Telithromycin の口腔組織移行性ならびに歯科・口腔外科領域感染症患者に対する有効性および安全性の検討
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A clinical pharmacology study to investigate the transferability of telithromycin (TEL), a novel ketolide oral antibiotic, into oral cavity tissues, and a phase II clinical study by TEL 600 mg once daily for 7 days (7 days' treatment study) and a phase III clinical study by TEL 600 mg once daily for 3 days (3 days'treatment study) against infectious patients in the field of dentistry and oral surgery were performed. Following results were obtained.<BR>1. Transferability into oral cavity tissues (clinical pharmacology study)<BR>The oral cavity tissue concentration 3 to 6 hours after the single treatment of TEL 600 mg in 11 cases for the data analysis was 1.72, ug/g in gingiva, 1.13, ug/mL in the wound exudate after exodontia, and so the transfer rate was 3.33 in gingiva and 2.20 in wound exudate after exodontia, respectively.<BR>2. Clinical efficacy<BR>The clinical efficacy rate by rating ratio after 7 days in 7 days' treatment study against 31 cases for the data analysis was 100%(31/31). The clinical efficacy rate by rating ratio after 3 days' in 3 days' treatment study against 24 cases for the data analysis was 91.7%(22/24).<BR>3. Bacteriological efficacy<BR>The eradication rate after 7 days in 7 days' treatment study against 29 cases for the data analysis of bacteriological efficacy was 100%(29/29). The eradication rate after 3 days in 3 days' treatment study against 22 cases for the data analysis of bacteriological efficacy was 95.5%(21/22).<BR>4. Safety<BR>The adverse events undeniable the causal relationship with TEL were not observed in the clinical pharmacology study, and occurred in 7 cases (21.9%, 10 events) out of 32 cases for the data analysis in 7 days' treatment study and in 3 cases (11.1%, 3 events) out of 27 cases for the data analysis in 3 days' treatment study.<BR>Considering from above results, it was suggested that TEL was well transferred into oral cavity tissues after TEL 600 mg oral treatment and TEL 600 mg once daily for 3 days' treatment exhibited sufficient efficacy against infectious patients in the field of dentistry and oral surgery and there were no problems in the safety and further the good drug-intake compliance was expected owing to the once daily treatment.
- 公益社団法人 日本化学療法学会の論文
- 2003-09-30
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