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玻璃体内注射的风险:一项全面综述。

Risks of intravitreous injection: a comprehensive review.

作者信息

Jager Rama D, Aiello Lloyd Paul, Patel Samir C, Cunningham Emmett T

机构信息

The Beetham Eye Institute, Joslin Diabetes Center and Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts, USA.

出版信息

Retina. 2004 Oct;24(5):676-98. doi: 10.1097/00006982-200410000-00002.

Abstract

PURPOSE

To evaluate the prevalence of the most common serious adverse events associated with intravitreous (IVT) injection.

METHODS

A systematic search of the literature via PubMed from 1966 to March 1, 2004, was conducted to identify studies evaluating the safety of IVT injection. Data submitted in New Drug Applications to the U.S. Food and Drug Administration for drugs administered into the vitreous were included where available. Serious adverse events reported in each study were recorded, and risk per eye and risk per injection were calculated for the following serious adverse events: endophthalmitis, retinal detachment, iritis/uveitis, intraocular hemorrhage, ocular hypertension, cataract, and hypotony. Rare complications also were noted.

RESULTS

Data from 14,866 IVT injections in 4,382 eyes were analyzed. There were 38 cases of endophthalmitis (including those reported as pseudoendophthalmitis) for a prevalence of 0.3% per injection and 0.9% per eye. Excluding cases reported specifically as pseudoendophthalmitis, the prevalence of endophthalmitis was 0.2% per injection and 0.5% per eye. Retinal detachment, iritis/uveitis, ocular hypertension, cataract, intraocular hemorrhage, and hypotony were generally associated with IVT injection of specific compounds and were infrequently attributed by the investigators to the injection procedure itself. Retinal vascular occlusions were described rarely in patients after IVT injection, and it was unclear in most cases whether these represented true injection-related complications or chance associations.

CONCLUSION

The risk of serious adverse events reported after IVT injection is low. Nevertheless, careful attention to injection technique and appropriate postinjection monitoring are essential because uncommon injection-related complications may be associated with permanent vision loss.

摘要

目的

评估与玻璃体内(IVT)注射相关的最常见严重不良事件的发生率。

方法

通过PubMed对1966年至2004年3月1日的文献进行系统检索,以确定评估IVT注射安全性的研究。如有可用数据,纳入向美国食品药品监督管理局提交的新药申请中有关玻璃体内给药药物的数据。记录每项研究中报告的严重不良事件,并计算以下严重不良事件的每只眼风险和每次注射风险:眼内炎、视网膜脱离、虹膜炎/葡萄膜炎、眼内出血、眼压升高、白内障和低眼压。还记录了罕见并发症。

结果

分析了4382只眼中14866次IVT注射的数据。有38例眼内炎(包括报告为假眼内炎的病例),每次注射的发生率为0.3%,每只眼为0.9%。排除专门报告为假眼内炎的病例后,眼内炎的发生率为每次注射0.2%,每只眼0.5%。视网膜脱离、虹膜炎/葡萄膜炎、眼压升高、白内障、眼内出血和低眼压通常与特定化合物的IVT注射有关,研究人员很少将其归因于注射操作本身。IVT注射后患者中很少描述视网膜血管阻塞,在大多数情况下尚不清楚这些是否代表真正的注射相关并发症或偶然关联。

结论

IVT注射后报告的严重不良事件风险较低。然而,由于不常见的注射相关并发症可能导致永久性视力丧失,因此必须仔细注意注射技术和适当的注射后监测。

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