Cardiac index-guided therapy to maintain optimised postinduction cardiac index in high-risk patients having major open abdominal surgery: the multicentre randomised iPEGASUS trial.

BACKGROUND: It is unclear whether optimising intraoperative cardiac index can reduce postoperative complications. We tested the hypothesis that maintaining optimised postinduction cardiac index during and for the first 8 h after surgery reduces the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery. METHODS: In three German and two Spanish centres, high-risk patients having elective major open abdominal surgery were randomised to cardiac index-guided therapy to maintain optimised postinduction cardiac index (cardiac index at which pulse pressure variation was <12%) during and for the first 8 h after surgery using intravenous fluids and dobutamine or to routine care. The primary outcome was the incidence of a composite outcome of moderate or severe complications within 28 days after surgery. RESULTS: We analysed 318 of 380 enrolled subjects. The composite primary outcome occurred in 84 of 152 subjects (55%) assigned to cardiac index-guided therapy and in 77 of 166 subjects (46%) assigned to routine care (odds ratio: 1.87, 95% confidence interval: 1.03-3.39, P=0.038). Per-protocol analyses confirmed the results of the primary outcome analysis. CONCLUSIONS: Maintaining optimised postinduction cardiac index during and for the first 8 h after surgery did not reduce, and possibly increased, the incidence of a composite outcome of complications within 28 days after surgery compared with routine care in high-risk patients having elective major open abdominal surgery. Clinicians should not strive to maintain optimised postinduction cardiac index during and after surgery in expectation of reducing complications. CLINICAL TRIAL REGISTRATION: NCT03021525.

Safety and efficacy of favipiravir in COVID-19 patients with pneumonia. A randomized, double-blind, placebo-controlled study (FAVID).

PURPOSE: To design a randomized clinical trial to assess the efficacy and safety of favipiravir in patients with COVID-19 disease with pneumonia. METHODS: A randomized, double blind, placebo-controlled clinical trial of favipiravir in patients with COVID-19 pneumonia was conducted in three Spanish sites. Randomization 1:1 to favipiravir or placebo (in both groups added to the Standard of Care) was performed to treat the patients with COVID-19 pneumonia. The primary endpoint was "time to clinical improvement," measured as an improvement for ≥ two categories on a 7-point WHO ordinal scale in an up to 28 days' time frame. RESULTS: Forty-four patients were randomized (23 in the favipiravir group and 21 in the placebo group). The median time to clinical improvement was not different between the favipiravir and the placebo arms (10 days for both groups) and none of the secondary endpoints showed significant differences between arms. The proportion of adverse events (both serious and non-serious) was statistically different between the favipiravir group (68.29%) and the placebo group (31.7%) (p = 0.019), but there was insufficient statistical evidence to correlate the degree of severity of the events with the treatment group. CONCLUSIONS: Favipiravir administered for ten days to patients with COVID-19 and pneumonia did not improve outcomes compared with placebo. Although this is an underpowered negative study, efficacy results align with other randomized trials. However, in the present study, the non-serious adverse events were more frequent in the favipiravir group.

Impact of the COVID-19 pandemic: Community and hospital shared pharmaceutical care model. Satisfaction and acceptability of patients with HIV infection on antiretroviral treatment / Impacto de la pandemia COVID-19: Modelo de atención farmacéutica compartida comunitaria y hospitalaria. Satisfacción y aceptabilidad depacientes con infección VIH en tratamiento antirretroviral

