Evaluation of Clinical Effectiveness and Safety of DL-8280 in Acute Lacunar Tonsillitis

In Comparison with Amoxicillin by Double-blind Method

Abstract

For the purpose of comparing the clinical effectiveness, side effect and utility of DL-8280, a new synthetic antimicrobial agent, and amoxicillin (APMC) in acute lacunar tonsillitis, DL-8280 and AMPC were administered orally for 7 days at the daily dose of 200mg t. i. d. and 250mg t. i. d., respectively, by double-blind method and the following results were obtained. 1) DL-8280 and AMPC were administered to 129 patients and 110 patients of DL-8280 group and 111 patients of AMPC group were examined for clinical efficacy. One hundred and twenty-six (126) patients were evaluated for safety in both groups. 2) The clinical effectiveness was judged by the criteria of attending doctors and that of the committee. The effectiveness rate, judged by doctors, of DL-8280 group and AMPC group were 93.6% and 94.6%, respectively. On the other hand, the effectiveness rate, judged by the committee, of DL-8280 group and AMPC group was 70.9% and 74.8%, respectively. No significant difference was noticed in both groups. 3) The bacteria were isolated from 85 % of patients examined for clinical efficacy. The distribution rate of β-Streptococcus, S. aureus and H. influenzae was 36.1%, 24.7% and 15.0% of all strains, respectively. As the bacteriological effectiveness, the eradication rate was 97.8% in DL-8280 group and 98.9% in AMPC group and no significant difference was noticed. 4) With regard to side effects, gastrointestinal disturbance and hypersensitivity were observed and the former was major. The rate of appearance was 4.8% in DL-8280 group and 4.0% in AMPC group and there was no significant difference between two groups. 5) No significant difference was noted between two groups in utility of the drug. From these results, it was concluded that DL-8280 was as useful as AMPC for the treatment of acute lacunar tonsillitis.