{"title":"阿布西普生物仿制药玻璃体内注射治疗糖尿病性黄斑水肿的疗效和安全性。","authors":"Gaixia Zhai, Chao Sun, Xia Zhang, Yuanzhen Su","doi":"10.3389/fmed.2025.1528104","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to evaluate the efficacy and safety of intravitreal injection of aflibercept biosimilar in the treatment of diabetic macular edema (DME).</p><p><strong>Methods: </strong>Clinical data were collected from 33 patients (40 eyes) newly diagnosed with DME in the ophthalmology department of our hospital between February and April 2024, all of whom were treated with the aflibercept biosimilar. Patients were managed according to the 3+ Pro re nata (PRN) regimen and completed a minimum follow-up period of 6 months. The best-corrected visual acuity (BCVA) testing, optical coherence tomography, optical coherence tomography angiography, and multifocal electroretinography were performed before and after treatment. BCVA and central retinal thickness (CRT) were compared at baseline and 1-, 3-, and 6-months post-treatment. Additionally, the changes in the foveal avascular zone area, vascular density (VD) of superficial and deep retinal capillaries in the macular region, and the first positive peak amplitude density in ring 1 were analyzed 6 months post-treatment.</p><p><strong>Results: </strong>BCVA improved significantly from 0.53 ± 0.12 logMAR at baseline to 0.31 ± 0.12, 0.26 ± 0.10, and 0.26 ± 0.08 logMAR at 1-, 3-, and 6-months post-treatment, respectively, (<i>p</i> < 0.05). CRT decreased significantly from 422.4 ± 63.04 μm at baseline to 294.7 ± 47.89, 272.1 ± 47.43, and 281.0 ± 40.72 μm at 1-, 3-, and 6-months post-treatment, respectively, (<i>p</i> < 0.05). The foveal avascular zone area significantly reduced from 0.40 ± 0.08 mm<sup>2</sup> at baseline to 0.35 ± 0.07 mm<sup>2</sup> at 6 months post-treatment. Superficial VD increased significantly from 38.90 ± 7.88% at baseline to 41.21 ± 7.98% at 6 months post-treatment, while deep VD significantly increased from 35.67 ± 7.50% at baseline to 38.72 ± 6.90% (<i>p</i> < 0.05). The first positive peak amplitude improved significantly from 55.30 ± 9.45 to 72.90 ± 7.44 nv/deg<sup>2</sup> at 6 months post-treatment (<i>p</i> < 0.05).</p><p><strong>Conclusion: </strong>Intravitreal injections of aflibercept biosimilar can significantly reduce DME, improve BCVA, enhance macular perfusion, and restore macular function.</p>","PeriodicalId":12488,"journal":{"name":"Frontiers in Medicine","volume":"12 ","pages":"1528104"},"PeriodicalIF":3.1000,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11973271/pdf/","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of intravitreal injection of aflibercept biosimilar for treating diabetic macular edema.\",\"authors\":\"Gaixia Zhai, Chao Sun, Xia Zhang, Yuanzhen Su\",\"doi\":\"10.3389/fmed.2025.1528104\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>This study aimed to evaluate the efficacy and safety of intravitreal injection of aflibercept biosimilar in the treatment of diabetic macular edema (DME).</p><p><strong>Methods: </strong>Clinical data were collected from 33 patients (40 eyes) newly diagnosed with DME in the ophthalmology department of our hospital between February and April 2024, all of whom were treated with the aflibercept biosimilar. Patients were managed according to the 3+ Pro re nata (PRN) regimen and completed a minimum follow-up period of 6 months. The best-corrected visual acuity (BCVA) testing, optical coherence tomography, optical coherence tomography angiography, and multifocal electroretinography were performed before and after treatment. BCVA and central retinal thickness (CRT) were compared at baseline and 1-, 3-, and 6-months post-treatment. Additionally, the changes in the foveal avascular zone area, vascular density (VD) of superficial and deep retinal capillaries in the macular region, and the first positive peak amplitude density in ring 1 were analyzed 6 months post-treatment.</p><p><strong>Results: </strong>BCVA improved significantly from 0.53 ± 0.12 logMAR at baseline to 0.31 ± 0.12, 0.26 ± 0.10, and 0.26 ± 0.08 logMAR at 1-, 3-, and 6-months post-treatment, respectively, (<i>p</i> < 0.05). CRT decreased significantly from 422.4 ± 63.04 μm at baseline to 294.7 ± 47.89, 272.1 ± 47.43, and 281.0 ± 40.72 μm at 1-, 3-, and 6-months post-treatment, respectively, (<i>p</i> < 0.05). The foveal avascular zone area significantly reduced from 0.40 ± 0.08 mm<sup>2</sup> at baseline to 0.35 ± 0.07 mm<sup>2</sup> at 6 months post-treatment. Superficial VD increased significantly from 38.90 ± 7.88% at baseline to 41.21 ± 7.98% at 6 months post-treatment, while deep VD significantly increased from 35.67 ± 7.50% at baseline to 38.72 ± 6.90% (<i>p</i> < 0.05). The first positive peak amplitude improved significantly from 55.30 ± 9.45 to 72.90 ± 7.44 nv/deg<sup>2</sup> at 6 months post-treatment (<i>p</i> < 0.05).