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Patient-centered outcomes with subcutaneous immunoglobulin use for infection control in primary and secondary immunodeficiencies: data of a GEIE Spanish Registry
Get PDFPatient-centered outcomes; Primary immunodeficiency; Subcutaneous immunoglobulinResultados centrados en el paciente; Inmunodeficiencia primaria; Inmunoglobulina subcutáneaResultats centrats en el pacient; Immunodeficiència primària; Immunoglobulina subcutàniaBackground and aim: Subcutaneous immunoglobulin (SCIg) has emerged as an alternative to intravenous administration for patients with primary (PID) and secondary immunodeficiencies (SID), offering benefits such as fewer systemic adverse reactions and greater patient autonomy. However, comprehensive real-world data on SCIg use, including clinical and patient-centered outcomes, remain scarce. This study, conducted by expert immunodeficiency nursing teams, assesses the clinical characteristics, reported adverse effects, and quality-of-life outcomes associated with SCIg therapy with different formulations in patients with PID and SID across Spain.
Methods: A multicenter, cross-sectional study was conducted across 8 immunodeficiency nursing units in Spain, involving 223 adult patients treated with SCIg from 2004 to 2024. Data on demographics, comorbidities, SCIg treatment characteristics, reported adverse events, and quality-of-life metrics (EuroQol-5D-3L, Gijón Scale) were collected and analyzed.
Results: The cohort (61.4% female, mean age: 47.1 years) included 65% PID patients, with common variable immunodeficiency being the most frequent diagnosis (39.8%). SCIg demonstrated good tolerability overall, with no significant differences in global adverse event rates between facilitated 10% (fSCIg) and 20% formulations. However, 10% fSCIg was associated with higher reported frequencies of mild local rash (58.7% vs. 36.9%, p=0.002) and fever (10.6% vs. 1.7%, p=0.01). Quality-of-life scores indicated minimal limitations in mobility and self-care, with a mean subjective health rating of 72.7/100. Patients using 20% SCIg required fewer educational sessions for self-administration compared to the 10% group.
Conclusion: The different SCIg formulations in this large, multicenter cohort was effective and generally well-tolerated, supporting its use for maintaining adequate IgG levels and promoting patient independence in PID and SID. The study’s findings advocate for tailored approaches that optimize patient satisfaction and address individual needs, emphasizing the critical role of dedicated immunodeficiency nursing teams in ensuring safe, effective, and patient-centered SCIg administration.The author(s) declare financial support was received for the research, authorship, and/or publication of this article. This study was partially funded by the Ayudas a la Investigacion 2024 program, granted by the Official College of Nursing of Valencia (Colegio Oficial de Enfermerıa de Valencia)
Improvement of intestinal inflammation after treatment with CFTR modulators in cystic fibrosis patients
Get PDFFibrosis quística; Moduladores CFTR; Inflamación intestinalCystic fibrosis; CFTR modulators; Intestinal inflammationFibrosi quística; Moduladors CFTR; Inflamació intestinalIntroducción
Los tratamientos con moduladores de la proteína CFTR han mejorado la salud respiratoria y digestiva de los pacientes con fibrosis quística.
Objetivo
Analizar los cambios en la inflamación intestinal mediante el estudio de la calprotectina fecal en pacientes con fibrosis quística durante el tratamiento con moduladores.
Material y métodos
Estudio multicéntrico prospectivo de los cambios en la calprotectina fecal de pacientes con fibrosis quística tratados con moduladores, comparando aquellos constituidos por dos moléculas (lumacaftor/ivacaftor o tezacaftor/ivacaftor) con los de tres moléculas (elexacaftor/tezacaftor/ivacaftor). Se recogen datos antes de iniciar el tratamiento, a los 6 y a los 12 meses.
