Abstract | OBJECTIVES: To investigate the efficacy and safety of Vancomycin Ophthalmic Ointment 1% (Toa Pharmaceutical Co., Ltd, Toyama, Japan) in patients with external ocular infections caused by methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-resistant Staphylococcus epidermidis (MRSE). DESIGN: A case series. SETTING: This study was a multicentre, open-label, uncontrolled study in Japan approved as orphan drug status. PARTICIPANTS: INTERVENTIONS: PRIMARY AND SECONDARY OUTCOME MEASURES: The subjective and objective clinical scores and bacterial cultures were collected at days 0 (baseline), 3, 7 and 14. The primary outcome was clinical response evaluation (efficacy rate) determined as complete response, partial response, no response and worsening. Secondary outcome was the eradication of the bacteria. Safety was assessed by adverse events including cases in which neither MRSA nor MRSE was detected. RESULTS: Twenty-five cases with MRSA (20) or MRSE (5) infections were enrolled. Of these 25 cases, 4 discontinued the treatment due to the negative results for bacterial culture during screening or at baseline. Of the 21 cases with conjunctivitis (14), blepharitis (3), meibomitis (1), dacryocystitis (2) or keratitis (1), 14 (66.7%) cases were evaluated as being excellently (complete response, 2 cases) or well (partial response, 12 cases) treated. The eradication rates were 68.4% in MRSA (13 of 19 cases) and 100% in MRSE (2 of 2 cases). Ten adverse events occurred in 7 (28.0%) of 25 cases at the local administration site. CONCLUSIONS:
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Authors | Chie Sotozono, Masahiko Fukuda, Masao Ohishi, Keiko Yano, Hideki Origasa, Yoshinori Saiki, Yoshikazu Shimomura, Shigeru Kinoshita |
Journal | BMJ open
(BMJ Open)
Vol. 3
Issue 1
(Jan 29 2013)
ISSN: 2044-6055 [Electronic] England |
PMID | 23364319
(Publication Type: Journal Article)
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