综述

Faricimab玻璃体腔内注射治疗视网膜静脉阻塞的研究进展

Advances in the treatment of retinal vein occlusion with Faricimab intravitreal injection

:586-592
 
视网膜静脉阻塞(retinal vein occlusion, RVO)是导致视力损害的主要眼底疾病之一,常引发视网膜缺血、出血、液体渗漏和黄斑水肿,从而导致视力下降甚至永久丧失。目前,RVO继发黄斑水肿的主要治疗方法是玻璃体腔内注射抗血管内皮生长因子(vascular endothelial growth factor, VEGF)药物。然而,RVO的病理机制不仅限于VEGF,还涉及血管生成素-2(angiopoietin-2, Ang-2)的作用。在病理状态下,Ang-2通过破坏血管稳定性,诱导新生血管形成,并加剧炎症反应,进一步促进RVO的病程进展。法瑞西单抗(Faricimab)作为一种双特异性抗体药物,能够同时抑制VEGF-A和Ang-2这两条关键的病理通路,显示出在改善患者视力方面的潜在优势。文章对Faricimab在RVO治疗中的作用机制、临床应用、相关治疗药物对比及未来发展前景进行了详细论述,为其在眼科领域的进一步应用提供了理论依据和参考。
Retinal vein occlusion (RVO) is one of the leading retinal diseases causing vision impairment and is often associated with retinal ischemia, hemorrhage, fluid leakage, and macular edema, ultimately resulting in decreased vision or even permanent vision loss. Currently, the primary treatment for RVO-associated macular edema is intravitreal injection of anti-vascular endothelial growth factor (VEGF) agents. However, the pathological mechanisms of RVO are not limited to VEGF alone, but also involve angiopoietin-2 (Ang-2). Under pathological conditions, Ang-2 disrupts vascular stability, induces neovascularization, and exacerbates inflammatory responses, thereby accelerating the progression of RVO. Faricimab, as a bispecific antibody, can simultaneously inhibit both VEGF-A and Ang-2 pathways, which are critical in RVO pathogenesis, and has shown potential advantages in improving visual outcomes. The article provides a detailed discussion on the mechanism of action, clinical applications, comparison with related therapeutic agents, and future development prospects of Faricimab in the treatment of RVO, offering a theoretical basis and reference for its further application in ophthalmology.
封面简介

广东省玻璃体腔注药操作及质量控制规范

Standard operating procedure and quality control standards for intravitreal injection in Guangdong Province

:-
 
玻璃体腔注药是年龄相关性黄斑变性、糖尿病视网膜病变、视网膜静脉阻塞等常见慢性眼底病的主要治疗方式,凭借其治疗量大、操作流程化、实施简便,已成为眼科临床常规诊疗项目。基于《“十四五”全国眼健康规划(2021-2025年)》要求,秉承以患者为中心的服务理念,在确保医疗安全的基础上,优化治疗流程,提升患者接受玻璃体腔注药治疗的就诊体验和治疗效果。同时,广东省将有望承接越来越多港澳的眼病患者,需要建立融合粤港澳大湾区的广东省注药标准。因此,在广东省医学会的领导下,由中山大学中山眼科中心联合广东省内其他21所医疗机构共同起草,通过函审、专家论证会等形式,共邀广东省内35名权威专家进行多轮会审,在参考国内外玻璃体腔注药标准的基础上,结合广东省粤港澳大湾区眼科现状,共同讨论最终确定了本标准。本团体标准系统地描述了玻璃体腔注药的基本要求、适应证与禁忌证,制定了全新的玻璃体腔注药标准操作流程及其质量控制标准,并且介绍了并发症或不适的预防及处理,为广东省各级具有资质的医疗机构所开展的玻璃体腔注药的临床应用以及质量评估提供指导。
玻璃体腔注药是年龄相关性黄斑变性、糖尿病视网膜病变、视网膜静脉阻塞等常见慢性眼底病的主要治疗方式,凭借其治疗量大、操作流程化、实施简便,已成为眼科临床常规诊疗项目。基于《“十四五”全国眼健康规划(2021-2025年)》要求,秉承以患者为中心的服务理念,在确保医疗安全的基础上,优化治疗流程,提升患者接受玻璃体腔注药治疗的就诊体验和治疗效果。同时,广东省将有望承接越来越多港澳的眼病患者,需要建立融合粤港澳大湾区的广东省注药标准。因此,在广东省医学会的领导下,由中山大学中山眼科中心联合广东省内其他21所医疗机构共同起草,通过函审、专家论证会等形式,共邀广东省内35名权威专家进行多轮会审,在参考国内外玻璃体腔注药标准的基础上,结合广东省粤港澳大湾区眼科现状,共同讨论最终确定了本标准。本团体标准系统地描述了玻璃体腔注药的基本要求、适应证与禁忌证,制定了全新的玻璃体腔注药标准操作流程及其质量控制标准,并且介绍了并发症或不适的预防及处理,为广东省各级具有资质的医疗机构所开展的玻璃体腔注药的临床应用以及质量评估提供指导。
眼底影像专栏

