ABSTRACT
Les effets indesirables aux antibiotiques constituent un reel probleme de sante publique. Dans ce travail; ont ete analyses la frequence; les types; les facteurs predisposant et la gravite des effets indesirables aux antibiotiques. Notre etude; de type retrospectif; porte sur les cas d'effets indesirables aux antibiotiques obtenus par notification spontanee au centre regional de pharmacovigilance de Sfax durant une periode de trois ans. Parmi 249 cas d'effets indesirables medicamenteux; 82 cas (32;93) ont ete lies aux antibiotiques. L'age variait de 5 a 86 ans. Il s'agissait de 55 femmes et de 27 hommes. Soixante dix effets indesirables lies aux antibiotiques (85.36) parmi 82 etaient de nature immunoallergique. Dans 60 cas (73.17); les patients avaient des antecedents medicaux: atopie; allergie medicamenteuse; maladies auto-immunes ou pathologies chroniques necessitant une polymedication. 54 patients (65.85) prenaient 3 medicaments ou plus. Les formes graves ont ete observees chez 12 patients parmi 82 (14.63). La polytherapie; les maladies chroniques et l'age avance sont des facteurs favorisant la survenue des effets indesirables aux antibiotiques. Nos resultats soulignent le risque augmente chez les sujets ayant un antecedent d'allergie a un antibiotique de developper une allergie a un autre antibiotique
Subject(s)
Anti-Bacterial Agents/adverse effects , Pharmacovigilance , Retrospective StudiesABSTRACT
OBJECTIVES: The aim of the present study was to compare the efficiency of pulmonary deposition of pentamidine using the Respirgard II jet nebuliser or the Fison ultrasonic nebuliser with 99m technetium (99m Tc) labelled pentamidine in the current conditions of recommended treatment. The study was designed in three stages, to verify particle size distribution, to validate the isotope labelling, and to compare pulmonary deposition of pentamidine isethionate with the two nebulisers. METHODS: Count median aerodynamic diameter and mass median aerodynamic diameter were measured using the velocimetry technique and aerosol dispersion was calculated according to the standard deviation defined by the ratio of diameters between 84.3% and 50% of the total distribution. Stability of labelling was checked both in vitro, by radiochromatography, and in vivo, by the absence of free technetium thyroid fixation after intravenous injection of the preparation to a rat and inhalation by baboons. The direct isotopic technique was used to compare pulmonary deposition of 300 mg aerosolized 99m Tc labelled pentamidine isothionate with the two nebulisers in four HIV patients treated with primary prophylaxis. RESULTS: Count median aerodynamic diameter and mass median aerodynamic diameter (MMAD) were higher with Fisoneb than with Respirgard II. Nevertheless Fisoneb MMAD remained in the optimal range for peripheral deposition. In one patient, pentamidine lung burden was higher using the Respirgard II (13% of dose originally in nebuliser) when compared with the Fisoneb (10.2% of dose originally in nebuliser). A better result was obtained in the 3 other patients with Fisoneb (mean = 14.3%) compared with Respirgard II (mean = 3.8%). In all 4 patients gastric contamination was higher with Fisoneb (mean = 5.2%) as compared with Respirgard II (mean = 2.6%). Cough and bronchospasm were not observed with either device. CONCLUSION: This study showed that Fisoneb, a practical and cheap nebuliser which has proved to be effective in clinical studies when used for pentamidine nebulisation, leads to correct particle size distribution and pulmonary deposition of the drug. We believe that such studies to evaluate aerosol characteristics should be recommended for any kind of nebuliser.