INTRODUCTION: It is hypothesized that systemically administered antibiotics penetrate wound sites more effectively during negative pressure wound therapy (NPWT). However, there is a lack of clinical data from patients who receive NPWT for deep sternal wound infection (DSWI) after open-heart surgery. Here, we evaluated vancomycin penetration into exudate in this patient group. PATIENTS AND METHODS: For this prospective observational study, we enrolled 10 consecutive patients treated with NPWT for post-sternotomy DSWI. On the first sampling day, serum and exudate samples were synchronously collected at 0 (pre-dose), 0.5, 1, 2, 3 and 6 h after vancomycin administration. On the following three consecutive days, additional samples were collected, only before vancomycin administration. RESULTS: The ratio of average vancomycin concentration in wound exudate to in serum was higher for free (unbound) (1.51 ± 0.53) than for total (bound + unbound) (0.91 ± 0.29) concentration (p = 0.049). The percentage of free vancomycin was higher in wound exudate than serum (0.79 ± 0.19 vs. 0.46 ± 0.16; p = 0.04). Good vancomycin wound penetration was maintained on the following three days (vancomycin trough exudate-to-serum concentration ratio > 1). The total hospital stay was significantly longer in patients with DSWI (46 ± 11.6 days) versus without DSWI (14 ± 11.7 days) (p < 0.001). There was no in-hospital or 90-day mortality. Two patients experienced late DSWI recurrence. All-cause mortality was 4.8% during a median follow-up of 2.5 years. CONCLUSION: Vancomycin effectively penetrates wound exudate in patients receiving NPWT for DSWI after open-heart surgery.The protocol for this study was registered at ClinicalTrials.gov on July 16, 2024 (NCT06506032).

• MeSH
• antibakteriální látky * farmakokinetika   aplikace a dávkování   MeSH
• exsudáty a transsudáty metabolismus   mikrobiologie   MeSH
• infekce chirurgické rány * MeSH
• kardiochirurgické výkony * škodlivé účinky   MeSH
• lidé středního věku MeSH
• lidé MeSH
• prospektivní studie MeSH
• senioři MeSH
• sternotomie * škodlivé účinky   MeSH
• sternum chirurgie   MeSH
• terapie ran pomocí řízeného podtlaku * metody   MeSH
• vankomycin * aplikace a dávkování   farmakokinetika   MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• pozorovací studie MeSH

BACKGROUND: Patients with systemic right ventricle (SRV), either d-transposition of the great arteries following an atrial switch procedure or congenitally corrected transposition of the great arteries, develop severe right ventricular dysfunction, prompting appropriate medical therapy. However, the efficacy of beta-blockers and angiotensin receptor blockers or angiotensin-converting enzyme inhibitors (ACEI) in SRV patients is unproven. OBJECTIVES: The objective of this study was to determine the effects of ACEI/ARB and beta-blockers on outcomes in SRV patients after accounting for likely cofounders affecting their use. METHODS: From a retrospective, multicenter study on heart failure-related outcome in individuals with SRV, those who were taking an ACEI/ARB, beta-blocker, or both of these medication were identified. We performed a propensity analysis to match them to those not using these medications at their initial visit. Matching was based on a propensity score, which captured co-morbidities, demographics, and baseline echocardiographic parameters. Primary outcome of death, transplant, or mechanical circulatory support, and secondary outcomes of heart failure hospitalizations/atrial arrhythmias were analyzed respectively. RESULTS: We identified 393 patients taking ACEI/ARB or beta-blocker, or taking both a beta-blocker and ACEI/ARB (62.1% male, median age 31.3 years) and 484 patients (56.4% male, median age of 26.0 years) who were neither on a beta-blocker nor on ACEI/ARB at the time of initial clinic visit. Median follow-up was ∼8 years. After propensity matching, medication use was not associated with decreased mortality, heart failure hospitalizations, or arrhythmias. Hazard ratios remained positive for beta blockers, implying potential harm rather than benefit. CONCLUSIONS: In this large multicenter propensity-matched observational study, patients with SRV taking beta-blockers or ACEI/ARB did not have a benefit in survival or reduced hospitalization. The likelihood of demonstrating favorable effects in larger studies appears remote.

