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
{"title":"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?","authors":"María Del Pino Cidad-Betegón,&nbsp;Félix Armadá-Maresca,&nbsp;Gloria Amorena-Santesteban,&nbsp;Javier Coca-Robinot,&nbsp;Oriana D'Anna-Mardero,&nbsp;Irene de la Rosa-Pérez,&nbsp;Beatriz Manzano-Muñoz,&nbsp;Jesús García-Martínez,&nbsp;Mónica Asencio-Durán,&nbsp;Gema Casado-Abad","doi":"10.1080/21556660.2020.1742723","DOIUrl":null,"url":null,"abstract":"<p><p><b>Purpose:</b> To describe a standardized protocol of the dexamethasone intravitreal (DEX) implant Ozurdex (Allergan, Dublin, Ireland) performed in a controlled environment surgical cabin (CESC). <b>Methods:</b> 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. <b>Results:</b> 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), <i>p</i> < 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. <b>Conclusions:</b> The CESC may be a good alternative to the conventional operating room for the administration of the intravitreal DEX implant.</p>","PeriodicalId":15631,"journal":{"name":"Journal of Drug Assessment","volume":"9 1","pages":"66-71"},"PeriodicalIF":2.4000,"publicationDate":"2020-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21556660.2020.1742723","citationCount":"3","resultStr":"{\"title\":\"Can the dexamethasone intravitreal implant Ozurdex be safely administered in an out-of-operating room setting?\",\"authors\":\"María Del Pino Cidad-Betegón,&nbsp;Félix Armadá-Maresca,&nbsp;Gloria Amorena-Santesteban,&nbsp;Javier Coca-Robinot,&nbsp;Oriana D'Anna-Mardero,&nbsp;Irene de la Rosa-Pérez,&nbsp;Beatriz Manzano-Muñoz,&nbsp;Jesús García-Martínez,&nbsp;Mónica Asencio-Durán,&nbsp;Gema Casado-Abad\",\"doi\":\"10.1080/21556660.2020.1742723\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b>Purpose:</b> To describe a standardized protocol of the dexamethasone intravitreal (DEX) implant Ozurdex (Allergan, Dublin, Ireland) performed in a controlled environment surgical cabin (CESC). <b>Methods:</b> 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. <b>Results:</b> 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), <i>p</i> < 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. <b>Conclusions:</b> The CESC may be a good alternative to the conventional operating room for the administration of the intravitreal DEX implant.</p>\",\"PeriodicalId\":15631,\"journal\":{\"name\":\"Journal of Drug Assessment\",\"volume\":\"9 1\",\"pages\":\"66-71\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2020-03-31\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.1080/21556660.2020.1742723\",\"citationCount\":\"3\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Drug Assessment\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1080/21556660.2020.1742723\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2020/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Drug Assessment","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1080/21556660.2020.1742723","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2020/1/1 0:00:00","PubModel":"eCollection","JCR":"","JCRName":"","Score":null,"Total":0}
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。

摘要图片

查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
Journal of Drug Assessment
Journal of Drug Assessment PHARMACOLOGY & PHARMACY-
自引率
0.00%
发文量
0
审稿时长
8 weeks
期刊最新文献
Treatment and comorbidity burden among people living with HIV: a review of systematic literature reviews. Investigation of potential substandard dry powder inhalers on EU and North African markets - evaluation of the delivered and fine particle doses. Real world evidence study on treatment patterns and health resource utilization in patients with HR+/HER2- locally advanced or metastatic breast cancer in Korea. A review of the risks of long-term consequences associated with components of the CHOP chemotherapy regimen. Real-world experience of ocrelizumab in multiple sclerosis in an Arab population.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1