Seiple William, Jennings Danna, Rosen Richard B, Borchert Leona, Canale Lee, Fagan Nora, Gordon Mark Forrest
Lighthouse Guild, Arlene R. Gordon Research Institute, New York, NY, USA; Department of Ophthalmology, NYU School of Medicine, New York, NY, USA; Institute of Vision, Aging in Vision and Action Lab, CNRS-INSERM, University Pierre & Marie Curie, Paris, France; Jesse Brown VA Medical Center, Chicago, IL, USA.
Institute for Neurodegenerative Disorders, Suite 8B, 60 Temple Street, New Haven, CT 06510, USA.
Parkinsons Dis. 2016;2016:8298503. doi: 10.1155/2016/8298503. Epub 2016 Dec 18.
Parkinson's disease (PD) progressively affects dopaminergic neurotransmission and may affect retinal dopaminergic functions and structures. This 2-year randomized, open-label, parallel-group, flexible-dose study, NCT00144300, evaluated ophthalmologic safety profiles of immediate-release (IR) pramipexole and ropinirole in patients with early idiopathic PD with ≤6 months' prior dopamine agonist exposure and without preexisting major eye disorders. Patients received labeled IR regimens of pramipexole ( = 121) or ropinirole ( = 125) for 2 years. Comprehensive ophthalmologic assessments (COA) included corrected acuity, Roth 28-color test, slit-lamp biomicroscopy, intraocular pressure, computerized visual field test, fundus photography, and electroretinography. At baseline, we observed retinal pigmentary epithelium (RPE) hypopigmentation not previously reported in PD patients. The estimated relative risk of 2-year COA worsening with pramipexole versus ropinirole was 1.07 (95% CI: 0.71-1.60). Mean changes from baseline in Unified Parkinson's Disease Rating System parts II+III total scores (pramipexole: 1 year, -4.1 ± 8.9, and 2 years, -0.7 ± 10.1, and ropinirole: 1 year, -3.7 ± 8.2, and 2 years, -1.7 ± 10.5) and Hoehn-Yahr stage distribution showed therapeutic effects on PD symptoms. Safety profiles were consistent with labeling. The risk of retinal deterioration did not differ in early idiopathic PD patients receiving pramipexole versus ropinirole. RPE hypopigmentation at baseline was not previously reported in this population. This trial is registered with NCT00144300.
帕金森病（PD）会逐渐影响多巴胺能神经传递，可能影响视网膜多巴胺能功能和结构。这项为期2年的随机、开放标签、平行组、灵活剂量研究（NCT00144300）评估了速释（IR）普拉克索和罗匹尼罗在既往多巴胺激动剂暴露≤6个月且无既往重大眼部疾病的早期特发性PD患者中的眼科安全性。患者接受普拉克索（ = 121）或罗匹尼罗（ = 125）的标记IR方案治疗2年。综合眼科评估（COA）包括矫正视力、Roth 28色试验、裂隙灯生物显微镜检查、眼压、计算机视野测试、眼底摄影和视网膜电图。在基线时，我们观察到PD患者中此前未报告过的视网膜色素上皮（RPE）色素减退。普拉克索与罗匹尼罗相比，2年COA恶化的估计相对风险为1.07（95%CI：0.71 - 1.60）。统一帕金森病评定量表第二部分+第三部分总分从基线的平均变化（普拉克索：1年，-4.1±8.9，2年，-0.7±10.1，罗匹尼罗：1年，-3.7±8.2，2年，-1.7±10.5）和Hoehn - Yahr分期分布显示对PD症状有治疗效果。安全性与标签一致。接受普拉克索与罗匹尼罗治疗的早期特发性PD患者视网膜恶化风险无差异。该人群基线时的RPE色素减退此前未被报告过。本试验已在NCT00144300注册。
