Pitt A M, O'Connor J L, Valeri C R, Castino F
Millipore Corporation, Bedford, MA 01730.
Life Support Syst. 1987 Oct-Dec;5(4):347-52.
Biocompatibility evaluations are a complex issue involving not only classical toxicity and animal testing but also the interactions of biological systems. The evaluations of the Therapore Primary System are reported for three model systems: (1) in vitro human blood, (2) a baboon (Papio anubis) animal model, and (3) normal human volunteer apheresis. Measurements of both complement (C3a) and platelet (BTG and TXB2) activation products during the apheresis procedures are given as a sensitive indicator of biocompatibility. No statistically significant elevations of these activation products were observed. Thus, the Therapore System was found to have negligible perturbations of the interacting biological systems evaluated even with the highly sensitive RIA procedures employed. These observations and methods establish a solid foundation for comprehensive biocompatibility evaluations of future extracorporeal devices.
生物相容性评估是一个复杂的问题，不仅涉及传统的毒性和动物试验，还涉及生物系统的相互作用。本文报道了Therapore初级系统在三种模型系统中的评估情况：（1）体外人体血液；（2）狒狒（埃及狒狒）动物模型；（3）正常人类志愿者单采。单采过程中补体（C3a）和血小板（BTG和TXB2）激活产物的测量结果作为生物相容性的敏感指标给出。未观察到这些激活产物有统计学意义的升高。因此，即使采用了高度敏感的放射免疫分析程序，Therapore系统对所评估的相互作用生物系统的干扰也可忽略不计。这些观察结果和方法为未来体外装置的综合生物相容性评估奠定了坚实的基础。
