Remy M, Thaler S, Schumann R G, May C A, Fiedorowicz M, Schuettauf F, Grüterich M, Priglinger S G, Nentwich M M, Kampik A, Haritoglou C
Department of Ophthalmology, Ludwig-Maximilians-University, Mathildenstr. 8, 80336 Munich, Germany.
Br J Ophthalmol. 2008 Aug;92(8):1142-7. doi: 10.1136/bjo.2008.138164.
BACKGROUND/AIMS: To evaluate the retinal toxicity of Brilliant Blue G (BBG) following intravitreal injection in rat eyes and examine the biocompatibility and the staining properties in humans.
BBG was injected into the 11 rat eyes to evaluate toxic effects with balanced salt solution (BSS) serving as control. Retinal toxicity was assessed by retinal ganglion cell (RGC) counts and by light microscopy 7 days later. In addition, BBG was applied during vitrectomy for macular hole (MH) (n = 15) or epiretinal membranes (ERM) (n = 3) in a prospective, non-comparative consecutive series of patients. Before and after surgery, all patients underwent a complete clinical examination including measurement of best corrected visual acuity (VA) and intraocular pressure, perimetry, fundus photography and optical coherence tomography. Patients were seen 1 day before surgery and then in approximately four weeks intervals.
No significant reduction in RGC numbers and no morphological alterations were noted. A sufficient staining of the internal limiting membrane (ILM) was seen in patients with MH, while the staining pattern in ERM cases was patchy, indicating that parts of the ILM were peeled off along with the ERM in a variable extent. All MHs could be closed successfully. VA improved in 10 eyes (56%; 8/15 MH patients, 2/3 ERM patients), was unchanged in four eyes (22%; all MH patients) and was reduced in four eyes (22%; 3/15 MH, 1/3 ERM). No toxic effects attributable to the dye were noted during patient follow-up. The ultrastructure of tissue harvested during surgery was unremarkable.
Brilliant Blue provides a sufficient and selective staining of the ILM. No retinal toxicity or adverse effects related to the dye were observed in animal and human studies. The long-term safety of this novel dye will have to be evaluated in larger patient series and a longer follow-up.
背景/目的：评估玻璃体腔内注射亮蓝G（BBG）对大鼠眼视网膜的毒性，并检测其在人体中的生物相容性和染色特性。
将BBG注入11只大鼠眼以评估毒性作用，用平衡盐溶液（BSS）作为对照。7天后通过视网膜神经节细胞（RGC）计数和光学显微镜评估视网膜毒性。此外，在黄斑裂孔（MH）（n = 15）或视网膜前膜（ERM）（n = 3）玻璃体切除术期间，对一系列前瞻性、非对照连续患者应用BBG。手术前后，所有患者均接受全面的临床检查，包括测量最佳矫正视力（VA）和眼压、视野检查、眼底照相和光学相干断层扫描。患者在手术前1天就诊，然后大约每4周复诊一次。
未观察到RGC数量显著减少，也未发现形态学改变。在MH患者中可见内界膜（ILM）有充分的染色，而ERM病例中的染色模式呈片状，表明部分ILM在不同程度上与ERM一起被剥离。所有MH均成功封闭。10只眼（56%；8/15 MH患者，2/3 ERM患者）的VA改善，4只眼（22%；均为MH患者）的VA不变，4只眼（22%；3/15 MH，1/3 ERM）的VA降低。在患者随访期间未观察到与染料相关的毒性作用。手术中采集的组织超微结构无异常。
亮蓝对ILM有充分且选择性的染色。在动物和人体研究中未观察到与染料相关的视网膜毒性或不良反应。这种新型染料的长期安全性将需要在更大的患者系列中进行评估，并进行更长时间的随访。
