RESUMO
In this study, a new oral granular formulation of ketoprofen lysine salt, a non steroidal antiinflammatory drug (NSAID) derived from propionic acid, and placebo, were compared for their local effect on the gastric mucosa of healthy, human volunteers. The study was carried out with a double-blind, randomized, parallel-group, design. 10 healthy volunteers were administered one sachet containing 80 mg of ketoprofen lysine salt and 10 volunteers with placebo. The subjects were gastroscoped at baseline and following 10 days drug administration; tolerability was assessed by analysis of the hematology and biochemistry laboratory results, the adverse reaction reports and by the Investigator's and subject's global assessment at the final visit. No symptoms of gastric intolerance were referred in both groups. No statistically significant differences were found between treatments in laboratory results and in final post-treatment tolerability evaluation (Mann-Whitney's test U, Phi and Cramer tests).
Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Mucosa Gástrica/efeitos dos fármacos , Gastroscopia , Cetoprofeno/análogos & derivados , Lisina/análogos & derivados , Adulto , Formas de Dosagem , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Cetoprofeno/administração & dosagem , Lisina/administração & dosagem , MasculinoRESUMO
BACKGROUND: The aim of the present epidemiological research was to select paediatric subjects who were suspicious of Primary Fibromyalgia (PF) and estimate its incidence in the students of the schools of Castiglione delle Stiviere (Mantova). METHODS: The students had to answer Campbell's questionnaire which was varied and simplified in order to make it comprehensive to everybody even if the key answers were unchanged. The questionnaire was distributed in primary schools (3dr up to 5th class), secondary schools and high schools and its compilation was carried out with a doctor's help. The authors collected and examined 2408 forms. After this evaluation 66 subjects, corresponding to 2.74%, had been considered suspected of PF and had been called to our Paediatric Department to continue the study. In the second phase of the research these 66 students have been submitted to a deep anamnesis, a careful clinical evaluation, a test of tender-points with a digital pressure algometer and some laboratory tests to exclude other rheumatic diseases. The map of the American College of Rheumatology adapted by Wolfe et al. (1990) was used to evaluate tender-points. RESULTS: After this phase 29 students (1.20%) proved to be affected by primary fibromyalgia.