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1.
World J Surg ; 48(2): 466-473, 2024 02.
Article in English | MEDLINE | ID: mdl-38310307

ABSTRACT

INTRODUCTION: The recurrence of acute diverticulitis (AD) of the colon is frequent and leads to hospital readmissions and the need for elective surgery in selected cases. It is important to individualize risk factors and develop predictive tools for their identification. MATERIALS AND METHODS: This prospective observational study included 368 patients who were diagnosed with AD between 2016 and 2021 in a tertiary general university hospital during their first episode and who had a good response to antibiotic, percutaneous, or peritoneal lavage treatment. Univariate and multivariate Cox regression analyses of the variables associated with recurrence were performed. Subsequently, a predictive risk score was developed and validated through survival studies. RESULTS: After a median follow-up of 50 months, there were 71 (19.3%) cases of recurrence out of a total of 368 patients. The mean time of recurrence was 15 months, and 73.3% of cases of recurrence occurred before 2 years of follow-up. Recurrence was independently associated with presentation with colonic perforation in the antimesenteric location (HR 3.67 95% CI [1.59-8.4]) and a CRP level greater than 100 mg/dl (HR 1.69 95% CI [1.04-2.77). A score with 5 variables was created that differentiated two risk groups: intermediate risk (0-3 points), with 19% recurrence and high risk (more than 3 points), with 42% recurrence. CONCLUSIONS: The risk of recurrence after the first episode of diverticulitis can be estimated using predictive scores. The detection of high-risk patients facilitates the individualization of follow-up and treatment.


Subject(s)
Diverticulitis, Colonic , Diverticulitis , Humans , Diverticulitis, Colonic/complications , Diverticulitis, Colonic/surgery , Recurrence , Diverticulitis/complications , Risk Factors , Prospective Studies , Retrospective Studies
2.
Hum Vaccin Immunother ; 18(1): 1981085, 2022 12 31.
Article in English | MEDLINE | ID: mdl-34614379

ABSTRACT

A fully liquid MenACWY-CRM vaccine presentation has been developed, modifying the meningococcal serogroup A (MenA) component from lyophilized to liquid. The safety and immunogenicity of the liquid presentation at the end of the intended shelf-life (aged for 24 or 30 months) were compared to the licensed lyophilized/liquid presentation. This multicenter, randomized (1:1), observer-blind, phase 2b study (NCT03433482) enrolled adolescents and young adults (age 10-40 years). In part 1, 844 participants received one dose of liquid presentation stored for approximately 24 months or licensed presentation. In part 2, 846 participants received one dose of liquid presentation stored for approximately 30 months or licensed presentation. After storage, the MenA free saccharide (FS) level was approximately 25% and O-acetylation was approximately 45%. The primary objective was to demonstrate non-inferiority of the liquid presentation to licensed presentation, as measured by human serum bactericidal assay (hSBA) geometric mean titers (GMTs) against MenA, 1-month post-vaccination. Immune responses against each vaccine serogroup were similar between groups. Between-group ratios of hSBA GMTs for MenA were 1.21 (part 1) and 1.11 (part 2), with two-sided 95% confidence interval lower limits (0.94 and 0.87, respectively) greater than the prespecified non-inferiority margin (0.5), thus meeting the primary study objective. No safety concerns were identified. Despite reduced O-acetylation of MenA and increased FS content, serogroup-specific immune responses induced by the fully liquid presentation were similar to those induced by the licensed MenACWY-CRM vaccine, with non-inferior anti-MenA responses. The safety profiles of the vaccine presentations were similar.


Subject(s)
Meningococcal Infections , Meningococcal Vaccines , Neisseria meningitidis , Adolescent , Adult , Aged , Antibodies, Bacterial , Child , Humans , Meningococcal Infections/prevention & control , Serogroup , Vaccines, Conjugate , Young Adult
3.
Adv Ther ; 38(6): 3325-3341, 2021 06.
Article in English | MEDLINE | ID: mdl-34013498

