Wilhelmus K R, Hyndiuk R A, Caldwell D R, Abshire R L, Folkens A T, Godio L B
Cullen Eye Institute, Baylor College of Medicine, Houston, Tex.
Arch Ophthalmol. 1993 Sep;111(9):1210-8. doi: 10.1001/archopht.1993.01090090062020.
To determine the efficacy and safety of topical 0.3% ciprofloxacin hydrochloride ophthalmic ointment in the treatment of bacterial keratitis.
Prospective case series with a nonrandomized comparison of culture-positive, evaluable cases (ciprofloxacin ointment group) with culture-positive, concurrent patients (nonenrolled group) treated with conventional therapy.
Multicenter clinical study.
After informed consent was obtained, 253 eligible patients underwent corneal scrapings and received topical ciprofloxacin ointment; 145 (57%) had positive cultures and completed the follow-up schedule. Forty (70%) of 57 apparently eligible patients had culture-positive bacterial keratitis but were not enrolled in the ciprofloxacin ointment study during the same period.
Ciprofloxacin ophthalmic ointment instilled every 1 to 2 hours for 2 days, then every 4 hours for 12 days.
Clinical evaluation of signs at 1, 3, 7, and 14 days of treatment and the overall condition classified as clinical success (cured or improved) or failure (unchanged or worse) during and after therapy.
Clinical success with the initial treatment occurred in 135 patients (93%) in the ciprofloxacin ointment group and in 28 patients (70%) in the nonenrolled group. Of the 10 ciprofloxacin clinical failures, seven were staphylococcal; two, pneumococcal; and one, polybacterial. The 90% minimum inhibitory concentration of ciprofloxacin was 3 mg/L or less for corneal bacterial isolates. No serious adverse event attributable to ciprofloxacin ointment occurred, although 32 (13%) of 253 patients developed a transient white crystalline corneal precipitate shown with liquid chromatography in two cases to be ciprofloxacin.
Ciprofloxacin ophthalmic ointment is an effective and safe topical antimicrobial agent for the treatment of bacterial keratitis caused by susceptible microorganisms.
确定局部应用0.3%盐酸环丙沙星眼膏治疗细菌性角膜炎的有效性和安全性。
前瞻性病例系列研究，将培养阳性、可评估的病例（环丙沙星眼膏组）与接受传统治疗的培养阳性、同期患者（未纳入组）进行非随机比较。
多中心临床研究。
在获得知情同意后，253例符合条件的患者接受了角膜刮片检查并局部应用环丙沙星眼膏；145例（57%）培养结果为阳性并完成了随访计划。57例表面符合条件的患者中有40例（70%）培养阳性细菌性角膜炎，但在同一时期未纳入环丙沙星眼膏研究。
每1至2小时滴注环丙沙星眼膏，持续2天，然后每4小时滴注12天。
治疗第1、3、7和14天的体征临床评估，以及治疗期间和治疗后总体状况分类为临床成功（治愈或改善）或失败（未改变或恶化）。
环丙沙星眼膏组135例患者（93%）初始治疗获得临床成功，未纳入组28例患者（70%）获得临床成功。在10例环丙沙星治疗失败的病例中，7例为葡萄球菌感染；2例为肺炎球菌感染；1例为混合细菌感染。角膜细菌分离株对环丙沙星的90%最低抑菌浓度为3mg/L或更低。尽管253例患者中有32例（13%）出现了短暂的白色结晶性角膜沉淀物，经液相色谱分析，其中2例显示为环丙沙星，但未发生与环丙沙星眼膏相关的严重不良事件。
环丙沙星眼膏是一种有效且安全的局部抗菌药物，可用于治疗由易感微生物引起的细菌性角膜炎。