• Publikační typ
• časopisecké články MeSH

BACKGROUND: Patients with severe aortic stenosis present frequently (∼50%) with concomitant obstructive coronary artery disease. Current guidelines recommend combined surgical aortic valve replacement (SAVR) and coronary artery bypass grafting (CABG) as the preferred treatment. Transcatheter aortic valve implantation (TAVI) and fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) represent a valid treatment alternative. We aimed to test the non-inferiority of FFR-guided PCI plus TAVI versus SAVR plus CABG in patients with severe aortic stenosis and complex coronary artery disease. METHODS: This international, multicentre, prospective, open-label, non-inferiority, randomised controlled trial was conducted at 18 tertiary medical centres across Europe. Patients (aged ≥70 years) with severe aortic stenosis and complex coronary artery disease, deemed feasible for percutaneous or surgical treatment according to the on-site Heart Team, were randomly assigned (1:1) to FFR-guided PCI plus TAVI or SAVR plus CABG according to a computer-generated sequence with random permuted blocks sizes stratified by site. The primary endpoint was a composite of all-cause mortality, myocardial infarction, disabling stroke, clinically driven target-vessel revascularisation, valve reintervention, and life-threatening or disabling bleeding at 1 year post-treatment. The trial was powered for non-inferiority (with a margin of 15%) and if met, for superiority. The primary and safety analyses were done per an intention-to-treat principle. This trial is registered with ClinicalTrials.gov (NCT03424941) and is closed. FINDINGS: Between May 31, 2018, and June 30, 2023, 172 patients were enrolled, of whom 91 were assigned to the FFR-guided PCI plus TAVI group and 81 to the SAVR plus CABG group. The mean age of patients was 76·5 years (SD 3·9). 118 (69%) of 172 patients were male and 54 (31%) patients were female. FFR-guided PCI plus TAVI resulted in favourable outcomes for the primary endpoint (four [4%] of 91 patients) versus SAVR plus CABG (17 [23%] of 77 patients; risk difference -18·5 [90% CI -27·8 to -9·7]), which was below the 15% prespecified non-inferiority margin (pnon-inferiority<0·001). FFR-guided PCI plus TAVI was superior to SAVR plus CABG (hazard ratio 0·17 [95% CI 0·06-0·51]; psuperiority<0·001), which was driven mainly by all-cause mortality (none [0%] of 91 patients vs seven (10%) of 77 patients; p=0·0025) and life-threatening bleeding (two [2%] vs nine [12%]; p=0·010). INTERPRETATION: The TCW trial is the first trial to compare percutaneous treatment versus surgical treatment in patients with severe aortic stenosis and complex coronary artery disease, showing favourable primary endpoint and mortality outcomes with percutaneous treatment. FUNDING: Isala Heart Centre and Medtronic.

• MeSH
• aortální stenóza * chirurgie   komplikace   MeSH
• chirurgická náhrada chlopně metody   MeSH
• frakční průtoková rezerva myokardu * MeSH
• koronární angioplastika * metody   MeSH
• koronární bypass * metody   MeSH
• lidé MeSH
• nemoci koronárních tepen * chirurgie   komplikace   terapie   MeSH
• prospektivní studie MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• transkatetrální implantace aortální chlopně * metody   MeSH
• výsledek terapie MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři nad 80 let MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• hodnocení ekvivalence MeSH
• multicentrická studie MeSH
• srovnávací studie MeSH