一站式玻璃体腔注药中心成立前后效果评价

The evaluation of the effects before and after the establishment of a one-stop intravitreal injection center

:252-260
 
目的:探讨一站式玻璃体腔注药中心成立前后不同管理模式下的成效,分析其对患者就医时间和就医体验的影响。方法:采用回顾性临床研究。选择2023年1月—2024年3月在汕头大学·香港中文大学联 合汕头国际眼科中心接受玻璃体腔注药的2955例患者纳入研究。将2023年1月—2023年8月玻璃体腔注 药中心成立前接受玻璃体腔注药的1399例患者作为对照组;2023年9月—2024年3月玻璃体腔注药中心成立后接受玻璃体腔注药的1556例患者作为观察组。对照组采用常规日间手术流程,观察组成立一 站式玻璃体腔注药中心,优化诊疗和护理服务流程。通过使用问卷调查比较两组患者就医期间从预约手术、手术当天到术后复查各节点的等待时间、健康教育知晓率、患者满意度及不良事件发生率的差异。结果:问卷调查结果显示,对照组、观察组患者间预约等待手术时间分别为(3.93±2.98) d、 (1.34±2.38) d,手术时间分别为(2.53±2.11) min、(1.93±1.82) min,在院时间分别为(313.62±184.96) min、(85.43±34.14) min,术后复查耗时分别为(45.92±48.44) min、(25.82±16.21) min,差异均有统计学意义(P<0.001);患者的总体健康教育知晓率成立前后分别为(95.50%、98.70%),差异有统计学意义 (χ2 =16.09,P<0.001);患者满意度调查结果显示,各项就医体验选项“非常满意”的占比成立后比 成立前明显提高。结论:一站式玻璃体腔注药中心护理模式简化了就医流程,极大地减少了患者就医期 间从预约手术、手术当天到术后复查各节点的等待时间、可显著提升工作效率,明显改善患者整体就 医体验。

To explore the application effects of different nursing models before and after the establishment of a one-stop intravitreal injection center, and to analyze their impact on patient's medical time and experience. Methods: A retrospective clinical study was conducted. From January 2023 to March 2024, 2955 patients who received anti-VEGF drug treatment at the Shantou International Eye Center, a joint initiative of Shantou University and the Chinese University of Hong Kong, were included in the study. The 1399 patients who received anti-VEGF drug treatment before the establishment of the intravitreal injection center from January 2023 to August 2023 were set as the control group; the 1556 patients who received anti-VEGF drug treatment after the establishment of the intravitreal injection center from September 2023 to March 2024 were set as the observation group. The control group followed the routine day surgery process, while the observation group established a one-stop intravitreal injection center to optimize the diagnosis, treatment, and nursing service process. A questionnaire survey was used to compare the differences in waiting time at various points from appointment to surgery, on the day of surgery, and postoperative review, health education awareness rate, patient satisfaction, and adverse event rate between the two groups. Results: The questionnaire survey showed that the waiting time for surgery between the control group and the observation group was (3.93±2.98) d, (1.34±2.38) d, respectively, the surgery time was (2.53±2.11) min, (1.93±1.82) mi, the in-hospital time was (313.62±184.96 min, 85.43±34.14) min, and the postoperative review time was (45.92±48.44) min, (25.82±16.21) min, with all differences being statistically significant (P <0.001); the overall health education awareness rate before and after the establishment was (95.50%, 98.70%), with a significant difference (P <0.001, χ2=16.09); the patient satisfaction survey showed that the proportion of "very satisfied" in various medical experience options was significantly higher after the establishment than before. Conclusions: The one-stop intravitreal injection center nursing model has simplified the medical process, greatly reducing the waiting time at various points from appointment to surgery, on the day of surgery, and postoperative review, significantly improving work efficiency, and significantly improving the overall medical experience of patients.

