The 2024 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines for chronic kidney disease (CKD) evaluation and management bring important updates, particularly for European laboratories. These guidelines emphasize the need for harmonization in CKD testing, promoting the use of regional equations. In Europe, the European Kidney Function Consortium (EKFC) equation is particularly suited for European populations, particularly compared to the CKD-EPI 2021 race-free equation. A significant focus is placed on the combined use of creatinine and cystatin C to estimate glomerular filtration rate (eGFRcr-cys), improving diagnostic accuracy. In situations where eGFR may be inaccurate or clinically insufficient, the guidelines encourage the use of measured GFR (mGFR) through exogenous markers like iohexol. These guidelines emphasize the need to standardize creatinine and cystatin C measurements, ensure traceability to international reference materials, and adopt harmonized reporting practices. The recommendations also highlight the importance of incorporating risk prediction models, such as the Kidney Failure Risk Equation (KFRE), into routine clinical practice to better tailor patient care. This article provides a European perspective on how these KDIGO updates should be implemented in clinical laboratories to enhance CKD diagnosis and management, ensuring consistency across the continent.
- MeSH
- Renal Insufficiency, Chronic * diagnosis therapy MeSH
- Cystatin C blood MeSH
- Glomerular Filtration Rate * MeSH
- Laboratories, Clinical MeSH
- Creatinine blood MeSH
- Humans MeSH
- Practice Guidelines as Topic * MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Geographicals
- Europe MeSH
BACKGROUND: Head tremor poses diagnostic problems, especially when present as an isolated or predominant symptom. OBJECTIVES: To assess how maneuvers activating upper limb postural tremor can help differentiate head tremor in essential tremor (ET) from dystonic tremor (DT) in cervical dystonia. METHODS: 48 patients with head tremor (25 ET, 23 DT), underwent clinical examination and accelerometric evaluation of head and upper limb tremor during routine tremor-inducing tasks. RESULTS: While accelerometric power and clinical scores of head tremor did not significantly differ between patient groups, task-induced variations revealed distinctions. ET patients exhibited increased head tremor power and clinical scores during forward outstretched and lateral wing-beating arm positions, unlike DT patients. Coherence between head and upper limb tremor remained consistent. Tremor stability index showed no significant differences. CONCLUSIONS: Task-induced changes in head tremor could aid in distinguishing between ET and DT. Further research is needed to refine diagnostic approaches for head tremor.
- MeSH
- Accelerometry instrumentation methods MeSH
- Diagnosis, Differential MeSH
- Adult MeSH
- Dystonia diagnosis physiopathology MeSH
- Essential Tremor * diagnosis physiopathology MeSH
- Head * physiopathology MeSH
- Middle Aged MeSH
- Humans MeSH
- Arm * physiopathology MeSH
- Posture physiology MeSH
- Aged MeSH
- Torticollis diagnosis physiopathology MeSH
- Tremor * diagnosis physiopathology MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
S nízkomolekulárními hepariny a konkrétně enoxaparinem se setkáváme v řadě indikací. Nejrozšířenější je nepochybně prevence a léčba tromboembolické nemoci. Od roku 2020 je na českém trhu k dispozici vedle originálního přípravku i enoxaparin biosimilární. Jeho indikace, dávkování a další aspekty použití zcela kopírují originál. Cílem uvedeného sdělení je vysvětlit, na jakém podkladě byla uvedená Data extrapolována, co víme o konkrétním biosimilárním enoxaparinu dostupném v České republice a jaká Data máme k dispozici k dalším podobným molekulám. Cílem je i upozornit na některé modality bezpečného používání biosimilárního enoxaparinu v běžné klinické praxi.
Low-molecular-weight heparins and specifically enoxaparin are used in a number of indications. The most common is undoubtedly the prevention and treatment of thromboembolic disease. Since 2020, biosimilar enoxaparin has been available on the Czech market alongside the original product. Its indications, posology and other aspects completely reflect the original. The aim of this article is to explain the principles of extrapolation, summarize Data on the specific biosimilar enoxaparin available in the Czech Republic and Data available on other similar molecules in the world. It also aims to highlight some modalities of the safe use of biosimilar enoxaparin in routine clinical practice.
Myelofibróza je myeloproliferativní onemocnění převážně pacientů staršího věku, které je doprovázeno hepatosplenomegalií a vysokou symptomatickou zátěží. Objev prvního ze skupiny inhibitorů Janusovy tyrosinkinázy (Janus tyrosine kinase, JAK), ruxolitinibu, znamenal průlom v terapii pacientů s myelofibrózou ve smyslu rychlé úlevy od symptomů a regrese splenomegalie. I po více než 10 letech od jeho uvedení do běžné klinické praxe představuje stále zlatý standard léčby pacientů s myelofibrózou s vyšším rizikem, který kromě zlepšení kvality života vede také k prodloužení celkového přežití.
