Study of doripenem distribution in ocular tissue and its clinical relevance in ophthalmological infection
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Accession number;05A0663334
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| Title;Study of doripenem distribution in ocular tissue and its clinical relevance in ophthalmological infection |
| Author;
OISHI MASAO
(Shiranekenseibyoin Ganka)
MIYANAGA YOSHITAKA
(Nishikasaiinoegankabyoin)
ONO SHIGEAKI
(Hokudai I Ganka)
FUJIWARA TAKAAKI
(School of Medicine, Kyorin Univ., JPN)
SASAKI KAZUYUKI
(School of Medicine, Kanazawa Medeical Univ., JPN)
SHIOTA HIROSHI
(Tokushimadai I Ganka)
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Journal Title;Japanese Journal of Chemotherapy
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Journal Code:F0608A
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ISSN:1340-7007
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VOL.53;NO.Supplement 1;PAGE.313-322(2005)
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| Figure&Table&Reference;FIG.2, TBL.10, REF.5 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;We studied the distribution of doripenem (DRPM), a new carbapenem antibiotic for injection, in ocular tissue (aqueous humor) after DRPM infusion at a dosage of 250 mg, and evaluated the efficacy and safety of DRPM administered in patients with corneal ulcer, orbital infection, and endophthalmitis after DRPM infusion at a dosage of 250 mg, b.i.d. or t.i.d., or at 500 mg, b.i.d. DRPM concentration in the aqueous humor of those undergoing cataract surgery was 0.16-0.87 .MU.g/mL within 70-115 minutes of the start of infusion. Plasma concentration in the same period was 6.86-12.9 .MU.g/mL. Of 15 patients evaluated for efficacy-corneal ulcer in 10, orbital infection in 4, and endophthalmitis in 1-DRPM was administered to 9 at a dose of 250 mg b.i.d., to 3 at a dose of 250 mg t.i.d., and to 3 at a dose of 500 mg b.i.d. Clinical efficacy, the primary endpoint in this study, was 100.0% (15/15). Improvement on Day 2, a secondary endpoint, was 100% (15/15). Bacteriological response was evaluated in 8 patients-corneal ulcer in 4, orbital infection in 3 and endophthalmitis in 1-1 of whom had .ALPHA.-Streptococcus infection, 3 (Corynebacterium sp. infection, 2 P. aeruginosa infection, 1 P. acues infection, and 1 S. aureus-P. intermedia mixed infection. Causative bacteria were eradicated in all 8 and no new strains appeared after DRPM administration. All 15 were evaluated for safety, with the primary endpoint the absence or presence of adverse drug reactions (symptoms and laboratory findings) and the secondary endpoint overall safety. In 4, the 8 adverse events observed were mild to moderate and none was judged to be related to DRPM. In the abnormal laboratory findings reported in 5 (5 events), the causal relationship to DRPM could not be ruled out resulting in these 5 adverse events judged to be adverse drug reactions (abnormal laboratory findings), including an increase in ALT (3 events), an increase in AST (1), and an increase in .GAMMA.-GPT (1).... (author abst.) |
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