ABSTRACT

INTRODUCTION: The economic burden of herpes zoster (HZ), including its most common complication, postherpetic neuralgia (PHN), and its impact on health-related quality of life (HRQL) is not well described in Spain. The aim of this study was to estimate HZ-related healthcare costs and impact on HRQL in Spanish adults aged 50 years or older. METHODS: A prospective, observational study was performed with patients with HZ recruited through four general practitioner networks in Spain (NCT01521286). HRQL data were collected using the EuroQoL-5 Dimension (EQ-5D) questionnaire; HZ-related pain and associated interference with activities of daily living (ADL) were assessed using the Zoster Brief Pain Inventory (ZBPI) questionnaire at days 0 (HZ rash onset), 15, 30, 60, and 90; patients with PHN were assessed up until day 270. Medical resource utilization was recorded throughout study follow-up. Work loss for patients/caregivers was also assessed. Costs were calculated from both the payer and societal perspectives. RESULTS: A total of 545 patients with Hz were included, of whom 25 developed PHN. During days 0-30 post HZ diagnosis, the mean EQ-5D utility score was 0.738, equating to a utility loss of 0.138. Sleep was the ADL most affected component. The mean costs for HZ in the overall cohort were €240 and €296 from the payer/societal perspective, respectively; €187/€242 for patients with HZ without any HZ-related complications; and €571/€712 for patients who developed PHN. The majority of costs were incurred during days 0-30. CONCLUSIONS: In Spain, HZ and HZ-related complications such as PHN reduce patient HRQL and increase the economic burden for both payers and society in general. TRAIL REGISTRATION: ClinicalTrials.gov identifier NCT01521286.


Subject(s)
Herpes Zoster , Neuralgia, Postherpetic , Activities of Daily Living , Adult , Cost of Illness , Herpes Zoster/epidemiology , Humans , Neuralgia, Postherpetic/epidemiology , Prospective Studies , Quality of Life , Spain/epidemiology
4.
An. pediatr. (2003. Ed. impr.) ; 87(6): 311-319, dic. 2017. tab, graf
Article in Spanish | IBECS | ID: ibc-170127

ABSTRACT

Introducción: El estudio se llevó a cabo para estimar la carga de enfermedad de la gripe confirmada por laboratorio en niños menores de 15 años. Pacientes y métodos: Los niños que acudieron al Hospital Universitario de Basurto con síntomas de infección respiratoria aguda y/o fiebre aislada entre noviembre de 2010 y mayo de 2011 fueron incluidos en el estudio (NCT01592799). Se tomaron 2 muestras de secreción nasofaríngea: una para un test de diagnóstico rápido en el Servicio de Urgencias y otra para análisis en laboratorio con reacción en cadena de la polimerasa en tiempo real y cultivo viral. Resultados: Se seleccionó a un total de 501 niños, de los que 91 fueron hospitalizados. El diagnóstico de gripe se confirmó en 131 (26,1%); 120/410 (29,3%) fueron tratados ambulatoriamente y 11/91 (12,1%), hospitalizados. En 370/501 niños (73,9%) el resultado no fue positivo. La proporción de otros virus respiratorios fue 145/501 (28,9%) casos y de coinfección con otro virus respiratorio además de gripe de 7/501 (1,4%). Los tipos de virus de gripe fueron: A (H1N1 y H3N2) 53,2% (67/126); B (Victoria y Yamagata) 46,0% (58/126); A + B 0,8% (1/126). El coste médico directo medio asociado con cada caso de gripe confirmada fue de 177,00 €(N=131). No se observaron diferencias estadísticamente significativas entre el coste asociado con gripe A o B. Conclusión: Casi la mitad de los casos fueron virus de gripe B. La administración de una vacuna que incluya tipos A y B de gripe debería reducir la carga de la enfermedad (AU)


Introduction: This study was undertaken to estimate the burden of morbidity associated with laboratory-confirmed influenza in children below 15 years of age. Patients and methods: Children presenting with acute respiratory infection and/or isolated fever at the Basurto University Hospital, Bilbao, Spain between November 2010 and May 2011 were included in this study (NCT01592799). Two nasopharyngeal secretion samples were taken from each; one for a rapid influenza diagnostic test in the emergency department, and the second for laboratory analysis using real-time polymerase chain reaction and viral culture. Results: A total of 501 children were recruited, of whom 91 were hospitalized. Influenza diagnosis was confirmed in 131 children (26.1%); 120 of 410 (29.3%) treated as outpatients and 11 of 91 (12.1%) hospitalized children. A total of 370 of 501 children (73.9%) had no laboratory test positive for influenza. The proportion of subjects with other respiratory viruses was 145/501 (28.9%) cases and co-infection with the influenza virus plus another respiratory virus was detected in 7/501 (1.4%) cases. Influenza virus types were: A (H1N1 and H3N2) 53.2% (67/126); B (Victoria and Yamagata) 46.0% (58/126); A + B 0.8% (1/126). The median direct medical costs associated with each case of laboratory-confirmed influenza was € 177.00 (N = 131). No significant differences were observed between the medical costs associated with influenza A and B. Conclusion: Almost half of the cases were influenza virus B type. The administration of a vaccine containing influenza A and B types to children below 15 years of age might reduce the overall burden of the illness (AU)


