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玻璃体内注射与Tenon囊下注射曲安奈德治疗难治性糖尿病性黄斑水肿的随机临床试验

Intravitreal injection versus sub-Tenon's infusion of triamcinolone acetonide for refractory diabetic macular edema: a randomized clinical trial.

作者信息

Bonini-Filho Marco A, Jorge Rodrigo, Barbosa José C, Calucci Daniela, Cardillo Jose A, Costa Rogério A

机构信息

Department of Ophthalmology, School of Medicine of Ribeirão Preto, Brazil.

出版信息

Invest Ophthalmol Vis Sci. 2005 Oct;46(10):3845-9. doi: 10.1167/iovs.05-0297.

DOI:10.1167/iovs.05-0297
PMID:16186372
Abstract

PURPOSE

To compare the effectiveness of posterior sub-Tenon's infusion (STi) and intravitreal injection (IVI) of triamcinolone acetonide (TA) for treatment of refractory diffuse diabetic macular edema.

METHODS

Thirty-six phakic diabetic patients with refractory diffuse diabetic macular edema were prospectively enrolled. Patients randomly received either 40 mg STi or 4 mg IVI of TA. Comprehensive ophthalmic evaluation was performed at baseline and 1, 2, 4, 8 +/- 1, 12 +/- 2 and 24 +/- 2 weeks after treatment. Macular morphologic changes detected by optical coherence tomography and visual acuity, intraocular pressure, and lens status were evaluated.

RESULTS

Twenty-eight patients (28 eyes) completed the 24-week study. Central macular thickness was significantly reduced in the IVI group when compared with the STi group at 2, 4, 8, 12, and 24 weeks after treatment (P < 0.01). Mean visual acuities (in logarithm of the minimum angle of resolution [logMAR]) at week-4, -8, and -12 follow-up examinations were significantly higher in the IVI group (0.74, 0.75, and 0.82, respectively) when compared with the STi group (0.88, 0.88, and 0.90, respectively; P < 0.01). A significant change from baseline in mean intraocular pressure (mm Hg) was seen at weeks 4 (+/-3.21) and 8 (+/-3.35) in STi the group (P < 0.01), and at week 8 (+/-2.78) in the IVI group (P < 0.05). No patient had cataract progression during the study.

CONCLUSIONS

Although the number of patients and length of follow-up in this preliminary study were limited, the changes in central macular thickness and visual acuity observed after treatment suggest that IVI TA may be more effective than STi for the management of refractory diffuse diabetic macular edema. Further studies are needed to confirm these preliminary findings.

摘要

目的

比较后Tenon囊下注射(STi)和玻璃体内注射(IVI)曲安奈德(TA)治疗难治性弥漫性糖尿病性黄斑水肿的疗效。

方法

前瞻性纳入36例患有难治性弥漫性糖尿病性黄斑水肿的有晶状体糖尿病患者。患者随机接受40mg STi或4mg IVI的TA。在基线以及治疗后1、2、4、8±1、12±2和24±2周进行全面的眼科评估。评估通过光学相干断层扫描检测到的黄斑形态变化以及视力、眼压和晶状体状态。

结果

28例患者(28只眼)完成了为期24周的研究。治疗后2、4、8、12和24周,IVI组的中心黄斑厚度与STi组相比显著降低(P<0.01)。在第4、8和12周的随访检查中,IVI组的平均视力(以最小分辨角的对数[logMAR]表示)(分别为0.74、0.75和0.82)显著高于STi组(分别为0.88、0.88和0.90;P<0.01)。STi组在第4周(±3.21)和第8周(±3.35)时平均眼压(mmHg)与基线相比有显著变化(P<0.01),IVI组在第8周(±2.78)时平均眼压与基线相比有显著变化(P<0.05)。研究期间无患者出现白内障进展。

结论

尽管这项初步研究的患者数量和随访时间有限,但治疗后观察到的中心黄斑厚度和视力变化表明,IVI TA在治疗难治性弥漫性糖尿病性黄斑水肿方面可能比STi更有效。需要进一步研究来证实这些初步发现。

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