Herold Tina Rike, Rist Kristina, Priglinger Siegfried Georg, Ulbig Michael Werner, Wolf Armin
University Eye Hospital - LMU, 80539, Munich, Germany.
Department of Ophthalmology, Ludwig-Maximilians Universität, 80539, Munich, Germany.
Graefes Arch Clin Exp Ophthalmol. 2017 Feb;255(2):221-229. doi: 10.1007/s00417-016-3436-5. Epub 2016 Jul 31.
To evaluate the long-term results of spironolactone in non-resolving central serous chorio-retinopathy (CSCR) and recurrence rates of CSCR.
Interventional uncontrolled open-label prospective clinical trial of patients with non-resolving CSCR who were treated with spironolactone 50 mg daily (Spironolacton AL® 50 mg, ALIUD PHARMA) for up to 16 weeks. Follow-up visits were performed at 3, 6, 9, and 12 months. Retreatment criteria for recurrence were: gain in sub-retinal fluid (SRF) of more than 25 % plus/or increase of central retinal thickness (CRT) of more than 50 μm plus visual symptoms compared to last visit.
12-month efficacy of upload treatment with spironolactone. Secondary outcome measure was the recurrence rate at 6, 9, and 12 months.
Of the 21 study eyes treated, 71 % (n = 15) showed significant improvement or complete regression on OCT examination over 12 months. Nineteen percent of the patients (n = 4) showed a stable course from visit 1 to visit 12. The overall reduction of sub-retinal fluid from visit 1 (156 μm ± 131 SD) to visit 12 (53 μm ± 93 SD) was statistically significant (p = 0.003). The change of mean visual acuity (log MAR) from 0.25 (± 0.17 SD) at baseline to 0.17 (± 0.18 SD) at visit 12 was statistically significant, with p = 0.044.
Our results confirm a positive effect of spironolactone in non-resolving CSCR in 71 % of cases. Evaluation of recurrence rates and retreatments showed good results in patients who responded to spironolactone primarily. A prospective randomized trial may provide better data about this non-invasive treatment.
评估螺内酯治疗不消退型中心性浆液性脉络膜视网膜病变(CSCR)的长期效果及CSCR的复发率。
对不消退型CSCR患者进行干预性非对照开放标签前瞻性临床试验,患者每日服用50毫克螺内酯(Spironolacton AL® 50毫克,ALIUD PHARMA),最长治疗16周。在3、6、9和12个月时进行随访。复发的再治疗标准为:与上次就诊相比,视网膜下液(SRF)增加超过25%加/或中心视网膜厚度(CRT)增加超过50μm加视觉症状。
螺内酯上载治疗12个月的疗效。次要观察指标是6、9和12个月时的复发率。
在接受治疗的21只研究眼中,71%(n = 15)在12个月的光学相干断层扫描(OCT)检查中显示出显著改善或完全消退。19%的患者(n = 4)从第1次就诊到第12次就诊病情稳定。视网膜下液从第1次就诊时的156μm±131标准差总体减少到第12次就诊时的53μm±93标准差,差异有统计学意义(p = 0.003)。平均视力(log MAR)从基线时的0.25(±0.17标准差)变化到第12次就诊时的0.17(±0.18标准差),差异有统计学意义,p = 0.044。
我们的结果证实,71%的病例中螺内酯对不消退型CSCR有积极作用。复发率和再治疗评估显示,对螺内酯主要有反应的患者效果良好。一项前瞻性随机试验可能会提供有关这种非侵入性治疗的更好数据。