Hasler Pascal W, Bloch Sara Brandi, Villumsen Jørgen, Fuchs Josefine, Lund-Andersen Henrik, Larsen Michael
Department of Ophthalmology, University Hospital Basel, Basel, Switzerland.
Acta Ophthalmol. 2015 Mar;93(2):122-5. doi: 10.1111/aos.12589. Epub 2014 Nov 17.
To evaluate and to compare the safety of intravitreal ranibizumab injections performed by physicians and nurses at a single large hospital clinic in Denmark during 5 years.
Retrospective, interventional, non-comparative study.
All eyes that underwent a protocolized ranibizumab injection procedure performed in an operating room mainly by nurses and physicians in their first year of ophthalmology training.
A total of 4623 eyes in 3679 patients with subretinal neovascularization secondary to a variety of retinal diseases, mainly neovascular AMD treated with intravitreal therapy (IVT) at the Glostrup Hospital from January 1, 2007 to December 31, 2011 with a mean follow-up of 12.2 months (95% confidence interval: 11.9-12.6).
Frequency of endophthalmitis, traumatic cataract, intraocular haemorrhage and retinal detachment from 2007 to 2012.
Overall, 38,503 intravitreal ranibizumab injections were performed in 4623 eyes. Injections were performed by nurses (32.5%), ophthalmology residents (61.3%) and vitreoretinal surgeons (6.2%). Severe complications to treatment were observed in 17 eyes: Endophthalmitis (14 eyes, 0.36 ‰ of injections whereof seven cases were culture-positive), anterior uveitis (one eye, 0.026 ‰), traumatic cataract (one eye, 0.026 ‰) and rhegmatogenous retinal detachment (one eye, 0.026 ‰). Retinal pigment epithelial tears were registered in 14 eyes in 14 subjects within the first year of treatment with ranibizumab. Of the 14 cases of endophthalmitis, seven occurred within a period of 5 weeks in 2010 when occasionally abnormal needle outflow resistance prompted the needle replacement in the operating room. No drug-related adverse events were recorded.
Intravitreal ranibizumab injection performed by nurses and physicians without preinjection topical antibiotics was associated with a rate of injection-related adverse events of 0.44 ‰.
评估并比较丹麦一家大型医院诊所的医生和护士在5年期间进行玻璃体内注射雷珠单抗的安全性。
回顾性、干预性、非对比研究。
所有接受标准化雷珠单抗注射程序的眼睛，该程序主要由护士和处于眼科培训第一年的医生在手术室进行。
2007年1月1日至2011年12月31日期间，格洛斯楚普医院共有3679例患有各种视网膜疾病继发的视网膜下新生血管的患者的4623只眼睛接受了玻璃体内治疗（IVT），主要治疗新生血管性年龄相关性黄斑变性，平均随访12.2个月（95%置信区间：11.9 - 12.6）。
2007年至2012年眼内炎、外伤性白内障、眼内出血和视网膜脱离的发生率。
总体而言，4623只眼睛共进行了38503次玻璃体内雷珠单抗注射。注射由护士（32.5%）、眼科住院医师（61.3%）和玻璃体视网膜外科医生（6.2%）进行。观察到17只眼睛出现严重治疗并发症：眼内炎（14只眼睛，占注射次数的0.36‰，其中7例培养阳性）、前葡萄膜炎（1只眼睛，0.026‰）、外伤性白内障（1只眼睛，0.026‰）和孔源性视网膜脱离（1只眼睛，0.026‰）。在接受雷珠单抗治疗的第一年，14名受试者的14只眼睛出现视网膜色素上皮撕裂。在14例眼内炎病例中，7例发生在2010年的5周内，当时手术室偶尔出现异常的针流出阻力促使更换针头。未记录与药物相关的不良事件。
护士和医生在未进行注射前局部使用抗生素的情况下进行玻璃体内雷珠单抗注射，与注射相关不良事件发生率为0.44‰相关。