Myelofibrosis is a myeloproliferative neoplasm with a higher incidence in older patients, associated with hepatosplenomegaly and high symptomatic burden. Discovery of ruxolitinib, first Janus tyrosine kinase (JAK) inhibitor, was a breakthrough in therapy of myelofibrosis that led to quick improvement of symptoms and reduction of splenomegaly. Even after more than 10 years after its introduction into routine clinical practice, ruxolitinib continues to be standard of care in higher-risk myelofibrosis. Ruxolitinib has been shown to not only improve quality of life but also to improve overall survival.
BACKGROUND: Sedation is often provided to resuscitated out-of-hospital cardiac arrest (OHCA) patients to tolerate post-cardiac arrest care, including temperature management. However, the evidence of benefit or harm from routinely administered deep sedation after cardiac arrest is limited. The aim of this trial is to investigate the effects of continuous deep sedation compared to minimal sedation on patient-important outcomes in resuscitated OHCA patients in a large clinical trial. METHODS: The SED-CARE trial is part of the 2 × 2 × 2 factorial Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, a randomized international, multicentre, parallel-group, investigator-initiated, superiority trial with three simultaneous intervention arms. In the SED-CARE trial, adults with sustained return of spontaneous circulation (ROSC) who are comatose following resuscitation from OHCA will be randomized within 4 hours to continuous deep sedation (Richmond agitation and sedation scale (RASS) -4/-5) (intervention) or minimal sedation (RASS 0 to -2) (comparator), for 36 h after ROSC. The primary outcome will be all-cause mortality at 6 months after randomization. The two other components of the STEPCARE trial evaluate sedation and temperature control strategies. Apart from the STEPCARE trial interventions, all other aspects of general intensive care will be according to the local practices of the participating site. Neurological prognostication will be performed according to European Resuscitation Council and European Society of Intensive Care Medicine guidelines by a physician blinded to the allocation group. To detect an absolute risk reduction of 5.6% with an alpha of 0.05, 90% power, 3500 participants will be enrolled. The secondary outcomes will be the proportion of participants with poor functional outcomes 6 months after randomization, serious adverse events in the intensive care unit, and patient-reported overall health status 6 months after randomization. CONCLUSION: The SED-CARE trial will investigate if continuous deep sedation (RASS -4/-5) for 36 h confers a mortality benefit compared to minimal sedation (RASS 0 to -2) after cardiac arrest.
- MeSH
- Conscious Sedation * methods MeSH
- Adult MeSH
- Deep Sedation * methods MeSH
- Cardiopulmonary Resuscitation * methods MeSH
- Humans MeSH
- Randomized Controlled Trials as Topic MeSH
- Out-of-Hospital Cardiac Arrest * therapy mortality MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial Protocol MeSH
- Comparative Study MeSH
BACKGROUND & AIMS: Despite strong evidence for improved preservation of donor livers by machine perfusion, longer post-transplant follow-up data are urgently needed in an unselected patient population. We aimed to assess long-term outcomes after transplantation of hypothermic oxygenated machine perfusion (HOPE)-treated donor livers based on real-world data (i.e., IDEAL-D stage 4). METHODS: In this international, multicentre, observational cohort study, we collected data from adult recipients of HOPE-treated livers transplanted between January 2012 and December 2021. Analyses were stratified by donation after brain death (DBD) and donation after circulatory death (DCD), sub-divided by their respective risk categories. The primary outcome was death-censored graft survival. Secondary outcomes included the incidence of primary non-function (PNF) and ischaemic cholangiopathy (IC). RESULTS: We report on 1,202 liver transplantations (64% DBD) performed at 22 European centres. For DBD, a total number of 99 benchmark (8%), 176 standard (15%), and 493 extended-criteria (41%) cases were included. For DCD, 117 transplants were classified as low risk (10%), 186 as high risk (16%), and 131 as futile (11%), with significant risk profile variations among centres. Actuarial 1-, 3-, and 5-year death-censored graft survival rates for DBD and DCD livers were 95%, 92%, and 91%, vs. 92%, 87%, and 81%, respectively (log-rank p = 0.003). Within DBD and DCD strata, death-censored graft survival was similar among risk groups (log-rank p = 0.26, p = 0.99). Graft loss due to PNF or IC was 2.3% and 0.4% (DBD), and 5% and 4.1% (DCD). CONCLUSIONS: This study shows excellent 5-year survival after transplantation of HOPE-treated DBD and DCD livers with low rates of graft loss due to PNF or IC, irrespective of their individual risk profile. HOPE treatment has now reached IDEAL-D stage 4, which further supports its implementation in routine clinical practice. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05520320. IMPACT AND IMPLICATIONS: This study demonstrates the excellent long-term performance of hypothermic oxygenated machine perfusion (HOPE) treatment of donation after circulatory and donation after brain death liver grafts irrespective of their individual risk profile in a real-world setting, outside the evaluation of randomised-controlled trials. While previous studies have established safety, feasibility, and efficacy against the current standard, according to the IDEAL-D evaluation framework, HOPE treatment has now reached the final IDEAL-D stage 4, which further supports its implementation in routine clinical practice.
