地塞米松玻璃体内植入物Ozurdex可以安全地在手术室外使用吗?

IF 2.4
Journal of Drug Assessment Pub Date : 2020-03-31 eCollection Date: 2020-01-01 DOI:10.1080/21556660.2020.1742723
María Del Pino Cidad-Betegón, Félix Armadá-Maresca, Gloria Amorena-Santesteban, Javier Coca-Robinot, Oriana D'Anna-Mardero, Irene de la Rosa-Pérez, Beatriz Manzano-Muñoz, Jesús García-Martínez, Mónica Asencio-Durán, Gema Casado-Abad
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引用次数: 3

摘要

目的:描述在受控环境手术舱(CESC)中进行地塞米松玻璃体内(DEX)植入Ozurdex (Allergan, Dublin, Ireland)的标准化方案。方法:对2011年5月至2019年6月在某三级大学医院行DEX植入的患者进行回顾性观察研究。本研究使用的受控环境手术舱(ArcSterile, Imex, Valencia, Spain)为MB 20(宽2 m,深1.60 m,高2 m),采用不间断动力系统(ARSSAI1)使手术舱工作20分钟。舱室是在开放式模式下使用的。设计了一套规范的受控环境手术舱内玻璃体内注射方案。结果:2011年5月至2015年2月,共在手术室植入了454个DEX植入物,2015年3月至2019年6月,使用CESC植入了1054个DEX植入物。手术室内DEX植入物平均数量/每周明显低于CESC[2.3(2.1至2.5)vs 3.8(3.6至4.1),平均差异1.5(1.2至1.8),p结论:CESC可能是传统手术室玻璃体内DEX植入物的良好替代方案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Can the dexamethasone intravitreal implant Ozurdex be safely administered in an out-of-operating room setting?

Can the dexamethasone intravitreal implant Ozurdex be safely administered in an out-of-operating room setting?

Purpose: To describe a standardized protocol of the dexamethasone intravitreal (DEX) implant Ozurdex (Allergan, Dublin, Ireland) performed in a controlled environment surgical cabin (CESC). Methods: Retrospective and observational study conducted on patients who underwent a DEX implant between May 2011 and June 2019, in a third level University Hospital. The controlled environment surgical cabin (ArcSterile, Imex, Valencia, Spain) used in this study was the MB 20 (2 m width, 1.60 m depth, and 2 m height) with an uninterrupted power system (ARSSAI1) to keep the cabin working for 20 min. The cabin was used in the open mode. A standardized protocol of intravitreal injections in controlled environment surgical cabin was designed. Results: From May 2011 to February 2015, a total of 454 DEX implants were performed in the operating room, whereas from March 2015 to June 2019, 1054 DEX devices were implanted using the CESC. The mean number of DEX implants/per week was significantly lower in the operating room than in the CESC [2.3 (2.1 to 2.5) versus 3.8 (3.6 to 4.1), mean difference 1.5 (1.2 to 1.8), p < 0.0001]. The incidence of endophthalmitis was similar in the two populations, 0/454 (0.0%; 95% CI 0.0 to 0.81%) and 0/1054 (0.0%; 95% CI 0.0 to 0.35%) in the operating room and in the CESC, respectively. Conclusions: The CESC may be a good alternative to the conventional operating room for the administration of the intravitreal DEX implant.

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来源期刊
Journal of Drug Assessment
Journal of Drug Assessment PHARMACOLOGY & PHARMACY-
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