Ophthalmology Department and Ophthalmic Research Center, Labbafinejad Medical Center, Shaheed Beheshti Medical University, Tehran, Iran.
Retina. 2011 Sep;31(8):1564-73. doi: 10.1097/IAE.0b013e31820bde7d.
To assess the effect of initial central macular thickness (CMT) on the response to treatment in diabetic macular edema.
The data of 150 eyes of 129 patients with clinically significant diabetic macular edema and no previous treatment who had been randomly assigned in the original trial to 1 of the 3 groups, 1) intravitreal bevacizumab (IVB) group (50 eyes); 2) combined intravitreal bevacizumab and triamcinolone (IVB/IVT) group (50 eyes); and 3) macular laser photocoagulation group (50 eyes), were reevaluated. This time the data of the cases were reanalyzed based on their initial CMT. Accordingly, the original treatment groups were categorized into 3 subgroups: 1) <250 μm, 2) 250 μm to 349 μm, and 3) ≥350 μm. Visual acuity and CMT changes in response to different treatments were compared. Main outcome measures were changes in visual acuity and CMT at Weeks 6, 12, 24, and 36.
At 6 weeks in all subgroups, mean visual acuity improvement in the IVB group was significantly greater than the other groups (P = 0.002, P = 0.003, P < 0.001, for subgroups of <250, 250-349, and ≥350 μm, respectively). At 12, 24, and 36 weeks in the subgroup >350 μm and at 24 weeks in the subgroup 250 μm to 349 μm, the difference of mean visual acuity changes among the groups reached to a significant level (P = 0.010, P = 0.028, P < 0.001, and P < 0.001, respectively) in favor of the IVB group. The difference in mean CMT changes at 6 weeks and 12 weeks was significant among the groups in the subgroup ≥350 μm (P < 0.001 and P < 0.001) in favor of the IVB group and in the subgroup 250 μm to 349 μm at 24 weeks in favor of combined IVB/IVT group (P < 0.001).
In the primary treatment of diabetic macular edema, initial CMT may be an important factor in decision making. Regardless of initial CMT, IVB caused a better visual outcome only at 6 weeks. With longer follow-up, however, IVB was superior to IVB/IVT and macular laser photocoagulation only in the eyes with initial CMT of ≥350 μm. Concerning CMT reduction, this superiority of IVB in the eyes with initial CMT of ≥350 μm was not observed beyond 12 weeks.
评估初始中央黄斑厚度(CMT)对糖尿病性黄斑水肿治疗反应的影响。
对既往未接受治疗的 129 例临床显著糖尿病性黄斑水肿患者的 150 只眼进行了随机分组,这些患者在最初的试验中被随机分配到 3 组中的 1 组,分别为 1)玻璃体腔内注射贝伐单抗(IVB)组(50 只眼);2)玻璃体腔内注射贝伐单抗联合曲安奈德(IVB/IVT)组(50 只眼);3)黄斑激光光凝组(50 只眼)。这次根据患者的初始 CMT 重新分析了这些病例的数据。因此,将最初的治疗组分为 3 个亚组:1)<250μm;2)250μm 至 349μm;3)≥350μm。比较不同治疗方法对视力和 CMT 的影响。主要观察指标为第 6、12、24 和 36 周时的视力和 CMT 变化。
在所有亚组中,6 周时 IVB 组的平均视力改善明显大于其他组(P=0.002,P=0.003,P<0.001,分别用于<250μm、250-349μm 和≥350μm 的亚组)。在>350μm 的亚组和 250μm 至 349μm 的亚组的 12、24 和 36 周时,各组间平均视力变化的差异达到显著水平(P=0.010,P=0.028,P<0.001,P<0.001,分别为),IVB 组的优势更为明显。在≥350μm 的亚组中,6 周和 12 周时 CMT 变化的平均差异具有统计学意义(P<0.001 和 P<0.001),IVB 组更为有利,而在 24 周时 250μm 至 349μm 的亚组中,联合 IVB/IVT 组更为有利(P<0.001)。
在糖尿病性黄斑水肿的初始治疗中,初始 CMT 可能是决策的重要因素。无论初始 CMT 如何,IVB 仅在 6 周时即可产生更好的视力结果。然而,随着随访时间的延长,IVB 仅在初始 CMT≥350μm 的眼中优于 IVB/IVT 和黄斑激光光凝。关于 CMT 的降低,在初始 CMT≥350μm 的眼中,IVB 的这种优势在 12 周后并未观察到。