Análisis de la temporada gripal 2017-2018, predominio del linaje Yamagata de la gripe B en los adultos

Introduction: The epidemiological and virological characteristics of the 2017-2018 flu season in its aspects of mortality and age groups are analyzed. Patients and method: Respiratory samples from both the Sentinel Influenza Surveillance Network and patients treated in the emergency room and hospitalized in our center were subjected to the detection of respiratory viruses using a commercial genomic amplification technique, type RT- PCR (Allplex Respiratory Panel, Seegen, North Korea), which identifies 16 different respiratory viruses simultaneously and differentially. Among them influenza viruses A (H1N1) pdm09 and A (H3N2) and influenza virus type B, although no difference between their two lineages. Results: During the flu season, 6,465 respiratory samples were analyzed, of which 3,228 (49.9%) were considered positive (detection of a respiratory virus). Of these, in 1232 a flu virus was detected, representing 19% of all processed samples and 38.2% of all positive samples. Of all the influenza viruses detected, 661 (53.6%) were identified as influenza A and 571 (46.4%) influenza B. The RCVG contributed 127 (10.3%) positive samples, 58 (8.7%) group A and 69 (12%) Influenza B. The rest of the positive samples, 1,105 (89.7%), came from the hospital setting, that is, 603 (91.3%) were influenza A and 502 (88%) were influenza B. Regarding the subtypes of influenza A, They detected 415 (62.7%) cases of the subtype A (H1N1) pdm09, 38 (9.1%) of the RCVG and 377 (90.9%) of the hospital setting. Subtype A (H3N2) detected 246 (37.3%) cases, of which 20 (8.1%) belonged to the RCVG and 226 (91.9%) to the hospital setting. When analyzing the subtypes on the total samples of each provenance, it is verified that of the 58 cases of influenza A belonging to the RCVG 38 (65.5%) were A (H1N1) pdm09 and 20 (34.5%) A (H3N2). In the hospital setting, of the 603 cases of influenza A, 377 (62.5%) were A (H1N1) pdm09 and 226 (37.5%) were A (H3N2), no significant differences were observed. Conclusions: The 2017-2018 flu season should be considered as an atypical season in which the co-circulation of the four flu types / subtypes determined the highest epidemiological rate and the highest number of cases registered in the Balearic Islands.Introducción: Se analizan las características epidemiológicas y virológicas de la temporada gripal 2017-2018 en sus aspectos de mortalidad y grupos etários. Pacientes y método: Las muestras respiratorias proceden tanto de la Red Centinela de Vigilancia de la Gripe como de los pacientes atendidos en urgencias y hospitalizados en nuestro centro fueron sometidas a la detección de los virus respiratorios mediante una técnica de amplificación genómica comercial, tipo RT-PCR (Allplex Respiratory Panel; Seegen, Corea del Norte), que identifica de forma simultánea y diferencial 16 virus respiratorios distintos. Entre ellos los virus gripales A (H1N1)pdm09 y A(H3N2) y el virus gripal tipo B, aunque no diferencia entre sus dos linajes. Resultados: A lo largo de la temporada gripal se han analizado 6.465 muestras respiratorias, de las cuales 3.228 (49.9%) fueron consideradas positivas (detección de algún virus respiratorio). De ellas, en 1.232 se detectó un virus gripal, representando el 19% de todas las muestras procesadas y el 38.2% de todas las muestras positivas. De todos los virus gripales detectados, 661 (53.6%) fueron identificados como gripe A y 571 (46.4%) gripe B. La RCVG aportó 127 (10.3%) muestras positivas, 58 (8.7%) gripo A y 69 (12%) gripe B. El resto de muestras positivas, 1.105 (89.7%), procedían del ámbito hospitalario, es decir 603 (91.3%) eran gripe A y 502 (88%) eran gripe B. En cuanto a los subtipos de la gripe A se detectaron 415 (62.7%) casos del subtipo A (H1N1) pdm09, 38 (9.1%) de la RCVG y 377 (90.9%) del ámbito hospitalario. Del subtipo A (H3N2) se detectaron 246 (37.3%) casos, de los cuales 20 (8.1%) pertenecían a la RCVG y 226 (91.9%) al ámbito hospitalario. Al analizar los subtipos sobre el total de muestras de cada procedencia se comprueba como de los 58 casos de gripe A pertenecientes a la RCVG 38 (65.5%) eran A (H1N1)pdm09 y 20 (34.5%) A (H3N2). En el ámbito hospitalario, de los 603 casos de gripe A, 377 (62.5%) eran A (H1N1)pdm09 y 226 (37.5%) eran A (H3N2), no observándose diferencias significativas. Conclusiones: La temporada gripal 2017-2018 debe considerarse como una temporada atípica en la que la cocirculación de los cuatro tipos/subtipos gripales determinó la mayor tasa epidemiológica y el mayor número de casos registrado en las Islas Baleares

