Vol.53 No.S-1 July 2005
Clinical studies on doripenem of dentistry and oral surgery
1)Tokai University Present: Department of Oral Surgery, Jinkoukai Hospital
3-8-11 Nakacho, Atsugi, Kanagawa, Japan
2)Department of Oral Surgery, School of Medicine, Tokai University
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 0.34-2.19 μg/g (70-105 min) in the gingiva and 0.36-1.10 μg/g (60-75 min) 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 250 mg b.i.d., 250 mg t.i.d., or 500 mg b.i.d. for 3-7 days.
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.
Key word
doripenem, tissue concentration, dental infection, surgery site infection, efficacy
Received
January 11, 2005
Accepted
February 22, 2005
Jpn. J. Chemother. 53 (S-1): 323-331, 2005
