We carried out a well-controlled study to evaluate the efficacy, safety, and usefulness of cefclidin (CFCL) in respiratory tract infections, using ceftazidime (CAZ) as the reference drug. Either CFCL or CAZ was given intravenously in a dose of 2 g daily (1 g b.i.d.) for 14 days as a rule. The following results were obtained: 1) The overall clinical efficacy rate assessed by attending physicians was 89.9% (62/69) for CFCL and 85.7% (72/84) for CAZ, and there was no statistically significant difference between the two agents. For moderate infections the efficacy rate and “excellent” response rate was significantly higher for CFCL than for CAZ (U-test, p<;0.05). In the judgment by the Efficacy Assessment Committee (Study Committee), the rates were 83.3% (60/70) for CFCL and 80.0% (68/85) for CAZ, with no statistically significant difference between the two agents. 2) With regard to bacteriological response, the eradication rate in monomicrobial infections was 91.2% (31/34) for CFCL and 69.2% (27/39) for CAZ (χ2-test, p<;0.05). The overall eradication rate was higher for CFCL than for CAZ, 90.5% (38/42) vs 72.5% (37/51). In particular, the eradication rate for Pseudomonas aeruginosa was 73.3% (11/15) for CFCL and 53.8% (14/26) for CAZ. 3) Adverse drug reactions were observed in 4.5% (4/89) in the CFCL group and 3.1% (3/96) in the CAZ group. The incidence of abnormal laboratory findings was judged by attending physicians to be 21.2% (18/85) in the CFCL group and 20.9% (19/91) in the CAZ group. The Study Committee rates were 23.5% (20/85) for CFCL and 26.4% (24/91) for CAZ. No severe symptoms or abnormal findings were observed, and there was no significant difference between the two drugs. 4) The usefulness rates judged by attending physicians were 88.4% (61/69) for CFCL and 82.1% (69/84) for CAZ (U-test, p<;0.05). The usefulness rates according to the Study Committee were 80.6% (58/72) for CFCL and 77.9% (67/86) for CAZ, with no significant difference. Based on the above results, it was concluded that CFCL is useful from the viewpoint of efficacy and safety in the treatment of respiratory tract infections. Since CFCL exhibits a potent in vitro activity and a high eradication rate against P. aeruginosa, it appears that this drug is likely to be useful in the treatment of refractory Pseudomonas respiratory infections.
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