PDF(Pubmed)
Abstract：
BACKGROUND: Anti-vascular endothelial growth factor (VEGF) agents have been the standard treatment for retinal diseases for almost two decades. These treatments are administered via intravitreal injection using single-use vials or prefilled syringes (PFS). In this systematic review, we evaluate health care resource use and clinical outcomes and experiences with PFS for intravitreal injection of anti-VEGF treatments.
METHODS: MEDLINE, EMBASE, and The Cochrane Library were searched from January 1, 2015 to February 8, 2024 to identify literature reporting outcomes regarding procedural efficiency, health care resource use, patient and clinician experiences, and safety for currently approved anti-VEGFs (ranibizumab, aflibercept, brolucizumab) administered using PFS. Comparators were vial-based injections of the same anti-VEGFs.
RESULTS: A total of 36 publications met the criteria for inclusion in the systematic literature review; the majority were non-randomized studies, with a small number of reviews, case series, survey studies, and opinion articles. Publications reported that preparation times were significantly shorter for PFS (40.3-57.9 s) versus vials (ranibizumab, 62.8-98.0 s; aflibercept, 71.9-79.5 s), with no differences in product stability between PFS and vials. Clinicians expressed a preference for PFS and thought PFS were faster, easier to use, and had increased safety versus vials. Publications consistently reported significantly lower rates of endophthalmitis per injection with PFS versus vials (ranibizumab PFS, 0-0.02%; aflibercept PFS, 0.01-0.02%; ranibizumab vial, 0.02-0.05%; aflibercept vial, 0.02-0.06%). Four publications reported increased rates of transient vision loss after aflibercept PFS injection versus vial-based injection. No publications reported outcomes regarding health care resource use or patient experiences.
CONCLUSIONS: The available literature supports the increased procedural efficiency of PFS versus vial-based intravitreal injection of anti-VEGFs. PFS are positively perceived by clinicians and have a safety benefit in the form of a decreased risk of endophthalmitis versus vials.
Anti-vascular endothelial growth factor (VEGF) drugs, given by injection into the eye, are commonly used to treat diseases that affect the back of the eye (the retina). Anti-VEGF drugs are provided in small containers (vials) or in syringes that are already filled with the drug (prefilled syringes). When someone is treated with an anti-VEGF drug from a vial, the drug must first be taken from the vial using a needle and syringe, and then injected. When someone is treated with an anti-VEGF drug from a prefilled syringe, the drug is injected directly from the prefilled syringe, i.e., there are fewer steps involved when a prefilled syringe is used. We searched the medical literature to see if there were differences in clinical outcomes and experiences between prefilled syringes and vials when used to inject anti-VEGF drugs. Clinicians spent about 50% less time getting ready for injections when prefilled syringes were used than when vials were used. Clinicians also preferred to use prefilled syringes than vials for injecting anti-VEGF drugs. Clinicians reported that prefilled syringes were easier to use, faster, and safer than vials. Patients who were given injections from prefilled syringes had a lower rate of infection of the inside of the eye (endophthalmitis) than patients who were given injections from vials. These results indicate that using prefilled syringes for injecting drugs into the eye can improve efficiency at ophthalmology clinics and improve safety for patients.
METHODS: MEDLINE, EMBASE, and The Cochrane Library were searched from January 1, 2015 to February 8, 2024 to identify literature reporting outcomes regarding procedural efficiency, health care resource use, patient and clinician experiences, and safety for currently approved anti-VEGFs (ranibizumab, aflibercept, brolucizumab) administered using PFS. Comparators were vial-based injections of the same anti-VEGFs.