BACKGROUND: Skeletal muscle alterations are associated with higher mortality and morbidity in patients with liver cirrhosis. Assessing these changes seems to be a promising method for identifying patients at a high risk of poor outcomes following liver transplantation (LT). This is particularly important given the current global shortage of organ donors. However, evidence of the impact of these alterations on the prognosis of patients undergoing LT is inconclusive. The aim of our prospective study was to evaluate the impact of skeletal muscle changes, reflected in sarcopenia, myosteatosis and metabolic changes in the calf muscles, on perioperative outcomes and long-term survival after LT. We also sought to determine the posttransplant evolution of the resting muscle metabolism. METHODS: We examined 134 adult LT candidates. Of these, 105 underwent LT. Sarcopenia and myosteatosis were diagnosed by measuring the skeletal muscle index and mean psoas muscle radiation attenuation, respectively, which were obtained from computed tomography (CT) scans taken during pretransplant assessment. Additionally, patients underwent 31P MR spectroscopy (MRS) of the calf muscles at rest before LT and 6, 12 and 24 months thereafter. The median follow-up was 6 years. RESULTS: Patients with abnormal 31P MRS results and CT-diagnosed myosteatosis prior to LT had significantly worse long-term survival after LT (hazard ratio (HR), 3.36; 95% confidence interval (CI), 1.48-7.60; p = 0.0021 and HR, 2.58; 95% CI, 1.06-6.29; p = 0.03, respectively). Multivariable analysis showed that abnormal 31P MR spectra (HR, 3.40; 95% CI, 1.50-7.71; p = 0.003) were a better predictor of worse long-term survival after LT than myosteatosis (HR, 2.78; 95% CI, 1.14-6.78; p = 0.025). Patients with abnormal 31P MR spectra had higher blood loss during LT (p = 0.038), required a higher number of red blood cell transfusions (p = 0.006) and stayed longer in ICU (p = 0.041) and hospital (p = 0.007). Myosteatosis was associated with more revision surgeries following LT (p = 0.038) and a higher number of received red blood cell transfusion units (p = 0.002). Sarcopenia had no significant effect on posttransplant patient survival. An improvement in the resting metabolism of the calf muscles was observed at 12 and 24 months after LT. CONCLUSIONS: Abnormal 31P MRS results of calf muscles were superior to CT-based diagnosis of myosteatosis and sarcopenia in predicting perioperative complications and long-term survival after LT. Resting muscle metabolism normalized 1 year after LT in most recipients.

• MeSH
• dospělí MeSH
• kosterní svaly * diagnostické zobrazování   metabolismus   MeSH
• lidé středního věku MeSH
• lidé MeSH
• magnetická rezonanční spektroskopie * metody   MeSH
• počítačová rentgenová tomografie * metody   MeSH
• prognóza MeSH
• prospektivní studie MeSH
• sarkopenie etiologie   metabolismus   MeSH
• senioři MeSH
• transplantace jater * MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

BACKGROUND: Perianal fistulas of Crohn's disease (CD) create a significant burden on patients' lives. However, the efficacy and safety of adipose-derived mesenchymal stem cell treatment are contradicting, and real-world evidence is lacking. AIMS: To examine the usability of darvadstrocel therapy in managing perianal CD. METHODS: We enrolled patients with CD and perianal fistulas in this retrospective multicenter study. The primary outcome was perianal clinical remission (defined as all treated fistulas closed) at weeks 26 and 52. Secondary outcomes were clinical response rates (≥ 1 fistulas closed), perianal activity (PDAI), patient satisfaction, and adverse events. Data were recorded at baseline and weeks 12, 26 and 52. Prediction of primary outcomes was performed by logistic regression. RESULTS: Overall, among 223 patients (male/female ratio: 0.48), perianal clinical remission was achieved in 78.2% and 62.3% until weeks 26 and 52. Baseline PDAI score (OR 0.75), number of fistulas (OR 0.28) and the number of weeks after preparation for surgery (OR 0.98) were associated with treatment failure. The clinical response rates were 84.8% and 79.8% at weeks 26 and 52. Improvement of subjective perianal symptoms was achieved in 77.8% and 78.4% of patients, respectively. Adverse events occurred in 13.5% of patients; perianal abscesses and proctalgia were the most frequently reported. CONCLUSION: Effectiveness data were higher than in clinical trials. The safety profile was reassuring, and patients' satisfaction was high. Appropriate patient selection, fistula preparation and expertise may help to achieve treatment success.

• MeSH
• Crohnova nemoc * terapie   komplikace   MeSH
• dospělí MeSH
• indukce remise MeSH
• kohortové studie MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• rektální píštěl * terapie   etiologie   MeSH
• retrospektivní studie MeSH
• spokojenost pacientů MeSH
• transplantace mezenchymálních kmenových buněk * metody   škodlivé účinky   MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH

