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1% 环戊索龙滴眼液与 1% 醋酸泼尼松龙治疗葡萄膜炎的疗效和安全性比较

Efficacy and safety of rimexolone 1% ophthalmic suspension vs 1% prednisolone acetate in the treatment of uveitis.

作者信息

Foster C S, Alter G, DeBarge L R, Raizman M B, Crabb J L, Santos C I, Feiler L S, Friedlaender M H

机构信息

Massachusetts Eye and Ear Infirmary, Boston, USA.

出版信息

Am J Ophthalmol. 1996 Aug;122(2):171-82. doi: 10.1016/s0002-9394(14)72008-2.

Abstract

PURPOSE

Two multicenter studies compared the efficacy and safety of rimexolone 1% ophthalmic suspension (Vexol 1%, Alcon) and 1% prednisolone acetate (Pred Forte, Allergan).

METHODS

Patients with acute uveitis, recurrent iridocyclitis, or chronic uveitis treatable by topical corticosteroid were enrolled. Treatment regimen was one or two drops every hour during Week 1, every two hours during Week 2, four times a day during Week 3, and once a day for the last three days. Efficacy and safety were determined on Days 3, 4, 7 to 10, 14, 21, and 28. A poststudy evaluation was conducted 36 to 72 hours after treatment was stopped.

RESULTS

When anterior chamber cell and flare were measured, rimexolone 1% was found to be as effective as 1% prednisolone. The largest difference observed between treatments was 0.5 score unit, not clinically significant. There were no statistically significant differences in cell scores in either study (P > .05). No statistically significant differences in flare scores were found except at Day 28 in Study One (P = .04). Also, prednisolone was found to be more likely than rimexolone to cause a clinically significant increase (10 mm Hg or more) in intraocular pressure (1.7 times more likely in Study One, eight times more likely in Study Two).

CONCLUSION

Rimexolone 1% ophthalmic suspension is safe and effective for the treatment of uveitis.

摘要

目的

两项多中心研究比较了1%环戊噻嗪醇眼用混悬液(Vexol 1%,爱尔康公司)和1%醋酸泼尼松龙(Pred Forte,眼力健公司)的疗效和安全性。

方法

纳入患有急性葡萄膜炎、复发性虹膜睫状体炎或可通过局部使用皮质类固醇治疗的慢性葡萄膜炎的患者。治疗方案为第1周每小时滴1或2滴,第2周每两小时滴1次,第3周每天滴4次,最后3天每天滴1次。在第3、4、7至10、14、21和28天确定疗效和安全性。在停止治疗后36至72小时进行研究后评估。

结果

在测量前房细胞和房水闪辉时,发现1%环戊噻嗪醇与1%醋酸泼尼松龙效果相当。治疗之间观察到的最大差异为0.5分单位,无临床意义。两项研究中细胞评分均无统计学显著差异(P>.05)。除了在研究一中第28天,闪辉评分无统计学显著差异(P=.04)。此外,发现醋酸泼尼松龙比环戊噻嗪醇更易导致眼压临床上显著升高(升高10mmHg或更多)(在研究一中可能性高1.7倍,在研究二中高8倍)。

结论

1%环戊噻嗪醇眼用混悬液治疗葡萄膜炎安全有效。

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