Constantinou Marios, Daniell Mark, Snibson Grant R, Vu Hien T, Taylor Hugh R
Corneal Clinic, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.
Ophthalmology. 2007 Sep;114(9):1622-9. doi: 10.1016/j.ophtha.2006.12.011.
To determine the clinical efficacy and safety of moxifloxacin (1.0%) in patients with bacterial keratitis compared with patients treated with ofloxacin (0.3%) or fortified tobramycin (1.33%)/cephazolin (5%).
Prospective randomized trial.
A total of 229 patients diagnosed with bacterial keratitis were enrolled in the study; 78 patients were randomized to the fortified tobramycin/cephazolin group, 77 patients to the moxifloxacin group, and 74 patients to the ofloxacin group. A total of 225 patients were evaluable for safety and 198 patients were included in the efficacy analysis.
After corneal specimens were obtained, the assigned study medication was instilled every hour, day and night, for 48 hours and on the third day, every hour by day and every 2 hours at night. For days 4 and 5, 1 drop every 2 hours by day and every 4 hours at night, and for days 6 and 7, 1 drop every 4 hours. After day 7, the antibiotic was tapered to every 6 hours and stopped when appropriate.
Resolution of keratitis and healing of ulcer, time to cure, mean time to discharge, clinical sign score, adverse reactions to study medication, and treatment failures.
Of the 186 nonexiting patients, resolution of the keratitis and healing of the ulcer occurred in 175 (94%) nonexiting patients. In the 175 patients in whom the corneal ulcer was cured, there were no statistically significant differences between the treatment groups for the mean time to cure (P = 0.25). There were no statistically significant differences between the 3 treatment groups in the various sign parameters including the sign score. A positive bacterial corneal culture was obtained in 190 (83%) of the 229 enrolled patients. The distribution of the species of bacterial organisms was similar in each treatment group and no significant difference in the percentage of isolates between the groups was observed. Twelve (5.2%) of the treated patients had serious complications (perforation or enucleation). No serious events attributable to therapy occurred during the study and all treatments were safe and well tolerated.
No difference in healing rate, cure rate, or complications between fortified cephazolin and tobramycin, ofloxacin, or moxifloxacin was seen in this study.
与接受氧氟沙星（0.3%）或强化妥布霉素（1.33%）/头孢唑林（5%）治疗的细菌性角膜炎患者相比，确定莫西沙星（1.0%）治疗细菌性角膜炎患者的临床疗效和安全性。
前瞻性随机试验。
共有229例被诊断为细菌性角膜炎的患者纳入本研究；78例患者随机分配至强化妥布霉素/头孢唑林组，77例患者至莫西沙星组，74例患者至氧氟沙星组。共有225例患者可进行安全性评估，198例患者纳入疗效分析。
获取角膜标本后，指定的研究药物日夜每小时滴注1次，共48小时，第三天白天每小时滴注1次，夜间每2小时滴注1次。第4天和第5天，白天每2小时滴注1滴，夜间每4小时滴注1滴；第6天和第7天，每4小时滴注1滴。第7天后，抗生素逐渐减量至每6小时1次，酌情停药。
角膜炎消退和溃疡愈合情况、治愈时间、平均出院时间、临床体征评分、对研究药物的不良反应及治疗失败情况。
在186例未退出研究的患者中，175例（94%）患者的角膜炎消退且溃疡愈合。在角膜溃疡治愈的175例患者中，各治疗组的平均治愈时间无统计学显著差异（P = 0.25）。3个治疗组在包括体征评分在内的各项体征参数方面无统计学显著差异。229例纳入研究的患者中，190例（83%）角膜细菌培养呈阳性。各治疗组细菌种类分布相似，各组分离株百分比无显著差异。12例（5.2%）接受治疗的患者出现严重并发症（穿孔或眼球摘除）。研究期间未发生与治疗相关的严重事件，所有治疗均安全且耐受性良好。
本研究中，强化头孢唑林与妥布霉素、氧氟沙星或莫西沙星在愈合率、治愈率或并发症方面未见差异。