INTRODUCTION: Ventilatory efficiency (V'E/V'CO2 ) has been shown to predict postoperative pulmonary complications (PPCs) in lung resection candidates. V'E/V'CO2 is determined by arterial partial pressure of carbon dioxide (PaCO2 ) and by dead space to tidal volume ratio (VD/VT). We hypothesised PaCO2 and VD/VT contribute equally to the increase in V'E/V'CO2 in lung resection patients. METHODS: Consecutive lung resection candidates from two prior prospective studies were included in this post hoc analysis. All subjects underwent preoperative spirometry, cardiopulmonary exercise testing and arterial blood gas analysis at rest and peak exercise. PPCs were prospectively assessed during the first 30 postoperative days, or hospital stay. A t-test, Mann-Whitney U-test and two-tailed Fisher's exact test were used to compare patients with and without PPCs. p-values <0.05 were considered statistically significant. RESULTS: Of 398 patients, PPC developed in 64 (16%). Patients with PPCs more frequently underwent lobectomy by open thoracotomy, had longer hospital and ICU length of stay and higher 30- and 90-day mortality. Moreover, patients with PPCs exhibited a higher V'E/V'CO2 ratio both at rest and peak exercise. Both ratios were independently associated with PPCs. At rest, the contribution of PaCO2 and VD/VT to the increase in V'E/V'CO2 ratio in patients with PPCs was 45% and 55%, respectively. At peak exercise, the contribution of PaCO2 and VD/VT to the increase in V'E/V'CO2 ratio was 16% and 84%, respectively. CONCLUSIONS: VD/VT (V'/Q' mismatch and/or rapid shallow breathing pattern) is the dominant contributor to the increase in V'E/V'CO2 in lung resection candidates who develop PPCs.

• Publikační typ
• časopisecké články MeSH

Úvod a cíl studie: Uterinní NK (uNK) buňky jsou specializovanou subpopulací NK (natural killer) lymfocytů nacházejících se v endometriu. Hrají klíčovou roli v regulaci imunitní odpovědi a v procesu implantace embrya. Cílem této studie je retrospektivní analýza výsledků léčby metodou in vitro fertilizace (IVF) v souboru žen, které podstoupily imunofenotypizaci uNK buněk a na základě výsledků tohoto vyšetření byly, nebo nebyly léčeny imunomodulační terapií. Metody: Studie zahrnovala 122 pacientek, které podstoupily imunofenotypizaci uNK buněk v období od dubna do prosince 2023. Imunofenotypizace byla provedena metodou průtokové cytometrie. Pacientky byly roztříděny do čtyř skupin dle fenotypu uNK buněk: normální nálezy, nízké absolutní a relativní počty uNK (LOW-IMMUNE profil), nízké počty uNK v kombinaci s nežádoucím posunem směrem k cytotoxickému uNKdim imunofenotypu (MIXED-IMMUNE profil) a normální počty uNK, ale nežádoucí posun v poměru cytotoxických a regulačních uNK s cytotoxickým fenotypem (OVER-IMMUNE profil). Byly hodnoceny výsledky embryotransferu a výskyt potratů do ukončeného 12. týdne těhotenství v jednotlivých skupinách. Výsledky: Nejvyšší míra dosažení klinické gravidity byla nalezena v léčené skupině OVER- -IMMUNE (70 %), následované skupinou MIXED-IMMUNE (60 %). Skupina LOW-IMMUNE se od neléčené NORMAL skupiny signifikantně nelišila (p = 0,205). Nedostatečná imunitní aktivace (LOW-IMMUNE profil) byla signifikantně nejčastěji sdružena s prvotrimestrální těhotenskou ztrátou (p < 0,0001). Závěr: Tato studie přináší nové poznatky o potenciálu imunofenotypizace uNK buněk a následné imunomodulační terapie v léčbě poruch plodnosti. Ačkoli výsledky naznačují možné klinické přínosy, je zapotřebí dalšího výzkumu k potvrzení těchto zjištění a k objasnění mechanizmů, které vedou ke zlepšení výsledků léčby technikami asistované reprodukce.

Introduction and objective: Uterine NK (uNK) cells, a specialized subpopulation of natural killer (NK) lymphocytes located in the endometrium, play a crucial role in regulating the immune response and in the process of embryo implantation. This study aims to retrospectively analyze the outcomes of in vitro fertilization (IVF) treatment in a cohort of women who underwent uNK cell immunophenotyping with subsequent immunomodulatory therapy applied based on the results. Methods: The study included 122 patients who underwent uNK cell immunophenotyping between April and December 2023. Immunophenotyping was performed using flow cytometry. Patients were categorized into four groups according to their uNK cell phenotypes: normal findings, low absolute and relative numbers of uNK cells (LOW-IMMUNE profile), low numbers of uNK cells combined with the shift towards the cytotoxic uNKc dim immunophenotype (MIXED-IMMUNE profile), and normal numbers of uNK cells, but an undesirable shift in the ratio of cytotoxic to regulatory uNK cells towards the cytotoxic uNK dim phenotype (OVER-IMMUNE profile). Embryo transfer outcomes and the occurrence of miscarriages up to the 12th week of pregnancy were evaluated in each group. Results: The highest clinical pregnancy rate was observed in the treated OVER-IMMUNE group (70%), fol lowed by the MIXED-IMMUNE group (60%). The LOW-IMMUNE group did not differ significantly from the untreated NORMAL group (P = 0.205). Insufficient immune activation (LOW-IMMUNE profile) was significantly associated with first-trimester pregnancy loss (P < 0.0001). Conclusion: This study provides new insights into the potential benefits of uNK cell immunophenotyping and subsequent immunomodulatory therapy in treating fertility disorders. While the results indicate possible clinical advantages, further research is necessary to confirm these findings and elucidate the mechanisms leading to improved outcomes in assisted reproductive techniques.

