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Concealed retro-iridic multi-cavitary melanoma revealed by ultrasound biomicroscopy 超声生物显微镜下发现的隐匿性后虹膜多空洞黑色素瘤。
IF 4.4 3区 医学 Q1 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.apjo.2024.100049
Miguel E. Hernandez-Emanuelli, Rolika Bansal, Thomas M. Catapano, Carol L. Shields
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引用次数: 0
Comment on “Phacogoniotomy versus phacotrabeculectomy for advanced primary angle-closure glaucoma with cataract: A randomized non-inferiority trial” 评论 "晚期原发性闭角型青光眼伴白内障的虹膜切开术与虹膜角膜切除术:随机非劣效性试验"。
IF 4.4 3区 医学 Q1 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.apjo.2024.100066
P. Connor Lentz , Leticia Checo , Isabella V. Wagner , Nithya Boopathiraj , Emily Dorairaj , Syril Dorairaj
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引用次数: 0
Cost-effectiveness of diabetic retinopathy screening for newly diagnosed type 2 diabetic patients: A nationwide population-based propensity score-matched cohort study 对新诊断的 2 型糖尿病患者进行糖尿病视网膜病变筛查的成本效益:基于全国人口的倾向得分匹配队列研究》。
IF 4.4 3区 医学 Q1 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.apjo.2024.100071
Yu-Chien Chung , Yi-Wei Kao , Yen-Chun Huang , Pei-En Chen , Shu-Chen Liao , Chih-Kuang Liu , Mingchih Chen

Aims

This study investigated the association between the frequency of screening for diabetic retinopathy (DR) versus the development of DR and corresponding medical expenses among patients newly diagnosed with type 2 diabetes mellitus (T2DM).

Methods

This longitudinal, population-based study used the Taiwan National Health Insurance Research Database (2004 to 2020) as a data source. Propensity score matching (PSM) (sex, age, comorbidities and concurrent medication use) was employed in the grouping of T2DM patients according to different frequency of DR screening. Outcome measures included the proportion of patients who developed DR, who received DR treatment, and the associated medical expenses and hospitalizations.

Results

The 17-year cohort included 337,046 patients. After PSM, three groups each containing 35,739 patients were assembled and analyzed. Compared to low-frequency screening, high-frequency screening was more effective in detecting patients requiring treatment; however, the net cost for treatment was significantly lower. Standard-frequency screening appears to provide the best balance in terms of DR detection, diagnosis interval, the risk of DR-related hospitalization, and DR treatment costs.

Conclusions

In this real-world cohort study covering all levels of the healthcare system, infrequent screening was associated with delayed diagnosis and elevated treatment costs, while a fundus screening interval of 1–2 years proved optimal in terms of detection and medical expenditures.

目的:本研究调查了新诊断为 2 型糖尿病(T2DM)的患者中,糖尿病视网膜病变(DR)筛查频率与 DR 发展及相应医疗费用之间的关联:这项基于人群的纵向研究以台湾国民健康保险研究数据库(2004-2020年)为数据来源。研究采用倾向得分匹配法(PSM)(性别、年龄、合并症和同时用药),根据不同的 DR 筛查频率对 T2DM 患者进行分组。结果衡量指标包括发生 DR 的患者比例、接受 DR 治疗的患者比例以及相关的医疗费用和住院费用:17 年的队列包括 337046 名患者。经过 PSM 筛选后,对各包含 35739 名患者的三个组进行了汇总和分析。与低频筛查相比,高频筛查能更有效地发现需要治疗的患者;但治疗的净成本却明显较低。标准频率筛查似乎在DR检出率、诊断间隔、DR相关住院风险和DR治疗成本方面实现了最佳平衡:在这项涵盖各级医疗系统的真实世界队列研究中,筛查频率过低与诊断延迟和治疗成本增加有关,而眼底筛查间隔 1-2 年则被证明在检出率和医疗支出方面是最佳的。
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引用次数: 0
Long-term efficacy and safety of posterior endoscopic cyclophotocoagulation in refractory glaucoma: A 5-year follow-up study at a tertiary eye center 后内窥镜环形光凝术治疗难治性青光眼的长期疗效和安全性:一家三级眼科中心的五年随访研究
IF 4.4 3区 医学 Q1 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.apjo.2024.100074
Yuxin Fang, Pengfei Zheng, Xin Tang, Qiyan Li

Purpose

To evaluate the long-term efficacy of endoscopic cyclophotocoagulation (ECP) via a pars plana approach in a large cohort of refractory glaucoma patients

Design

Single-center, retrospective, longitudinal, cohort study.