Background. The health crisis due to the COVID-19 pandemic is a challenge in the dispensing of outpatient hospital medication (OHM). Models of Antiretroviral Therapy (ART) based on community pharmacy support (ARTCP) have proven to be successful. The aim was to evaluate the degree of satisfaction, acceptability and limitations of the implementation of ARTCP, in the context of a pandemic, in our environment. Methods. Descriptive cross-sectional study carried out in a Barcelona hospital, during the months of July-November 2020. A telephone survey was carried out via a questionnaire on the quality dimensions of the model (degree of satisfaction, acceptability) and associated inconveniences. Data collected: demographics, antiretroviral treatment (ART), concomitant medication, drug interactions (DDIs), CD4 lymphocyte count and plasma viraemia. Data analysis included descriptive statistics. Results. A total of 533 (78.0%) HIV patients receiving ART were included. 71.9% (383/533) of these patients were very satisfied and 76.2% preferred attending the community pharmacy rather than the hospital. The mean satisfaction rating was 9.3 (DS: 1.4). The benefits reported were: 1) proximity to home (406: 76.1%); 2) lower risk of contagion of COVID-19 (318: 59.7%); 3) shorter waiting time (201: 37.1%); 4) time flexibility (104: 19.5%); 5) reduction of financial expenses (35: 6.57%). A total of 11 (2%) patients reported no benefit. Only 22.9% reported disadvantages associated with ARTCP: 1) lack of privacy (65: 12.2%); 2) lack of coordinationorganization (57: 10.7%). Conclusion. The COVID-19 pandemic has had an impact on the provision of pharmaceutical care for HIV patients. The ARTPC model has proved efficient, with patients reporting a high degree of satisfaction. (AU)

Introducción. La crisis sanitaria por la pandemia COVID-19 plantea un desafío en la dispensación de la medicación hospitalaria de dispensación ambulatoria (MHDA). Los modelos de terapia antirretroviral basados en el apoyo de la farmacia comunitaria (TARFC) han demostrado tener éxito. El objetivo del estudio fue evaluar el grado de satisfacción, aceptabilidad y limitaciones de la implementación del TARFC, en contexto de pandemia, en nuestro entorno. Métodos. Estudio descriptivo transversal realizado en un hospital de Barcelona, durante los meses de julio-noviembre del 2020. Se realizó una encuesta telefónica, mediante un cuestionario sobre dimensiones de calidad del modelo (grado de satisfacción, aceptabilidad) e inconvenientes asociados. Se recogieron datos: demográficos, tratamiento antirretroviral (TAR), medicación concomitante, interacciones farmacológicas (DDIs), recuento de linfocitos CD4 y viremia plasmática. El análisis de datos incluyó estadística descriptiva. Resultados. Se incluyeron 533 pacientes VIH adherentes al TAR. El 71,9% (383/533) de pacientes estaban muy satisfechos y el 76,2% preferían acudir a la farmacia comunitaria frente a la hospitalaria. La calificación de satisfacción media fue de 9,3 (DS: 1,4). Los beneficios reportados fueron: 1) cercanía al domicilio (406: 76,1%); 2) menor riesgo de contagio de COVID-19 (318: 59,7%) 3) menor tiempo de espera (201: 37,1%); 4) flexibilidad horaria (104: 19,5%); 5) reducción de gastos económicos (35: 6,57%). Un total de 11 (2%) pacientes no reportaron ningún beneficio. Únicamente el 22,9% reportaron desventajas asociadas al TARFC: 1) falta de privacidad (65:12,2%); 2) falta de coordinación-organización (57: 10,7%) Conclusión. La pandemia de COVID-19 tiene un impacto en la prestación de atención farmacéutica al VIH. El modelo TARFC ha resultado eficiente con un elevado grado de satisfacción por parte de los pacientes. (AU)

Diagnóstico e tratamento dos eventos adversos do ácido hialurônico: recomendações de consenso do painel de especialistas da América Latina / Diagnosis and treatment of hyaluronic acid adverse events: Latin American expert panel consensus recommendations