Resultados
Análisis de 117 pacientes (69% F508del/F508del). Mediana basal de calprotectina fecal 49 μg/g (RIC: 23-108); 48,7% con > 50 μg/g; 11% con > 250 μg/g. Hubo disminución de calprotectina fecal en ambos grupos, siendo mayor en aquellos con elexacaftor/tezacaftor/ivacaftor. Se observó una disminución progresiva de los valores anormales (> 50 μg/g) a los 6 meses 48,7% vs 33,1% (p = 0,0067) y a los 12 meses 54% vs 33,5% (p = 0,0218). En el grupo elexacaftor/tezacaftor/ivacaftor, solo 2 pacientes a los 6 meses y 1 paciente a los 12 meses tenían > 250 μg/g. El cambio estimado (IC 95%) a 12 meses en el grupo con triple terapia en comparación con el otro grupo fue de −133 μg/g (−254 a −13, p = 0,030), y ajustado por sexo, probióticos y Pseudomonas aeruginosa, de −130 μg/g (−259 a −1, p = 0,049).
Conclusiones
El tratamiento con moduladores CFTR reduce la inflamación intestinal en pacientes con fibrosis quística, siendo la mejoría más destacada en pacientes tratados con la triple terapia.ntroduction
Treatments with CFTR protein modulators have improved respiratory and digestive health in patients with cystic fibrosis.
Objective
To assess changes in intestinal inflammation through the analysis of fecal calprotectin in patients with cystic fibrosis during treatment with CFTR modulators.
Material and methods
Prospective multicenter study of changes in fecal calprotectin in patients with cystic fibrosis treated with CFTR modulators, comparing double combinations (lumacaftor/ivacaftor or tezacaftor/ivacaftor) and triple combinations (elexacaftor/tezacaftor/ivacaftor). We collected data before treatment initiation and at 6 and 12 months.
Results
Analysis of 117 patients (69% with F508del/F508del). The median baseline fecal calprotectin level was 49 μg/g (IQR: 23-108); 48.7% had median levels greater than 50 μg/g and 11% levels greater than 250 μg/g. Fecal calprotectin decreased in both groups, with a greater decrease in patients treated with elexacaftor/tezacaftor/ivacaftor. We found a progressive decrease in abnormal values (> 50 μg/g) at 6 months (48.7% vs 33.1%; P = .0067) and at 12 months (54% vs 33.5%; P = .0218). In the elexacaftor/tezacaftor/ivacaftor group, only two patients at 6 months and one patient at 12 months had levels greater than 250 μg/g. The estimated change at 12 months in the triple therapy group compared to the other group was −133 μg/g (95% CI: − 254 to − 13; P = .030); and, adjusting for sex, probiotics and Pseudomonas aeruginosa, − 130 μg/g (−259 to − 1; P = .049).
Conclusions
Treatment with CFTR modulators reduces intestinal inflammation in patients with cystic fibrosis, with a greater decrease in patients treated with triple therapy
Impact of zinc on hepatocellular carcinoma cell behavior and metallothionein expression: Insights from preclinical models
Get PDFCarcinoma hepatocel·lular; Zinc; BiomarcadorHepatocellular carcinoma; Zinc; BiomarkerCarcinoma hepatocelular; Zinc; BiomarcadorBackground
Zinc (Zn) is an essential trace element involved in a wide variety of cellular processes and is vital for optimal liver function. Our objective was to elucidate the potential therapeutic role of Zn in hepatocellular carcinoma (HCC), the third leading cause of cancer-related death and the first cause of death in patients with cirrhosis.
Methods
The impact of Zn supplementation on proliferation, invasion, migration, cell cycle, and apoptosis was conducted on four HCC cell lines as well as in a xenograft mouse model of HCC from which tumor gene expression profiles were also analyzed. Gene deregulation and protein expression were validated in human HCC tissues. Finally, Zn and MT1 (Metallothionein 1) levels were quantified in plasma from patients with HCC.
