...2 ori/zi; 2 - 1 dată/zi); IMG - intensity of glycemic monitoring (0 - more than 2 times/day, 1 - 1...2 times/day; 2 - 1 time/day);

NAC - neuropatia autonomă cardiovasculară stabilită cu ajutorul bateriei de teste Ewing (1 - lipsă; 2 - formă uşoară; 3 - formă moderată; 4 - formă severă); NAC - cardiovascular autonomic neuropathy established using the Ewing test battery (1 - absent; 2 - mild form; 3 - moderate form; 4 - severe form);

DDZ - durata diabetului zaharat (ani), DDD - duration of diabetes mellitus (years),

şi dacă F<0, se pronostichează prezenţa insuficienţei exocrine pancreatice, iar dacă F>0, se pronostichează lipsa insuficienţei exocrine pancreatice. and if F<0, the presence of pancreatic exocrine insufficiency is predicted, and if F>0, the absence of pancreatic exocrine insufficiency is predicted.

Rezultatul constă în pronosticarea insuficienţei exocrine pancreatice la pacienţii cu diabet zaharat tip 1, utilizând parametrii clinici accesibili, care rezultă din evaluarea obligatorie a pacienţilor cu diabet zaharat tip 1. Metoda poate fi utilizată de către medicii endocrinologi, care evaluează complicaţiile microvasculare ale pacienţilor cu diabet zaharat. The result consists in predicting pancreatic exocrine insufficiency in patients with type 1 diabetes mellitus, using accessible clinical parameters, which result from the mandatory evaluation of patients with type 1 diabetes mellitus. The method can be used by endocrinologists, who evaluate microvascular complications of patients with 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 confirmarea diagnosticului de insuficientă exocrină pancreatică (evaluarea elastazei pancreatice în materiile fecale). Depistarea 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 to confirm the diagnosis of pancreatic exocrine insufficiency (evaluation of pancreatic elastase in feces). The detection of this dysfunction would allow the initiation of enzyme replacement treatment if necessary.

Metoda se realizează în modul următor. The method is carried out in the following way.

Se înregistrează datele anamnestice şi anume durata diabetului zaharat (DDZ) şi intensitatea monitorizării glicemice (IMG), se efectuează examenul clinic cu stabilirea punctajului neuropatiei diabetice periferice conform scorului Toronto (NDP) şi neuropatiei autonome cardiovasculare stabilite cu ajutorul bateriei de teste Ewing (NAC) şi se calculează funcţia discriminantă (F) conform formulei: The anamnestic data, namely the duration of diabetes mellitus (DDZ) and the intensity of glycemic monitoring (IMG), are recorded, the clinical examination is performed with the establishment of the score of diabetic peripheral neuropathy according to the Toronto score (NDP) and cardiovascular autonomic neuropathy established using the Ewing test battery (NAC) and the discriminant function (F) is calculated according to the formula:

F = 3,532 - 0,157·NDP - 0,876·IMG - 0,104·NAC - 0,079·DDZ, F = 3.532 - 0.157·NDP - 0.876·IMG - 0.104·NAC - 0.079·DDZ,

unde: where:

NDP - punctajul neuropatiei diabetice periferice conform scorului Toronto; NDP - diabetic peripheral neuropathy score according to the Toronto score;

IMG - intensitatea monitorizării glicemice (0 - mai mult de 2 ori/zi, 1 - 1...2 ori/zi; 2 - 1 dată/zi); IMG - intensity of glycemic monitoring (0 - more than 2 times/day, 1 - 1...2 times/day; 2 - 1 time/day);

NAC - neuropatia autonomă cardiovasculară stabilită cu ajutorul bateriei de teste Ewing (1 - lipsă; 2 - formă uşoară; 3 - formă moderată; 4 - formă severă); NAC - cardiovascular autonomic neuropathy established using the Ewing test battery (1 - absent; 2 - mild form; 3 - moderate form; 4 - severe form);

DDZ - durata diabetului zaharat (ani), DDD - duration of diabetes mellitus (years),

şi dacă F<0, se pronostichează prezenţa insuficienţei exocrine pancreatice, iar dacă F>0, se pronostichează lipsa insuficienţei exocrine pancreatice. and if F<0, the presence of pancreatic exocrine insufficiency is predicted, and if F>0, the absence of pancreatic exocrine insufficiency is predicted.

Verificarea funcţiei discriminante s-a efectuat pe un lot de 138 de pacienţi cu diagnosticul de diabet zaharat tip 1. Rezultatul pozitiv, care vorbeşte despre prezenţa insuficienţei exocrine pancreatice a fost considerat în cazul în care F<0 şi rezultat negativ a fost considerat pentru F>0. The discriminant function test was performed on a group of 138 patients diagnosed with type 1 diabetes. The positive result, which speaks of the presence of pancreatic exocrine insufficiency, was considered if F<0 and a negative result was considered for F>0.

