Articulos Científicos Medicina

Sentinel lymph node detection in gastric cancer using a dual tracer (Superparamagnetic iron oxide and methylene blue): a prospective study with histological and OSNA validation

Thu, 01 Jan 2026 00:00:00 GMT

Sentinel lymph node detection in gastric cancer using a dual tracer (Superparamagnetic iron oxide and methylene blue): a prospective study with histological and OSNA validation Escalera Pérez, Raquel; Medina-Achirica, C.; García-Molina, F.J.; Del Rio-Ignacio, J.J.; Lagares Franco, Carolina María; Estella García, Ángel; Mateo Vallejo, Francisco de Asís Gastric cancer (GC) remains an oncological challenge, with lymph node involvement being a major prognostic factor. Sentinel lymph node (SLN) mapping may improve staging and reduce morbidity. This study evaluated a dual-tracer technique (superparamagnetic iron oxide: SPIO and methylene blue) for ex vivo detection; assessed one-step nucleic acid amplification (OSNA) versus conventional histology; and applied OSNA-pooling analysis in non-SLN. Prospective study of patients undergoing curative gastrectomy with lymphadenectomy (2017–2022). SLNs were identified in fresh specimens by Sentimag® and/or macroscopic staining. Each lymph node was bisected, with one half analyzed by hematoxylin–eosin (H&E) and the other by OSNA. Non-SLN were assessed using pooled OSNA to enhance diagnostic performance. Diagnostic performance metrics and agreement (Cohen’s κ) were calculated. Survival was estimated by Kaplan–Meier. Thirty-eight patients were included (mean age 64.3 years; 58% male); 71.1% received neoadjuvant therapy. SLN detection rate was 84.2% (32/38), with 80 SLNs identified. The dual-tracer approach demonstrated high sensitivity (93.1%) and moderate specificity (44.4%), resulting in an accuracy of 81.6%. Tracer concordance was moderate (κ = 0.42; p < 0.007). OSNA showed good agreement with H&E (sensitivity 80%, specificity 87%), and better performance for micrometastases. The pooling analysis evaluated 1155 non-SLN simultaneously; this novel strategy showed good concordance with conventional histology. After a median follow-up of 53 months, OSNA and H&E status were associated with overall survival in exploratory analyses; however, these findings should be interpreted with caution given the limited sample size and ex vivo proof-of-concept design. Combining SPIO and methylene blue is technically feasible for ex vivo SLN mapping. OSNA complements histology, and its pooled use represents an innovative methodological approach. These results are preliminary and hypothesis-generating; larger prospective in vivo studies are required before clinical applicability can be evaluated. Dual-tracer sentinel node mapping in gastric cancer proved feasible and accurate. OSNA complemented histology, pooled analysis improved detection efficiency, and neoadjuvant therapy did not affect diagnostic performance.

Efficacy and Safety of Guselkumab in Real-World Evidence: A Systematic Review and Meta-Analysis

