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Performance evaluation of Procleix® UltrioPlex E® Assay for multiplexed automated NAT screening of blood donors for HCV, HIV, HBV, HEV and recommendation in case of HEV detection in donors
No full textBackground: The Procleix UltrioPlex E assay for use with the Procleix Panther is a qualitative test applying the TMA method, for the detection of HCV RNA, HBV DNA, HEV RNA and HIV-1 RNA in human plasma and serum. The assay simultaneously identifies HIV, HCV, HEV and HBV (multiplex). An optional component of the system is the Procleix Xpress instrument that creates pools from individual samples.
Aim: To evaluate the Procleix UltrioPlex E assay in individual donations and in plasma pools using the Procleix Xpress instrument.
Material and methods: Analytical sensitivity was assessed with serial dilutions of the WHO International Standards (IS): HCV, HIV-1, HBV (NIBSC) and International Standard for Hepatitis E Virus (PEI). Correct identification of reactive donations, clinical sensitivity and the risk of contamination were tested in two formats: individually (IDT) and in pools of 4 donations (MP4). In each format 193 negative and 7 reactive donations — 4 with HCV, HIV, HBV or HEV and 3 samples with co-infection (HEV+HCV, HEV+HIV or HEV+HBV) were tested. Additionally, 20 plasma samples from living cells, tissue and organ donors (Hematopoietic stem-cell transplantation donors, HSCT) were examined.
Results: 95% Limits of detection (with 95% confidence interval) for Procleix UltrioPlex E assay were 4,0 IU/mL (2,8–12,0), 2,9 IU/mL (1,9–8,7), 66,8 IU/mL (40,8–159,3) and 5,5 IU/mL (4,0–11,2) for HCV, HBV, HIV-1 and HEV respectively. Due to the lower sensitivity for HIV-1 RNA obtained in the assay evaluation compared to the manufacturer’s instruction (4th IS WHO 16/194 was used in both laboratories), additional tests of the BioQControl P0290 HIV-1 RNA subtype B panel, which was calibrated to 2nd IS WHO 97/650, were performed. Probit analysis of the tested BioQControl panel demonstrated an analytical sensitivity of 17.9 IU/mL (95% LOD) for HIV-1 RNA. During the simulation of screening in individual donations, correct identification of HIV/HCV/HBV and HEV infections and co-infections was found. In the tested mini-pools created with the Procleix Xpress System, infected donations were also correctly detected. There were no false negative or false reactive results during the evaluation. Conclusions: The Procleix UltrioPlex E assay on the Procleix Panther System, including the Procleix Xpress instrument, demonstrated high sensitivity and satisfactory specificity required by the Polish blood donation system. The Procleix UltrioPlex E assay correctly identified infected donations without false results. Differences in the ability to detect HIV-1 RNA in sample dilutions when using the 4th WHO HIV-1 Standard (16/194) and BioQControl P0290 HIV-1 RNA subtype B (calibrated to 97/650) may be caused by heat-inactivation of the first reference material applied during manufacturing. In case of assay implementation, since international guidelines are not available the authors proposed a country recommendation on HEV screening, management of infected donors and donations and HEV infection reporting should be introduced
Olbrzymiokomórkowe zapalenie tętnic — szybka ścieżka diagnostyczna począwszy od gabinetu lekarza rodzinnego
No full textGiant cell arteritis (GCA) is a primary inflammation of large and medium-sized arteries. Its cranial variant - temporal arteritis, is one of the most symptomatic and most dangerous forms, posing the risk of irreversible vision loss. A key element in diagnosing temporal arteritis, alongside a history and laboratory tests, is a duplex ultrasound examination of the temporal arteries. Performed within the first 24 hours of suspected GCA, it significantly accelerates the diagnostic and therapeutic pathway, allowing for early initiation of therapy and thus significantly minimizing the risk of complications. Given its widespread availability, a structured approach to GCA diagnosis supported by ultrasonography, starting with a family physician seems especially