Outcomes and survival of tracheostomised patients during the COVID-19 pandemic in a third level hospital.

PURPOSE: Analyse the evolution and outcomes of COVID-19 tracheostomised patients. Clarify if this cohort presents an increased risk of haemorrhagic complications and verify the correlation between some risk factors with increased mortality. METHODS: A retrospective single-centre observational study of a prospective cohort of all COVID-19 patients admitted to our centre between March and April 2020. A control group was obtained from a historical cohort of patients who required tracheostomy due to prolonged invasive mechanical ventilation (IMV) before 2020. RESULTS: A total of 1768 patients were included: 67 tracheostomised non-COVID-19 patients (historic cohort), 1371 COVID-19 patients that did not require ICU admission, 266 non-tracheostomised COVID-19 patients and 64 tracheostomised COVID-19 patients. Comparing the obesity prevalence, 54.69% of the tracheostomised COVID-19 patients were obese and 10.53% of the non-tracheostomised COVID-19 patients (p < 0.001). The median of ICU admission days was lower (p < 0.001) in the non-tracheostomised cohort (12.5 days) compared with the COVID-19 tracheostomised cohort (34 days). The incidence of haemorrhagic complications was significantly higher in tracheostomised COVID-19 patients (20.31%) compared with tracheostomised non-COVID-19 patients (5.97%) and presented a higher percentage of obesity, hypertension, diabetes and smoking, significantly different from the historic cohort (p < 0.001). A Cox model showed that tracheostomy had no statistically significant effect on mortality in COVID-19 patients. CONCLUSION: Obesity and smoking may be risk factors for tracheostomy in COVID-19 patients, tracheostomised COVID-19 patients present a higher risk of bleeding complications than those admitted for other reasons and an elevated LDH and INR on ICU admission may be associated with increased mortality.

Salvage surgery after head and neck squamous cell carcinoma treated with bioradiotherapy.

BACKGROUND: The purpose of this study was to describe the results and complications of primary site salvage surgery after head and neck squamous cell carcinoma (HNSCC) treated with bioradiotherapy. METHODS: We conducted a retrospective chart review of 268 patients treated with bioradiotherapy between March 2006 and December 2013 at the Hospital Universitari de Bellvitge-ICO. RESULTS: Fifty-nine patients developed local recurrence or had residual disease with a 1-year and 3-year overall survival of 47% and 15.4%, respectively. Salvage surgery was feasible in 22 patients (37.3%). There were 16 complications in these 22 patients (72.7%), 11 (50%) of which were major. Bilateral neck dissection was identified as a risk factor for complications. CONCLUSION: Salvage surgery after bioradiotherapy is associated with a high rate of complications. Neck dissection seems to be related to an increased rate of complications with no survival improvement. © 2016 Wiley Periodicals, Inc. Head Neck 39: 116-121, 2017.

Colgajo antebraquial radial en cabeza y cuello: nuestra experiencia / Free radial forearm flap in head and neck: our experience

Introducción: La cirugía oncológica conlleva a importantes defectos y secuelas, así como alteraciones funcionales y cosméticas notables. En este aspecto, la cirugía reconstructiva tiene un papel esencial, permitiendo mayor radicalidad en la exéresis y disminución de las morbilidades funcionales y cosméticas asociadas. El objetivo de este estudio es presentar y evaluar la experiencia y resultados de la Unidad de Microcirugía Reconstructiva del Servicio de Otorrinolaringología de nuestro centro. Métodos: Estudio retrospectivo de procedimientos realizado entre los años 2006-2012. Resultados: Un total de 36 casos fueron revisados. El tumor primario se localizó en la mayoría de los casos en orofaringe (58%). En 5 casos se realizó el procedimiento para reconstrucción y cierre de fístulas (4 faringostomas y una fístula traqueoesofágica). El fracaso por necrosis total fue del 16% (6/39). No se produjo mortalidad asociada. Las complicaciones postoperatorias más frecuentes fueron: dehiscencia de sutura en 5 pacientes y faringostoma (fístula) en 5 casos. La radioterapia previa influyó de forma significativa en el aumento de la incidencia global de las complicaciones (p < 0,05). Conclusiones: Actualmente, la cirugía reconstructiva juega un papel fundamental en la cirugía oncológica de cabeza y cuello. El colgajo radial es un método seguro y fiable para la reconstrucción de la mayoría de defectos en la esfera otorrinolaringológica. Asumir este tipo de intervención ofrece una mayor autonomía y seguridad en la cirugía oncológica (AU)

Introduction: Oncologic surgery leads to important defects and sequelae, as well as notable cosmetic and functional alterations. In this aspect reconstructive surgery has an essential role, allowing more radical excision and lower associated functional and cosmetic morbidities. The aim of this study was to present and evaluate the experience and results of the reconstructive microsurgery unit in our centre's ENT department. Methods: Retrospective study of procedures performed between 2006 and 2012. Results: A total of 36 cases were reviewed. The primary tumour was found in the oropharynx (58%) in the majority of cases. In 5 cases the procedure was performed for reconstruction and fistula closure (4 pharyngostoma and 1 tracheoesophageal fistula). Failure from total necrosis was 16% (6/36). No associated mortality has been reported. The most common postoperative complications were wound dehiscence in 5 patients and pharyngostoma (fistula) in 5 cases. Prior radiotherapy significantly influenced the increase in the overall incidence of complications (P<0.05). Conclusions: Reconstructive surgery currently plays an important role in surgery for head and neck cancer. The radial forearm flap is a safe, reliable method for reconstruction of most defects in the ENT field. This type of intervention provides greater autonomy and safety in surgical oncology (AU)

[Free radial forearm flap in head and neck: our experience]. / Colgajo antebraquial radial en cabeza y cuello: nuestra experiencia.