Rezultat aşteptat Rezultat real Favorabil Nefavorabil Total Favorabil, persoane (%) 36 (83,72%) 7 (16,28%) 43 (100%) Nefavorabil, persoane (%) 22 (23,16%) 73 (76,84%) 95 (100%) Total, persoane (%) 58 (42,03%) 80 (57,97%) 138 (100%)Expected result Actual result Favorable Unfavorable Total Favorable, people (%) 36 (83.72%) 7 (16.28%) 43 (100%) Unfavorable, people (%) 22 (23.16%) 73 (76.84%) 95 (100%) Total, people (%) 58 (42.03%) 80 (57.97%) 138 (100%)

Drept indicaţie pentru utilizarea acestei metode constituie depistarea pacienţilor cu risc sporit de dezvoltare a insuficienţei exocrine pancreatice în scopul stabilirii precoce a diagnosticului corect şi iniţierea terapiei de substituţie enzimatică. The indication for using this method is the detection of patients at increased risk of developing pancreatic exocrine insufficiency in order to establish the correct diagnosis early and initiate enzyme replacement therapy.

Contraindicaţii pentru utilizarea acestei metode nu sunt. There are no contraindications for using this method.

Exemple concrete de realizare. Concrete examples of achievement.

Exemplul 1 Example 1

Pacientul B., 36 ani, cu diagnosticul de diabet zaharat tip 1, stabilit de 10 ani. Au fost evaluate complicaţiile microvasculare diabetice. Neuropatia diabetică periferică a fost apreciată cu 17 puncte, conform scorului Toronto. Pacientul efectuează autocontrol glicemic de 1...2 ori/zi. Conform rezultatelor stabilite cu ajutorul bateriei de teste Ewing, la pacient se atestă un grad avansat al neuropatiei autonome cardiovasculare. S-au obţinut următoarele rezultate: NDP=17; IMG=2; NAC=4; DDZ=10. Valoarea calculată a funcţiei discriminante este de F=-2,095; deci F<0, ceea ce permite pronosticarea existenţei insuficienţei exocrine pancreatice la acest pacient. Metoda aplicată a demonstrat coincidenţa pronosticării cu rezultatul real, pacientul având valoarea elastazei pancreatice corespunzatoare unui grad sever de insuficienţă pancreatică exocrină. Patient B., 36 years old, with a diagnosis of type 1 diabetes mellitus, established for 10 years. Diabetic microvascular complications were evaluated. Peripheral diabetic neuropathy was assessed with 17 points, according to the Toronto score. The patient performs glycemic self-control 1...2 times/day. According to the results established using the Ewing test battery, the patient has an advanced degree of cardiovascular autonomic neuropathy. The following results were obtained: NDP=17; IMG=2; NAC=4; DDZ=10. The calculated value of the discriminant function is F=-2.095; therefore F<0, which allows the prediction of the existence of pancreatic exocrine insufficiency in this patient. The applied method demonstrated the coincidence of the prediction with the real result, the patient having the pancreatic elastase value corresponding to a severe degree of exocrine pancreatic insufficiency.

Exemplul 2 Example 2

Pacienta B., 22 ani, cu diagnosticul de diabet zaharat tip 1, stabilit de 8 ani. Au fost evaluate complicaţiile microvasculare diabetice. Neuropatia diabetică periferică a fost apreciată cu 0 puncte, conform scorului Toronto. Pacienta efectuează autocontrol glicemic de 1...2 ori/zi. Conform rezultatelor stabilite cu ajutorul bateriei de teste Ewing, pacienta nu are semne de neuropatie autonomă cardiovasculară. S-au obţinut urmatoarele rezultate: NDP=0; IMG=1; NAC=1; DDZ=8. Valoarea calculată a funcţiei discriminante este de F=1,920; deci F>0, ceea ce permite să pronosticăm lipsa insuficienţei exocrine pancreatice la această pacientă. Metoda aplicată a demonstrat coincidenţa pronosticării cu rezultatul real, pacienta având valoarea elastazei pancreatice în limitele corespunzatoare unei funcţii exocrine pancreatice intacte. Patient B., 22 years old, with a diagnosis of type 1 diabetes mellitus, established for 8 years. Diabetic microvascular complications were evaluated. Peripheral diabetic neuropathy was assessed with 0 points, according to the Toronto score. The patient performs glycemic self-control 1...2 times/day. According to the results established using the Ewing test battery, the patient has no signs of cardiovascular autonomic neuropathy. The following results were obtained: NDP=0; IMG=1; NAC=1; DDZ=8. The calculated value of the discriminant function is F=1.920; therefore F>0, which allows us to predict the absence of pancreatic exocrine insufficiency in this patient. The applied method demonstrated the coincidence of the prediction with the real result, the patient having the value of pancreatic elastase within the limits corresponding to an intact pancreatic exocrine function.