- MeSH
- Tissue Donors statistics & numerical data MeSH
- Adult MeSH
- Cohort Studies MeSH
- Middle Aged MeSH
- Humans MeSH
- Perfusion * methods instrumentation MeSH
- Graft Survival * MeSH
- Aged MeSH
- Hypothermia, Induced methods MeSH
- Liver Transplantation * methods adverse effects MeSH
- Organ Preservation * methods MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Observational Study MeSH
BACKGROUND AND AIMS: Gastric restriction techniques have recently emerged as minimally invasive bariatric procedures. Endoscopic sutured gastroplasty (ESG) with the Endomina (Endo Tools Therapeutics, Gosselies, Belgium) triangulation platform proved to be safe and effective for the treatment of class I and II obesity in prospective studies. In this registry, we aimed to further assess on a larger scale the safety and efficacy of the procedure in routine practice with a dedicated device. METHODS: This was a multicenter, observational, prospective post-market study including patients with obesity undergoing Endomina ESG. The primary safety outcome was the occurrence of serious adverse device effects (SADEs) at 12 months. The primary efficacy outcome was the technical success defined by completing the procedure without premature abortion owing to technical issues. The rates of procedure-related adverse events, weight loss outcomes, and quality of life changes were collected. RESULTS: A total of 142 patients underwent ESG in 3 centers from July 2020 to March 2023. Of these, 67 (mean body mass index, 38.5 ± 6.3 kg/m2) reached at least 12 months of follow-up up to October 2022. Technical success was 100%. No SADEs occurred. Seven mild procedure-related adverse events were reported overall. Mean percentage of excess weight loss and total body weight loss at 12 months' follow-up were 48.5% ± 38.6 and 15.3% ± 10.6, respectively (n = 67). Improved quality of life was observed following ESG. CONCLUSIONS: ESG is safe and effective, thus offering a satisfactory therapeutic option for a wide range of obese patients on a large scale.
- MeSH
- Adult MeSH
- Gastroplasty * methods adverse effects MeSH
- Gastroscopy methods MeSH
- Weight Loss MeSH
- Quality of Life MeSH
- Middle Aged MeSH
- Humans MeSH
- Obesity, Morbid surgery MeSH
- Obesity surgery complications MeSH
- Postoperative Complications MeSH
- Product Surveillance, Postmarketing * MeSH
- Prospective Studies MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Observational Study MeSH
Úvod: Erektilní dysfunkce (ED) je vysoce prevalenční porucha, která významně ovlivňuje kvalitu života mužů i jejich partnerek. Inhibitory fosfodiesterázy typu 5 (PDE5i), zejména sildenafil, tvoří základní linii farmakologické léčby ED. Tradiční tabletová forma však může být u části pacientů spojena s pomalejším nástupem účinku, vyšším výskytem nežádoucích účinků a sníženou adherencí. Inovativní léková forma – orálně rozpustný film (ORF) s obsahem sildenafilu – byla vyvinuta s cílem tyto limity překonat. Metodika: Článek shrnuje dostupná klinická a farmakokinetická data o účinnosti, bezpečnosti a pacientské preferenci nové lékové formy sildenafilu ve formě ORF. Zohledněna jsou randomizovaná kontrolovaná hodnocení, farmaceutické studie a zkušenosti z klinické praxe. Výsledky: Sildenafil ve formě ORF vykazuje srovnatelnou účinnost jako klasická tableta, přičemž dosahuje rychlejšího nástupu účinku díky částečnému vstřebávání přes sliznici dutiny ústní. Při dávce 50 mg bývá dosaženo optimálního terapeutického efektu u většiny pacientů, což může snižovat výskyt nežádoucích účinků. Léková forma rovněž umožňuje diskrétní užití bez nutnosti zapíjení, čímž zvyšuje komfort a adherenci pacientů. Závěr: ORF s obsahem sildenafilu představuje moderní a klinicky přínosnou alternativu v léčbě ED. Jeho využití může být zvláště vhodné u pacientů s preferencí rychlého nástupu účinku, u osob s dysfagií nebo u těch, kteří upřednostňují diskrétní formu užití. Další výzkum by měl ověřit přínosy této formy v běžné klinické praxi a její vliv na dlouhodobou adherenci a spokojenost pacientů.
