A DOUBLE BLIND CONTROLLED STUDY ON S6472 CAPSULES AND GRANULES IN COMPLICATED URINARY TRACT INFECTION

Abstract

The efficacy, safety and usefulness of S6472 capsules (cefaclor, long-acting preparation) were investigated in non-catheterized patients with complicated cystitis using the double blind method with S6472 granules as a control. Each of the patients was orally administrated with 375 mg of the drug twice a day for 7 days, and clinical effectiveness was evaluated according to the Criteria of Drug Efficacy of UTI (the Third Edition). The following results were obtained.
1. There was no significant bias between the capsule-administrated group (A) and the granule-administrated group (B) in background factors.
2. The overall clinical efficacy rates were 78.7% in Group A and 80.5% in Group B, which showed no significant difference. No significant difference was observed also between groups IV and VI in the efficacy for any of the UTI groups.
3. Eradication rates in bacteriological response were 85.9% and 86.0% in Group A and B, respectively.
4. Clinical efficacy rates evaluated according to doctors in charge of patients were 78.7% and 74.7% in Group A and B, respectively, showing no significant difference between the two groups.
5. The incidences of adverse reactions were 3.0% in Group A (3 out of 101 cases) and 7.1% in Group B (7 out of 98), thus no significant difference was found between the two groups.
Abnormal test values in laboratory examinations included 5 cases (in 4 among 75 patients) in Group A, but were not detected in any of the 76 patients in Group B. No statistically significant difference were observed between the two groups, however.
6. No significant difference between the two groups was observed in the usefulness evaluation including efficacy and safety profiles on an analog scale by the doctors in charge of patients.
These results indicate that S6472 capsules have the same efficacy, safety and usefulness as S6472 granules, suggesting that both drugs are equally excellent for non-catheterized patients with complicated cystitis.