Introdução: Na última década, o uso do preenchimento com ácido hialurônico para aprimoramento facial aumentou na América Latina. O preenchimento com ácido hialurônico é considerado seguro com baixa incidência de eventos adversos. Como eventos adversos são pouco observados na prática clínica ou têm sido possivelmente sub-relatados são necessárias mais orientações para diagnosticar e tratar eventos adversos relacionados ao ácido hialurônico. Objetivo: Compreender melhor os eventos adversos relacionados ao ácido hialurônico e propor recomendações para o diagnóstico e tratamento. Métodos: Reunião em painel de 25 especialistas médicos multidisciplinares da América Latina foi realizada em São Paulo, Brasil, para discutir o que se conhece sobre eventos adversos relacionados ao ácido hialurônico e fornecer conhecimentos baseados na experiência clínica. Por meio de consenso, foram desenvolvidos recomendações e algoritmos. Resultados: O painel categorizou eventos adversos relacionados ao ácido hialurônico baseado em três momentos de início (imediato, precoce e tardio) e propôs um novo termo para eventos adversos que apresentam edema tardio intermitente persistente ("Etip"). Foram criados algoritmos para diagnóstico e tratamento em cada momento. Conclusões: Novos algoritmos consensuais para diagnósticos e tratamentos associados ao momento de início dos eventos adversos relacionados ao ácido hialurônico orientarão melhores práticas no uso clínico do preenchimento com ácido hialurônico.

Introduction: In the last decade, the use of hyaluronic acid fillers for facial enhancement has increased in Latin America. Hyaluronic acid fillers are considered relatively safe with a low incidence of adverse events. Because adverse events are not seen frequently in clinical practice or have been potentially underreported, there is a need for more guidance on the diagnosis and treatment of Hyaluronic acid-related adverse events. Objecti ve: To provide an enhanced understanding of hyaluronic acid-related adverse events and to propose recommendations for their diagnosis and treatment. Methods: A 25-member multi-disciplinary expert panel meeting of Latin-American physicians was convened in Sao Paulo, Brazil to discuss what is known about hyaluronic acid-related adverse events and to provide insights based on clinical experience. Recommendations and algorithms were developed through a consensus process. Results: The panel categorized hyaluronic acid-related adverse events based on 3 time frames of onset (immediate, early and Late) and proposed a new term for adverse events that display persistent, intermittent, delayed Swelling (PIDS). Algorithms were created for diagnosis and treatment for each time frame. Conc lusions: The new consensus algorithms for time-related diagnosis and treatment of hyaluronic acid-related adverse events will provide guidance for best practices in the clinical use of hyaluronic acid fillers.

Synthesis and performance of 3D-megaporous structures for enzyme immobilization and protein capture.

The preparation of megaporous bodies, with potential applications in biotechnology, was attempted by following several strategies. As a first step, naive and robust scaffolds were produced by polymerization of selected monomers in the presence of a highly soluble cross-linker agent. Ion-exchange function was incorporated by particle embedding, direct chemical synthesis, or radiation-induced grafting. The total ionic capacity of such systems was 1.5 mmol H(+)/g, 1.4 mmol H(+)/g, and 17 mmol H(+)/g, respectively. These values were in agreement with the ability to bind model proteins: observed dynamic binding capacity at 50% breakthrough was ≅7.2 mg bovine serum albumin/g, ≅7.4 hen egg-white lysozyme (HEWL) mg/g, and ≅108 HEWL mg/g. In the later case, total (static) binding capacity reached 220 mg/g. It was observed that the structure and size of the megapores remained unaffected by the grafting procedure which, however, allowed for the highest protein binding capacity. Lysozyme supported on grafted body showed extensive clarification activity against a Micrococcus lysodekticus suspension in the flow-through mode, i.e., 90% destruction of suspended microbial cells was obtained with a residence time ≈ 18 min. Both protein capture and biocatalysis applications are conceivable with the 3D-megaporous materials described in this work.

Causas no oncológicas del síndrome de Kinsbourne / Non oncologic causes of Kisbourne syndrome

