Hossam Eldin M. A. Khalil, Hazem E. Haroun, Alaa A. I. Shalan, Waleed M. Mahran
{"title":"玻璃体内注射雷尼单抗和亚丁诺曲安奈酮联合治疗难治性糖尿病黄斑水肿:埃及的一项临床研究","authors":"Hossam Eldin M. A. Khalil, Hazem E. Haroun, Alaa A. I. Shalan, Waleed M. Mahran","doi":"10.1186/s43088-025-00598-x","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Among those aged 20–74 in industrialized countries, diabetic retinopathy (DR) is the main cause of visual impairment. Diabetic macular edema (DME) is the leading cause of blindness in people with DR. DME that is resistant to therapy is now being treated with a number of different management strategies. This research was to examine the efficacy of sub-tenon steroid and anti- vascular endothelial growth factor (VEGF) injections as a combination therapy for the treatment of resistant DME, owing to the synergistic effect of this combination.</p><h3>Methods</h3><p>This is a two-arm, randomized, prospective clinical trial that included 100 eyes of patients with refractory DME divided into 2 equal groups: group 1 received posterior subtenon triamcinolone (STTA) and anti-VEGF injections (0.5 mg ranibizumab), and group 2 received anti-VEGF injections (0.5 mg ranibizumab) only, in the same session. The 2 groups were followed up for a period of 6 months.</p><h3>Results</h3><p>Group 1 showed significant improvements in best corrected visual acuity (BCVA) (from 0.20 ± 0.11 to 0.32 ± 0.12, <i>p</i> = 0.04) and central macular thickness (CMT) (from 393.2 ± 35.29 to 260.2 ± 11.43 µm, <i>p</i> = 0.001), with fewer injections required compared to Group 2. Recurrence rates were significantly higher in Group 2 (42% vs. 12%, <i>p</i> = 0.026). After injections, there was a noticeable rise in intraocular pressure (IOP) (16.02 ± 1.56 Vs 16.26 ± 1.24 in both groups respectively). However, this elevation is usually just transitory lasting for short periods of time and is within the safe, insignificant rise ranges.</p><h3>Conclusion</h3><p>The use of combined therapy with anti-VEGF treatment and STTA has been found to be an effective and safe approach to managing resistant DME. The lower number of injections needed help to reduce the economic burden, especially under constrained financial circumstances.</p></div>","PeriodicalId":481,"journal":{"name":"Beni-Suef University Journal of Basic and Applied Sciences","volume":"14 1","pages":""},"PeriodicalIF":2.5000,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://bjbas.springeropen.com/counter/pdf/10.1186/s43088-025-00598-x","citationCount":"0","resultStr":"{\"title\":\"Combination therapy of intravitreal ranibizumab and sub-tenon triamcinolone for treatment of resistant diabetic macular edema: a clinical study in Egypt\",\"authors\":\"Hossam Eldin M. A. Khalil, Hazem E. Haroun, Alaa A. I. Shalan, Waleed M. Mahran\",\"doi\":\"10.1186/s43088-025-00598-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>Among those aged 20–74 in industrialized countries, diabetic retinopathy (DR) is the main cause of visual impairment. Diabetic macular edema (DME) is the leading cause of blindness in people with DR. DME that is resistant to therapy is now being treated with a number of different management strategies. This research was to examine the efficacy of sub-tenon steroid and anti- vascular endothelial growth factor (VEGF) injections as a combination therapy for the treatment of resistant DME, owing to the synergistic effect of this combination.</p><h3>Methods</h3><p>This is a two-arm, randomized, prospective clinical trial that included 100 eyes of patients with refractory DME divided into 2 equal groups: group 1 received posterior subtenon triamcinolone (STTA) and anti-VEGF injections (0.5 mg ranibizumab), and group 2 received anti-VEGF injections (0.5 mg ranibizumab) only, in the same session. The 2 groups were followed up for a period of 6 months.