1994 Volume 42 Issue 10 Pages 1194-1201
Three oral prophylactic regimens, each 6 months in duration, with ciprofloxacin (CPFX) and/or erythromycin (EM): a single drug regimen with 1×200mg/day each of ciprofloxacin (regimen A) or erythromycin alone (regimen B), and a combined regimen with 1×200mg/day each of ciprofloxacin and erythromycin (regimen C) were compared as to efficacy in controlling repeated exacerbations of chronic respiratory tract infections. The 50 patients included in this study consisted of 19 with bronchiectasis, 15 with chronic bronchitis, eight with chronic pulmonary emphysema, six with diffuse pan-bronchiolitis, one each with pulmonary fibrosis and old pulmonary tuberculosis, : 15 on regimen A, 17 on regimen B and 18 on regimenC. By comparing the pre-study period with the intra-study period, it was found that the corrected mean incidence of exacerbations per case decreased from 1.73 to 0.71 with regimen A, from 2.35 to 1.71 with regimen B, and from 2.47 to 1.38 with regimen C. With regimens B and C there was a significant difference in the incidence of exacerbation between the prestudy period and the intra-study period, as shown by statistical analysis using the cumulative X2-test, when the severity of infection was also taken into consideration. One case on regimen C was excluded from evaluation because no documents were available concerning the incidence of acute exacerbation during the six months prior to the study. During exacerbations, several species of potential pathogens were isolated from regimen B subjects. On the other hand, potential pathogens other than Pseudomonas aeruginosa were isolated only infrequently fromthose on regimens A and C. The development of resistant strains was not clinically important, because only 1 of 10 persistent isolates of P. aeruginosa acquired a discernible degree of resistance to ciprofloxacin during the study, as shown by the results of MIC deter-mination (MIC: 0.05→3.13). Safety was evaluated in 58 patients, namely in the above 50 patients plus six patients in whom evaluation of clinical efficacy could not be made because no clinical data and bacteriological documents were available, and in two other patients for whom treatment was interrupted because of adverse reactions within three months after the start of the study. Abnormalities in laboratory findings related to adverse reactions, which were found in one patient on regimen A and in three patients on regimen C, returned to normal and/or disappeared immediately after cessation of the therapy. From the above results, we conclude that the long-term administration of new-quinolones and macrolides, especially of combined regimens using both, is useful in controlling acute exacerbations of chronic repiratory tract infections.