Exemplul 3 Example 3

Pacientul T., 28 ani, cu diagnosticul de diabet zaharat tip 1, stabilit de 6 de ani. Au fost evaluate complicaţiile microvasculare diabetice. Neuropatia diabetică periferică a fost apreciată cu 14 puncte, conform scorului Toronto. Pacientul efectuează autocontrol glicemic de 1...2 ori/zi. Conform rezultatelor stabilite cu ajutorul bateriei de teste Ewing, pacientul are un grad moderat de neuropatie autonomă cardiovasculară. S-au obţinut următoarele rezultate: NDP=14; IMG=2; NAC=3; DDZ=6. Valoarea calculată a funcţiei discriminante este de F =-1,204; adică F<0, ceea ce ar permite pronosticarea insuficienţei exocrine pancreatice. In realitate însă, valoarea elastazei pancreatice în materiile fecale a fost în limitele normei, fără a exista semne de insuficienţă exocrină pancreatică. Patient T., 28 years old, with a diagnosis of type 1 diabetes mellitus, established for 6 years. Diabetic microvascular complications were evaluated. Peripheral diabetic neuropathy was assessed with 14 points, according to the Toronto score. The patient performs glycemic self-control 1...2 times/day. According to the results established using the Ewing test battery, the patient has a moderate degree of cardiovascular autonomic neuropathy. The following results were obtained: NDP=14; IMG=2; NAC=3; DDZ=6. The calculated value of the discriminant function is F =-1.204; i.e. F<0, which would allow the prognosis of pancreatic exocrine insufficiency. In reality, however, the value of pancreatic elastase in feces was within normal limits, without any signs of pancreatic exocrine insufficiency.

Având la bază datele obţinute în rezultatul evaluării elastazei pancreatice în materii fecale la pacienţii examinaţi, metoda de pronosticare a insuficienţei exocrine pancreatice propusă permite depistarea categoriei de persoane cu diabet zaharat tip 1, la care ar trebui aplicate metode de investigaţie specifice, care ar permite confirmarea diagnosticului acestei patologii şi conduita 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 predicting 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 confirmation of the diagnosis of this pathology and optimal therapeutic conduct.

1. Larger E. et al. Pancreatic exocrine function in patients with diabetes. Diabetic Medicine, 2012, vol. 29, supl. 8, p. 1047-1054 1. Larger E. et al. Pancreatic exocrine function in patients with diabetes. Diabetic Medicine, 2012, vol. 29, suppl. 8, p. 1047-1054

Claims (1)

Metodă de pronosticare a insuficienţei pancreatice exocrine la pacienţii cu diabet zaharat tip 1, care constă în aceea că se înregistrează datele anamnestice şi anume durata diabetului zaharat (DDZ) şi intensitatea monitorizării glicemice (IMG), se efectuează examenul clinic cu stabilirea punctajului neuropatiei diabetice periferice conform scorului Toronto (NDP) şi neuropatiei autonome cardiovasculare stabilite cu ajutorul bateriei de teste Ewing (NAC) şi se calculează funcţia discriminantă (F) conform formulei:Method for predicting exocrine pancreatic insufficiency in patients with type 1 diabetes mellitus, which consists of recording anamnestic data, namely the duration of diabetes mellitus (DDZ) and the intensity of glycemic monitoring (IMG), performing a clinical examination with the establishment of the score of diabetic peripheral neuropathy according to the Toronto score (NDP) and cardiovascular autonomic neuropathy established using the Ewing test battery (NAC), and calculating the discriminant function (F) according to the formula: F = 3,532 - 0,157·NDP - 0,876·IMG - 0,104·NAC - 0,079·DDZ,F = 3.532 - 0.157·NDP - 0.876·IMG - 0.104·NAC - 0.079·DDZ, unde:where: NDP - punctajul neuropatiei diabetice periferice conform scorului Toronto;NDP - diabetic peripheral neuropathy score according to the Toronto score; IMG - intensitatea monitorizării glicemice (0 - mai mult de 2 ori/zi, 1 - 1...2 ori/zi; 2 - 1 dată/zi);IMG - intensity of glycemic monitoring (0 - more than 2 times/day, 1 - 1...2 times/day; 2 - 1 time/day); NAC - neuropatia autonomă cardiovasculară stabilită cu ajutorul bateriei de teste Ewing (1 - lipsă; 2 - formă uşoară; 3 - formă moderată; 4 - formă severă);NAC - cardiovascular autonomic neuropathy established using the Ewing test battery (1 - absent; 2 - mild form; 3 - moderate form; 4 - severe form); DDZ - durata diabetului zaharat (ani),DDD - duration of diabetes mellitus (years), şi dacă F<0, se pronostichează prezenţa insuficienţei exocrine pancreatice, iar dacă F>0, se pronostichează lipsa insuficienţei exocrine pancreatice.and if F<0, the presence of pancreatic exocrine insufficiency is predicted, and if F>0, the absence of pancreatic exocrine insufficiency is predicted.
MDS20190076A 2019-07-15 2019-07-15 Method for predicting pancreatic exocrine insufficiency in patients with type 1 diabetes MD1419Z (en)

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