玻璃體注射阿柏西普治療糖尿病視網膜病變玻璃體出血不優於玻璃體切除術
作者：
小柯機器人發布時間：2020/12/17 12:53:48
美國哈佛大學Jennifer K. Sun聯合夏洛特眼耳鼻喉協會Andrew N. Antoszyk團隊比較了玻璃體內注射阿柏西普與全視網膜光凝玻璃體切除術治療增殖性糖尿病視網膜病變玻璃體出血的療效。2020年12月15日，該研究發表在《美國醫學會雜誌》上。
增生性糖尿病視網膜病變引起的玻璃體出血可導致視力下降。最佳管理方法尚不清楚。為了比較玻璃體內注射阿柏西普與全視網膜光凝玻璃體切除術治療增殖性糖尿病視網膜病變玻璃體出血的療效，2016年11月至2017年12月，研究組在美國和加拿大的39個DRCR視網膜網絡機構進行了一項隨機臨床試驗，招募了205名因增生性糖尿病性視網膜病引起玻璃體出血而導致視力喪失的成年人。2020年1月完成最終隨訪。
將參與者隨機分組，其中100名接受玻璃體內注射阿柏西普治療，105名接受玻璃體切除術並進行視網膜光凝術。被分配給阿柏西普的參與者最初接受了4個月的注射。主要結果是治療24周的平均視力字母評分（範圍為0-100；評分越高表示視力越好），該研究能夠檢測出8個字母的差異。
205名參與者的平均年齡為57歲，男性佔56％，平均視力字母得分為34.5分，95％完成了24周的隨訪，90％完成了為期2年的隨訪。阿柏西普組患者24周時的平均視力字母得分為59.3分，而玻璃體切除術組中為63.0分，差異不顯著。在23項次要結局中，有15項沒有顯著差異。
在第4周時，阿柏西普組的平均視力字母得分為52.6分，顯著低於玻璃體切除術組（62.3分）；2年後兩組平均視力字母得分分別為73.7分和71.0分，差異不顯著。2年後，阿柏西普組中有33眼（33％）接受了玻璃體切除術，而玻璃體切除術組中有34眼（32％）接受了隨後的阿柏西普注射治療。
研究結果表明，對於因增生性糖尿病視網膜病變而導致眼玻璃體出血的患者，採用玻璃體腔內注射阿柏西普或玻璃體切除術聯合全視網膜光凝治療，24周時的平均視力字母評分在統計學上並無顯著差異。
附：英文原文
Title: Effect of Intravitreous Aflibercept vs Vitrectomy With Panretinal Photocoagulation on Visual Acuity in Patients With Vitreous Hemorrhage From Proliferative Diabetic Retinopathy: A Randomized Clinical Trial
Author: Andrew N. Antoszyk, Adam R. Glassman, Wesley T. Beaulieu, Lee M. Jampol, Chirag D. Jhaveri, Omar S. Punjabi, Hani Salehi-Had, John A. Wells, Maureen G. Maguire, Cynthia R. Stockdale, Daniel F. Martin, Jennifer K. Sun, DRCR Retina Network
Issue&Volume: 2020/12/15
Abstract:
Importance Vitreous hemorrhage from proliferative diabetic retinopathy can cause loss of vision. The best management approach is unknown.
Objective To compare initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation for vitreous hemorrhage from proliferative diabetic retinopathy.
Design, Setting, and Participants Randomized clinical trial at 39 DRCR Retina Network sites in the US and Canada including 205 adults with vison loss due to vitreous hemorrhage from proliferative diabetic retinopathy who were enrolled from November 2016 to December 2017. The final follow-up visit was completed in January 2020.
Interventions Random assignment of eyes (1 per participant) to aflibercept (100 participants) or vitrectomy with panretinal photocoagulation (105 participants). Participants whose eyes were assigned to aflibercept initially received 4 monthly injections. Both groups could receive aflibercept or vitrectomy during follow-up based on protocol criteria.
Main Outcomes and Measures The primary outcome was mean visual acuity letter score (range, 0-100; higher scores indicate better vision) over 24 weeks (area under the curve); the study was powered to detect a difference of 8 letters. Secondary outcomes included mean visual acuity at 4 weeks and 2 years.
Results Among 205 participants (205 eyes) who were randomized (mean [SD] age, 57 [11] years; 115 [56%] men; mean visual acuity letter score, 34.5 [Snellen equivalent, 20/200]), 95% (195 of 205) completed the 24-week visit and 90% (177 of 196, excluding 9 deaths) completed the 2-year visit. The mean visual acuity letter score over 24 weeks was 59.3 (Snellen equivalent, 20/63) (95% CI, 54.9 to 63.7) in the aflibercept group vs 63.0 (Snellen equivalent, 20/63) (95% CI, 58.6 to 67.3) in the vitrectomy group (adjusted difference, 5.0 [95% CI, 10.2 to 0.3], P=.06). Among 23 secondary outcomes, 15 showed no significant difference. The mean visual acuity letter score was 52.6 (Snellen equivalent, 20/100) in the aflibercept group vs 62.3 (Snellen equivalent, 20/63) in the vitrectomy group at 4 weeks (adjusted difference, 11.2 [95% CI, 18.5 to 3.9], P=.003) and 73.7 (Snellen equivalent, 20/40) vs 71.0 (Snellen equivalent, 20/40) at 2 years (adjusted difference, 2.7 [95% CI, 3.1 to 8.4], P=.36). Over 2 years, 33 eyes (33%) assigned to aflibercept received vitrectomy and 34 eyes (32%) assigned to vitrectomy received subsequent aflibercept.
Conclusions and Relevance Among participants whose eyes had vitreous hemorrhage from proliferative diabetic retinopathy, there was no statistically significant difference in the primary outcome of mean visual acuity letter score over 24 weeks following initial treatment with intravitreous aflibercept vs vitrectomy with panretinal photocoagulation. However, the study may have been underpowered, considering the range of the 95% CI, to detect a clinically important benefit in favor of initial vitrectomy with panretinal photocoagulation.
DOI: 10.1001/jama.2020.23027
Source: https://jamanetwork.com/journals/jama/article-abstract/2774049