Mon, 11 May 2026 00:00:00 GMT

Efficacy and Safety of Guselkumab in Real-World Evidence: A Systematic Review and Meta-Analysis Dodero-Anillo, Jose Manuel; Fernandez-Pujol-Marzo, Marta; Pedrosa Martínez, María José; Ruiz-Villaverde, Ricardo; Armario Hita, José Carlos Background: Guselkumab, a selective anti-IL-23p19 monoclonal antibody, has shown high efficacy in randomized trials for moderate-to-severe psoriasis and active psoriatic arthritis (PsA). Real-world evidence is essential to assess treatment performance in broader and more heterogeneous patient populations. Objectives: To synthesize the available real-world evidence on the effectiveness and safety of guselkumab in psoriasis and PsA, and to quantify pooled clinical responses across clinically relevant follow-up windows. Methods: A systematic review and meta-analysis was conducted according to PRISMA 2020. PubMed/MEDLINE, MEDLINE, and Web of Science were searched for observational real-world studies of guselkumab in adults with psoriasis and/or PsA. Primary pooled outcomes were PASI 90 and PASI 100 in psoriasis and DAPSA < 14 in PsA. Random-effects meta-analysis of proportions was performed using a logit transformation. Cohort overlap was explicitly assessed and overlapping publications were not allowed to contribute concurrently to the same pooled estimate. Results: Thirty-four studies were included (29 psoriasis, 5 PsA). In psoriasis, pooled PASI 90 response rates were 50.8% (95% CI 46.8–54.8) at 12–16 weeks, 68.4% (95% CI 66.3–70.4) at 20–28 weeks, 71.2% (95% CI 64.9–76.8) at 36–60 weeks, and 77.1% (95% CI 74.9–79.3) at ≥96 weeks. Pooled PASI 100 response rates were 49.8% (95% CI 47.5–52.2) at 20–28 weeks and 49.7% (95% CI 47.1–52.3) at 36–60 weeks. In PsA, pooled DAPSA < 14 response rates were 56.9% (95% CI 23.0–85.3) at 20–28 weeks and 69.5% (95% CI 62.5–75.7) at 48–60 weeks. Safety reporting was heterogeneous, but serious adverse events and discontinuations due to adverse events were uncommon. Conclusions: Real-world evidence supports guselkumab as an effective treatment for psoriasis and a clinically useful option for PsA, with a safety profile broadly consistent with the known trial experience. Interpretation remains limited by observational designs, heterogeneous denominators, and inconsistent safety reporting.

Optimising Therapeutic Intervals for Anti-TNF Biologics in Rheumatoid Arthritis: A Retrospective Real-World Study

Fri, 24 Apr 2026 00:00:00 GMT

Optimising Therapeutic Intervals for Anti-TNF Biologics in Rheumatoid Arthritis: A Retrospective Real-World Study Dodero-Anillo, Jose Manuel; Rosety Rodríguez, Manuel; Pedrosa Martínez, María José Background: Therapeutic drug monitoring (TDM) of anti-TNF biologics may help optimise treatment in rheumatoid arthritis (RA), but current therapeutic ranges do not always reflect clinical response in routine practice. Methods: We conducted a retrospective observational study including 224 adults with RA treated with infliximab (IFX), adalimumab (ADL), or etanercept (ETN) during the maintenance phase at Hospital Universitario Puerto Real between May 2016 and May 2023. Drug and anti-drug antibody levels were measured by sandwich ELISA and analysed against clinical response using DAS28. Demographic and clinical variables, associations between drug levels and response, the effect of antibodies, correlations between serum concentrations and DAS28, and the performance of current and proposed therapeutic ranges were evaluated. Results: The cohort was mainly female (62.1%), with a mean age of 57.7 years, BMI of 28.5 kg/m2, and mean DAS28 of 3.33. ETN was most frequently used (62.5%), followed by ADL (21.9%) and IFX (15.6%). Drug levels were significantly associated with response (p < 0.001). Anti-drug antibodies were strongly linked to non-response, especially with IFX and ADL. Serum drug levels correlated inversely with disease activity for IFX and ADL, but not for ETN. Current therapeutic ranges showed low sensitivity, while lower proposed ranges improved sensitivity considerably. Conclusions: Current anti-TNF therapeutic ranges have limited ability to identify responders in real-world RA. Lowering the lower bound improves sensitivity and supports more individualised TDM, particularly for IFX and ADL, pending prospective validation.

Diagnostic accuracy of SeptiCyte® RAPID to discriminate sepsis from non-infectious critical illness in patients meeting sepsis criteria according to sepsis-3 definition at ICU admission