Methods

This study recruited patients who underwent ECP and consecutively visited and were followed up for at least 5 years at Beijing Tongren Eye Center, China from January 2013 to December 2017. All patients underwent a complete ophthalmic examination. Treatment success was defined as 6 mmHg ≤ IOP ≤ 21 mmHg with or without anti-glaucoma medications.

Results

A total of 121 eyes of 105 patients including 51 children and 54 adults were enrolled. The mean follow-up was 7.2 ± 1.3 years. The most common glaucoma diagnoses were secondary glaucoma (74 eyes, 61.1 %) and primary congenital glaucoma (19 eyes 15.7 %). The mean extent of the first ECP was 259 degrees. There was an overall decrease in IOP of 38.3 % from 33.3 ± 9.0 mmHg preoperatively to 20.5 ± 7.5 mmHg after surgery, which was statistically significant (P < 0.001). The success rate after 1 or more ECP surgery was 65.3 %. After adjusting for sex, number of prior TCP surgeries and the extent of ECP degree, the failure of ECP was associated with being children (as compared with adults; P = 0.028; OR = 2.549) and higher preoperative IOP (P = 0.001; OR = 1.084).

Conclusion

ECP is an effective procedure for lowing IOP in refractory glaucoma, particularly in patients who are also candidates for vitreoretinal interventions. Hence, a collaborative approach between glaucoma and retinal specialists is of utmost importance in devising an optimal management strategy for glaucoma treatment.

目的评估在一大批难治性青光眼患者中通过旁路进行内镜环形光凝术(ECP)的长期疗效设计单中心、回顾性、纵向、队列研究方法本研究招募了 2013 年 1 月至 2017 年 12 月期间在中国北京同仁眼科中心接受 ECP 治疗并连续就诊和随访至少 5 年的患者。所有患者均接受了全面的眼科检查。无论是否使用抗青光眼药物,治疗成功定义为眼压≤21 mmHg的6 mmHg。平均随访时间为 7.2 ± 1.3 年。最常见的青光眼诊断是继发性青光眼(74 眼,61.1%)和原发性先天性青光眼(19 眼,15.7%)。首次 ECP 的平均范围为 259 度。眼压从术前的 33.3 ± 9.0 mmHg 下降到术后的 20.5 ± 7.5 mmHg,总体下降了 38.3%,具有统计学意义(P < 0.001)。接受过一次或多次 ECP 手术的成功率为 65.3%。结论ECP是一种有效的降低难治性青光眼患者眼压的手术,尤其适用于同时接受玻璃体视网膜介入治疗的患者。因此,青光眼和视网膜专科医生之间的合作对于制定青光眼治疗的最佳管理策略至关重要。
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引用次数: 0
Etiology including epigenetic defects of retinoblastoma 视网膜母细胞瘤的病因,包括表观遗传缺陷。
IF 4.4 3区 医学 Q1 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.apjo.2024.100072
Linbin Zhou , Yan Tong , Bo Man Ho , Jiahui Li , Hoi Ying Emily Chan , Tian Zhang , Lin Du , Jing Na He , Li Jia Chen , Clement C. Tham , Jason C. Yam , Chi Pui Pang , Wai Kit Chu

Retinoblastoma (RB), originating from the developing retina, is an aggressive intraocular malignant neoplasm in childhood. Biallelic loss of RB1 is conventionally considered a prerequisite for initiating RB development in most RB cases. Additional genetic mutations arising from genome instability following RB1 mutations are proposed to be required to promote RB development. Recent advancements in high throughput sequencing technologies allow a deeper and more comprehensive understanding of the etiology of RB that additional genetic alterations following RB1 biallelic loss are rare, yet epigenetic changes driven by RB1 loss emerge as a critical contributor promoting RB tumorigenesis. Multiple epigenetic regulators have been found to be dysregulated and to contribute to RB development, including noncoding RNAs, DNA methylations, RNA modifications, chromatin conformations, and histone modifications. A full understanding of the roles of genetic and epigenetic alterations in RB formation is crucial in facilitating the translation of these findings into effective treatment strategies for RB. In this review, we summarize current knowledge concerning genetic defects and epigenetic dysregulations in RB, aiming to help understand their links and roles in RB tumorigenesis.

