抄録
Long acting amoxicillin granules (C-AMOX), a newly developed presentation of amoxicillin (AMPC), maintains an effective blood level for an extended period. In order to confirm the utility of C-AMOX, a double-blind comparative study with AMPC capsule was carried out in the treatment of various oral and maxillofacial infections.
A total of 233 cases were participated in the study and 208 cases were evaluated in the efficacy (105 for C-AMOX group and 103 for AMPC group) .
Results obtained were as follows:
1) Clinical efficacy was evaluated according to the criteria of numerical judgement established by the Japanese Society of Oral Surgery (1973) and, in addition, judged by doctor in charge. In the evaluation of numerical judgement, the efficacy rate was 82.0 for C-AMOX group and 80.7% for AMPC group. There was no significant difference between the two groups.
In judgement of clinical efficacy by doctor in charge, the efficacy rate was 81.5% for C-AMOX group and 74.7% for AMPC group. C-AMOX group was superior to AMPC group in the evaluation and difference was significant (p<0.05) .
2) The organisms were isolated from 84 cases (166 strains-aerobic bacteria 72 and anaerobic bacteria 94) out of 90 cases. C-AMOX and AMPC group showed an excellent MIC against both aerobic and anaerobic pathogens. There was no significant difference in the bacteriological efficacy.
3) As for safety evaluation, slight adverse reactions such as diarrhea, nausea, headache and flare of face were observed in 4 cases (3.8%) treated with C-AMOX group and in 4 cases (4.0%) treated with AMPC group. The administration of one case in C-AMOX group was discontinued.
Abnormal laboratory findings were observed in one case with C-AMOX and in 2 cases with AMPC.
There was no significant difference between the two groups.
