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葡萄膜炎患者白内障手术后预防复发的围手术期预防措施:一项双中心、前瞻性、随机试验。

Perioperative prophylaxis to prevent recurrence following cataract surgery in uveitic patients: a two-centre, prospective, randomized trial.

作者信息

Mora Paolo, Gonzales Stefania, Ghirardini Stella, Rubino Pierangela, Orsoni Jelka G, Gandolfi Stefano A, Majo Francois, Guex-Crosier Yan

机构信息

Institute of Ophthalmology, University Hospital of Parma, Parma, Italy.

Department of Ophthalmology, Jules-Gonin Eye Hospital, University of Lausanne, Lausanne, Vaud, Switzerland.

出版信息

Acta Ophthalmol. 2016 Sep;94(6):e390-4. doi: 10.1111/aos.12955. Epub 2016 Feb 5.

DOI:10.1111/aos.12955
PMID:26846356
Abstract

PURPOSE

To compare the postoperative risk of inflammatory relapse in two groups of uveitic patients who underwent cataract surgery: one group had perioperative topical steroids alone and the other used topical and oral steroids.

METHODS

Prospective, randomized, unmasked, duocentric clinical trial conducted at the University of Parma (Italy), and the Jules Gonin Eye Hospital of Lausanne (Switzerland). Patients with a history of non-infectious uveitis requiring cataract surgery in 2009-2013 were assigned to two groups of perioperative prophylaxis: (A) intensive topical steroids alone; (B) the same topical regimen combined with oral steroids. Uveitis relapse over a period of 6 months was assessed.

RESULTS

In total, 52 eyes in 50 patients were randomized: 28 eyes were assigned to group A (topical) and 24 eyes to group B (topical + oral). Mean relapse-free survival time was 131 ± 11 days in group A and 150 ± 13 days in group B. This difference was not statistically significant (p = 0.42). At the end of follow-up, the groups were also comparable in terms of significant improvement in visual acuity (p < 0.01), mean central macular thickness (CMT) and IOP variation.

CONCLUSIONS

Absolute and long-lasting control of ocular, and possibly systemic, inflammation predisposes uveitis patients to satisfactory results after cataract extraction and intraocular lens implantation. Despite a lower rate of recurrences following oral steroid supplementation, the efficacy of an intensive perioperative topical steroid regimen alone in preventing postoperative uveitis relapse was statistically comparable. Secondary outcomes were also comparable between the two groups. Transient IOP elevation should be expected until treatment discontinuation.

摘要

目的

比较两组接受白内障手术的葡萄膜炎患者术后炎症复发的风险:一组仅在围手术期使用局部类固醇,另一组使用局部和口服类固醇。

方法

在意大利帕尔马大学和瑞士洛桑朱尔斯·戈宁眼科医院进行的前瞻性、随机、非盲、双中心临床试验。将2009年至2013年有非感染性葡萄膜炎病史且需要进行白内障手术的患者分为两组进行围手术期预防:(A)仅强化局部类固醇;(B)相同的局部治疗方案联合口服类固醇。评估6个月内的葡萄膜炎复发情况。

结果

总共50例患者的52只眼被随机分组:28只眼被分配到A组(局部用药),24只眼被分配到B组(局部+口服)。A组的平均无复发存活时间为131±11天,B组为150±13天。这种差异无统计学意义(p=0.42)。随访结束时,两组在视力显著改善(p<0.01)、平均中心黄斑厚度(CMT)和眼压变化方面也具有可比性。

结论

对眼部以及可能的全身炎症进行绝对和持久的控制,使葡萄膜炎患者在白内障摘除和人工晶状体植入术后能获得满意的结果。尽管口服类固醇补充后复发率较低,但仅强化围手术期局部类固醇方案在预防术后葡萄膜炎复发方面的疗效在统计学上具有可比性。两组的次要结局也具有可比性。在治疗停止前应预期会出现短暂的眼压升高。

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