Introducción. Kinsbourne en 1962, enmarca una tríada caracterizada por opsoclonos, mioclonos y ataxia cerebelosa. Su incidencia no está definida y es poco común; ocurre en su mayoría en la edad pediátrica. Se han propuesto diferentes etiologías, dentro de las más frecuentes se relaciona con entidades paraneoplásicas (50% asociado a neuroblastoma). Objetivo: analizar las causas del paciente con síndrome de Kinsbourne (SK) atendidos en el Hospital Infantil de México Federico Gómez en el período comprendido entre 1993-2004. Material y métodos. Se realizó un estudio retrospectivo en pacientes de ambos sexos, menores de 16 años, atendidos en el período comprendido entre 1993 y 2004; estableciéndose la frecuencia de pacientes con SK en dicho período de tiempo estudiado; además de los síntomas más frecuentes y el seguimiento de estos pacientes. Resultados. Se obtuvieron 26 pacientes, la edad de presentación más frecuente fue de 21 meses de edad. El tiempo que transcurrió entre la presentación de los síntomas y el diagnóstico de la enfermedad fue en promedio de 3.8 meses. El signo inicial en 88.5% de los pacientes fue la ataxia. Dentro de las etiologías más frecuentes se encontró en primer lugar las causas infecciosas, seguidos de trauma craneoencefálico leve y procesos inflamatorios. En 27% de los casos no se consignó algún antecedente patológico relacionado al inicio de los síntomas. Sólo se encontró un caso asociado a neuroblastoma. Conclusión. La causa más frecuente encontrada en nuestra población fue la de origen infeccioso, lo cual da pauta a redefinir la búsqueda y los protocolos de estudio en estos pacientes, así como los tratamientos y pronósticos propuestos. Es interesante observar que a cinco años de seguimiento, únicamente se encontró un proceso neoplásico, lo cual también puede redefinir el pronóstico en general de estos pacientes.

Introduction. In 1962 Kinsbourne describes a triad characterized by opsoclonus, myoclonus and ataxia.The incidence is rare; it occurs predominantly in pediatric population. It may express different etiologies; the most frequently cause associated is with paraneoplasia (50% with neuroblastoma).The great variety of diagnosis proposed for the Kinsbourne syndrome (KS) implies a great number of treatments too. Besides KS is rarely seen, the dramatic presentation, sudden appear, characterized triad and torpid evolution that can be in relationship with a paraneoplasia makes the syndrome a entity of great interest for the medical doctors, making of great importance known the different etiologies of each community for establish standardized protocols for the clinical study and follow adequate for these patients. With this revision, we suspect to identify the different etiologies in the KS in the population attended in the Hospital Infantil de Mexico Federico Gomez (HIMFG). Objective: describe and analyze the different causes of KS attended in the HIMFG between 1990-2004. Material and methods. With a retrospective study, we include patients of both sexes, <16 years, seen between 1990 and 2004. We study the frequency of patients seen in that period, the most frequent etiologies and the evolution of these patients. Results. Of 26 patients, the most frequent age of presentation was 21 months of age. The time between the first symptoms and the diagnosis was approx. 3.8 months.The initial symptom in 88.5% was ataxia.The most frequent etiologies related were infections, craneoencephalic trauma and inflammatory process. In 27% of the patients there were no antecedents. Only one of the patients was associated with neuroblastoma. Conclusion. The infection was the most frequent cause in our series that results implies the necessity to make strategies in the search of these patients.

Trabeculectomía con suturas liberales / The trabeculectomy with removable sutures

Las modificaciones en la técnica de la cirugía filtrante están encaminadas a que los resultados sean cada vez más efectivos. La trabeculectomía con suturas liberales tiene por objeto lograr un mejor control de la presión intraocular (PIO) y diminuir las complicaciones postoperatorias. Se estudió la evolución de 42 ojos de 32 pacientes sometidos a trabeculectomía con suturas liberales. La PIO preoperatoria promedio, que era de 32.3 ñ 10.4 mmHg., disminuyó a 14.3 ñ 6.9 mmHg., (p<.001) después de un periodo de seguimiento de 6 a 30 meses (x 13.6 ñ 7.7). La única complicación considerable fue un desprendimiento coroide hemorrágico. La trabeculectomía con suturas liberales combina las ventajas de la trabeculectomía y las de la cirugía filtrante no protegida, manteniendo un cierre hermético inicial del colgajo escleral para evitar la hipotonía en el postoperatorio inmediato y permitiendo posteriomente obtener una mayor filtración conforme las suturas van siendo liberadas.