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辅助性曲安奈德用于艾哈迈德青光眼引流阀植入术:一项随机临床试验。

Adjunctive triamcinolone acetonide for Ahmed glaucoma valve implantation: a randomized clinical trial.

作者信息

Yazdani Shahin, Doozandeh Azadeh, Pakravan Mohammad, Ownagh Vahid, Yaseri Mehdi

机构信息

Ocular Tissue Engineering Research Center, Shahid Beheshti University of Medical Sciences, Tehran - Iran.

Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran - Iran.

出版信息

Eur J Ophthalmol. 2017 Jun 26;27(4):411-416. doi: 10.5301/ejo.5000892. Epub 2016 Oct 27.

Abstract

PURPOSE

To evaluate the effect of intraoperative sub-Tenon injection of triamcinolone acetonide (TA) as an adjunct to Ahmed glaucoma valve (AGV) implantation.

METHODS

In this triple-blind randomized clinical trial, 104 eyes with refractory glaucoma were randomly assigned to conventional AGV (non-TA group) or AGV with adjunctive triamcinolone (TA group). In the TA group, 10 mg TA was injected in the sub-Tenon space around the AGV plate intraoperatively. Patients were followed for 1 year. The main outcome measure was intraocular pressure (IOP). Other outcome measures included best-corrected visual acuity (BCVA), occurrence of hypertensive phase (HP), peak IOP, number of antiglaucoma medications, and complications.

RESULTS

A total of 90 patients were included in the final analysis. Mean IOP was lower in the TA group at most follow-up visits; however, the difference was statistically significant only at the first month (p = 0.004). Linear mixed model showed that mean IOP was 1.5 mm Hg lower in the TA group throughout the study period (p = 0.006). Peak postoperative IOP was significantly lower in the TA group (19.3 ± 4.8 mm Hg versus 29 ± 9.2 mm Hg, p = 0.032). Rates of success (defined as 6 < IOP <21 mm Hg) were similar in both groups at 12 months. There was no difference in the occurrence of the HP between the 2 groups (p = 0.123). Loss of BCVA >2 lines was more common in the non-TA group (p = 0.032).

CONCLUSIONS

Adjunctive intraoperative TA injection during AGV implantation can blunt peak IOP levels and reduce mean IOP up to 1 year. Visual outcomes also seem to be superior to standard surgery.

摘要

目的

评估术中在Tenon囊下注射曲安奈德(TA)作为艾哈迈德青光眼引流阀(AGV)植入辅助手段的效果。

方法

在这项三盲随机临床试验中,104例难治性青光眼患者被随机分为接受传统AGV植入(非TA组)或联合曲安奈德的AGV植入(TA组)。在TA组中,术中在AGV板周围的Tenon囊下间隙注射10mg TA。对患者进行为期1年的随访。主要观察指标为眼压(IOP)。其他观察指标包括最佳矫正视力(BCVA)、高血压期(HP)的发生情况、眼压峰值、抗青光眼药物的使用数量以及并发症。

结果

共有90例患者纳入最终分析。在大多数随访时间点,TA组的平均眼压较低;然而,仅在第1个月时差异具有统计学意义(p = 0.004)。线性混合模型显示,在整个研究期间,TA组的平均眼压低1.5mmHg(p = 0.006)。TA组术后眼压峰值显著更低(19.3±4.8mmHg对29±9.2mmHg,p = 0.032)。12个月时两组的成功率(定义为眼压6 < IOP < 21mmHg)相似。两组间HP的发生率无差异(p = 0.123)。非TA组BCVA下降>2行更为常见(p = 0.032)。

结论

AGV植入术中辅助注射TA可降低眼压峰值,并在长达1年的时间内降低平均眼压。视觉效果似乎也优于标准手术。

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