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雷珠单抗玻璃体腔内注射给药系统的 refill-exchange 操作流程:概述和临床试验经验。

Refill-Exchange Procedure of the Port Delivery System With Ranibizumab: Overview and Clinical Trial Experience.

出版信息

Ophthalmic Surg Lasers Imaging Retina. 2022 May;53(5):257-265. doi: 10.3928/23258160-20220412-01. Epub 2022 May 1.

DOI:10.3928/23258160-20220412-01
PMID:35575741
Abstract

PURPOSE

To describe the Port Delivery System with ranibizumab refill-exchange procedure.

METHODS

Procedure based on the clinical trial program in patients with retinal diseases.

RESULTS

The refill-exchange procedure is performed under topical anesthesia and strict aseptic conditions. Supplemental task lighting and magnification are recommended throughout the procedure. Ranibizumab is aseptically transferred from the vial with the filter needle and air is removed from the syringe. The filter needle is then replaced with the refill needle; any remaining air is removed from the syringe and the plunger is advanced to the 0.1-mL mark. Targeting the implant septum center, the refill needle is inserted perpendicularly to the globe until the soft stop contacts the conjunctiva (perpendicular orientation and conjunctival contact are maintained throughout the procedure); a cotton-tipped applicator is recommended for globe stabilization. The entire syringe contents are slowly injected over 5-10 seconds while existing solution fills the fluid collection reservoir. Once completed, the needle is carefully withdrawn while maintaining perpendicularity. The procedure can be successfully performed in rare, specific cases, including subconjunctival thickening or fibrous capsule formation, fluid-filled bleb formation, and corneal patch grafts.

CONCLUSION

The procedure is straightforward but distinct from intravitreal injections and requires adherence to standardized techniques. With appropriate preparation, the procedure can be performed in specific cases. .

摘要

目的

描述雷珠单抗补充装-交换程序的端口输送系统。

方法

基于视网膜疾病患者临床试验方案的程序。

结果

补充装-交换程序在局部麻醉和严格无菌条件下进行。建议在整个过程中使用补充任务照明和放大。雷珠单抗用带过滤器的针头从小瓶中无菌转移,将空气从注射器中抽出。然后用补充装针头替换过滤器针头;将注射器中剩余的空气抽出,将柱塞推进到 0.1 毫升标记处。将补充装针头垂直插入眼球,瞄准植入物隔中心,直到软止动器接触结膜(整个过程中保持垂直方向和结膜接触);建议使用棉签稳定眼球。将整个注射器内容物缓慢注入 5-10 秒,同时现有的溶液充满液体收集储液器。完成后,在保持垂直的同时小心地拔出针头。该程序可以在罕见的特定情况下成功进行,包括结膜下增厚或纤维囊形成、充满液体的滤泡形成和角膜贴片移植。

结论

该程序简单直接,但与玻璃体内注射不同,需要遵守标准化技术。经过适当的准备,该程序可以在特定情况下进行。

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