糖尿病视网膜病变严重程度评分变化的临床意义。
The Clinical Importance of Changes in Diabetic Retinopathy Severity Score.
机构信息
Doheny Eye Institute, David Geffen School of Medicine, University of California-Los Angeles, Los Angeles, California.
Genentech, Inc., South San Francisco, California.
出版信息
Ophthalmology. 2017 May;124(5):596-603. doi: 10.1016/j.ophtha.2017.01.003. Epub 2017 Mar 8.
PURPOSE
To investigate the clinical importance of changes in diabetic retinopathy severity score (DRSS) in patients with diabetic macular edema (DME) treated with intravitreal ranibizumab.
DESIGN
Post hoc analysis of the phase III RIDE and RISE studies of ranibizumab for treatment of DME.
PARTICIPANTS
Four hundred sixty-eight eyes treated with ranibizumab from randomization with gradable DRSS on baseline fundus photographs.
METHODS
Visual and anatomic outcomes were examined in eyes grouped according to DRSS change from baseline to month 24.
MAIN OUTCOME MEASURES
Mean best-corrected visual acuity (BCVA) letter score change, proportion of patients with 15 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letter score change, mean contrast sensitivity change, proportion of patients with resolved macular edema, and leakage on fluorescein angiography.
RESULTS
Most (56.8%) patients treated with ranibizumab experienced 1-step or more improvement in DRSS from baseline to month 24; 40.0% had no change, and 3.2% experienced DRSS worsening. Patients with DRSS stability or improvement had greater mean BCVA letter score changes (+15.1, +14.2, +11.3, and +11.2 letters for ≥3-step improvement, ≥2-step improvement, 1-step improvement, and no DRSS change, respectively) compared with +5.0 letters in patients who had any DRSS worsening. Best-corrected visual acuity letter score gain of 15 letters or more was more common in patients with 2-step or 3-step or more DRSS improvement (51.9% and 44.6%, respectively) compared with those with a 1-step DRSS improvement, no change, or worsening (37.9%, 39.6%, and 26.7%, respectively). A loss of 15 letters or more in BCVA was more common in patients with any DRSS worsening (13.3%) compared with patients who had stable or improved DRSS (0%-2.8%). Resolution of macular edema was more common in patients with DRSS improvement: 84.2%, 87.7%, and 92.3% of patients with 1-step, 2-step or more, and 3-step or more improvement in DRSS achieved central foveal thickness of 250 μm or less, compared with 65.2% and 53.3% of patients who had no DRSS change or any DRSS worsening.
CONCLUSIONS
These findings provide further support that improvement in DRSS is a clinically important outcome that should be evaluated as a measure of treatment effectiveness in future studies of diabetic eye disease.
目的
研究玻璃体内注射雷珠单抗治疗糖尿病性黄斑水肿（DME）患者时糖尿病视网膜病变严重程度评分（DRSS）变化的临床意义。
设计
雷珠单抗治疗 DME 的 III 期 RIDE 和 RISE 研究的事后分析。
参与者
468 只接受雷珠单抗治疗的眼睛，从随机分组到基线眼底照片上可分级的 DRSS。
方法
根据从基线到 24 个月时 DRSS 的变化，对接受雷珠单抗治疗的眼睛进行分组，观察视力和解剖学结果。
主要观察指标
最佳矫正视力（BCVA）字母评分变化的平均值、15 个或更多早期治疗糖尿病性视网膜病变研究（ETDRS）字母评分变化的患者比例、平均对比敏感度变化、黄斑水肿消退的患者比例以及荧光素血管造影上的渗漏。
结果
大多数（56.8%）接受雷珠单抗治疗的患者在从基线到 24 个月时 DRSS 有 1 步或更多的改善；40.0%无变化，3.2%DRSS 恶化。与任何 DRSS 恶化的患者相比，DRSS 稳定或改善的患者的平均 BCVA 字母评分变化更大（分别为≥3 步改善、≥2 步改善、1 步改善和无 DRSS 变化的患者为+15.1、+14.2、+11.3 和+11.2 个字母）。与 1 步 DRSS 改善、无变化或恶化的患者相比（分别为 37.9%、39.6%和 26.7%），2 步或更多步或 3 步或更多步 DRSS 改善的患者中，BCVA 字母评分提高 15 个或更多的更常见（分别为 51.9%和 44.6%）。与 DRSS 稳定或改善的患者相比（0%-2.8%），任何 DRSS 恶化的患者中（13.3%）BCVA 损失 15 个或更多的更为常见。与无 DRSS 变化或任何 DRSS 恶化的患者相比（分别为 65.2%和 53.3%），DRSS 改善的患者中，84.2%、87.7%和 92.3%的患者中央视网膜厚度达到 250μm 或以下，1 步、2 步或更多步和 3 步或更多步 DRSS 改善的患者中，65.2%和 53.3%的患者中央视网膜厚度达到 250μm 或以下。
结论
这些发现进一步支持了 DRSS 的改善是一个临床重要的结果，应该作为未来糖尿病眼病研究中治疗效果的衡量标准。
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