背景:非感染性眼内炎可能被误诊,导致严重的临床意义。到目前为止,其致病因素仍然未知。因此,这项研究评估了硅油和注射器搅动在玻璃体内注射阿柏西普后炎症发展中的作用。
方法:随机,双盲,对照临床试验包括在增殖性糖尿病视网膜病变行玻璃体切除术前接受玻璃体内抗血管生成治疗指征的受试者.手术前48小时注射阿柏西普。对照组接受无躁动的注射,而干预组通过用硅化或无硅油的注射器轻弹注射预先搅动的注射器。主要终点是48小时前房反应(ACR)的存在。收集水性样品并进行细胞计数珠阵列分析以定量白细胞介素和趋化因子。
结果:纳入41例个体(躁动组21例,无躁动组20例)。纳入的眼睛均未显示AC细胞的基线体征,充血或疼痛主诉,而对照组的10%和搅拌组的80%在用SR注射器注射阿柏西普后48小时显示AC细胞。所有细胞因子和趋化因子的平均变化根据搅动状态没有差异。然而,硅化的IP-10(p=0.057)和IL-8(p=0.058)的平均变化之间略有显着增加。
结论:该临床试验揭示了在玻璃体内注射阿柏西普后,躁动和硅化注射器在炎症发展中的潜在作用。这些发现对于进行玻璃体内注射的所有医疗保健从业人员具有重要的临床意义。
背景:巴西临床试验注册中心,RBR-95ddhp。2019年5月12日注册,http://www。ensaiosclinicos.govbr/rg/RBR-95ddhp/.
BACKGROUND: Noninfectious endophthalmitis may be misdiagnosed, leading to serious clinical implications. So far, its causative factors remain unknown. Therefore, this
study assessed the role of silicone oil and
syringe agitation in the development of inflammation after intravitreal injection of aflibercept.
METHODS: A randomized, double-blind, controlled clinical
trial included subjects with an indication of intravitreal antiangiogenic therapy prior to vitrectomy for proliferative diabetic retinopathy. Aflibercept was injected 48 h before surgery. The control group received the injection without agitation, while the intervention group was injected with a previously agitated
syringe by flicking with either a siliconized or silicone oil-free
syringe. The primary endpoint was the presence of anterior chamber reaction (ACR) at 48 h. Aqueous samples were collected and underwent cytometric bead array analysis for quantification of interleukins and chemokines.
RESULTS: Forty-one individuals were included (21 in the agitation group and 20 in the no-agitation group). None of the included eyes showed baseline signs of AC cells, hyperemia or pain complaint, while 10% of control group and 80% of agitation group showed AC cells 48 h after injection of aflibercept with SR syringe. There were no differences in the mean variations of all cytokines and chemokines by agitation status. However, there was a marginally significant increase between the mean variations of IP-10 (p = 0.057) and IL-8 (p = 0.058) in the siliconized one.
CONCLUSIONS: This clinical
trial discloses a potential role of agitation and siliconized syringes in the development of inflammation after an intravitreal injection of aflibercept. These findings have important clinical implications for all healthcare practitioners who perform intravitreal injections.
BACKGROUND: Brazilian Registry of Clinical Trials, RBR-95ddhp. Registered 12 May 2019, http://www.ensaiosclinicos.gov.br/rg/RBR-95ddhp/.