A randomized, double-blind, placebo-controlled 12-week trial of infliximab in patients with juvenile-onset spondyloarthritis

Objective: To assess the efficacy and safety of infliximab versus placebo in the treatment of patients with juvenile-onset spondyloarthritis (JoSpA). Methods: Phase III, randomized, double-blind, placebo-controlled trial of 12 weeks that included patients <= 18 years old with JoSpA not responding to nonsteroidal anti-inflammatory drugs, sulfasalazine, or methotrexate. Patients were randomly assigned 1:1 to the infusion of infliximab 5mg/kg or placebo; completers entered then an open-label extension (OLE) period of 42 weeks. The primary endpoint was the number of active joints. Secondary outcomes included the assessment of disease activity, tender entheses, spinal mobility, serum C-reactive protein (CRP), the Bath Ankylosing Spondylitis Disease Activity and Functional Index, and the Childhood Health Assessment Questionnaire (CHAQ). Results: We randomized 12 patients to infliximab and 14 to placebo. No significant differences were found between groups at baseline. At week 12, the mean number of active joints was 1.4 (SD 2.4) in the infliximab group and 4.1 (SD 3.0) in the placebo group (p = 0.0002). A repeated-measures mixed model analysis that included all endpoints in the study demonstrated sustained favourable outcomes of infliximab for active joints, tender joints, swollen joints, and tender enthesis counts, as well as for CHAQ and CRP (p < 0.01). Adverse events were more frequent in the infliximab group, including infections and infusion reactions, but none of them was serious. Conclusion: Infliximab is efficacious for patients with JoSpA with an inadequate response to conventional treatment. No serious adverse events with the use of infliximab were observed.</p

A randomized, double-blind, placebo-controlled 12-week trial of infliximab in patients with juvenile-onset spondyloarthritis

Objective To assess the efficacy and safety of infliximab versus placebo in the treatment of patients with juvenile-onset spondyloarthritis (JoSpA). Methods Phase III, randomized, double-blind, placebo-controlled trial of 12 weeks that included patients <= 18 years old with JoSpA not responding to nonsteroidal anti-inflammatory drugs, sulfasalazine, or methotrexate. Patients were randomly assigned 1:1 to the infusion of infliximab 5mg/kg or placebo; completers entered then an open-label extension (OLE) period of 42 weeks. The primary endpoint was the number of active joints. Secondary outcomes included the assessment of disease activity, tender entheses, spinal mobility, serum C-reactive protein (CRP), the Bath Ankylosing Spondylitis Disease Activity and Functional Index, and the Childhood Health Assessment Questionnaire (CHAQ). Results We randomized 12 patients to infliximab and 14 to placebo. No significant differences were found between groups at baseline. At week 12, the mean number of active joints was 1.4 (SD 2.4) in the infliximab group and 4.1 (SD 3.0) in the placebo group (p = 0.0002). A repeated-measures mixed model analysis that included all endpoints in the study demonstrated sustained favourable outcomes of infliximab for active joints, tender joints, swollen joints, and tender enthesis counts, as well as for CHAQ and CRP (p < 0.01). Adverse events were more frequent in the infliximab group, including infections and infusion reactions, but none of them was serious. Conclusion Infliximab is efficacious for patients with JoSpA with an inadequate response to conventional treatment. No serious adverse events with the use of infliximab were observed.Pathophysiology and treatment of rheumatic disease

Characteristics and mortality of Mexican patients with COVID-19 and mechanical ventilation

Introduction: COVID-19-associated mortality in patients who require mechanical ventilation is unknown in the Mexican population. Objective: To describe the characteristics of Mexican patients with COVID-19 who required mechanical ventilation. Methods: Observational cohort study carried out in an intensive care unit from March 25 to July 17, 2020. Data were obtained from a prospective database and electronic medical records, and were analyzed with the chi-square test, Fisher’s exact test or Mann-Whitney’s U-test. Results: One hundred patients required mechanical ventilation; median age was 56 years, 31 % were females and 97 % were Latin American. Most common comorbidities were obesity (36 %), diabetes (26 %), hypertension (20 %), and chronic or end-stage kidney disease (10 %). At the end of the analysis, 11 patients remained in the ICU, 31 had been discharged alive and 58 (65.2 %) died; survivors were younger, had lower scores on severity and organ dysfunction scales, lower levels of C-reactive protein at ICU admission, were less likely to receive hemodialysis and vasopressors, and had longer hospital and ICU stays. Conclusions: This study adds information on the presentation and results of SARS-CoV- 2-infected patients who require mechanical ventilation

Utility of a clinical risk scale to predict the requirement of advanced airway management in patients with a diagnosis of deep neck abscess