Subject(s)
Humans , Male , Female , Infant , Child, Preschool , Child , Adolescent , Influenza, Human/epidemiology , Hospitalization/statistics & numerical data , Respiratory Tract Infections/epidemiology , Prospective Studies , Child, Hospitalized/statistics & numerical data , Influenza A virus/isolation & purification , Influenza B virus/isolation & purification , Gammainfluenzavirus/isolation & purification , Influenza Vaccines/administration & dosage
5.
An Pediatr (Barc) ; 87(6): 311-319, 2017 Dec.
Article in Spanish | MEDLINE | ID: mdl-28363360

ABSTRACT

INTRODUCTION: This study was undertaken to estimate the burden of morbidity associated with laboratory-confirmed influenza in children below 15 years of age. PATIENTS AND METHODS: Children presenting with acute respiratory infection and/or isolated fever at the Basurto University Hospital, Bilbao, Spain between November 2010 and May 2011 were included in this study (NCT01592799). Two nasopharyngeal secretion samples were taken from each; one for a rapid influenza diagnostic test in the emergency department, and the second for laboratory analysis using real-time polymerase chain reaction and viral culture. RESULTS: A total of 501 children were recruited, of whom 91 were hospitalized. Influenza diagnosis was confirmed in 131 children (26.1%); 120 of 410 (29.3%) treated as outpatients and 11 of 91 (12.1%) hospitalized children. A total of 370 of 501 children (73.9%) had no laboratory test positive for influenza. The proportion of subjects with other respiratory viruses was 145/501 (28.9%) cases and co-infection with the influenza virus plus another respiratory virus was detected in 7/501 (1.4%) cases. Influenza virus types were: A (H1N1 and H3N2) 53.2% (67/126); B (Victoria and Yamagata) 46.0% (58/126); A+B 0.8% (1/126). The median direct medical costs associated with each case of laboratory-confirmed influenza was €177.00 (N=131). No significant differences were observed between the medical costs associated with influenza A and B. CONCLUSION: Almost half of the cases were influenza virus B type. The administration of a vaccine containing influenza A and B types to children below 15 years of age might reduce the overall burden of the illness.


Subject(s)
Hospitalization/statistics & numerical data , Influenza, Human/epidemiology , Adolescent , Child , Child, Preschool , Cost of Illness , Emergency Service, Hospital , Female , Humans , Infant , Infant, Newborn , Male , Prospective Studies , Spain/epidemiology , Time Factors
6.
An Pediatr (Engl Ed) ; 87(6): 311-319, 2017 Dec.
Article in English | MEDLINE | ID: mdl-32289043

ABSTRACT

INTRODUCTION: This study was undertaken to estimate the burden of morbidity associated with laboratory-confirmed influenza in children below 15 years of age. PATIENTS AND METHODS: Children presenting with acute respiratory infection and/or isolated fever at the Basurto University Hospital, Bilbao, Spain between November 2010 and May 2011 were included in this study (NCT01592799). Two nasopharyngeal secretion samples were taken from each; one for a rapid influenza diagnostic test in the emergency department, and the second for laboratory analysis using real-time polymerase chain reaction and viral culture. RESULTS: A total of 501 children were recruited, of whom 91 were hospitalized. Influenza diagnosis was confirmed in 131 children (26.1%); 120 of 410 (29.3%) treated as outpatients and 11 of 91 (12.1%) hospitalized children. A total of 370 of 501 children (73.9%) had no laboratory test positive for influenza. The proportion of subjects with other respiratory viruses was 145/501 (28.9%) cases and co-infection with the influenza virus plus another respiratory virus was detected in 7/501 (1.4%) cases. Influenza virus types were: A (H1N1 and H3N2) 53.2% (67/126); B (Victoria and Yamagata) 46.0% (58/126); A + B 0.8% (1/126). The median direct medical costs associated with each case of laboratory-confirmed influenza was €177.00 (N = 131). No significant differences were observed between the medical costs associated with influenza A and B. CONCLUSION: Almost half of the cases were influenza virus B type. The administration of a vaccine containing influenza A and B types to children below 15 years of age might reduce the overall burden of the illness.


