State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.
Retina. 2011 May;31(5):838-45. doi: 10.1097/IAE.0b013e3181f4420d.
To compare the efficacy and safety of intravitreal triamcinolone acetonide (IVT) versus intravitreal bevacizumab (IVB) for the treatment of macular edema (ME) secondary to central retinal vein occlusion.
Prospective, consecutive, clinical interventional study. A total of 31 consecutive patients (32 eyes) with ME associated with central retinal vein occlusion were randomized to 2 groups. Sixteen eyes were treated with intravitreal injection of 4 mg/0.1 mL preservative-free triamcinolone acetonide; 16 eyes received IVB 1.25 mg/0.05 mL. Patients were given additional injections if they had ME as determined by optical coherence tomography 3 months after the first treatment or visual acuity loss of at least 2 lines in a Snellen chart. Best-corrected visual acuity, slit-lamp biomicroscopy, intraocular pressure, fundus fluorescein angiography, optical coherence tomography, the number of required injections, and adverse events were recorded during the 9-month follow-up period.
Best-corrected visual acuity was significantly improved at 2 weeks and 1, 3, 6, and 9 months after injection in both the IVT and IVB groups, but no statistical difference was found between the 2 treatment groups during the 9-month follow-up period. The mean central macular thickness decreased at 1, 3, 6, and 9 months after injection within each treatment group, and no statistical difference was found between the 2 treatment groups at any time during the follow-up period (P > 0.05). Patients who received IVT treatment appeared to have quicker visual recovery and improved central macular thickness at Week 2 compared with those who received IVB treatment. Five of 16 eyes in the IVT group and 12 of 16 eyes in the IVB group required a repeated injection because of recurrent ME or unresolved intraretinal or subretinal fluid. The mean number of treatment was 1.31 ± 0.48 in the IVT group, as compared with 2.38 ± 1.04 in the IVB group. Significant intraocular pressure increase was found only in the IVT group, and six patients received topical intraocular pressure lowering medication, and one patient required trabeculectomy. Premacular membranes were developed in 2 patients in the IVT group.
This is a prospective interventional study evaluating the efficacy and safety outcomes of IVT and IVB treatment for ME secondary to central retinal vein occlusion. Both IVT and IVB treatments can effectively improve best-corrected visual acuity and reduce central macular thickness in patients with ME secondary to central retinal vein occlusion without systemic side effects; no statistical differences were found in either best-corrected visual acuity or mean central macular thickness measurement between the two treatment groups. Both the effect of triamcinolone acetonide and that of bevacizumab were not permanent, and less injections were performed in the IVT group. However, triamcinolone acetonide causes more adverse events than bevacizumab.
比较玻璃体内注射曲安奈德(IVT)与玻璃体内注射贝伐单抗(IVB)治疗视网膜中央静脉阻塞(CRVO)所致黄斑水肿(ME)的疗效和安全性。
前瞻性、连续、临床干预研究。31 例(32 只眼)CRVO 相关 ME 患者被随机分为 2 组。16 只眼接受玻璃体内注射 4mg/0.1mL 无防腐剂的曲安奈德;16 只眼接受玻璃体内注射 1.25mg/0.05mL 的贝伐单抗。如果在第一次治疗后 3 个月通过光学相干断层扫描(OCT)发现 ME 或视力至少下降两行 Snellen 图表,则给予额外注射。在 9 个月的随访期间,记录最佳矫正视力、裂隙灯生物显微镜检查、眼压、眼底荧光素血管造影、OCT、所需注射次数和不良事件。
IVT 和 IVB 组在注射后 2 周和 1、3、6 和 9 个月时最佳矫正视力均显著提高,但在 9 个月的随访期间,两组间无统计学差异。两组患者在每个治疗组的治疗后 1、3、6 和 9 个月时中央黄斑厚度均降低,且在随访期间任何时间两组间无统计学差异(P>0.05)。与接受 IVB 治疗的患者相比,接受 IVT 治疗的患者在第 2 周时似乎有更快的视力恢复和改善的中央黄斑厚度。IVT 组 16 只眼中有 5 只和 IVB 组 16 只眼中有 12 只需要重复注射,因为 ME 复发或视网膜内或视网膜下液体未解决。IVT 组的平均治疗次数为 1.31±0.48 次,而 IVB 组为 2.38±1.04 次。仅在 IVT 组发现眼压显著升高,6 例患者接受局部降眼压药物治疗,1 例患者接受小梁切除术。IVT 组有 2 例患者出现黄斑前膜。
这是一项评估玻璃体内注射曲安奈德和贝伐单抗治疗视网膜中央静脉阻塞引起的黄斑水肿的疗效和安全性的前瞻性干预研究。IVT 和 IVB 治疗均可有效提高 CRVO 继发 ME 患者的最佳矫正视力和降低中央黄斑厚度,且无全身副作用;两组最佳矫正视力或平均中央黄斑厚度测量值均无统计学差异。曲安奈德和贝伐单抗的效果都不是永久性的,IVT 组注射次数更少。然而,曲安奈德引起的不良反应比贝伐单抗多。