[A double-blind comparative study on the efficacy of S6472, cefaclor, in the treatment of bacterial bronchitis].

Abstract

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.

• Authors: S Oshima, Y Yokoyama, T Kikuiri, T Murakami, H Nishihara, T Shimizu, M Abe, Y Kurihara, C Itoh, K Takeuchi
• Journal: The Japanese journal of antibiotics (Jpn J Antibiot) Vol. 39 Issue 10 Pg. 2726-53 (Oct 1986) ISSN: 0368-2781 [Print] Japan
• PMID: 3543432 (Publication Type: Clinical Trial, Controlled Clinical Trial, English Abstract, Journal Article)

Chemical References

• Cefaclor
• Cephalexin

Topics

• Adult
• Aged
• Bacterial Infections (drug therapy)
• Bronchitis (drug therapy, microbiology)
• Cefaclor (pharmacology, therapeutic use)
• Cephalexin (analogs & derivatives)
• Clinical Trials as Topic
• Double-Blind Method
• Drug Resistance, Microbial
• Female
• Gram-Negative Bacteria (drug effects)
• Gram-Positive Bacteria (drug effects)
• Humans
• Male
• Middle Aged