</p><h3>Results</h3><p>Group 1 showed significant improvements in best corrected visual acuity (BCVA) (from 0.20 ± 0.11 to 0.32 ± 0.12, <i>p</i> = 0.04) and central macular thickness (CMT) (from 393.2 ± 35.29 to 260.2 ± 11.43 µm, <i>p</i> = 0.001), with fewer injections required compared to Group 2. Recurrence rates were significantly higher in Group 2 (42% vs. 12%, <i>p</i> = 0.026). After injections, there was a noticeable rise in intraocular pressure (IOP) (16.02 ± 1.56 Vs 16.26 ± 1.24 in both groups respectively). However, this elevation is usually just transitory lasting for short periods of time and is within the safe, insignificant rise ranges.</p><h3>Conclusion</h3><p>The use of combined therapy with anti-VEGF treatment and STTA has been found to be an effective and safe approach to managing resistant DME. 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引用次数: 0
摘要
在工业化国家20-74岁的人群中,糖尿病视网膜病变(DR)是造成视力损害的主要原因。糖尿病性黄斑水肿(DME)是dr患者致盲的主要原因,DME对治疗具有耐药性,目前正在采用多种不同的治疗策略进行治疗。本研究旨在探讨亚腱类固醇和抗血管内皮生长因子(VEGF)注射联合治疗耐药二甲醚的疗效,因为这种联合治疗具有协同作用。方法:这是一项双组、随机、前瞻性临床试验,纳入100只眼的难治性二甲醚患者,分为两组:1组接受后路曲安奈德(STTA)和抗vegf注射(0.5 mg雷尼单抗),2组在同一疗程中仅接受抗vegf注射(0.5 mg雷尼单抗)。两组患者均随访6个月。结果1组最佳矫正视力(BCVA)(从0.20±0.11提高到0.32±0.12,p = 0.04)和中央黄斑厚度(CMT)(从393.2±35.29提高到260.2±11.43µm, p = 0.001)显著改善,所需注射量较2组减少。2组复发率明显高于对照组(42% vs. 12%, p = 0.026)。注射后眼压(IOP)明显升高(两组分别为16.02±1.56 Vs 16.26±1.24)。然而,这种上升通常只是短暂的,持续很短的时间,并且在安全的、微不足道的上升范围内。结论抗vegf联合STTA治疗耐药DME是一种安全有效的治疗方法。减少注射次数有助于减轻经济负担,特别是在财政拮据的情况下。
Combination therapy of intravitreal ranibizumab and sub-tenon triamcinolone for treatment of resistant diabetic macular edema: a clinical study in Egypt
Background
Among those aged 20–74 in industrialized countries, diabetic retinopathy (DR) is the main cause of visual impairment. Diabetic macular edema (DME) is the leading cause of blindness in people with DR. DME that is resistant to therapy is now being treated with a number of different management strategies. This research was to examine the efficacy of sub-tenon steroid and anti- vascular endothelial growth factor (VEGF) injections as a combination therapy for the treatment of resistant DME, owing to the synergistic effect of this combination.
Methods
This is a two-arm, randomized, prospective clinical trial that included 100 eyes of patients with refractory DME divided into 2 equal groups: group 1 received posterior subtenon triamcinolone (STTA) and anti-VEGF injections (0.5 mg ranibizumab), and group 2 received anti-VEGF injections (0.5 mg ranibizumab) only, in the same session. The 2 groups were followed up for a period of 6 months.
Results
Group 1 showed significant improvements in best corrected visual acuity (BCVA) (from 0.20 ± 0.11 to 0.32 ± 0.12, p = 0.04) and central macular thickness (CMT) (from 393.2 ± 35.29 to 260.2 ± 11.43 µm, p = 0.001), with fewer injections required compared to Group 2. Recurrence rates were significantly higher in Group 2 (42% vs. 12%, p = 0.026). After injections, there was a noticeable rise in intraocular pressure (IOP) (16.02 ± 1.56 Vs 16.26 ± 1.24 in both groups respectively). However, this elevation is usually just transitory lasting for short periods of time and is within the safe, insignificant rise ranges.
Conclusion
The use of combined therapy with anti-VEGF treatment and STTA has been found to be an effective and safe approach to managing resistant DME. The lower number of injections needed help to reduce the economic burden, especially under constrained financial circumstances.
期刊介绍:
Beni-Suef University Journal of Basic and Applied Sciences (BJBAS) is a peer-reviewed, open-access journal. This journal welcomes submissions of original research, literature reviews, and editorials in its respected fields of fundamental science, applied science (with a particular focus on the fields of applied nanotechnology and biotechnology), medical sciences, pharmaceutical sciences, and engineering. The multidisciplinary aspects of the journal encourage global collaboration between researchers in multiple fields and provide cross-disciplinary dissemination of findings.