Retina Service, Department of Ophthalmology, Mass. Eye and Ear Infirmary, Harvard Medical School, Boston, MA, USA.
EBioMedicine. 2016 Feb 4;5:198-203. doi: 10.1016/j.ebiom.2016.01.033. eCollection 2016 Mar.
Age-related macular degeneration (AMD) remains the leading cause of blindness in developed countries, and affects more than 150 million worldwide. Despite effective anti-angiogenic therapies for the less prevalent neovascular form of AMD, treatments are lacking for the more prevalent dry form. Similarities in risk factors and pathogenesis between AMD and atherosclerosis have led investigators to study the effects of statins on AMD incidence and progression with mixed results. A limitation of these studies has been the heterogeneity of AMD disease and the lack of standardization in statin dosage.
We were interested in studying the effects of high-dose statins, similar to those showing regression of atherosclerotic plaques, in AMD.
Pilot multicenter open-label prospective clinical study of 26 patients with diagnosis of AMD and the presence of many large, soft drusenoid deposits. Patients received 80 mg of atorvastatin daily and were monitored at baseline and every 3 months with complete ophthalmologic exam, best corrected visual acuity (VA), fundus photographs, optical coherence tomography (OCT), and blood work (AST, ALT, CPK, total cholesterol, TSH, creatinine, as well as a pregnancy test for premenopausal women).
Twenty-three subjects completed a minimum follow-up of 12 months. High-dose atorvastatin resulted in regression of drusen deposits associated with vision gain (+ 3.3 letters, p = 0.06) in 10 patients. No subjects progressed to advanced neovascular AMD.
High-dose statins may result in resolution of drusenoid pigment epithelial detachments (PEDs) and improvement in VA, without atrophy or neovascularization in a high-risk subgroup of AMD patients. Confirmation from larger studies is warranted.
年龄相关性黄斑变性（AMD）仍然是发达国家致盲的主要原因，全世界有超过 1.5 亿人受其影响。尽管对于较少见的新生血管形式的 AMD 有有效的抗血管生成治疗方法，但对于更常见的干性形式，治疗方法仍然缺乏。AMD 和动脉粥样硬化之间在危险因素和发病机制上的相似性促使研究人员研究他汀类药物对 AMD 发病率和进展的影响，但结果喜忧参半。这些研究的一个局限性是 AMD 疾病的异质性和他汀类药物剂量缺乏标准化。
我们有兴趣研究与动脉粥样硬化斑块消退相关的高剂量他汀类药物对 AMD 的影响。
一项针对 26 名诊断为 AMD 且有许多大的、软性玻璃膜疣沉积的患者的多中心开放性前瞻性临床研究。患者每天接受 80 毫克阿托伐他汀治疗，并在基线和每 3 个月进行全面眼科检查、最佳矫正视力（VA）、眼底照片、光学相干断层扫描（OCT）和血液检查（AST、ALT、CPK、总胆固醇、TSH、肌酐，以及绝经前女性的妊娠试验）。
23 名患者完成了至少 12 个月的随访。高剂量阿托伐他汀导致与视力提高相关的玻璃膜疣沉积消退（+3.3 个字母，p=0.06），10 名患者中有 10 名。没有患者进展为晚期新生血管性 AMD。
高剂量他汀类药物可能导致玻璃膜疣上皮细胞脱离（PED）的消退和 VA 的改善，而不会导致 AMD 高危亚组的萎缩或新生血管形成。需要更大规模的研究来证实。
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