DataSheet1_Routine Clinical Practice Treatment Outcomes of Eplerenone in Acute and Chronic Central Serous Chorioretinopathy.docx

Purpose: To evaluate efficacy of eplerenone therapy vs. observation on resolution of subretinal fluid (SRF) in patients with acute and chronic central serous chorioretinopathy (CSCR) in routine clinical practice.
Methods: Retrospective comparative case series of eyes diagnosed with CSCR treated with eplerenone or observation. Primary outcome measure was maximum height of SRF at 12 months. Secondary outcome was percentage of eyes with complete resolution of SRF, percentage of eyes with reduction of SRF ≥50%, and best corrected visual acuity (VA) at 12 months. Separate analysis was conducted for eyes with acute and chronic CSCR.
Results: Sixty-eight eyes of 60 patients (82% male) were included. Eleven of the 38 eyes with acute CSCR, and seven of the 30 eyes with chronic CSCR, received eplerenone. Subretinal fluid decreased from baseline to 12 months in acute (287 ± 221 to 31 ± 63 µm) and chronic (148 ± 134 to 40 ± 42 µm) CSCR. Kaplan-Meier curves were similar for treated and observed eyes and COX regression analysis did not show a significant difference in SRF resolution in treated vs. observed eyes (p = 0.6 for acute, p = 0.2 for chronic CSCR).
Conclusion: This routine clinical practice outcome study did not show evidence of efficacy of eplerenone on resolution of SRF in acute nor chronic CSCR.

研究目的：旨在于常规临床实践场景中，评估依普利酮（eplerenone）疗法相较于观察组，对急性及慢性中心性浆液性脉络膜视网膜病变（CSCR）患者视网膜下液（SRF）吸收效果的疗效。
研究方法：本研究为回顾性对照病例系列研究，纳入经依普利酮治疗或仅接受常规观察随访的确诊中心性浆液性脉络膜视网膜病变患眼。主要结局指标为随访12个月时视网膜下液最大高度；次要结局指标包括12个月时视网膜下液完全吸收的患眼占比、视网膜下液减少幅度≥50%的患眼占比，以及最佳矫正视力（VA）。本研究针对急性及慢性中心性浆液性脉络膜视网膜病变患眼分别开展独立分析。
研究结果：本研究共纳入60例患者的68只患眼（男性占比82%）。其中38只急性中心性浆液性脉络膜视网膜病变患眼中，11只接受依普利酮治疗；30只慢性中心性浆液性脉络膜视网膜病变患眼中，7只接受依普利酮治疗。急性组与慢性组患眼的视网膜下液均从基线至随访12个月时出现下降：急性组从287±221 μm降至31±63 μm，慢性组从148±134 μm降至40±42 μm。治疗组与观察组的卡普兰-迈耶曲线（Kaplan-Meier）趋势相近，COX回归分析显示，治疗组与观察组患眼的视网膜下液吸收无显著统计学差异（急性CSCR组p=0.6，慢性CSCR组p=0.2）。
研究结论：本项常规临床实践结局研究未发现依普利酮可促进急性或慢性中心性浆液性脉络膜视网膜病变患者视网膜下液吸收的疗效证据。