Abdulla Shaheen, Divy Mehra, Seyyedehfatemeh Ghalibafan, Shivam Patel, Fatima Buali, Sugi Panneerselvam, Nathalie Perez, Sandra Hoyek, Harry W Flynn, Nimesh Patel, Nicolas A Yannuzzi
{"title":"抗血管内皮生长因子注射和手术治疗 AMD 相关黄斑下出血的有效性和安全性：系统回顾与元分析》。","authors":"Abdulla Shaheen, Divy Mehra, Seyyedehfatemeh Ghalibafan, Shivam Patel, Fatima Buali, Sugi Panneerselvam, Nathalie Perez, Sandra Hoyek, Harry W Flynn, Nimesh Patel, Nicolas A Yannuzzi","doi":"10.1016/j.oret.2024.07.024","DOIUrl":null,"url":null,"abstract":"<p><strong>Topic: </strong>This systematic review and meta-analysis investigates the efficacy and safety of anti-VEGF injections compared with surgical intervention in improving visual acuity (VA) and reducing complications for patients with submacular hemorrhage (SMH) due to neovascular age-related macular degeneration (AMD).</p><p><strong>Clinical relevance: </strong>Determining the optimal intervention for SMH in AMD is crucial for patient care.</p><p><strong>Methods: </strong>We included studies on anti-VEGF injections or surgical interventions for SMH in AMD from 7 databases, searched up to May 2024. Data extraction and quality assessment were done by 2 independent reviewers. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Meta-analysis employed random-effects models. Primary outcomes were pooled mean logarithm of the minimum angle of resolution VA difference (initial examination minus last follow-up VA) and adverse events rates.</p><p><strong>Results: </strong>A total of 43 observational studies were included: 21 (960 eyes) on anti-VEGF and 22 (455 eyes) on surgery. Comparisons were made across separate studies due to lack of head-to-head studies. Meta-analysis included 11 anti-VEGF studies (444 eyes) and 12 surgical studies (195 eyes) for VA outcomes. The mean difference in VA was -0.16 (95% confidence interval (CI), -0.24 to -0.08) for anti-VEGF and -0.36 (95% CI, -0.68 to -0.04) for surgery, with no significant difference between groups (chi-square = 1.70, df = 1, P = 0.19). Heterogeneity was high in surgical studies (I<sup>2</sup> = 96.2%, τ<sup>2</sup> = 0.23, P < 0.01) and negligible in anti-VEGF studies (I<sup>2</sup> = 7%, τ<sup>2</sup> = 0.003, P = 0.38). The GRADE certainty was moderate for anti-VEGF and low for surgery. Anti-VEGF had lower rates of cataract (0% vs. 4.6%), proliferative vitreoretinopathy (0.1% vs. 2.0%), and retinal detachment (0.1% vs. 10.6%), but similar rates of recurrent hemorrhage (5.4% vs. 5.3%). Complications were summarized descriptively due to zero-cell problem.</p><p><strong>Conclusion: </strong>Both anti-VEGF and surgery treat SMH in AMD with similar VA outcomes but different safety profiles. Anti-VEGF is preferred for less severe hemorrhage, whereas surgery is suited for extensive hemorrhage. Despite uncertain comparative VA outcomes, treatment should be guided by clinical judgment and patient factors.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>","PeriodicalId":19501,"journal":{"name":"Ophthalmology. 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Data extraction and quality assessment were done by 2 independent reviewers. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Meta-analysis employed random-effects models. Primary outcomes were pooled mean logarithm of the minimum angle of resolution VA difference (initial examination minus last follow-up VA) and adverse events rates.</p><p><strong>Results: </strong>A total of 43 observational studies were included: 21 (960 eyes) on anti-VEGF and 22 (455 eyes) on surgery. Comparisons were made across separate studies due to lack of head-to-head studies. Meta-analysis included 11 anti-VEGF studies (444 eyes) and 12 surgical studies (195 eyes) for VA outcomes. The mean difference in VA was -0.16 (95% confidence interval (CI), -0.24 to -0.08) for anti-VEGF and -0.36 (95% CI, -0.68 to -0.04) for surgery, with no significant difference between groups (chi-square = 1.70, df = 1, P = 0.19). Heterogeneity was high in surgical studies (I<sup>2</sup> = 96.2%, τ<sup>2</sup> = 0.23, P < 0.01) and negligible in anti-VEGF studies (I<sup>2</sup> = 7%, τ<sup>2</sup> = 0.003, P = 0.38). The GRADE certainty was moderate for anti-VEGF and low for surgery. Anti-VEGF had lower rates of cataract (0% vs. 4.6%), proliferative vitreoretinopathy (0.1% vs. 2.0%), and retinal detachment (0.1% vs. 10.6%), but similar rates of recurrent hemorrhage (5.4% vs. 5.3%). Complications were summarized descriptively due to zero-cell problem.