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1% 环戊索龙与1% 醋酸泼尼松龙治疗前葡萄膜炎的疗效和安全性——一项随机三盲研究

Efficacy and safety of 1% rimexolone versus 1% prednisolone acetate in the treatment of anterior uveitis--a randomized triple masked study.

作者信息

Biswas Jyotirmay, Ganeshbabu T M, Raghavendran S Ramesh, Raizada Seemant, Mondkar Sandeep V, Madhavan H N

机构信息

Medical and Vision Research Foundations, Sankara Nethralaya, 18, College Road, Chennai 600 006, India.

出版信息

Int Ophthalmol. 2004 May;25(3):147-53. doi: 10.1007/s10792-004-5195-2.

DOI:10.1007/s10792-004-5195-2
PMID:15847313
Abstract

PURPOSE

To evaluate the efficacy and safety of 1% rimexolone versus 1% prednisolone acetate ophthalmic suspension in the treatment of anterior uveitis.

METHODS

A randomised triple masked, parallel comparison of rimexolone and prednisolone acetate ophthalmic suspensions was carried out on 78 patients with acute, chronic and recurrent anterior uveitis. Treatment regimen included instillation of one or two drops of drug one hourly through the waking hours during the first week, two hourly in the second week, four times a day in the third week, two times a day for the first 4 days and once a day for the 3 days in the last week. The patient was clinically evaluated on the 3-4th, 7-10th, 14th, 21st and 28th days. The patient was also reviewed on the 30th day. Anterior chamber cells and flare reactions were compared for evaluating the efficacy of the drugs.

RESULT

Rimexolone is as effective as prednisolone acetate ophthalmic suspension in the treatment of anterior uveitis. The largest difference found was 0.1 in the flare reaction (statistically insignificant; p = 0.3) and 0.2 score units (statistically significant; p = 0.01) in the cells. Overall, comparison of the drugs shows no clinical significance in the treatment of anterior uveitis by either drug. Difference in intraocular pressure (IOP) was also statistically insignificant (p > 0.05). However, three patients in the prednisolone acetate group and 1 patient from the rimexolone group showed a rise in IOP.

CONCLUSION

Rimexolone 1% ophthalmic suspension is as effective as and safer than prednisolone acetate 1% ophthalmic suspension in the treatment of anterior uveitis.

摘要

目的

评估1%利美索龙与1%醋酸泼尼松龙滴眼液治疗前葡萄膜炎的疗效与安全性。

方法

对78例急性、慢性及复发性前葡萄膜炎患者进行随机、三盲、平行对照研究,比较利美索龙与醋酸泼尼松龙滴眼液。治疗方案为:第1周,清醒时每小时滴1或2滴药物;第2周,每2小时滴1次;第3周,每日4次;第4周的前4天,每日2次;最后1周的3天,每日1次。在第3 - 4天、7 - 10天、14天、21天和28天对患者进行临床评估,第30天也进行复查。比较前房细胞和闪光反应以评估药物疗效。

结果

利美索龙在治疗前葡萄膜炎方面与醋酸泼尼松龙滴眼液疗效相当。发现最大差异为闪光反应相差0.1(无统计学意义;p = 0.3),细胞计数相差0.2分(有统计学意义;p = 0.01)。总体而言,两种药物治疗前葡萄膜炎在临床上无显著差异。眼压差异也无统计学意义(p > 0.05)。然而,醋酸泼尼松龙组有3例患者眼压升高,利美索龙组有1例患者眼压升高。

结论

1%利美索龙滴眼液在治疗前葡萄膜炎方面与1%醋酸泼尼松龙滴眼液疗效相当且更安全。

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