• Klíčová slova
• uterinní NK buňky, imunofenotypizace lymfocytů, opakované selhání implantace,
• MeSH
• buňky NK MeSH
• endometrium cytologie   MeSH
• fertilizace in vitro * MeSH
• habituální potrat MeSH
• imunofenotypizace MeSH
• imunomodulace MeSH
• lidé MeSH
• průtoková cytometrie metody   MeSH
• retrospektivní studie MeSH
• ženská infertilita * MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH

Kontext: Procento nezralých granulocytů (immature granulocytes, iG%) je časným markerem zánětu s prognostickou hodnotou u řady onemocnění. Cíl: V této studii jsme se pokusili zjistit, zda má procento nezralých granulocytů prognostickou hodnotu z hlediska 28denní mortality pacientů s akutním koronárním syndromem (AKS). Metoda: Jednalo se o retrospektivní studii provedenou v období mezi 1. lednem 2019 a 30. červnem 2019 na Klinice urgentní medicíny lékařské fakulty univerzity v tureckém Mersinu. Do studie byli zařazeni všichni pacienti ve věku nad 18 let, kteří byli dopraveni na kliniku urgentní medicíny s bolestí na hrudi a hospitalizováni s předběžnou diagnózou AKS. Pacienti byli rozděleni do dvou skupin, na ty, kteří přežili, a ty, kteří nepřežili. Byly zaznamenány hodnoty iG% a dalších laboratorních parametrů a následně byl analyzován vztah mezi hodnotami iG% a 28denní mortalitou. Kromě toho byla pro srovnání diagnostické přesnosti hodnot iG% a dalších proměnných provedena analýza roc. Výsledky: Do studie bylo zařazeno celkem 617 pacientů, z tohoto počtu bylo 423 (68,6 %) mužů. Průměrný věk pacientů dosahoval 63,9 ± 12,7 roku. hodnota iG% byla vyšší u nepřeživších pacientů (1,2 ± 1,4) než u přeživších (0,5 ± 0,5 ) (p = 0,007). V predikci 28denní mortality, pokud byla mezní hodnota iG% > 0,6, byla zjištěna specificita ve výši 93,70 % a senzitivita 54,55 % (Auc = 0,717; p = 0,000). V predikci 28denní mortality na AKS představovalo iG% nezávislý rizikový faktor (poměr rizik [hazard ratio, hr] 632,962; 95% interval spolehlivosti 3,389–118 206,572; p = 0,016). Závěr: u pacientů s AKS může hodnota iG% souviset s 28denní mortalitou.

Background: The percentage of immature granulocytes (IG%) is an early marker of inflammation and has a prognostic significance in many diseases. Objective: In this study, we tried to investigate whether the percentage of immature granulocytes has a prognostic value in 28-day mortality in patients with acute coronary syndrome (ACS). Method: This study was carried out retrospectively between 1.1.2019 and 30.6.2019 at Mersin University Faculty of Medicine, Department of Emergency Medicine. Patients older than 18 years who applied to the emergency department with chest pain and were hospitalized with a preliminary diagnosis of ACS were included in the study. The patients were divided into two groups as survivors and non-survivors. IG% and other laboratory parameters were recorded. The relationship between IG% and 28-day mortality was analyzed. In addition, ROC analysis was performed to compare the diagnostic accuracy of IG% and other variables. Results: A total of 617 patients, including 423 (68.6%) men, were included in the study. The mean age of the patients were 63.9 ± 12.7. IG% was higher in non-survivor patients (1.2 ± 1.4) than in surviving patients (0.5 ± 0.5) (p = 0.007). In predicting 28-day mortality, when the cut-off value for IG% was >0.6, the specifi- city was found to be 93.70% and the sensitivity to be 54.55% (AUC = 0.717, p = 0.000). In predicting 28-day mortality for ACS, IG% was an independent risk factor (hazard ratio [HR] 632.962, 95% confidence interval 3.389-118206.572, p = 0.016). Conclusion: IG% may be associated with a 28-day mortality in patients with ACS.

