ABSTRACT
Em ensaios clínicos 8.861 pacientes foram tratados com ciprofloxacina a nível mundial. Dos tratamentos realizados,03.822 foram válidos para análise da eficácia, de acordo cocm os padröes do FDA. Em geral foram administradas as seguintes doses: infecçöes do trato urinário: 100 a 50 mg duas vezes por dia, por via oral ou 100 mg duas vezes por dia, por via intravenosa; infecçöes do trato respiratório: 250 a 1.000 mg, duas vezes ao dia, por via oral ou 200 mg duas vezes por dia, por via intravenosa; septicemia: 200 mg duas vezes por dia, por via intravenosa; gonorréia: 250 a 500 mg, por via oral, em dose única; todas as outras infecçöes: 500 a 1000 mg duas vezes por dia, por via oral ou 200 mg, duas vezes por dia, por via intravenosa. A ciprofloxacina foi administrada em 762 tratamentos de infecçöes respiratórias baixas, 88 infecçöes respiratórias altas, 108 bacteremias, 766 infecçöes de pele e anexos, 142 infecçöes dos ossos e articulaçöes, 149 infecçöes intra-abdominais, 33 infecçöes gastrintestinais, 1.633 infecçöes do trato urinário, 49 infecçöes pélvicas, 279 doenças transmitidas sexualmente, principalmente gonorréia, e em três meningites. A resposta clínica foi cura em 76%, melhora em 18% e falha em apenas 6%. A resposta bacteriológica em relaçäo a todos os locais avaliáveis foi: patógenos erradicados em 74%, acentuadamente reduzidos em 2% e persistentes em 10%. Ocorrem recidivas em 4% e reinfecçöes em outros 6%. A resposta global foi favorável em 90% dos pacientes. A segurança da droga foi estabelecida com base nos dados de 8.861 tratamentos a nível mundial. De acordo com a terminologia de COSTART, foram observadas as seguintes reaçöes adversas: digestivas 5%, metabólico-nutricionais 4,6% sistema nervoso central 1,6%, pele 1,4%, hematológicas e linfáticas 1%, cardiovasculares 0,4%, urogenitais 0,3%, órgäos dos sentidos 0,3%, músculo-esqueléticas 0,1%, respiratórias 0,08%...
Subject(s)
Infant , Child, Preschool , Child , Adolescent , Adult , Middle Aged , Humans , Male , Female , Ciprofloxacin/therapeutic use , Bacterial Infections/drug therapy , Ciprofloxacin/administration & dosage , Ciprofloxacin/adverse effects , Clinical Trials as TopicABSTRACT
During the clinical trials 8,861 patients have been treated with ciprofloxacin worldwide. 3,822 of the therapeutic courses were valid for analysis of efficacy according to FDA standards. The following dosages were usually administered: UTI: 100 to 500 mg twice daily orally or 100 mg twice daily intravenously; RTI: 250 to 1000 mg twice daily orally or 200 mg twice daily intravenously; septicemia: 200 mg intravenously twice daily; gonorrhea: 250 to 500 mg single tablet orally; all other infections: 500 to 1000 mg twice daily orally or 200 mg twice daily intravenously. Ciprofloxacin was administered to 762 courses of lower RTI, 88 courses of upper RTI, 108 courses of bacteremia, 766 courses of skin structure infection, 142 courses of bone and joint infections, 149 courses of intra-abdominal infections, 33 courses of gastrointestinal infections, 1,633 courses of UTI, 49 courses of pelvic infections, 279 courses of STD, mainly gonorrhea, and three courses of meningitis. The clinical response was resolution in 76%, improvement in 18% and failure in only 6%. Bacteriologic response by all sites evaluable: pathogens were eradicated from 74%, markedly reduced in 2%, persisted in 10%. Relapse occurred in 4% and reinfection was observed in another 6%. The overall response was favourable for 90% of the patients. Drug safety was established on a data base of 8,861 courses worldwide. The following side-effects according to COSTART terminology were observed: digestive 5%, metabolic nutritional 4.6%, central nervous 1.6%, skin 1.4%, hemic and lymphatic 1%, cardiovascular 0.4%, body as a whole 0.4%, urogenital 0.3%, special senses 0.3%, musculo-skeletal 0.1%, respiratory 0.08%. Several courses had more than one reaction. Thus the total incidence of side-effects for the treated patient population was 10.2%. Ciprofloxacin is a highly effective drug and a breakthrough in several areas of medical interest. It is relatively safe and side-effects are usually mild or moderate in intensity and transient.
Subject(s)
Bacterial Infections/drug therapy , Ciprofloxacin/therapeutic use , Ciprofloxacin/toxicity , Clinical Trials as Topic , Female , Humans , MaleABSTRACT
Azlocillin, an acylureidopenicillin particularly active against Pseudomonas aeruginosa, was used to treat 124 patients, 36 of whom were children, presenting with pulmonary infections (including cystic fibrosis), urinary, genital, intra-abdominal, osteoarticular and skin infections as well as septicaemia, otitis and meningitis. The causative agent in all cases was Ps. aeruginosa either alone or associated with other pathogens. Azlocillin was administered alone in 75% of the cases and in combination with an aminoglycoside in 25%. Dosage was 240 mg/kg/24 h in three intravenous infusions in adults and in children older than 3 months, and 75 to 225 mg/kg/24 h in two intravenous injections in neonates and prematures. The duration of treatment varied according to the site of infection, with a mean of 10 days. One-hundred and eight pathogenic organisms were isolated, including 114 strains of Pseudomonas, 43 of which were carbenicillin-resistant. A satisfactory clinical response was observed in 86.5% of the infections. The bacteriological response was similar to the clinical response, with 76.6% cures, 10% improvements and 13.5% failures. Microbiologically, 77.5% of the germs were eradicated, 7.5% reappeared and 15% persisted. Azlocillin was well tolerated systemically and biochemically and had no detrimental effect on renal function.
Subject(s)
Bacterial Infections/drug therapy , Penicillins/therapeutic use , Pseudomonas Infections/drug therapy , Adult , Azlocillin , Child , Clinical Trials as Topic , Humans , Meningitis/drug therapy , Middle Aged , Otitis Media/drug therapy , Penicillins/adverse effects , Pseudomonas aeruginosa/drug effects , Respiratory Tract Infections/drug therapy , Sepsis/drug therapy , Urinary Tract Infections/drug therapyABSTRACT
The acylureidopenicillin mezlocillin -- the first penicillin with activity against both ampicillin -- and carbenicillin-resistant micro-organisms--has been clinically tested on a world-wide scale on more than 4000 patients. The present study summarizes the results of clinical trials conducted in France on 580 patients, most of whom had urinary tract or respiratory tract infection, as well as septicaemia, meningitis and various post-operative infections. The daily dosage ranged from 100 to 250 mg/kg (6 to 15 g) divided into three 8-hourly intravenous bolus injections or infusions, or 2 to 3 g doses administered intramuscularly. Eighty-two p. cent of the organisms isolated were completely eradicated, and the incidence of relapses was only 5 %. Therapeutic results were satisfactory in about 90 % of the cases. The best results were obtained in upper and lower UTIs, respiratory infections meningitis, biliary tract infections, peritonitis and septicaemia. Side-effects were those common to all penicillins, i.e. allergic or digestive disorders : they seldom occurred and were always reversible. This, together with the lack of renal or hepatic disturbances, should encourage the use of mezlocillin in extremely or moderately severe infections caused by sensitive organisms. The antibiotic appears to be particularly valuable in patients with impaired renal function or immunodepressed.
