Clinical application of rivaroxaban and apixaban does not require therapeutic monitoring. Commercial anti-activated factor X (anti-FXa) inhibition methods for all anti-FXa drugs are based on the same ...principle, so there are attempts to evaluate potential clinical application of heparin-calibrated anti-FXa assay as an alternative method for direct FXa inhibitors. We aimed to evaluate relationship between anti-FXa methods calibrated with low molecular weight heparin (LMWH) and with drug specific calibrators, and to determine whether commercial LMWH anti-FXa assay can be used to exclude the presence of clinically relevant concentrations of rivaroxaban and apixaban.
Low molecular weight heparin calibrated reagent (Siemens Healthineers, Marburg, Germany) was used for anti-FXa activity measurement. Innovance heparin (Siemens Healthineers, Marburg, Germany) calibrated with rivaroxaban and apixaban calibrators (Hyphen BioMed, Neuville-sur-Oise, France) was used for quantitative determination of FXa inhibitors.
Analysis showed good agreement between LMWH calibrated and rivaroxaban calibrated activity (κ = 0.76) and very good agreement with apixaban calibrated anti-Xa activity (κ = 0.82), respectively. Low molecular weight heparin anti-FXa activity cut-off values of 0.05 IU/mL and 0.1 IU/mL are suitable for excluding the presence of clinically relevant concentrations (< 30 ng/mL) of rivaroxaban and apixaban, respectively. Concentrations above 300 ng/mL exceeded upper measurement range for LMWH anti-FXa assay and cannot be determined by this method.
Low molecular weight heparin anti-FXa assay can be used in emergency clinical conditions for ruling out the presence of clinically relevant concentrations of rivaroxaban and apixaban. However, use of LMWH anti-FXa assay is not appropriate for their quantitative determination as an interchangeable method.
Optic nerve sheath diameter (ONSD) enlargement is detectable in traumatic brain injury patients with raised intracranial pressure (ICP). The aim was to assess its value in neurological patients ...suspected to have increased ICP. Patient clinical imaging data and hospitalization outcome were analyzed. Patients were divided into groups according to brain pathology and level of consciousness with Glasgow Coma Score (GCS). Poor hospitalization outcome was assessed by modified Rankin scale (mRS) >3. Data obtained by ocular sonography performed in acute setting were compared with data of 100 control subjects. Data were expressed as mean + or - SD. Intergroup comparison was performed by Student's t-test. Data of 34 patients (63+16 years) were suitable for analysis, including 8 primary intracerebral hemorrhage (PICH), 8 subarachnoid hemorrhage (SAH), 12 PICH or SAH and intraventricular hemorrhage (IVH), 4 tumors and 2 ischemic strokes. The mean ONSD was 5.86+0.69 mm in patients versus 4.38+0.41 mm in controls (p<0.01). ONSD was 6.28+0.61 mm in patients with GCS <8 and 5.77+0.55 mm in other patients (p<0.05). ONSD was 5.72+0.59 mm in PICH versus 6.20+0.65 mm in PICH/SAH with IVH (p=0.1). ONSD was 5.73+0.38 mm in SAH in comparison to PICH/SAH with IVH (p=0.05). There was no statistically significant diference in optic nerve diameter between patients and controls (2.48+0.28 mm vs. 2.39+0.33 mm; p>0.05). Pronounced enlargement of ONSD was observed in patients with ICH or SAH with IVH, and in patients with GCS <8. Enlarged ONSD was associated with poor neurological outcome (mRS >3). Key words: Optic nerve; Brain injuries, traumatic; Intracranial pressure; Ultrasonography
Transorbital sonography is a reliable method for non-invasive assessment of optic nerve diameter (OND) and optic nerve sheath diameter (ONSD) in patients with increased intracranial pressure. A wide ...range of regular ONSD values has been reported in the literature. The aim of this study was to determine normal values for OND and ONSD, to determine differences between OND and ONSD considering sex, age, and body mass index (BMI), and to evaluate inter - and intra - examiner variability. The study included 100 healthy subjects, aged 22 - 87 years, who underwent transbulbar sonography by the two examiners, each examiner measuring OND and ONSD twice on both eyes at a depth of 3 mm behind the optic nerve papilla. Measurement and analysis of OND and ONSD was possible in all subjects. Mean OND was 2.39 +/- 0.28 mm and mean ONSD was 4.48 +/- 0.76 mm. In males, mean OND was 2.47 +/- 0.28 mm and in females 2.35 +/- 0.27 mm (p = 0.042). There was no statistically significant difference between mean ONSD values between sexes (p > 0.001). Correlation between age and mean OND and ONSD wasn`t observed. Positive correlation between mean OND and BMI (p = 0.001) was observed. Positive correlation within and between investigator measurements (p < 0.01) was shown. Men have a wider OND compared to women, but no difference in ONSD was observed. Age doesn`t effect on the width of OND and ONSD. BMI correlates positively with OND, but not with ONSD. Positive correlation within and between investigator measurements was shown.