Cíl: Správné indikace podání transfuzních přípravků (TP) jsou klíčem k účelné a bezpečné hemoterapii. Cílem této práce bylo zhodnotit indikační kritéria podávání TP, porovnat změny v indikacích TP mezi dvěma obdobími a získat podklady pro zkvalitnění hemoterapie v Krajské nemocnici Liberec, a.s. (KNL). Materiál a metoda: Sledovaným souborem byly všechny TP (erytrocyty, trombocyty, plazma) aplikované v KNL v období od 1. 10. 2020 do 30. 9. 2021 a od 1. 8. 2022 do 31. 7. 2023. Z databáze laboratorního informačního systému byly k jednot- livým TP přiřazeny laboratorní výsledky příjemců TP: hemoglobin (Hb), počet trombocytů a protrombinový čas – poměr (PT-R). Výsledky byly přiřazeny, pokud byly vyšetřeny před výdejem TP do předchozího kalendářního dne, tj. do 48 hodin před výdejem TP. Výsledky: V období 2020/21 bylo 35 % erytrocytů deleukotizovaných (ED) vydáno pacientům s Hb > 80g/l, v období 2022/23 32 % ED. Porovnáním hodnot průměrného Hb nebyl zjištěn statisticky významný rozdíl mezi obdobími (p = 0,61), přístup k indikacím ED se nezměnil. V období 2020/2021 bylo pacientům s počtem trombocytů > 50 × 109/l vydáno 29 % TP trombocytů, v období 2022/2023 16 % TP trombocytů. TP trombocytů byly v období 2022/23 vydávány pacientům s nižším počtem trombocytů než v období 2020/21 (p < 0,001). Zda se jednalo o racionalizaci indikací nebo bylo odlišné složení pacientů, nelze posoudit. V období 2020/2021 bylo pacientům s hodnotou PT-R ≤ 1,5 vydáno 52 % klinické plazmy (P), v období 2022/2023 47 % P. Při porovnání hodnot průměrného PT-R nebyl nalezen statisticky významný rozdíl mezi hodnocenými obdobími (p = 0,45). Závěr: Přístup k indikacím TP erytrocytů stejně jako u klinické plazmy byl konzistentní. U TP plazmy byl v porovnání s lite - raturou uvážlivější přístup v případě hraničních indikací. U TP trombocytů došlo k racionalizaci indikací nebo bylo odlišné složení pacientů. Obecně TP byly indikovány racionálně. S výsledky studie budeme dále pracovat.

Aim: Correct indications of blood components (BC) are the key to effective and safe haemotherapy. The aim of this study was to evaluate the indication criteria of BC, to compare the changes in BC indications between two periods and to improve the quality of haemotherapy at the Regional Hospital Liberec, as (KNL). Materials and methods: The study population consisted of all BCs (erythrocytes, platelets, plasma) administered in the KNL in the period from 1 October 2020 to 30 September 2021 and from 1 August 2022 to 31 July 2023. From the database of the laboratory information system, the laboratory results of BC recipients were matched to each BC: haemoglobin (Hb), platelet count, and prothrombin time - ratio (PT-R). These results were matched if they were tested before the administration of the BC within the previous calendar day, i.e., within 48 hours before the issue of the BC. Results: In 2020/21, 35% of red blood cells, leucocyte-depleted in additive solution (ED) were administered to patients with Hb > 80 g/l, and in 2022/23, 32% of ED. Comparison of mean Hb values revealed no statistically significant difference between the periods (p = 0.61), and the approach to ED indications did not change. In 2020/2021, 29% of platelet BCs were administered to patients with platelet counts > 50 × 109/l, and in 2022/2023, 16% of platelet BCs. Platelet BCs were issued to patients with lower platelet counts in 2022/23 than in 2020/21 (p < 0.001). Whether this was a rationalization of indications or a different patient make-up, cannot be assessed. In 2020/2021, 52% of plasma, fresh frozen (P) was administered to patients with a PT-R ≤ 1.5, and in 2022/2023, 47% of P. When comparing mean PT-R values, there was no statistically significant difference between the evaluated periods (p = 0.45). Conclusion: The approach to erythrocyte and plasma BC indications was consistent. A more considered approach was taken for plasma BCs for borderline indications, when compared with the literature. For platelet BCs, indications were rationalized or patient make-up was different. In general, BCs were rationally indicated. We will continue to work with the results of the study.

