Terai Naim, Haustein Michael, Siegel Anastasia, Stodtmeister Richard, Pillunat Lutz E, Sandner Dirk
Department of Ophthalmology, University Hospital Dresden, Dresden, Germany.
Retina. 2014 Jul;34(7):1466-72. doi: 10.1097/IAE.0000000000000095.
PURPOSE: To investigate the effect(s) of intravitreally injected ranibizumab on retinal vessel diameter in patients with diabetic macular edema. METHODS: Participants of this prospective study were 14 men and 16 women (30 eyes) aged 60 ± 11 years (mean ± standard deviation), all with clinically significant diabetic macular edema. Treatment comprised 3 intravitreal injections of ranibizumab given at 4-week intervals. Examinations were conducted before the first (baseline), before the second (Month 1), before the third (Month 2) injections, and 3 months after baseline (Month 3). Measured parameters included systemic blood pressure, static retinal vessel analysis (central retinal artery equivalent and central retinal vein equivalent), and dynamic retinal vessel analysis, as measured by the change in vessel diameter in response to flicker stimulation during three measurement cycles. Flicker stimulation was accomplished using a 50-second baseline recording, followed by an online measurement during 20-second flicker stimulation and 80-second online measurements in both arteriolar and venular vessel segments. RESULTS: Static retinal vessel analysis showed a reduction of central retinal artery equivalent from 186.25 ± 51.40 μm (baseline) to 173.20 ± 22.2 μm (Month 1), to 174.30 ± 27.30 μm (Month 2), and to 170.56 ± 22.89 μm (Month 3), none of which was statistically significant (P = 0.23, 0.12, and 0.14, respectively). Central retinal vein equivalent was reduced from 216.21 ± 25.0 μm (baseline) to 214.48 ± 25.4 μm (Month 1), to 214.80 ± 24.30 μm (Month 2), and to 211.41 ± 24.30 μm (Month 3), revealing no statistically significant differences between examination time points (P = 0.54, 0.06, and 0.24, respectively). Dynamic vessel analysis yielded a mean retinal arterial diameter change of +1.47% ± 2.3 (baseline), +1.91% ± 2.5 (Month 1), +1.76% ± 2.2 (Month 2), and +1.66% ± 2.1 (Month 3), none of which showed statistically significant differences (P = 0.32, 0.49, and 0.70, respectively). Mean retinal venous diameter changes were +3.15% ± 1.7 (baseline), +3.7% ± 2.3 (Month 1), +4.0% ± 2.0 (Month 2), and +4.95% ± 1.9 (Month 3), none of which showed statistically significant differences (P = 0.12, 0.17, and 0.14, respectively). Central retinal thickness, as measured by spectral domain optical coherence tomography, decreased significantly from 435.2 ± 131.8 μm (baseline) to 372.3 ± 142.8 μm (Month 3), P = 0.01. Regression analysis of arteriolar and venular diameters indicated that there was no significant correlation between these 2 parameters (r = 0.053; P = 0.835 and r = 0.06; P = 0.817, respectively). Also, no significant correlation was observed between the difference in the central retinal thickness and change in arteriolar or venular dilatation (r = 0.291, P = 0.241 and r = 0.06, P = 0.435, respectively). CONCLUSION: Intravitreally applied ranibizumab did not significantly affect retinal vessel diameter in patients with diabetic macular edema. Decline in the central foveal thickness after ranibizumab therapy, as measured by spectral domain optical coherence tomography, was not linked to any change in retinal vessel diameter or dilatatory response, neither for arterioles nor venules.
目的：研究玻璃体内注射雷珠单抗对糖尿病性黄斑水肿患者视网膜血管直径的影响。 方法：这项前瞻性研究的参与者为14名男性和16名女性（30只眼），年龄60±11岁（均值±标准差），均患有具有临床意义的糖尿病性黄斑水肿。治疗包括每隔4周进行3次玻璃体内注射雷珠单抗。在第一次注射前（基线）、第二次注射前（第1个月）、第三次注射前（第2个月）以及基线后3个月（第3个月）进行检查。测量参数包括全身血压、静态视网膜血管分析（视网膜中央动脉等效直径和视网膜中央静脉等效直径）以及动态视网膜血管分析，动态视网膜血管分析通过在三个测量周期内对闪烁刺激作出反应时血管直径的变化来测量。闪烁刺激是通过50秒的基线记录完成的，随后是在20秒闪烁刺激期间的在线测量以及在小动脉和小静脉血管段进行的80秒在线测量。 结果：静态视网膜血管分析显示，视网膜中央动脉等效直径从186.25±51.40μm（基线）降至173.20±22.2μm（第1个月）、降至174.30±27.30μm（第2个月）、降至170.56±22.89μm（第3个月），这些变化均无统计学意义（P值分别为0.23、0.12和0.14）。视网膜中央静脉等效直径从216.21±25.0μm（基线）降至214.48±25.4μm（第1个月）、降至214.80±24.30μm（第2个月）、降至211.41±24.30μm（第3个月），各检查时间点之间无统计学显著差异（P值分别为0.54、0.06和0.24）。动态血管分析得出视网膜动脉直径的平均变化在基线时为+1.47%±2.3、第1个月时为+1.91%±2.5、第2个月时为+1.76%±2.2、第3个月时为+1.66%±2.1，均无统计学显著差异（P值分别为0.32、0.49和0.70）。视网膜静脉直径的平均变化在基线时为+3.15%±1.7、第1个月时为+3.7%±2.3、第2个月时为+4.0%±2.0、第3个月时为+4.95%±1.9，均无统计学显著差异（P值分别为0.12、0.17和0.14）。通过频域光学相干断层扫描测量的视网膜中央厚度从435.2±131.8μm（基线）显著降至372.3±142.8μm（第3个月），P = 0.01。小动脉和小静脉直径的回归分析表明，这两个参数之间无显著相关性（r = 0.053；P = 0.835以及r = 0.06；P = 0.817）。此外，视网膜中央厚度的差异与小动脉或小静脉扩张变化之间未观察到显著相关性（r = 0.291，P = 0.241以及r = 0.06，P = 0.435）。 结论：玻璃体内应用雷珠单抗对糖尿病性黄斑水肿患者的视网膜血管直径无显著影响。通过频域光学相干断层扫描测量，雷珠单抗治疗后中心凹厚度的下降与视网膜血管直径或扩张反应的任何变化均无关联，无论是小动脉还是小静脉。
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