Transient Facial Nerve Paralysis (Bell's Palsy) following Intranasal Delivery of a Genetically Detoxified Mutant of Escherichia coli Heat Labile Toxin

BACKGROUND: An association was previously established between facial nerve paralysis (Bell's palsy) and intranasal administration of an inactivated influenza virosome vaccine containing an enzymatically active Escherichia coli Heat Labile Toxin (LT) adjuvant. The individual component(s) responsible for paralysis were not identified, and the vaccine was withdrawn. METHODOLOGY/PRINCIPAL FINDINGS: Subjects participating in two contemporaneous non-randomized Phase 1 clinical trials of nasal subunit vaccines against Human Immunodeficiency Virus and tuberculosis, both of which employed an enzymatically inactive non-toxic mutant LT adjuvant (LTK63), underwent active follow-up for adverse events using diary-cards and clinical examination. Two healthy subjects experienced transient peripheral facial nerve palsies 44 and 60 days after passive nasal instillation of LTK63, possibly a result of retrograde axonal transport after neuronal ganglioside binding or an inflammatory immune response, but without exaggerated immune responses to LTK63. CONCLUSIONS/SIGNIFICANCE: While the unique anatomical predisposition of the facial nerve to compression suggests nasal delivery of neuronal-binding LT-derived adjuvants is inadvisable, their continued investigation as topical or mucosal adjuvants and antigens appears warranted on the basis of longstanding safety via oral, percutaneous, and other mucosal routes

The database of the Danish Renal Cancer Group

Astrid Christine Petersen,1 Mette Søgaard,2 Frank Mehnert,2 Erik Højkjær Larsen,3 Frede Donskov,4 Nessn H Azawi,5 Bjarne Kromann-Andersen6 1Department of Pathology, Aalborg University Hospital, Aalborg, 2Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, 3Department of Urology, Odense University Hospital, Odense, 4Department of Oncology, Aarhus University Hospital, Aarhus, 5Department of Urology, Zealand University Hospital, Roskilde, 6Department of Urology, Herlev and Gentofte Hospital, Copenhagen, Denmark Aim of the database: The main purpose of the database of the Danish Renal Cancer Group (DaRenCaData) is to improve the quality of renal cancer treatment in Denmark and secondarily to conduct observational research. Study population: DaRenCaData includes all Danish patients with a first-time diagnosis of renal cancer in the Danish National Pathology Registry since August 1, 2010. Main variables: DaRenCaData holds data on demographic characteristics, treatments, and pathology collected through linkage to central registries and online registration of a few clinical key variables. Eight quality indicators have been selected for monitoring treatment quality and outcome after renal cancer. Descriptive data: The incidence of renal cancer in Denmark has increased from 12.7 per 100,000 population-years in 2010–2011 to 15.9 per 100,000 population-years in 2014–2015. A total of 3,977 Danish patients with renal cancer have been enrolled in the database in the period August 1, 2010–July 31, 2015. The completeness of data registration has increased substantially since the first years of the database. A tendency toward smaller and less advanced tumors, less invasive surgery, and a shorter hospital stay was observed, while the postoperative morbidity and mortality remained stable. Concurrently, the 1-year survival has improved and was 84.1% in 2014–2015. Conclusion: DaRenCaData provides valuable information on quality of and outcome after renal cancer treatment. Efforts to improve collection and registration of data are ongoing. Keywords: kidney cancer, database, clinical quality, indicators, incidence, survival, observational researc

Use of venous-thrombotic-embolic prophylaxis in patients undergoing surgery for renal tumors: a questionnaire survey in the Nordic countries (The NORENCA -2 study)

Lars Lund,1,2 Harry Nisen,3 Petrus Järvinen,3 Magnus Fovaeus,4 Eirikur Gudmundson,5 Bjarne Kromann-Andersen,6 Börje Ljungberg,7 Frode Nilsen,8 Pernilla Sundqvist,9 Peter E Clark,10 Christian Beisland11,12 1Department of Urology, Odense University Hospital, 2Clinical Institute, Southern University of Denmark, Odense, Denmark; 3Department of Urology, Helsinki University Hospital, Helsinki, Finland; 4Department of Urology, Sahlgrenska University Hospital, Gothenburg, Sweden; 5Department of Urology, Landspitali University Hospital, Reykjavik, Iceland; 6Department of Urology, Herlev University Hospital, Copenhagen, Denmark; 7Department of Surgical and Perioperative Sciences, Urology and Andrology, Umeå University, Umeå, Sweden; 8Department of Urology, Akershus University Hospital, Lörenskog, Norway; 9Department of Urology, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; 10Department of Urology, Atrium Health, Charlotte, NC, USA; 11Department of Urology, Haukeland University Hospital, 12Department of Clinical Medicine, University of Bergen, Bergen, Norway Purpose: To examine the variation in venous thromboembolism prophylactic treatment (VTEP) among renal cancer patients undergoing surgery.Materials and methods: An Internet-based questionnaire on renal tumor management before and after surgery was mailed to all Nordic departments of urology. The questions focused on the use of VTEP and were subdivided into different surgical modalities.Results: Questionnaires were mailed to 91 institutions (response rate 53%). None of the centers used VTEP before surgery, unless the patient had a vena caval tumor thrombus. Overall, the VTEP utilized during hospitalization for patients undergoing renal surgery included early mobilization (45%), compression stockings (52%) and low-molecular-weight heparin (89%). In patients undergoing open radical Nx, 80% of institutions used VTEP during their hospitalization (23% compression stockings and 94% low-molecular-weight heparin). After leaving the hospital, the proportion and type of VTEP received varied considerably across institutions. The most common interval, used in 60% of the institutions, was for a period of 4 weeks. The restriction to the Nordic countries was a limitation and, therefore, may not reflect the practice patterns elsewhere. It is a survey study and, therefore, cannot measure the behaviors of those institutions that did not participate.Conclusion: We found variation in the type and duration of VTEP use for each type of local intervention for renal cancer. These widely disparate variations in care strongly argue for the establishment of national and international guidelines regarding VTEP in renal surgery. Keywords: venous-thrombotic-embolic prophylaxis kidney cancer, surgery, nephrectomy, mortality, complication, minimally invasive methods, thrombosis prophylaxi

Transient facial nerve paralysis (Bell's palsy) following intranasal delivery of a genetically detoxified mutant of Escherichia coli heat labile toxin.

An association was previously established between facial nerve paralysis (Bell's palsy) and intranasal administration of an inactivated influenza virosome vaccine containing an enzymatically active Escherichia coli Heat Labile Toxin (LT) adjuvant. The individual component(s) responsible for paralysis were not identified, and the vaccine was withdrawn