Klingel Reinhard, Fassbender Cordula, Fassbender Thurid, Göhlen Britta
Apheresis Research Institute, Stadwaldguertel 77, 50935 Cologne, Germany.
Transfus Apher Sci. 2003 Aug;29(1):71-84. doi: 10.1016/S1473-0502(03)00101-0.
In the majority of age-related macular degeneration (AMD) patients the therapeutic situation is very unsatisfactory, especially for patients with dry AMD. Rheopheresis is a safe and effective modality of therapeutic apheresis to treat microcirculatory disorders, and represents a novel therapeutic approach for patients with dry AMD and soft drusen. Elimination of a defined spectrum of high molecular weight proteins from human plasma including pathophysiologically relevant risk factors for AMD such as fibrinogen, LDL-cholesterol, alpha 2-macroglobulin, fibronectin, and von-Willebrand factor results in the reduction of blood and plasma viscosity as well as erythrocyte and thrombocyte aggregation. Pulses of lowering blood and plasma viscosity performed as series of Rheopheresis treatments lead to rapid changes of blood flow, subsequently inducing sustained improvement of microcirculation, and recovery of retinal function. Two controlled randomized clinical trials demonstrated safety and efficacy of Rheopheresis for the treatment of AMD patients, especially with the dry form. Recently the interim-analysis of the sham-controlled, double blinded, randomized multicenter MIRA-I trial confirmed these results. The RheoNet-registry and the development and continuous update of therapy guidelines provide an appropriate framework for the quality management of the interdisciplinary cooperation between ophthalmologists with apheresis specialists. A hypothesis based upon current knowledge of pathogenic mechanisms of the development and progression of AMD can be conclusively linked with the putative mechanism of action of Rheopheresis for AMD. A recommendation for high-risk AMD-patients was defined. Based on the positive results of the MIRA-1 interim analysis eight Rheopheresis treatments are currently recommended as the initial treatment series.
在大多数年龄相关性黄斑变性（AMD）患者中，治疗情况非常不理想，尤其是对于干性AMD患者。血液成分单采术是一种治疗性血液成分单采的安全有效方式，用于治疗微循环障碍，是干性AMD和软性玻璃膜疣患者的一种新型治疗方法。从人血浆中清除特定范围的高分子量蛋白质，包括与AMD病理生理相关的危险因素，如纤维蛋白原、低密度脂蛋白胆固醇、α2巨球蛋白、纤连蛋白和血管性血友病因子，可降低血液和血浆粘度以及红细胞和血小板聚集。作为一系列血液成分单采术治疗进行的降低血液和血浆粘度的脉冲可导致血流迅速变化，随后诱导微循环持续改善和视网膜功能恢复。两项对照随机临床试验证明了血液成分单采术治疗AMD患者，尤其是干性AMD患者的安全性和有效性。最近，假手术对照、双盲、随机多中心MIRA-I试验的中期分析证实了这些结果。RheoNet注册库以及治疗指南的制定和持续更新为眼科医生与血液成分单采专家之间的跨学科合作质量管理提供了适当框架。基于目前对AMD发生和发展的致病机制的了解所提出的假设可以与血液成分单采术对AMD的假定作用机制明确联系起来。为高危AMD患者制定了一项建议。基于MIRA-1中期分析的阳性结果，目前建议将八次血液成分单采术治疗作为初始治疗系列。