important.Olbrzymiokomórkowe zapalenie tętnic (GCA , giant cell arteritis) to pierwotne zapalenie tętnic dużego i średniego kalibru, którego wariant czaszkowy — zapalenie tętnicy skroniowej jest jedną z najbardziej charakterystycznych pod względem symptomatologii i jednocześnie najgroźniejszą, z racji zagrożenia nieodwracalną utartą wzroku postacią. Kluczowym elementem rozpoznania zapalenia tętnicy skroniowej, obok wywiadu i badań laboratoryjnych jest badanie USG doppler dupleks tętnic skroniowych. Jego wykonane w ciągu pierwszej doby od postawienia podejrzenia GCA znacząco przyspiesza ścieżkę diagnostyczno-terapeutyczną, umożliwiając wczesne włączenie terapii i tym samym minimalizując w sposób istotny ryzyko wystąpienia powikłań. Z uwagi na szeroką dostępność ultrasonografii, tym ważniejsze wydaje się usystematyzowane podejście do diagnostyki GCA już na etapie opieki lekarza rodzinnego
Cemiplimab w leczeniu chorych na niedrobnokomórkowego raka płuca w monoterapii oraz skojarzeniu z chemioterapią wobec obowiązującego programu lekowego leczenia raka płuca i międzybłoniaka opłucnej
No full textCemiplimab is a monoclonal antibody against PD-1, which has European approval for monotherapy in patients with NSCLC with PD-L1 expression ≥ 50% and in combination with chemotherapy in a group with PD-L1 expression ≥ 1%. In Poland, the use of cemiplimab is possible in these indications according to the criteria of the Drug Programme B6. The EMPOWER-Lung 1 trial showed significant improvement in overall survival-OS (HR - 0.57) and progression-free survival-PFS (HR - 0.51) in favour of cemiplimab with a lower risk of adverse events compared to chemotherapy alone. The use of cemiplimab in combination with chemotherapy significantly improves OS (HR = 0.65) and PFS (HR = 0.55) and increases objective response rates. The efficacy of cemiplimab in combination with chemotherapy is limited to the group of patients with PDL1 expression >1% and is observed regardless of the histological type of NSCLC. The toxicity profile of cemiplimab is characteristic of the anti-PD1 and anti-PDL1 antibody groups. Studies evaluating patients' quality of life indicate that cemiplimab treatment is associated with a lower risk of worsening quality of life compared to chemotherapy. When used as monotherapy or in combination with chemotherapy, cemiplimab is one of the currently available therapeutic options and has reasonable use in relevant patient populations.Cemiplimab jest przeciwciałem monoklonalnym skierowanym przeciwko receptorowi PD-1, które w Europie posiada rejestrację w monoterapii u chorych na NDRP z ekspresją PD-L1 ≥ 50% oraz w połączeniu z chemioterapią w grupie z ekspresją PD-L1 ≥ 1%. W Polsce zastosowanie cemiplimabu jest możliwe w wymienionych wskazaniach w ramach programu lekowego B.6.
W badaniu klinicznym EMPOWER-Lung 1 wykazano znamienną poprawę OS (HR = 0,57) i PFS (HR = 0,51) na korzyść cemiplimabu, przy mniejszym ryzyku działań niepożądanych w porównaniu z samą chemioterapią.
Zastosowanie cemiplimabu w połączeniu z chemioterapią znamiennie poprawia OS (HR = 0,65) i PFS (HR = 0,55) oraz zwiększa odsetek odpowiedzi obiektywnych. Skuteczność cemiplimabu w skojarzeniu z chemioterapią ogranicza się do grupy chorych z ekspresją PD-L1 ≥ 1% i jest obserwowana niezależnie od typu histologicznego NDRP.
Profil toksyczności cemiplimabu jest charakterystyczny dla grupy przeciwciał anty-PD-1 i anty-PD-L1. Badania oceniające jakość życia chorych wskazują, że leczenie cemiplimabem wiąże się z mniejszym ryzykiem pogorszenia jakości życia w porównaniu z chemioterapią.
Cemiplimab stosowany w monoterapii lub połączeniu z chemioterapią jest jedną z aktualnie dostępnych w Polsce opcji terapeutycznych i znajduje uzasadnione zastosowanie w odpowiednich populacjach chorych
Pregnancy after bariatric surgery — does weight loss surgery influence maternal and fetal outcomes? Findings from the maternal outcomes of bariatric surgery and pregnancy study (MOMBARIS 2)
No full textObjectives: Obesity negatively affects female fertility and pregnancy outcomes. Bariatric surgery improves weight, metabolism, and fertility, but concerns remain about maternal and neonatal outcomes.
