Korenfeld Michael S, Silverstein Steven M, Cooke David L, Vogel Roger, Crockett Robert S
Comprehensive Eye Care Ltd., 901 East 3rd Street, Washington, Missouri 63090, USA.
J Cataract Refract Surg. 2009 Jan;35(1):26-34. doi: 10.1016/j.jcrs.2008.09.024.
To assess the efficacy and safety of difluprednate ophthalmic emulsion 0.05% (Durezol) 2 or 4 times a day compared with those of a placebo in the treatment of inflammation and pain associated with ocular surgery.
Twenty-six clinics in the United States.
One day after unilateral ocular surgery, patients who had an anterior chamber cell grade of 2 or higher (>10 cells) were treated with 1 drop of difluprednate 2 times or 4 times a day or with a placebo (vehicle) 2 times or 4 times a day in the study eye for 14 days. This was followed by a 14-day tapering period and a 7-day safety evaluation. Outcome measures included cleared anterior chamber inflammation (grade 0, <or=1 cell), absence of pain, and analysis of ocular adverse events.
Of the 438 patients, 111 received difluprednate 2 times a day, 107 received difluprednate 4 times a day, and 220 received a placebo 2 or 4 times a day. Both difluprednate dosage regimens reduced postoperative ocular inflammation and pain safely and effectively compared with the placebo. A greater proportion of difluprednate-treated patients had a reduction in inflammation and pain at 8 days and 15 days. Three percent of patients in both difluprednate groups had a clinically significant IOP rise (>or=10 mm Hg and >or=21 mm Hg from baseline, respectively) versus 1% in the placebo group.
Difluprednate given 2 or 4 times a day cleared postoperative inflammation and reduced pain rapidly and effectively. There were no serious ocular adverse events. Fewer adverse events were reported in the difluprednate-treated groups than in the placebo group.
评估0.05%地氟泼尼龙眼用乳剂（Durezol）每日2次或4次给药与安慰剂相比，在治疗与眼科手术相关的炎症和疼痛方面的疗效和安全性。
美国26家诊所。
单侧眼科手术后一天，前房细胞分级为2级或更高（>10个细胞）的患者，研究眼每日滴用1滴地氟泼尼龙，每日2次或4次，或每日2次或4次滴用安慰剂（赋形剂），持续14天。随后是14天的逐渐减量期和7天的安全性评估。观察指标包括前房炎症消退（0级，≤1个细胞）、无疼痛以及眼部不良事件分析。
438例患者中，111例每日接受2次地氟泼尼龙治疗，107例每日接受4次地氟泼尼龙治疗，220例每日接受2次或4次安慰剂治疗。与安慰剂相比，两种地氟泼尼龙给药方案均能安全有效地减轻术后眼部炎症和疼痛。在第8天和第15天，接受地氟泼尼龙治疗的患者中，炎症和疼痛减轻的比例更高。地氟泼尼龙组中3%的患者眼压出现临床显著升高（分别较基线升高≥10 mmHg和≥21 mmHg），而安慰剂组为1%。
每日2次或4次给予地氟泼尼龙可迅速有效地消除术后炎症并减轻疼痛。未出现严重的眼部不良事件。与安慰剂组相比，地氟泼尼龙治疗组报告的不良事件较少。