Objectives: To analyze the clinical utility of a clinical risk scale to predict the need for advanced airway management in patients with deep neck abscess. Methods: Observational, analytical, cross-sectional study. Patients over 18 years old, both genders, with surgical management of a deep neck abscess, between January 1st, 2015 to December 31th, 2021, who were applied the clinical risk scale (https://7-414-5-19.shinyapps.io/ClinicalRiskScore/). The sensitivity, specificity, and predictive values of the scale were calculated based on the identified clinical outcomes. A p < 0.05 was considered significant. Results: A sample of 213 patients was obtained, 121 (56.8%) men, of whom 50 (23.5%) required advanced airway management. Dyspnea was the variable with the most statistical weight in our study, (p = 0.001) as well as the multiple spaces involvement, (p = 0.001) the presence of air corpuscles, (p = 0.001) compromise of the retropharyngeal space (p = 0.001) and age greater than 55 years (p = 0.001). Taking these data into account, were found for the clinical risk scale a sensitivity of 97% and a specificity of 65% (p = 0.001, 95% CI 0.856–0.984). Conclusions: The clinical risk scale developed to predict advanced airway management in patients with a diagnosis of deep neck abscess may be applicable in our environment with high sensitivity and specificity. Level of evidence: IV

Use of N-acetylcysteine plus simethicone to improve mucosal visibility in upper digestive endoscopy via systematic alphanumeric-coded endoscopy: a randomized, double-blind controlled trial

Background The use of antifoaming and mucolytic agents prior to upper gastrointestinal (GI) endoscopy and a thorough systematic review are essential to optimize lesion detection. This study evaluated the effect of simethicone and N-acetylcysteine on the adequate mucosal visibility (AMV) of the upper GI tract by an innovative systematic method. Methods This randomized, double-blind controlled trial included consecutive patients who underwent diagnostic upper GI endoscopy for screening for early neoplasms between August 2019 and December 2019. The upper GI tract was systematically assessed by systematic alphanumeric-coded endoscopy. Patients were divided into 4 groups: 1) water; 2) only simethicone; 3) N-acetylcysteine + simethicone; and 4) only N-acetylcysteine. The following parameters were assessed in each group: age, sex, body mass index, level of adequate mucosal visibility, and side-effects. Results A total of 4564 images from upper GI areas were obtained for evaluation. The mean AMV in the 4 groups was 93.98±7.36%. The N-acetylcysteine + simethicone group had a higher cleaning percentage compared with the other groups (P=0.001). There was no significant difference among the remaining groups, but several areas had better cleaning when a mucolytic or antifoam alone was used. No side-effects were found in any group. Conclusion The combination of N-acetylcysteine plus simethicone optimizes the visibility of the mucosa of the upper GI tract, which could potentially increase diagnostic yield. © 2024 Hellenic Society of Gastroenterology

Development of Polyvinyl Alcohol Hydrogels for Controlled Glucose Release in Biomedical Applications

Polyvinyl alcohol (PVA) hydrogels have a wide range of applications in the pharmaceutical and biomedicine fields due to their exceptional biophysical properties. The study focuses on preparing and characterizing capsule-shaped PVA hydrogels to enhance their biocompatibility and porosity for controlled glucose release and cell proliferation. The hydrogels were prepared using different concentrations (Cs) and molecular weights (MWs) of PVA, with two different lengths, A (10 mm) and B (20 mm), to control glucose release over 60 min. The preparation process involved PVA gel preparation and PVA hydrogel formation. A total of 500 µL of glucose was injected into all dehydrated hydrogels in groups A and B. Glucose release was studied by immersing the hydrogels in saline at 37 °C with stirring at 500 rpm. The SUP-B15 cell line was grown in six A1 hydrogels for biocompatibility testing. The results indicate that all hydrogels remained stable at 37 °C without degrading. Those with a higher C and MW exhibited a denser and less porous structure, lower glucose storage capacity, and higher elongation at break. Significant differences in glucose release, diffusion speed, and flux were observed, which were more evident in A1 > A4, B1 > B4, and B1 > A1 over 60 min. A1 and B1 had higher values because their higher porosity distribution allowed glucose to diffuse more easily. B1, being larger, has more glucose due to its increased length. The cell growth response and viability at 48 h in contact with the hydrogels was similar to that of the control (4.5 × 105 cells/mL, 98.5% vs. 4.8 × 105 cells/mL, 99.7% viability), thus demonstrating biocompatibility. The hydrogels effectively released glucose over 60 min, with variations based on porosity, C, MW, and length, and demonstrated good biocompatibility with the cell line