O'Brien T P, Maguire M G, Fink N E, Alfonso E, McDonnell P
Johns Hopkins University, Ocular Microbiology Laboratory, Wilmer Ophthalmological Institute, Baltimore, MD 21287-9121, USA.
Arch Ophthalmol. 1995 Oct;113(10):1257-65. doi: 10.1001/archopht.1995.01100100045026.
To compare ofloxacin solution with a combination of fortified antibiotic cefazolin sodium and tobramycin sulfate solutions in the treatment of bacterial keratitis.
Patients under care at any one of 28 participating clinical centers who had an eye with suspected bacterial keratitis were randomly allocated in a double-masked manner to treatment with 0.3% ofloxacin solution or a combination of the fortified antibiotics (1.5% tobramycin and 10.0% cefazolin solutions).
Time to healing defined as complete re-epithelization, accompanied by a nonprogressive stromal infiltrate for two consecutive visits. Secondary outcome measures included patient symptoms and signs of infection and adverse reactions to study medications. Only patients with a positive bacterial corneal culture were included in most analyses.
A positive bacterial corneal culture was obtained in 140 (56%) of the 248 enrolled patients. The time to healing was similar among the 73 patients receiving ofloxacin and the 67 patients receiving fortified antibiotics (P = .70). By 7 days after study entry, the keratitis in 37% of the ofloxacin group and 38% of the fortified antibiotics group had healed. By 28 days, keratitis in 89% of the ofloxacin group and 86% of the fortified antibiotics group had healed. Two patients receiving ofloxacin and one receiving fortified antibiotics discontinued study medication because of lack of efficacy. Patients receiving ofloxacin reported substantially less burning and stinging on instillation than the patients receiving fortified antibiotics (P < .001). Five of six patients among the 140 with positive bacterial cultures who had study medications discontinued because of ocular side effects were in the fortified antibiotics group; an additional three patients, all in the fortified antibiotics group, among the remaining 108 receiving study medications had ocular side effects.
The efficacy of ofloxacin solution in treating bacterial keratitis is equivalent to that of the fortified cefazolin and tobramycin solutions. The reduced frequency of ocular toxic effects and the relative ease of preparation of ofloxacin are additional considerations.
比较氧氟沙星溶液与强化抗生素头孢唑林钠和硫酸妥布霉素溶液联合用药在治疗细菌性角膜炎中的效果。
在28个参与研究的临床中心接受治疗的疑似细菌性角膜炎患者被随机双盲分配，分别使用0.3%氧氟沙星溶液或强化抗生素联合用药（1.5%妥布霉素和10.0%头孢唑林溶液）进行治疗。
愈合时间定义为角膜完全重新上皮化，且连续两次复诊时基质浸润无进展。次要观察指标包括患者的症状、感染体征以及对研究药物的不良反应。大多数分析仅纳入角膜细菌培养呈阳性的患者。
248例入组患者中有140例（56%）角膜细菌培养呈阳性。接受氧氟沙星治疗的73例患者与接受强化抗生素治疗的67例患者的愈合时间相似（P = 0.70）。研究开始后7天，氧氟沙星组37%的患者和强化抗生素组38%的患者角膜炎已愈合。到28天时，氧氟沙星组89%的患者和强化抗生素组86%的患者角膜炎已愈合。两名接受氧氟沙星治疗的患者和一名接受强化抗生素治疗的患者因疗效不佳而停止研究用药。接受氧氟沙星治疗的患者在滴眼时报告的烧灼感和刺痛感明显少于接受强化抗生素治疗的患者（P < 0.001）。在140例角膜细菌培养呈阳性且因眼部副作用而停止研究用药的患者中，有5例在强化抗生素组；在其余108例接受研究用药的患者中，另有3例均在强化抗生素组出现了眼部副作用。
氧氟沙星溶液治疗细菌性角膜炎的疗效与强化头孢唑林和妥布霉素溶液相当。氧氟沙星眼部毒性作用发生率较低且制备相对简便，也是需要考虑的因素。
