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0.5%酮咯酸或0.1%双氯芬酸眼药水对白内障手术后炎症的比较效果。

Comparative effects of ketorolac 0.5% or diclofenac 0.1% ophthalmic solutions on inflammation after cataract surgery.

作者信息

Flach A J, Dolan B J, Donahue M E, Faktorovich E G, Gonzalez G A

机构信息

Department of Veterans Affairs San Francisco, California, USA.

出版信息

Ophthalmology. 1998 Sep;105(9):1775-9. doi: 10.1016/S0161-6420(98)99053-4.

Abstract

OBJECTIVE

Ketorolac tromethamine 0.5% and diclofenac sodium 0.1% ophthalmic solutions are approved for use by the U.S. Food and Drug Administration to avoid excessive postoperative inflammation after cataract surgery and implantation of an intraocular lens. This study compares the efficacy and toxicity of these nonsteroidal anti-inflammatory drugs for the first time.

DESIGN

Randomized, double-masked, prospective clinical trial.

PARTICIPANTS

A total of 120 patients assigned in equal numbers to 1 of the 2 treatment regimens.

INTERVENTION

Treatment with either ketorolac 0.5% or diclofenac 0.1% ophthalmic solutions instilled four times daily for 30 days beginning the first postoperative day after surgery.

MAIN OUTCOME MEASURES

Objective (Kowa FC 1000 laser cell and flare meter) and subjective (slit-lamp biomicroscope) measurements of inflammation and toxicity were made and compared at three separate post-operative visits.

RESULTS

The anti-inflammatory effects of the two treatment regimens were not statistically different at any of the postoperative visits. Patients tolerated both treatments equally well.

CONCLUSIONS

This study shows diclofenac sodium 0.1% and ketorolac tromethamine 0.5% ophthalmic solutions are equally effective and safe for the control of postoperative inflammation after uncomplicated cataract surgery performed by phacoemulsification followed by the implantation of a foldable intraocular lens.

摘要

目的

美国食品药品监督管理局已批准使用0.5%的酮咯酸氨丁三醇和0.1%的双氯芬酸钠眼药水,以避免白内障手术及人工晶状体植入术后出现过度炎症反应。本研究首次比较了这些非甾体抗炎药的疗效和毒性。

设计

随机、双盲、前瞻性临床试验。

参与者

总共120名患者,平均分为两组,分别接受两种治疗方案中的一种。

干预措施

从术后第一天开始,每天四次滴注0.5%的酮咯酸或0.1%的双氯芬酸钠眼药水,持续30天。

主要观察指标

在术后三次不同的随访中,采用客观指标(Kowa FC 1000激光细胞和闪光光度计)和主观指标(裂隙灯生物显微镜)对炎症和毒性进行测量并比较。

结果

在任何一次术后随访中,两种治疗方案的抗炎效果均无统计学差异。患者对两种治疗的耐受性相当。

结论

本研究表明,对于通过超声乳化白内障吸除术并植入可折叠人工晶状体的非复杂性白内障手术,0.1%的双氯芬酸钠眼药水和0.5%的酮咯酸氨丁三醇眼药水在控制术后炎症方面同样有效且安全。

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