INTRODUCTION: Oncologic surgery leads to important defects and sequelae, as well as notable cosmetic and functional alterations. In this aspect reconstructive surgery has an essential role, allowing more radical excision and lower associated functional and cosmetic morbidities. The aim of this study was to present and evaluate the experience and results of the reconstructive microsurgery unit in our centre's ENT department. METHODS: Retrospective study of procedures performed between 2006 and 2012. RESULTS: A total of 36 cases were reviewed. The primary tumour was found in the oropharynx (58%) in the majority of cases. In 5 cases the procedure was performed for reconstruction and fistula closure (4 pharyngostoma and 1 tracheoesophageal fistula). Failure from total necrosis was 16% (6/36). No associated mortality has been reported. The most common postoperative complications were wound dehiscence in 5 patients and pharyngostoma (fistula) in 5 cases. Prior radiotherapy significantly influenced the increase in the overall incidence of complications (P<05). CONCLUSIONS: Reconstructive surgery currently plays an important role in surgery for head and neck cancer. The radial forearm flap is a safe, reliable method for reconstruction of most defects in the ENT field. This type of intervention provides greater autonomy and safety in surgical oncology.

La adquisición del género: el lugar de la educación en el desarrollo de la identidad sexual / No disponible

En este trabajo se revisan las diferentes teorías psicológicas que han tratado de explicar los procesos de adquisición de la identidad sexual y los principales ámbitos desde los que se han estudiado las diferencias que presentan los seres humanos en función de su sexo. A partir de la reflexión acerca de la segregación que chicas y chicos presentan habitualmente en las situaciones de juego. se plantean los elementos de carácter educativo que están en la base de la socialización genérica del alumnado (AU)

This work is a revision of the different psychological theories which have tried to explain the processes of adquisition of sexual identity. and the main parameters from which human sexual differences have been studied. A reflection on the segregation boys and girls usually present in situations of play. leads to the analysis of the educational elements that are at the base of pupils’ gender socialization (AU)

Estudio sobre la identificación y vivencia de violencia en parejas adolescentes / I study on the identification and experience of violence in teen pairs

El tema de esta investigación se centra en la violencia en las relaciones de pareja adolescentes, cuya existencia se detecta durante el noviazgo antes de la convivencia en pareja y cuyo estudio resulta crucial porque en esas primeras relaciones se asientan las bases de lo que puede ocurrir en la etapa adulta. El estudio se plantea conocer las conductas de maltrato en la pareja que identifican y reconocen vivir los chicos y chicas de 4º ESO de dos Institutos de Educación Secundaria de uba localodad cordobesa, empleando para ello un cuestionario. Los resultados señalan que es considerable el número de alumnado que no identifica la violencia en las parejas adolescentes, siendo las conductas de maltrato físico las que se identifican más fácilmente. Por otro lado, se muestra que la experiencia de violencia en el noviazgo se produce con uan frecuencia considerable, siendo más vividas las de tipo sexual y psicológico(AU)

The subjet of this investigation focuses on violence on the relationship before the couple, whose existence is detected in the early stages of the relationship before the couple lives together. This study is of value because the nature of an adolescent relationship at the beginning sets precedent for what will happen in the future when the couple is settled and both parties are adults.The goal of this investigation is to find out types of mistreatment in adolescent relationship that students from two secondary schools aged between 15-16 years old, identify and acknowledge to live, utilizing a questionnaire. The results show that there is a considerable number of student that do not identify the the abuse en adolescent relationship. On the other hand, the result also shows that the experience of dating violence happens with considerable frequency, being more experiencie the sexual and psychological type(AU)

Mycophenolate mofetil 500-mg tablet under fasting conditions: single-dose, randomized-sequence, open-label, four-way replicate crossover, bioequivalence study in healthy subjects.

