The clinical efficacy and safety of T-2588 were compered with those of cefaclor (CCL) in patients with chronic respiratory tract infection by a double-blind study. Administration was performed by oral for a fixed period of 14 days and the daily dosage was fixed at 600 mg for T-2588or 750 mg for CCL.
The following results were obtained.
1) Clinical efficacy rate by committee judgement was 83.6% for T-2588 and 56.3% for CCL, respectively. The statistical analysis of these results revealed that T-2588 was significantly moreeffective than CCL.
2) The results of the clinical efficacy judged by the doctors in charge was similar to efficacy judged by the committee.
3) The bacteriological eradication rate of causative organisms by committee judgement was 77.6% for T-2588 and 52.4% for CCL, respectively. Furthermore, eradication rate of T-2588 in
H. influenzae was significantly superior to that of CCL.
4) With respect to the rate of improvement of clinical signs, symptoms and laboratory findings the T-2588 was superior to the CCL in the improvement for cough, sputum volume, sputum property, rale and ESR.
5) The incidence rate of side effect was 4.5% for T-2588 and 6.5% for CCL, respectively, and these were no significant difference between the two drug group. Abnormal laboratory findings were observed at the rate of 15.5% for T-2588 and 5.8% for CCL, respectively. Incidence rate ofabnormal laboratory findings was significantly higher in T-2588 and the most frequent finding was eosinophilia.
6) Usefulness rate judged by committee members for T-2588 and CCL were 80.2% and 55.7%, respectively, and these were significantly different statistically.
7) The results of clinical usefulness judged by the doctors in charge were similar to the usefulness judged by committee. These results indicated that T-2588 is useful drug for the treatment of chronic respiratory tract infections.
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