ObjectiveTo assess the efficacy of flurbiprofen 8.75 mg delivered as a spray or lozenge in patients with sore throat due to upper respiratory tract infection (URTI).Materials and methodsThis multicenter, double-blind, double-dummy, non-inferiority study randomized 440 adults with recent-onset, moderate-to-severe sore throat due to URTI to a single dose of either flurbiprofen 8.75 mg spray (n=218) or flurbiprofen 8.75 mg lozenge (n=222). The presence or absence of beta-hemolytic streptococci (A or C) was confirmed by culture tests (throat swab). The primary efficacy end point was the difference from baseline to 2 hours post-dose in sore throat pain intensity scale (STPIS pain intensity difference [PID] 2h), a validated 100 mm visual analog scale (from 0=“no pain” to 100=“severe pain”), with a non-inferiority margin of −6 mm. Secondary end points included STPIS PID at 1 hour (STPIS PID 1h) and over 2 hours (STPIS sum of sore throat pain intensity differences [SPID]0–2h) and ratings of patient satisfaction and investigator assessment of drug efficacy at 2 hours. Safety (adverse events [AEs]) was also assessed.ResultsReductions in sore throat pain intensity at 2 hours (STPIS PID 2h) were similar for spray (least square mean −40.51) and lozenge (−40.10) (difference: 0.41, 95% confidence interval [95% CI] −3.20, 4.01), with non-inferiority demonstrated. Subgroup analyses showed similar efficacy (STPIS PID 2h) for patients testing positive or negative for Strep A or C. There was no significant difference between spray and lozenge in STPIS PID 1h or STPIS SPID0–2h, and patient satisfaction and investigators’ assessment of efficacy at 2 hours were similar for both groups. There were no significant differences in AEs between the two groups, with 17 drug-related events across both groups, all being mild and none being serious.ConclusionBoth formulations demonstrated comparable efficacy and safety profiles and provide patients with two different treatment formats to choose from for effective symptomatic relief of sore throat, depending on their preference.
ObjectiveTo assess the speed of relief provided by flurbiprofen 8.75 mg spray and lozenge and their effect on many of the different qualities and characteristics of throat pain and discomfort, and the many articulations of the broad term “sore throat” (ST).Patients and methodsFour hundred and forty adults with recent-onset, moderate-to-severe ST due to upper respiratory tract infection (URTI) were randomized to a single dose of either flurbiprofen 8.75 mg spray (n=218) or flurbiprofen 8.75 mg lozenge (n=222). Throat swabs for bacterial culture were taken at baseline. ST relief was assessed at 1 minute, 1 and 2 hours post-dose using the Sore Throat Relief Rating Scale. The change from baseline at 1 and 2 hours post-dose in difficulty swallowing and swollen throat was assessed using the difficulty swallowing scale and the swollen throat scale, respectively. Patients’ experience of URTI symptoms was assessed using a URTI questionnaire at baseline and 2 hours post-dose. The change in Qualities of Sore Throat Index, a 10-item index of qualities of ST, from baseline at 2 hours post-dose was also measured.ResultsST relief was evident in the spray and the lozenge treatment groups at 1 minute, 1 and 2 hours post-dose (P>0.05). In both groups, scores for difficulty swallowing and swollen throat significantly improved at 1 and 2 hours post-dose compared with baseline. At 2 hours post-dose, the number of patients experiencing URTI symptoms that can be attributed to or associated with ST decreased relative to baseline. The mean change from baseline to 2 hours post-dose for each individual score on the Qualities of Sore Throat Index showed significant improvements for flurbiprofen spray and lozenge (all P<0.0001).ConclusionNon-inferiority was established, and flurbiprofen spray and lozenge provided effective relief from ST pain and many of the other commonly reported qualities of ST.