Results
Zn supplementation significantly modulated proliferation, invasion, and migration in HCC cell lines and induced apoptosis in a dose-dependent manner. Although Zn did not exhibit a significant increase in survival, Zn supplementation significantly altered the expression of MT genes. Specifically, MT1G and MT1H expression were notably suppressed in HCC tissues from mice and these results were validated in human HCC samples. Overall, gene and protein MTs expression was significantly lower in HCC areas compared to adjacent liver tissue and plasma Zn levels exhibited substantial variation across different stages of the liver disease.
Conclusion
Zn supplementation influences key cellular behaviors in a dose-dependent manner and upregulates the expression of MT family genes, which may have tumor-suppressive properties, in vitro an in vivo models. Future research should investigate the prognostic implications of Zn supplementation as part of a comprehensive therapeutic strategy for HCC patients.This work has been funded by a research grant from Laboratorios Viñas. BM is supported by competitive funding by Instituto de Salud Carlos III (ISCIII) (PI18/00961 and PI21/00714) and co-funded by the European Union
Functioning Assessment Short Test (FAST): validity and reliability in adolescent and young adults with Borderline Personality Disorder (BPD)
Get PDFBorderline Personality Disorder; Factor analysis; Psychosocial functioningTrastorn límit de la personalitat; Anàlisi factorial; Funcionament psicosocialTrastorno límite de la personalidad; Análisis factorial; Funcionamiento psicosocialBackground
Borderline Personality Disorder (BPD) significantly impacts individuals, causing substantial distress and impairing social, occupational, and other critical areas of functioning. Current tools to assess functioning in BPD are limited and often lack validation in BPD-specific populations. Furthermore, available instruments focus primarily on global functioning rather than specific areas such as cognitive functioning or interpersonal relationships. This study aims to validate the Functioning Assessment Short Test (FAST) in adolescents and young adults with BPD in a Spanish population.
Methods
An observational study was conducted with 216 BPD patients and 107 healthy controls (HC) matched by age and sex. Participants were assessed using the FAST, and additional clinical measures were applied. Internal consistency, inter-rater reliability, exploratory and confirmatory factor analysis, discriminant validity through ROC analysis, and logistic regression were performed to evaluate the psychometric properties of the FAST. Additionally, sensitivity to change was assessed to determine the FAST’s responsiveness to clinical improvements.
Results
The FAST demonstrated high internal consistency (Cronbach's alpha = 0.869) and a six-factor structure. Inter-rater reliability analysis indicated excellent agreement (ICC=0.997, 95 % CI=0.991–0.999). The tool showed high discriminant capacity between BPD patients and HC (AUC=0.947), with a cutoff score of >11 achieving 88 % sensitivity and 90.7 % specificity. Sensitivity to change analyses in a subgroup of 35 BPD patients revealed significant effect sizes (ES=-0.98), supporting the FAST’s ability to detect functional improvements over time.
Conclusions
The FAST is a valid and reliable instrument for assessing psychosocial functioning in adolescents and young adults with BPD.Financial support was provided by public funds from the Department of Mental Health and Addictions (Government of Catalonia, Health Department). SA thanks the support of the Spanish Ministry of Innovation and Science (PI24/00671), funded by the Instituto de Salud Carlos III and cofinanced by the European Union (FEDER) “Una manera de hacer Europa” and La Marató-TV3 Foundation grants (202234-32)
Landiolol is effective and safe in paediatric supraventricular tachycardia: evidence from a European prospective multicentre open-label phase III study (LANDI-PED)
Get PDFHeart rate; Paediatrics; Supraventricular tachycardiaFrecuencia cardíaca; Pediatría; Taquicardia supraventricularFreqüència cardíaca; Pediatria; Taquicàrdia supraventricularAims
Landiolol, an ultra-fast acting super-selective beta-blocker, was investigated for the first time in Europe in a prospective clinical study for the management of supraventricular tachycardia (SVT) among paediatric patients.
