背景:黄斑水肿(ME)是视网膜分支静脉阻塞(BRVO)后的常见并发症,也是视觉障碍的主要原因。本研究旨在比较玻璃体内雷珠单抗(IVR)或地塞米松植入(IDI)单一疗法的疗效和安全性,以及IVR和IDI注射的组合,继发于视网膜分支静脉阻塞(BRVO)的ME患者。
方法:这个多中心,prospective,比较研究包括292例继发于BRVO的单侧ME受累患者(共292只眼).将患者随机分为3组,随访12个月。第1组患者(n=96)接受3剂量负荷IVR注射,然后进行prorenata(PRN)方案治疗。第2组患者(n=98)接受IVR联合IDI注射,其次是IVRPRN方案。第3组患者(n=98)接受IDI注射液治疗,然后根据临床需要反复注射IDI。最佳矫正视力(BCVA),中央视网膜厚度(CRT),并发症,记录并比较三组之间的注射频率。
结果:在基线时,三组的年龄没有差异,性别,我的持续时间,BCVA,IOP,和CRT(P>0.05)。12个月内每只眼睛的平均总注射次数在第1组中为7.1±2.3(范围4-9),在第2组中为3.7±1.5(范围2-6),在第3组中为1.8±0.4(范围1-3)。第1组和第2组之间的注射次数有统计学差异(P=0.037)。第3组的眼睛接受的注射少于第2组,但差异无统计学意义(P=0.052)。所有组均实现了BCVA改善和CRT减少,在第12个月末,三组之间没有显着差异。然而,在第3组中,IOP升高和白内障进展更为频繁,尤其是在那些接受重复IDI注射的患者中。
结论:三种治疗方案对BRVO继发ME的疗效相当。联合治疗在保持较好的疗效方面具有优势,重复注射和并发症较少。
■这项研究符合《赫尔辛基宣言》的原则,并获得西安爱尔古城眼科医院的批准,西安爱尔眼科医院,和咸阳爱尔眼科医院伦理委员会(2022SF-367)。
BACKGROUND: Macular edema (ME) is a common complication following branch retinal vein occlusion (BRVO) and is also the main reason for visual impairment. This
study aimed to compare the efficacy and safety of intravitreal ranibizumab (IVR) or dexamethasone implant (IDI) monotherapy, as well as the combination of IVR and IDI injections, in patients with ME secondary to branch retinal vein occlusion (BRVO).
METHODS: This multicenter, prospective, and comparative
study included 292 patients with unilateral ME involvement (total of 292 eyes) secondary to BRVO. The patients were randomly assigned to three groups and followed up for 12 months. Patients in group 1 (n = 96) were treated with 3-dose loading IVR injections followed by a pro re nata (PRN) regimen. Patients in group 2 (n = 98) received IVR combined with IDI injection, followed by IVR PRN regimen. Patients in group 3 (n = 98) were treated with IDI injection, followed by repeated IDI injection based on clinical necessity. Best corrected visual acuity (BCVA), central retinal thickness (CRT), complications, and frequency of injections were recorded and compared between the three groups.
RESULTS: At baseline, the three groups did not differ in age, gender, duration of ME, BCVA, IOP, and CRT (P > 0.05). Mean number of total injections per eye within 12 months were 7.1 ± 2.3 (range 4-9) in group 1, 3.7 ± 1.5 (range 2-6) in group 2, and 1.8 ± 0.4 (range 1-3) in group 3. There was a statistical difference in the number of injections between group 1 and group 2 (P = 0.037). Eyes in group 3 received fewer injections than those in group 2, but the difference was not statistically significant (P = 0.052). BCVA improvement and CRT reduction were achieved in all groups and there was no significant difference between the three groups at the end of the 12th month. However, IOP elevation and cataract progression were more frequent in group 3, especially in those patients who received repeated IDI injections.
CONCLUSIONS: Three therapeutic regimens had comparable efficacy in treating ME secondary to BRVO. Combination therapy had an advantage in maintaining good effect with fewer re-injections and complications.
UNASSIGNED: The
study complied with the principles of the Declaration of Helsinki and was approved by Xi\'an Aier Ancient City Eye Hospital, Xi\'an Aier Eye Hospital, and Xianyang Aier Eye Hospital ethics committees (2022SF-367).