团体标准

广东省玻璃体腔注药操作及质量控制规范

Standard operating procedure and quality control Standards for Intravitreal Injection in Guangdong Province

:223-230
 
玻璃体腔注药是年龄相关性黄斑变性、糖尿病视网膜病变、视网膜静脉阻塞等常见慢性眼底病的主要治疗方式,凭借其治疗量大、操作流程化、实施简便,已成为眼科临床常规诊疗项目。基于《“十四五”全国眼健康规划(2021-2025年)》要求,秉承以患者为中心的服务理念,在确保医疗安全的基础上,优化治疗流程,提升患者接受玻璃体腔注药治疗的就诊体验和治疗效果。同时,广东省将有望承接越来越多港澳的眼病患者,需要建立融合粤港澳大湾区的广东省注药标准。因此,在广东省医学会的领导下,由中山大学中山眼科中心联合广东省内其他21所医疗机构共同起草,通过函审、专家论证会等形式,共邀广东省内35名权威专家进行多轮会审,在参考国内外玻璃体腔注药标准的基础上,结合粤港澳大湾区眼科现状,共同讨论最终确定了本标准。本团体标准系统地描述了玻璃体腔注药的基本要求、适应证与禁忌证,制定了全新的玻璃体腔注药标准操作流程及其质量控制标准,并且介绍了并发症或不适的预防及处理,为广东省各级具有资质的医疗机构所开展的玻璃体腔注药的临床应用以及质量评估提供指导。
Intravitreal injection represents the primary method of drug administration for a range of common chronic endophthalmic diseases, including age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. Recognized for its high clinical efficacy, procedural standardization, and operational accessibility, this has become a routine clinical practice in ophthalmology. In alignment with the "National Eye Health Plan during the 14th Five-Year Plan period (2021–2025)" and the patient-centered service philosophy, this approach optimizes treatment processes and enhances patient experience and therapeutic outcomes while ensuring medical safety. Furthermore, Guangdong Province is poised to become a pivotal hub for ophthalmic care within the Guangdong-Hong Kong-Macao Greater Bay Area, anticipating a growing influx of patients from Hong Kong and Macao. This necessitates the development of a unified intravitreal injection standard tailored to regional healthcare integration. Under the auspices of the Guangdong Medical Association, a consortium led by Zhongshan Ophthalmic Center, Sun Yat-sen University, and 21 collaborating medical institutions across Guangdong, formulated this standard. Through iterative reviews involving correspondencebased evaluations and multidisciplinary expert consultations, 35 distinguished specialists refined the standard, synthesizing global best practices with insights into the Greater Bay Area’s unique ophthalmological landscape. This group standard systematically outlines the basic requirements, indications and contraindications of intravitreal injection, establishes a new standard operating procedure for intravitreal injection and quality control standards for this procedure. In addition, we have introduced guidance for the clinical application of this technique and quality assessment, as well as for the prevention and management of complications or adverse reactions.

标准操作程序在玻璃体腔内注药术护理中的应用

Application of standard operation procedure in the intravitreal injection

:181-184
 

目的:探讨标准操作程序在玻璃体腔内注药术护理中的应用效果。方法:选择 2018 年 至 12 月中山大学中山眼科中心眼底专科门诊 504 例玻璃体腔内注药术患者作为研究对象,对护理人力资源的整合、患者等待手术时间、患者和家属的满意度、医护人员满意度进行评价。结果:标准操作程序后明确护士岗位职责,护士操作水平和综合能力有效提升,患者手术等待时间由原来的预约 周缩短为 2 d。患者和家属的满意度分别由 92.0% 和 91.0% 提高到 98.5% 和 97.0%。医护人员满意度的评价由 95% 提到至 98.4%结论:玻璃体腔内注药术标准操作程序不仅提升了工作效率,更提升了患者和家属、医务人员的满意度,规范化的标准操作程序是玻璃体腔内注药的安全保障。