INTRODUCCIÓN: El estudio se llevó a cabo para estimar la carga de enfermedad de la gripe confirmada por laboratorio en niños menores de 15 años. PACIENTES Y MÉTODOS: Los niños que acudieron al Hospital Universitario de Basurto con síntomas de infección respiratoria aguda y/o fiebre aislada entre noviembre de 2010 y mayo de 2011 fueron incluidos en el estudio (NCT01592799). Se tomaron 2 muestras de secreción nasofaríngea: una para un test de diagnóstico rápido en el Servicio de Urgencias y otra para análisis en laboratorio con reacción en cadena de la polimerasa en tiempo real y cultivo viral. RESULTADOS: Se seleccionó a un total de 501 niños, de los que 91 fueron hospitalizados. El diagnóstico de gripe se confirmó en 131 (26,1%); 120/410 (29,3%) fueron tratados ambulatoriamente y 11/91 (12,1%), hospitalizados. En 370/501 niños (73,9%) el resultado no fue positivo. La proporción de otros virus respiratorios fue 145/501 (28,9%) casos y de coinfección con otro virus respiratorio además de gripe de 7/501 (1,4%). Los tipos de virus de gripe fueron: A (H1N1 y H3N2) 53,2% (67/126); B (Victoria y Yamagata) 46,0% (58/126); A + B 0,8% (1/126). El coste médico directo medio asociado con cada caso de gripe confirmada fue de 177,00 € (N = 131). No se observaron diferencias estadísticamente significativas entre el coste asociado con gripe A o B. CONCLUSIÓN: Casi la mitad de los casos fueron virus de gripe B. La administración de una vacuna que incluya tipos A y B de gripe debería reducir la carga de la enfermedad.

7.
Surg Innov ; 22(1): 54-60, 2015 Feb.
Article in English | MEDLINE | ID: mdl-24902692

ABSTRACT

BACKGROUND: The suture dehiscence has traditionally represented a major surgical problem that has not fully resolved. Surgeons should perform sutures in nonoptimal conditions using different methods of sealing and/or reinforcement of suture. The aim is to assess the effectiveness of TachoSil in an experimental model of colon perforations in a simulated precarious situation. METHODS: Forty Wistar rats of both genders (14-24 weeks old) were equally divided in 2 groups; study group was submitted to extended starvation and segmental ischemia. The surgical complications analyzed were animal death, colonic leaks, or intra-abdominal infection, either as local abscesses or diffuse peritonitis. The burst pressure was measured in millimeters of mercury. The histological analysis was performed according to Ehrlich and Hunt numerical scale modified by Phillips. RESULTS: Only 1 animal belonging to the study group died as a consequence of the colonic ischemia. The eventual colonic leak or diffuse peritonitis was reported. Three local abscesses were observed in the study group and one in the control group, and numerous microscopic abscesses in histological analysis (12 vs. 11) were detected. The average burst pressure in the study group was 209.47 ± 50.274 versus 203 ± 51.514 mm Hg in the control group. No differences were observed in any of the variables analyzed in the histological activity. CONCLUSION: TachoSil has proven useful as a sealant of colonic perforations in our experimental study. We therefore conclude that its use in situations of insecurity may be adequate, even in optimal conditions in which reinforcement of previous suture is not strictly required.


Subject(s)
Digestive System Surgical Procedures/methods , Fibrinogen/therapeutic use , Intestinal Perforation/surgery , Thrombin/therapeutic use , Animals , Digestive System Surgical Procedures/adverse effects , Disease Models, Animal , Drug Combinations , Female , Intraabdominal Infections , Male , Postoperative Complications , Pressure , Rats , Rats, Wistar
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