新型预灌封注射器阿弗利百普设计。阿弗利贝赛 PFS 后无症状眼压飙升的原因?

Irene Loscos-Giménez, Daniela Rego-Lorca, Francisca Bassaganyas-Vilarrasa, Jaume Crespí-Vilimelis, Jesús Díaz-Cascajosa, José Ignacio Vela Segarra
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引用次数: 0

摘要

目的描述使用新型 aflibercept 预灌封注射器后出现的眼压升高病例,并评估这些眼睛的主要特征及其与眼压(IOP)变化可能存在的关联:方法:病例系列。方法:病例系列。我们报告了 2021 年 4 月至 2023 年 12 月期间我科使用阿弗利百普预充注射器(PFS)治疗后的所有眼压升高病例:结果:共有 4183 只眼睛接受了阿弗利百普预充注射器治疗。注射后立即观察到 13 例暂时性眼压升高(0.3%)。两只眼的眼压在 30-35 mmHg 之间,五只眼的眼压在 36-55 mmHg 之间,三只眼的眼压大于 56 mmHg。平均眼压为 45.5 mmHg±11.33。只有六只眼睛需要进行前房旁路穿刺(37.5%)。其他患者均接受了保守治疗(眼部按摩和/或降眼压药水)。治疗后的平均眼压为 15.71 mmHg±7.20。讨论:讨论:与其他注射剂相比,有报告显示使用阿弗利百普(aflibercept PSF)时,中度和重度眼压峰值的发生率较高。欧洲药品管理局(EMA)认为,眼压的显著升高与注射器操作不当导致注射量增大有关。虽然柱塞错位似乎是造成眼压骤升的原因之一,但这种新型注射器的其他一些特性也可能起作用。注射器直径、柱塞对准和注射力等因素都可能导致这一问题。一些作者发现,静脉注射后眼压升高与阿弗利百普的PFS无明显差异,其原因可能是患者的特征存在差异,而这些特征也可能在静脉注射后的眼压变化中发挥重要作用:结论:aflibercept PFS后的眼压峰值可以用注射器的特性来解释。aflibercept的PFS有一个圆顶柱塞。柱塞底部与黑色剂量线之间的对齐不正确可能会导致注射量增加。此外,aflibercept PFS 较宽的注射器直径可能意味着较大的注射力,增加了眼压升高的风险。患者的特征,如既往的 VPP、轴向长度或青光眼病史,也可能是影响因素之一。要开发出理想的玻璃体内注射器,还需要进一步的研究。
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New prefilled syringe aflibercept design. A cause of symptomatic IOP spike after aflibercept PFS?

Objective: To describe ocular hypertension cases after using a new aflibercept prefilled syringe and to assess the main characteristics of these eyes and their possible association with intraocular pressure (IOP) changes.

Methods: Case series. We reported all the cases of ocular hypertension following aflibercept prefilled syringes (PFS) treatment in our department between April 2021 and December 2023.

Results: A total of 4183 eyes were treated with aflibercept PSF. Thirteen transitory IOP elevations were observed immediately after injection (0.3%). Two eyes had an IOP between 30-35 mmHg, five eyes had an IOP between 36-55 mmHg and three eyes had an IOP > 56 mmHg. The mean IOP was 45.5 mmHg±11.33. Only six eyes needed anterior chamber paracentesis (37.5%). The other patients were treated conservatively (ocular massage and/or IOP-lowering drops). The mean IOP after treatment was 15.71 mmHg±7.20. Visual acuity improved after treatment in all the patients.

Discussion: Compared with other injectors, reports have indicated a higher incidence of moderate and severe IOP spikes with aflibercept PSF. The European Medicine Agency (EMA) has associated this significant increase with incorrect syringe handling, leading to higher injection volumes. Although plunger misalignment seems to play a role in the IOP spikes, some other characteristics of this new injector could play a role. Factors such as syringe diameter, plunger alignment, and injection force may contribute to this issue. The reason some authors found no significant differences in IOP elevation after IVI, with aflibercept PFS, could be due to variations in patient characteristics, which may also play an important role in post-IVI pressure changes.

Conclusions: Intraocular pressure spikes after aflibercept PFS can be explained by injector characteristics. The PFS of aflibercept has a domed plunger. Incorrect alignment between the base of the plunger and the black dosing line could cause an increase in the injected volume. Furthermore, the wider syringe diameter of aflibercept PFS could imply a larger injection force, increasing the risk of IOP elevation. Patient characteristics, such as previous VPP, axial length, or glaucoma history, may also play a role. Further studies are required to develop an ideal intravitreal syringe.

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