Objective: To investigate the effect of standard operation procedure in the intravitreal injection. Methods: A total of 504 patients visiting the fundus clinics of our hospital from September to December 2018 were selected in this study. The integration of nursing human resources, patient waiting time, patient and family satisfaction, and medical staff satisfaction were evaluated. Results: The nursesjob responsibilities were clarified, and the Nursesoperation level and comprehensive ability were improved. The patientswaiting time for surgery was shortened from 2 weeks to 2 days. Patient and family satisfaction increased from 92.0% and 91.0% to 98.5% and 97.0%, respectively. The evaluation of the satisfaction of medical staff was elevated from 95% to 98.4%. Conclusion: The standard operation procedure of intravitreal injection not only improves the work efficiency, but also significantly increases the satisfaction of patients and their families and medical staffs. Therefore, the standard operation procedure can guarantee the safety of intravitreal injection.

眼科护理

标准操作程序在玻璃体腔内注药术护理中的应用

Application of standard operation procedure in the intravitreal injection

:181-184
 
目的:探讨标准操作程序在玻璃体腔内注药术护理中的应用效果。方法:选择2018年9至12月中山大学中山眼科中心眼底专科门诊504例玻璃体腔内注药术患者作为研究对象,对护理人力资源的整合、患者等待手术时间、患者和家属的满意度、医护人员满意度进行评价。结果:标准操作程序后明确护士岗位职责,护士操作水平和综合能力有效提升,患者手术等待时间由原来的预约2周缩短为2 d。患者和家属的满意度分别由92.0%和91.0%提高到98.5%和97.0%。医护人员满意度的评价由95%提到至98.4%。结论:玻璃体腔内注药术标准操作程序不仅提升了工作效率,更提升了患者和家属、医务人员的满意度,规范化的标准操作程序是玻璃体腔内注药的安全保障。
Objective: To investigate the effect of standard operation procedure in the intravitreal injection. Methods: A total of 504 patients visiting the fundus clinics of our hospital from September to December 2018 were selected in this study. The integration of nursing human resources, patient waiting time, patient and family satisfaction,and medical staff satisfaction were evaluated. Results: The nurses’ job responsibilities were clarified, and the nurses’ operation level and comprehensive ability were improved. The patients’ waiting time for surgery was shortened from 2 weeks to 2 days. Patient and family satisfaction increased from 92.0% and 91.0% to 98.5% and 97.0%, respectively. The evaluation of the satisfaction of medical staff was elevated from 95% to 98.4%.Conclusion: The standard operation procedure of intravitreal injection not only improves the work efficiency, but also significantly increases the satisfaction of patients and their families and medical staffs. Therefore, the standard operation procedure can guarantee the safety of intravitreal injection.
论著

玻璃体腔注射术后眼内炎的临床分析

Clinical analysis on endophthalmitis after intravitreal injection

:343-346
 
目的:分析玻璃体腔注射术后眼内炎的发生并总结原因,旨在进一步提高手术安全性。方法:回顾性分析中国人民解放军总医院第六医学中心2010年9月至2019年11月行玻璃体腔注射术的421例患者(973眼)的术后1 d、1周、1个月的随访资料。归纳注射药物种类、注射病因、患者全身病史,总结术后眼内炎的发生及治疗情况。结果:玻璃体腔注射术安全性高,但严重并发症眼内炎(0.41%)仍偶有发生。4例眼内炎患者中2例为Irvine-Gass综合征患者行曲安奈德玻璃体腔注射后,1例为视网膜中央静脉阻塞患者行曲安奈德玻璃体腔注射后,1例为中心性渗出性视网膜脉络膜病变患者行雷珠单抗玻璃体腔注射后。其中曲安奈德引起的眼内炎(1.99%)明显高于抗血管内皮生长因子(vascular endothelial growth factor,VEGF)药物引起的眼内炎(0.12%)。结论:严格按照操作指南操作,当针对高血压老年群体尤其是Irvine-Gass综合征患者玻璃体腔注射曲安奈德时尤其防范眼内炎的发生。
Objective: To analyze the incidence and causes of endophthalmitis after intravitreal injection and to further improve the safety of the surgery. Methods: The follow-up data of 973 eyes of 421 patients who received intravitreal injection in our hospital in the past 9 years at 1 day, 1 week and 1 month were retrospectively analyzed.The types of injected drugs, the cause of injection and systemic history were summarized, and the occurrence and treatment of postoperative endophthalmitis were summarized. Results: The intravitreal injections were safe.However, the severe complication of endophthalmitis (0.41%) occurred occasionally. Among these 4 patients with endophthalmitis, 2 patients were intravitreal injected triamcinolone acetonide because of Irvine-Gass syndrome;1 patient accepted intravitreal injection by Ranibizumab because of central retinal vein occlusion; 1 patient accepted intravitreal injection by Ranibizumab because of central exudative chorioretinopathy. The incidence of endophthalmitis (1.99%) after intravitreal injection of triamcinolone acetonide was higher than that of anti-vascular endothelial growth factor (VEGF) agents (0.12%). Conclusion: The clinical operating guideline of intravitreal injection should be followed strictly. Furthermore, the elderly people with hypertension diagnosed of Irvine-Gass syndrome have a higher risk of endophthalmitis after intravitreal injection of triamcinolone acetonide than others and should be paid more important attention.
论著

