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酮咯酸 0.45% 滴眼液。

Ketorolac 0.45% ophthalmic solution.

机构信息

Adis, Wolters Kluwer Business, Auckland, New Zealand.

出版信息

Drugs Aging. 2011 Jul 1;28(7):583-9. doi: 10.2165/11207450-000000000-00000.

Abstract

Ketorolac 0.45% ophthalmic solution is a topical NSAID indicated in the US for the treatment of ocular pain and inflammation following cataract surgery. In animal studies, the ocular relative bioavailability of single-dose topical ketorolac 0.45% ophthalmic solution was 2- to 3-fold higher than that of ketorolac 0.4% ophthalmic solution. In two identically designed, randomized, double-masked, multicentre trials in adult patients undergoing cataract extraction, the proportions of patients with a summed ocular inflammation score of zero for anterior chamber cell count plus anterior chamber flare on day 14 after surgery were significantly greater in those treated with topical ketorolac 0.45% ophthalmic solution than in those treated with vehicle placebo. Compared with placebo, topical ketorolac 0.45% ophthalmic solution significantly increased the proportion of patients who were pain-free on the day after surgery in both trials. Ketorolac 0.45% ophthalmic solution was generally well tolerated in clinical trials with lower overall incidences of treatment-emergent and treatment-related adverse events than placebo, and with no single treatment-related adverse event having a higher incidence than with placebo.

摘要

酮咯酸 0.45%滴眼液是一种局部用非甾体抗炎药,在美国被批准用于治疗白内障手术后的眼部疼痛和炎症。在动物研究中,单次局部使用酮咯酸 0.45%滴眼液的眼部相对生物利用度是酮咯酸 0.4%滴眼液的 2-3 倍。在两项设计相同、随机、双盲、多中心的成年白内障摘除患者临床试验中,术后第 14 天接受酮咯酸 0.45%滴眼液治疗的患者前房细胞计数加前房闪辉的总和眼部炎症评分均为零的患者比例显著高于接受载体安慰剂治疗的患者。与安慰剂相比,酮咯酸 0.45%滴眼液在两项试验中均显著增加了术后第 1 天无疼痛的患者比例。酮咯酸 0.45%滴眼液在临床试验中总体耐受性良好,与安慰剂相比,治疗出现的和与治疗相关的不良事件总发生率较低,且没有任何单一与治疗相关的不良事件发生率高于安慰剂。

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