RESUMO
An open, multicenter non-comparative study was carried out in 8 centres in Italy to evaluate the efficacy, safety and tolerability of cefixime (Suprax - Lederle), a third generation oral cephalosporin administered once daily to patients affected by exacerbation of chronic bronchitis. All patients, 124 males and 21 females, aged between 50 and 85, were treated with Suprax at the dose of 400 mg/day for a mean period of 7.4 days. Clinical and laboratory examinations were performed at: T0 (beginning of treatment), T1 (3-4 days after the beginning of treatment), T2 (end of treatment). The following signs/symptoms were recorded in order to evaluate the therapeutic efficacy: sputum quality and quantity, cough, dyspnoea, fever, bronchospasm, chest clinical findings. All these signs and symptoms significantly improved (p between < 0.001 and < 0.05; mean improvement for sign, weighted for time of improvement). Bio-humoral parameters were also recorded in order to evaluate potential therapeutic influences. A significant decrease was observed (p < 0.01 Student t test for paired data) in the white blood cell count and the leukocyte formula. The datum regarding the white blood cell count and leukocyte formula is to be considered a primary effect of the treatment, proving its success. A microbiological search for the pathogen responsible for the infectious process was also performed: in 70/145 subjects the responsible pathogen was identified. The micro-organism was eradicate in 66/70 at T2 (94.3%), the difference T0 = T2 is significant. The X-Ray evidence suggesting a chronic bronchitis, was also evaluated in 81 patients. At T2, in 75/81 subjects the X-Ray evidence turned out to be negative, while in 6/81 it remained positive. This difference was statistically significant (p < 0.01 sign test). An overall clinical evaluation showed a therapeutic success in 133/145 treated patients (91.7%). No side effects were observed.
