部分凝血激活酶时间试验及全血凝固时间试验方法用于评价心血管系统外部接入器械凝血性能的研究

A Comparative Study of PTT and CT Tests for Coagulation Evaluation of Cardio-vascular System External Communicating Devices

以GB/T16886.4-2003标准为基础,采用部分凝血激活酶时间(PTT)试验和全血凝固时间(CT)试验对5种以金属与高分子为主要材质的心血管系统外部接入器械的凝血性能进行了研究。结果提示PTT试验能够较好地反映材料对凝血系统的激活,可以应用于医疗器械凝血性能评价。在GB/T16886.4-2003标准中PTT试验被作为外部接入器械凝血性能评价的推荐方法之一。CT试验受凝血过程的各个相关因素影响较多,试验还受到动物个体差异的影响,在操作上不容易标准化。与PTT试验相比,按照GB/T14233.2-2005标准附录中试管法(Lee-White法)进行的CT试验数据变异度更大。因为其较多的影响因素,怎样确定合适的阴性对照来进行CT试验的器械材料凝血评价也需进行进一步的研究。

Based on GB/T16886.4-2003 Standard, the coagulation effects of 5 cardiovascular system external communicating devices made consist of metal and polymer were assessed using the partial thromboplastin time（PTT） and Lee-White coagulation time（CT） tests. The results indicate that PTT test is a stable and valuble method for evaluating the coagulating pathway disturbance of the devices. In line with GB/T 16886.4-2003 Standard, PTT test is a recommendable method for evaluating the external communicating devices Based on GB/T14233.2-2005 Standard, CT test is a method more liable to variation, compared with PTT test. This is due to the complex relativity in the test itself, due to all the factors of coagulating cascade, and due to the individual difference of animal. The question of how to select proper negative control for coagulation evaluation of the Cardiovascular System External Communicating Devices in clinical setting for CT test should be addressed and studied.