Ophthalmic Consultants of Long Island, Rockville Centre, New York 11570, USA.
Am J Ophthalmol. 2011 Mar;151(3):420-6.e1. doi: 10.1016/j.ajo.2010.09.003. Epub 2010 Dec 9.
To evaluate the efficacy and safety of twice-daily, preservative-free ketorolac 0.45% (Acuvail; Allergan, Inc, Irvine, California, USA) administration for treatment of inflammation and pain after cataract surgery.
Prospective, randomized trial.
Two multicenter, double-masked studies randomized 511 cataract surgery patients (2:1) to receive twice-daily ketorolac 0.45% or vehicle in the operative eye for 16 days, beginning 1 day before surgery. The primary efficacy end point was the percentage of patients with a summed ocular inflammation score of 0 for anterior chamber cell and flare on postoperative day 14. The main secondary efficacy end point was the percentage of patients with no pain on postoperative day 1.
On day 14, 52.5% of ketorolac patients and 26.5% of vehicle patients had an summed ocular inflammation score of 0 (P < .001). On day 1, 72.4% of ketorolac patients and 39.7% of vehicle patients had a pain score of 0 (P < .001). Median time to pain resolution was 1 day in the ketorolac group and 2 days in the vehicle group (P < .001). The percentage of ketorolac and vehicle patients who had a +3-line or more improvement in best-corrected visual acuity from baseline was 60.5% versus 44.0% on day 14 (P = .002). Overall, adverse events were more prevalent in the vehicle group than in the ketorolac group (48.5% vs 35.2%; P = .004). Burning or stinging (per a composite Medical Dictionary for Regulatory Activities) was reported by 1.5% of ketorolac patients and 0.6% of vehicle patients.
Twice-daily ketorolac 0.45% was well tolerated and effectively treated inflammation and pain following cataract surgery.
评估每日 2 次给予不含防腐剂的酮咯酸 0.45%（Acuvail；Allergan，Inc，加利福尼亚州欧文市，美国）治疗白内障手术后炎症和疼痛的疗效和安全性。
前瞻性、随机试验。
2 项多中心、双盲研究将 511 例白内障手术患者（2:1）随机分为接受每日 2 次的手术眼酮咯酸 0.45%或载体治疗 16 天，从手术前 1 天开始。主要疗效终点是术后第 14 天眼前房细胞和闪光的总和眼部炎症评分（SOIS）为 0 的患者百分比。主要次要疗效终点是术后第 1 天无疼痛的患者百分比。
第 14 天，52.5%的酮咯酸患者和 26.5%的载体患者的 SOIS 评分为 0（P<.001）。第 1 天，72.4%的酮咯酸患者和 39.7%的载体患者的疼痛评分为 0（P<.001）。酮咯酸组疼痛缓解的中位时间为 1 天，而载体组为 2 天（P<.001）。从基线开始，最佳矫正视力提高 3 行或更多的酮咯酸和载体患者的百分比分别为 60.5%和 44.0%，第 14 天（P=.002）。总体而言，与酮咯酸组相比，载体组的不良事件更为常见（48.5%比 35.2%；P=.004）。1.5%的酮咯酸患者和 0.6%的载体患者报告出现烧灼感或刺痛（根据综合医学词典药物监管活动）。
每日 2 次酮咯酸 0.45%耐受性良好，能有效治疗白内障手术后的炎症和疼痛。
