自制活化凝血酶原复合物的主要药效成分分析  

Analysis of main pharmacodynamic components of self-made activated prothrombin complex concentrate

作　　者：黄雨薇 赵娅菲 叶刚 刘卿 晏晓晨 杜晞[1] 马莉[1] HUANG Yuwei;ZHAO Yafei;YE Gang;LIU Qing;YAN Xiaochen;DU Xi;MA Li(Chinese Academy of Medical Sciences,Peking Union Medical College,Institute of Blood Transfusion,Chengdu 610052,Sichuan Province,China;不详)

机构地区：[1]中国医学科学院北京协和医学院输血研究所,四川成都610052 [2]郑州莱士血液制品有限公司,河南郑州450001

出　　处：《中国生物制品学杂志》2025年第3期312-317,共6页Chinese Journal of Biologicals

基　　金：四川省科技计划项目(2021YFS0056).

摘　　要：目的分析本课题组自制活化凝血酶原复合物(activated prothrombin complex concentrate,aPCC)中药效成分组成,并探讨各药效成分与凝血因子Ⅷ(coagulation factorⅧ,FⅧ)旁路活性的相关性。方法以自制aPCC浓缩物为研究对象,采用凝固法检测样本中FⅧ旁路活性,凝固法和发色底物法检测样本中系列非活化凝血因子、活化凝血因子以及抗凝血因子活性,同时以市售凝血酶原复合物(PCC)作为对照,分析各药效成分与FⅧ旁路活性的相关性。结果自制aPCC浓缩物FⅧ旁路活性[(43.53±3.07)IU/mL]与PCC制品[(0.10±0.02)IU/mL]相比,差异有统计学意义(t=20.16,P<0.01)。与PCC制品相比,自制aPCC浓缩物中非活化凝血因子FⅦ、FⅨ活性差异显著(t分别为22.72、8.00,P均<0.05),FⅡ、FⅩ活性差异无统计学意义(t分别为1.67、-0.96,P均>0.05);活化凝血因子中活化凝血因子Ⅱ(activated coagulation factorⅡ,FⅡa)、FⅨa及FⅩa活性差异显著(t分别为15.92、32.93、34.64,P均<0.01),FⅦa活性差异无统计学意义(t=2.34,P>0.05);抗凝血因子中蛋白S(PS)活性差异显著(t=12.82,P<0.01),肝素含量、蛋白C(PC)活性差异无统计学意义(t分别为0.85、-0.34,P均>0.05)。自制aPCC浓缩物和PCC制品中FⅧ旁路活性与FⅦ、FⅨ、FⅡa、FⅨa、FⅩa及PS活性具有显著相关性(r分别为0.999、0.971、0.988、0.994、0.974、-0.984,P均<0.01),与FⅩa/FⅡ有相关性(r=0.827,P<0.05)。结论自制aPCC浓缩物具有较高的FⅧ旁路活性,可能与其中具有较高活性的FⅦ、FⅨ、FⅡa、FⅨa、FⅩa有关。Objective To analyze the composition of the pharmacodynamic components in the activated prothrombin complex concentrate(aPCC)developed by our research group,and to study the relationship between each pharmacodynamic component and the coagulation factorⅧ(FⅧ)bypassing activity.Methods The self-made aPCC concentrates were used as the research object,and the FⅧbypassing activity was firstly detected by the coagulation method,and then the activities of a series of non-activated coagulation factors,activated coagulation factors and anti-coagulation factors were detected by the coagulation method and chromogenic substrate method.The prothrombin complex concentrate(PCC)in the market was used as a control to analyze the correlation between each pharmacodynamic component and FⅧbypassing activity.Results The FⅧbypassing activity of self-made aPCC concentrates and control PCC products were(43.53±3.07)IU/mL and(0.10±0.02)IU/mL,respectively,with a significant difference(t=20.16,P<0.01).Compared with the control PCC products,in the non-activated coagulation factors of self-made aPCC concentrates,the activities of coagulation factorⅦ(FⅦ)and coagulation factorⅨ(FⅨ)were significantly different(t=22.72 and 8.00,respectively,each P<0.05),and the activities of coagulation factorⅡ(FⅡ)and coagulation factorⅩ(FⅩ)showed no significant difference(t=1.67 and-0.96,respectively,each P>0.05);in the activated coagulation factors of self-made aPCC concentrates,the activities of activated coagula-tion factorⅡ(FⅡa),activated coagulation factorⅨ(FⅨa),and activated coagulation factorⅩ(FⅩa)were significantly different(t=15.92,32.93 and 34.64,respectively,each P<0.01),and there was no significant difference in the activity of activated coagulation factorⅦ(FⅦa)(t=2.34,P>0.05);in the anti-coagulation factors of self-made aPCC concentrates,there was a significant difference in protein S(PS)activity(t=12.82,P<0.01),and there was no significant difference in heparin content or protein C(PC)activity(t=0.85 and-0.

关 键 词：活化凝血酶原复合物 凝血酶原复合物 FⅧ旁路活性 抑制物患者 

分 类 号：R973.1[医药卫生—药品]