Factors Associated with Worsening Proliferative Diabetic Retinopathy in Eyes Treated with Panretinal Photocoagulation or Ranibizumab.

Factors Associated with Worsening Proliferative Diabetic Retinopathy in Eyes Treated with Panretinal Photocoagulation or Ranibizumab.
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DOI:
10.1016/j.ophtha.2016.12.005
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发表时间:
2017-04
期刊:
影响因子:
13.7
通讯作者:
Diabetic Retinopathy Clinical Research Network
Diabetic Retinopathy Clinical Research Network
中科院分区:
医学1区
文献类型:
--
作者:
Bressler SB;Beaulieu WT;Glassman AR;Gross JG;Jampol LM;Melia M;Peters MA;Rauser ME;Diabetic Retinopathy Clinical Research Network

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比较接受全视网膜光凝(PRP)或雷尼比珠单抗治疗增殖性糖尿病视网膜病变(PDR)的患者的发病率,并确定表示PDR恶化的事件的预测因素。随机临床试验(55个美国站点)。394只研究眼,视力20/320或以上,无视网膜色素变性病史,随访2年。PRP或玻璃体内注射雷尼比珠单抗(0.5-mg/0.05毫升)。从随机化到复合型PDR恶化的时间--定义为首次发生玻璃体出血、视网膜脱离、眼前段新生血管或新生血管性青光眼。经过2年的治疗,糖尿病视网膜病变恶化的累积概率分别为42%和34%(危险比[HR]=1.33,99%可信区间=0.9~1.98;P=0.063)。糖尿病视网膜病变严重程度较差的基线水平(早期治疗糖尿病视网膜病变研究量表)与糖尿病视网膜病变恶化的风险增加无关(%[高度或更严重的PDR]对23%[中度或更好的PDR],HR=3.972.48to6.36;P<0.001)。在PRP组中,接受图案扫描的眼睛与传统的单点PRP相比,发生PDR恶化的风险也更高(60%比39%,HR=2.041.02至4.08P=0.008),无论完成初始PRP的斑点数量或坐次数。两组中视力受损(视力20/32或更差)中心性糖尿病黄斑水肿(CI-DME)的眼均需接受雷尼比单抗治疗CI-DME。因此,在基线时没有视力受损的CI-DME的眼睛亚组中,通过治疗来比较综合结果。对于这些眼,PRP组的增殖性视网膜病变恶化的比率比雷尼比珠单抗高(45%比31%,HR=1.62,1.01到2.6;P=0.008)。在患有PDR的眼睛中,与PRP相比,雷尼比珠单抗导致的PDR恶化较少,特别是在CI-DME不需要接受雷尼比单抗治疗的眼睛。尽管抗血管内皮生长因子治疗需要遵守比PRP更频繁的就诊计划,但这些发现提供了额外的证据,支持使用雷尼比单抗作为PDR的PRP替代疗法,至少通过2年的随访。雷尼比单抗治疗PDR恶化事件的发生率似乎比PRP低,特别是在中心受累的DME的基线不需要雷尼比单抗的眼睛中。高危PDR和使用图案扫描激光与较高的事件发生率相关。
Compare rates and identify predictive factors for events that represent worsening of proliferative diabetic retinopathy (PDR) in eyes treated with panretinal photocoagulation (PRP) or ranibizumab for PDR. Randomized clinical trial (55 United States sites). Three hundred ninety-four study eyes from 305 adults with PDR, visual acuity 20/320 or better, no history of PRP, followed for 2 years. PRP or intravitreous ranibizumab injections (0.5-mg/0.05mL). Time from randomization to a composite PDR-worsening outcome defined as the first occurrence of vitreous hemorrhage, retinal detachment, anterior segment neovascularization, or neovascular glaucoma. Through 2 years, the cumulative probability of PDR-worsening was 42% (PRP) versus 34% (ranibizumab) (hazard ratio [HR] = 1.33, 99% confidence interval = 0.90 to 1.98; P = 0.063). Worse baseline levels of diabetic retinopathy severity (Early Treatment Diabetic Retinopathy Study Scale) were associated with increased risk of PDR-worsening regardless of treatment group (64% [high-risk PDR or worse] vs. 23% [moderate PDR or better], HR = 3.97, 2.48 to 6.36; P < 0.001). In the PRP group, eyes receiving pattern scan versus conventional single-spot PRP were also at higher risk for PDR-worsening (60% vs. 39%, HR = 2.04, 1.02 to 4.08; P = 0.008), irrespective of the number of spots placed or number of sittings to complete the initial PRP. Eyes in both groups with vision-impairing (visual acuity 20/32 or worse) center-involved diabetic macular edema (CI-DME) at baseline were required to receive ranibizumab for CI-DME. Therefore the composite outcome was compared by treatment in the subgroup of eyes that did not have vision-impairing CI-DME at baseline. For these eyes, the rate of PDR-worsening was greater with PRP than ranibizumab (45% vs. 31%, HR = 1.62, 1.01 to 2.60; P = 0.008). In eyes with PDR, ranibizumab resulted in less PDR-worsening compared to PRP, especially in eyes not required to receive ranibizumab for CI-DME. Although anti-vascular endothelial growth factor therapy requires compliance to a more frequent visit schedule than PRP, these findings provide additional evidence supporting use of ranibizumab as an alternative therapy to PRP for PDR, at least through 2 years of follow-up. Rates of PDR-worsening events appeared lower with ranibizumab than PRP, particularly among eyes not requiring ranibizumab at baseline for center-involved DME. High-risk PDR and use of pattern scan laser were associated with higher event rates.
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发表时间: 2011-04
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