Abstract
We conducted clinical studies on doripenem (DRPM), a new injectable carbapenem antibiotic, of dentistry and oral surgery.
1. Clinical pharmacology study
The oral tissue concentration after single administration of DRPM in 10 cases was 0.34-2.19μg/g (70-105min) in the gingiva and 0.36-1.10μg/g (60-75min) in the cyst wall, so the tissue/plasma concentration ratio was 14.3-47.9% in the gingiva and 7.7-21.4% in the cyst wall.
2. Clinical study
1) Clinical efficacy
Patients with infection were administrated DRPM by intravenous infusion at 250mg b. i. d., 250mg t. i. d., or 500mg b. i. d. for 3-7days.
Clinical efficacy was excellent in 11 and good in 2, for an efficacy of 100.0% in osteitis, excellent in 6, and good in 5, and an efficacy of 100.0% in cellulitis.
2) Bacteriological effect
The bacteriological effect was eradication in 13, eradication of 100.0% in osteitis, eradication in 10, and persistence in 1, and eradication of 90.9% in cellulitis.
3) Safety
The incidence of nonlaboratory adverse drug reactions was 4.2%(1/24) and of laboratory adverse drug reactions 33.3%(8/24).
These results suggest that DRPM is useful, reflecting potent and well-balanced activity against aerobic and anaerobic gram-positive and gram-negative bacteria