Methods and results
The LANDI-PED study was a prospective, multicentre, open-label, uncontrolled phase III study aiming to investigate the efficacy, safety, and pharmacokinetics (PK) of landiolol in paediatric patients. Sixty patients in surgical and non-surgical settings aged ≥1 day to <18 years with SVTs of various aetiologies received landiolol as a continuous intravenous infusion starting with 5 μg/kg/min titrated up to 40 μg/kg/min depending on heart rate (HR) reduction for up to a maximum of 24 h. The primary endpoint was restoration of normal sinus rhythm (NSR) within 210 min of infusion start. The primary endpoint was achieved in 15 (25.0%) patients. A total of 24 (40.0%) patients achieved a HR reduction of at least 20% within 210 min of landiolol infusion. A significant HR reduction was observed within minutes post-infusion, with a mean (±SD) reduction after 210 min of −13.2 (±11.5)% (P < 0.0001) in the overall population. By infusion end, 51.7% of patients achieved HR reduction of at least 20% from baseline and/or NSR conversion. The PK characteristics were consistent with the known profile of landiolol among adults. The most common adverse drug reaction was hypotension (10%).
Conclusion
Landiolol is effective and safe in the treatment of SVTs in the paediatric population as demonstrated by reduction of HR and/or restoring NSR. Landiolol was well tolerated with no novel safety concerns reported.
Clinical Trial Registration
EU Clinical Trial Register; EudraCT Number: 2015-001129-17.The study was sponsored by the AOP Orphan Pharmaceuticals GmbH
Nutritional Status in Locally Advanced or Metastatic Solid Cancer Patients Treated With Chemotherapy, Radiotherapy, and Immunotherapy in Spanish Outpatient Oncology Units
Get PDFCancer; Chemotherapy; Nutritional statusCàncer; Quimioteràpia; Estat nutricionalCáncer; Quimioterapia; Estado nutricionalObjectives: Malnutrition is a prevalent condition in cancer patients that significantly impacts patients' clinical outcomes and health-related quality of life (HR-QoL). The outcome was to characterize the nutritional status by describing the prevalence of malnutrition (mild, moderate, or severe) and its risk in outpatient cancer patients.
Methods: Multicenter, prospective, cross-sectional, descriptive, two-cohort study conducted on consecutive adult patients with locally advanced or metastatic solid tumors (stages III-IV). The study was conducted in 10 Spanish hospitals distributed all over the Spanish geography, with a recruitment period of 5 months (between April and September 2020). Study patients were divided into two groups according to their cancer therapy: group A, patients who underwent immunotherapy, and group B, patients who received combined therapy (immunotherapy plus chemotherapy and radiotherapy).
Results: A total of 585 patients were included. The proportion of patients at risk of malnutrition was notably more significant in the combination group (chemotherapy and/or radiotherapy) than in the immunotherapy-only group (28.3% versus 58.5%, respectively, P < .0001). According to this evaluation the highest proportion of patients at risk were those with pancreatic cancer (51 patients; 89.5%), followed by large intestine cancer (52 patients; 55.3%) and lung cancer (56 patients; 29.3%), P < .0001.
Conclusions: Patients treated with only immunotherapy seemed to have better nutritional status, which indicated health-related quality of life improvement. Additionally, there was a trend associating nutritional status with tumor location. Treatment strategy, treatment duration, performance status, and treatment location were independently associated with malnutrition.