视网膜母细胞瘤(RB)起源于发育中的视网膜,是儿童时期一种侵袭性眼内恶性肿瘤。在大多数 RB 病例中,RB1 的双叶缺失通常被认为是启动 RB 发育的先决条件。有人认为,在 RB1 基因突变后,由于基因组的不稳定性而产生的其他基因突变是促进 RB 发展的必要条件。高通量测序技术的最新进展使人们对 RB 的病因有了更深入、更全面的了解,即 RB1 双倍序列缺失后的额外基因改变非常罕见,但 RB1 缺失驱动的表观遗传学改变成为促进 RB 肿瘤发生的关键因素。目前已发现多种表观遗传调节因子失调并导致 RB 的发生,包括非编码 RNA、DNA 甲基化、RNA 修饰、染色质构象和组蛋白修饰。充分了解遗传和表观遗传改变在 RB 形成中的作用对于将这些发现转化为有效的 RB 治疗策略至关重要。在这篇综述中,我们总结了目前有关 RB 遗传缺陷和表观遗传失调的知识,旨在帮助人们了解它们在 RB 肿瘤发生中的联系和作用。
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引用次数: 0
Risk factors for diabetic retinopathy, diabetic macular edema, and sight-threatening diabetic retinopathy 糖尿病视网膜病变、糖尿病黄斑水肿和危及视力的糖尿病视网膜病变的风险因素。
IF 4.4 3区 医学 Q1 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.apjo.2024.100067
Guihua Zhang , Weiqi Chen , Haoyu Chen , Jianwei Lin , Ling-Ping Cen , Peiwen Xie , Yi Zheng , Tsz Kin Ng , Mårten Erik Brelén , Mingzhi Zhang , Chi Pui Pang

Objective

To identify the risk factors for the development of diabetic retinopathy (DR), diabetic macular edema (DME), and sight-threatening DR (STDR) based on a city-wide diabetes screening program.

Research design and methods

Diabetic patients were prospectively recruited between June 2016 and December 2022. All patients underwent dilated fundus photography centered on the disc and macula or macular spectral domain optical coherence tomography (SD-OCT) scan. Complete medical history was documented. Systematic examination, blood analysis, and urinalysis were performed. Multivariate logistic regression analysis adjusting for age and sex was conducted.

Results

Out of 7274 diabetic patients, 6840 had gradable images, among which 3054 (42.0%) were graded as DR, 1153 (15.9%) as DME, and 1500 (20.6%) as STDR. The factors associated with DR, DME, and STDR included younger age (odds ratio [OR]: 0.96, 0.97, and 0.96 respectively), lower BMI (OR: 0.97, 0.95, and 0.95 respectively), longer duration of diabetes (OR: 1.07, 1.03, and 1.05 respectively) and positive of urinary albumin (OR: 2.22, 2.56, and 2.88 respectively). Other associated factors included elevated blood urea nitrogen (OR: 1.22, 1.28, and 1.27 respectively), higher LDL-cholesterol, lower blood hemoglobin (OR: 0.98, 0.98, and 0.98), insulin intake, presence of diabetic foot pathologies and diabetic peripheral neuropathy. We also identified novel risk factors, including high serum potassium (OR: 1.37, 1.46, and 1.55 respectively), high-serum sodium (OR: 1.02, 1.02, and 1.04 respectively). Better family income was a protective factor for DR, DME, and STDR. Alcohol consumption once a week was also identified as a protective factor for DR.

Conclusions

Similar risk factors for DR, DME, and STDR were found in this study. Our data also indicates high serum sodium, high serum potassium, low blood hemoglobin, and level of family income as novel associated factors for DR, DME, and STDR, which can help with DR monitoring and management.