RESULTS: A total of 36 publications met the criteria for inclusion in the systematic literature review; the majority were non-randomized studies, with a small number of reviews, case series, survey studies, and opinion articles. Publications reported that preparation times were significantly shorter for PFS (40.3-57.9 s) versus vials (ranibizumab, 62.8-98.0 s; aflibercept, 71.9-79.5 s), with no differences in product stability between PFS and vials. Clinicians expressed a preference for PFS and thought PFS were faster, easier to use, and had increased safety versus vials. Publications consistently reported significantly lower rates of endophthalmitis per injection with PFS versus vials (ranibizumab PFS, 0-0.02%; aflibercept PFS, 0.01-0.02%; ranibizumab vial, 0.02-0.05%; aflibercept vial, 0.02-0.06%). Four publications reported increased rates of transient vision loss after aflibercept PFS injection versus vial-based injection. No publications reported outcomes regarding health care resource use or patient experiences.
CONCLUSIONS: The available literature supports the increased procedural efficiency of PFS versus vial-based intravitreal injection of anti-VEGFs. PFS are positively perceived by clinicians and have a safety benefit in the form of a decreased risk of endophthalmitis versus vials.
Anti-vascular endothelial growth factor (VEGF) drugs, given by injection into the eye, are commonly used to treat diseases that affect the back of the eye (the retina). Anti-VEGF drugs are provided in small containers (vials) or in syringes that are already filled with the drug (prefilled syringes). When someone is treated with an anti-VEGF drug from a vial, the drug must first be taken from the vial using a needle and syringe, and then injected. When someone is treated with an anti-VEGF drug from a prefilled syringe, the drug is injected directly from the prefilled syringe, i.e., there are fewer steps involved when a prefilled syringe is used. We searched the medical literature to see if there were differences in clinical outcomes and experiences between prefilled syringes and vials when used to inject anti-VEGF drugs. Clinicians spent about 50% less time getting ready for injections when prefilled syringes were used than when vials were used. Clinicians also preferred to use prefilled syringes than vials for injecting anti-VEGF drugs. Clinicians reported that prefilled syringes were easier to use, faster, and safer than vials. Patients who were given injections from prefilled syringes had a lower rate of infection of the inside of the eye (endophthalmitis) than patients who were given injections from vials. These results indicate that using prefilled syringes for injecting drugs into the eye can improve efficiency at ophthalmology clinics and improve safety for patients.
