2种测定TNK-tPA生物学活性测定方法的比对分析

目的：应用2种溶栓活性检测方法检测重组人组织型纤溶酶原激活剂TNK突变体（recombinant TNK mutant of human tissue-type plasminogen activator，TNK-tPA）生物学活性并统计分析两者结果是否一致。方法：采用纤维蛋白平板溶圈法和气泡上升法测定TNK-tPA生物学活性，并对结果进行统计分析。结果：纤维蛋白平板溶圈法测定结果几何均数为2.89×10⁴ IU·支^-1，气泡上升法测定结果几何均数为2.95×10⁴ IU·支^-1。经t检验分析，2种方法检测结果无显著性差异（P>0.05）。经置换检验（permutation test）分析，2种方法检测结果数据相当（接受度概率约为90%）。结论：2种方法均可用于实验室的常规检验，但建议对于TNK-tPA的生物学活性检测使用气泡上升法。

Objective: Two thrombolytic activity methods of recombinant human tissue type plasminogen activator mutant(TNK-tPA) were carried out and the results were analyzed to deduce if the results were similar. Methods: The biological activity of TNK-tPA was determined by dissolution-ring method and bubble-rising method,and the results were analyzed statistically. Results: The geometric mean of dissolution-ring method was 2.89×10⁴ IUper vial and the geometric mean of bubble-rising method was 2.95×10⁴ IUper vial. T test analysis showed that there was no significant difference between the two methods(P >0.05). According to permutation test,the data of the two methods were similar to each other(acceptance probability was about 90%). Conclusion: The both two methods can be used for routine laboratory tests.But the bubble-rising method was used for detecting the biological activity of TNK-tPA.