Implications for nursing practice: Integrating nutritional assessment into routine clinical practice will improve the quality of life of oncology patients. An integrative approach to health improves overall results in terms of nutritional status and improved quality of life and shows that daily living activities are more satisfactory for patients with nursing interventions. Nursing interventions are consistent with an educational approach to patients as long as the interventions described in international guidelines are detailed in the framework of the patient care.This work was supported by Baxter Healthcare Corporation INC competitive program grant. The funding body provides funds for research assistant CRO and engagement of statistical support from Clinical Research Associates. It pays for all study-related expenses such as reimbursements of study participants and manuscripts processing fees. The funders had no role in the study's design, collecting, analyzing, or interpreting data, writing the manuscript, or deciding to publish the results
Butll Farmacovigil Cat
No full textFarmacologia; Medicaments; Reaccions adversesPharmacology; Drug; Adverse ReactionsFarmacología; Medicamentos; Reacciones adversasLa síndrome de Takotsubo: una reacció adversa poc coneguda o poc reconeguda?. Tinció dental associada a Glutaferro®(sulfat de ferroglicina). Comunicacions sobre riscos per medicaments notificades per l’Agència Espanyola de Medicaments i Productes Sanitaris (AEMPS). Altres informacions sobre seguretat. III Jornada de Farmacovigilància de Catalunya.El síndrome de Takotsubo: ¿una reacción adversa poco conocida o poco reconocida?. Tinción dental asociada a Glutaferro® (sulfato de ferroglicina). Comunicaciones sobre riesgos por medicamentos notificadas por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Otras informaciones de seguridad. III Jornada de Farmacovigilancia de Cataluña
Revision Anterior Cruciate Ligament Reconstruction in Combination With Meniscal and Osteochondral Allograft Transplantation for Complex Knee Injury
Get PDFAnterior cruciate ligament; Meniscal allograft transplantation; Complex knee injuryLligament creuat anterior; Trasplantament d'al·lograft meniscal; Lesió de genollLigamento cruzado anterior; Trasplante de aloinjerto meniscal; Lesión de rodillaRevision anterior cruciate ligament reconstruction (ACLR) may present a challenge as a result of several factors, including malpositioned bone tunnels, tunnel osteolysis, and the presence of previous hardware. In addition, concomitant pathology, specifically meniscal and cartilaginous injuries, may be present and should be addressed to minimize the risk of re-rupture. Revision ACLR and treatment of accompanying injuries can be performed either as a 1-stage or 2-stage procedure, yet the latter may increase surgical risk for the patient and extend recovery time. The over-the-top technique serves as a good option for revision ACLR and can be performed with careful consideration of patient-specific anatomy and with proper surgical planning. Therefore, this Technical Note aims to present our 1-stage surgical technique for revision ACLR using over-the-top technique with an Achilles tendon allograft, along with concomitant treatment for meniscal deficiency and a medial femoral condyle chondral defect using meniscal and osteochondral allografts, respectively
Grado de conocimiento de los pacientes con migraña sobre su tratamiento preventivo oral: resultados de un estudio nacional
Get PDFDrug knowledge; Migraine; Preventive treatmentConocimiento del medicamento; Migraña; Tratamiento preventivoConeixement del medicament; Migranya; Tractament preventiuBackground
Patients’ knowledge about their medications is key to guarantee therapeutic compliance in chronic diseases.
Aims of the study
To determine patients’ knowledge of oral preventive treatment (OPT) in migraine.
Methods
This is a cross-sectional study evaluating knowledge of medication with a validated questionnaire that assessed: therapeutic objective, process of use, safety and conservation.
Results
198 patients were included. Mean age was 45.4 ± 11.5 years-old and 92.4% were women. A 61.1% of migraine patients did not know the medication they used, 55.1% showed insufficient knowledge and 6.1% had no knowledge. The most known dimension was conservation (80.3%) and the most unknown dimension of was safety (33.7%). In this regard, 82.3% considered that they should not take precautions when taking the treatment, 80.3% stated that it had no contraindications and 82.8% were unaware of possible interactions with other medications. Worse knowledge about OPT was associated with longer time since migraine onset (p = .049), higher scores on the Hospital Anxiety and Depression Scale (p = .021), less qualified jobs (p = .045), use of monotherapy (p = .001) and longer periods since OPT initiation (p = .013).
Conclusions
The majority of migraine patients did not adequately know their preventive treatment, despite identifying some of the items related to their medication. The present study shows that knowledge of patients about their preventive treatment should be evaluated in clinical practice and could help migraine patients in the correct use of OPT.Introducción
El conocimiento de los pacientes sobre su medicación es clave para garantizar el cumplimiento terapéutico en las enfermedades crónicas.