目的根据全市范围内的糖尿病筛查计划,确定发生糖尿病视网膜病变(DR)、糖尿病黄斑水肿(DME)和视力威胁性DR(STDR)的风险因素:在 2016 年 6 月至 2022 年 12 月期间前瞻性地招募了糖尿病患者。所有患者均接受了以视盘和黄斑为中心的扩张眼底照相术或黄斑光谱域光学相干断层扫描(SD-OCT)扫描。系统检查、血液分析和尿液分析均已完成。对年龄和性别进行了多变量逻辑回归分析:在 7274 名糖尿病患者中,有 6840 人获得了可分级图像,其中 3054 人(42.0%)被分级为 DR,1153 人(15.9%)被分级为 DME,1500 人(20.6%)被分级为 STDR。与 DR、DME 和 STDR 相关的因素包括年龄较小(几率比 [OR]:分别为 0.96、0.97 和 0.96)、体重指数较低(OR:分别为 0.97、0.95 和 0.95)、糖尿病病程较长(OR:分别为 1.07、1.03 和 1.05)以及尿白蛋白呈阳性(OR:分别为 2.22、2.56 和 2.88)。其他相关因素包括血尿素氮升高(OR 值分别为 1.22、1.28 和 1.27)、低密度脂蛋白胆固醇升高、血红蛋白降低(OR 值分别为 0.98、0.98 和 0.98)、胰岛素摄入量、糖尿病足病变和糖尿病周围神经病变。我们还发现了一些新的风险因素,包括高血清钾(OR 分别为 1.37、1.46 和 1.55)、高血清钠(OR 分别为 1.02、1.02 和 1.04)。较好的家庭收入是DR、DME和STDR的保护因素。每周饮酒一次也被认为是 DR 的保护因素:本研究揭示了高血清钠、高血清钾、低血红蛋白和家庭收入水平是 DR 的新型相关因素,这有助于 DR 的监测和管理。
{"title":"Risk factors for diabetic retinopathy, diabetic macular edema, and sight-threatening diabetic retinopathy","authors":"Guihua Zhang ,&nbsp;Weiqi Chen ,&nbsp;Haoyu Chen ,&nbsp;Jianwei Lin ,&nbsp;Ling-Ping Cen ,&nbsp;Peiwen Xie ,&nbsp;Yi Zheng ,&nbsp;Tsz Kin Ng ,&nbsp;Mårten Erik Brelén ,&nbsp;Mingzhi Zhang ,&nbsp;Chi Pui Pang","doi":"10.1016/j.apjo.2024.100067","DOIUrl":"10.1016/j.apjo.2024.100067","url":null,"abstract":"<div><h3>Objective</h3><p>To identify the risk factors for the development of diabetic retinopathy (DR), diabetic macular edema (DME), and sight-threatening DR (STDR) based on a city-wide diabetes screening program.</p></div><div><h3>Research design and methods</h3><p>Diabetic patients were prospectively recruited between June 2016 and December 2022. All patients underwent dilated fundus photography centered on the disc and macula or macular spectral domain optical coherence tomography (SD-OCT) scan. Complete medical history was documented. Systematic examination, blood analysis, and urinalysis were performed. Multivariate logistic regression analysis adjusting for age and sex was conducted.</p></div><div><h3>Results</h3><p>Out of 7274 diabetic patients, 6840 had gradable images, among which 3054 (42.0%) were graded as DR, 1153 (15.9%) as DME, and 1500 (20.6%) as STDR. The factors associated with DR, DME, and STDR included younger age (odds ratio [OR]: 0.96, 0.97, and 0.96 respectively), lower BMI (OR: 0.97, 0.95, and 0.95 respectively), longer duration of diabetes (OR: 1.07, 1.03, and 1.05 respectively) and positive of urinary albumin (OR: 2.22, 2.56, and 2.88 respectively). Other associated factors included elevated blood urea nitrogen (OR: 1.22, 1.28, and 1.27 respectively), higher LDL-cholesterol, lower blood hemoglobin (OR: 0.98, 0.98, and 0.98), insulin intake, presence of diabetic foot pathologies and diabetic peripheral neuropathy. We also identified novel risk factors, including high serum potassium (OR: 1.37, 1.46, and 1.55 respectively), high-serum sodium (OR: 1.02, 1.02, and 1.04 respectively). Better family income was a protective factor for DR, DME, and STDR. Alcohol consumption once a week was also identified as a protective factor for DR.</p></div><div><h3>Conclusions</h3><p>Similar risk factors for DR, DME, and STDR were found in this study. Our data also indicates high serum sodium, high serum potassium, low blood hemoglobin, and level of family income as novel associated factors for DR, DME, and STDR, which can help with DR monitoring and management.</p></div>","PeriodicalId":8594,"journal":{"name":"Asia-Pacific Journal of Ophthalmology","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2162098924000689/pdfft?md5=d2a990b0030a8bf37cf5bb7507b10252&pid=1-s2.0-S2162098924000689-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140943293","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Diabetic retinopathy 糖尿病视网膜病变。
IF 4.4 3区 医学 Q1 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.apjo.2024.100077
Jost B. Jonas
{"title":"Diabetic retinopathy","authors":"Jost B. Jonas","doi":"10.1016/j.apjo.2024.100077","DOIUrl":"10.1016/j.apjo.2024.100077","url":null,"abstract":"","PeriodicalId":8594,"journal":{"name":"Asia-Pacific Journal of Ophthalmology","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2162098924000781/pdfft?md5=94c51c48644902d0c7e86dd6417f05b7&pid=1-s2.0-S2162098924000781-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141154873","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Response: Comment on “Phacogoniotomy versus phacotrabeculectomy for advanced primary angle-closure glaucoma with cataract: A randomized non-inferiority trial” 回复:关于 "晚期原发性闭角型青光眼伴白内障的虹膜切开术与虹膜角膜切除术:随机非劣效性试验 "的评论
IF 4.4 3区 医学 Q1 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.apjo.2024.100076
Yunhe Song, Fei Li, Xiulan Zhang
{"title":"Response: Comment on “Phacogoniotomy versus phacotrabeculectomy for advanced primary angle-closure glaucoma with cataract: A randomized non-inferiority trial”","authors":"Yunhe Song,&nbsp;Fei Li,&nbsp;Xiulan Zhang","doi":"10.1016/j.apjo.2024.100076","DOIUrl":"10.1016/j.apjo.2024.100076","url":null,"abstract":"","PeriodicalId":8594,"journal":{"name":"Asia-Pacific Journal of Ophthalmology","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S216209892400077X/pdfft?md5=078a02af33f311a5bab22e695a3dd5a5&pid=1-s2.0-S216209892400077X-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141140741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Association of baseline factors with 1-year outcomes in the SB11-ranibizumab equivalence trial: A post hoc analysis SB11-拉尼珠单抗等效试验中基线因素与 1 年疗效的关系:事后分析
IF 4.4 3区 医学 Q1 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.apjo.2024.100069
Se Joon Woo , Jin Ah Jung , Taehyung Kim , Inkyung Oh , Mercy Yeeun Kim , Neil M. Bressler

