Sutter Florian K P, Simpson Judy M, Gillies Mark C
Save Sight Institute, Department of Clinical Ophthalmology and Eye Health, The University of Sydney, Sydney, NSW, Australia.
Ophthalmology. 2004 Nov;111(11):2044-9. doi: 10.1016/j.ophtha.2004.05.025.
To determine whether an intravitreal injection of triamcinolone acetonide for persistent diabetic macular edema after adequate laser treatment improves visual acuity.
Prospective, double-masked, placebo-controlled, randomized clinical trial.
Sixty-nine eyes of 43 patients were entered into the study, with 34 eyes randomized to receive active treatment and 35 randomized to receive a placebo injection. Sixty-five of 69 eyes (94%) completed the 3-month study visit.
Using a 27-gauge needle, 0.1 ml of triamcinolone acetonide was injected through the pars plana. The procedure was performed in a minor procedures area in the outpatient clinic under sterile conditions and using topical and subconjunctival anesthesia. Eyes randomized to placebo received a subconjunctival saline injection using the identical procedure for preparation.
The main outcome measures were improvement of best-corrected logarithm of the minimum angle of resolution visual acuity by 5 or more letters and incidence of moderate or severe adverse events.
Eighteen of 33 eyes (55%) treated with triamcinolone gained 5 or more letters of best-corrected visual acuity compared with 5 of 32 eyes (16%) treated with placebo (P = 0.002). Macular edema was reduced by 1 or more grades as determined by masked semiquantitative contact lens examination in 25 of 33 treated eyes (75%) versus 5 of 32 untreated eyes (16%; P<0.0001). Optical coherence tomography showed a mean reduction of central retinal thickness of 152 mum in the 21 treated eyes that were examined compared with a reduction of 36 mum in 20 placebo-treated eyes. Infectious endophthalmitis developed in 1 triamcinolone-treated eye that was treated adequately without loss of visual acuity.
In the short term, intravitreal triamcinolone is an effective and relatively safe treatment for eyes with diabetic macular edema that have failed laser treatment. Although it will be essential to study longer-term outcomes, the use of intravitreal triamcinolone may be considered in 1 eye of patients who continue to lose vision from diabetic macular edema despite conventional management.
确定在充分的激光治疗后，玻璃体内注射曲安奈德治疗持续性糖尿病性黄斑水肿是否能提高视力。
前瞻性、双盲、安慰剂对照、随机临床试验。
43例患者的69只眼纳入研究，其中34只眼随机接受积极治疗，35只眼随机接受安慰剂注射。69只眼中的65只眼（94%）完成了为期3个月的研究访视。
使用27号针头，通过睫状体扁平部注射0.1毫升曲安奈德。该操作在门诊小手术区域无菌条件下进行，采用表面麻醉和结膜下麻醉。随机分配到安慰剂组的眼睛采用相同的准备程序接受结膜下生理盐水注射。
主要观察指标为最佳矫正最小分辨角视力提高5个或更多字母以及中度或重度不良事件的发生率。
曲安奈德治疗的33只眼中有18只眼（55%）最佳矫正视力提高了5个或更多字母，而安慰剂治疗的32只眼中有5只眼（16%）提高了5个或更多字母（P = 0.002）。通过盲法半定量隐形眼镜检查确定，33只治疗眼中有25只眼（75%）黄斑水肿减轻1个或更多等级，而32只未治疗眼中有5只眼（16%）减轻（P<0.0001）。光学相干断层扫描显示，接受检查的21只治疗眼中视网膜中心厚度平均减少152μm，而20只安慰剂治疗眼中减少36μm。1只接受曲安奈德治疗的眼睛发生感染性眼内炎，经充分治疗后视力未丧失。
短期内，玻璃体内注射曲安奈德对于激光治疗失败的糖尿病性黄斑水肿眼是一种有效且相对安全的治疗方法。尽管研究长期结果至关重要，但对于尽管采用了传统治疗方法仍因糖尿病性黄斑水肿而持续视力下降的患者，可考虑在一只眼中使用玻璃体内注射曲安奈德。