To evaluate reproductive and perinatal outcomes in Polish women who conceived after bariatric surgery (MOMBARIS 2).
Material and methods: A retrospective study (2015–2024) in 11 bariatric centers included 160 women post-surgery; 154 conceived and were analyzed for fertility, pregnancy, and neonatal outcomes.
Results: Pregnancy occurred in 97.5% of participants, mostly spontaneous (83.8%) and planned (58.7%). BMI dropped from 43.1 to 30.45 kg/m². Complications: anemia (35.9%), gestational diabetes (16.2%), hypertension (10.2%). Cesarean rate: 52.7%. Neonatal outcomes were favorable: median birth weight 3,330 g, gestational age 39 weeks, 97.9% had Apgar 10, and 3.0% had anomalies.
Conclusions: Despite maternal risks, neonatal outcomes were excellent. Bariatric surgery improves fertility without compromising fetal health
The role of vorasidenib, a dual inhibitor of the mutant IDH1 and IDH2 enzymes, in the treatment of diffuse adult-type gliomas
No full textDiffuse gliomas (DG) constitute a complex group of the most common primary brain tumors in adults. A key mutation, present in about 80% of low-grade gliomas, is the isocitrate dehydrogenase (IDH) gene mutation, the mutant IDH (IDHmut) produces the oncometabolite D-2-hydroxyglutarate, resulting in alterations in the genome-wide methylation profile, metabolic alterations, tumorigenesis, microenvironmental changes and immunosuppression. The aim of this review was to discuss the molecular biology of IDHmut DG and present the results of the registration study of the first IDH1/2 inhibitor — vorasidenib. Given that vorasidenib is a newly registered drug, literature using PubMed and Google Scholar was reviewed. In addition to preclinical studies, results from the INDIGO study and preliminary results of vorasidenib use in clinical practice were found. INDIGO showed a significant prolongation of progression-free survival (PFS) and delayed the need for further therapies in patients with IDH-mutant gliomas treated with vorasidenib monotherapy. Further analyses revealed health-related quality of life, neurocognitive stabilization, controlled seizures, significant decrease in tumor growth rate, and a measurable radiographic response. Real-world studies confirmed the drug’s effectiveness in a broader population. The result of a study evaluating the combination of this drug with an immune checkpoint inhibitor is expected in 2027. In conclusion, vorasidenib significantly prolongs PFS in IDHmut low-grade gliomas; its efficacy in other settings requires further investigation
Association of superior vena cava syndrome with small cell lung cancer
No full textIntroduction. Small cell lung cancer (SCLC) is one of the most common malignant causes of superior vena cava syndrome (SVCS). Still, the clinical consequences of this syndrome have yet to be fully understood. In this study, the aim was to determine the clinical significance of SVCS in patients with SCLC.
Material and methods. A total of 374 SCLC patients were retrospectively investigated and evaluated.
Results. Small cell lung cancer was present in 24 (6.4%) patients at the time of diagnosis. In SVCS patients, all tumors were located in the right lung (p = 0.0001); most were in the upper lobes (n = 19, p = 0.009); and a greater number of tumors were larger than 5 cm (n = 21, p = 0.002). No correlation was found between the presence of SVCS and other clinical parameters, such as age, gender, weight loss, performance status, clinical stage, metastasis pattern, chemotherapy response, and recurrence. Overall survival rates were found to be similar in patients with and without SVCS (p = 0.1).
Conclusions. While tumor location and size were found to be associated with SVCS in SCLC patients, SVCS was not found to have prognostic value in terms of survival.
The role of metastasectomy and chemotherapy in the multimodal treatment of extraskeletal myxoid chondrosarcoma — a case series with literature review
No full textIntroduction. Extraskeletal myxoid chondrosarcoma (EMC) is an extremely rare soft tissue sarcoma (≤ 1/1,000,000 inhabitants/year), characterized by an indolent but metastasizing course; distant metastases (M1) occur in 30–50% of cases, predominantly to the lungs. However, there is limited research on the management of metastatic disease, particularly when metastasectomy and chemotherapy (CHT) are employed.
