Kretschmer V, Söhngen D, Göddecke W, Kadar J G, Pelzer H, Prinz H, Eckle R
Department of Transfusion Medicine and Coagulation Physiology, University Clinics, Marburg.
Infusionstherapie. 1989 Aug;16 Suppl 2:10-20; discussion 28-9. doi: 10.1159/000222419.
Cytaphereses are safe and can be used routinely like whole blood donations on the premise that standard techniques based on appropriate guidelines and regulations are performed. Before the introduction of a new cell or plasma separator, a thorough clinical investigation is always recommended in order to demonstrate biocompatibility and safety features. In this context cell loss and damage as well as activation of coagulation and complement should be tested primarily. The examination should consist of a direct comparison with an approved system. In addition, it is necessary to repeat periodically on multicenter studies adverse donor reactions such as those already described so that it is possible to recognize even rare side effects. Of special importance are long-term studies of donors undergoing frequent cytaphereses for many years in order to detect relevant immunological changes. On the other hand, harm caused by the plasticizer or cancer due to cancerogenicity of the plastics are only speculative at the moment.
血细胞分离术是安全的，并且在按照基于适当指南和法规的标准技术进行操作的前提下，可以像全血捐献一样常规使用。在引入新的细胞或血浆分离器之前，始终建议进行全面的临床研究，以证明其生物相容性和安全特性。在这种情况下，应主要测试细胞损失和损伤以及凝血和补体的激活情况。检查应包括与已批准系统的直接比较。此外，有必要定期重复进行多中心研究，观察如已描述的那些不良供体反应，以便能够识别即使是罕见的副作用。特别重要的是对多年来频繁接受血细胞分离术的供体进行长期研究，以检测相关的免疫变化。另一方面，目前关于增塑剂造成的危害或塑料致癌性导致的癌症只是推测。
