Clinical studies on doripenem of dentistry and oral surgery

Accession number;05A0663335
Title;Clinical studies on doripenem of dentistry and oral surgery
Author; SASAKI JIRO (Tokai Univ.) KANEKO AKIHIRO (Tokai Univ., Sch. of Med.)
Journal Title;Japanese Journal of Chemotherapy
Journal Code:F0608A
ISSN:1340-7007
VOL.53;NO.Supplement 1;PAGE.323-331(2005)
Figure&Table&Reference;TBL.13, REF.11
Pub. Country;Japan
Language;Japanese
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 .MU.g/g (70-105 min) in the gingiva and 0.36-1.10 .MU.g/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. (author abst.)