Purpose

To identify baseline factors associated with 1-year outcomes when treating neovascular age-related macular degeneration (nAMD) with ranibizumab biosimilar SB11 or reference ranibizumab (rRBZ), and to compare efficacy of the two products within subgroups judged to be clinically relevant.

Design

Post hoc analysis of a prospective, equivalence phase 3 randomized clinical trial (RCT)

Methods

705 patients with nAMD were randomized 1:1 to receive SB11 or rRBZ for 48 weeks. Pooled and randomized groups were used to identify baseline factors associated with clinical outcomes at Week 52 using multiple linear regression models. Significant factors identified in regression analyses were confirmed in analyses of variance. Subgroup analyses comparing best-corrected visual acuity (BCVA) changes between SB11 and rRBZ were conducted.

Results

634 (89.9%) participants completed the 52-week visit. Regression analyses showed that younger age, lower BCVA, and smaller total lesion area at baseline were associated with greater BCVA gain at Week 52, while older age, lower BCVA, and thicker central subfield thickness (CST) at baseline were predictors of greater CST reduction in the pooled group. Subgroup analyses demonstrated that BCVA outcomes appeared comparable for the SB11 and rRBZ groups.

Conclusion

Post hoc analyses of the SB11-rRBZ equivalence study showed that baseline age, BCVA, CST, and total lesion area were prognostic factors for visual or anatomical outcomes of nAMD, while subgroup analyses demonstrated comparable results for SB11 and rRBZ. Collectively, the results appear comparable to similar RCTs of anti-vascular endothelial growth factor reference products for nAMD and strengthen confidence in the biosimilarity of SB11.

