Prajna N V, George C, Selvaraj S, Lu K L, McDonnell P J, Srinivasan M
Aravind Eye Hospital, Madurai, India.
Cornea. 2001 Mar;20(2):175-8. doi: 10.1097/00003226-200103000-00013.
To compare the efficacy and safety of ofloxacin 0.3% ophthalmic solution with ciprofloxacin 0.3% ophthalmic solution in patients with culture-positive bacterial keratitis.
Patients with a microbiologic diagnosis of bacterial keratitis were included in this double-masked, parallel-group study and were randomized to treatment with either ofloxacin 0.3% or ciprofloxacin 0.3% ophthalmic solution. One drop of the study medication was instilled during the daytime according to the following schedule: every half-hour on study day 1, every hour on days 2 through 4, and every 2 hours on days 5 through 21. Healing, the primary outcome measure, was defined as complete reepithelialization, accompanied by nonprogression of stromal infiltrate for 2 days. Secondary outcome measures included signs and symptoms of infection. Patients were monitored throughout the study period for any adverse events.
A total of 217 patients completed the study: 112 were treated with ofloxacin and 105 were treated with ciprofloxacin. Streptococcus pneumoniae was the most commonly encountered pathogen in all patients. Complete corneal reepithelialization occurred in 85% of those treated with ofloxacin and in 77% of those treated with ciprofloxacin (p = 0.32). The average time to corneal ulcer healing was 13.7 days in those treated with ofloxacin and 14.4 days in those treated with ciprofloxacin. Both treatments were well tolerated with no patient discontinuing the study because of side effects.
Ofloxacin 0.3% and ciprofloxacin 0.3% ophthalmic solutions are effective and safe in the treatment of patients with culture-positive bacterial keratitis.
比较0.3%氧氟沙星滴眼液与0.3%环丙沙星滴眼液治疗培养阳性细菌性角膜炎患者的疗效和安全性。
本双盲、平行组研究纳入微生物学诊断为细菌性角膜炎的患者,随机分为0.3%氧氟沙星或0.3%环丙沙星滴眼液治疗组。研究药物在白天按以下方案滴注一滴:研究第1天每半小时一次,第2至4天每小时一次,第5至21天每2小时一次。主要结局指标愈合定义为角膜完全重新上皮化,同时基质浸润2天无进展。次要结局指标包括感染的体征和症状。在整个研究期间对患者进行任何不良事件监测。
共有217例患者完成研究:112例接受氧氟沙星治疗,105例接受环丙沙星治疗。肺炎链球菌是所有患者中最常见的病原体。接受氧氟沙星治疗的患者中85%角膜完全重新上皮化,接受环丙沙星治疗的患者中77%角膜完全重新上皮化(p = 0.32)。接受氧氟沙星治疗的患者角膜溃疡愈合平均时间为13.7天,接受环丙沙星治疗的患者为14.4天。两种治疗耐受性均良好,无患者因副作用而中断研究。
0.3%氧氟沙星滴眼液和0.3%环丙沙星滴眼液治疗培养阳性细菌性角膜炎患者有效且安全。