Comparison of ciprofloxacin ophthalmic solution 0.3% to fortified tobramycin-cefazolin in treating bacterial corneal ulcers
Comparison of ciprofloxacin ophthalmic solution 0.3% to fortified tobramycin-cefazolin in treating bacterial corneal ulcers
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DOI：
10.1016/s0161-6420(96)30416-8
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发表时间：
1996-11-01
期刊：
影响因子：
13.7
通讯作者：
Wolf, TC
中科院分区：
文献类型：
--
作者：
Hyndiuk, RA;Eiferman, RA;Wolf, TC
目的：本研究的目的是比较环丙沙星滴眼液0.3%（Ciloxan）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。方法：本随机，平行组，双盲，多中心研究进行了324例患者在28个中心在美国，欧洲和印度。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-头孢唑啉治疗。324例患者中有188例（58%）获得了阳性微生物培养。其中，176例患者符合方案标准，并进行了疗效评价：环丙沙星组82例，标准治疗组94例。两个治疗组的给药方案为每30分钟1 - 2滴第一种研究药物（环丙沙星或强化妥布霉素），持续6小时，然后在第1天的剩余时间内每小时1滴，第2天和第3天每小时1 - 2滴;第4天和第5天每2小时1 - 2滴，然后在第6天至第14天每4小时1 - 2滴。第二种药物（环丙沙星或头孢唑林）在第一种药物后5至15分钟滴入，给药频率相同。临床成功，治愈率，眼部体征和症状的变化和治疗失败率的医生的判断是主要的疗效criteris.Results：局部环丙沙星单药治疗在临床上和统计学上相当于强化抗生素的标准治疗方案。环丙沙星（91.5%）和标准治疗（86.2%）在总体临床疗效方面无统计学显著性差异（P = 0.34）。同样，在临床体征和症状的消退（P > 0.08）或治愈时间（P = 0.55）方面没有观察到差异。环丙沙星组治疗失败的发生率（8.5%）低于标准治疗组（13.8%）。环丙沙星治疗的患者明显少于标准治疗方案治疗的患者（P = 0.01）。结论：0.3%环丙沙星滴眼液单药治疗在临床和统计学上等同于标准治疗（强化妥布霉素-头孢唑啉）治疗细菌性角膜溃疡，并产生明显较少的不适。
Purpose: 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.Methods: 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 signs, and symptoms and the rate of treatment failures were the primary efficacy criteria.Results: 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).Conclusion: 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.