Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
BMJ Open. 2013 Jan 29;3(1):e001206. doi: 10.1136/bmjopen-2012-001206.
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).
A case series.
This study was a multicentre, open-label, uncontrolled study in Japan approved as orphan drug status.
Patients with MRSA or MRSE external ocular infections unresponsive to the treatment of fluoroquinolone eye drops.
Vancomycin Ophthalmic Ointment 1% was administered four times daily.
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.
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.
Vancomycin Ophthalmic Ointment 1% was considered to be useful for the treatment of intractable ocular MRSA/MRSE infections.
研究 1%盐酸万古霉素眼膏(日本武田制药株式会社,富山)治疗耐甲氧西林金黄色葡萄球菌(MRSA)或耐甲氧西林表皮葡萄球菌(MRSE)引起的外眼感染的疗效和安全性。
病例系列。
本研究是日本的一项多中心、开放标签、非对照研究,被批准为孤儿药。
对氟喹诺酮滴眼液治疗无反应的 MRSA 或 MRSE 外眼感染患者。
盐酸万古霉素眼膏 1%每日四次给药。
在第 0 天(基线)、第 3 天、第 7 天和第 14 天收集主观和客观临床评分和细菌培养物。主要结局是临床反应评估(疗效率),定义为完全缓解、部分缓解、无反应和恶化。次要结局是细菌的清除。安全性通过包括筛查或基线时细菌培养物均未检出 MRSA 或 MRSE 的情况下的不良事件来评估。
25 例 MRSA(20 例)或 MRSE(5 例)感染患者入组。在这 25 例患者中,有 4 例因筛查或基线时细菌培养物阴性而停止治疗。在结膜炎(14 例)、睑缘炎(3 例)、睑板腺炎(1 例)、泪囊炎(2 例)或角膜炎(1 例)的 21 例患者中,14 例(66.7%)患者治疗效果评价为极好(完全缓解 2 例)或良好(部分缓解 12 例)。MRSA 的清除率为 68.4%(19 例中的 13 例),MRSE 为 100%(2 例中的 2 例)。25 例患者中有 7 例(28.0%)在局部给药部位发生了 10 起不良事件。
1%盐酸万古霉素眼膏被认为对外眼难治性 MRSA/MRSE 感染的治疗有用。