SummaryBackgroundSince the 1918 influenza pandemic, non-randomised studies and small clinical trials have suggested that convalescent plasma or anti-influenza hyperimmune intravenous immunoglobulin (hIVIG) might have clinical benefit for patients with influenza infection, but definitive data do not exist. We aimed to evaluate the safety and efficacy of hIVIG in a randomised controlled trial.MethodsThis randomised, double-blind, placebo-controlled trial was planned for 45 hospitals in Argentina, Australia, Denmark, Greece, Mexico, Spain, Thailand, UK, and the USA over five influenza seasons from 2013–14 to 2017–18. Adults (≥18 years of age) were admitted for hospital treatment with laboratory-confirmed influenza A or B infection and were randomly assigned (1:1) to receive standard care plus either a single 500-mL infusion of high-titre hIVIG (0·25 g/kg bodyweight, 24·75 g maximum; hIVIG group) or saline placebo (placebo group). Eligible patients had a National Early Warning score of 2 points or greater at the time of screening and their symptoms began no more than 7 days before randomisation. Pregnant and breastfeeding women were excluded, as well as any patients for whom the treatment would present a health risk. Separate randomisation schedules were generated for each participating clinical site using permuted block randomisation. Treatment assignments were obtained using a web-based application by the site pharmacist who then masked the solution for infusion. Patients and investigators were masked to study treatment. The primary endpoint was a six-category ordinal outcome of clinical status at day 7, ranging in severity from death to resumption of normal activities after discharge. The choice of day 7 was based on haemagglutination inhibition titres from a pilot study. It was analysed with a proportional odds model, using all six categories to estimate a common odds ratio (OR). An OR greater than 1 indicated that, for a given category, patients in the hIVIG group were more likely to be in a better category than those in the placebo group. Prespecified primary analyses for safety and efficacy were based on patients who received an infusion and for whom eligibility could be confirmed. This trial is registered with ClinicalTrials.gov, NCT02287467.Findings313 patients were enrolled in 34 sites between Dec 11, 2014, and May 28, 2018. We also used data from 16 patients enrolled at seven of the 34 sites during the pilot study between Jan 15, 2014, and April 10, 2014. 168 patients were randomly assigned to the hIVIG group and 161 to the placebo group. 21 patients were excluded (12 from the hIVIG group and 9 from the placebo group) because they did not receive an infusion or their eligibility could not be confirmed. Thus, 308 were included in the primary analysis. hIVIG treatment produced a robust rise in haemagglutination inhibition titres against influenza A and smaller rises in influenza B titres. Based on the proportional odds model, the OR on day 7 was 1·25 (95% CI 0·79–1·97; p=0·33). In subgroup analyses for the pr...

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Beristain JL, Sabater L, Calatayud A, Calvete J, Rausell M, Lledó S, Tosca J, Sastre J, Aparisi L. Pancreatitis autoinmune: pseudotumor inflamatorio, afectación multifocal, hipertensión portal y evolución a largo plazo. Rev Esp Enferm Dig 2008; 100: 652-658. RESUMENLa pancreatitis autoinmune es una enfermedad recientemente caracterizada y que en la actualidad constituye un reto diagnóstico especialmente su diferenciación con el cáncer de páncreas. Su evolución a largo plazo es poco conocida, presentándose un caso estudiado a lo largo de 14 años y mostrando su evolución clínica, bioquímica y morfológica.Paciente mujer de 54 años que debuta con un cuadro de ictericia obstructiva y molestias abdominales inespecíficas y constatación en la TAC de un aumento de la cabeza del páncreas, todo ello sugestivo de neoplasia de páncreas. Fue intervenida evidenciándose un aumento difuso de todo el páncreas descartándose malignidad intraoperatoriamente, realizando únicamente colecistectomía y coledocoduodenostomía, quedando diagnosticada entonces como pancreatitis crónica. Durante los años posteriores fueron apareciendo diferentes procesos autoinmunes como asma, sialoadenitis y colangitis esclerosante secundaria, así como episodios recurrentes de ictericia e insuficiencia pancreática endocrina y exocrina. La aparición de estas complicaciones y la detección de niveles séricos elevados de IgG4 y de anticuerpos antianhidrasa carbónica II condujo a la reevaluación de la histología inicial concluyendo finalmente con el diagnóstico de pancreatitis autoinmune al evidenciarse una infiltración linfocitaria y plasmacitaria IgG4+, así como fibrosis y flebitis obliterativa. En los últimos años se ha añadido a las anteriores complicaciones una fibrosis retroperitoneal con hipertensión portal, varices esofágicas y esplenomegalia. ABSTRACTAutoimmune pancreatitis is a recently characterized disease that still constitutes a diagnostic challenge, especially regarding differential diagnosis from neoplasia. Long-term outcome is poorly known. We herein report a case of a patient with autoimmune pancreatitis and 14 years of follow-up, and show its clinical, biochemical, and morphological characteristics.A 54-year-old female presented with obstructive jaundice and abdominal tenderness, as well as a mass at the pancreatic head on a CT scan, suggestive of pancreatic neoplasia. Surgery showed an increase of the whole pancreas, malignancy was intraoperatively ruled out, and a cholecystectomy and choledochoduodenostomy were carried out. The diagnosis was chronic pancreatitis. Over the following years different autoimmune complications developed, including asthma, salivary gland swelling, and sclerosing cholangitis, as well as recurrent episodes of jaundice, and exocrine and endocrine pancreatic failure. The development of these complications combined with the demonstration of high serum levels of IgG4 and carbonic anhydrase II led to a re-evaluation of the initial histology of the pancreas, leading to a final diagnosis of autoimmune pancreatitis: IgG4+ l...

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