Cambios en la distribución etaria de los casos de gripe B observados en la Comunidad balear en dos temporadas epidémicas recientes (2012/13 y 2014/15)

Introduction: Influenza is an infectious disease caused by influenza viruses A and B that affects the general population. Influenza B seems to predominate in children (<15 years). The aim of this study was to compare the age pattern of presentation of cases of influenza B. Methods: We performed a prospective study comparing the age distribution of influenza B cases diagnosed during influenza seasons 2012/13 and 2014/15. Viral detection was performed by RT-PCR in real time. Results: In 2012/13 290 204 cases of influenza corresponding to influenza B (70.3%), of which 38 (18.6%) in the RedC and 166 (81.4%) in hospitals were diagnosed. In season 2014/15 flu cases were 618 and 107 of them (17.3%) were influenza B; the RedC provided 26 (24.2%) cases and Hosp 81 (75.8%). The distribution of cases by age were 128 (62.7%) in children under 15 years and 76 (37.3%) in older in 2012/13 and 35 cases (32.7%) and 72 cases (67.3%) respectively in the 2014/15 season. The number of severe cases of the 2012/13 season were 38, of which 19 (50%) were <15 years; in the 2014/15 season the number of severe cases was 59, 6 (10.1%) of whom were influenza B. Conclusions: This study confirms that overall influenza B occurs in children under 15 years, although it should be accepted that the most concrete would say in those under 50 years. The epidemiological pattern of influenza B can be variable so that in one season may largely affect children and another on the adults.Introducción: La gripe es una enfermedad infecciosa causada por los virus gripales A y B que afecta a la población general. La gripe B parece predominar en la población infantil (<15 años). El objetivo de este estudio en comparar el patrón etário de presentación de los casos de gripe B. Métodos: Se ha realizado un estudio prospectivo comparativo entre la distribución etária de los casos de gripe B diagnosticados durante las temporadas gripales 2012/13 y 2014/15. La detección viral se realizó mediante una RT-PCR en tiempo real. Resultados: En la temporada 2012/13 se diagnosticaron 290 casos de gripe correspondiendo 204 a gripe B (70.3%), de ellos 38 (18.6%) en la RedC y 166 (81.4%) en el ámbito hospitalario. En la temporada 2014/15 los casos de gripe fueron 618 y de ellos 107 (17.3%) correspondieron a gripe B; la RedC aportó 26 (24.2%) casos y el Hosp 81 (75.8%). La distribución de casos por edad fueron de 128 (62.7%) en menores de 15 años y 76 (37.3%) en mayores de esa edad en la temporada 2012/13 y de 35 casos (32.7%) y 72 casos (67.3%) respectivamente en la temporada 2014/15. El número de casos graves de la temporada 2012/13 fueron de 38, de los cuales 19 (50%) eran <15 años; en la temporada 2014/15 el número de casos graves fue de 59, 6 (10.1%) de los cuales eran gripe B. Conclusiones: En este estudio se confirma que globalmente la gripe B se presenta en los menores de 15 años, aunque debería aceptarse que lo mas concreto sería decir en los menores de 50 años. El patrón epidemiológico de la gripe B puede ser variable de modo que en una temporada puede afectar mayoritariamente a la población infantil y en otra a la adulta

Intravenous zanamivir or oral oseltamivir for hospitalised patients with influenza: an international, randomised, double-blind, double-dummy, phase 3 trial

