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0.5% 酮咯酸氨丁三醇滴眼液治疗季节性变应性结膜炎的临床评价

Clinical evaluation of ketorolac tromethamine 0.5% ophthalmic solution for the treatment of seasonal allergic conjunctivitis.

作者信息

Ballas Z, Blumenthal M, Tinkelman D G, Kriz R, Rupp G

机构信息

Division of Allergy and Immunology, University of Iowa, Iowa City.

出版信息

Surv Ophthalmol. 1993 Jul-Aug;38 Suppl:141-8. doi: 10.1016/0039-6257(93)90038-9.

DOI:10.1016/0039-6257(93)90038-9
PMID:8236005
Abstract

We evaluated 148 patients with allergic conjunctivitis in a double-masked, paired comparison clinical trial comparing ketorolac 0.5% ophthalmic solution with vehicle. Patients received one drop of each study medication in preassigned eyes, four times a day, for seven days. Both treatments showed significant changes from baseline in the signs and symptoms associated with allergic conjunctivitis. Evaluations at the final visit (day 7 or 8) showed that ketorolac-treated eyes had a significant treatment response when compared to vehicle-treated eyes for conjunctival inflammation (p = 0.010), ocular itching (p = 0.006), swollen eyes (p = 0.002), discharge/tearing (p = 0.021), foreign body sensation (p = 0.035), and conjunctival injection (p = 0.016). Mean scores evaluating the overall therapeutic effect of the study treatments at the completion of the study were higher for ketorolac-treated eyes than for vehicle-treated eyes as rated by investigators (p = 0.004) and study patients (p < 0.001). Results of this study confirmed the trends of a previous study showing that ketorolac 0.5% ophthalmic solution applied topically is an effective therapy for allergic conjunctivitis.

摘要

在一项双盲、配对比较的临床试验中,我们对148例过敏性结膜炎患者进行了评估,比较了0.5%酮咯酸眼用溶液与赋形剂。患者在预先指定的眼睛中每天滴入一滴每种研究药物,共四次,持续七天。两种治疗方法在与过敏性结膜炎相关的体征和症状方面均显示出与基线相比有显著变化。末次随访(第7天或第8天)的评估显示,与赋形剂治疗的眼睛相比,酮咯酸治疗的眼睛在结膜炎症(p = 0.010)、眼部瘙痒(p = 0.006)、眼睛肿胀(p = 0.002)、分泌物/流泪(p = 0.021)、异物感(p = 0.035)和结膜充血(p = 0.016)方面有显著的治疗反应。在研究结束时,研究者(p = 0.004)和研究患者(p < 0.001)对研究治疗总体疗效的评估得分,酮咯酸治疗的眼睛高于赋形剂治疗的眼睛。本研究结果证实了先前一项研究的趋势,即局部应用0.5%酮咯酸眼用溶液是治疗过敏性结膜炎的有效疗法。

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