Hyndiuk R A, Eiferman R A, Caldwell D R, Rosenwasser G O, Santos C I, Katz H R, Badrinath S S, Reddy M K, Adenis J P, Klauss V
Medical College of Wisconsin, Milwaukee, USA.
Ophthalmology. 1996 Nov;103(11):1854-62; discussion 1862-3. doi: 10.1016/s0161-6420(96)30416-8.
The purpose of the study is to compare the clinical efficacy and safety of ciprofloxacin ophthalmic solution 0.3% (Ciloxan) with a standard therapy regimen (fortified tobramycin, 1.3%-cefazolin, 5.0%) for treating bacterial corneal ulcers.
This randomized, parallel group, double-masked, multicenter study was conducted in 324 patients at 28 centers in the United States, Europe, and India. Patients were randomized into 2 treatment groups: 160 to ciprofloxacin and 164 to fortified tobramycin-cefazolin. Positive microbiologic cultures were obtained in 188 (58%) of 324 patients. Of these, 176 patients met protocol criteria and were evaluated for treatment efficacy: 82 in the ciprofloxacin group and 94 in the standard therapy group. The dosing schedule for both treatment groups was 1 to 2 drops of the first study medication (ciprofloxacin or fortified tobramycin) every 30 minutes for 6 hours, then hourly for the remainder of day 1; 1 to 2 drops every hour on days 2 and 3; 1 to 2 drops every 2 hours on days 4 and 5, followed by 1 to 2 drops every 4 hours on days 6 to 14. The second medication (ciprofloxacin or cefazolin) was instilled 5 to 15 minutes after the first drug, following the same dosing frequency. Physician's judgment of clinical success, cure rate, changes in ocular sings, and symptoms and the rate of treatment failures were the primary efficacy criteria.
Topical ciprofloxacin monotherapy is equivalent clinically and statistically to the standard therapy regimen of fortified antibiotics. No statistically significant treatment differences were found between ciprofloxacin (91.5%) and standard therapy (86.2%) in terms of overall clinical efficacy (P = 0.34). Similarly, no differences were noted in resolution of the clinical signs and symptoms (P > 0.08) or the time to cure (P = 0.55). The incidence of treatment failures was less in the ciprofloxacin group (8.5%) compared with the standard therapy group (13.8%). Significantly fewer patients treated with ciprofloxacin reported discomfort than did patients treated with the standard therapy regimen (P = 0.01).
Ciprofloxacin ophthalmic solution 0.3% monotherapy is equivalent clinically and statistically to standard therapy (fortified tobramycin-cefazolin) for the treatment of bacterial corneal ulcers and produces significantly less discomfort.
本研究旨在比较0.3%环丙沙星滴眼液（西洛仙）与标准治疗方案（强化妥布霉素，1.3%；头孢唑林，5.0%）治疗细菌性角膜溃疡的临床疗效和安全性。
这项随机、平行组、双盲、多中心研究在美国、欧洲和印度的28个中心对324例患者进行。患者被随机分为2个治疗组：160例接受环丙沙星治疗，164例接受强化妥布霉素-头孢唑林治疗。324例患者中有188例（58%）获得阳性微生物培养结果。其中，176例患者符合方案标准并接受治疗疗效评估：环丙沙星组82例，标准治疗组94例。两个治疗组的给药方案均为：首剂研究药物（环丙沙星或强化妥布霉素）每30分钟滴1至2滴，共6小时，然后在第1天剩余时间每小时滴1至2滴；第2天和第3天每小时滴1至2滴；第4天和第5天每2小时滴1至2滴，随后在第6至14天每4小时滴1至2滴。第二种药物（环丙沙星或头孢唑林）在第一种药物滴入后5至15分钟滴入，给药频率相同。医生对临床成功、治愈率、眼部体征和症状变化以及治疗失败率的判断是主要疗效标准。
局部使用环丙沙星单药治疗在临床和统计学上与强化抗生素标准治疗方案相当。环丙沙星组（91.5%）和标准治疗组（86.2%）在总体临床疗效方面无统计学显著差异（P = 0.34）。同样，在临床体征和症状的缓解（P > 0.08）或治愈时间（P = 0.55）方面也未发现差异。环丙沙星组的治疗失败发生率（8.5%）低于标准治疗组（13.8%））。与接受标准治疗方案的患者相比，接受环丙沙星治疗的患者报告不适的人数明显较少（P = 0.01）。
0.3%环丙沙星滴眼液单药治疗在临床和统计学上与标准治疗（强化妥布霉素-头孢唑林）治疗细菌性角膜溃疡相当，且产生的不适明显较少。
