抄録
Roxithromycin (RXM), a macrolide antibiotic, is currently prescribed in a dose of 150 mg twice a day (BID) . In our study, efficacy, safety, and usefulness of a dose of 300 mg once a day (OAD) of RXM was clinically investigated.
1) A single dose of 300 mg of RXM was preoperatively administered to 98 patients who were undergoing oral surgery, and drug concentration levels were determined in their blood, effusion in tooth extraction wound, and various oral tissues. The blood levels were 0.085-19.0 iig/ml 0.67-20.05 hours after administration. The levels in the effusion in the tooth extraction wound were ND-14.4 ii g/ml 1.05-20.17 hours after administration. Concentration levels in various oral tissues were ND-5.06 ii g/ml in gingivae 0.58-26.5 hours after administration ; ND-4.79 tLg/ml in the cyst wall 1-10.37 hours after administration ; and ND-2.99, ig/ml in the mandibula, alveolar bone, etc. 1-10.37 hours after administration.
2) A dose of 300 mg OAD of RXM was clinically studied in 112 patients with dental and oral surgery infections. The evaluation of clinical efficacy was 83.0 % (93/112) in the scoring evaluation and the efficacy rate (good or excellent) was 81.6 % (93/114) in the attending physicians'evaluation.
3) In 49 patients, germs were detected in the closed abscess at the start of administration, and the bacterial eradication rate was 89.6 % (43/48) for these patients.
4) Concomitant symptoms were observed in 5 patients, representing 4.35 % (5/115) in incidence : facial edema, vomiting and discomfort in the stomach, soft stool, eruption, and vomiting and abdominal pain in one case each. None were serious. Abnormal laboratory findings were obtained in 11.3 % (12/106) .
5) Safety rate (mostly safe or no problem) was 96.2 % (102/106) .
6) Usefulness rate (useful or markedly useful) was 81.1 % (86/106) .