摘要：
背景：抗血管内皮生长因子（VEGF）药物已成为视网膜疾病的标准治疗方法近二十年。使用单次使用小瓶或预填充注射器(PFS)通过玻璃体内注射施用这些治疗。在这次系统审查中，我们评估了玻璃体腔注射抗VEGF治疗的医疗保健资源使用和临床结局以及PFS的经验.
方法：MEDLINE，EMBASE,和Cochrane图书馆从2015年1月1日至2024年2月8日进行了搜索，以确定报告有关程序效率的结果的文献，医疗保健资源的使用，患者和临床医生的经验，和目前批准的抗VEGF（雷珠单抗，aflibercept,brolucizumab)使用PFS给药。比较物是相同抗VEGF的基于小瓶的注射。
结果：共有36篇出版物符合纳入系统文献综述的标准；大多数是非随机研究，有少量的评论，案例系列,调查研究，和意见文章。出版物报道，PFS（40.3-57.9s）与小瓶（雷珠单抗，62.8-98.0s；自由，71.9-79.5s)，PFS和小瓶之间的产品稳定性没有差异。临床医生表示偏爱PFS，并认为PFS更快，更容易使用,与小瓶相比，安全性提高了。出版物一致报道，与小瓶相比，每次注射PFS的眼内炎发生率显着降低（雷珠单抗PFS，0-0.02%；afliberceptPFS，0.01-0.02%；雷珠单抗小瓶，0.02-0.05%；阿柏西普小瓶，0.02-0.06%）。四个出版物报道了阿柏西普PFS注射与基于小瓶的注射后的瞬时视力丧失率增加。没有出版物报告有关医疗保健资源使用或患者体验的结果。
结论：现有文献支持与基于小瓶的玻璃体内注射抗VEGF相比，PFS的手术效率提高。PFS被临床医生积极地感知，并且与小瓶相比，具有降低眼内炎风险的安全性益处。
抗血管内皮生长因子（VEGF）药物，通过注射进入眼睛，通常用于治疗影响眼睛后部（视网膜）的疾病。抗VEGF药物在小容器（小瓶）或已经充满药物的注射器（预填充注射器）中提供。当有人用小瓶中的抗VEGF药物治疗时，首先必须使用针头和注射器从小瓶中取出药物，然后注射。当有人用预填充注射器的抗VEGF药物治疗时，药物直接从预填充的注射器注射，即，使用预填充注射器时涉及的步骤较少。我们搜索了医学文献，以了解在用于注射抗VEGF药物时，预充式注射器和小瓶之间的临床结果和经验是否存在差异。当使用预充式注射器时，临床医生花费的准备注射时间比使用小瓶时减少约50％。临床医生还优选使用预充式注射器而不是用于注射抗VEGF药物的小瓶。临床医生报告说，预充式注射器更容易使用，更快,比小瓶更安全。与从小瓶中注射的患者相比，从预充式注射器中注射的患者的眼内感染率（眼内炎）较低。这些结果表明，使用预充式注射器将药物注射到眼睛中可以提高眼科诊所的效率并提高患者的安全性。
方法：MEDLINE，EMBASE,和Cochrane图书馆从2015年1月1日至2024年2月8日进行了搜索，以确定报告有关程序效率的结果的文献，医疗保健资源的使用，患者和临床医生的经验，和目前批准的抗VEGF（雷珠单抗，aflibercept,brolucizumab)使用PFS给药。比较物是相同抗VEGF的基于小瓶的注射。
结果：共有36篇出版物符合纳入系统文献综述的标准；大多数是非随机研究，有少量的评论，案例系列,调查研究，和意见文章。出版物报道，PFS（40.3-57.9s）与小瓶（雷珠单抗，62.8-98.0s；自由，71.9-79.5s)，PFS和小瓶之间的产品稳定性没有差异。临床医生表示偏爱PFS，并认为PFS更快，更容易使用,与小瓶相比，安全性提高了。出版物一致报道，与小瓶相比，每次注射PFS的眼内炎发生率显着降低（雷珠单抗PFS，0-0.02%；afliberceptPFS，0.01-0.02%；雷珠单抗小瓶，0.02-0.05%；阿柏西普小瓶，0.02-0.06%）。四个出版物报道了阿柏西普PFS注射与基于小瓶的注射后的瞬时视力丧失率增加。没有出版物报告有关医疗保健资源使用或患者体验的结果。
结论：现有文献支持与基于小瓶的玻璃体内注射抗VEGF相比，PFS的手术效率提高。PFS被临床医生积极地感知，并且与小瓶相比，具有降低眼内炎风险的安全性益处。
抗血管内皮生长因子（VEGF）药物，通过注射进入眼睛，通常用于治疗影响眼睛后部（视网膜）的疾病。抗VEGF药物在小容器（小瓶）或已经充满药物的注射器（预填充注射器）中提供。当有人用小瓶中的抗VEGF药物治疗时，首先必须使用针头和注射器从小瓶中取出药物，然后注射。当有人用预填充注射器的抗VEGF药物治疗时，药物直接从预填充的注射器注射，即，使用预填充注射器时涉及的步骤较少。我们搜索了医学文献，以了解在用于注射抗VEGF药物时，预充式注射器和小瓶之间的临床结果和经验是否存在差异。当使用预充式注射器时，临床医生花费的准备注射时间比使用小瓶时减少约50％。临床医生还优选使用预充式注射器而不是用于注射抗VEGF药物的小瓶。临床医生报告说，预充式注射器更容易使用，更快,比小瓶更安全。与从小瓶中注射的患者相比，从预充式注射器中注射的患者的眼内感染率（眼内炎）较低。这些结果表明，使用预充式注射器将药物注射到眼睛中可以提高眼科诊所的效率并提高患者的安全性。
