Kandarakis Stylianos, Kontaxakis Anastasios, Doumazos Leonidas, Petrou Petros, Droutsas Konstantinos, Papaconstantinou Demetrios, Georgalas Ilias
Department of Ophthalmology, National and Kapodistrian University of Athens, 1st University Eye Clinic, G. Gennimatas General Hospital, Athens, Greece.
Cutan Ocul Toxicol. 2022 Mar;41(1):25-32. doi: 10.1080/15569527.2021.2003376. Epub 2022 Jan 25.
The aim of this study was to determine whether glaucoma patients after trabeculectomy could benefit more from subconjunctival injections of bevacizumab than 5-FU or placebo.
Fifty-one eyes of 51 patients were recruited for primary MMC (0.2 mg/mL for 1 min) augmented trabeculectomy. 17 patients were randomly assigned to receive 1.25 mg (0.05 mL) of bevacizumab augmentation, 21 patients were assigned to receive 0.1 mL of 50 mg/mL 5-FU and 13 patients were assigned to a control group receiving a normal saline injection as a placebo. Initial recruitment included 58 patients, but seven patients had to be excluded from the study for various reasons. Postoperative follow up of IOP and bleb characteristics was carried out at 1 day, 1 week, 3 weeks, 6 weeks, 6 months and 1 year after surgery. All analyses where carried out by two masked clinicians. IOP reduction was statistically significant ( < 0.05) across all three groups between baseline visit and final 1-year postoperative visit. There was no significant difference of the final average IOP values between the three groups. Bleb evaluation was made using the Moorfields bleb grading system (MBGS) after 1 year follow up. Central bleb area was statistically greater in the Bevacizumab group when compared with the 5-FU group but not with the placebo group. The vascularity of the central bleb was significantly different between the groups with the Bevacizumab group showing the least vascularity. Vascularity of the peripheral bleb was also decreased in the Bevacizumab group when compared with the placebo group but not with the 5-FU group.
The 12-month IOP results showed no significant differences between the groups of patients after Bevacizumab, 5-FU or placebo to augment primary MMC enhanced trabeculectomy. However, by the analysis of bleb morphology there was a significant difference in terms of central bleb area and vascularity.
本研究旨在确定小梁切除术后的青光眼患者结膜下注射贝伐单抗是否比5-氟尿嘧啶或安慰剂获益更多。
51例患者的51只眼接受了原发性丝裂霉素C（0.2mg/mL，持续1分钟）强化小梁切除术。17例患者被随机分配接受1.25mg（0.05mL）贝伐单抗强化治疗，21例患者被分配接受0.1mL 50mg/mL的5-氟尿嘧啶治疗，13例患者被分配至对照组接受生理盐水注射作为安慰剂。最初纳入58例患者，但7例患者因各种原因不得不被排除在研究之外。术后在术后1天、1周、3周、6周、6个月和1年对眼压和滤过泡特征进行随访。所有分析均由两名盲法临床医生进行。在基线访视和术后1年最终访视之间，所有三组患者的眼压降低均具有统计学意义（P<0.05）。三组最终平均眼压值无显著差异。随访1年后，使用 Moorfields滤过泡分级系统（MBGS）进行滤过泡评估。与5-氟尿嘧啶组相比，贝伐单抗组中央滤过泡面积在统计学上更大，但与安慰剂组相比无差异。中央滤过泡的血管化程度在各组之间有显著差异，贝伐单抗组的血管化程度最低。与安慰剂组相比，贝伐单抗组周边滤过泡的血管化程度也降低，但与5-氟尿嘧啶组相比无差异。
12个月的眼压结果显示，在原发性丝裂霉素C强化小梁切除术中，接受贝伐单抗、5-氟尿嘧啶或安慰剂强化治疗的患者组之间无显著差异。然而，通过对滤过泡形态的分析，在中央滤过泡面积和血管化程度方面存在显著差异。