目的:确定使用雷尼珠单抗生物类似物SB11或参考雷尼珠单抗(rRBZ)治疗新生血管性老年黄斑变性(nAMD)时与1年疗效相关的基线因素,并比较两种产品在被判定为临床相关的亚组中的疗效:方法:705 例 nAMD 患者按 1:1 随机分配接受 SB11 或 rRBZ 治疗 48 周。使用多元线性回归模型对汇总组和随机组进行分析,以确定与第 52 周临床结果相关的基线因素。回归分析中确定的重要因素在方差分析中得到了证实。还进行了分组分析,比较 SB11 和 rRBZ 的最佳矫正视力 (BCVA) 变化:634名参与者(89.9%)完成了为期52周的访问。回归分析表明,年龄较小、BCVA 较低和基线总病变面积较小与第 52 周 BCVA 增幅较大相关,而年龄较大、BCVA 较低和基线中央子场厚度 (CST) 较厚则是汇总组 CST 降低幅度较大的预测因素。亚组分析表明,SB11组和rRBZ组的BCVA结果似乎相当:SB11-rRBZ等效研究的事后分析表明,基线年龄、BCVA、CST和总病变面积是nAMD视觉和解剖结果的预后因素,而亚组分析表明SB11和rRBZ的结果具有可比性。总之,这些结果与治疗 nAMD 的抗血管内皮生长因子参考产品的类似 RCT 结果相当,增强了人们对 SB11 生物相似性的信心。
{"title":"Association of baseline factors with 1-year outcomes in the SB11-ranibizumab equivalence trial: A post hoc analysis","authors":"Se Joon Woo ,&nbsp;Jin Ah Jung ,&nbsp;Taehyung Kim ,&nbsp;Inkyung Oh ,&nbsp;Mercy Yeeun Kim ,&nbsp;Neil M. Bressler","doi":"10.1016/j.apjo.2024.100069","DOIUrl":"10.1016/j.apjo.2024.100069","url":null,"abstract":"<div><h3>Purpose</h3><p>To identify baseline factors associated with 1-year outcomes when treating neovascular age-related macular degeneration (nAMD) with ranibizumab biosimilar SB11 or reference ranibizumab (rRBZ), and to compare efficacy of the two products within subgroups judged to be clinically relevant.</p></div><div><h3>Design</h3><p>Post hoc analysis of a prospective, equivalence phase 3 randomized clinical trial (RCT)</p></div><div><h3>Methods</h3><p>705 patients with nAMD were randomized 1:1 to receive SB11 or rRBZ for 48 weeks. Pooled and randomized groups were used to identify baseline factors associated with clinical outcomes at Week 52 using multiple linear regression models. Significant factors identified in regression analyses were confirmed in analyses of variance. Subgroup analyses comparing best-corrected visual acuity (BCVA) changes between SB11 and rRBZ were conducted.</p></div><div><h3>Results</h3><p>634 (89.9%) participants completed the 52-week visit. Regression analyses showed that younger age, lower BCVA, and smaller total lesion area at baseline were associated with greater BCVA gain at Week 52, while older age, lower BCVA, and thicker central subfield thickness (CST) at baseline were predictors of greater CST reduction in the pooled group. Subgroup analyses demonstrated that BCVA outcomes appeared comparable for the SB11 and rRBZ groups.</p></div><div><h3>Conclusion</h3><p>Post hoc analyses of the SB11-rRBZ equivalence study showed that baseline age, BCVA, CST, and total lesion area were prognostic factors for visual or anatomical outcomes of nAMD, while subgroup analyses demonstrated comparable results for SB11 and rRBZ. Collectively, the results appear comparable to similar RCTs of anti-vascular endothelial growth factor reference products for nAMD and strengthen confidence in the biosimilarity of SB11.</p></div>","PeriodicalId":8594,"journal":{"name":"Asia-Pacific Journal of Ophthalmology","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2162098924000707/pdfft?md5=c8cf11a3be79272bfc0b578ca7da56fc&pid=1-s2.0-S2162098924000707-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140954993","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Discrepancies in reported prevalence rates of keratoconus in Russia 俄罗斯角膜病患病率报告中的差异。
IF 4.4 3区 医学 Q1 Medicine Pub Date : 2024-05-01 DOI: 10.1016/j.apjo.2024.100065
Alejandro Tello
{"title":"Discrepancies in reported prevalence rates of keratoconus in Russia","authors":"Alejandro Tello","doi":"10.1016/j.apjo.2024.100065","DOIUrl":"10.1016/j.apjo.2024.100065","url":null,"abstract":"","PeriodicalId":8594,"journal":{"name":"Asia-Pacific Journal of Ophthalmology","volume":null,"pages":null},"PeriodicalIF":4.4,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2162098924000665/pdfft?md5=b309f01559a1a1f5aa1cd4f86b838763&pid=1-s2.0-S2162098924000665-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140907941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
期刊
Asia-Pacific Journal of Ophthalmology
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