The first hospital-based registry of patients with multiple sclerosis (MS) was established at the University Department of Neurology, Sestre milosrdnice University Hospital Centre, Zagreb, Croatia, ...in 2014. The aim of the registry was to continuously provide data on the number of hospital-managed MS patients, patterns of disease progression, predictors of disability progression, changes in lifespan and long-term outcomes. Relevant medical data included age and gender of MS patients, family history of MS, data on previous immunization, disease course, Expanded Disability Status Scale (EDSS) score, cerebral magnetic resonance imaging (MRI) lesion load quantification, and cerebrospinal fluid analysis. Lifestyle habits in MS patients including smoking and alcohol consumption were also analyzed. All data were obtained from primary medical records between January 1, 2014 and January 1, 2015, and entered into the database. Data were evaluated retrospectively according to age and gender differences. Results showed that the majority of patients enrolled in the registry had the remitting relapsing course of disease, with low EDSS score indicating no disability or minimal disability. Cerebrospinal fluid analysis showed that oligoclonal bands were present in the majority of MS patients, with affected blood-brain-barrier permeability. According to the remitting relapsing course of the disease, cerebral MRI quantitative analysis demonstrated a significant lesion load in the majority of patients. When stratified by lifestyle habits, smokers and alcohol consumers were more prevalent among male patients. Our hospital-based registry might be considered as a prototype for the national MS registry and should be improved for reliable statistical analysis.
Povećanje promjera ovojnice optičkog živca (POOŽ) vidljivo je u bolesnika s traumatskom ozljedom mozga s povećanim intrakranijskim tlakom. Cilj je bio procijeniti njegovu vrijednost u neuroloških ...bolesnika sa sumnjom na porast intrakranijskog tlaka. Analizirani su klinički podaci, nalazi slikovnog prikaza i ishod hospitalizacije. Bolesnici su podijeljeni u skupine prema moždanoj patologiji i razini svijesti prema rezultatu na Glasgow Coma Score (GCS). Nepovoljan ishod procijenjen je modificiranom Rankinovom skalom (mRS) >3. Podaci okularne sonografije u akutnim uvjetima uspoređeni su s podacima 100 zdravih kontrolnih osoba. Vrijednosti su prikazane kao srednje vrijednosti i standardne devijacije. Usporedba između skupina provedena je Studentovim t-testom. Za analizu su bili prikladni podaci 34 bolesnika (63+16 godina): 8 primarnih intracerebralnih krvarenja (PICK), 8 subarahnoidnih krvarenja (SAK), 12 PICK ili SAK s intraventrikulskim krvarenjem (IVK), 4 tumora i 2 ishemijska moždana udara. U bolesnika je prosječni POOŽ bio 5,86+0,69 mm u usporedbi s 4,38+0,41 mm u kontrolnih osoba (p<0,01). U bolesnika s GSK <8 POOŽ je bio 6,28+0,61 mm, kod ostalih bolesnika 5,77+0,55 mm (p<0,05). POOŽ u PICK je bio 5,72+0,59 mm, a kod PICK/SAK s IVK 6,20+0,65 mm (p=0,1). POOŽ u SAK je bio 5,73+0,38 mm u usporedbi s PICK/SAK s IVK (p=0,05). Nije bilo statistički značajne razlike u POŽ između bolesnika i kontrolnih osoba (2,48+0.28 mm odnosno 2,39+0,33 mm; p>0,05). Izrazito je povećanje POOŽ zabilježeno u bolesnika s ICK ili SAK s IVK te u bolesnika s GSK <8.Povećani POOŽ bio je povezan s lošim neurološkim ishodom (mRS >3).
