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患者报告的玻璃体腔内注射后并发症及其预测因素。

Patient-Reported Complications after Intravitreal Injection and Their Predictive Factors.

机构信息

Cole Eye Institute, Cleveland Clinic Foundation, Cleveland, Ohio.

Emory Eye Center, Department of Ophthalmology, Emory University, Atlanta, Georgia.

出版信息

Ophthalmol Retina. 2021 Jul;5(7):625-632. doi: 10.1016/j.oret.2020.09.024. Epub 2020 Oct 12.

Abstract

PURPOSE

The intravitreal injection (IVI) of pharmacologic agents is the most commonly performed ocular procedure and is associated with a host of complications. Most IVI-related complications data are derived from randomized controlled clinical trials, which report a high adverse event rate. The nature of these protocol-driven trials limit their applicability to the diverse circumstances seen in routine clinical practice. The goal of this study was to determine the prevalence of patient-reported IVI-related complications, their risk factors, and the manner in which patients sought treatment at a tertiary eye care center.

DESIGN

Retrospective, institutional review board-approved study.

PARTICIPANTS

Forty-four thousand seven hundred thirty-four injections in 5318 unique patients at the Cleveland Clinic Cole Eye Institute from 2012 through 2016.

METHODS

Intravitreal injection.

MAIN OUTCOME MEASURES

Complication occurrence within 15 days of injection.

RESULTS

From 2012 through 2016, a total of 44734 injections were performed in 5318 unique patients. Overall, complication rates were low, representing 1.9% of all injections, with 1031 unique complications in 685 patients (12.9%). The most common minor complications, or those not requiring intervention, were irritation (n = 312) and subconjunctival hemorrhage (n = 284). The most common serious complications, or those requiring intervention, were corneal abrasion (n = 46) and iritis (n = 31). Most complications (66%) were managed adequately by a telephone or Epic (Epic Systems Corp., Verona, WI) electronic message encounter only. Importantly, no injection protocol parameter, such as type of anesthesia, preparation, or post-injection medication, increased the risk of a complication. However, a patient's gender, age, number of previous injections, and provider strongly influenced the risk of patient-reported complications.

CONCLUSIONS

Overall, complication rates seen in routine clinical practice were low compared with clinical trial reporting. Providers should feel confident in the safety and administration of IVI during times when follow-up office visits and resources may be limited. When performing an IVI, factors such as a patient's gender, age, number of previous injections, and provider must be taken into account to ensure the best possible outcomes.

摘要

目的

玻璃体内注射(IVI)是最常进行的眼部手术,与许多并发症有关。大多数与 IVI 相关的并发症数据均来自随机对照临床试验,这些试验报告的不良事件发生率较高。这些基于方案的试验的性质限制了其在常规临床实践中所见的各种情况下的适用性。本研究的目的是确定在三级眼科护理中心患者报告的 IVI 相关并发症的发生率、其危险因素以及患者寻求治疗的方式。

设计

回顾性,机构审查委员会批准的研究。

参与者

2012 年至 2016 年,克利夫兰诊所科尔眼研究所的 5318 位独特患者共进行了 44734 次注射。

方法

玻璃体内注射。

主要观察指标

注射后 15 天内发生的并发症。

结果

2012 年至 2016 年,5318 位独特患者共进行了 44734 次注射。总体而言,并发症发生率较低,占所有注射的 1.9%,685 位患者中有 1031 次出现并发症(12.9%)。最常见的轻微并发症(即无需干预的并发症)为刺激(312 次)和结膜下出血(284 次)。最常见的严重并发症(即需要干预的并发症)为角膜擦伤(46 次)和虹膜炎(31 次)。大多数并发症(66%)仅通过电话或 Epic(Epic Systems Corp., Verona,WI)电子消息即可妥善处理。重要的是,没有任何注射方案参数(如麻醉类型、准备情况或注射后药物)增加并发症的风险。但是,患者的性别、年龄、既往注射次数和医生强烈影响了患者报告的并发症风险。

结论

与临床试验报告相比,在常规临床实践中观察到的总体并发症发生率较低。在可能需要限制随访就诊和资源的情况下,医生应该对 IVI 的安全性和管理有信心。在进行 IVI 时,必须考虑患者的性别、年龄、既往注射次数和医生等因素,以确保获得最佳的治疗效果。

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