光学相干断层扫描血管成像观察玻璃体腔注射抗VEGF治疗视网膜分支静脉阻塞合并黄斑水肿的疗效

Optical coherence tomography angiography used to observe intravitreal injection of anti-VEGF on branch retina vein occlusion combined with macular edema

:28-32
 
目的:以光学相干断层扫描血管成像(optical coherence tomography angiography,OCTA)观察视网膜分支静脉阻塞(branch retinal vein occlusion,BRVO)抗血管内皮生长因子(vascular endothelial growth factor,VEGF)治疗前后的变化。方法:回顾性收集从2017年1月至2018年1 2月在汕头国际眼科中心的确诊为BRVO合并黄斑水肿的患者共3 1例3 2眼。患眼行玻璃体腔注射抗VEGF药物治疗,记录治疗前和治疗后1个月的最佳矫正视力(best corrected visual acuity,BCVA),OCTA检查视网膜黄斑中心凹厚度(foveal macular thickness,FMT)、黄斑区血流密度。比较治疗前后各指标的变化。结果:治疗后BCVA较治疗前显著提高,差异有统计学意义(P<0.001);FMT[(242.13±86.02) μm]较治疗前[(521.44±190.27) μm]明显下降,差异有统计学 意义(P<0.001);中心凹浅层血流密度[(18.44±4.98)%]及中心凹旁浅层血流密度[(44.83±3.19)%]均较治疗前[(25.46±9.21)%,(46.06±5.25)%]相比明显下降,差异有统计学意义(P <0.001)。结论:玻璃体腔注射抗VEGF治疗BRVO合并黄斑水肿效果显著;OCTA能有效评价抗VEGF治疗BRVO合并黄斑水肿的临床疗效。
Objective: To evaluate the efficacy in patients with macular edema due to branch retinal vein occlusion (BRVO) treated with intravitreal anti-VEGF drug. Methods: In this retrospective study, 32 eyes of 31 patients with BRVO combined with macular edema at Joint Shantou international eye center of Shantou University and TheChinese University of Hong Kong during January 2017 to December 2018 were enrolled in this study. All the affected eyes received intravitreal anti-VEGF drug injections. BCVA (best corrective visual acuity) and optical coherence tomography angiography (OCTA) were performed before and one month after intravitreal anti-VEGF drug injections. Foveal macular thickness (FMT), macular blood flow density was measured in all eyes and compared. Results: The BCVA before therapy was (0.77±0.46) LogMAR and increased to (0.46±0.30) LogMAR in one month after therapy, which showed a statistical difference (P<0.001). The FMT, foveal superficial vascular plexus flow density and para foveal superficial vascular plexus flow density before therapy were (521.44±190.27) μm, (21.85±6.17)% and (46.29±2.70)%, respectively. The FMT, foveal superficial vascular plexus flow density and para foveal superficial vascular plexus flow density decreased to (242.13±86.02) μm, (18.40±5.18)% and (44.75±3.40)%, respectively. There was significant statistical difference for them (P<0.001). Conclusion: Intravitreal injection of anti-VEGF is effective in the treatment of BRVO combined with macular edema. OCTA can effectively evaluate the clinical efficacy of anti-VEGF in the treatment of BRVO combined with macular edema.
其他期刊
  • 眼科学报

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
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  • Eye Science

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
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