Thu, 01 Jan 2026 00:00:00 GMT

Diagnostic accuracy of SeptiCyte® RAPID to discriminate sepsis from non-infectious critical illness in patients meeting sepsis criteria according to sepsis-3 definition at ICU admission Cantón-Bulnes, María Luisa; García Garmendia, José Luis; Estella García, Ángel; Fernández-Galilea, Adela; Blanco, Isidro; Estecha-Foncea, María Antonia; Gordillo-Resina, Marina; Rodríguez-Gómez, Jorge; Pineda-Capitán, Jesús; Martínez-Fernández, Carmen; Escoresca-Ortega, Ana; Amaya Villar, Rosario; Mora-Ordóñez, Juan; González-Soto, Sara; Garnacho-Montero, José Objectives: The aim of this study was to validate the SeptiCyte® RAPID assay, a molecular test to distinguish sepsis from sterile inflammation, by determining its diagnostic accuracy in critically ill patients who meet criteria for sepsis according to Sepsis-3 definition on ICU admission Design: This is an observational, prospective, and multicenter study.Setting: Carried out in seven hospitals in Andalusia (Spain). A 2.5 mL whole blood sample was collected and tested in a SeptiCyte RAPID kit on a real time PCR platform (IdyllaTM). A score from 0 to 15 (SeptiScore™) was generated that falls into four bands based on the increasing likelihood of infection-positive systemic inflammation. Patients: Patients aged 18 years or older, admitted to the ICU with a diagnosis of sepsis.Main results: We enrolled 354 patients, of whom 86 (24.3%) did not present sepsis at the researchers´ discretion. SeptiCyte® RAPID showed an AUC of [0.84 (CI95% 0.79-0.87)] for differentiating sepsis from sterile systemic inflammation. SeptiCyte® RAPID was significantly better for sepsis diagnosis than CRP [0.75 (CI95% 0.70-0.80)] (p =0.003) but without significant differences with PCT [0.80 (CI95% 0.75-0.84)]. SeptiScore distribution in patients with sepsis was higher than patients with sterile inflammation, with a PPV of 68.8% and 92.2% (Bands 3 and 4) for sepsis diagnosis and a PPV of 100% for sterile inflammation (Band 1). Independent risk factors for sepsis were estimated probability of sepsis [OR 8.02 (CI 95% 4.50-14.28), p<0.001], SeptiScore [OR 1.64 (CI 95% 1.35-1.99), p<0.001], and log procalcitonin [OR 1.68 (CI 95% 1.09-2.59), p=0.020].Conclusions: SeptiCyte® RAPID discriminates sepsis from sterile inflammation in critically ill adults, adding value to the diagnosis of sepsis. Purpose: The aim of this study was to validate the SeptiCyte® RAPID assay, a molecular test to distinguish sepsis from sterile inflammation, by determining its diagnostic accuracy in critically ill patients who meet criteria for sepsis according to Sepsis-3 definition on ICU admission.Methods: This is an observational, prospective, and multicenter study. Carried out in seven hospitals in Andalusia (Spain). A 2.5 mL whole blood sample was collected and tested in a SeptiCyte RAPID kit on a real time PCR platform (IdyllaTM). A score from 0 to 15 (SeptiScore™) was generated that falls into four bands based on the increasing likelihood of infection-positive systemic inflammation.Patients aged 18 years or older, admitted to the ICU with a diagnosis of sepsis were included. Results: We enrolled 353 patients, of whom 86 (23.7%) did not present sepsis at the researchers´ discretion. SeptiCyte® RAPID showed an AUC of [0.84 (CI95% 0.79-0.87)] for differentiating sepsis from sterile systemic inflammation. SeptiCyte® RAPID was significantly better for sepsis diagnosis than CRP [0.75 (CI95% 0.70-0.80)] (p =0.003) but without significant differences with PCT [0.80 (CI95% 0.75-0.84)]. SeptiScore distribution in patients with sepsis was higher than patients with sterile inflammation, with a PPV of 68.8% and 92.2% (Bands 3 and 4) for sepsis diagnosis and a PPV of 100% for sterile inflammation (Band 1). Independent risk factors for sepsis were physicians´ subjective likelihood of sepsis [intermediate probabilty OR 4.55 (95% CI 1.61-12.83), p=0.004 and high probabilty OR 72.04 (95% CI 20.85-248.93), p<0.001], SeptiScore [OR 1.65 (95% CI 1.32-2.07), p<0.001], and log procalcitonin [OR 1.74 (95% CI 1.08-2.79), p=0.022].Conclusions: SeptiCyte® RAPID discriminates sepsis from sterile inflammation in critically ill adults, adding value to the diagnosis of sepsis.