RESUMO
OBJECTIVE: To assess the safety, tolerability and efficacy of low-dose ketoprofen (75-150 mg daily for 5 to 15 days) in a general practice setting. DESIGN: Open label, non-controlled study of ketoprofen 25 mg tablets in the treatment of pain in ENT diseases, dysmenorrhoea, and musculoskeletal disorders. SETTING: General practice, 600 investigators SUBJECTS: Four thousand and sixty-eight patients, aged 13-93 years, mean 42.3 years, 1009 with ENT diseases (mean age 38.8 (13-83) years, 53% female), 978 with dysmenorrhoea (mean age 30.3 (13-60) years, 100% female), 2081 with musculoskeletal disorders (mean age 49.6 (16-93) years, 54% female). MAIN OUTCOME MEASURES: Occurrence of adverse events, on patient and physician evaluation; dose and duration of treatment prescribed/taken (diary); global evaluation of efficacy by patient and physician. RESULT: Twenty-two patients were lost to follow-up (<1%); dose effectively taken was lower than prescribed (3.3 versus 3.6 tablets/day); treatment was stopped prematurely in 3.3% of patients because of adverse events, in 17.1% because of early success of therapy. Gastrointestinal adverse events (AE) were the most frequent (76%) of AE), occurring in 10% of patients. They were more frequent in patients with musculoskeletal pain, who were older and had more associated diseases. Five patients were hospitalized, two for preplanned hospitalizations, the others for one asthma attack, one worsening of low back pain, and one angina attack, none attributed to treatment by the GP. None of the AE was life-threatening. Identified risk factors for AE were age and previous medical history, especially of gastrointestinal disorders. CONCLUSIONS: Good quality large scale studies with little or no loss to follow-up can be done in a general practice setting. At the dose used, ketoprofen was generally well tolerated, and used at a lower dose than prescribed, it was not associated with severe or new side-effects. The results of this study could justify its use in self-medication in these indications.
RESUMO
Effectiveness and clinical tolerance of the tixocortol-neomycin combination (Pivalone-Neomycin nasal suspension) used as monotherapy were evaluated in a double-blind placebo-controlled study (placebo: vehicle i.e., N-cetylpyridinium chloride, sodium chloride, sodium hydroxide solution, benzyl alcohol, purified water, monosodium phosphate) in 211 pediatric patients (aged 6 months to 8 years) with uncomplicated acute rhinopharyngitis. After seven days therapy, improvement in symptoms of acute rhinopharyngitis, especially rhinorrhea and nocturnal cough, was greater in the tixocortol-neomycin group. Physical evaluation documented significant improvements in local superinfection with disappearance of mucopurulent nasal secretions and posterior drip. Locoregional outcome, evaluated on severity of infectious complications and antibiotic use, was also more favorable in the tixocortol-neomycin group. These results, together with the good clinical tolerance of the study drug, demonstrate the value of single-drug therapy with this local corticosteroid-neomycin combination in children with uncomplicated acute rhinopharyngitis. They confirm that local administration of corticosteroids to combat inflammatory phenomena is useful not only in the well-recognized lower respiratory tract indications (asthma, respiratory syncitial virus infections) but also in nasal diseases (rhinitis).