BACKGROUND: Mycophenolate mofetil (MMF), a prodrug of mycophenolic acid (MPA), is an immunosuppressive agent indicated for the prophylaxis of organ rejection in allogeneic kidney, heart, or liver transplant recipients. The European regulatory authorities require bioequivalence studies for the marketing of generic products. OBJECTIVE: The aim of this study was to assess the bioequivalence of a generic (test) and branded (reference) formulation of MMF 500 mg and MPA. METHODS: This single-center, single-dose, randomized, open-label, 4-way crossover study was conducted at Anapharm's Clinical Research Facility, Québec, Québec, Canada. Healthy volunteers aged 18 to 55 years were eligible. Subjects were assigned to receive, in randomized order, a single dose of the test and reference formulations of MMF 500 mg under fasting conditions. Because the study design was 4-way replicate, there were 2 test periods and 2 reference periods. The 4 study periods were each separated by a 14-day washout period. Blood samples were collected over a period of 12 hours after administration for the determination of MMF pharmacokinetic properties, and over 48 (+/-0.5) hours, for MPA properties. Concentrations of the analytes were determined by reverse LC and detected using LC-MS/MS. Pharmacokinetic parameters were calculated from MMF and MPA concentration data using noncompartmental analysis. C(max) and AUC(0-t) were the primary evaluation criteria, while AUC(0-infinity) was a secondary parameter. The drugs were to be considered bioequivalent if the 90% CIs for the test/reference ratios of natural logarithm-transformed values of these parameters (obtained using ANOVA) were between 80% and 125%, per European regulations for bioequivalence. Tolerability was monitored using physical examination, including vital sign measurements, laboratory analysis, and adverse-events (AE) monitoring (including patient interview). RESULTS: A total of 103 subjects were enrolled (64 men, 39 women; 101 white, 2 black; mean [SD] age, 38 [10] years; weight, 68.2 [9.1] kg). The 90% CIs were as follows: MMF, C(max), 85.94% to 106.63%; AUC(0-t), 91.94% to 102.20%; and AUC(0-infinity), 93.15% to 105.48%; MPA, C(max), 92.03% to 105.82%; AUC(0-t), 97.42% to 100.59%; and AUC(0-infinity), 96.96% to 100.90%. These values met with the regulatory definition of bioequivalence. A total of 148 AEs were reported (68 in subjects who received the test treatment and 80 in subjects who received the reference treatment). The most commonly reported AEs were procedural pain (13/102 [12.7%] and 10/101 [9.9%] with the test and reference formulations, respectively), procedural site reaction (12 [11.8%] and 4 [4.0%]), and somnolence (7 [6.9%] and 14 [13.9%]). CONCLUSIONS: The generic and branded formulations of MMF 500 mg met the European regulatory criteria for assuming bioequivalence, based on the rate and extent of absorption of a single dose under fasting conditions. Both formulations were well tolerated in these healthy volunteers.

Results of a single-center, single-dose, randomized-sequence, open-label, two-way crossover bioequivalence study of two formulations of valsartan 160-mg tablets in healthy volunteers under fasting conditions.

BACKGROUND: Valsartan is a nonpeptide, orally active angiotensin II type 1 receptor blocker used to treat hypertension alone or in combination with other antihypertensive agents. OBJECTIVE: The aim of this study was to compare the relative bioavailability of a new valsartan 160-mg formulation (ie, test drug) and that of a reference formulation so that bioequivalence could be assessed, as required by European regulatory authorities for the marketing of a generic product. METHODS: This was a single-center, single-dose, randomized-sequence, open-label, 2-way crossover study with a minimum washout period of 7 days; drug was administered to healthy volunteers under fasting conditions. Blood samples were collected up to 36 hours postadministration, and valsartan levels were gauged from plasma by reverse liquid chromatography and tandem mass spectrometry detection (ie, the LC-MS/MS method). Pharmacokinetic parameters were calculated from valsartan concentration data using noncompartmental analysis. AUC(last), AUC(infinity), and C(max) were analyzed. The 90% CIs of the ratios of the test-versus-reference pharmacokinetic parameters (AUC(last), AUC(infinity), and C(max)) were obtained by ANOVA on ln-transformed data. The 90% CIs were required to be within 80.00% to 125.00% of the 90% CI to meet the criteria for bioequivalence. Tolerability was monitored using physical examination (including vital-sign measurements) and ECG performed at screening, as well as laboratory analysis, including biochemistry tests, hematology tests, and urinalysis, which were performed at screening and during the study period. RESULTS: Thirty-eight white (90.5%), 2 black (4.8%), and 2 Hispanic subjects (4.8%) enrolled in the study; the sample included a total of 27 men and 15 women. The mean (SD) age was 37 (11) years and mean weight was 65.4 (7.6) kg. The 90% CI values for pharmacokinetic measurements were as follows: AUC(last), 94.45% to 118.59%; AUC(infinity), 93.58% to 116.51%; and C(max), 93.61% to 122.02%. Thus, they were all within the predefined 80.00% to 125.00% range. Thirty-six postadministration adverse events were reported; the most common was blood pressure decrease. A decrease of blood pressure was experienced by 6 subjects (14.6%) after the administration of the test formulation, and by 5 subjects (12.5%) after the administration of the reference formulation. Thirty-three of these adverse events were graded as mild and 3 as moderate; 11 were judged as probably related, 12 as possibly related, 3 as remotely related, and 10 as unrelated to the study medication. CONCLUSIONS: In this open-label study of healthy volunteers, the test and reference formulations of valsartan 160 mg met the European regulatory definition of bioequivalence, based on the rate and extent of absorption of a single dose under fasting conditions. Both formulations were well tolerated.