A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema.
A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema.
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DOI：
10.1016/j.ophtha.2008.06.015
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发表时间：
2008-09
期刊：
影响因子：
13.7
通讯作者：
Diabetic Retinopathy Clinical Research Network
中科院分区：
文献类型：
--
作者：
Diabetic Retinopathy Clinical Research Network
评价1 mg和4 mg剂量的不含抗生素的玻璃体内曲安奈德与局灶/网格光凝治疗糖尿病黄斑水肿（DME）的疗效和安全性。多中心随机临床试验693例DME受试者的840只研究眼（涉及中央凹，视力20/40至20/320）随机接受局灶性/网格状光凝（N=330）、1 mg玻璃体内曲安奈德（N=256）或4 mg玻璃体内曲安奈德（N=254）。每隔4个月对持续性或新发水肿进行重新治疗。主要结局为2年。采用电子早期治疗糖尿病视网膜病变研究（E-ETDRS）方法测量的视力（主要）、光学相干断层扫描（OCT）测量的视网膜厚度（次要）和安全性。4个月时，4 mg曲安奈德组的平均视力优于激光组（P<0.001）或1 mg曲安奈德组（P=0.001）。到1年时，各组之间的平均视力无显著差异。在16个月访视时和2年时的主要结局访视时，激光组的平均视力优于其他两组（2年时，激光组和1 mg组比较P = 0.02，激光组和4 mg组比较P=0.002，1 mg组和4 mg组比较P=0.49）。治疗组视力结果的差异不能仅归因于白内障形成。OCT结果通常会影响视力结果。在任何访视时，三个治疗组中分别有4%、16%和33%的患眼的眼压较基线升高≥10 mm Hg，三个治疗组中分别有13%、23%和51%的患眼进行了白内障手术。在2年的时间内，对于大多数DME患者（其特征与本临床试验中的队列相似），局灶性/网格光凝比1 mg或4 mg剂量的不含抗生素的玻璃体内曲安西龙更有效，副作用更少。这项研究的结果也支持局灶/网格光凝目前应该是DME临床试验中比较其他治疗方法的基准。
To evaluate the efficacy and safety of 1 mg and 4 mg doses of preservative-free intravitreal triamcinolone in comparison with focal/grid photocoagulation for the treatment of diabetic macular edema (DME). Multi-center randomized clinical trial 840 study eyes of 693 subjects with DME involving the fovea and visual acuity 20/40 to 20/320 Eyes were randomized to focal/grid photocoagulation (N=330), 1 mg intravitreal triamcinolone (N=256), or 4 mg intravitreal triamcinolone (N=254). Retreatment was given for persistent or new edema at 4-month intervals. The primary outcome was at 2 years. Visual acuity measured with the Electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) method (primary), optical coherence tomography (OCT)-measured retinal thickness (secondary), and safety. At 4 months, mean visual acuity was better in the 4 mg triamcinolone group than in either the laser group (P<0.001) or the 1 mg triamcinolone group (P=0.001). By 1 year, there were no significant differences among groups in mean visual acuity. At the 16-month visit and extending through the primary outcome visit at 2 years, mean visual acuity was better in the laser group than in the other two groups (at 2 years, P=0.02 comparing the laser and 1 mg groups, P=0.002 comparing the laser and 4 mg groups, and P=0.49 comparing the 1mg and 4 mg groups). Treatment group differences in the visual acuity outcome could not be attributed solely to cataract formation. OCT results generally paralleled the visual acuity results. Intraocular pressure was increased from baseline by ≥10 mm Hg at any visit in 4%, 16%, and 33% of eyes in the three treatment groups, respectively, and cataract surgery was performed in 13%, 23%, and 51% of eyes in the three treatment groups, respectively. Over a 2-year period, focal/grid photocoagulation is more effective and has fewer side effects than 1 mg or 4 mg doses of preservative-free intravitreal triamcinolone for most patients with DME who have characteristics similar to the cohort in this clinical trial. The results of this study also support that focal/grid photocoagulation currently should be the benchmark against which other treatments are compared in clinical trials of DME.
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影响因子：
13.7
作者：
Chun, Dal W.;Heier, Jeffrey S.;Bankert, Joy M.
通讯作者：
Bankert, Joy M.
DOI：
10.1097/00006982-200607000-00021
发表时间：
2006-07-01
影响因子：
3.3
作者：
Freund, K. Bailey;Laud, Ketan;Spaide, Richard F.
通讯作者：
Spaide, Richard F.
影响因子：
4.2
作者：
Avitabile, T;Longo, A;Reibaldi, A
通讯作者：
Reibaldi, A
影响因子：
4.2
作者：
Harbour, JW;Smiddy, WE;Rubsamen, PE
通讯作者：
Rubsamen, PE
影响因子：
13.7
作者：
Jonas, JB;Degenring, RF;Kamppeter, BA
通讯作者：
Kamppeter, BA