Background Neuraminidase inhibitors are effective for the treatment of acute uncomplicated influenza. However, there is an unmet need for intravenous treatment for patients admitted to hospital with severe influenza. We studied whether intravenous zanamivir was a suitable treatment in this setting. Methods In this international, randomised, double-blind, double-dummy, phase 3 trial, we recruited patients aged 16 years or older with severe influenza admitted to 97 hospitals from 26 countries. We randomly assigned patients (1:1:1 stratified by symptom onset ≤4 days or 5–6 days) to receive 300 mg or 600 mg intravenous zanamivir, or standard-of-care (75 mg oral oseltamivir) twice a day for 5–10 days; patients were followed up for 28 days. The randomisation schedule, including stratification, was generated using GlaxoSmithKline's RandAll software. Patients, site study staff, and sponsor were masked to study treatment. The primary endpoint was time to clinical response—a composite of vital sign stabilisation and hospital discharge—in the influenza-positive population. The trial was powered to show an improvement of 1·5 days or greater with 600 mg intravenous zanamivir. Pharmacokinetic, safety, and virology endpoints were also assessed. This trial is registered with ClinicalTrials.gov, number NCT01231620. Findings Between Jan 15, 2011, and Feb 12, 2015, 626 patients were randomly assigned to receive 300 mg intravenous zanamivir (n=201), 600 mg intravenous zanamivir (n=209), or 75 mg oral oseltamivir (n=205) twice a day; 11 patients discontinued the study before receiving any study treatment. 488 (78%) of 626 patients had laboratory-confirmed influenza. Compared with a median time to clinical response of 5·14 days in the 600 mg intravenous zanamivir group, the median time to clinical response was 5·87 days (difference of −0·73 days, 95% CI −1·79 to 0·75; p=0·25) in the 300 mg intravenous zanamivir group and 5·63 days (difference of −0·48 days, 95% CI −2·11 to 0·97; p=0·39) in the oseltamivir group. Four patients with influenza A/H1N1pdm09 in the oseltamivir group developed H275Y resistance mutations. Adverse events were reported in 373 (61%) of treated patients and were similar across treatment groups; the most common adverse events (300 mg intravenous zanamivir, 600 mg intravenous zanamivir, oseltamivir) were diarrhoea (10 [5%], 15 [7%], 14 [7%]), respiratory failure (11 [5%], 14 [7%], 11 [5%]), and constipation (7 [3%], 13 [6%], 10 [5%]). 41 (7%) treated patients died during the study (15 [7%], 15 [7%], 11 [5%]); the most common causes of death were respiratory failure and septic shock. Interpretation Time to clinical response to intravenous zanamivir dosed at 600 mg was not superior to oseltamivir or 300 mg intravenous zanamivir. All treatments had a similar safety profile in hospitalised patients with severe influenza. Funding GlaxoSmithKline.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

A randomized, double-blind, placebo-controlled, phase 2b Study to evaluate the safety and efficacy of recombinant human soluble thrombomodulin, ART-123, in patients with sepsis and suspected disseminated intravascular coagulation

Objectives: To determine the safety and efficacy of recombinant thrombomodulin (ART-123) in patients with suspected sepsis-associated disseminated intravascular coagulation. design: Phase 2b, international, multicenter, double-blind, randomized, placebo-controlled, parallel group, screening trial. setting: Two hundred and thirty-three ICUs in 17 countries. patients: All adult patients admitted with sepsis and suspected disseminated intravascular coagulation as assessed using a modified International Society on Thrombosis and Hemostasis score. interventions: Patients were randomized to receive IV ART-123 (0.06 mg/kg/d) for 6 days or placebo, in addition to standard of care. The primary endpoint was reduction in mortality. Secondary endpoints included reversal of overt disseminated intravascular coagulation and reduction in disease severity. Measurements and main results: A total of 750 patients were randomized, nine of whom did not receive the allocated treatment so that 371 patients received ART-123 and 370 received placebo. There were no meaningful differences between the two groups in any of the baseline variables. Twenty-eight-day mortality was 17.8% in the ART-123 group and 21.6% in the placebo group (Cochran-Mantel-Haenszel two-sided p value of 0.273 in favor of ART-123, which met the predefined statistical test for evidence suggestive of efficacy). There were no statistically significant differences in event-free and alive days between the two groups. d-dimer, prothrombin fragment F1.2 and TATc concentrations were lower in the ART-123 group than in the placebo group. There were no differences between the two groups in organ function, inflammatory markers, bleeding or thrombotic events or in the development of new infections. In post hoc analyses, greatest benefit from ART-123 was seen in patients with at least one organ system dysfunction and an international normalized ratio greater than 1.4 at baseline. conclusions: ART-123 is a safe intervention in critically ill patients with sepsis and suspected disseminated intravascular coagulation. The study provided evidence suggestive of efficacy supporting further development of this drug in sepsis-associated coagulopathy including disseminated intravascular coagulation. Future study should focus on using ART-123 in the subgroup of patients most likely to respond to this agent. Copyright © 2013 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins.SCOPUS: ar.jinfo:eu-repo/semantics/publishe