Prvi bolnički registar bolesnika s multiplom sklerozom (MS) u Hrvatskoj uspostavljen je 2014. godine u Klinici za neurologiju, Klinički bolnički centar “Sestre milosrdnice”, Zagreb. Cilj registra je ...kontinuirano prikupljanje podataka o broju hospitalno obrađenih bolesnika s MS, oblicima bolesti, prediktorima napredovanja onesposobljenosti, životnim navikama i dugoročnim ishodima za bolesnike. Relevantni medicinski podaci u registru MS uključivali su procjenu dobi i spola bolesnika, obiteljsku anamnezu na MS, podatke o prethodnim imunizacijama, tijeku bolesti, procjenu funkcionalne onesposobljenosti, kvantitativni prikaz lezija mozga magnetskom rezonancijom (MRI) i analizu cerebrospinalnog likvora. Nadalje, analizirane su životne navike bolesnika uključujući pušenje i konzumaciju alkohola. Svi podaci iz bolničke medicinske dokumentacije koji su prikupljeni od 1. siječnja 2014. godine do 1. siječnja 2015. godine upisani su u bazu podataka. Retrospektivno smo analizirali podatke prema dobi i spolu. Relevantni rezultati su pokazali da većina registriranih bolesnika ima relapsno remitirajući oblik bolesti s niskim stupnjem funkcionalne onesposobljenosti. Analiza cerebrospinalnog likvora u većine bolesnika pokazala je pozitivne oligoklonske vrpce i poremećenu propusnost krvno-moždane barijere. Kvantitativna MRI analiza mozga pokazala je značajno opterećenje brojem cerebralnih lezija u većine bolesnika, što odgovara relapsno remitirajućem obliku bolesti. Podjela prema životnim navikama pokazala je da je bilo više pušača i konzumenata alkohola u skupini muških bolesnika. Naš bolnički registar može poslužiti kao prototip za uspostavljanje nacionalnog registra MS, ali ga treba pobolj šati kako bi se osigurali svi potrebni podaci za pouzdanu statističku analizu podataka.
Multipla skleroza (MS) je bolest središnjeg živčanog sustava koja se prezentira brojnim simptomima iz različitih funkcijskih cjelina toga sustava. Kako se posljednjih godina povećao broj dostupnih ...lijekova, ukazuje se potreba trajne provjere saznanja o dijagnostici i liječenju ove bolesti putem medicine temeljene na dokazima. Time se nameće i potreba kontinuiranog obnavljanja nacionalnih i međunarodnih smjernica, u našem slučaju, na razini regionalnih smjernica Europskog odbora za liječenje i istraživanje multiple skleroze (engl. ECTRIMS, European Committee of Treatment and Research in Multiple Sclerosis) i Europske neurološke akademije (engl. EAN, European Academy of Neurology) s ciljem omogućavanja najbolje medicinske terapije za svakog bolesnika, koja je temeljena na individualiziranom pristupu. Temelji novih smjernica su nedavno ažurirane EAN-ove preporuke za razvoj smjernica, koje su rezultat iscrpnog istraživanja literature do prosinca 2016. godine. S obzirom na rizik od sistemske pogreške, kvaliteta dokaza za svaki ishod bila je stupnjevana u četiri kategorije kako slijedi: vrlo visoka, visoka, niska i vrlo niska. S obzirom na kvalitetu dokaza te omjera rizika i dobrobiti preporukama je pridružena snažna i slaba jačina. Pozornost istraživanja bila je usmjerena na nekoliko najvažnijih pitanja, koja su obuhvaćala uspješnost liječenja, odgovor na primijenjenu terapiju, strategiju za prepoznavanje odgovarajućeg odgovora i sigurnost, te terapijsku strategiju liječenja multiple skleroze u trudnoći. Smjernicama su obuhvaćeni svi lijekovi koji modifi ciraju tijek bolesti, a koji su odobreni od strane Europske agencije za lijekove (engl. EMA, European Medicine Agency). U posebne skupine raspoređeni su bolesnici s klinički izoliranim sindromom koji ne ispunjavaju dijagnostičke kriterije za klinički defi nitivnu MS, dok su bolesnici s dokazanom MS podijeljeni s obzirom na različite kliničke podtipove MS-a sukladno važećim dijagnostičkim smjernicama.