[A double-blind comparative study on the efficacy of S6472, cefaclor, in the treatment of bacterial bronchitis].
Clinical efficacy and safety of S6472 (long active cefaclor (CCL)) and CCL were compared by a double-blind study using 248 patients with bacterial bronchitis. Patients were orally administered with either 375 mg of S6472 2 times or 250 mg of CCL 3 times daily for 7 days, and the following results were obtained. Clinical efficacy judged by a committee: The efficacy rates on acute bronchitis were 87.2% for S6472 and 82.6% for CCL, and the efficacy rates on chronic bronchitis were 70.3% for S 6472 and 64.7% for CCL. There was no significant difference between the 2 drugs in clinical efficacy. Clinical efficacy judged by doctors in charge: Results of the clinical efficacy judged by doctors in charge were similar to the efficacy judged by the committee. Bacteriological efficacy judged by the committee: Eradication rate for the S6472 group was 71.1% (32 of 45 patients) and that for the CCL group was 67.4% (29 of 43 patients). There was no significant difference between the 2 drugs in the bacteriological efficacy. Side effects and abnormal laboratory findings: Side effects were observed in 5 cases (4.2%) in the S6472 group and in 5 cases (4.0%) in the CCL group. These side effects, however, were not serious, and no remarkable abnormal laboratory values were observed. There was no significant difference between the 2 drugs in the incidence of side effects or abnormal laboratory findings. Clinical utility: When the clinical utility was expressed by the utility rate (very useful and useful), it was 79.5% in the S6472 group (117 patients) and 76.2% in the CCL group (122 patients) (judged by the committee). When the utility was judged by doctors in charge, it was 73.3% in S6472 group (120 patients) and 71.4% in CCL group (126 patients). From the above results, it has been concluded that S6472 taken twice daily is equivalent to CCL in effectiveness on bacterial bronchitis.
D000328:Adult; D000368:Aged; D001424:Bacterial Infections / Q000188:drug therapy*; D001991:Bronchitis / Q000188:drug therapy* / Q000382:microbiology; D002433:Cefaclor / Q000494:pharmacology / Q000627:therapeutic use*; D002506:Cephalexin / Q000031:analogs & derivatives*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004352:Drug Resistance, Microbial; D005260:Female; D006090:Gram-Negative Bacteria / Q000187:drug effects; D006094:Gram-Positive Bacteria / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged
D002433:Cefaclor; D002506:Cephalexin