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Untoward Events (untoward + event)
Selected AbstractsImmediate and Midterm Complications of Sclerotherapy: Report of a Prospective Multicenter Registry of 12,173 Sclerotherapy SessionsDERMATOLOGIC SURGERY, Issue 2 2005FACPH, Jean-Jérôme Guex MD Background Growing interest in sclerotherapy has emphasized the need for complete knowledge of all aspects of this method. Objective To precisely delineate the actual incidence of immediate and delayed untoward events of daily sclerotherapy. Methods A multicenter prospective registry was established in 22 phlebology clinics to report their activity and complications. Results During the study period, 12,173 sessions of sclerotherapy were carried out, 5,434 with liquid, 6,395 with foam, and 344 using both. Four thousand eighty-eight (33.9%) sessions were carried out with ultrasound guidance. Forty-nine incidents or accidents (0.4%) occurred, of which 12 were with liquid and 37 with foam. These were reported during the time of the study and an additional 1-month follow-up. Most numerous were 20 cases of visual disturbances (in 19 cases, foam or air block was used); all resolved shortly, without any after-effects. A femoral vein thrombosis was the only severe adverse event in this study. Conclusions This study demonstrates that sclerotherapy is a safe technique. FUNDING FOR RESEARCH WAS PROVIDED BY THE FRENCH SOCIETY OF PHLEBOLOGY, A NONPROFIT ORGANIZATION. [source] An approach to the management of necrotising fasciitis in neonatesINTERNATIONAL WOUND JOURNAL, Issue 2 2005Soraya Zuloaga-Salcedo MD Abstract Necrotising fasciitis is a severe, life-threatening soft tissue infection. It produces an extensive cellulitis with severe involvement of subcutaneous tissue, fascia, muscle or both, resulting in necrosis of the tissue. All age groups, including neonates, can be affected. Patients with necrotising fasciitis present with more severe constitutional symptoms and have a poor outcome, unless aggressive antibiotic therapy and surgical debridement are instituted promptly. The debridement of necrotic tissue is imperative to control the infection, but results in deep wounds that require further treatment. In this study, the neonate was treated with alginate dressings and negative pressure therapy after resolution of cellulitis, with excellent results and no untoward events. [source] The pharmacokinetics and pharmacodynamics of alfaxalone in cats after single and multiple intravenous administration of Alfaxan® at clinical and supraclinical dosesJOURNAL OF VETERINARY PHARMACOLOGY & THERAPEUTICS, Issue 6 2008T. WHITTEM This study aimed to determine the pharmacokinetic parameters and pharmacodynamics of alfaxalone in a 2-hydroxypropyl-,-cyclodextrin alfaxalone formulation (Alfaxan®, Jurox Pty Ltd, Rutherford, NSW, Australia) in cats after single administration at clinical and supraclinical dose rates and as multiple maintenance doses. First, a prospective two-period cross-over study was conducted at single clinical and supraclinical doses. Second, a single group multiple dose study evaluated the effect of maintenance doses. Eight (five female and three male) domestic cats completed the cross-over experiment and six female cats completed the multiple dose study. In the first experiment, alfaxalone was administered intravenously (IV) at 5 or 25 mg/kg with a washout period of 14 days. In the second experiment, alfaxalone was administered IV at 5 mg/kg followed by four doses each of 2 mg/kg, administered at onset of responsiveness to a noxious stimulus. Blood was collected at prescribed intervals and analysed by LCMS for plasma alfaxalone concentration. Noncompartmental pharmacokinetics were used to analyse the plasma alfaxalone data. The plasma clearance of alfaxalone at 5 and 25 mg/kg differed statistically at 25.1 and 14.8 mL/kg/min respectively. The elimination half lives were 45.2 and 76.6 min respectively. Alfaxalone has nonlinear pharmacokinetics in the cat. Nevertheless, for cats dosed with sequential maintenance doses, a regression line through their peak plasma concentrations indicated that there was no clinically relevant pharmacokinetic accumulation. The duration of nonresponsiveness after each maintenance dose was similar at approximately 6 min, indicating a lack of