Introduction: Erectile dysfunction (ED) is a highly prevalent disorder that significantly affects the quality of life of men and their partners. Phosphodiesterase type 5 inhibitors (PDE5i), particularly sildenafil, form the first line of pharmacological treatment for ED. However, the traditional tablet form may be associated with a slower onset of action, a higher incidence of adverse effects, and reduced adherence in some patients. An innovative drug form - an orally dissolvable film (ORF) containing sildenafil - has been developed to overcome these limitations. Methodology: The article summarizes the available clinical and pharmacokinetic data on the efficacy, safety, and patient preference of the new sildenafil dosage form as an orally dissolving film. Randomized controlled trials, pharmaceutical studies, and clinical experience are taken into account. Results: Sildenafil in ORF form shows comparable efficacy to the classic tablet, with a faster onset of action due to partial absorption through the oral mucosa. At a dose of 50 mg, the optimal therapeutic effect is achieved in most patients, which may reduce the incidence of adverse effects. The dosage form also allows for discreet use without the need for water, thereby increasing patient comfort and adherence. Conclusion: An orally dissolvable film containing sildenafil represents a modern and clinically beneficial alternative in the treatment of ED. Its use may be particularly suitable for patients who prefer a rapid onset of action, those with dysphagia, or those who prefer a discreet form of administration. Further research should verify the benefits of this form in routine clinical practice and its impact on long-term adherence and patient satisfaction.
- MeSH
- Administration, Oral MeSH
- Administration, Sublingual MeSH
- Erectile Dysfunction * drug therapy MeSH
- Phosphodiesterase 5 Inhibitors administration & dosage pharmacokinetics therapeutic use MeSH
- Humans MeSH
- Sildenafil Citrate administration & dosage pharmacokinetics therapeutic use MeSH
- Drug Administration Routes MeSH
- Check Tag
- Humans MeSH
Male infertility is a multifactorial condition contributing to approximately 50% of all cases of couple infertility. In recent years, significant advances have been made in both diagnostics and treatment. This review summarizes key developments from 2019 to 2024 with direct relevance to routine clinical practice in Czech urology and andrology. Particular attention is paid to the updated semen analysis standards (World Health Organisation 6th edition, 2021), sperm DNA fragmentation testing, genetic evaluation (karyotyping, Y chromosome microdeletions, and exome sequencing), surgical management of varicocele, and sperm retrieval techniques for azoospermia, including microdissection testicular sperm extraction (micro-TESE). The article also discusses pharmacological options (gonadotropins, selective estrogen receptor modulators, antioxidants), the impact of lifestyle factors, and the importance of interdisciplinary collaboration with assisted reproduction centers. Future perspectives, including the role of preventive strategies in male reproductive health, are also addressed. The aim is to provide a comprehensive and clinically applicable overview of current recommendations and therapeutic approaches in andrology, with a focus on their implementation in the Czech urological setting.
- MeSH
- Semen Analysis methods MeSH
- Antioxidants pharmacology therapeutic use MeSH
- Reproductive Techniques, Assisted MeSH
- Genetic Testing methods MeSH
- Gonadotropins therapeutic use MeSH
- Humans MeSH
- Infertility, Male * diagnosis etiology therapy MeSH
- Sperm Retrieval MeSH
- Selective Estrogen Receptor Modulators pharmacology therapeutic use MeSH
- Varicocele surgery MeSH
- Life Style MeSH
- Check Tag
- Humans MeSH
- Publication type
- Systematic Review MeSH
Introduction: The central venous catheter (CVC) and its use represents a step forward in patient treatment, but involves numerous potential complications. Applying nursing standards to clinical practice achieves high-quality nursing care. Design: Cross-sectional quantitative study using a questionnaire. Methods: Quantitative research using questionnaire technique was conducted to examine nurses' knowledge of nursing care for central venous catheters and adherence to nursing standards. The research sample consisted of 256 nurses in selected regional hospitals in the Slovak Republic. The criterion for including nurses in the sample was the provision of CVC care in routine practice. The data were analysed using descriptive statistics and statistical testing methods. Results: The research found that nurses have certain shortcomings in nursing care for central venous catheters. Nurses know how to work correctly according to aseptic procedures (81%), but they are unsure what barrier devices are needed for dressing and treatment (25%). Conclusion: Based on the research results, it can be concluded that despite nurses' knowledge being adequate, it is necessary to provide regular training on the principles of CVC care to reduce infections associated with healthcare.