• MeSH
• krevní plazma MeSH
• krevní transfuze metody   MeSH
• lidé MeSH
• převod jednotlivých krevních složek * metody   MeSH
• transfuze erytrocytů metody   MeSH
• transfuze trombocytů metody   MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• klinická studie MeSH

BACKGROUND: Spinal cord injury results in permanent neurological impairment and disability due to the absence of spontaneous regeneration. NG101, a recombinant human antibody, neutralises the neurite growth-inhibiting protein Nogo-A, promoting neural repair and motor recovery in animal models of spinal cord injury. We aimed to evaluate the efficacy of intrathecal NG101 on recovery in patients with acute cervical traumatic spinal cord injury. METHODS: This randomised, double-blind, placebo-controlled phase 2b clinical trial was done at 13 hospitals in the Czech Republic, Germany, Spain, and Switzerland. Patients aged 18-70 years with acute, complete or incomplete cervical spinal cord injury (neurological level of injury C1-C8) within 4-28 days of injury were eligible for inclusion. Participants were initially randomly assigned 1:1 to intrathecal treatment with 45 mg NG101 or placebo (phosphate-buffered saline); 18 months into the study, the ratio was adjusted to 3:1 to achieve a final distribution of 2:1 to improve enrolment and drug exposure. Randomisation was done using a centralised, computer-based randomisation system and was stratified according to nine distinct outcome categories with a validated upper extremity motor score (UEMS) prediction model based on clinical parameters at screening. Six intrathecal injections were administered every 5 days over 4 weeks, starting within 28 days of injury. Investigators, study personnel, and study participants were masked to treatment allocation. The primary outcome was change in UEMS at 6 months, analysed alongside safety in the full analysis set. The completed trial was registered at ClinicalTrials.gov, NCT03935321. FINDINGS: From May 20, 2019, to July 20, 2022, 463 patients with acute traumatic cervical spinal cord injury were screened, 334 were deemed ineligible and excluded, and 129 were randomly assigned to an intervention (80 patients in the NG101 group and 49 in the placebo group). The full analysis set comprised 78 patients from the NG101 group and 48 patients from the placebo group. 107 (85%) patients were male and 19 (15%) patients were female, with a median age of 51·5 years (IQR 30·0-60·0). Across all patients, the primary endpoint showed no significant difference between groups (with UEMS change at 6 months 1·37 [95% CI -1·44 to 4·18]; placebo group mean 19·20 [SD 11·78] at baseline and 30·91 [SD 15·49] at day 168; NG101 group mean 18·23 [SD 15·14] at baseline and 31·31 [19·54] at day 168). Treatment-related adverse events were similar between groups (nine in the NG101 group and six in the placebo group). 25 severe adverse events were reported: 18 in 11 (14%) patients in the NG101 group and seven in six (13%) patients in the placebo group. Although no treatment-related fatalities were reported in the NG101 group, one fatality not related to treatment occurred in the placebo group. Infections were the most common adverse event affecting 44 (92%) patients in the placebo group and 65 (83%) patients in the NG101 group. INTERPRETATION: NG101 did not improve UEMS in patients with acute spinal cord injury. Post-hoc subgroup analyses assessing UEMS and Spinal Cord Independence Measure of self-care in patients with motor-incomplete injury indicated potential beneficial effects that require investigation in future studies. FUNDING: EU program Horizon2020; Swiss State Secretariat for Education, Research and Innovation; Wings for Life; the Swiss Paraplegic Foundation; and the CeNeReg project of Wyss Zurich (University of Zurich and Eidgenössische Technische Hochschule Zurich).

• MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• krční mícha * zranění   MeSH
• krční obratle MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• Nogo proteiny * MeSH
• poranění míchy * farmakoterapie   MeSH
• senioři MeSH
• spinální injekce * MeSH
• výsledek terapie MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH