This study aimed to evaluate the real-world safety profile of combination therapy with a sodium-glucose cotransporter-2 inhibitor (SGLT-2i) and metformin relative to monotherapy, utilizing the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database.

We extracted adverse event (AE) reports from the FAERS database from the first quarter (Q1) of 2013 to the fourth quarter (Q4) of 2025 in which the combined regimen (ertugliflozin, dapagliflozin, empagliflozin, or canagliflozin plus metformin) was designated as the primary suspect. Disproportionality analyses were performed using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS) algorithms. Additionally, we examined the time-to-onset distribution and the clinical outcomes of the documented AEs.

A total of 23,407 combination-therapy reports were included. At the System Organ Class (SOC) level, ROR-based signal detection identified pronounced disproportionalities in metabolism and nutrition disorders (ROR = 9.00), renal and urinary disorders (ROR = 3.91), reproductive system and breast disorders (ROR = 2.59), and infections and infestations (ROR = 2.49). At the Preferred Term (PT) level, the five most frequently reported events cross-validated by all four algorithms were diabetic ketoacidosis (n = 3,522), weight decreased (n = 1,294), blood glucose increased (n = 1,226), acute kidney injury (n = 1,153), and euglycaemic diabetic ketoacidosis (euDKA, n = 1,114). Notably, euDKA demonstrated the highest signal intensity (ROR = 335.43), with the point estimate for the combination group being numerically higher than that observed for SGLT-2i monotherapy (ROR = 185.24). Regarding documented outcomes, hospitalisation or prolonged hospitalisation constituted the most prevalent serious outcome (33.7%), followed by life-threatening events (7.6%) and death (2.7%). In the sub-cohort with definitive time-to-onset data, 39.56% of AEs occurred within the first 30 days following treatment initiation.

This pharmacovigilance analysis of the FAERS database detected significant disproportionality signals for SGLT-2i/metformin combination therapy, particularly within metabolic/nutritional, renal/urinary, and infectious disease categories. The euDKA signal appeared prominent in descriptive comparisons. The predominance of hospitalisation-related events, coupled with the substantial concentration of AEs within the initial 30-day window, highlights the early treatment phase as a potentially critical monitoring period. These exploratory findings warrant rigorous validation through prospective cohort studies.

Prophylactic cranial irradiation (PCI) is the standard preventive strategy for limited-stage small-cell lung cancer (LS-SCLC). However, the evidence supporting this strategy is largely based on the pre-MRI era. With the advancement of modern MRI and treatment techniques, the survival benefit of PCI remains unclear, particularly given the potential for neurocognitive toxicity to impair quality of life. This study aims to re-evaluate the value of PCI in contemporary LS-SCLC patients and investigate whether active MRI surveillance is non-inferior to PCI regarding overall survival (OS).

This is a prospective, randomized, multicenter, phase III trial, enrolling patients with LS-SCLC who achieve complete response (CR) or partial response (PR) after platinum-based chemoradiotherapy. Participants will be randomly assigned (1:1) to receive either PCI or active MRI surveillance. The primary endpoint is OS. Secondary endpoints include 1- and 3-year OS rates, progression-free survival (PFS), brain metastasis rate, and neurocognitive function. Exploratory analyses will integrate clinical characteristics with the longitudinal kinetics of tumor biomarkers in collected peripheral blood to identify patient subgroups who are more likely to benefit from PCI.

This study will re-evaluate the role of PCI in the MRI era for LS-SCLC. If active MRI surveillance proves non-inferior, it may provide evidence supporting a less intensive management approach that could potentially reduce treatment-related neurotoxicity and preserve quality of life. Furthermore, our trial aims to identify patient subgroups that derive a clinical benefit from PCI, and leverage serial biomarker dynamics to guide personalized clinical management for LS-SCLC patients.

This trial is registered at ClinicalTrials.gov (NCT04829708).

Patients with colorectal carcinoma (CRC) frequently experience adverse effects during chemotherapy, including gastrointestinal reactions, weight loss, and myelosuppression, which may compromise treatment continuity and functional status. Gut microbiota dysbiosis has been associated with CRC progression, chemotherapy-related adverse effects, and treatment response. This study aims to evaluate the clinical efficacy and safety of Jianpi Jiedu optimized formula (JPJDYHF) as an adjunct to chemotherapy in patients with stage Ⅲ-Ⅳ CRC and to investigate its effects on gut microbiota composition.

A total of 121 patients with primary stage III-IV CRC were prospectively enrolled and allocated, according to patient preference, to a combination group (JPJDYHF plus chemotherapy) or a control group (chemotherapy alone). The control group received first-line chemotherapy regimens recommended by the Chinese Society of Clinical Oncology (CSCO) guidelines, whereas the combination group additionally received JPJDYHF Formula No.1 and Formula No.2 orally in a stage-specific manner. After exclusion of dropouts, 113 patients who completed 6 chemotherapy cycles were included in propensity score matching (PSM) based on 9 baseline variables, including age, sex, TNM stage, and chemotherapy regimen. Using 1꞉1 nearest-neighbor matching with a caliper of 0.25, 60 patients were selected for statistical analysis, with 30 patients in each group. The ability to proceed with chemotherapy from the first to the second cycle was recorded. At the end of each chemotherapy cycle, the objective response rate (ORR), disease control rate (DCR), Karnofsky Performance Status (KPS) score, traditional Chinese medicine (TCM) syndrome score, and chemotherapy-related adverse effects, including gastrointestinal reactions, weight loss, and myelosuppression, were assessed. Serum carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9), and liver and renal function indices were measured before and after chemotherapy. After completion of six chemotherapy cycles, fecal samples were collected and total DNA was extracted. High-throughput sequencing targeting the V3-V4 region of the 16S ribosomal RNA (16S rRNA) gene was performed. Alpha and beta diversity were evaluated, and differentially abundant taxa were identified using linear discriminant analysis effect size (LEfSe). Functional profiles were predicted using Phylogenetic Investigation of Communities by Reconstruction of Unobserved States 2 (PICRUSt2) and the Clusters of Orthologous Groups (COG) database.

After PSM, baseline characteristics were well balanced between the two groups. In terms of clinical efficacy, the combination group showed better chemotherapy continuation than the control group and had higher ORR (46.67% vs 16.67%) and DCR (90.00% vs 73.33%) (both P<0.05). The overall response rate for TCM syndromes was 73.3% in the combination group, significantly higher than 30.0% in the control group (P<0.05). At cycles 3 and 6, KPS scores were higher in the combination group than in the control group (both P<0.05). Regarding safety and adverse effects, by the end of cycle 6, the combination group showed less severe gastrointestinal reactions, less weight loss, and less myelosuppression than the control group (all P<0.05), whereas changes in liver and renal function indices did not differ significantly between the groups (all P>0.05). For serum biomarkers, CEA levels were lower and the reduction rate was greater in the combination group at the end of cycles 5 and 6 (all P<0.05), whereas no significant between-group differences were observed in CA19-9 levels or reduction rates (all P>0.05). Gut microbiota analysis showed no significant difference in alpha diversity between the 2 groups (P>0.05), whereas beta diversity showed significant separation (P<0.05). LEfSe analysis indicated decreased relative abundances of Bacteroidota, Fusobacteriota, and Campylobacterota in the combination group. At the genus level, the relative abundances of Bacteroides, Parabacteroides, and cancer-associated genus Fusobacterium were reduced, whereas the relative abundances of the short-chain fatty acid-producing genera Blautia and Ruminococcaceae-UCG-014 were increased (all P<0.05). COG-based functional prediction showed downregulation of pathways related to lipid transport and metabolism and cell wall/membrane/envelope biogenesis, together with activation of signal transduction functions, in the gut microbiota of the combination group.

In patients with stage III-IV CRC, adjunctive JPJDYHF may improve chemotherapy tolerance and short-term objective response, reduce myelosuppression and gastrointestinal adverse effects, promote reductions in serum CEA levels, and improve overall functional status. These effects may be related to remodeling of the gut microbial ecosystem, including reduced abundance of drug resistance-associated taxa such as Fusobacterium and enrichment of short-chain fatty acid-producing bacteria, thereby modulating lipid metabolism and signal transduction pathways. Future studies integrating multi-omics approaches with large multicenter cohorts are warranted to further clarify the specific molecular targets through which gut microbiota-derived metabolites regulate host immunity and enhance chemotherapy efficacy.

Objective: To systematically evaluate the clinical efficacy and safety of endoscopic submucosal dissection (ESD) versus surgical resection for early gastric cancer (EGC) in patients aged 75 years and above. Methods: A systematic search was conducted in PubMed, Embase, Cochrane Library, and CNKI from the inception of the database to April 2026, to include relevant literature on ESD and surgery for aged 75 years and above patients with EGC. The experimental group consisted of patients aged≥75 years treated with ESD (ESD group), while the control group included those treated with surgery (surgery group). According to inclusion and exclusion criteria, two researchers independently performed literature screening, data extraction using the Newcastle-Ottawa Scale, and conducted meta-analysis using RevMan 5.4 and Stata 18.0 software to assess heterogeneity using I². Outcome measures included the 5-year survival rate, recurrence rate, recurrence-related mortality rate, and tumor incidence rates across different mucosal layers in both groups of patients. Funnel plots and leave-one-out analysis were adopted for publication bias analysis and sensitivity analysis. Results: A total of 6 studies involving 2 045 patients were included, with 988 in the ESD group and 1 057 in the control group. The 5-year survival rate (82.9% vs 77.4%, OR=1.29, 95%CI: 1.01-1.65, P=0.040, I²=0) and gastric cancer recurrence rate (8.5% vs 4.3%, OR=2.39, 95%CI: 1.37-4.14, P=0.002, I²=24%) were higher in the ESD group than those in the surgical group, whereas the recurrence-related mortality rate was lower in the ESD group (1.9% vs 4.9%, OR=0.47, 95%CI: 0.25-0.86, P=0.020, I²=34%). Subgroup analysis by tumor incidence rates across different mucosal layers showed that the proportion of mucosal tumors was higher in the ESD group than that in the surgical group (78.8% vs 38.3%, OR=3.40, 95%CI: 1.15-10.07, P=0.030, I²=95%), whereas the proportion of submucosal tumors was lower in the ESD group than in the surgical group (20.7% vs 61.4%, OR=0.29, 95%CI: 0.10-0.87, P=0.030, I²=95%). Funnel plot analysis showed that the studies were generally symmetrically distributed on both sides of the pooled effect size (log OR), forming an inverted funnel shape; sensitivity analysis demonstrated that the point estimates of individual studies fluctuated slightly around the original pooled effect size (log OR=1.05). Conclusion: For EGC patients aged 75 years and above, ESD demonstrates superior clinical efficacy and safety compared to surgical treatment.

The sensitive, point-of-care detection of acute myeloid leukemia (AML)-derived exosomes is essential for non-invasive diagnosis and therapy monitoring, but remains technically challenging. Here we report a colorimetric biosensor based on a dual -aptamer-initiated catalytic cascade, where simultaneous recognition of exosomal markers CD63 and PTK7 by engineered aptamers triggers an in situ rolling circle amplification (RCA) reaction. The resulting RCA product templates the assembly of a metal-organic framework (MOF) nanozyme, which acts as an efficient peroxidase mimic to generate a colorimetric readout. This integrated "recognition -amplification-transduction" nanoarchitecture achieves a detection limit of 0.1 ng/mL for PTK7-positive exosomes and successfully discriminates patient serum samples from healthy controls as well as AML-bearing mouse models from healthy mice, with consistent results obtained via UV-vis spectroscopy, visual colorimetry, and smartphone-based grayscale analysis. By synergizing nucleic acid nanotechnology with nanozyme catalysis, this work provides a rapid, equipment-free visual platform for exosome-based liquid biopsy in AML management.

Artificial intelligence (AI) is increasingly integrated into oncology care, with oncology nurses playing a key role in patient education, communication, and trust in these technologies. Although artificial intelligence is increasingly integrated into healthcare, existing AI perception and technology acceptance scales have largely been developed for general healthcare settings and do not adequately capture the unique clinical, ethical, and workflow-related aspects of oncology practice. This study aimed to develop and psychometrically validate a scale measuring oncology patients' perceptions of artificial intelligence. The study focused on instrument development rather than testing a theoretical model of technology acceptance.

A methodological, cross-sectional scale development study. The scale was developed according to established nursing research guidelines. An initial item pool was generated using the Technology Acceptance Model, literature review and expert opinions from oncology nursing and interdisciplinary healthcare professionals. Content validity was assessed using the Davis technique and Lawshe method. Data were collected from 382 adult cancer patients receiving nursing care. Construct validity was examined using exploratory and confirmatory factor analyses. Reliability was evaluated using Cronbach's α, split-half reliability and composite reliability. Structural equation modeling with bootstrapping tested the theoretical model.

The final scale included 33 items across three factors: knowledge, awareness, and trust; perceived benefit; and acceptance and use tendencies. Exploratory factor analysis explained 82.37% of the total variance. Confirmatory factor analysis demonstrated good model fit (CFI = 0.99, RMSEA = 0.079, SRMR = 0.038). Internal consistency was excellent for the total scale (α = 0.97) and subscales (α = 0.97-0.98). Perceived benefit partially mediated the relationship between knowledge and acceptance, explaining 52% of the variance.

The scale is a valid and reliable instrument for assessing cancer patients' perceptions and acceptance of AI in oncology nursing practice. This scale provides oncology nurses and nurse researchers with a standardized tool to support nursing-led patient education, shared decision-making and the integration of AI into patient-centred oncology nursing care.

Objectives. Endocrine etiologies of secondary hypertension (HTN) are frequent and increasingly diagnosed according to the learned societies. Adrenal causes as primary aldosteronism (PA), pheochromocytomas (PHEO), and ACTH-independent Cushing's syndrome (CS) are widely described separately regarding their clinical, biochemical, and morphological aspects and only a few studies have developed the particular aspect of associated HTN. For this reason, we conducted a retrospective observational descriptive study at a tertiary referral center. Subjects. Fifty-five subjects were included (PA: 52.8%, PHEO: 29.1%, and CS: 18.1%). We found a slight female preponderance (60%). The average age of participants was 47.0±14.9 years. First-degree family history of HTN was described in up to two thirds of cases. Regarding HTN characteristics, subjects with PA presented significantly younger age at diagnosis and had more severe and resistant profile and required higher number of antihypertensive drugs. HTN-mediated organ damage (HMOD) was mainly cardiovascular and ocular. Patients with PHEO were significantly older at diagnosis and had more severe and paroxysmal HTN. Patients with CS had less severe HTN and less HMOD. Specific treatments were indicated in all cases aiming complete remission of HTN. Subjects with PA were treated medically with mineralocorticoid receptor antagonists in 72.4% of cases and HTN remission was achieved in only 21.8% after surgical treatment. All subjects with PHEO were operated with adrenalectomy and the remission was observed in 37.5% of cases, while patients with CS were surgically managed in 50% of cases with 40% of HTN remission. Conclusions. Diagnosis and management of adrenal endocrine HTN diseases are challenging for healthcare professionals and early screening is crucial for prevention of cardiovascular morbidity.

Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL) is a rare, aggressive intestinal T-cell lymphoma with poorly defined prognostic factors and limited therapeutic evidence. This study presents a retrospective, pooled patient-level analysis of MEITL cases, including those previously classified as type II enteropathy-associated T-cell lymphoma, consistent with modern MEITL criteria. Among 299 patients, the median age was 60 years, with a male preponderance. Cases clustered predominantly in East Asia. Abdominal pain was the most frequent presentation, and perforation occurred in 31.9% of cases. The canonical CD3+, CD4-, CD5-, CD8+, CD56+ phenotype was present in 65.9% of fully annotated cases. Median OS was 12 months, and median PFS was 5 months. Elevated LDH ≥ 250 U/L (p = 0.002), advanced Lugano stage II2/IIE/IV (p = 0.042), and non-ileal-only disease distribution were associated with inferior OS, whereas isolated ileal involvement was favorable (p = 0.004). In multivariable analysis, advanced Lugano stage, non-ileal-only involvement, and failure to achieve complete or partial response remained independently adverse. An exploratory prognostic score incorporating stage, anatomic distribution, and LDH showed preliminary risk group separation in a small subset of patients (C-index 0.734). Stem cell transplantation (SCT) was associated with improved survival in fixed-time analyses, but this association was attenuated after accounting for transplant timing; exploratory responder-restricted and landmark analyses suggested that any potential SCT benefit may be concentrated among patients with chemotherapy-sensitive disease. MEITL demonstrates poor survival despite multimodality therapy. Disease extent, anatomic distribution, LDH, treatment response, and response-adapted SCT may inform risk stratification and management.

Cervical cancer remains a major public health challenge in Brazil. A molecular testing for human papillomavirus (HPV) was incorporated into the national screening program, current strategies prioritize HPV-16 and HPV-18, potentially overlooking other high-risk genotypes circulating regionally. This cross-sectional study evaluated HPV prevalence and genotype distribution among 8073 women in routine cervical screening and a separately recruited research cohort of sexually active women aged 15-25 years in 25 municipalities in southern Espírito Santo, Brazil, from September 2024 to September 2025. Cervicovaginal samples were tested using the Allplex HPV28 real-time quantitative PCR assay, which detects 28 HPV genotypes. Sociodemographic and behavioral data were collected via standardized questionnaires and vaccination status was verified for women aged 15-25 years using official records. Associations were analyzed using odds ratios (ORs) and 95% confidence intervals (CIs). Overall HPV prevalence was 27.9%, increasing to 57.0% among those aged 15-25 years. Carcinogenic genotypes comprised 43.4% of infections. The most prevalent relevant genotypes were HPV-53 (3.6%), HPV-68 (3.1%), HPV-52 (2.9%), HPV-16 (2.9%), and HPV-58 (2.3%). Multiple carcinogenic/probable or possible carcinogenic infections occurred in 48.5% of HPV-positive cases, with HPV-52, HPV-53, and HPV-68 forming a central coinfection cluster. Among women aged 15-25 years, 30.4% were vaccinated; no vaccine-covered genotypes were detected in vaccinated women, compared with 6.4% in unvaccinated women (OR, 0.17; 95% CI, 0.009-3.08; p = 0.18). Non-16/18 genotypes predominate in this population, but the two most prevalent (HPV-53 and HPV-68) carry comparatively low attributable risk for invasive cervical cancer under current global classifications, whereas genotypes with established high carcinogenic potential (16, 18, 31, 33, 35, 45, 52, and 58) accounted for only 31.5% of detected infections. These findings support continued regional genotype surveillance and vaccine-impact monitoring but, in the absence of histological or invasive-cancer outcome data from this population, do not by themselves justify changes to screening panels or vaccine composition based on prevalence alone.

Prior transurethral resection of the prostate (TURP) may distort bladder neck and apical anatomy and complicate robot-assisted radical prostatectomy (RARP). Its effect on anastomotic recovery and oncological control remains controversial. To evaluate perioperative, anastomotic, pathological, and available PSA outcomes after RARP in patients with and without prior TURP. We retrospectively analyzed a prospectively maintained database of 3,332 consecutive RARP procedures performed between August 2011 and December 2024. Ninety-seven patients with prior TURP were matched 1:3 to 291 TURP-naive controls using propensity scores derived from age, body mass index, clinical stage, ISUP grade, prostate-specific antigen (PSA), positive biopsy cores, and prostate volume. Comparative outcome analyses used available cases within the matched cohort. Baseline characteristics were well balanced after matching. Operative duration was similar between groups (median 135 vs. 139 min; p = .584). Prior TURP was associated with longer catheterization (7 [IQR 4.5-11.5] vs. 6 [4-7] days; p = .004), more cystographies (p = .004), more frequent catheterization beyond 7 days (33.7% vs. 20.1%; p = .011), and a higher rate of complications within 3 months (13.4% vs. 6.2%; p = .030). Cystographic leakage was numerically more frequent after TURP (25.4% vs. 14.8%; p = .061). Pathological stage, nodal positivity, positive surgical margin rate and length, and available PSA outcomes at 1 and 2 years were comparable. After Bonferroni adjustment, catheterization duration and the number of cystographies remained statistically significant. Prior TURP was associated primarily with greater postoperative anastomotic management reflected by longer catheterization and more cystographic follow-up; the observed increase in 3-month complications did not remain significant after correction for multiple comparisons. Available PSA data did not indicate a clear between-group difference, although incomplete follow-up precluded robust conclusions regarding biochemical control.