Mid Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.
Massachusetts Eye and Ear Infirmary, Harvard Medical School, Boston, Massachusetts, USA.
Am J Ophthalmol. 2019 Mar;199:200-208. doi: 10.1016/j.ajo.2018.11.023. Epub 2018 Dec 13.
To compare the rates of infectious endophthalmitis following intravitreal injection of ranibizumab using prefilled syringes vs conventional preparation.
Multicenter retrospective cohort study.
All eyes receiving intravitreal injection of 0.5 mg ranibizumab for retinal vascular diseases at 10 retina practices across the United States (2016 to 2017) and Japan (2009 to 2017) were included. The total numbers of eyes and injections were determined from billing codes. Endophthalmitis cases were determined from billing records and evaluated with chart review. Primary outcome was the rate of postinjection acute endophthalmitis. Secondary outcomes were visual acuity and microbial spectrum.
A total of 243 754 intravitreal 0.5 mg ranibizumab injections (165 347 conventional and 78 407 prefilled) were administered to 43 132 unique patients during the study period. In the conventional ranibizumab group, a total of 43 cases of suspected endophthalmitis occurred (0.026%; 1 in 3845 injections) and 22 cases of culture-positive endophthalmitis occurred (0.013%; 1 in 7516 injections). In the prefilled ranibizumab group, 12 cases of suspected endophthalmitis occurred (0.015%; 1 in 6534 injections) and 2 cases of culture-positive endophthalmitis occurred (0.0026%; 1 in 39 204 injections). Prefilled syringes were associated with a trend toward decreased risk of suspected endophthalmitis (odds ratio 0.59; 95% confidence interval 0.31-1.12; P = .10) and a statistically significant decreased risk of culture-positive endophthalmitis (odds ratio 0.19; 95% confidence interval 0.045-0.82; P = .025). Average logMAR vision loss at final follow-up was significantly worse for eyes that developed endophthalmitis from the conventional ranibizumab preparation compared to the prefilled syringe group (4.45 lines lost from baseline acuity vs 0.38 lines lost; P = .0062). Oral-associated flora was found in 27.3% (6/22) of conventional ranibizumab culture-positive endophthalmitis cases (3 cases of Streptococcus viridans, 3 cases of Enterococcus faecalis) compared to 0 cases in the prefilled ranibizumab group.
In a large, multicenter, retrospective study the use of prefilled syringes during intravitreal injection of ranibizumab was associated with a reduced rate of culture-positive endophthalmitis, including from oral flora, as well as with improved visual acuity outcomes.
比较使用预装注射器与传统制备方法行玻璃体内注射雷珠单抗后发生感染性眼内炎的比率。
多中心回顾性队列研究。
纳入在美国（2016 年至 2017 年）和日本（2009 年至 2017 年）10 个视网膜实践中心接受玻璃体内注射 0.5mg 雷珠单抗治疗视网膜血管疾病的所有患者（共 243754 只眼和 243754 次注射）。根据计费代码确定眼数和注射次数。根据计费记录确定眼内炎病例，并通过图表审查进行评估。主要结局是注射后急性眼内炎的发生率。次要结局是视力和微生物谱。
在研究期间，共有 43132 名患者接受了 165347 次传统雷珠单抗和 78407 次预装注射器的玻璃体内 0.5mg 雷珠单抗注射。在传统雷珠单抗组中，共发生 43 例疑似眼内炎（0.026%；1/3845 次注射）和 22 例培养阳性眼内炎（0.013%；1/7516 次注射）。在预装雷珠单抗组中，发生 12 例疑似眼内炎（0.015%；1/6534 次注射）和 2 例培养阳性眼内炎（0.0026%；1/39204 次注射）。预装注射器与疑似眼内炎风险降低趋势相关（比值比 0.59；95%置信区间 0.31-1.12；P=0.10），且与培养阳性眼内炎风险显著降低相关（比值比 0.19；95%置信区间 0.045-0.82；P=0.025）。与预装注射器组相比，来自传统雷珠单抗制剂的眼内炎患者的最终随访时平均对数视力损失明显更差（从基线视力损失 4.45 行 vs 0.38 行；P=0.0062）。在传统雷珠单抗培养阳性眼内炎病例中，发现与口腔相关的菌群占 27.3%（22 例中的 6 例）（3 例草绿色链球菌，3 例粪肠球菌），而预装雷珠单抗组中无此类情况。
在一项大型、多中心、回顾性研究中，在玻璃体内注射雷珠单抗时使用预装注射器可降低培养阳性眼内炎的发生率，包括来自口腔菌群的眼内炎，同时改善视力结局。