</p><p><strong>Conclusion: </strong>Intravitreal injections of aflibercept biosimilar can significantly reduce DME, improve BCVA, enhance macular perfusion, and restore macular function.</p>\",\"PeriodicalId\":12488,\"journal\":{\"name\":\"Frontiers in Medicine\",\"volume\":\"12 \",\"pages\":\"1528104\"},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2025-03-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11973271/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Frontiers in Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3389/fmed.2025.1528104\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Frontiers in Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3389/fmed.2025.1528104","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
摘要
目的：本研究旨在评价玻璃体内注射阿布西普生物类似药治疗糖尿病性黄斑水肿（DME）的疗效和安全性。方法：收集我院眼科2024年2 - 4月新诊断为二甲醚患者33例（40眼）的临床资料，均采用阿布西普生物类似药治疗。根据3+ Pro re nata （PRN）方案对患者进行管理，并完成至少6 个月的随访期。治疗前后行最佳矫正视力（BCVA）检查、光学相干断层扫描、光学相干断层血管造影、多焦视网膜电图检查。在基线和治疗后1、3、6个月比较BCVA和中央视网膜厚度（CRT）。分析治疗后6 个月中央凹无血管区面积、黄斑区视网膜浅、深毛细血管密度（VD）及环1第一峰振幅密度的变化。结果:从0.53 BCVA明显改善 ±0.12 logMAR从基线值的0.31 ± 0.12,0.26 ± 0.10,和0.26 ±0.08 logMAR 1 -, 3 -,后处理和6个月,分别在基线(p p 2到0.35 ±0.07 平方毫米 6个月治疗。肤浅的VD显著增加从38.90 ± 7.88%至41.21基线 ± 7.98% 6个月治疗后,虽然深VD显著增加从35.67 ± 7.50%至38.72基线 ± 6.90% (p 2 6个月治疗后(p 结论:Intravitreal注射aflibercept推出可以显著降低测距装置,提高BCVA,提高黄斑灌注,并恢复黄斑功能。
Efficacy and safety of intravitreal injection of aflibercept biosimilar for treating diabetic macular edema.
Purpose: This study aimed to evaluate the efficacy and safety of intravitreal injection of aflibercept biosimilar in the treatment of diabetic macular edema (DME).
Methods: Clinical data were collected from 33 patients (40 eyes) newly diagnosed with DME in the ophthalmology department of our hospital between February and April 2024, all of whom were treated with the aflibercept biosimilar. Patients were managed according to the 3+ Pro re nata (PRN) regimen and completed a minimum follow-up period of 6 months. The best-corrected visual acuity (BCVA) testing, optical coherence tomography, optical coherence tomography angiography, and multifocal electroretinography were performed before and after treatment. BCVA and central retinal thickness (CRT) were compared at baseline and 1-, 3-, and 6-months post-treatment. Additionally, the changes in the foveal avascular zone area, vascular density (VD) of superficial and deep retinal capillaries in the macular region, and the first positive peak amplitude density in ring 1 were analyzed 6 months post-treatment.
Results: BCVA improved significantly from 0.53 ± 0.12 logMAR at baseline to 0.31 ± 0.12, 0.26 ± 0.10, and 0.26 ± 0.08 logMAR at 1-, 3-, and 6-months post-treatment, respectively, (p < 0.05). CRT decreased significantly from 422.4 ± 63.04 μm at baseline to 294.7 ± 47.89, 272.1 ± 47.43, and 281.0 ± 40.72 μm at 1-, 3-, and 6-months post-treatment, respectively, (p < 0.05). The foveal avascular zone area significantly reduced from 0.40 ± 0.08 mm2 at baseline to 0.35 ± 0.07 mm2 at 6 months post-treatment. Superficial VD increased significantly from 38.90 ± 7.88% at baseline to 41.21 ± 7.98% at 6 months post-treatment, while deep VD significantly increased from 35.67 ± 7.50% at baseline to 38.72 ± 6.90% (p < 0.05). The first positive peak amplitude improved significantly from 55.30 ± 9.45 to 72.90 ± 7.44 nv/deg2 at 6 months post-treatment (p < 0.05).
Conclusion: Intravitreal injections of aflibercept biosimilar can significantly reduce DME, improve BCVA, enhance macular perfusion, and restore macular function.
期刊介绍：
Frontiers in Medicine publishes rigorously peer-reviewed research linking basic research to clinical practice and patient care, as well as translating scientific advances into new therapies and diagnostic tools. Led by an outstanding Editorial Board of international experts, this multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide.
In addition to papers that provide a link between basic research and clinical practice, a particular emphasis is given to studies that are directly relevant to patient care. In this spirit, the journal publishes the latest research results and medical knowledge that facilitate the translation of scientific advances into new therapies or diagnostic tools. The full listing of the Specialty Sections represented by Frontiers in Medicine is as listed below. As well as the established medical disciplines, Frontiers in Medicine is launching new sections that together will facilitate
- the use of patient-reported outcomes under real world conditions
- the exploitation of big data and the use of novel information and communication tools in the assessment of new medicines
- the scientific bases for guidelines and decisions from regulatory authorities
- access to medicinal products and medical devices worldwide
- addressing the grand health challenges around the world
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