</p><p><strong>Conclusion: </strong>Both anti-VEGF and surgery treat SMH in AMD with similar VA outcomes but different safety profiles. Anti-VEGF is preferred for less severe hemorrhage, whereas surgery is suited for extensive hemorrhage. Despite uncertain comparative VA outcomes, treatment should be guided by clinical judgment and patient factors.</p><p><strong>Financial disclosure(s): </strong>Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.</p>\",\"PeriodicalId\":19501,\"journal\":{\"name\":\"Ophthalmology. Retina\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":4.4000,\"publicationDate\":\"2024-08-03\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Ophthalmology. 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引用次数: 0
摘要
主题本系统综述和荟萃分析研究了抗血管内皮生长因子（anti-VEGF）注射与手术干预相比，在改善新生血管性老年黄斑变性（AMD）引起的黄斑下出血（SMH）患者视力（VA）和减少并发症方面的有效性和安全性：临床相关性：确定治疗老年性黄斑变性黄斑下出血的最佳干预方法对患者护理至关重要：我们从 7 个数据库中纳入了有关抗血管内皮生长因子注射或手术干预 AMD SMH 的研究，检索时间截至 2024 年 5 月。数据提取和质量评估由两名独立审稿人完成。对证据的确定性采用 GRADE 方法进行评估。元分析采用随机效应模型。主要结果为汇总的平均对数MAR VA差值（初始检查减去最后一次随访VA）和不良事件发生率：共纳入 43 项观察性研究：结果：共纳入 43 项观察性研究：21 项研究（960 只眼）涉及抗 VEGF，22 项研究（455 只眼）涉及手术。由于缺乏 "头对头 "研究，因此对不同研究进行了比较。Meta 分析纳入了 11 项抗血管内皮生长因子研究（444 只眼）和 12 项手术研究（195 只眼）的 VA 结果。抗血管内皮生长因子的 VA 平均差异（MD）为-0.16（95%CI：-0.26,-0.07），手术为-0.36（95%CI：-0.68,-0.04），组间差异不显著（X2=1.70，df=1，p=0.19）。手术研究的异质性较高（I2=96.2%，tau2=0.23，p2=7%，tau2=0.003，p=0.38）。抗血管内皮生长因子的 GRADE 确定性为中度，手术的 GRADE 确定性为低度。抗 VEGF 的白内障（0% vs 4.6%）、增殖性玻璃体视网膜病变（PVR，0.1% vs 2.0%）和视网膜脱离（RD，0.1% vs 10.6%）发生率较低，但复发性出血发生率相似（5.4% vs 5.3%）。结论：抗血管内皮生长因子和手术都能治疗视网膜病变：抗血管内皮生长因子和手术治疗 AMD SMH 的 VA 结果相似，但安全性不同。抗血管内皮生长因子疗法适用于不太严重的出血，而手术则适用于大面积出血。尽管视网膜损伤的比较结果不确定，但治疗应根据临床判断和患者因素而定。
Efficacy and Safety of Anti-VEGF Injections and Surgery for Age-Related Macular Degeneration-Related Submacular Hemorrhage: A Systematic Review and Meta-Analysis.
Topic: This systematic review and meta-analysis investigates the efficacy and safety of anti-VEGF injections compared with surgical intervention in improving visual acuity (VA) and reducing complications for patients with submacular hemorrhage (SMH) due to neovascular age-related macular degeneration (AMD).
Clinical relevance: Determining the optimal intervention for SMH in AMD is crucial for patient care.
Methods: We included studies on anti-VEGF injections or surgical interventions for SMH in AMD from 7 databases, searched up to May 2024. Data extraction and quality assessment were done by 2 independent reviewers. Certainty of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. Meta-analysis employed random-effects models. Primary outcomes were pooled mean logarithm of the minimum angle of resolution VA difference (initial examination minus last follow-up VA) and adverse events rates.
Results: A total of 43 observational studies were included: 21 (960 eyes) on anti-VEGF and 22 (455 eyes) on surgery. Comparisons were made across separate studies due to lack of head-to-head studies. Meta-analysis included 11 anti-VEGF studies (444 eyes) and 12 surgical studies (195 eyes) for VA outcomes. The mean difference in VA was -0.16 (95% confidence interval (CI), -0.24 to -0.08) for anti-VEGF and -0.36 (95% CI, -0.68 to -0.04) for surgery, with no significant difference between groups (chi-square = 1.70, df = 1, P = 0.19). Heterogeneity was high in surgical studies (I2 = 96.2%, τ2 = 0.23, P < 0.01) and negligible in anti-VEGF studies (I2 = 7%, τ2 = 0.003, P = 0.38). The GRADE certainty was moderate for anti-VEGF and low for surgery. Anti-VEGF had lower rates of cataract (0% vs. 4.6%), proliferative vitreoretinopathy (0.1% vs. 2.0%), and retinal detachment (0.1% vs. 10.6%), but similar rates of recurrent hemorrhage (5.4% vs. 5.3%). Complications were summarized descriptively due to zero-cell problem.
Conclusion: Both anti-VEGF and surgery treat SMH in AMD with similar VA outcomes but different safety profiles. Anti-VEGF is preferred for less severe hemorrhage, whereas surgery is suited for extensive hemorrhage. Despite uncertain comparative VA outcomes, treatment should be guided by clinical judgment and patient factors.
Financial disclosure(s): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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