低分子肝素活性测定中生物统计的应用

Evaluation the potency of low-molecular-weight heparin by bio-statistical methods

目的:对低分子肝素(LMWH)生物活性(抗-FⅩa和抗-FⅡa)测定中几种生物统计方法进行探讨。方法:LMWH生物活性测定采用发色底物分光光度法,运用量反应平行线原理生物统计,比较几种实验设计、统计方法,检测实验可靠性、计算效价、精密度的差异。结果:发色底物分光光度法的量反应平行线法几种实验设计、统计方法结果相似,其差异无统计学意义(P>0.05)。结论:对LMWH的抗-FⅩa和抗-FⅡa效价测定采用发色底物分光光度法;以量反应平行线法进行分析中。在符合标准规定前提下,几种生物统计方法和实验设计都可应用。

Objective： Discussion of bio - statistical methods for anti - factor Xa or anti - factor IIa of low - molecu- lar - weight heparin （ LMWH ） evaluation. Method： Chromogenic assay was used for bio - activity of LMWH by quantity response parallel line analysis. Different bio - statistical methods and design were compared for experimen- tal reliability examination, potency and precise in analysis results. Results： The differences of several bio - statistical methods and design by parallel line analysis were small and not statistically significant （ P 〉 0.05 ）. Conclusion ： Several bio- statistical methods and design could be used in validation of the anti -factor Xa or anti -factor Ⅱa chromogenic assays for the potency assessment of LMWH by parallel line analysis, when the results conforms to the standard.