accumulation of pharmacodynamic effect. The cardiovascular and respiratory parameters measured in cats after administration of the labelled doses of Alfaxan® were stable. In conclusion, the pharmacokinetics of alfaxalone in cats are nonlinear. At clinical dose rates, however, neither alfaxalone nor its effects accumulated to a clinically relevant extent. Further, in the un-premedicated cat the induction and maintenance of surgical anaesthesia was free of untoward events after a dose of 5 mg alfaxalone/kg body weight followed by four sequential doses of 2 mg/kg as needed (i.e., approximately 7 to 8 mg/kg/h). [source] Complications of Surgery for Nasal Polyposis and Chronic Rhinosinusitis: The Results of a National Audit in England and WalesTHE LARYNGOSCOPE, Issue 8 2006Claire Hopkins Abstract Objective: The objective of this study was to determine the rate of complications of surgery for nasal polyposis and chronic rhinosinusitis as well as their risk factors. Study Design, Setting, Participants, and Outcome Measures: The authors conducted a prospective study of 3,128 patients who underwent sinonasal surgery during 2000 and 2001 in 87 National Health Service hospitals in England and Wales. Patients completed a preoperative questionnaire that included the Sino-Nasal Outcome Test, a measure of sinonasal symptoms severity and health-related quality of life. Surgeons provided information about polyp extent, opacity of the sinuses on computed tomography (Lund-Mackay score), comorbidity (American Society of Anesthesiologists score), and the occurrence of perioperative complications. Results: Major complications (orbital or intracranial complications, bleeding requiring ligation or orbital decompression, or return to the operating room) occurred in 11 patients (0.4%). Minor complications (all other untoward events) occurred in 207 patients (6.6%). Most frequently reported minor complications were excessive perioperative hemorrhage bleeding (5.0%) as well as postoperative hemorrhage requiring treatment (0.8%). Multivariate analysis indicated that the complication rate was linked to the extent of disease measured in terms of symptom severity and health-related quality of life, the extent of polyposis, level of opacity of the sinuses on computed tomography, and the presence of comorbidity, but not surgical characteristics (extent of surgery, use of endoscope or microdebrider, grade of surgeon, and adjunctive turbinate surgery). Conclusions: The risk of complications depended on patient characteristics rather than on the surgical technique used. Measures of the extent of disease and comorbidity may help in identifying patients at high risk of complications. [source] A Human Anti-CD40 Monoclonal Antibody, 4D11, for Kidney Transplantation in Cynomolgus Monkeys: Induction and Maintenance TherapyAMERICAN JOURNAL OF TRANSPLANTATION, Issue 8 2009T. Aoyagi Blockade of CD40,CD154 signaling pathway is an attractive strategy to induce potent immunosuppression and tolerance in organ transplantation. Due to its strong immunosuppressive effect shown in nonhuman primate experiments, anti-CD154 monoclonal antibodies (mAbs) have been tried in clinical settings, but it was interrupted by unexpected thromboembolic complications. Thus, inhibition of the counter molecule, CD40, has remained an alternative approach. In the previous preliminary study, we have shown that 4D11, a novel fully human anti-CD40 mAb, has a fairly potent immunosuppressive effect on kidney allograft in nonhuman primates. In this study, we aimed to confirm the efficacy and untoward events of the 2-week induction and 180-day maintenance 4D11 treatments. In both, 4D11 significantly suppressed T-cell-mediated alloimmune responses and prolonged allograft survival. Addition of weekly 4D11 administration after the induction treatment further enhanced graft survival. Complete inhibition of both donor-specific Ab and anti-4D11 Ab productions was obtained only with higher-dose maintenance therapy. No serious side effect including thromboembolic complications was noted except for a transient reduction of hematocrit in one animal, and decrease of peripheral B-cell counts in all. These results indicate that the 4D11 appears to be a promising candidate for immunosuppression in clinical organ transplantation. [source] | ||||||||||