Material and methods. Two patients with a histopathologically confirmed diagnosis of EMC are described and were treated between 2013 and 2024 at a reference center, who underwent metastasectomy in the course of metastatic disease.
Results. Both patients underwent radical resection of the primary tumor (R0) and perioperative radiotherapy. Pulmonary M1 were indentified 17 months and 1 month after surgery, respectively. A total of 5 metastasectomies were performed. M1 recurrences were typical — the first after approximately 3 months in patient A and between 6 and 34 months after subsequent resections in patient B, with widespread progression diagnosed 24 months after the last extrapulmonary M1 resection. In the treatment of metastatic disease, first-line CHT (ADIC regimen; agents and dosing varied by case) was used in patient B with radiological progression after 3 months, while in patient A the ADIC regimen was limited due to a high risk of cardiotoxicity — LVEF 35–40%. In the second line, GEM/DTX brought short-term stabilization in patient B; in the case of A, second-line treatment was not implemented for cardiological reasons. No lasting systemic responses were achieved.
Conclusions. Metastasectomy in patients diagnosed with EMC allows for temporary control of the disease, however, does not prevent subsequent M1 recurrences — repeat surgical procedures are necessary. The implementation of CHT is of limited benefit and cardiac risk has to be considered
Nadciśnienie tętnicze oporne u pacjenta poradni lekarza rodzinnego — opis przypadku
No full textHypertension is a leading cause of death from cardiovascular disease. The differential diagnosis of hypertension should include secondary hypertension, including primary hyperaldosteronism (PA), particularly in young patients with treatment-resistant hypertension and hypokalemia. Due to the lack of specific symptoms and the unavailability of routine screening tests, PA can be challenging to diagnose.Nadciśnienie tętnicze jest jedną z głównych przyczyn zgonów z powodu chorób układu krążenia. W diagnostyce różnicowej nadciśnienia tętniczego należy uwzględnić nadciśnienie tętnicze wtórne, w tym pierwotny hiperaldosteronizm (PA, primary hyperaldosteronism), szczególnie u młodych pacjentów z nadciśnieniem tętniczym oporn ym na leczenie oraz hipokaliemią. Z powodu braku specyficznych objawów oraz niedostępności rutynowych badań przesiewowych, rozpoznanie PA może sprawiać trudności
Obstructive sleep apnea: it is time to focus on performing aerobic exercise that may improve erectile dysfunction associated with the disease
No full textDiabetes and severe complication of canaliculitis caused by Actinomyces spp. — case report and brief review
No full textAim: This study aimed to report a severe and rare complication of actinomycotic lacrimal canaliculitis requiring corneal transplantation.Methods: The study was a single case report performed at the Department of Diagnostics and Microsurgery of Glaucoma in Lublin, Poland.Results: An 86-year-old pigeon breeder had a long history of canaliculitis. After 1.5 years, he was admit-ted to the hospital with painful keratitis of the left eye, purulent discharge in the conjunctival sac, corneal perforation with Descemetocele, and choroidal detachment. The acuity of vision was critically low; the patient saw only hand motion in front of the infected eye. Swabs from the conjunctival sac, lacrimal can-aliculi, and corneal scrapings were collected and sent for microbiological culture analysis. Only deposits resembling "sulfur granules" led to the suspicion of actinomycetes. Therefore, ophthalmologists empirically administered intravenous cefazolin, topical moxifloxacin, and gentamicin to the patient. The culture results confirmed Actinomyces spp. and revealed co-infection with Klebsiella pneumoniae (ESBL-negative) and coagulase-negative staphylococci (CoNS). Corneal perforation required a customized deep anterior lamellar transplant. During the 3-month follow-up, the healing process was observed. The patient did not experience any pain, and the visual acuity improved significantly.Conclusions: Primary canaliculitis is a relatively rare chronic condition mostly caused by forgotten Actino-myces spp. As it turns out, it can also develop as a co-infection with other pathogens. This case highlights the importance of early diagnosis and treatment, particularly in elderly patients with comorbidities or immunodeficiencies