Objetivo
Determinar el grado de conocimiento de los pacientes con migraña sobre su tratamiento preventivo oral (TPO).
Métodos
Estudio transversal que evaluó el conocimiento de los pacientes sobre su medicación (CPM) mediante un cuestionario validado que valora cuatro dimensiones: objetivo terapéutico, proceso de uso, seguridad y conservación.
Resultados
Se incluyeron 198 pacientes: 92,4% mujeres, edad promedio 45,4 ± 11,5 años. El 61,1% desconocía la medicación que utilizaba para su migraña, de los que un 55,1% mostraba un conocimiento insuficiente y un 6,1% no tenía ningún conocimiento. La dimensión más conocida fue “conservación” (80,3%) y la menos conocida fue “seguridad” (33,7%). A este respecto, el 82,3% consideró que no debía tomar precauciones en la toma de su tratamiento, el 80,3% afirmó no conocer las posibles contraindicaciones y el 82,8% desconocía la existencia de interacciones con otros medicamentos. Un peor conocimiento global se asoció con puestos laborales menos cualificados (p = 0,045), un mayor tiempo desde el inicio de la migraña (p = 0,049), mayores periodos desde el inicio del TPO (p = 0,013), uso del fármaco en monoterapia (p = 0,001), y una mayor puntuación en la Escala de Ansiedad y Depresión Hospitalaria (p = 0,021).
Conclusiones
Pese a identificar algunos de los aspectos relacionados con su medicación, la mayoría de los pacientes con migraña no conocen adecuadamente su tratamiento preventivo. Por ello, el conocimiento sobre el TPO debería ser evaluado en la práctica clínica ya que podría ayudar a un uso correcto de su medicación
European recommendations from healthcare professionals and people living with obesity on safe practice for bariatric and metabolic surgery medical tourism: a modified Delphi consensus statement from EASO, IFSO-EC, and ECPO
Get PDFBariatric and metabolic surgery; Medical tourism; Delphi consensusTurismo médico; Cirugía bariátrica y metabólica; Consenso delphiTurisme mèdic; Cirurgia bariàtrica i metabòlica; Consens delphiBackground:
Bariatric and metabolic surgery tourism (BMT) is becoming an increasingly popular route to treatment for patients living with obesity. Recent reports have highlighted that some patients travelling abroad for bariatric surgery have received inadequate care, fraudulent care, and, tragically, some cases have resulted in death. This study aimed to define consensus in Europe regarding safe practices concerning BMT.
Materials and methods:
IFSO-EC, EASO and ECPO initiated a task force to delineate safe practices in BMT. Two expert European panels were convened, one comprised of healthcare professionals (identified from EASO and IFSO-EC) and the other of patient representatives (identified from ECPO). The study utilized a modified Delphi consensus methodology, and 135 questions were administered. Surveys were conducted anonymously online, and consensus was defined as 70% agreement. Themes analyzed regarding BMT included regulation, pre-operative evaluation, operative care, post-operative care, advertising and online information.
Results:
One hundred and nineteen healthcare professionals and 88 patient representatives participated from 26 countries. The healthcare professional panel included 66 bariatric surgeons, 28 endocrinologists, 18 dietitians, three nurses, two psychologists, one general practitioner and one gastroenterologist. Three questionnaire rounds were conducted for the healthcare professional panel, and two were performed for the patient representative panel. Consensus recommendations were given across all themes relevant to BMT. These included evaluating and managing psychological health, sleep apnea, cardiovascular disease, liver health and dietetic assessment. The recommendations covered the requirements for regulatory standards, including surgeon accreditation and procedural volume. They also included recommendations regarding patient education, standardized operative care, online information provision, and follow-up.
Conclusions:
Through collaboration with healthcare professionals and patients living with obesity, we provide European recommendations regarding safe practices concerning BMT. Further evaluation is required regarding outcomes following BMT. These data, alongside the Delphi consensus recommendations, will inform BMT clinical guideline development