Department of Ophthalmology, School of Medicine of Ribeirão Preto, Ribeirão Preto, SP, Brazil.
Acta Ophthalmol. 2011 Nov;89(7):e567-72. doi: 10.1111/j.1755-3768.2011.02184.x. Epub 2011 Jul 5.
To evaluate the effects of panretinal photocoagulation (PRP) compared with PRP plus intravitreal injection of 0.5 mg of ranibizumab (IVR) in patients with high-risk proliferative diabetic retinopathy (PDR).
Prospective study included patients with high-risk PDR and no prior laser treatment randomly assigned to receive PRP (PRP group) or PRP plus IVR (PRPplus group). PRP was administered in two sessions (weeks 0 and 2), and IVR was administered at the end of the first laser session in the PRPplus group. Standardized ophthalmic evaluations including best-corrected visual acuity (BCVA) measured according to the methods used in the Early Treatment Diabetic Retinopathy Study (BCVA), fluorescein angiography to measure area of fluorescein leakage (FLA) and optical coherence tomography (OCT) for the assessment of central subfield macular thickness (CSMT), were performed at baseline and at weeks 16 (± 2), 32 (± 2) and 48 (± 2).
Twenty-nine of 40 patients (n = 29 eyes) completed the 48-week study follow-up period. At baseline, mean ± SE FLA (mm(2)) was 9.0 ± 1.3 and 11.7 ± 1.3 (p = 0.1502); BCVA (logMAR) was 0.31 ± 0.05 and 0.27 ± 0.06 (p = 0.6645); and CSMT (μm) was 216.3 ± 10.7 and 249.4 ± 36.1 (p = 0.3925), in the PRP and PRPplus groups, respectively. There was a significant (p < 0.05) FLA reduction at all study visits in both groups, with the reduction observed in the PRPplus group significantly larger than that in the PRP group at week 48 (PRP = 2.9 ± 1.3 mm(2) ; PRPplus = 5.8 ± 1.3 mm(2) ; p = 0.0291). Best-corrected visual acuity worsening was observed at 16, 32 and 48 weeks after treatment in the PRP group (p < 0.05), while no significant BCVA changes were observed in the PRPplus group. A significant CSMT increase was observed in the PRP group at all study visits, while a significant decrease in CSMT was observed in the PRPplus group at week 16, and no significant difference in CSMT from baseline was observed at weeks 32 and 48.
Intravitreal ranibizumab after PRP was associated with a larger reduction in FLA at week 48 compared with PRP alone in eyes with high-risk PDR, and the adjunctive use of IVR appears to protect against the modest visual acuity loss and macular swelling observed in eyes treated with PRP alone.
评估全视网膜光凝术（PRP）与 PRP 联合玻璃体内注射 0.5mg 雷珠单抗（IVR）治疗高危增殖性糖尿病视网膜病变（PDR）患者的效果。
前瞻性研究纳入了无激光治疗史的高危 PDR 患者，随机分为接受 PRP（PRP 组）或 PRP 联合 IVR（PRPplus 组）的患者。PRP 在 0 周和 2 周时进行两次治疗，PRPplus 组在第一次激光治疗结束时给予 IVR。在基线时和第 16 周（±2 周）、32 周（±2 周）和 48 周（±2 周）进行标准化眼科评估，包括根据早期治疗糖尿病视网膜病变研究（ETDRS）中使用的方法测量最佳矫正视力（BCVA）、荧光素血管造影测量荧光素渗漏面积（FLA）和光学相干断层扫描（OCT）评估中央视网膜黄斑厚度（CSMT）。
40 例患者中的 29 例（n=29 只眼）完成了 48 周的研究随访。基线时，PRP 组和 PRPplus 组的平均±SE FLA（mm²）分别为 9.0±1.3 和 11.7±1.3（p=0.1502）；BCVA（logMAR）分别为 0.31±0.05 和 0.27±0.06（p=0.6645）；CSMT（μm）分别为 216.3±10.7 和 249.4±36.1（p=0.3925）。两组患者在所有研究访视中均观察到 FLA 显著减少（p<0.05），PRPplus 组在第 48 周时的 FLA 减少明显大于 PRP 组（PRP=2.9±1.3mm²；PRPplus=5.8±1.3mm²；p=0.0291）。PRP 组在治疗后 16、32 和 48 周时出现 BCVA 恶化（p<0.05），而 PRPplus 组未观察到 BCVA 显著变化。PRP 组在所有研究访视中均观察到 CSMT 显著增加，而 PRPplus 组在第 16 周时 CSMT 显著下降，在第 32 周和第 48 周时与基线相比 CSMT 无显著差异。
高危 PDR 患者接受 PRP 联合玻璃体内雷珠单抗治疗后，第 48 周时 FLA 减少较 PRP 单独治疗更明显，IVR 的辅助应用似乎可预防 PRP 单独治疗后出现的轻微视力丧失和黄斑肿胀。