Background:The symptoms of viral and bacterial sore throats are similar, making it difficult to distinguish between them using clinical features alone. We evaluated the Clinical Assessment of Strep Throat (CAST) for predicting beta-haemolytic streptococcal infection. Results were compared to throat cultures that provide a definitive streptococcal diagnosis.Methods & Materials: A total of 440 patients with recent-onset sore throat due to upper respiratory tract infection were randomised to receive a single dose of flurbiprofen 8.75 mg delivered as a spray or lozenge. Using the patient's history, symptoms and physical findings, investigators performed the CAST to make a clinical judgement on the likelihood of streptococcal infection using a 4-point categorical scale (unlikely [-1], uncertain [0], likely [1], very likely [2]). Throat swabs for culture identified patients with Strep A or C infection (n = 433).Results: Streptococcal infection was considered 'very likely' in one patient, 'likely' in 78 patients (18.0%), 'uncertain' (ie a lack of diagnosis) in 123 patients (28.4%) and 'unlikely' in 231 patients (53.3%). Overall, 25 patients had Strep A-or C-positive throat cultures; of these only 8 were considered 'likely' or 'very likely' to have a streptococcal infection using the CAST. The sensitivity and specificity of the CAST was 32% and 55.9%, respectively. The misclassification rate (clear errors in prediction) was 17.1%. However, a trend test showed the 'likely' and 'very likely' categories were associated with higher probability of streptococcal infection (p = 0.0003). Conclusion:While the number of Strep A or C cases was relatively low, these results clearly show the difficulty in predicting the likelihood of infection based on clinical features alone. Of the 79 patients identified as 'likely'/'very likely' to have a streptococcal infection using the CAST, 71 patients could have potentially received antibiotics inappropriately. Such a large proportion is critical, as inappropriate antibiotic usage contributes to the global problem of antibiotic resistance. Flurbiprofen is an alternative to inappropriate antibiotics and in this study provided symptomatic relief in patients with or without streptococcal infection.Conflicts of interest: Reckitt Benckiser funded this study. Adrian Shephard and Valeria Bychkova are employees of Reckitt Benckiser, and Natalia Burova's organisation received Reckitt Benckiser funding for the study.
Abstract. The purpose of the study was to establish an ultrasonographic picture of the upper urinary system in cats with chronic kidney disease at different stages and their prognostic significance. Research methods. The study involved 40 cats of different sex, age and breed with an established diagnosis of chronic kidney disease from stage 1 to stage 4, 10 animals in each group. The staging of the stage was based on the concentration of the serum creatinine level. All animals underwent ultrasonographic examination of the urinary system on the ChisonQBit 11 apparatus with a high-frequency linear sensor in longitudinal and cross sections. The nature of structural changes in the kidneys as a result of ultrasonographic examination were correlated with the stage of the disease. Scientific novelty. Chronic kidney disease is one of the most common pathologies in cats older than 7 years. The disease is progressive, which proves the need for early detection and preparation of therapeutic and diagnostic measures to prolong and improve the life of the animal. Ultrasound diagnostics is included in the diagnostic plan, which allows to identify animals with structural changes in the kidneys, but is not decisive in the diagnosis and stage of chronic kidney disease in cats. Results. In cats at stage 1 of chronic kidney disease, ultrasound changes in the structure of the kidneys were absent in 60 % of cases, ultrasound signs of polycystic and hyperechogenic medullary rim (ring) were detected in 10 % of cases. In cats at stage 2, ultrasound changes of the kidneys were absent in 30 % of cases, signs of nephrolithiasis (concretions in the projection of the pelvis without signs of obstruction) were found in 20 % of cases, and signs of nephrosclerosis/hypoplasia unilaterally were found in 10 % of cases. At stage 3, diffuse kidney changes were detected in 100 % of cases, signs of nephrosclerosis/hypoplasia in 40 % of cases, nephrolithiasis in 20 %, polycystic disease in 10 % of cases. At stage 4, diffuse changes were present in 100 %, signs of nephrosclerosis/hypoplasia in 30 %, and nephrolithiasis in 10 % of cases. Thus, there are no specific signs that allow us to establish the stage of chronic kidney disease in cats according to the results of ultrasonographic examination.
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